Dynamic Characterization of a Low-Cost Fully and Continuously 3D Printed Capacitive Pressure-Sensing System for Plantar Pressure Measurements.

In orthopedics, the evaluation of footbed pressure distribution maps is a valuable gait analysis technique that aids physicians in diagnosing musculoskeletal and gait disorders. Recently, the use of pressure-sensing insoles to collect pressure distributions has become more popular due to the passive collection of natural gait data during daily activities and the reduction in physical strain experienced by patients. However, current pressure-sensing insoles face the limitations of low customizability and high cost. Previous works have shown the ability to construct customizable pressure-sensing insoles with capacitive sensors using fused-deposition modeling (FDM) 3D printing. This work explores the feasibility of low-cost fully and continuously 3D printed pressure sensors for pressure-sensing insoles using three sensor designs, which use flexible thermoplastic polyurethane (TPU) as the dielectric layer and either conductive TPU or conductive polylactic acid (PLA) for the conductive plates. The sensors are paired with a commercial capacitance-to-voltage converter board to form the sensing system. Dynamic sensor performance is evaluated via sinusoidal compressive tests at frequencies of 1, 3, 5, and 7 Hz, with pressure levels varying from 14.33 to 23.88, 33.43, 52.54, and 71.65 N/cm2 at each frequency. Five sensors of each type are tested. Results show that all sensors display significant hysteresis and nonlinearity. The PLA-TPU sensor with 10% infill is the best-performing sensor with the highest average sensitivity and lowest average hysteresis and linearity errors. The range of average sensitivities, hysteresis, and linearity errors across the entire span of tested pressures and frequencies for the PLA-TPU sensor with 10% infill is 11.61-20.11·10-4 V/(N/cm2), 11.9-31.8%, and 9.0-22.3%, respectively. The significant hysteresis and linearity error are due to the viscoelastic properties of TPU, and some additional nonlinear effects may be due to buckling of the infill walls of the dielectric.

The impact of sarcopenia and acute muscle mass loss on long-term outcomes in critically ill patients with intra-abdominal sepsis.

BACKGROUND: Sarcopenia is a known risk factor for poor outcomes across many chronic diseases. The impact on outcomes of both pre-existing sarcopenia and acute muscle wasting (AMW) in acute critical illness caused by sepsis remain unclear. METHODS: We conducted a prospective longitudinal cohort study of critically ill patients with intra-abdominal sepsis utilizing abdominal computed tomography at sepsis onset to determine baseline skeletal muscle index (SMI). Biomarkers of inflammation and catabolism were measured through 28 days while hospitalized. We performed follow-up evaluations of strength and physical function at 3, 6, and 12 months, with interval CT analyses at 3 and 12 months to evaluate changes in muscle mass. Measured clinical outcomes included development of chronic critical illness (≥14 days in intensive care with persistent organ dysfunction), long-term functional status, and 1 year mortality. RESULTS: Among 47 sepsis patients enrolled (mean age 53 ± 14 years), half (n = 23; 49%) were sarcopenic at baseline. Overall, sepsis patients exhibited acute and persistent muscle wasting with an average 8% decrease in SMI from baseline at 3 months (P = 0.0008). Sarcopenic (SAR) and non-sarcopenic (NSAR) groups were similar in regards to age and comorbidity burden. SAR patients had greater acute physiologic derangement (APACHE II, 18 vs. 12.5), higher incidence of multiple organ failure (57% vs. 17%), longer hospital (21 vs. 12 days) and intensive care unit length of stays (13 vs. 4 days), and higher inpatient mortality (17% vs. 0%; all P < 0.05). Pre-existing SAR was a strong independent predictor of early death or developing chronic critical illness (odds ratio 11.87, 95% confidence interval CI 1.88-74.9; P = 0.009, area under the curve 0.880) and was associated with significantly higher risk of 1-year mortality (34.9% vs. 4.2%, p = 0.007). Lower baseline SMI was also predictive of poor functional status at 12 months (OR 0.89, 95% confidence interval 0.80-0.99; p = 0.039, area under the curve 0.867). Additionally, SAR patients had AMW with persistent muscle mass loss at 3 months that was associated with decreased health-related quality of life and SF-36 physical function domains (P < 0.05). Persistent AMW at 3 months was not predictive of mortality or poor functional status, with return to near-baseline muscle mass among sepsis survivors by 6 months. CONCLUSIONS: Critically ill patients have an acute and persistent loss of muscle mass after intra-abdominal sepsis, which is associated with decreased health-related quality of life and physical function at 3 months. However, pre-existing sarcopenia, rather than persistent acute muscle mass loss at 3 months after sepsis, is independently associated with poor long-term functional status and increased 1 year mortality.

Compartmental force and contact location sensing in instrumented total knee replacements.

For the past three decades, total knee replacement has become the main solution for progressed knee injuries and diseases. Due to a lack of postoperative in vivo data, a universal correlation between intra- and postoperative soft tissue balance in the knee joint has not been established. In this work, an instrumented knee implant design with six piezoelectric transducers embedded in the tibial bearing is proposed. The aim of the presented device is to measure the total and compartmental forces as well as to track the location of contact points on the medial and lateral compartments of the bearing. A numerical analysis using finite element software is first performed to obtain the best sensory system arrangement inside the bearing. The chosen design is then used to fabricate a prototype of the device. Several experiments are designed and performed using the prototype, and the ability of the proposed system to track the location and magnitude of applied compartmental forces on the bearing is evaluated. The experimental results show that the instrumented knee bearing is able to accurately measure the compartmental force quantities with a maximum error of 2.6% of the peak axial load, and the contact point locations with a maximum error of less than 1 mm.

Design, Analysis, and Fabrication of a Piezoelectric Force Tray for Total Knee Replacements.

Force plates have been widely adopted in biomechanical gait analysis to measure reaction forces and the center of pressure. In this work, the force plate concept is miniaturized and extended for use within the polyethylene bearing insert of a total knee replacement (TKR). A simplified rectangular-shaped force plate with multiple integrated piezoelectric sensors, including designs with six and eight transducers, is presented in this work. The performance of the sensory system is investigated through finite element analysis and experimental validation. Initially, the ability of the two designs in sensing compartmental forces and contact point locations on one side of the force plate is numerically investigated. Selected designs of the force plate are then fabricated and used to experimentally validate the performance of the system. The results show a maximum error of less than 6% and 4.5% in compartmental force amplitude sensing for the force plates with six and eight transducers, respectively. The force plates were able to detect the contact point location with maximum errors of less than 1 mm. The relatively small sensing error quantities show the potential of using a piezoelectric force plate sensor design in TKR as well as other force sensing applications.

Fabrication and selection of surrogate knee implant bearings for experimental evaluation of embedded in-vivo sensors.

Total Knee Replacement (TKR) is a common procedure that is gaining importance with the aging American population. Although TKR is common, about 20% of patients report being unhappy with their results. Previous research has pointed to misalignment and loosening as contributing factors to negative outcomes. What is lacking in the field of TKR is a sensory system that can determine the internal loads of the knee in a direct manner. Implant bearings embedded with piezoelectric transducers have already shown promise in providing accurate sensing data. To perform further experimentation, prototype implant bearings that can be accurately and efficiently produced are needed. This work investigates various fabrication processes and possible materials to provide a foundation for developing surrogate biomechanical implants, especially those with integrated smart sensors. In this study, an original knee bearing is scanned and the resulting geometries used to generate prototypes. The prototypes are fabricated using a variety of methods including CNC machining and additive manufacturing. The prototypes are then tested to determine load distribution, active sensor performance, as well as kinematic performance under loading. The results of this study show that FDM printing provides quick and affordable results but is not ideal for rigorous experimentation. SLA printed prototypes are improved in final quality with an increase in fabrication time. Lastly, CNC machined processes are more labor intensive but can provide the best material characteristics. The findings from this study aim to have an impact not only on researchers studying biomedical sensing, but on the field of biomechanical implants.

The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.

BACKGROUND: The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results. METHODS: Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment. RESULTS: Of those who responded to recruitment, 83% responded to mailings. A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening. The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (n=1.789). Of the 1,305 initial screening visits, 1,087 participants had slow gait speed (<1 m/s). Of these, 701 (64%) had elevated interleukin-6 and were eligible for second screening visits. Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the losartan (57% of goal), and 66 in the combination (44% of goal). The telephone screen and first screening visit to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1,782. CONCLUSION: Recruitment for ω-3 exceeded goals, but goals for the losartan and combination strata were not met due to the high proportion of participants taking angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.

Force detection, center of pressure tracking, and energy harvesting from a piezoelectric knee implant.

Recent developments in the field of orthopedic materials and procedures have made the total knee replacement (TKR) an option for people who suffer from knee diseases and injuries. One of the ongoing debates in this area involves the correlation of postoperative joint functionality to intraoperative alignment. Due to a lack of in vivo data from the knee joint after surgery, the establishment of a well-quantified alignment method is hindered. In order to obtain information about knee function after the operation, the design of a self-powered instrumented knee implant is proposed in this study. The design consists of a total knee replacement bearing equipped with four piezoelectric transducers distributed in the medial and lateral compartments. The piezoelectric transducers are utilized to measure the total axial force applied on the tibial bearing through the femoral component of the joint, as well as to track the movement in the center of pressure (CoP). In addition, the generated voltage from the piezoelectrics can be harvested and stored to power embedded electronics for further signal conditioning and data transmission purposes. Initially, finite element (FE) analysis is performed on the knee bearing to select the best location of the transducers with regards to sensing the total force and location of the CoP. A series of experimental tests are then performed on a fabricated prototype which aim to investigate the sensing and energy harvesting performance of the device. Piezoelectric force and center of pressure measurements are compared to actual experimental quantities for twelve different relative positions of the femoral component and bearing of the knee implant in order to evaluate the performance of the sensing system. The output voltage of the piezoelectric transducers is measured across a load resistance to determine the optimum extractable power, and then rectified and stored in a capacitor to evaluate the realistic energy harvesting ability of the system. The results show only a small level of error in sensing the force and the location of the CoP. Additionally, a maximum power of 269.1 µW is achieved with a 175 kΩ optimal resistive load, and a 4.9 V constant voltage is stored in a 3.3 mF capacitor after 3333 loading cycles. The sensing and energy harvesting results present the promising potential of this system to be used as an integrated self-powered instrumented knee implant.

Energy Harvesting and Sensing with Embedded Piezoelectric Ceramics in Knee Implants.

The knee replacement is one of the most common orthopedic surgical interventions in the United States; however, recent studies have shown up to 20% of patients are dissatisfied with the outcome. One of the key issues to improving these operations is a better understanding of the ligamentous balance during and after surgery. The goal of this work is to investigate the feasibility of embedding piezoelectric transducers in the polyethylene bearing of a total knee replacement to act as self-powered sensors to aid in the alignment and balance of the knee replacement by providing intra- and postoperative feedback to the surgeon. A model consisting of a polyethylene disc with a single embedded piezoelectric ceramic transducer is investigated as a basis for future work. A modeling framework is developed including a biomechanical model of the knee joint, a finite element model of the knee bearing with encapsulated transducer, and an electromechanical model of the piezoelectric transducer. Model predictions show that a peak voltage of 2.3 V with a load resistance of 1.01 MΩ can be obtained from a single embedded piezoelectric stack, and an average power of 12 µW can be obtained from a knee bearing with four embedded piezoelectric transducers. Uniaxial compression testing is also performed on a fabricated sample for model validation. The results found in this work show promising potential of embedded piezoelectric transducers to be utilized for autonomous, self-powered in vivo knee implant force sensors.

Parametric analysis of electromechanical and fatigue performance of total knee replacement bearing with embedded piezoelectric transducers.

Total knee arthroplasty (TKA) is a common procedure in the United States; it has been estimated that about 4 million people are currently living with primary knee replacement in this country. Despite huge improvements in material properties, implant design, and surgical techniques, some implants fail a few years after surgery. A lack of information about in vivo kinetics of the knee prevents the establishment of a correlated intra- and postoperative loading pattern in knee implants. In this study, a conceptual design of an ultra high molecular weight (UHMW) knee bearing with embedded piezoelectric transducers is proposed, which is able to measure the reaction forces from knee motion as well as harvest energy to power embedded electronics. A simplified geometry consisting of a disk of UHMW with a single embedded piezoelectric ceramic is used in this work to study the general parametric trends of an instrumented knee bearing. A combined finite element and electromechanical modeling framework is employed to investigate the fatigue behavior of the instrumented bearing and the electromechanical performance of the embedded piezoelectric. The model is validated through experimental testing and utilized for further parametric studies. Parametric studies consist of the investigation of the effects of several dimensional and piezoelectric material parameters on the durability of the bearing and electrical output of the transducers. Among all the parameters, it is shown that adding large fillet radii results in noticeable improvement in the fatigue life of the bearing. Additionally, the design is highly sensitive to the depth of piezoelectric pocket. Finally, using PZT-5H piezoceramics, higher voltage and slightly enhanced fatigue life is achieved.

Bending strength of piezoelectric ceramics and single crystals for multifunctional load-bearing applications.

The topic of multifunctional material systems using active or smart materials has recently gained attention in the research community. Multifunctional piezoelectric systems present the ability to combine multiple functions into a single active piezoelectric element, namely, combining sensing, actuation, or energy conversion ability with load-bearing capacity. Quantification of the bending strength of various piezoelectric materials is, therefore, critical in the development of load-bearing piezoelectric systems. Three-point bend tests are carried out on a variety of piezoelectric ceramics including soft monolithic piezoceramics (PZT-5A and PZT-5H), hard monolithic ceramics (PZT-4 and PZT-8), single-crystal piezoelectrics (PMN-PT and PMN-PZT), and commercially packaged composite devices (which contain active PZT-5A layers). A common 3-point bend test procedure is used throughout the experimental tests. The bending strengths of these materials are found using Euler-Bernoulli beam theory to be 44.9 MPa for PMN-PZT, 60.6 MPa for PMN-PT, 114.8 MPa for PZT- 5H, 123.2 MPa for PZT-4, 127.5 MPa for PZT-8, 140.4 MPa for PZT-5A, and 186.6 MPa for the commercial composite. The high strength of the commercial configuration is a result of the composite structure that allows for shear stresses on the surfaces of the piezoelectric layers, whereas the low strength of the single-crystal materials is due to their unique crystal structure, which allows for rapid propagation of cracks initiating at flaw sites. The experimental bending strength results reported, which are linear estimates without nonlinear ferroelastic considerations, are intended for use in the design of multifunctional piezoelectric systems in which the active device is subjected to bending loads.

Very large scale integration of nanopatterned YBa2Cu3O7-delta Josephson junctions in a two-dimensional array.

Very large scale integration of Josephson junctions in a two-dimensional series-parallel array has been achieved by ion irradiating a YBa(2)Cu(3)O(7-delta) film through slits in a nanofabricated mask created with electron beam lithography and reactive ion etching. The mask consisted of 15820 high aspect ratio (20:1), 35 nm wide slits that restricted the irradiation in the film below to form Josephson junctions. Characterizing each parallel segment k, containing 28 junctions, with a single critical current I(ck) we found a standard deviation in I(ck) of about 16%.