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Research Papers

J. Med. Devices. 2018;13(1):011001-011001-9. doi:10.1115/1.4041414.

Mechanical circulatory support (MCS) options are limited for patients with dysfunctional single ventricle physiology. To address this unmet clinical need, we are developing an axial-flow blood pump to provide mechanical assistance to the cavopulmonary circulation. In this study, we investigate the use of high-resolution cardiac magnetic resonance imaging (MRI) to visualize the complex fluid flow conditions of mechanical circulatory assist in two patient-specific Fontan anatomies. A three-bladed axial-flow impeller coupled to a supportive cage with a four-bladed diffuser was positioned in the inferior vena cava (IVC) of each Fontan anatomy. Cardiac magnetic resonance (CMR) imaging and power efficiency studies were conducted at physiologic relevant parameters with cardiac outputs of 2, 3, and 4 L/min with impeller rotational speeds of 2000 and 4000 rpm. The axial-flow impeller was able to generate improved flow in the total cavopulmonary connection (TCPC). The higher rotational speed was able to redistribute flow in the TCPC anastomosis aiding in removing stagnant blood. No retrograde flow was observed or measured in the superior vena cava (SVC). As an extension of the CMR data, a scalar stress analysis was performed on both models and found a maximum scalar stress of approximately 42 Pa for both patient anatomies. The power efficiency experiments demonstrated a maximum energy gain of 8.6 mW for TCPC Anatomy 1 and 12.58 mW for TCPC Anatomy 2 for a flow rate of 4 L/min and at 4000 rpm. These findings support the continued development of axial blood pumps for mechanical cavopulmonary assist.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):011002-011002-7. doi:10.1115/1.4041336.

Attendant wheelchairs provide a means to transport patients or mobility to people with walking disability. They can be attendant propelled, which are highly maneuverable in confined spaces, but offer no power assistance. Also, they can be electric powered with joystick control interface, which provides power assistance, but not as maneuverable as the attendant propelled wheelchair. With the objective of providing power assistance and having excellent maneuverability, this paper presents a motorized attendant wheelchair with haptic interface. Its control approach is based on virtual/desired dynamics, which is not the true dynamics of the wheelchair, but a mathematical model describing the motion behavior of a desired system. The desired dynamics takes the user's applied force/torque and yields desired velocities of the wheelchair. In the evaluation, tasks in confined spaces that require a lot of maneuvers were given and performed using the motorized wheelchair with haptic and joystick control interfaces. The results in terms of task completion times showed that motorized wheelchair with haptic significantly outperformed the motorized wheelchair with joystick interface. In addition, the performance of the motorized with haptic interface and attendant propelled wheelchairs were evaluated at two different loads. At heavy load, the task completion times of motorized wheelchair with haptic interface were comparable to the attendant propelled wheelchair.

Topics: Haptics , Wheelchairs
Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):011003-011003-11. doi:10.1115/1.4041591.

Pin-jointed wrist mechanisms provide compact articulation for surgical robotic applications, but are difficult to miniaturize at scales suitable for small body cavity surgery. Solid surface cable guide channels, which eliminate the need for pulleys and reduce overall length to facilitate miniaturization, were developed within a three-degree-of-freedom cable-driven pin-jointed wrist mechanism. A prototype was 3D printed in steel at 5 mm diameter. Friction generated by the guide channels was experimentally tested to determine increases in cable tension during constant cable velocity conditions. Cable tension increased exponentially from 0 to 37% when the wrist pitched from 0 deg to 90 deg. The shape of the guide channel groove and angle, where the cable exits the channel impacts the magnitude of cable tension. A spring tensioning and cam actuation mechanism were developed to account for changing cable circuit path lengths during wrist pitch. This work shows that pulley-free cable wrist mechanisms can facilitate miniaturization below current feasible sizes while retaining compact articulation at the expense of increases in friction under constant cable velocity conditions.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):011004-011004-7. doi:10.1115/1.4041805.

Most blood-contacting medical devices must be assessed for potential thrombogenicity prior to regulatory approval. A common assay for screening and qualifying devices involves monitoring the reduction of platelet and leukocyte (P&L) counts in whole blood exposed to the device. We have validated an improved method for assessing a device's effect on platelet activation and surface adhesion, offering significant improvement over the current ASTM F2888-13 method, which uses blood fully anticoagulated by acidified citrate (known to significantly inhibit platelet responsiveness). Our method uses minimal heparinization (final concentration 1 IU/mL) to optimize the response to commonly used control materials: latex, black rubber, and high-density polyethylene (HDPE). We also have shown the assay's capacity to appropriately assess a legally marketed comparator device (LMCD) with a documented clinical history. The test materials were prepared for incubation and allowed to remain in contact with the citrated or heparinized blood for ∼1 h at 37 °C. A complete blood count was performed prior to exposure, and at the end of the incubation period, reductions in P&L counts were recorded. Results from citrate-anticoagulated assay showed only a marginal response to the positive control, black rubber. Using heparinized blood, the assay generated a robust response to the positive controls, the “intermediate scoring” controls, and also assessed a legally marketed and approved device as clearly nonthrombogenic. This modification adds robustness and sensitivity to this quick and inexpensive thrombogenicity assay and should be incorporated into the next ASTM standards.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):011005-011005-15. doi:10.1115/1.4041589.

Readily available store brand, or “home,” thermometers are used countless times in the home and clinic as a first diagnostic measure of body temperature. Measurement inaccuracies may lead to unnecessary medical visits or medication (false positives), or, potentially worse, lack of intervention when a person is truly sick (false negatives). A critical first step in the design process is to determine the shortcomings of the existing designs. For this project, we evaluated the accuracy of three currently available store brand thermometers in a pediatric population. The accuracies of the thermometers were assessed by comparing their body temperature predictions to those measured by a specially designed and calibrated and fast-responding reference thermometer. The reference thermometer was placed at the measurement site simultaneously with the store brand thermometer and recorded the temperature at the measurement site continuously. More than 300 healthy or sick pediatric subjects were enrolled in this study. Temperatures were measured at both the oral and axillary (under the arm) sites. The store brand thermometer measurements characteristically deviated from the reference thermometer temperature after 120 s, and the deviations did not follow a consistent pattern. The Brand C thermometers had the greatest deviations of up to 3.7 °F (2.1 °C), while the Brand A thermometers had the lowest deviations; however, they still deviated by up to 1.9 °F (1.1 °C). The data showed that the tested store brand thermometers had lower accuracy than the ±0.2 °F (0.1 °C) indicated in their Instructions for Use. Our recorded reference (transient) data showed that there was a wide variation in the transient temperature profiles. The store brand thermometers tested stated in their documentation that they are able to predict a body temperature based on transient temperature values over the first 5–10 s of measurements, implying that they use an embedded algorithm to extrapolate to the steady-state temperature. Significant deviations from the maximum temperature after time t = 4.6t0.63 illustrated that the transient temperature profiles may not be represented by an exponential function with a single time constant, t0.63. The accuracy of those embedded algorithms was not confirmed by our study, since the predicted body temperatures do not capture the large variations observed over the initial 10 s of the measurements. A thermometer with an error of several degrees Fahrenheit may result in a false positive or negative diagnosis of fever in children. The transient temperature measurements from our clinical study represent unique and critical data for helping to design the next generation of readily available, highly accurate, home thermometers.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):011006-011006-9. doi:10.1115/1.4041588.

Many children with physical disabilities experience difficulty using traditional exercise equipment for gait rehabilitation and fitness training, and the clinician resources required to deliver intensive overground or treadmill-based therapies are infrequently available in most clinics, hospitals, and school settings. This work describes design and testing of a comprehensive set of modifications that enabled children to use a commercially available robotic exercise device (i.e., Intelligently Controlled Assistive Rehabilitation Elliptical (ICARE)) initially developed to address walking and fitness goals of adults with physical disabilities and chronic conditions. Fifteen children (3–11 years old) concurrently enrolled in physical therapy due to varied neurologic conditions were recruited with their parent(s) to evaluate the safety, comfort, and usability of the adult ICARE and pediatric-modified ICARE. After children tried each device, feedback was recorded. To assess feasibility, each child then participated in up to ten sessions (two to five sessions per week; average session length: 38 min, range 21–66 min) using the pediatric-modified ICARE. Parents, on average, perceived that the pediatric-modified ICARE was significantly safer, more comfortable and usable than the adult ICARE. Children's perceptions of the pediatric-modified ICARE were similar, although not statistically significant. Children used the prototype device during 133 sessions for over 3800 min and more than 162,000 cycles. In conclusion, this study demonstrated the feasibility of using the pediatric-modified ICARE with children as young as 3 years old as an adjunct to ongoing therapy.

Commentary by Dr. Valentin Fuster

Technical Brief

J. Med. Devices. 2018;13(1):014501-014501-6. doi:10.1115/1.4041190.

Pectus carinatum (PC) presents itself as a protrusion on the chest wall of adolescent individuals. Current treatment for PC is performed with a Pectus carinatum orthosis (PCO) that applies a compressive force to the protrusion. While this treatment is accepted, the magnitude of compressive forces applied remains unknown leading to excessive or deficient compression. Although the need for this quantitative data is recognized, no studies reporting the data or methods are available. The purpose of this study was to design an accurate force measurement system (FMS) that could be incorporated into a PCO with minimal bulk. Components of the FMS were three-dimensional (3D)-printed and incorporated into an existing PCO design. The FMS was calibrated using a custom indenter that applied forces to the FMS in a controlled manner. Evaluation of the FMS on five human participants was also performed. A reliability measure of the FMS was calculated for analysis. The FMS was implemented into the PCO and able to withstand the applied forces. The calibration revealed an increase in load cell error with increased magnitude of applied force (mean error [SD] = 5.59 N [6.48 N]). Participants recruited to evaluate the FMS demonstrated reliable forces (R = 96%) with smaller standard deviations than those during the calibration. The FMS was shown capable of measuring PCO forces but requires further testing and improvement. This system is the foundational component in a wireless, minimalistic sensor system to provide real time force feedback to both the clinician and patient.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):014502-014502-7. doi:10.1115/1.4041487.

Needle biopsy is a routine medical procedure for examining tissue or biofluids for the presence of disease using standard methods of pathology. The finite element analysis (FEA) methodology can provide guidance for optimizing the geometric parameters. The needle biopsy is simulated and analyzed while varying the needle angle, the aperture size and the slice-push ratio k. The results indicate that tissue reaction force in the axial direction of needle gradually decreases, and the stress and strain are more concentrated at the tip of needle with the increases of tip angle; the tissue reaction force decreases, and the torque increases while the slice-push ratio increases; and higher slice–push ratio can increase the peak stress concentration on the cutting edge and deformation of tissue; in the process of core needle cutting, increasing slice–push ratio can reduce the tissue reaction force significantly. While the aperture on distal wall of outer cannula becomes wider, the tissue reaction force increases significantly, and the cutting process will be more unstable. The results have the potential to provide important insight for improving the needle biopsy design process.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):014503-014503-4. doi:10.1115/1.4041634.

In this paper, a previously developed medical software using orthogonal frontal and lateral X-rays is employed to reconstruct the rib cage and thoracic volume for scoliosis patients. The thoracic volumes of ten adult scoliosis patients with different treatments during their adolescence are followed up. This study provides an evidence that thoracic volume measurement can be used to infer the pulmonary function for spine deformity patients with moderate to severe scoliosis Cobb angle. Based on the calculation of the thoracic volumes in scoliosis patients, we correlate the parameters in the pulmonary function test to the measured thoracic volume through our software. The findings show the strong correlation between total lung capacity and the thoracic volume, and a significant correlation between the vital capacity/residual volume and the thoracic volume. An interpretation of the findings, limitation, and the future application are pointed out.

Topics: Scoliosis , Lung , X-rays
Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):014504-014504-5. doi:10.1115/1.4041696.

Instrument-assisted soft tissue mobilization (IASTM) is a manual therapy technique that is commonly used to treat dysfunctions in ligaments and other musculoskeletal tissues. The objective of this study was to develop a simple hand-held device that helps users accurately apply targeted compressive forces and stroke frequencies during IASTM treatments. This portable device uses a force sensor, tablet computer, and custom software to guide the application of user-specified loading parameters. To measure performance, the device was used to apply a combination of targeted forces and stroke frequencies to foam blocks and silicone pads. Three operators using the device applied targeted forces between 0.3 and 125 N with less than 10% error and applied targeted stroke frequencies between 0.25 and 1.0 Hz with less than 3% error. The mean error in applying targeted forces increased significantly at compressive forces less than 0.2 N and greater than 125 N. For experimental validation, the device was used to apply a series of IASTM treatments over three-weeks to rodents with a ligament injury, and the targeted compressive force and stroke frequency were repeatedly applied with an average error less than 5%. This validated device can be used to investigate the effect of IASTM loading parameters on tissue healing in animal and human studies, and therefore can support the optimization and adoption of IASTM protocols that improve patient outcomes.

Commentary by Dr. Valentin Fuster

Design Innovation Paper

J. Med. Devices. 2018;13(1):015001-015001-9. doi:10.1115/1.4041335.

Error and uncertainty in needle placement can drastically impact the clinical outcome of both diagnostic and therapeutic needle-based procedures. In this work, we aim to estimate the shape of a bent needle during insertion and provide a prototype design of a needle whose deflection is tracked in real time. We calculate slope along a needle by measuring the movement of fixed wires running along its length with a compact image-based sensor. Through the use of the Euler–Bernoulli beam theory, we calculate shape and trajectory of a needle. We constructed a prototype needle with two wires fixed along its length and measured wire-movement using a vertical-cavity surface-emitting laser (VCSEL) mouse sensor. This method was able to estimate needle tip deflection within 1 mm in a variety of deflection scenarios in real time. We then provide a design of a needle with real-time deflection tracking in 3D, providing the user with a simple display to convey needle deflection in tissue. This method could be applied to needle-based biopsy or therapy procedures to improve the diagnostic accuracy or treatment delivery quality.

Commentary by Dr. Valentin Fuster
J. Med. Devices. 2018;13(1):015002-015002-4. doi:10.1115/1.4041337.

Cardiovascular assessment and fitness training are often overlooked in physical rehabilitation. Many current rehabilitation exercise devices do not allow for the recording and exportation of variables related to cardiovascular fitness. Therefore, the purpose of this work was to design, prototype, and validate a data logger that measures, records, and exports time, heart rate (HR), and speed data with the commercially available rehabilitation device called the Intelligently Controlled Assistive Rehabilitation Elliptical (ICARE). Validation involved using the data logger device in parallel with devices currently used in research environments for measuring HR (TrueOne 2400 metabolic cart with polar HR monitoring chest strap) and speed (ICARE's console). Ten healthy individuals without known disability impacting walking or ability to use the ICARE, exercised on the ICARE while HR and ICARE speed were measured. It was found that the data logger can be used to accurately measure, record, and export HR (linear regression: P < 0.001; R2 = 0.892) and speed (linear regression: P < 0.001; R2 = 0.997) data when used with the ICARE.

Commentary by Dr. Valentin Fuster

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