Clinical treatment of Glioblastoma Multiforme (GBM) is generally ineffective in increasing patient survival. Convection-enhanced delivery (CED) is an alternative, investigative therapy in which a small caliber catheter is placed directly into the brain parenchyma. However, standard CED drug delivery techniques are unable to reach the entirety of the brain tumor, attributing to the failure of Phase III clinical trials. Fiber optic microneedle devices (FMDs), capable of simultaneous fluid and laser energy delivery, have shown potential to increase the drug dispersal volume when compared to fluid only devices. Previously described FMDs have had low laser transmission efficiency. In this work, we present two FMD manufacturing methods, a solid fiber inside capillary (SFIC) FMD and a modified fusion spliced (FS) FMD. Transmission efficiency of the two proposed FMDs were measured using a 1064 nm laser and an integrating sphere detector with air, deionized water, and black ink inside of the bore of the FMDs. The transmission efficiency of the FS FMD was between 45 and 127% larger than that of previously reported FS FMDs. Additionally, the transmission efficiency of the SFIC was significantly higher than the FS FMD (p ≤ 0.04 for all groups). However, the SFIC FMDs suffered catastrophic fracture failure at bend radii smaller than the manufacture specification, likely due to scribing of the capillary during the FMD fabrication process. Modifying FS FMDs appears to be the preferred fabrication method providing improved light transmission efficiency and mechanical strength on par with the capillary manufacturer’s specifications.

Ultrasound-guided central venous cannulation (CVC) has become standard to care. Ultrasound imaging allows the CVC procedure to be completed much safer than a standard blind landmark approach. To enhance medical personnel’s skill in performing challenging ultrasound-guided CVC, an adult size CVC phantom that simulated the human head to the chest, with a detachable CVC operational part, was proposed in this study to provide medical personnel with realistic needle insertion haptic feedback and ultrasound imaging. The detachable CVC operational part could be customized to simulate different patient conditions, such as adult patient (with normal standard size of vascular), the elderly (with collapsed vascular), children (with smaller diameter of vascular), vascular fibrosis patient (with hardening of vascular) and obese patient (with thick fat tissue). In the current stage of prototype development, a CVC operational part with simulated blood vessels and clavicle embedded inside the fat- and muscle-mimicking tissue was produced. Both the fat- and muscle-mimicking tissue pose mechanical and acoustic properties similar to real tissues. The target vein for CVC procedure could be recognized from the ultrasound imaging of the CVC operational part.

Medical device companies that aim to sell catheters with pressure sensing elements need a way to test their systems during the design phase. An example of one of these products is an Intra-aortic Balloon Pump (IABP) which provides mechanical pumping assistance to a patient experiencing cardiogenic shock. To test these devices, companies will place the assembly in controlled pressure chamber to examine the response to pressure changes. However, commercially available systems are cost prohibitive. To solve this problem, a custom, low-cost, pneumatic catheter test chamber was designed and built to provide a benchtop platform for experimentation. In order to control the chamber pressure, the electromechanical system utilizes feedback control and solenoid valves controlled by an Arduino microcontroller. Since pneumatic systems exhibit nonlinear behavior, a novel control method was used to implement proportional-integral control and simulate the pressure profile experienced in the human body.

Traumatic brain injury (TBI) has been considered a precarious health issue especially within the military population. Research has shown that early treatment of TBI could reduce possible neurocognitive injury. However, the nature of military triage has created challenges for early TBI detection. Intracranial pressure (ICP), which is used as a biomarker of outcomes in TBI, is not only expensive to measure but is also invasive and requires specialized surgical and procedural skills. Episcleral venous pressure (EVP) was proven to be a good alternative biomarker to ICP. However, the current technology in measuring EVP is not portable, and requires a skilled operator with a slit-lamp for testing. Moreover, the measurement is highly subjective and depends on the operator’s skill and technique. Therefore, there is a critical need for alternative technology for non-clinical TBI diagnosis. In this paper, we present an improved venomanometer design for measuring EVP in the field.

In recent years, magnetic particle spectroscopy (MPS) has emerged as a new technology for immunoassay applications. In MPS, alternating magnetic fields are applied to magnetic nanoparticles (MNPs). The magnetic responses of these nanoparticles are collected and recorded by a pair of specially designed pick-up coils. These magnetic responses contain higher harmonics that are specific to the physical changes of the nanoparticles such as the binding events of target analytes to nanoparticles. This volumetric-based bioassay method analyses the response signal from the whole nanoparticle suspension, thus, allows one step and wash-free immunoassay with minimum technical requirements. In this work, we developed a handheld MPS system as a future highly sensitive, cheap, in vitro, and easy-to-use point-of-care (POC) detection kit.

Upper airway stimulation (UAS) is shown to be effective with high adherence for patients with moderate to severe obstructive sleep apnea. However, the consistency of adherence among medical sites remains to be verified. This study examines the adherence to UAS among medical sites in an international multicenter registry. A statistically significant adherence decrease between 6-month and 12-month visit was found in the study cohort as well as in most sites. No significant heterogeneity was found among sites with either all patients or only patients who had adherence at both visits recorded. In addition, there is no enough evidence that region and experience of sites influences the adherence. This study indicates that UAS therapy adherence is consistent among sites, regardless of region and experience of sites.

Wasted time in the operating room results in higher operating costs and greater post-operative complications. One effective way to reduce operation time is automating basic processes that occur during surgery. Given the rise of smart-home devices, implementation of virtual assistants became a feasible solution in many medical settings. With a consumer smart-home device and off-the-shelf components, we engineered a voice-controlled smart surgical bed that adjusts the bed configuration via a voice input. The resulting device is expected to optimize human resources and reduce surgical site infection by eliminating the need of a traditional touch control mechanism. Future work is needed to develop its proprietary hardware and software, and continuous collaboration with medical personnel to bring this device into market.

Assessment of neuromuscular blockade during anesthesia is achieved using the Train of Four (TOF) monitoring technique. However, current devices are limited to conditions in which the hand can move freely during operation. The goal of this project was to design, prototype, and test a device which extends the TOF technique to conditions where movement is restricted. Interviews were conducted with stakeholders to better understand the need for this device and to get feedback on preliminary designs. The resulting device consists of a thumb-mounted balloon, which converts the force due to thumb twitches into pressure, which then acts as the physical analog to muscle response. This pressure is transduced and analyzed to produce a TOF count and TOF ratio. A prototype was constructed and tested on human subjects with different hand geometries.

Although intravenous therapy (IV) is one of the most frequently utilized approaches for fluid delivery in modern healthcare, it is associated with some form of complication up to 40% of the time. While many complications are minor, occlusion and extravasation can prevent the delivery of a needed fluid-based intervention or cause delivery into the subdermal space, which can lead to distributed tissue damage and necrosis. To address this need, this group developed the IV patency monitoring device (IVP) to generate and analyze a small pulse wave within the IV fluid. The study hypothesis was that changes in the IV’s communication with the blood stream could be detected as an alteration in this signal. This study investigated wave characteristics generated by the IVP in a benchtop tissue phantom. Results demonstrated that wave characteristics change detectably between simulated patent communication with a simulated blood stream and states of extravasation or occlusion. Future work will focus on improved detection methods and integrating a real-time alert system, which will better prepare the IVP for clinical translation and impact.

Preterm birth (PTB) is one of the leading causes of neonatal morbidities and mortalities. Limited methods are available to physicians for mitigating PTB, thus posing an urgent need to develop effective methods for its prevention. In prior research, a benchtop electronic uterine control device (EUCD) was developed for tocolysis through injection of current pulses. However, the benchtop version is wall tethered and constrains patients to hospitals, i.e., it is unsuitable for deployment in outpatient or home settings. This paper focuses on the development of a mechatronics-based, low-cost, battery-powered, portable, and reproducible EUCD, which is suitable for use in home and clinical environments. The developed mechatronic version is validated for electrical performance with resistive load-tests, which indicate that the mechatronic device can generate current pulses similar to the existing benchtop EUCD. Furthermore, the signals generated from the device are evaluated for repeatability using coefficient of variation (CV) analysis and the results indicate that the mechatronic version can produce repeatable frequency (1–100Hz), amplitude (1–17mA), and pulse width (1–120ms) modulated current signals. An internet of medical things (IoMT) methodology is discussed to enable seamless transition of the developed device from a clinical environment to a home-based setting for remote use by the patients.

The task-specific assistive device (TAD) is a compact and portable assistive device, consisting of an actuated six-bar linkage, designed to facilitate the activity of drinking from a cup without using the hands. In this paper, we examine the effectiveness of the device in supporting patients with conditions of incomplete tetraplegia and hemiplegia by simulating disability in 17 healthy subjects. The average percentage reduction in bending angle of torso with the use of TAD was found to be 40.31% for subjects with simulated incomplete tetraplegia and 37.14% for subjects with simulated hemiplegia. Users also completed the system usability scale (SUS), indicating that the device was easy to use. The user workload, measured using the NASA task load index (NASA-TLX), was found to be minimal and the device was found to be robust through user response to a user experience questionnaire. The results of this work indicate that TAD is a promising solution for facilitating independence in a basic activity of daily living such as drinking from a cup without using the hands.

Radiopaque scales have numerous uses in the field of surgery, especially orthopaedic surgery. Scales of this nature can be used to guide surgeons by taking intra-operative measurements, pinpoint insertion points on bones and detect locations of deformations and tumours inside the body. Despite this, these scales are not used widely enough because of its high cost and that there are no widely acceptable ways of developing them from off the shelf materials. This paper details the method of inventing a novel low-cost radiopaque scale using off the shelf materials such as Barium Sulfate and Iodinated Contrast Agent (ICA). The radiopaque scale was manufactured using Perspex ® and was filled with the contrast agents. The scales were then scanned using low-dose X-ray machines. The scale filled with Barium was found to be provide a better contrast image suggesting that the Barium to be a better high-contrast agent when compared to iodine and is recommended for use.

The immediate post-partum period offers a convenient time to have an intrauterine device placed because of the co-location of a non-pregnant woman and her clinician; however, this practice is associated with increased expulsion rates of up to 30%, compared with a 3% expulsion rate for interval insertions. This paper presents a device and method to improve intrauterine device delivery and retention in the immediate postpartum period. This initial feasibility study illustrates that it is possible to temporarily tether a commercially available intrauterine device within the uterus of an immediately postpartum baboon. The results indicate this device and method are technically feasible, but further studies will be needed to evaluate safety and efficacy in reducing expulsion rates.

Pediatric laryngoscope blades do not vary in size and shape as patients’ airways do. Difficult airway intubations may require physicians to try different blade sizes and even improvise. In addition to physical trauma and complications, difficult intubations may result in longer operating room times. As advanced three-dimensional (3D) imaging, modeling, and printing technologies become more ubiquitous at the point-of-care, so will the development and fabrication of patient-specific solutions. Here we introduce a method for the design and fabrication of patient-specific, single-use pediatric laryngoscope blades. The process seeks to optimize procedures and mitigate complications by providing physicians with the right tool at the right time.

This project sought to develop a method to provide a clinically meaningful, surrogate measure for viscosity that will help analyze complex biofluids. Goals for this project included precise measurements that differentiate a wide variety of standard viscosities, table-top level of size, and ease-of-use. The design utilized a custom 3D-printed analog of a cone and plate viscometer with an attachment for a smartphone to provide gyroscopic data. The device is currently in the stages of final validation and will ultimately be tested in a 40-patient clinical trial intended to assess efficacy of mucolytic therapy in mechanically ventilated patients.

Proprioceptive afferents from the ankle joint are essential feedback for maintaining balance. However, there is no widely accepted test or measurement system available for determining the proprioceptive accuracy of the human ankle joint. Here, we present a system with a novel hardware design that applies an established psychometric testing protocol that generates a Just-Noticeable-Difference (JND) threshold as a measure of ankle proprioceptive acuity at the end of testing. To establish the system validity, twelve healthy adult participants completed the assessment. Testing required 25 trials and took approximately 10 minutes to complete. We show exemplar data of the ankle JND threshold and the summary results for all twelve participants. This assessment has the potential to become a tool for clinicians to identify proprioceptive impairment at the ankle and to assess the efficacy of sensorimotor interventions for improving balance in clinical populations.

Proprioceptive signals from mechanoreceptors embedded in ligaments, tendons, and muscles are essential for the control of muscle tone and voluntary movement. Numerous neurological and orthopedic disorders are associated with proprioceptive dysfunction that impairs the control of balance and/or fine motor function. However, obtaining objective measures of proprioceptive function is difficult in most clinical settings, because available assessment methods rely on specialized equipment, expertise, or are too time-consuming. This paper presents a new tablet-based system that objectively measures finger position sense by implementing a psychophysical threshold search method. We here provide initial data that demonstrate the ease-of-use and efficacy of the system.

Congenital Tracheal Stenosis (CTS) is a rare birth defect requiring surgical interventions when it affects more than 30% of the trachea. Slide tracheoplasty, the current standard of care, is associated with reinterventions including the need for intraluminal stenting leading to increased airway infections. We propose a novel Bio-Synthetic Graft for long segment tracheal reconstructions in CTS patients. Preliminary bench performance testing, using lamb tracheas, shows that the Bio-Synthetic Graft reconstructed tracheas have comparable radial, axial and bending stiffness in hyperextension to healthy tracheas and resist collapse when subjected to bending in flexion. These results suggest that Bio-Synthetic Graft could be a promising alternative to existing solutions for long segment CTS.

Tracheobronchomalacia (TBM) is a condition where the trachealis muscle is too weak to withstand the pressure difference between the outer and inner walls of the trachea. This causes the airway to narrow or collapse. Patients with TBM may have symptoms including coughing, wheezing, and/or difficulty in breathing. There are current treatments available but each one has their own limitations and complications. Such complications of current commercially available airway stents are migration, breakage, and mucus build-up. The team has developed a unique airway stent that potentially has fewer complications called the Low Profile Airway Stent. It is a thin, metal zig-zag shaped wire that will be anchored parallel to the trachealis muscle to prevent trachea narrowing and collapsing. The Low Profile Airway Stent will not fully cover the cilia in the trachea which reduces mucus build-up. The stent will also be anchored to the walls of the trachea which will prevent migration. The team is still in the process of developing an anchoring method and delivery device for the stent.

This paper presents a modular robot for assisting individuals with spinal cord injury with everyday tasks. The basic premise of modularity for task-variable environments is laid out, and the modular robot design is detailed including needs assessment, kinematics, and hardware. Early pilot testing of the robot is also described.