Design and Evaluation of a Spoke-Based Double-Lumen Pediatric Gastrostomy Tube.

Gastrostomy tubes (G-tubes) are the gold standard for feeding assistance for children with feeding dysfunction. Current G-tubes pose complications that interrupt the delivery of feed, including tube displacement and difficulty of at-home use. This study details an alternative, spoke-based, double-lumen G-tube design and preliminary validation of its function and usability. Pull force testing was performed on spoke G-tube models across three sizes and two classifications (hard/soft). Preliminary models were evaluated against market standards. Though the pull force of the spoke model was found to be lower than that of both market standards, hard modifications to the spoke model improved retentive force. Ease of use was tested amongst users unfamiliar with G-tube placement. The spoke design required 12.3 ± 4.7 s to deploy, less than half the time required for market standards. However, balloon G-tubes were still perceived to be easiest to use by 70% of participants, with indications that a spoke design may be easier to use if sized similarly to current G-tubes, with auxiliary improvements to factors such as grip. While there is a need for improvements in the material properties and manufacturing of the proposed design, this study provides early validation of the potential to address complications of existing G-tubes.

Measurement of Magnetically Induced Torque on Lightweight Medical Devices in the Magnetic Resonance Environment for ASTM F2213.

OBJECTIVE: Use of medical devices in the magnetic resonance environment is regulated by standards that include the ASTM-F2213 magnetically induced torque. This standard prescribes five tests. However, none can be directly applied to measure very low torques of slender lightweight devices such as needles. METHODS: We present a variant of an ASTM torsional spring method that makes a "spring" of 2 strings that suspend the needle by its ends. The magnetically induced torque on the needle causes it to rotate. The strings tilt and lift the needle. At equilibrium, the magnetically induced potential energy is balanced by the gravitational potential energy of the lift. Static equilibrium allows calculating the torque from the needle rotation angle, which is measured. Moreover, a maximum rotation angle corresponds to the maximum acceptable magnetically induced torque, under the most conservative ASTM acceptability criterion. A simple apparatus using the 2-string method is shown, it can be 3D printed, and the design files are shared. RESULTS: The analytical methods were tested against a numeric dynamic model, showing perfect concordance. The method was then tested experimentally in 1.5T and 3T MRI with commercial biopsy needles. Numeric test errors were immeasurably small. Torques between 0.0001 Nm and 0.0018 Nm were measured in MRI with 7.7% maximum difference between tests. The cost to make the apparatus is 58USD and design files are shared. CONCLUSION: The apparatus is simple and inexpensive and provides good accuracy as well. SIGNIFICANCE: The 2-string method provides a solution to measure very low torques in the MRI.

A novel pneumatic drill for bone biopsy under MRI imaging.

PURPOSE: Bone biopsies are currently conducted under computed tomography (CT) guidance using a battery-powered drill to obtain tissue samples for diagnosis of suspicious bone lesions. However, this procedure is suboptimal as images produced under CT lack soft tissue discrimination and involve ionizing radiation. Therefore, our team developed an MRI-safe pneumatic drill to translate this clinical workflow into the MR environment, which can improve target visualization and eliminate radiation exposure. We compare drill times and quality of samples between the 2 drills using animal bones. METHODS: Five porcine spare rib bones were obtained from a butcher shop. Each bone was drilled twice using the Arrow OnControl battery-powered drill and twice using our pneumatically actuated drill. For this study, we used an 11-gauge bone biopsy needle set with an internal core capturing thread. A stopwatch recorded the overall time of drilling for each specimen obtained. RESULTS: All 20 samples collected contained a high-quality inner core and cortex. The total average time for drilling with the pneumatic drill was 8.5 s (+ / - 2.5 s) and 7.1 s (+ / - 1.4 s) with the standard battery-powered drill. CONCLUSION: Both drills worked well and were able to obtain comparable specimens. The pneumatic drill took slightly longer, 1.39 s on average, but this extra time would not be significant in clinical practice. We plan to use the pneumatic drill to enable MRI-safe bone biopsy for musculoskeletal lesions. Biopsy under MRI would provide excellent lesion visualization with no ionizing radiation.

Evaluation of a novel MRI-safe needle guidance toolkit for streamlined arthrography procedures.

Currently, Magnetic Resonance arthrography procedures require two rooms and two imaging modalities: fluoroscopically guided needle insertion in a fluoroscopy suite, followed by diagnostic MRI in a separate MRI suite. The use of fluoroscopy for needle placement exposes patients to ionizing radiation, which is an important concern, especially in pediatrics. The need for two different rooms and coordinating times for these rooms complicates hospital resource scheduling and logistics. In addition, the added delays could expose younger children to additional risks associated with the use of general anesthesia. To address these issues, we propose a new technique to streamline the arthrography procedure. Our proposed technology aims to eliminate exposure to ionizing radiation and to streamline arthrography procedures that are conducted solely under MRI. This toolkit consists of a 3D slicer-based user interface, a spatially unique silicone grid template, and a hand-held needle guidance device. Together, these tools are intended to simplify and shorten the procedure while maintaining accuracy and precision comparable to the current gold standard procedure. In our cadaver study, we evaluated the feasibility and accuracy of our novel MRI-safe Needle Guidance Toolkit for MRI arthrography procedures, achieving an average targeting accuracy of 3.2 ± 1.0 mm. The results presented in this study showed the feasibility and promise of our novel MRI-safe needle guidance toolkit for arthrography procedures.

Assessing the Effect of Augmented Reality on Procedural Outcomes During Ultrasound-Guided Vascular Access.

OBJECTIVE: Augmented reality devices are increasingly accepted in health care, though most applications involve education and pre-operative planning. A novel augmented reality ultrasound application, HoloUS, was developed for the Microsoft HoloLens 2 to project real-time ultrasound images directly into the user's field of view. In this work, we assessed the effect of using HoloUS on vascular access procedural outcomes. METHODS: A single-center user study was completed with participants with (N = 22) and without (N = 12) experience performing ultrasound-guided vascular access. Users completed a venipuncture and aspiration task a total of four times: three times on study day 1, and once on study day 2 between 2 and 4 weeks later. Users were randomized to use conventional ultrasound during either their first or second task and the HoloUS application at all other times. Task completion time, numbers of needle re-directions, head adjustments and needle visualization rates were recorded. RESULTS: For expert users, task completion time was significantly faster using HoloUS (11.5 s, interquartile range [IQR] = 6.5-23.5 s vs. 18.5 s, IQR = 11.0-36.5 s; p = 0.04). The number of head adjustments was significantly lower using the HoloUS app (1.0, IQR = 0.0-1.0 vs. 3.0, IQR = 1.0-5.0; p < 0.0001). No significant differences were identified in other measured outcomes. CONCLUSION: This is the first investigation of augmented reality-based ultrasound-guided vascular access using the second-generation HoloLens. It demonstrates equivalent procedural efficiency and accuracy, with favorable usability, ergonomics and user independence when compared with traditional ultrasound techniques.

Non-Metallic MR-Guided Concentric Tube Robot for Intracerebral Hemorrhage Evacuation.

OBJECTIVE: We aim to develop and evaluate an MR-conditional concentric tube robot for intracerebral hemorrhage (ICH) evacuation. METHODS: We fabricated the concentric tube robot hardware with plastic tubes and customized pneumatic motors. The robot kinematic model was developed using a discretized piece-wise constant curvature (D-PCC) approach to account for variable curvature along the tube shape, and tube mechanics model was used to compensate torsional deflection of the inner tube. The MR-safe pneumatic motors were controlled using a variable gain PID algorithm. The robot hardware was validated in a series of bench-top and MRI experiments, and the robot's evacuation efficacy was tested in MR-guided phantom trials. RESULTS: The pneumatic motor was able to achieve a rotational accuracy of 0.32°±0.30° with the proposed variable gain PID control algorithm. The kinematic model provided a positional accuracy of the tube tip of 1.39 ± 0.54 mm. The robot was able to evacuate an initial 38.36 mL clot, leaving a residual hematoma of 8.14 mL after 5 minutes, well below the 15 mL guideline suggesting good post-ICH evacuation clinical outcomes. CONCLUSION: This robotic platform provides an effective method for MR-guided ICH evacuation. SIGNIFICANCE: ICH evacuation is feasible under MRI guidance using a plastic concentric tube, indicating potential feasibility in future live animal studies.

In situ guidance for MRI interventions using projected feedback.

PURPOSE: To develop and evaluate an augmented reality instrument guidance system for MRI-guided needle placement procedures such as musculoskeletal biopsy and arthrography. Our system guides the physician to insert a needle toward a target while looking at the insertion site without requiring special headgear. METHODS: The system is comprised of a pair of stereo cameras, a projector, and a computational unit with a touch screen. All components are designed to be used within the MRI suite (Zone 4). Multi-modality fiducial markers called VisiMARKERs, detectable in both MRI and camera images, facilitate automatic registration after the initial scan. The navigation feedback is projected directly onto the intervention site allowing the interventionalist to keep their focus on the insertion site instead of a secondary monitor which is often not in front of them. RESULTS: We evaluated the feasibility and accuracy of this system on custom-built shoulder phantoms. Two radiologists used the system to select targets and entry points on initial MRIs of these phantoms over three sessions. They performed 80 needle insertions following the projected guidance. The system targeting error was 1.09 mm, and the overall error was 2.29 mm. CONCLUSION: We demonstrated both feasibility and accuracy of this MRI navigation system. The system operated without any problems inside the MRI suite close to the MRI bore. The two radiologists were able to easily follow the guidance and place the needle close to the target without any intermediate imaging.

Modeling of Ultrasound Stimulation of Adolescent Pancreas for Insulin Release Therapy.

OBJECTIVES: Our previous published studies have focused on safety and effectiveness of using therapeutic ultrasound (TUS) for treatment of type 2 diabetes mellitus (T2DM) in preclinical models. Here we present a set of simulation studies to explore potential ultrasound application schemes that would be feasible in a clinical setting. METHODS: Using the multiphysics modeling tool OnScale, we created two-dimensional (2D) models of the human abdomen from CT images captured from one normal weight adolescent patient, and one obese adolescent patient. Based on our previous studies, the frequency of our TUS was 1 MHz delivered from a planar unfocused transducer. We tested five different insonation angles, as well as four ultrasound intensities combined with four different duty factors and five durations of application to explore how these variables effect the peak pressure and temperature delivered to the pancreas as well as surrounding tissue in the model. RESULTS: We determined that ultrasound applied directly from the anterior of the patient abdomen at 5 W/cm2 delivered consistent acoustic pressures to the pancreas at the levels which we have previously found to be effective at inducing an insulin release from preclinical models. CONCLUSIONS: Our modeling work indicates that it may be feasible to non-invasively apply TUS in clinical treatment of T2DM.

Benign Bone Tumors: State of the Art in Minimally Invasive Percutaneous Interventions.

Painful benign bone tumors most commonly affect pediatric patients and young adults. They may be associated with skeletal-related events such as intractable pain, pathologic fracture, neurologic deficit as a consequence of nerve or spinal cord compression, as well as growth disturbance. Consequently, they often result in diminished activity and adversely affect quality of life. There have been substantial recent advances in percutaneous minimally invasive image-guided interventions for treatment of painful benign bone tumors including thermal ablation (radiofrequency ablation, cryoablation, microwave ablation, laser photocoagulation, and high-intensity focused US ablation), chemical (alcohol) ablation, cementoplasty, and intralesional injections. The safety, efficacy, and durability of such interventions have been established in the recent literature and as such, the role of musculoskeletal interventional radiologists in the care of patients with benign bone lesions has substantially expanded. The treatment goal of minimally invasive musculoskeletal interventions in patients with benign bone tumors is to achieve definitive cure. The authors detail the most recent advances and available armamentarium in minimally invasive image-guided percutaneous interventions with curative intent for the management of benign bone tumors. © RSNA, 2022.

A Study of Postoperative Complications Occurring at Home With Pediatric Gastrostomy Feeding Tubes.

OBJECTIVE: Gastrostomy tubes (G-tubes) provide long-term feeding assistance to children with severe feeding dysfunction. Although there are a host of complications that occur at home with current pediatric G-tube feeding, their prevalences and outcomes remain relatively unstudied. This study aims to identify and describe such complications. METHODS: A dual-round survey was administered to 98 participants through the Feeding Tube Awareness Foundation, a 501(c)(3) organization that supports parents and caretakers of G-tube-fed children. Information was collected broadly regarding G-tube complications, causes, and attitudes toward such complications. RESULTS: Infection (56%), itching/irritation/redness (52%), and leakage (51%) were the leading G-tube related complications. The average time that G-tubes were replaced was 3.4 ± 1.2 months as compared to the typical recommended period of up to 6 months. Of the caretakers who had not experienced G-tube displacement, 7.9% wanted to see a change in current G-tubes to address the issue, compared with 75% of those who had experienced displacement. This 67.1% differential in caretakers' attitudes toward G-tubes based on their prior experience with a particular complication was the largest gap among all other listed complications. CONCLUSIONS: G-tube complications are prevalent and varied. A sizable portion of G-tube users experience complications severe enough to require intervention. Of these, G-tube displacement is particularly critical and frequently precedes other prevalent complications, namely gastric leakage, infection, and tissue granulation.

Focused Ultrasound for Pediatric Diseases.

Focused ultrasound (FUS) is a noninvasive therapeutic technology with multiple pediatric clinical applications. The ability of focused ultrasound to target tissues deep in the body without exposing children to the morbidities associated with conventional surgery, interventional procedures, or radiation offers significant advantages. In 2021, there are 10 clinical pediatric focused ultrasound studies evaluating various musculoskeletal, oncologic, neurologic, and vascular diseases of which 8 are actively recruiting and 2 are completed. Pediatric musculoskeletal applications of FUS include treatment of osteoid osteoma and bone metastases using thermal ablation and high-intensity FUS. Pediatric oncologic applications of FUS include treatment of soft tissue tumors including desmoid tumors, malignant sarcomas, and neuroblastoma with high-intensity FUS ablation alone, or in combination with targeted chemotherapy delivery. Pediatric neurologic applications include treatment of benign tumors such as hypothalamic hamartomas with thermal ablation and malignant diffuse intrinsic pontine glioma with low-intensity FUS for blood brain barrier opening and targeted drug delivery. Additionally, low-intensity FUS can be used to treat seizures. Pediatric vascular applications of FUS include treatment of arteriovenous malformations and twin-twin transfusion syndrome using ablation and vascular occlusion. FUS treatment appears safe and efficacious in pediatric populations across many subspecialties. Although there are 7 Food and Drug Administration-approved indications for adult applications of FUS, the first Food and Drug Administration approval for pediatric patients with osteoid osteoma was obtained in 2020. This review summarizes the preclinical and clinical research on focused ultrasound of potential benefit to pediatric populations.

MRI-guided lumbar spinal injections with body-mounted robotic system: cadaver studies.

INTRODUCTION: This paper reports the system integration and cadaveric assessment of a body-mounted robotic system for MRI-guided lumbar spine injections. The system is developed to enable MR-guided interventions in closed bore magnet and avoid problems due to patient movement during cannula guidance. MATERIAL AND METHODS: The robot is comprised by a lightweight and compact structure so that it can be mounted directly onto the lower back of a patient using straps. Therefore, it can minimize the influence of patient movement by moving with the patient. The MR-Conditional robot is integrated with an image-guided surgical planning workstation. A dedicated clinical workflow is created for the robot-assisted procedure to improve the conventional freehand MRI-guided procedure. RESULTS: Cadaver studies were performed with both freehand and robot-assisted approaches to validate the feasibility of the clinical workflow and to assess the positioning accuracy of the robotic system. The experiment results demonstrate that the root mean square (RMS) error of the target position to be 2.57 ± 1.09 mm and of the insertion angle to be 2.17 ± 0.89°. CONCLUSION: The robot-assisted approach is able to provide more accurate and reproducible cannula placements than the freehand procedure, as well as to reduce the number of insertion attempts.

HoloUS: Augmented reality visualization of live ultrasound images using HoloLens for ultrasound-guided procedures.

PURPOSE: Microsoft HoloLens is a pair of augmented reality (AR) smart glasses that could improve the intraprocedural visualization of ultrasound-guided procedures. With the wearable HoloLens headset, an ultrasound image can be virtually rendered and registered with the ultrasound transducer and placed directly in the practitioner's field of view. METHODS: A custom application, called HoloUS, was developed using the HoloLens and a portable ultrasound machine connected through a wireless network. A custom 3D-printed case with an AR-pattern for the ultrasound transducer permitted ultrasound image tracking and registration. Voice controls on the HoloLens supported the scaling and movement of the ultrasound image as desired. The ultrasound images were streamed and displayed in real-time. A user study was performed to assess the effectiveness of the HoloLens as an alternative display platform. Novices and experts were timed on tasks involving targeting simulated vessels using a needle in a custom phantom. RESULTS: Technical characterization of the HoloUS app was conducted using frame rate, tracking accuracy, and latency as performance metrics. The app ran at 25 frames/s, had an 80-ms latency, and could track the transducer with an average reprojection error of 0.0435 pixels. With AR visualization, the novices' times improved by 17% but the experts' times decreased slightly by 5%, which may reflect the experts' training and experience bias. CONCLUSION: The HoloUS application was found to enhance user experience and simplify hand-eye coordination. By eliminating the need to alternately observe the patient and the ultrasound images presented on a separate monitor, the proposed AR application has the potential to improve efficiency and effectiveness of ultrasound-guided procedures.

Feasibility of magnetic resonance-guided high-intensity focused ultrasound treatment targeting distinct nodular lesions in neurofibromatosis type 1.

BACKGROUND: Patients with Neurofibromatosis Type 1 (NF1) and plexiform neurofibromas (PN) often have radiographically diagnosed distinct nodular lesions (DNL) which can cause pain and weakness. Magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) can precisely and accurately deliver heat to thermally ablate target tissue. The aim of this study is to evaluate whole-body MRIs from patients with NF1 and DNL, applying volumetrics and a consistent treatment planning approach to determine the feasibility of MR-HIFU ablation of DNL. METHODS: A retrospective review of whole-body MRI scans from patients with NF1 and PN from CNH and NCI was performed. DNL are defined as lesions >3 cm, distinct from PN and lacking the "central dot" feature. Criteria for MR-HIFU thermal ablation include target location 1-8 cm from skin surface; >1 cm from visible plexus, spinal canal, bladder, bowel, physis; and ability to ablate ≥50% of lesion volume. Lesions in skull and vertebral body were excluded. RESULTS: In 26 patients, 120 DNL were identified. The majority of DNL were located in an extremity (52.5%). Other sites included head/neck (7%), chest (13%), and abdomen/pelvis (28%). The predefined HIFU ablation criteria was not met for 47.5% of lesions (n = 57). The main limitation was proximity to a vital structure or organ (79%). Complete and partial HIFU ablation was feasible for 25% and 27.5% of lesions, respectively. CONCLUSION: Based on imaging review of lesion location, technical considerations and ability to target lesions, thermal ablation with MR-HIFU may be a feasible noninvasive alternative for symptom management in patients with NF1 and symptomatic DNL.

Aortic quadfurcation with persistent left sciatic artery: an extremely rare anatomic variant in a 3-year-old boy.

Reports of aortoiliac variant anatomy are rare, especially in the pediatric population. A 3-year-old male patient with hypertension and left foot polydactyly with syndactyly was referred to our interventional radiology service for evaluation of a possible renovascular cause of the hypertension. Angiograms revealed an extremely rare anatomic variant consisting of the absence of the common iliac arteries bilaterally, resulting from quadfurcation of the abdominal aorta into the bilateral internal and external iliac arteries. Additionally, a persistent left sciatic artery was identified.

Body-Mounted Robotic System for MRI-Guided Shoulder Arthrography: Cadaver and Clinical Workflow Studies.

This paper presents an intraoperative MRI-guided, patient-mounted robotic system for shoulder arthrography procedures in pediatric patients. The robot is designed to be compact and lightweight and is constructed with nonmagnetic materials for MRI safety. Our goal is to transform the current two-step arthrography procedure (CT/x-ray-guided needle insertion followed by diagnostic MRI) into a streamlined single-step ionizing radiation-free procedure under MRI guidance. The MR-conditional robot was evaluated in a Thiel embalmed cadaver study and healthy volunteer studies. The robot was attached to the shoulder using straps and ten locations in the shoulder joint space were selected as targets. For the first target, contrast agent (saline) was injected to complete the clinical workflow. After each targeting attempt, a confirmation scan was acquired to analyze the needle placement accuracy. During the volunteer studies, a more comfortable and ergonomic shoulder brace was used, and the complete clinical workflow was followed to measure the total procedure time. In the cadaver study, the needle was successfully placed in the shoulder joint space in all the targeting attempts with translational and rotational accuracy of 2.07 ± 1.22 mm and 1.46 ± 1.06 degrees, respectively. The total time for the entire procedure was 94 min and the average time for each targeting attempt was 20 min in the cadaver study, while the average time for the entire workflow for the volunteer studies was 36 min. No image quality degradation due to the presence of the robot was detected. This Thiel-embalmed cadaver study along with the clinical workflow studies on human volunteers demonstrated the feasibility of using an MR-conditional, patient-mounted robotic system for MRI-guided shoulder arthrography procedure. Future work will be focused on moving the technology to clinical practice.

Comparison of Smartphone Augmented Reality, Smartglasses Augmented Reality, and 3D CBCT-guided Fluoroscopy Navigation for Percutaneous Needle Insertion: A Phantom Study.

PURPOSE: To compare needle placement performance using an augmented reality (AR) navigation platform implemented on smartphone or smartglasses devices to that of CBCT-guided fluoroscopy in a phantom. MATERIALS AND METHODS: An AR application was developed to display a planned percutaneous needle trajectory on the smartphone (iPhone7) and smartglasses (HoloLens1) devices in real time. Two AR-guided needle placement systems and CBCT-guided fluoroscopy with navigation software (XperGuide, Philips) were compared using an anthropomorphic phantom (CIRS, Norfolk, VA). Six interventional radiologists each performed 18 independent needle placements using smartphone (n = 6), smartglasses (n = 6), and XperGuide (n = 6) guidance. Placement error was defined as the distance from the needle tip to the target center. Placement time was recorded. For XperGuide, dose-area product (DAP, mGy*cm2) and fluoroscopy time (sec) were recorded. Statistical comparisons were made using a two-way repeated measures ANOVA. RESULTS: The placement error using the smartphone, smartglasses, or XperGuide was similar (3.98 ± 1.68 mm, 5.18 ± 3.84 mm, 4.13 ± 2.38 mm, respectively, p = 0.11). Compared to CBCT-guided fluoroscopy, the smartphone and smartglasses reduced placement time by 38% (p = 0.02) and 55% (p = 0.001), respectively. The DAP for insertion using XperGuide was 3086 ± 2920 mGy*cm2, and no intra-procedural radiation was required for augmented reality. CONCLUSIONS: Smartphone- and smartglasses-based augmented reality reduced needle placement time and radiation exposure while maintaining placement accuracy compared to a clinically validated needle navigation platform.

Pediatric lung imaging features of COVID-19: A systematic review and meta-analysis.

RATIONALE: Pediatric COVID-19 studies have been mostly restricted to case reports and small case series, which have prevented the identification of specific pediatric lung disease patterns in COVID-19. The overarching goal of this systematic review and meta-analysis is to provide the first comprehensive summary of the findings of published studies thus far describing COVID-19 lung imaging data in the pediatric population. METHODS: A systematic literature search of PubMed was performed to identify studies assessing lung-imaging features of COVID-19 pediatric patients (0-18 years). A single-arm meta-analysis was conducted to obtain the pooled prevalence and 95% confidence interval (95% CI). RESULTS: A total of 29 articles (n = 1026 children) based on chest computerized tomography (CT) images were included. The main results of this comprehensive analysis are as follows: (1) Over a third of pediatric patients with COVID-19 (35.7%, 95% CI: 27.5%-44%) had normal chest CT scans and only 27.7% (95% CI: 19.9%-35.6%) had bilateral lesions. (2) The most typical pediatric chest CT findings of COVID-19 were ground-glass opacities (GGO) (37.2%, 95% CI: 29.3%-45%) and the presence of consolidations or pneumonic infiltrates (22.3%, 95% CI: 17.8%-26.9%). (3) The lung imaging findings in children with COVID-19 were overall less frequent and less severe than in adult patients. (4) Typical lung imaging features of viral respiratory infections in the pediatric population such as increased perihilar markings and hyperinflation were not reported in children with COVID-19. CONCLUSION: Chest CT manifestations in children with COVID-19 could potentially be used for early identification and prompt intervention in the pediatric population.