Objective: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. Methods: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. Results: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9 ± 4.2 N, 46.7 ± 1.9 N, 25.6 ± 0.7 N, 13.5 ± 0.6 N and 6.3 ± 0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm. Conclusion: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects. Significance: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.

@en

Purpose: To present a novel methodical approach to compare visibility of percutaneous needles in ultrasound images. Methods: A motor-driven rotation platform was used to gradually change the needle angle while capturing image data. Data analysis was automated using block-matching-based registration, with a tracking and refinement step. Every 25 frames, a Hough transform was used to improve needle alignments after large rotations. The method was demonstrated by comparing three commercial needles (14G radiofrequency ablation, RFA; 18G Trocar; 22G Chiba) and six prototype needles with different sizes, materials, and surface conditions (polished, sand-blasted, and kerfed), within polyvinyl alcohol phantom tissue and ex vivo bovine liver models. For each needle and angle, a contrast-to-noise ratio (CNR) was determined to quantify visibility. CNR values are presented as a function of needle type and insertion angle. In addition, the normalized area under the (CNR-angle) curve was used as a summary metric to compare needles. Results: In phantom tissue, the first kerfed needle design had the largest normalized area of visibility and the polished 1 mm diameter stainless steel needle the smallest (0.704 ± 0.199 vs. 0.154 ± 0.027, p < 0.01). In the ex vivo model, the second kerfed needle design had the largest normalized area of visibility, and the sand-blasted stainless steel needle the smallest (0.470 ± 0.190 vs. 0.127 ± 0.047, p < 0.001). As expected, the analysis showed needle visibility peaks at orthogonal insertion angles. For acute or obtuse angles, needle visibility was similar or reduced. Overall, the variability in needle visibility was considerably higher in livers. Conclusion: The best overall visibility was found with kerfed needles and the commercial RFA needle. The presented methodical approach to quantify ultrasound visibility allows comparisons of (echogenic) needles, as well as other technological innovations aiming to improve ultrasound visibility of percutaneous needles, such as coatings, material treatments, and beam steering approaches.

@en

During ultrasound-guided percutaneous interventions, needle localization can be a challenge. To increase needle visibility, enhancements of both the imaging methods and the needle surface properties have been investigated. However, a methodical approach to compare potential solutions is currently unavailable. The work described here involves automated image acquisition, analysis and reporting techniques to collect large amounts of data efficiently, delineate relevant factors and communicate effects. Data processing included filtering, line fitting and image intensity analysis steps. Foreground and background image samples were used to compute a contrast-to-noise ratio or a signal ratio. The approach was evaluated in a comparative study of commercially available and custom-made needles. Varied parameters included needle material, diameter and surface roughness. The shafts with kerfed patterns and the trocar and chiba tips performed best. The approach enabled an intuitive polar depiction of needle visibility in ultrasound images for a large range of insertion angles.

@en

Radio frequency ablation is commonly used in the treatment of hepatocellular carcinoma. Clinicians rely on imaging techniques, such as medical ultrasound, to confirm an accurate needle placement. This accuracy may improve by means of active needle steering techniques, which are currently in development. Needle steering will likely increase the clinician’s reliance on imaging techniques. This has motivated the study of the echogenicity of steerable needle joint structures. Two needles were manufactured with arrays of kerfs, similar to the compliant joint structures found in steerable needles. The needle visibility was compared to a smooth surface needle and a commercially available RFA needle. The visibility was quantified for both the shaft and tip, by means of a contrast-to-noise ratio (CNR). CNR data were obtained for three insertion angles. The results show that the CNRs of the compliant joint structures were consistently higher than those of the smooth surface needle, whereas they were either higher than or comparable to those of the RFA needle. For acute insertion angles, the bevel tip of the RFA needle had a higher CNR than the conical tip of the kerfed needles, motivating the extension of this visibility study to the full needle design.@en