Orthopedic surgery relies on bone drills to create tunnels for fracture fixation, bone fusion, or tendon repair. Traditional rigid and straight bone drills often pose challenges in accessing the desired entry points without risking damage to the surrounding anatomical structures, especially in minimal invasive procedures. In this study, we explore the use of hydraulic pressure waves in a flexible bone design to facilitate bone drilling. The HydroFlex Drill includes a handle for generating a hydraulic pressure wave in the flexible, fluid-filled shaft to transmit an impulse to the hammer tip, enabling bone drilling. We evaluated seven different hammer tip shapes to determine their impact on drilling efficiency. Subsequently, the most promising tip was implemented in the HydroFlex Drill. The HydroFlex Drill Validation demonstrated the drill's ability to successfully transfer the impulse generated in the handle to the hammer tip, with the shaft in different curves. This combined with the drill's ability to create indentations in bone phantom material is a promising first step towards the development of a flexible or even steerable bone drill. With ongoing research to enhance the drilling efficiency, the HydroFlex Drill opens possibilities for a range of orthopedic surgical procedures where minimally invasive drilling is essential.@en

Metal additive manufacturing is a promising technology for the production of functional medical products, due to its high shape complexity and resolution, and ability to withstand sterilization temperatures. This study explores the possibility of designing a completely non-assembly steerable surgical instrument using Selective Laser Melting. Despite its advantages for medical devices, the rough surface quality of unfinished parts can be problematic for non-assembly designs, leading to increased friction and wear in rigid body mechanisms and tendon-actuated mechanisms. We investigated printing of rolling contact joints with crossed flexures as low-friction joints, adjusted for printing in titanium for the design of the instrument. Grid-based lattice structures were incorporated as miniature flexures, and we explored the influence of various grid sizes on the flexibility and bending stiffness of the lattices. Based on this exploration, we altered the rolling joint configuration from two crossed flexures to a single straight flexure for our design. The resulting steerable surgical instrument design is completely non-assembly, including its actuation, facilitates easy removal of support structures, and requires no surface finishing steps. It has a diameter of less than 20 mm, facilitates opening and closing of a grasper, and steering of the grasper by 20 degrees.

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In percutaneous interventions, needles are used to reach target locations inside the body. However, when the needle is pushed through the tissue, forces arise at the needle tip and along the needle body, making the needle prone to buckling. Recently, needles that prevent buckling inspired by the ovipositor of female parasitic wasps have been developed. Building on these needle designs, this study proposes a manual actuation unit that allows the operator to drive the wasp-inspired needle through stationary tissue. The needle consists of six 0.3-mm spring steel wires, of which one is advanced while the others are retracted. The advancing needle segment has to overcome a cutting and friction force while the retracting ones experience a friction force in the opposite direction. The actuation unit moves the needle segments in the required sequence using a low-friction ball spline mechanism. The moving components of the needle have low inertia, and its connection to the actuation unit using a ball spline introduces a small friction force, generating a small push force on the needle that facilitates the needle’s propulsion into tissue while preventing needle buckling. Experimental testing evaluated the needle’s ability to move through stationary 15-wt% gelatin tissue phantoms for different actuation velocities. It was found that the needle moved through the tissue phantoms with mean slip ratios of 0.35, 0.31, and 0.29 for actuation velocities of π, 2π, and 3π rad/s, respectively. Furthermore, evaluation in 15-wt%, 10-wt%, and 5-wt% gelatin tissue phantoms showed that decreasing the gelatin concentration decreased the mean slip ratios from 0.35 to 0.19 and 0.18, respectively. The needle actuation system design is a step forward in developing a wasp-inspired needle for percutaneous procedures that prevents buckling.@en

Pedicle screws have long been established as the gold standard for spinal bone fixation. However, their fixation strength can be compromised in cases of low bone density, particularly in osteoporotic bone, due to the reliance on a micro-shape lock between the screw thread and the surrounding bone. To address this challenge, we propose augmenting conventional pedicles screws with a curved compliant anchor. This anchor integrates a curved super-elastic nitinol rod that is advanced through a canulated pedicle screw, forming a macro-shape lock within the vertebral body to aid the fixation strength. Both placement safety and fixation strength of this novel spinal bone anchor were validated on tissue phantoms (Sawbones). The radius of the curved compliant anchor’s path demonstrates high precision while exhibiting strong dependence on the bone density in which the anchor is placed. When the curved compliant anchor is combined with a conventional pedicle screw, the mean maximum pull-out force elevated to 290 N, marking a 14% enhancement in pull-out resistance compared to using pedicle screw alone. Further augmentation with multiple curved compliant anchors holds promise for even greater fixation. The application of a curved compliant spinal bone anchor offers a promising means of increasing the fixation strength of pedicles screws, which is especially relevant in challenging clinical scenarios such a patient suffering from osteoporosis.@en

Transperineal laser ablation is a minimally invasive thermo-ablative treatment for prostate cancer that requires the insertion of a needle for accurate optical fiber positioning. Needle insertion in soft tissues may cause tissue motion and deformation, resulting in tissue damage and needle positioning errors. In this study, we present a wasp-inspired self-propelled needle that uses pneumatic actuation to move forward with zero external push force, thus avoiding large tissue motion and deformation. The needle consists of six parallel 0.25-mm diameter Nitinol rods driven by a pneumatic actuation system. The pneumatic actuation system consists of Magnetic Resonance (MR) safe 3D-printed parts and off-the-shelf plastic screws. A self-propelled motion is achieved by advancing the needle segments one by one, followed by retracting them simultaneously. The advancing needle segment has to overcome a cutting and friction force, while the stationary needle segments experience a friction force in the opposite direction. The needle self-propels through the tissue when the friction force of the five stationary needle segments overcomes the sum of the friction and cutting forces of the advancing needle segment. We evaluated the prototype’s performance in 10-wt% gelatin phantoms and ex vivo porcine liver tissue inside a preclinical Magnetic Resonance Imaging (MRI) scanner in terms of the slip ratio of the needle with respect to the phantom or liver tissue. Our results demonstrated that the needle was able to self-propel through the phantom and liver tissue with slip ratios of 0.912–0.955 and 0.88, respectively. The prototype is a promising step toward the development of self-propelled needles for MRI-guided transperineal laser ablation as a method to treat prostate cancer.@en

Introduction: This study focuses on the quantification of and current guidelines on the hazards related to needle positioning in prostate cancer treatment: (1) access restrictions to the prostate gland by the pubic arch, so-called Pubic Arch Interference (PAI) and (2) needle positioning errors. Next, we propose solution strategies to mitigate these hazards. Methods: The literature search was executed in the Embase, Medline ALL, Web of Science Core Collection*, and Cochrane Central Register of Controlled Trials databases. Results: The literature search resulted in 50 included articles. PAI was reported in patients with various prostate volumes. The level of reported PAI varied between 0 and 22.3 mm, depending on the patient’s position and the measuring method. Low-Dose-Rate Brachytherapy induced the largest reported misplacement errors, especially in the cranio-caudal direction (up to 10 mm) and the largest displacement errors were reported for High-Dose-Rate Brachytherapy in the cranio-caudal direction (up to 47 mm), generally increasing over time. Conclusions: Current clinical guidelines related to prostate volume, needle positioning accuracy, and maximum allowable PAI are ambiguous, and compliance in the clinical setting differs between institutions. Solutions, such as steerable needles, assist in mitigating the hazards and potentially allow the physician to proceed with the procedure. This systematic review was performed in accordance with the PRISMA guidelines. The review was registered at Protocols.io (DOI: dx.doi.org/10.17504/protocols.io.6qpvr89eplmk/v1).

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The success rate of spinal fusion surgery is mainly determined by the fixation strength of the spinal bone anchors. This study explores the use of an L-shaped spinal bone anchor that is intended to establish a macro-shape lock with the posterior cortical layer of the vertebral body, thereby increasing the pull-out resistance of the anchor. The performance of this L-shaped anchor was evaluated in lumbar vertebra phantoms (L1-L5) across four distinct perpendicular orientations (lateral, medial, superior, and inferior). During the pull-out experiments, the pull-out force, and the displacement of the anchor with respect to the vertebra was measured which allowed the determination of the maximal pull-out force (mean: 123 N ± 25 N) and the initial pull-out force, the initial force required to start motion of the anchor (mean: 23 N ± 16 N). Notably, the maximum pull-out force was observed when the anchor engaged the cortical bone layer. The results demonstrate the potential benefits of utilising a spinal bone anchor featuring a macro-shape lock with the cortical bone layer to increase the pull-out force. Combining the macro shape-lock fixation method with the conventional pedicle screw shows the potential to significantly enhance the fixation strength of spinal bone anchors.@en

Pipelines, vital for fluid transport, pose an important yet challenging inspection task, particularly in small, flexible biological systems, that robots have yet to master. In this study, we explored the development of an innovative robot inspired by the ovipositor of parasitic wasps to navigate and inspect pipelines. The robot features a flexible locomotion system that adapts to different tube sizes and shapes through a mechanical inflation technique. The flexible locomotion system employs a reciprocating motion, in which groups of three sliders extend and retract in a cyclic fashion. In a proof-of-principle experiment, the robot locomotion efficiency demonstrated positive linear correlation (r = 0.6434) with the diameter ratio (ratio of robot diameter to tube diameter). The robot showcased a remarkable ability to traverse tubes of different sizes, shapes and payloads with an average of (70%) locomotion efficiency across all testing conditions, at varying diameter ratios (0.7 1.5). Furthermore, the mechanical inflation mechanism displayed substantial load-carrying capacity, producing considerable holding force of (13 N), equivalent to carrying a payload of (≈5.8 Kg) inclusive the robot weight. This soft robotic system shows promise for inspection and navigation within tubular confined spaces, particularly in scenarios requiring adaptability to different tube shapes, sizes, and load-carrying capacities. The design of this system serves as a foundation for a new class of pipeline inspection robots that exhibit versatility across various pipeline environments, potentially including biological systems.

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While articulated surgical instruments have enabled the proliferation of minimally invasive interventions, procedures such as laparo-endoscopic single-site surgery are waning in popularity. One potential reason for this decline is a lack of sufficiently dexterous instruments. Although multi-steerable instruments exist, these are often complex and therefore expensive assemblies. Even when 3D printing was used to simplify the design of these instruments, the requirement for high-performance 3D printers limited the reduction in manufacturing costs. To tackle this issue, we propose six guidelines for converting a 3D printed compliant medical instrument from printing on a Digital Light Processing (DLP) printer to a Fused Filament Fabrication (FFF) printer. These guidelines provide a framework to manage and compensate for differences in the two processes to achieve comparable results at a reduced cost. The proposed guidelines were evaluated by assembling a FFF 3D printed prototype that shows equivalent performance to its DLP 3D printed counterpart.

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Needles are commonly used in medical procedures. However, current needle designs have some disadvantages. Therefore, a new generation of hypodermic needles and microneedle patches drawing inspiration from mechanisms found in nature (i.e. bioinspiration) is being developed. In this systematic review, 80 articles were retrieved from Scopus, Web of Science, and PubMed and classified based on the strategies for needle-tissue interaction and propulsion of the needle. The needle-tissue interaction was modified to reduce grip for smooth needle insertion or enlarge grip to resist needle retraction. The reduction of grip can be achieved passively through form modification and actively through translation and rotation of the needle. To enlarge grip, interlocking with the tissue, sucking the tissue, and adhering to the tissue were identified as strategies. Needle propelling was modified to ensure stable needle insertion, either through external (i.e. applied to the prepuncturing movement of the needle) or internal (i.e. applied to the postpuncturing movement of the needle) strategies. External strategies include free-hand and guided needle insertion, while friction manipulation of the tissue was found to be an internal strategy. Most needles appear to be using friction reduction strategies and are inserted using a free-hand technique. Furthermore, most needle designs were inspired by insects, specifically parasitoid wasps, honeybees, and mosquitoes. The presented overview and description of the different bioinspired interaction and propulsion strategies provide insight into the current state of bioinspired needles and offer opportunities for medical instrument designers to create a new generation of bioinspired needles.

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Conventional medical instruments are not capable of passing through tortuous anatomy as required for natural orifice transluminal endoscopic surgery due to their rigid shaft designs. Nevertheless, developments in minimally invasive surgery are pushing medical devices to become more dexterous. Amongst devices with controllable flexibility, so-called Follow-The-Leader (FTL) devices possess motion capabilities to pass through confined spaces without interacting with anatomical structures. The goal of this literature study is to provide a comprehensive overview of medical devices with FTL motion. A scientific and patent literature search was performed in five databases (Scopus, PubMed, Web of Science, IEEExplore, Espacenet). Keywords were used to isolate FTL behavior in devices with medical applications. Ultimately, 35 unique devices were reviewed and categorized. Devices were allocated according to their design strategies to obtain the three fundamental sub-functions of FTL motion: steering, (controlling the leader/end-effector orientation), propagation, (advancing the device along a specific path), and conservation (memorizing the shape of the path taken by the device). A comparative analysis of the devices was carried out, showing the commonly used design choices for each sub-function and the different combinations. The advantages and disadvantages of the design aspects and an overview of their performance were provided. Devices that were initially assessed as ineligible were considered in a possible medical context or presented with FTL potential, broadening the classification. This review could aid in the development of a new generation of FTL devices by providing a comprehensive overview of the current solutions and stimulating the search for new ones.

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Introduction: Bone biopsies have great value for the diagnosis of, amongst others, hematologic diseases. Although the bone biopsy procedure is mostly performed minimally invasive with the use of a slender cannula, the patient may still experience discomfort, especially when the procedure has to be repeated due to an unsuccessful biopsy. Areas covered: This review presents a comprehensive overview of bone biopsy devices presented in the patent literature. The patents were obtained using a classification search combined with keywords in the Espacenet patent database and were subsequently verified using pre-set eligibility criteria. This resulted in 62 unique patents included in this review. Expert opinion: The included patents were categorized based on the used strategies for the three steps that can be identified during a bone biopsy (1) biopsy sampling, (2) biopsy severing and (3) biopsy harvesting. Most patents described strategies for multiple steps. Insight into the used strategies and the comprehensive overview may serve as a source of inspiration for the design of novel bone biopsy devices.

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A vitrectome is a commonly used instrument in eye surgery, which is used to cut and aspirate the vitreous body out of the eye. The mechanism of the vitrectome consists of miniature components that need to be assembled by hand due to their size. Non-assembly 3D printing, in which fully functional mechanisms can be produced in a single production step, can help create a more streamlined production process. We propose a vitrectome design based on a dual-diaphragm mechanism, which can be produced with minimal assembly steps using PolyJet printing. Two different diaphragm designs were tested to fulfill the requirements of the mechanism: a homogenous design based on ‘digital’ materials and a design using an ortho-planar spring. Both designs were able to fulfill the required displacement for the mechanism of 0.8 mm, as well as cutting forces of at least 8 N. The requirements for the cutting speed of the mechanism of 8000 RPM were not fulfilled by both designs, since the viscoelastic nature of the PolyJet materials resulted in a slow response time. The proposed mechanism does show promise to be used in vitrectomy; however, we suggest that more research into different design directions is required. @en

The fixation strength of pedicle screws could be increased by fixating along the much stronger cortical bone layer, which is not possible with the current rigid and straight bone drills. Inspired by the tsetse fly, a single-plane steerable bone drill was developed. The drill has a flexible transmission using two stacked leaf springs such that the drill is flexible in one plane and can drill along the cortical bone layer utilizing wall guidance. A proof-of-principle experiment was performed which showed that the Tsetse Drill was able to successfully drill through 5, 10 and 15 PCF cancellous bone phantom which has similar mechanical properties to severe osteoporotic, osteoporotic and healthy cancellous bone. Furthermore, the Tsetse Drill was able to successfully steer and drill along the cortical wall utilizing wall guidance for an insertion angle of 5°, 10° and 15°. The experiments conclude that the tsetse fly-inspired drilling method is successful and even allows the drilling along the cortical bone layer. The Tsetse Drill can create curved tunnels utilizing wall guidance which could increase the fixation strength of bone anchors and limit the risk of cortical breach and damage to surrounding anatomy.@en

Magnetostrictive strain sensors with high spinorbit coupling have been integrated with Fiber-Bragg-Grating sensors wherein the gap within the gratings varies with strain within the encapsulating magnetostrictive material. Terfenol-D has been chosen as the mm sized magnetostrictive material which exhibits the largest known bulk magnetostriction. The setup utilised consists of an optical to electrical transducer leading to lower noise in the system while carrying out sensing in the magneto-optic domain. Non-linear isotropic analytical modeling and linear anisotropic finite element modeling is carried out to gain further insight into the variation of material parameters with external magnetic field intensity. The operated magnetic fields lie within 100 µT with a sensor sensitivity of 0.6 kHz/ppm, thus reducing risks due to any prolonged or repeated exposure. This technology can be integrated with state-of-the-art sensors with high sensitivity to create smaller and safer tracking systems, particularly in-vivo.

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Purpose: To create an updated and comprehensive overview of the modeling studies that have been done to understand the mechanics underlying deformities of adolescent idiopathic scoliosis (AIS), to predict the risk of curve progression and thereby substantiate etiopathogenetic theories. Methods: In this systematic review, an online search in Scopus and PubMed together with an analysis in secondary references was done, which yielded 86 studies. The modeling types were extracted and the studies were categorized accordingly. Results: Animal modeling, together with machine learning modeling, forms the category of black box models. This category is perceived as the most clinically relevant. While animal models provide a tangible idea of the biomechanical effects in scoliotic deformities, machine learning modeling was found to be the best curve-progression predictor. The second category, that of artificial models, has, just as animal modeling, a tangible model as a result, but focusses more on the biomechanical process of the scoliotic deformity. The third category is formed by computational models, which are very popular in etiopathogenetic parameter-based studies. They are also the best in calculating stresses and strains on vertebrae, intervertebral discs, and other surrounding tissues. Conclusion: This study presents a comprehensive overview of the current modeling techniques to understand the mechanics of the scoliotic deformities, predict the risk of curve progression in AIS and thereby substantiate etiopathogenetic theories. Although AIS remains to be seen as a complex and multifactorial problem, the progression of its deformity can be predicted with good accuracy. Modeling of AIS develops rapidly and may lead to the identification of risk factors and mitigation strategies in the near future. The overview presented provides a basis to follow this development.

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Parts produced with metal additive manufacturing often suffer from a poor surface finish. Surface finishing techniques are effective to improve the quality of 3D printed surfaces, however they have as downsides that they also slightly change the geometry of the part, in an unpredictable way. This effect on the geometrical features of complex parts has received little attention. In this research, we illustrate a method to visualize the impact of surface finishing techniques on geometrical features, as well as their effectiveness on parts with high shape-complexity, by using centrifugal disk finishing as a case study. We designed and 3D printed test parts with different features using selective laser melting, which were coated with a blue metal lacquer prior to polishing. After polishing, the blue lacquer was eroded away from the spots that were easily reached by the polishing process, yet had remained on the surfaces that could not be reached by the process. We used measurements of material removal and image processing of the remaining blue lacquer on the surfaces to analyze these effects. Using this method, we were able to derive a number of specific design guidelines that can be incorporated while designing metal AM parts for centrifugal disk finishing. We suggest that this visualization method can be applied to different polishing methods to gain insight into their influence, as well as being used as an aid in the design process.

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Gripping slippery and flexible tissues during minimal invasive surgery (MIS) is often challenging using a conventional tissue gripper. A force grip has to compensate for the low friction coefficient between the gripper’s jaws and the tissue surface. This study focuses on the development of a suction gripper. This device applies a pressure difference to grip the target tissue without the need to enclose it. Inspiration is taken from biological suction discs, as these are able to attach to a wide variety of substrates, varying from soft and slimy surfaces to rigid and rough rocks. Our bio-inspired suction gripper is divided into two main parts: (1) the suction chamber inside the handle where vacuum pressure is generated, and (2) the suction tip that attaches to the target tissue. The suction gripper fits through a ∅ 10 mm trocar and unfolds in a larger suction surface when being extracted. The suction tip is structured in a layered manner. The tip integrates five functions in separate layers to allow for safe and effective tissue handling: (1) foldability, (2) air-tightness, (3) slideability, (4) friction magnification and (5) seal generation. The contact surface of the tip creates an air-tight seal with the tissue and enhances frictional support. The suction tip’s shape grip allows for the gripping of small tissue pieces and enhances its resistance against shear forces. The experiments illustrated that our suction gripper outperforms man-made suction discs, as well as currently described suction grippers in literature in terms of attachment force ( 5.95 ± 0.52 N on muscle tissue) and substrate versatility. Our bio-inspired suction gripper offers the opportunity for a safer alternative to the conventional tissue gripper in MIS.

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Stereolithography is emerging as a promising additive manufacturing technology for a range of applications in the medical domain. However, for miniature, medical devices such as those used in ophthalmic surgery, a number of production challenges arise due to the small size of the components. In this work, we investigate the challenges of creating sub-millimeter features for a miniature, functional trocar using Stereolithography. The trocar cannula system is used in eye surgery to facilitate a passage for other instruments. A standard trocar consists of a hollow cannula and a flexible check valve. The research was performed in two stages: in the first stage we investigated the effect of different materials and print settings on the current design of the cannula and the valve separately, and in the second stage we used these findings to optimize the design and production process. After the first investigation, it became apparent that even though the dimensions of the trocar are within the feature size range of Stereolithography, all hollow features tended to fuse shut during printing. This effect appeared regardless of the materials or print settings, and can be attributed to refraction of the laser source. In order to circumvent this, we identified two potential strategies: (1) increasing the negative space surrounding features; and (2) decreasing the surface area per layer. By applying these strategies, we tested a new design for the cannula and valve and managed to 3D print a functional trocar, which was tested in an artificial eye. The design of the 3D printed trocar allows for further personalization depending on the specific requirements of both patient and surgeon. The proposed strategies can be applied to different applications to create miniature features using Stereolithography.@en

Navigation inside luminal organs is an arduous task that requires non-intuitive coordination between the movement of the operator's hand and the information obtained from the endoscopic video. The development of tools to automate certain tasks could alleviate the physical and mental load of doctors during interventions allowing them to focus on diagnosis and decision-making tasks. In this paper we present a synergic solution for intraluminal navigation consisting of a 3D printed endoscopic soft robot that can move safely inside luminal structures. Visual servoing based on Convolutional Neural Networks (CNNs) is used to achieve the autonomous navigation task. The CNN is trained with phantoms and in-vivo data to segment the lumen and a model-less approach is presented to control the movement in constrained environments. The proposed robot is validated in anatomical phantoms in different path configurations. We analyze the movement of the robot using different metrics such as task completion time smoothness error in the steady-state mean and maximum error. We show that our method is suitable to navigate safely in hollow environments and conditions which are different than the ones the network was originally trained on.@en