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

Currently existing tubular transportation systems for the extraction of large tissue masses during Minimal Invasive Surgery (MIS) are subjected to a large amount of operating limitations. In this study, a novel transportation mechanism (patented) was developed inspired by the egg-laying structure of wasps. The developed mechanism consists of an outer tube within which six reciprocating semi-cylindrical blades are present and tissue is transported using a friction differential between the blades. Two motion sequences were developed: (1) 1–5 motion sequence, in which one blade moves forward, while the remaining five blades move backward and (2) 2–4 motion sequence, in which four blades move backward while two blades move forward. A proof-of-principle experiment was performed to investigate the effects of tissue elasticity, tissue heterogeneity, and the motion sequence on the transportation rate [mg/s], transportation efficiency [%], and transportation reliability [%]. The mean transportation rate and reliability was highest for the 9 wt% gelatine phantoms at 4.21 ± 0.74 mg/s and the 1–5 sequence at 100%, respectively. The prototype has shown that the friction-based transportation principle has the potential of becoming a viable and reliable alternative to aspiration as a transportation method within MIS.

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During percutaneous interventions, medical needles are inserted through the skin inside the body to collect diagnostic samples or to inject substances in a minimally invasive manner. However, when the target to be reached is located deep inside the body, needle insertion becomes challenging: the needle should be long enough to reach the target, thin (diameter lower than 1 mm) to limit tissue damage, and preferably steerable in order to move around obstructing anatomical structures. No needle currently used in medical practice combines all these characteristics: slender (i.e., long-and-thin) needles are susceptible to buckling, and steerable mechanisms require space, inhibiting miniaturization. In nature, such needles exist. Some species of parasitic wasps use their slender ovipositor to puncture, advance and steer through solid substrates, such as fruits or wood. These wasps use a push-pull mechanism to advance their ovipositor through the substrate without buckling. Translating that mechanism into a technical system might help to solve the current challenges with medical needles. Accordingly, this thesis aimed to design, develop, and evaluate a new ovipositor-inspired ultra-thin (i.e., submillimetre diameter) and long needle that can self-propel through solid substrates. A series of needles were developed that combined morphological and functional features inspired by the ovipositor of parasitic wasps. The proposed bio-inspired needle design and mechanism of motion hold great promise to improve accuracy and safety during delicate percutaneous procedures and to perform those that are not yet possible.@en

Needles with diameter under 1 mm are used in various medical applications to limit the risk of complication and patient discomfort during the procedure. Next to a small diameter, needle steerability is an important property for reaching targets located deep inside the body accurately and precisely. In this paper, we present a 0.5-mm prototype probe which is able to steer in three dimensions (3D) without the need of axial rotation. The prototype consists of three Nitinol wires (each with a diameter of 0.125 mm) with a pre-curved tip. The wires are kept together by a stainless steel tube. Each wire is clamped to a block which translates along a leadscrew, the rotation of the latter being controlled by a wheel connected at the distal end of the leadscrew. The tip bends upon retraction of one or two wires. When pushed through a soft solid structure (e.g., a soft tissue or soft tissue phantom), the probe deflects due to off-axis forces acting on its tip by the surrounding structure. We tested the performance of the prototype into a 10% wt gelatine phantom, in terms of the predictability of the steering direction and the controllability of the final position after steering inside the substrate. The results showed that the probe steered in the direction of the retracted wire and that the final position varied from small deflections from the straight path when the wires were slightly retracted, to sharp curvatures for large wire retraction. The probe could be used in various applications, from cases where only a small correction of the path in one direction is needed to cases where the path to be followed includes obstacles and curves in multiple directions.

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In percutaneous interventions, reaching targets located deep inside the body with minimal tissue damage and patient pain requires the use of long and thin needles. However, when pushed through a solid substrate, a structure with a high aspect ratio is prone to buckle. We developed a series of multi-element needles with a diameter smaller than 1 mm and a length larger than 200 mm, and we experimentally evaluated the performance of a bio-inspired insertion mechanism that prevents needle buckling of such slender structures. The needles consisted of Nitinol wires and advance into a substrate by pushing the wires forward one after the other, followed by pulling all the wires simultaneously backward. The resulting net push force is low, allowing the needles to self-propel through the substrate. We investigated the effect of the needle design parameters (number of wires and their diameter) and substrate characteristics (stiffness and number of layers) on the needle motion. Three needle prototypes (consisting of six 0.25-mm wires, six 0.125-mm wires, and three 0.25-mm wires, respectively) were inserted into single- and multi-layered tissue-mimicking phantoms. The prototypes were able to move forward in all phantoms without buckling. The amount of needle slip with respect to the phantom was used to assess the performance of the prototypes. The six-wire 0.25-mm prototype exhibited the least slip among the three prototypes. Summarizing, we showed that a bio-inspired motion mechanism prevents buckling in very thin (diameter <1 mm), long (length >200 mm) needles, allowing deep insertion into tissue-mimicking phantoms.

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This work focuses on the design of a new device (called ChoRe) to place artificial chords in the mitral valve structure during a trans-catheter procedure. The aim of the device is to restore the correct functionality of the valve and solve mitral valve regurgitation, that is, a common consequence of chordae tendineae rupture. An analysis of the requirements was carried out and used to design and develop a first functional prototype. The resulting device was able to connect artificial chords at the posterior leaflet of the mitral valve and at the apex of the left ventricle, also allowing the control of the artificial chord length. The ChoRe was tested ex-vivo in bovine hearts. The qualitative assessment of the ChoRe focused on the performance of the device and preliminary evaluation of the procedure time. Results demonstrated that the device is able to create a top and bottom fixation in an average time of 3.45 ± 1.44 min. Future improvements will focus on enhancing the connection at the leaflet, as well as the overall functionality, in order to guarantee better control of the artificial chord length. This work shows future potentials for more patient-specific treatments in trans-catheter scenarios for mitral valve repair.

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Introduction: Conventional surgical drills are rigid straight instruments used to make holes in bones. They lack the ability to follow a curved pathway, making them impractical for several surgical procedures. For this reason, there is a continuous need for improved devices for surgical drilling of curved holes. Areas covered: This review provides a comprehensive overview and classification of the patent literature of surgical drills able to produce a curved hole. The goal is to identify the fundamental mechanical designs of the drills. The medical section of the Web of Science Derwent Innovation Index was scanned combining keywords for both steering and drilling. Overall, 41 unique patents were reviewed and categorized. Expert opinion: Drills were subdivided in four groups based on the capability of either drilling a single curved path or a multi-curved path and on their ability to adjust the path after insertion of the drill into the bone. We found patents describing instrument designs for all these four groups. The insight in the drilling capabilities and in the mechanical designs described in the patents may serve as a source of inspiration for the design of novel surgical drills and the development of new surgical procedures.

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Flexible steerable needles have the potential to allow surgeons to reach deep targets inside the human body with higher accuracy than rigid needles do. Furthermore, by maneuvering around critical anatomical structures, steerable needles could limit the risk of tissue damage. However, the design of a thin needle (e.g., diameter under 2 mm) with a multi-direction steering mechanism is challenging. The goal of this paper is to outline the design and experimental evaluation of a biologically inspired needle with a diameter under 2 mm that advances through straight and curved trajectories in a soft substrate without being pushed, without buckling, and without the need of axial rotation. The needle design, inspired by the ovipositor of parasitoid wasps, consisted of seven Nickel Titanium wires and had a total diameter of 1.2 mm. The motion of the needle was tested in gelatin phantoms. Forward motion of the needle was evaluated based on the lag between the actual and the desired insertion depth of the needle. Steering was evaluated based on the radius of curvature of a circle fitted to the needle centerline and on the ratio of the needle deflection from the straight path to the insertion depth. The needle moved forward inside the gelatin with a lag of 0.21 (single wire actuation) and 0.34 (double wire actuation) and achieved a maximum curvature of 0.0184 cm-1and a deflection-to-insertion ratio of 0.0778. The proposed biologically inspired needle design is a relevant step towards the development of thin needles for percutaneous interventions.@en

High accuracy and precision in reaching target locations inside the human body is necessary for the success of percutaneous procedures, such as tissue sample removal (biopsy), brachytherapy, and localized drug delivery. Flexible steerable needles may allow the surgeon to reach targets deep inside solid organs while avoiding sensitive structures (e.g. blood vessels). This article provides a systematic classification of possible mechanical solutions for three-dimensional steering through solid organs. A scientific and patent literature search of steerable instrument designs was conducted using Scopus and Web of Science Derwent Innovations Index patent database, respectively. First, we distinguished between mechanisms in which deflection is induced by the pre-defined shape of the instrument versus mechanisms in which an actuator changes the deflection angle of the instrument on demand. Second, we distinguished between mechanisms deflecting in one versus two planes. The combination of deflection method and number of deflection planes led to eight logically derived mechanical solutions for three-dimensional steering, of which one was dismissed because it was considered meaningless. Next, we classified the instrument designs retrieved from the scientific and patent literature into the identified solutions. We found papers and patents describing instrument designs for six of the seven solutions. We did not find papers or patents describing instruments that steer in one-plane on-demand via an actuator and in a perpendicular plane with a pre-defined deflection angle via a bevel tip or a pre-curved configuration.@en

Flexible steerable needles can follow complex curved paths inside the human body. In a previous work, we developed a multiple-part steerable needle prototype with a diameter of 1.2 mm, inspired by the ovipositor of parasitoid wasps. The needle consisted of seven nickel-titanium longitudinally aligned wires held together at the tip by a cylindrical ring with seven holes. The steerability of the needle was evaluated in a gelatin phantom and was found to be lower than that of other steerable needles in the literature. One possible cause of this limited steerability is that during motion the wires tend to separate from each other (i.e., bifurcate). Our aim here was to reduce bifurcation in order to increase the steering curvature of the needle, while keeping the diameter around 1.5 mm, and thus compatible with needles used in medical practice. To achieve that, we changed the shape of the ring from cylindrical to conical. We evaluated the steering performance in gelatin, using the conical ring in two configurations: (1) with the apex of the cone towards the needle tip, so that the wires converge, thus expected to reduce bifurcation, (2) with the apex of the cone placed towards the needle base, so that the wires diverge, thus expected to magnify bifurcation. Results showed that the diverging ring generated larger steering curvatures. We can conclude that reducing the bifurcation of the wires is not enough for increasing the steering curvature and that inducing this same phenomenon instead could actually lead to higher curvatures.

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