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.

Current surgical grippers rely on friction grip, where normal loads (i.e. pinch forces) are translated into friction forces. Operating errors with surgical grippers are often force-related, including tissue slipping out of the gripper because of too low pinch forces and tissue damaging due to too high pinch forces. Here, we prototyped a modular surgical gripper with elastomeric soft pads reinforced in the shear direction with a carbon-fiber fabric. The elastomeric component provides low normal stiffness to maximize contact formation without the need of applying high normal loads (i.e. pinch forces), whereas the carbon-fiber fabric offers high shear stiffness to preserve the formed contact under the lateral loads (i.e. shear forces) that occur during tissue lifting. Additionally, we patterned the pads with a sub-surface micropattern, to further reduce the normal stiffness and increase shear stiffness. The body of the prototype gripper, including shaft, joints, and gripper tips, was fabricated in a single step using 3D printing, followed by manual attachment of the soft pads to the gripper. The gripping performance of the newly developed soft gripper on soft tissues was experimentally compared to reference grippers equipped with metal patterned pads. The soft-pad gripper generated similar gripping forces but significantly lower pinch forces than metal-pad grippers. We conclude that grippers with anisotropic-stiffness pads are promising for secure and gentle tissue grip.

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.

Goal: Additive manufacturing, also known as 3D printing, has begun to play a significant role in the field of medical devices. This review aims to provide a comprehensive overview and classification of additively manufactured medical instruments for diagnostics and surgery by identifying medical and technical aspects. Methods: A scientific literature search on additively manufactured medical instruments was conducted using the Scopus database. Results: We categorized the relevant articles (71) by considering the novelty of each proposed instrument and its clinical application. Then, we analyzed the relevant articles by examining the reasons behind choosing additive manufacturing technology to produce instruments for diagnostics and surgery. Possible customization (27%) and Cost-effectiveness (23%) were the main reasons expressed. Technical specifications of the additive manufacturing technology and the material used were also analyzed, and a tendency of using material extrusion technology (35% of the applications) and polymeric materials (86% of the applications) was shown. Conclusions: Additive manufacturing is opening the door to a new approach in the production of medical devices, which allows the complexity of their designs to be pushed to the extreme. However, we found that technical limitations need to be tackled and important aspects such as sterilization or debris contamination are still not considered to be relevant factors during the design and fabrication process. Keeping in mind the challenges of such a new field, additive manufacturing technology can be considered as a great opportunity to provide easy access to healthcare in developing countries as well as an important step toward patient-specific medicine.

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.

Needles are advanced tools commonly used in minimally invasive medical procedures. The accurate manoeuvrability of flexible needles through soft tissues is strongly determined by variations in tissue stiffness, which affects the needle-tissue interaction and thus causes needle deflection. This work presents a variable stiffness mechanism for percutaneous needles capable of compensating for variations in tissue stiffness and undesirable trajectory changes. It is composed of compliant segments and rigid plates alternately connected in series and longitudinally crossed by four cables. The tensioning of the cables allows the omnidirectional steering of the tip and the stiffness tuning of the needle. The mechanism was tested separately under different working conditions, demonstrating a capability to exert up to 3.6 N. Afterwards, the mechanism was integrated into a needle, and the overall device was tested in gelatine phantoms simulating the stiffness of biological tissues. The needle demonstrated the capability to vary deflection (from 11.6 to 4.4 mm) and adapt to the inhomogeneity of the phantoms (from 21 to 80 kPa) depending on the activation of the variable stiffness mechanism. [Figure not available: see fulltext.]