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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The minimally invasive approach has revolutionized the standard in surgery. In conventional open procedures, the surgeon exposes the diseased area with a relatively large incision. Contrary to conventional surgery, in minimally invasive surgery, several small incisions are used to insert the surgical instruments and reach the target area, reducing the risk of infections and surgical trauma. The surgical instruments currently used are straight and rigid, allowing only straight paths to be followed. An alternative is passively flexible instruments, such as endoscopes and catheters, that require external guidance, e.g., the blood vessel wall, and therefore cannot provide a stable platform to operate. Areas with a high density, like the brain, or situations that demand to actively decide the path to follow, such as in the peripheral bronchi of the lungs, require snake-like instruments that are able to follow multi-curved paths and can maintain their position without external support. Because of the great potential advantages that these types of instruments could offer and because of the new surgical possibilities that might be explored, companies and researchers are working on creating solutions. However, the complexity of such instruments creates difficulties in the surgical implementation and remain a major challenge. In this context, additive manufacturing, also known as 3D printing, offers a new paradigm for design, manufacturing, and assembly, allowing the production of complex geometries difficult to produce with conventional manufacturing. Using additive manufacturing might help to solve some of the major challenges in snake-like surgical instruments, such as a large number of components and long assembly time. Therefore, the main purpose of the research described in this thesis, is to explore how the combination of additive manufacturing and mechanical solutions can help in designing snake-like instruments, while minimizing the assembly and device complexity. This thesis is organized into three parts as the main components of a snake-like surgical instrument: Part I, Control, focuses on the control side of the instrument with particular attention to mechanical solutions. Part II, Shaft, focuses on the possibility of fabricating snake-like instruments with additive manufacturing technology, and Part III, End-Effector, on the use of 3D printing to enhance end-effector functions. @en

With the increase in Natural Orifice Transluminal Endoscopic Surgery procedures, there is an increasing demand for surgical instruments with additional degrees of freedom, able to travel along tortuous pathways and guarantee dexterity and high accuracy without compromising the surrounding environment. The implementation of follow-the-leader motion in surgical instruments allows propagating the decided shape through its body and moving through curved paths avoiding sensitive areas. Due to the limited operational area and therefore the instrument size, the steerable shaft of these instruments is usually driven by cables that are externally actuated. However, a large number of degrees of freedom requires a great number of actuators, increasing the system complexity. Therefore, our goal was to design a new memory system able to impose a follow-the-leader motion to the steerable shaft of a medical instrument without using actuators. We present a memory mechanism to control and guide the cable displacements of a cable-driven shaft able to move along a multi-curved path. The memory mechanism is based on a programmable physical track with a mechanical interlocking system. The memory system, called MemoBox, was manufactured as a proof-of-concept demonstration model, measuring 70 mm × 64 mm × 6 mm with 11 programmable elements and featuring a minimum resolution of 1 mm. The prototype shows the ability to generate and shift complex 2D pathways in real-time controlled by the user.@en

In laparoscopy, a small incision size improves the surgical outcome but increases at the same time the rigidity of the instrument, with consequent impairment of the surgeon’s maneuverability. Such reduction introduces new challenges, such as the loss of wrist articulation or the impossibility of overcoming obstacles. A possible approach is using multi-steerable cable-driven instruments fully mechanical actuated, which allow great maneuverability while keeping the wound small. In this work, we compared the usability of the two most promising cable configurations in 3D printed multi-steerable instruments: a parallel configuration with all cables running straight from the steerable shaft to the handle; and a multi configuration with straight cables in combination with helical cables. Twelve participants were divided into two groups and asked to orient the instrument shaft and randomly hit six targets following the instructions in a laparoscopic simulator. Each participant carried out four trials (two trials for each instrument) with 12 runs per trial. The average task performance time showed a significant decrease over the first trial for both configurations. The decrease was 48% for the parallel and 41% for the multi configuration. Improvement of task performance times reached a plateau in the second trial with both instruments. The participants filled out a TLX questionnaire after each trial. The questionnaire showed a lower burden score for the parallel compared to multi configuration (23% VS 30%). Even though the task performance time for both configurations was comparable, a final questionnaire showed that 10 out of 12 participants preferred the parallel configuration due to a more intuitive hand movement and the possibility of individually orienting the distal end of the steerable shaft@en

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.

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In the field of medical instruments, additive manufacturing allows for a drastic reduction in the number of components while improving the functionalities of the final design. In addition, modifications for users’ needs or specific procedures become possible by enabling the production of single customized items. In this work, we present the design of a new fully 3D-printed handheld steerable instrument for laparoscopic surgery, which was mechanically actuated using cables. The pistol-grip handle is based on ergonomic principles and allows for single-hand control of both grasping and omnidirectional steering, while compliant joints and snap-fit connectors enable fast assembly and minimal part count. Additive manufacturing allows for personalization of the handle to each surgeon’s needs by adjusting specific dimensions in the CAD model, which increases the user’s comfort during surgery. Testing showed that the forces on the instrument handle required for steering and grasping were below 15 N, while the grasping force efficiency was calculated to be 10–30%. The instrument combines the advantages of additive manufacturing with regard to personalization and simplified assembly, illustrating a new approach to the design of advanced surgical instruments where the customization for a single procedure or user’s need is a central aspect. @en

In minimally invasive surgery, maneuverability is usually limited and a large number of degrees of freedom (DOF) is highly demanded. However, increasing the DOF usually means increasing the complexity of the surgical instrument leading to long fabrication and assembly times. In this work, we propose the first fully 3D printed handheld, multi-steerable device. The proposed device is mechanically actuated, and possesses five serially controlled segments. We designed a new compliant segment providing high torsion and axial stiffness as well as a low bending stiffness by merging the functions of four helicoids and a continuum backbone. Compliant segments were combined to form the compliant shaft of the new device. In order to control this compliant shaft, a control handle was designed that mimics the shaft structure. A prototype called the HelicoFlex was built using only three 3D printed parts. HelicoFlex, with its 10 degrees of freedom, showed a fluid motion in performing single and multi-curved paths. The multi-steerable instrument was 3D printed without any support material in the compliant shaft itself. This work contributes to enlarge the body of knowledge regarding how additive manufacturing could be used in the production of multi-steerable surgical instruments for personalized medicine.

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The fields of Minimally Invasive Surgery (MIS) and Natural Orifices Transluminal Endoscopic Surgery (NOTES) strive to reduce the level of invasiveness by entering the body through smaller incisions and natural orifices. Hyper-redundant snake-like instruments can help in this pursuit of reducing invasiveness. Such instruments can pass along multi-curved pathways through the body without any support or guidance from its anatomical environment. In this way, the width of the surgical pathway and thus the invasiveness of the procedure can be reduced significantly. This is referred to as Follow-the-Leader (FTL) motion. Generally, surgical instruments intended for FTL-motion are robotic systems that require medical grade actuators, sensors, and controllers, driving up costs and increasing their footprint in the operation room. Our goal was to discard the need for these elements and develop a non-robotic instrument capable of FTL-motion along pre-determined paths. A proof of concept prototype called MemoFlex II was developed, consisting of a cable-driven hyper-redundant shaft that is controlled via four physical tracks. The MemoFlex II was able to perform 3D FTL-motion along pre-determined paths. Among other things, this study reports on a Ø8 mm shaft containing seven segments and 14 degrees of freedom (DOFs) following several multi-curved paths with an average maximal footprint between 11.0 and 17.1 mm.

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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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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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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.

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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.]

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Needles are instruments frequently employed in Minimally Invasive Surgery (MIS), and are especially requested in percutaneous diagnosis and in local therapies [1]. During procedures, tissue inhomogeneity, tissue deformation, and thus needle deflection can cause tip misplacement resulting in inaccurate anesthesia, repuncturing with additional damages of the tissue or false negative detection [2]. Previous studies focused on needle-tissue interaction and possibilities to improve the needle steerability [3]. The proposed work is aimed to design a new concept of needle based on variable stiffness able both to balance tissue inhomogeneity and to guarantee needle steering during the insertion. The structure of the Variable Stiffness Mechanism (VSM) allows the needle to adjust the deflection when passing through tissues, while the omnidirectional steering of the tip facilitates the achievement of the target.@en