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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 (MN) 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.

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.

Positioning and stabilizing a catheter at the required location inside a vessel or the heart is a complicated task in interventional cardiology. In this review we provide a structured classification of catheter stabilization mechanisms to systematically assess their challenges during cardiac interventions. Commercially available, patented, and experimental prototypes of catheters were classified with respect to their stabilizing mechanisms. Subsequently, the classification was used to define requirements for future cardiac catheters and persisting challenges in catheter stabilization. The classification showed that there are two main stabilization mechanisms: surface-based and volume-based. Surface-based mechanisms apply attachment through surface anchoring, while volume-based mechanisms make use of locking through shape or force against the vessel or cardiac wall. The classification provides insight into existing catheter stabilization mechanisms and can possibly be used as a tool for future design of catheter stabilization mechanisms to keep the catheter at a specific location during an intervention. Additionally, insight into the requirements and challenges for catheter stabilization inside the heart and vasculature can lead to the development of more dedicated systems in the future, allowing for intervention- and patient-specific instrument manipulation.

Introduction: Conventional cancer treatments such as radical surgery and systemic therapy targeting the organ or organ system might have side effects because of damage to the surrounding tissue. For this reason, there is a need for new instruments that focally treat cancer. Areas covered: This review provides a comprehensive overview of the patent literature on minimally and noninvasive focal therapy instruments to treat localized cancer. The medical section of the Google Patents database was scanned, and 128 patents on focal therapy instruments published in the last two decades (2000–2021) were retrieved and classified. The classification is based on the treatment target (cancer cell or network of cancer cells), treatment purpose (destroy the cancerous structure or disable its function), and treatment means (energy, matter, or a combination of both). Expert opinion: We found patents describing instruments for all groups, except for the instruments that destroy a cancer cell network structure by applying matter (e.g. particles) to the network. The description of the different treatment types may serve as a source of inspiration for new focal therapy instruments to treat localized cancer.

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 O8 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.

This review provides an overview of the patent literature on posteriorly placed intrapedicular bone anchors. Conventional pedicle screws are the gold standard to create a fixation in the vertebra for spinal fusion surgery but may lack fixation strength, especially in osteoporotic bone. The ageing population demands new bone anchors that have an increased fixation strength, that can be placed safely, and, if necessary, can be removed without damaging the surrounding tissue.The patent search was conducted using a classification search in the Espacenet patent database. Only patents with a Cooperative Patent Classification of A61B17/70 or A61B17/7001 concerning spinal positioners and stabilizers were eligible for inclusion. The search query resulted in the identification of 731 patents. Based on preset inclusion criteria, a total of 56 unique patents on different anchoring methods were included, reviewed and categorized in this study.Five unique fixation methods were identified; (1) anchors that use threading, (2) anchors that utilize a curved path through the vertebra, (3) anchors that (partly) expand, (4) anchors that use cement and (5) anchors that are designed to initiate bone ingrowth. Of the anchor designs included in this study, eight had a corresponding commercial product, six of which were evaluated in clinical trials.This review provides insights into worldwide patented intrapedicular bone anchors that aim to increase the fixation strength compared to the conventional pedicle screw. The identified anchoring methods and their working principles can be used for clinical decision-making and as a source of inspiration when designing novel bone anchors.

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.

Tissue transport is a challenge during Minimally Invasive Surgery (MIS) with the current suction-based instruments as the increasing length and miniaturisation of the outer diameter requires a higher pressure. Inspired by the wasp ovipositor, a slender and bendable organ through which eggs can be transported, a flexible transport mechanism for tissue was developed that does not require a pressure gradient. The flexible shaft of the mechanism consists of ring magnets and cables that can translate in a similar manner as the valves in the wasp ovipositor. The designed transport mechanism was able to transport 10wt% gelatine tissue phantoms with the shaft in straight and curved positions and in vertical orientation against gravity. The transport rate can be increased by increasing the rotational velocity of the cam. A rotational velocity of 25 RPM resulted in a transport rate of 0.8 mm/s and increasing the rotation velocity of the cam to 80 RPM increased the transport rate to 2.3 mm/s though the stroke efficiency decreased by increasing the rotational velocity of the cam. The transport performance of the flexible transport mechanism is promising. This means of transportation could in the future be an alternative for tissue transport during MIS.

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. 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, propagation, and conservation. 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.

Purpose In previous studies we developed two mechanical prototypes of steerable catheters: the Sigma, which uses joysticks to actuate two steerable tip segments, and the Epsilon, which has a handle that is an enlarged version of the tip. In this study, we present a first performance evaluation of the prototypes in the cardiac environment. The evaluation was carried out by an expert user, an electrophysiologist with over 20 years of experience, to obtain insight in clinically relevant factors. Methods Two experiments were conducted. In the first experiment, the Sigma was used in a passive beating heart setup connected to pumps with a saline solution and camera visualization, and compared with the expert’s past experience with conventional steerable catheters. In the second experiment, the Sigma was used in an active beating heart setup with blood perfusion through the coronary arteries and echo visualization, and compared with the Epsilon prototype. The prototype was evaluated through questionnaires on task performance, catheter usability, and workload. After each of the experiments, the catheter characteristics were evaluated via a survey and followed by an in-depth interview. Results & Conclusions The expert user found the passive beating heart setup to more successful than the active beating heart setup for the purpose of this experiment, with insightful visualization while the heart was in beating condition. The steerability of the prototypes was experienced as useful and clinically relevant. Based on the questionnaires and interview we were able to identify future design improvements and developments for the steerable catheter prototypes.

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.

Various upper-limb prostheses have been designed for 3D printing but only a few of them are based on bio-inspired design principles and many anatomical details are not typically incorporated even though 3D printing offers advantages that facilitate the application of such design principles. We therefore aimed to apply a bio-inspired approach to the design and fabrication of articulated fingers for a new type of 3D printed hand prosthesis that is body-powered and complies with basic user requirements. We first studied the biological structure of human fingers and their movement control mechanisms in order to devise the transmission and actuation system. A number of working principles were established and various simplifications were made to fabricate the hand prosthesis using a fused deposition modelling (FDM) 3D printer with dual material extrusion. We then evaluated the mechanical performance of the prosthetic device by measuring its ability to exert pinch forces and the energy dissipated during each operational cycle. We fabricated our prototypes using three polymeric materials including PLA, TPU, and Nylon. The total weight of the prosthesis was 92 g with a total material cost of 12 US dollars. The energy dissipated during each cycle was 0.380 Nm with a pinch force of ≈16 N corresponding to an input force of 100 N. The hand is actuated by a conventional pulling cable used in BP prostheses. It is connected to a shoulder strap at one end and to the coupling of the whiffle tree mechanism at the other end. The whiffle tree mechanism distributes the force to the four tendons, which bend all fingers simultaneously when pulled. The design described in this manuscript demonstrates several bio-inspired design features and is capable of performing different grasping patterns due to the adaptive grasping provided by the articulated fingers. The pinch force obtained is superior to other fully 3D printed body-powered hand prostheses, but still below that of conventional body powered hand prostheses. We present a 3D printed bio-inspired prosthetic hand that is body-powered and includes all of the following characteristics: adaptive grasping, articulated fingers, and minimized post-printing assembly. Additionally, the low cost and low weight make this prosthetic hand a worthy option mainly in locations where state-of-the-art prosthetic workshops are absent.

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.

The aim of this research is to integrate spectral tissue sensing technology inside a cardiac bioptome for real-time measurements of tissue characteristics. Bioptome tip and handle components were designed and manufactured to house and guide optical fibers. The designed components were assembled on a cardiac bioptome together with optical fibers. A technical feasibility test was carried out to study the functionality of the instrument and the effect of the optical technology on the biopsy performance. Biopsy samples were taken from five different tissue types in a porcine heart and the resulting optical spectra were compared. Spectral tissue sensing fibers were successfully integrated inside a conventional cardiac bioptome. The integrated instrument allowed differentiation between ventricular tissue, blood, and cardiac fat tissue based on blood and fat percentage and amount of scattering. Moreover, differences between scarred and nonscarred tissue were clearly visible. A first step has been made in the use of spectral tissue sensing for the detection of different tissue structures for endo-myocardial biopsy (EMB). The instrument was able to differentiate between various tissues, as well as between healthy and diseased cardiac tissues. Future research should focus on measurements of naturally diseased cardiac tissue, repeated measurements with statistical value, and improvements to the instrument design. Having the ability to measure tissue characteristics prior to acquiring a biopsy sample will not only allow easier positioning of the bioptome at the correct location but can also prevent sampling undesired tissue or scar tissue from previous biopsies.

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.

In recent years, steerable catheters have been developed to combat the effects of the dynamic cardiac environment. Mechanically actuated steerable catheters appear the most in the clinical setting; however, they are bound to a number of mechanical limitations. The aim of this research is to gain insight in these limitations and use this information to develop a new prototype of a catheter with increased steerability. The main limitations in mechanically steerable catheters are identified and analysed, after which requirements and solutions are defined to design a multi-steerable catheter. Finally, a prototype is built and a proof-of-concept test is carried out to analyse the steering functions. The mechanical analysis results in the identification of five limitations: (1) low torsion, (2) shaft shortening, (3) high unpredictable friction, (4) coupled tip-shaft movements, and (5) complex cardiac environment. Solutions are found to each of the limitations and result in the design of a novel multi-steerable catheter with four degrees of freedom. A prototype is developed which allows the dual-segmented tip to be steered over multiple planes and in multiple directions, allowing a range of complex motions including S-shaped curves and circular movements. A detailed analysis of limitations underlying mechanically steerable catheters has led to a new design for a multi-steerable catheter for complex cardiac interventions. The four integrated degrees of freedom provide a high variability of tip directions, and repetition of the bending angle is relatively simple and reliable. The ability to steer inside the heart with a variety of complex shaped curves may potentially change conventional approaches in interventional cardiology towards more patient-specific and lower complexity procedures. Future directions are headed towards further design optimizations and the experimental validation of the prototype.

Background: The group of passive prostheses consists of prosthetic hands and prosthetic tools. These can either be static or adjustable. Limited research and development on passive prostheses has been performed although many people use these prosthesis types. Although some publications describe passive prostheses, no recent review of the peer-reviewed literature on passive prostheses is available. Objective: Review the peer-reviewed literature on passive prostheses for replacement of the hand. Study design: Literature review. Methods: Four electronic databases were searched using a Boolean combination of relevant keywords. English-language articles relevant to the objective were selected. Results: In all, 38 papers were included in the review. Publications on passive prosthetic hands describe their users, usage, functionality, and problems in activities of daily living. Publications on prosthetic tools mostly focus on sport, recreation, and vehicle driving. Conclusion: Passive hand prostheses receive little attention in prosthetic research and literature. Yet one out of three people with a limb deficiency uses this type of prosthesis. Literature indicates that passive prostheses can be improved on pulling and grasping functions. In the literature, ambiguous names are used for different types of passive prostheses. This causes confusion. We present a new and clear classification of passive prostheses. Clinical relevance This review provides information on the users of passive prosthetic hands and tools, their usage and the functionality. Passive prostheses receive very little attention and low appreciation in literature. Passive prosthetic hands and tools show to be useful to many unilateral amputees and should receive more attention and higher acceptance.

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.

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.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.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.

Additive Manufacturing (AM) or 3D printing has enabled the production of increasingly complex parts that are difficult to produce with conventional manufacturing methods. Its additive nature has made it possible to create interlocking parts in a single production step. This creates opportunities for new ways of designing and producing mechanisms, which do not need to be assembled after production, called non-assembly mechanisms. Non-assembly mechanisms are different from traditional mechanisms, since they show an unprecedented integration between geometry, material and structure. In this review, by means of a systematic literature search the current state-of-the-art of non-assembly mechanisms is reviewed and analyzed based on the challenges encountered in their design and production. The found examples were categorized according to types of mechanism that have similar production considerations. Per category is discussed what the challenges and opportunities are for the design of non-assembly mechanisms. This review aims to provide a helpful overview of best-practice examples that can be used as inspiration for further development of innovative non-assembly mechanisms.

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.

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 200 mm) needles, allowing deep insertion into tissue-mimicking phantoms.

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.

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.