Enhancing spinal bone anchor pull-out resistance with an L-shaped anchor.

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.

Bone biopsy devices - a patent review.

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.

Polishing of metal 3D printed parts with complex geometry: Visualizing the influence on geometrical features using centrifugal disk finishing.

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.

Tsetse fly inspired steerable bone drill-a proof of concept.

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.

Bioinspired medical needles: a review of the scientific literature.

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.

A bio-inspired expandable soft suction gripper for minimal invasive surgery-an explorative design study.

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.

Exploring High-Precision Non-Assembly Mechanisms: Design of a Vitrectome Mechanism for Eye Surgery.

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.

Follow-The-Leader Mechanisms in Medical Devices: A Review on Scientific and Patent Literature.

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.

MemoBox: A mechanical follow-the-leader system for minimally invasive surgery.

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.

Comparison of two cable configurations in 3D printed steerable instruments for minimally invasive surgery.

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.

Design and evaluation of an MRI-ready, self-propelled needle for prostate interventions.

Prostate cancer diagnosis and focal laser ablation treatment both require the insertion of a needle for biopsy and optical fibre positioning. Needle insertion in soft tissues may cause tissue motion and deformation, which can, in turn, result in tissue damage and needle positioning errors. In this study, we present a prototype system making use of a wasp-inspired (bioinspired) self-propelled needle, which is able to move forward with zero external push force, thereby avoiding large tissue motion and deformation. Additionally, the actuation system solely consists of 3D printed parts and is therefore safe to use inside a magnetic resonance imaging (MRI) system. The needle consists of six parallel 0.25-mm diameter Nitinol rods driven by the actuation system. In the prototype, the self-propelled motion is achieved by advancing one needle segment while retracting the others. The advancing needle segment has to overcome a cutting and friction force while the retracting needle segments experience a friction force in the opposite direction. The needle self-propels through the tissue when the friction force of the five retracting needle segments overcomes the sum of the friction and cutting forces of the advancing needle segment. We tested the performance of the prototype in ex vivo human prostate tissue inside a preclinical MRI system in terms of the slip ratio of the needle with respect to the prostate tissue. The results showed that the needle was visible in MR images and that the needle was able to self-propel through the tissue with a slip ratio in the range of 0.78-0.95. The prototype is a step toward self-propelled needles for MRI-guided transperineal laser ablation as a method to treat prostate cancer.

A Toggling Resistant In-Pedicle Expandable Anchor: A Preliminary Study.

Loosening of pedicle screws after spinal fusion surgery can prevent the desired fusion between vertebrae and may be a reason for revision surgery. Especially in osteoporotic bone, toggling of pedicle screws is a common problem that compromises the fixation strength of these screws and can lead to loosening or axial pull-out of the screw. In this study, we explore the use of an in-pedicle expandable anchor that shapes to the pedicle to increase the toggling resistance of the anchor by increasing the contact area between the anchor and the dense cortical bone of the pedicle. A scaled-up, two-dimensional prototype was designed. The prototype consists of a bolt and ten stainless steel wedges that expand by tensioning the bolt. During the expansion, the wedges are required to compress the cancellous bone. Based on the first preliminary experiment, it was found that the expansion of the wedges resulted in successful compression of 5 PCF cancellous bone phantom (Sawbones). This preliminary study shows that an expandable in-pedicle anchor could be a feasible option to increase the toggling resistance of spinal bone anchors, especially in osteoporotic bone. Clinical Relevance- Toggling of pedicle screws is a major cause of screw loosening. In this preliminary study, the use of an in-pedicle expandable anchor to increase the toggling resistance of spinal bone anchors is explored.

Beyond the pedicle screw-a patent review.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Additive Manufacturing of a Miniature Functional Trocar for Eye Surgery.

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.

A Fully 3D-Printed Steerable Instrument for Minimally Invasive Surgery.

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.

Design of a Flexible Wasp-Inspired Tissue Transport Mechanism.

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.

Focal therapy for localized cancer: a patent review.

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.

Stabilizing interventional instruments in the cardiovascular system: A classification of mechanisms.

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.

Design of a 3D-printed hand prosthesis featuring articulated bio-inspired fingers.

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.

Implementation of anisotropic soft pads in a surgical gripper for secure and gentle grip on vulnerable tissues.

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.