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.

Review of Techniques to Achieve Optical Surface Cleanliness and Their Potential Application to Surgical Endoscopes.

A clear visualization of the operative field is of critical importance in endoscopic surgery. During surgery the endoscope lens can get fouled by body fluids (eg, blood), ground substance, rinsing fluid, bone dust, or smoke plumes, resulting in visual impairment. As a result, surgeons spend part of the procedure on intermittent cleaning of the endoscope lens. Current cleaning methods that rely on manual wiping or a lens irrigation system are still far from ideal, leading to longer procedure times, dirtying of the surgical site, and reduced visual acuity, potentially reducing patient safety. With the goal of finding a solution to these issues, a literature review was conducted to identify and categorize existing techniques capable of achieving optically clean surfaces, and to show which techniques can potentially be implemented in surgical practice. The review found that the most promising method for achieving surface cleanliness consists of a hybrid solution, namely, that of a hydrophilic or hydrophobic coating on the endoscope lens and the use of the existing lens irrigation system.

Control devices and steering strategies in pathway surgery.

For pathway surgery, that is, minimally invasive procedures carried out transluminally or through instrument-created pathways, handheld maneuverable instruments are being developed. As the accompanying control interfaces of such instruments have not been optimized for intuitive manipulation, we investigated the effect of control mode (1DoF or 2DoF), and control device (joystick or handgrip) on human performance in a navigation task. The experiments were conducted using the Endo-PaC (Endoscopic-Path Controller), a simulator that emulates the shaft and handle of a maneuverable instrument, combined with custom-developed software animating pathway surgical scenarios. Participants were asked to guide a virtual instrument without collisions toward a target located at the end of a virtual curved tunnel. The performance was assessed in terms of task completion time, path length traveled by the virtual instrument, motion smoothness, collision metrics, subjective workload, and personal preference. The results indicate that 2DoF control leads to faster task completion and fewer collisions with the tunnel wall combined with a strong subjective preference compared with 1DoF control. Handgrip control appeared to be more intuitive to master than joystick control. However, the participants experienced greater physical demand and had longer path lengths with handgrip than joystick control.

Spatial orientation in pathway surgery.

BACKGROUND: In the field of minimally invasive surgery, specifically in pathway surgery (i.e. minimal invasive procedures carried out transluminally or through instrument-created pathways), spatial disorientation is a common experience to endoscopists. In this article, two effects that may cause spatial disorientation in pathway surgery, 'control-display compatibility' and 'local disorientation', were studied. METHOD: A custom-developed simulator Endo-PaC was developed and used for mimicking pathway surgical scenarios. In Study 1, two ways of control-display alignment, normal mapping and mirrored mapping, were tested in combination with two control devices, thumb control and wrist control, in an orienting task using Endo-PaC. In Study 2, a tethered viewpoint was added to the virtual instrument tip. It was hypothesized that the visible tip would provide a cue of orientating direction in the reference frame during the instrument navigation. In both studies, novice participants were involved, and their performance was evaluated with regard to task time, path length travelled by the virtual tip, time and number of warnings, and subjective workload and personal preference. RESULTS: In Study 1, normal-thumb and normal-wrist mapping yielded significantly lower means than mirrored-thumb and mirrored-wrist control for all investigated objective and subjective performance measurements. Out of 24 participants, 20 participants preferred normal control mapping. In Study 2, participants performed the task in shorter time and with shorter path length when the tip was visible tip on the monitor using a tethered viewpoint, but with a lower number and time of warnings without a visible tip. CONCLUSION: The results of our studies show that eliminating the visual-display misalignment would greatly improve novice participants' performance, reduce the training time and their cognitive workload. A visible tip on the monitor would provide strong direction cue and shorten the performance time, but might introduce collision errors to novices and therefore requires longer training time.

A state of the art review and categorization of multi-branched instruments for NOTES and SILS.

BACKGROUND: Since the advent of Natural Orifice Translumenal Endoscopic Surgery (NOTES) and single incision laparoscopic surgery (SILS), a variety of multitasking platforms have been under development with the objective to allow for bimanual surgical tasks to be performed. These instruments show large differences in construction, enabled degrees of freedom (DOF), and control aspects. METHODS: Through a literature review, the absence of an in-depth analysis and structural comparison of these instruments in the literature is addressed. All the designed and prototyped multitasking platforms are identified and categorized with respect to their actively controlled DOF in their shafts and branches. Additionally, a graphical overview of patents, bench test experiments, and animal and/or human trials performed with each instrument is provided. RESULTS: The large range of instruments, various actuation strategies, and different direct and indirect control methods implemented in the instruments show that an optimal instrument configuration has not been found yet. Moreover, several questions remain unanswered with respect to which DOF are essential for bimanual tasks and which control methods are best suited for the control of these DOF. CONCLUSIONS: Considering the complexity of the currently prototyped and tested instruments, future NOTES and SILS instrument development will potentially necessitate a reduction of the available DOF to minimize the control complexity, thereby allowing for single surgeon bimanual task execution.

Robust Hand Motion Tracking through Data Fusion of 5DT Data Glove and Nimble VR Kinect Camera Measurements.

Vision based interfaces for human computer interaction have gained increasing attention over the past decade. This study presents a data fusion approach of the Nimble VR vision based system, using the Kinect camera, with the contact based 5DT Data Glove. Data fusion was achieved through a Kalman filter. The Nimble VR and filter output were compared using measurements performed on (1) a wooden hand model placed in various static postures and orientations; and (2) three differently sized human hands during active finger flexions. Precision and accuracy of joint angle estimates as a function of hand posture and orientation were determined. Moreover, in light of possible self-occlusions of the fingers in the Kinect camera images, data completeness was assessed. Results showed that the integration of the Data Glove through the Kalman filter provided for the proximal interphalangeal (PIP) joints of the fingers a substantial improvement of 79% in precision, from 2.2 deg to 0.9 deg. Moreover, a moderate improvement of 31% in accuracy (being the mean angular deviation from the true joint angle) was established, from 24 deg to 17 deg. The metacarpophalangeal (MCP) joint was relatively unaffected by the Kalman filter. Moreover, the Data Glove increased data completeness, thus providing a substantial advantage over the sole use of the Nimble VR system.

Attaining high bending stiffness by full actuation in steerable minimally invasive surgical instruments.

INTRODUCTION: Steerable instruments are a promising trend in minimally invasive surgery (MIS), due to their manoeuvring capabilities enabling reaching over obstacles. Despite the great number of steerable joint designs, currently available steerable tips tend to be vulnerable to external loading, thus featuring low bending stiffness. This work aims to provide empirical evidence that the bending stiffness can be considerably increased by using fully actuated joint constructions, enabling left/right and up/down tip rotations with the minimum of two degrees of freedom (DOF), rather than conventional underactuated constructions enabling these rotations with more than two DOF. MATERIAL AND METHODS: A steerable MIS instrument prototype with a fully actuated joint construction was compared to state-of-the-art underactuated steerable instruments in a number of tip deflection experiments. The tip deflections due to loading were measured by means of a universal testing machine in four bending scenarios: straight and bent over 20°, 40° and 60°. RESULTS AND CONCLUSIONS: The experimental results support the claim that a fully actuated joint construction exhibits a significantly larger bending stiffness than an underactuated joint construction. Furthermore, it was shown that the underactuated instrument tips show a considerable difference between their neutral positions before and after loading, which could also be greatly minimised by full actuation.

Method for minimising rolling joint play in the steerable laparoscopic instrument prototype DragonFlex.

INTRODUCTION: The steerable laparoscopic instrument prototype DragonFlex was recently developed with the vision of a minimalistic fully functional design, readily produced by additive manufacturing and requiring little assembly. Steering functionality is provided by rolling joints that, besides simplifying the assembly, help minimise cable fatigue and equalise force requirements on steering cables. However, the perfectly circular rolling joint design introduced some mechanism play, undermining the joint's bending stiffness. Hence, the aim of this paper is to present an innovative solution for play reduction in rolling joints. MATERIAL AND METHODS: The original play-compensating mechanism, a shaft-embedded compression spring, proved unsatisfactory for play reduction. Therefore, a new non-circular rolling joint curvature was designed with the objective to compensate for any cable slack and thus minimise the joint play. The new rolling joint design was evaluated in several tip deflection experiments and compared to the original one. RESULTS AND CONCLUSIONS: The experimental results proved that the optimised rolling joint curvature significantly minimises play, thus being a major improvement compared to the original design. The optimised rolling joint was implemented in a new real-scale DragonFlex prototype. The presented optimisation method enables elimination of a conventionally used cable tensioning device and it is generally applicable to steerable minimally invasive instruments that use a rolling joint.

Design and evaluation of a pneumatic actuation unit for a wasp-inspired self-propelled needle.

Transperineal laser ablation is a minimally invasive thermo-ablative treatment for prostate cancer that requires the insertion of a needle for accurate optical fiber positioning. Needle insertion in soft tissues may cause tissue motion and deformation, resulting in tissue damage and needle positioning errors. In this study, we present a wasp-inspired self-propelled needle that uses pneumatic actuation to move forward with zero external push force, thus avoiding large tissue motion and deformation. The needle consists of six parallel 0.25-mm diameter Nitinol rods driven by a pneumatic actuation system. The pneumatic actuation system consists of Magnetic Resonance (MR) safe 3D-printed parts and off-the-shelf plastic screws. A self-propelled motion is achieved by advancing the needle segments one by one, followed by retracting them simultaneously. The advancing needle segment has to overcome a cutting and friction force, while the stationary needle segments experience a friction force in the opposite direction. The needle self-propels through the tissue when the friction force of the five stationary needle segments overcomes the sum of the friction and cutting forces of the advancing needle segment. We evaluated the prototype's performance in 10-wt% gelatin phantoms and ex vivo porcine liver tissue inside a preclinical Magnetic Resonance Imaging (MRI) scanner in terms of the slip ratio of the needle with respect to the phantom or liver tissue. Our results demonstrated that the needle was able to self-propel through the phantom and liver tissue with slip ratios of 0.912-0.955 and 0.88, respectively. The prototype is a promising step toward the development of self-propelled needles for MRI-guided transperineal laser ablation as a method to treat prostate cancer.

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.

Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors.

INTRODUCTION: This study focuses on the quantification of and current guidelines on the hazards related to needle positioning in prostate cancer treatment: (1) access restrictions to the prostate gland by the pubic arch, so-called Pubic Arch Interference (PAI) and (2) needle positioning errors. Next, we propose solution strategies to mitigate these hazards. METHODS: The literature search was executed in the Embase, Medline ALL, Web of Science Core Collection*, and Cochrane Central Register of Controlled Trials databases. RESULTS: The literature search resulted in 50 included articles. PAI was reported in patients with various prostate volumes. The level of reported PAI varied between 0 and 22.3 mm, depending on the patient's position and the measuring method. Low-Dose-Rate Brachytherapy induced the largest reported misplacement errors, especially in the cranio-caudal direction (up to 10 mm) and the largest displacement errors were reported for High-Dose-Rate Brachytherapy in the cranio-caudal direction (up to 47 mm), generally increasing over time. CONCLUSIONS: Current clinical guidelines related to prostate volume, needle positioning accuracy, and maximum allowable PAI are ambiguous, and compliance in the clinical setting differs between institutions. Solutions, such as steerable needles, assist in mitigating the hazards and potentially allow the physician to proceed with the procedure.This systematic review was performed in accordance with the PRISMA guidelines. The review was registered at Protocols.io (DOI: dx.doi.org/10.17504/protocols.io.6qpvr89eplmk/v1).

Review of manual control methods for handheld maneuverable instruments.

By the introduction of new technologies, surgical procedures have been varying from free access in open surgery towards limited access in minimal access surgery. Improving access to difficult-to-reach anatomic sites, e.g. in neurosurgery or percutaneous interventions, needs advanced maneuverable instrumentation. Advances in maneuverable technology require the development of dedicated methods enabling surgeons to stay in direct, manual control of these complex instruments. This article gives an overview of the state-of-the-art in the development of manual control methods for handheld maneuverable instruments. It categorizes the manual control methods in three levels: a) number of steerable segments, b) number of Degrees Of Freedom (DOF), and c) coupling between control motion of the handle and steering motion of the tip. The literature research was completed by using Web of Science, Scopus and PubMed. The study shows that in controlling single steerable segments, direct as well as indirect control methods have been developed, whereas in controlling multiple steerable segments, a gradual shift can be noticed from parallel and serial control to integrated control. The development of multi-segmented maneuverable instruments is still at an early stage, and an intuitive and effective method to control them has to become a primary focus in the domain of minimal access surgery.

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.

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.

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.

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.

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.

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.

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.