Category Archives: Maneuverable Devices

Ovipositor needle II – self-propelling & steering through tissue

Developed in 2016, diameter 1.2 mm (tip) & 0.75 mm (body).

A wasp ovipositor is a needle-like structure composed out of three elements, called valves. A female wasp uses this structure to drill into wood or fruit and deposit eggs inside a living host. The propagation of the ovipositor through the substrate is achieved by a push-pull mechanism, in which one of the valves is pushed while the other two are pulled.

Inspired by the ovipositor of parasitoid wasps, we developed a new Ovipositor Needle with a diameter of 1.2 mm at the tip and 0.75 mm along the body. The needle consists of six superelastic Nickel Titanium (NiTi) wires (Ø 0.25 mm, length 160 mm) concentrically arranged around a seventh NiTi wire. The seven wires are interconnected at the tip with a flower-shaped ring (Ø 1.2 mm, length 2.0 mm), manufactured for minimal resistance during propulsion. The ring has a central hole to which the central wire is glued and six holes through which the six other wires can slide back and forth.

Each proximal end of the six movable wires is connected to a stepper motor, in which a leadscrew-slider mechanism converts rotational motion into linear motion. During an experiment, the needle was inserted in a stationary tissue-mimicking phantom, placed on a cart with low-friction wheels. The wires were sequentially moved back and forth inside the phantom, generating a net pulling motion of the phantom towards the actuation unit, and resulting in the needle moving forward inside the phantom. Different sequences of wire actuation were used to achieve both straight, curved and S-shaped trajectories.

In a follow-up prototype we changed the shape of the interlocking ring from cylindrical to conical to investigate the effect of pre-curved wires. We found out that pre-curved wires facilitate steering, however, at the drawback of a slightly larger tip diameter due to the use of a conical flower-ring.

Ovipoistor Needle II is, to our knowledge, world’s thinnest self-propelled-steerable needle. Our novel bio-inspired steering and propulsion mechanism allows for the design of extremely long and thin needles that can be used to reach deep targets inside the body without a risk of buckling and with the possibility to correct the trajectory.

Ovipositor Needle II is part of the WASP project that focuses on the development of steerable needles for localized therapeutic drug delivery or tissue sample removal (biopsy). We are currently  working on further miniaturization to diameters <0.5 mm.

(Picture at the top adapted from “Braconid Wasp Ovipositing” by Katja Schulz is licensed under CC BY 2.0.)

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Ovipositor Needle I – Self-Propelling through Tissue

Developed in 2014, thickness 2 mm.

Wasp ovipositors  are thin and flexible needle-like structures used for laying eggs inside wood or larvae.  Wasp ovipositors are composed out of  longitudinal segments, called “valves”, that can be actuated individually and independently of each other with musculature located in the abdomen of the insect. In this way the wasp can steer the ovipositor along curved trajectories inside different substrates without a need for rotatory motion or axial push.

Inspired by the anatomy of wasp ovipositors, we developed an Ovipositor Needle containing a 2 mm thick “needle” composed out of four sharp and polished stainless steel rods, representing four ovipositor valves. The four valves can be individually moved forward and backward by means of  electromechanical actuators mounted in a propulsion unit that is standing on four passive wheels. If the needle is inserted into a gel that represents tissue, and if the four valves are sequentially moved forward and backward, the friction behaviour around the valves in the gel will result in a net pulling motion that drives the needle forward through the gel. The ovipositor needle is therefore self-propelling, meaning that it does not need a net pushing motion for moving forward through tissue like normal needles do.

Ovipositor Needle I is part of the  WASP project that focuses on the development of steerable needles for localized therapeutic drug delivery or tissue sample removal (biopsy). In a new prototype that is currently under development, we aim to extend the self-propelled needle with steering capabilities at an outer diameter of just 1 mm.

 

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HelixFlex – Squid-like motion by helical steering

Developed in 2013-2014, diameter 5 mm, steering range: ±150º in all directions.

Nature exhibits two inherently different approaches for creating maneuverable structures: the endo- or exoskeleton approach, and the hydrostatic skeleton approach. An endo- or exoskeleton  is a rigid structure  connected by joints that enable motion, for example in our own body.  A hydrostatic skeleton, however, is a compliant structure solely contructed out of soft tissues, for example in the tentacle of a squid or in the trunk of an elephant.

Conventional steerable designs, based on rigid links and hinged mechanisms, are best comparable with nature’s endo- or exoskeleton approach. These conventional  designs have proven  to be highly effective at large dimensions, as for example in the scales of an excavator. At the smaller dimensions needed for minimally invasive surgery, however, the fabrication of such hinged structures becomes increasingly difficult.

The muscular hydrostatic skeleton in the arms of Loliginid squid consists out of differently orientated muscle layers (see Figure). Simultaneous contraction of these muscle layers results in a flexible, fluent motion. This led to the development of a new principle of steering via simultaneous actuation of multiple, differently orientated cable layers.

Inspired by nature’s hydrostatic skeleton approach, the multi-maneuvrable tip of the HelixFlex consists of a single compliant segment, and incorporates three different cable layers: one with parallel cables and two with helically-oriented cables. Simultanuous actuation of these cable layers is accomplished via a similarly shaped  joystick in the handle of the instrument. By manually controlling this joystick, the user can control the movement of HelixFlex’ tip in four Degrees of Freedom, resulting in a  fluent motion that greatly reflects the motion of squid tentacles (see movie).

To our knowledge, the HelixFlex is the first instrument that uses simultaneous actuation of parallel- and helical-routed cable layers, and therefore a patent is pending.

*Left: A section view of the Loliginidae squid tentacle showing the differently orientated muscle layers. Right: the steerable tip of HelixFlex containing multiple differently orientated cable layers.
Left: A section view of the Loliginidae squid tentacle showing the differently orientated muscle layers. Right: the steerable tip of HelixFlex containing multiple differently orientated cable layers. [1]

 

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DragonFlex Micro – Towards the Limits of 3D-Printing

Developed in 2012-2015, thickness 5 mm, steering range: ±90º in all directions, complex components made by 3D-printing.

The DragonFlex has been developed in close-collaboration with Dr. Filip Jelinek, former PhD from the BITE-Group and currently employed at ACMIT.

In follow-up of the successful DragonFlex Macro, the DragonFlex Micro has been miniaturized to a 5 mm scale, where special attention has been given to the reliability and precision of the mechanism and optimization of the 3D-printing technique for such small scale components. Developing and optimising new design methodologies for 3D-printing,  a number of prototypes have been manufactured from different materials, resulting in world’s first steerable surgical instrument made entirely by 3D printing.

 

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DragonFlex Macro – Smart Steering by 3D-Printing

Developed in 2010-2011, thickness 15 mm, steering range: ±90º in all directions, made entirely by 3D-printing.

Despite its success, e.g. in prostatectomy, da Vinci’s steerable grasper EndoWrist from Intuitive Surgical has a complex design prone to steel cable fatigue, potential sterilization issues and high associated costs, all of which insinuate a need for an alternative. The aim of our DragonFlex project is to demonstrate a design of a structurally simple handheld steerable laparoscopic grasping forceps free from cable fatigue, while attaining sufficient bending stiffness for surgery and improving on EndoWrist’s maneuverability and dimensions.

Having equal joint functionality to EndoWrist, DragonFlex’s instrument tip contains only four parts, driven and bound by two cables mechanically fixed in the handle. Two orthogonal planar joints feature an innovative rolling link mechanism allowing the cables to follow circular arc profiles of a diameter 1.5 times larger than the width of the instrument shaft. Besides maximizing the cable lifespan, the rolling link was designed to equalize the force requirements on both cables throughout joint rotation, making the handling fluid and effortless. The smart stacked joint design enables control of seven Degrees of Freedom (DOF) by only two cables and seven instrument components in tip, shaft and handgrip altogether.

The DragonFlex prototype was developed by means of 3D-printing, allowing grasping and omnidirectional steering over ±90°, exhibiting promisingly high bending stiffness and featuring extreme simplicity. DragonFlex concept sheds new light on the possibilities of additive manufacturing of surgical instruments, allowing for a feature-packed design, simple assembly, suitability for disposable use and potential MRI compatibility.

 

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Dendritic Instruments – Outreaching the Squid

This VICI-research project is funded by the Netherlands Organization for Scientific Research NWO.

Background

In ‘standard’ minimal access surgery, the surgeon inserts rigid instruments through small incisions in the skin or natural orifices to reach targeted areas inside the human body. This approach drastically reduces the invasiveness of surgery compared to conventional open approaches, yet the reduced size of the surgical entry-point does also severely restrict the maneuverability of the used instrumentation. This lack of instrument maneuverability becomes especially apparent when considering Endoscopic Skull Base Surgery (ESBS). A prime target of ESBS are tumors on the pituitary gland positioned at the skull base, the region that separates the brain from the rest of the head. The nose is used as the surgical entry-point, and due to the rigid nature of the used instrumentation, the surgeon needs to create a straight surgical pathway to the pituitary gland. The limited width of this pathway in combination with the need for multiple instruments severely limits sideway movements of the instruments. This situation leads to a phenomenon called swordfighting wherein the shafts of instruments collide and, moreover, it severely restricts the maneuverability of the individual tools (i.e. grasper, scissors, etc.).

We strive to improve on overall instrument maneuverability with the development of dendritic instruments. A dendritic instrument is a maneuverable single-shaft instrument that branches into multiple independently steerable tools. Such an instrument would eliminate the occurrence of swordfighting, as the number or shafts is reduced to one, while providing the surgeon sufficient maneuverability of the individual tools. This research project is divided into two main topics; the mechanical construction and methods of control of dendritic instruments, such that these instruments are able to be implemented in operating theatre in the near future.

Steering

The mechanical construction of a dendritic instrument consists of two basic parts. First, there is the shape memory shaft that should be capable of following a curved trajectory up to the targeted area while providing a stable base. Secondly, there are the individual steerable branches that sprout from this stable base and provide independent maneuverability of each individual tool.

Creating a steerable branch starts with a flexible structure, either containing joints or a compliant backbone. The actuation of such this flexible structure can then be realized by several actuation methods, including the use of electric motors, hydraulic actuators, and shape memory alloys. Our research is focused on a fully mechanical actuation method based on cable-structures. This allows for structures that are easy to miniaturize, eliminates the need for possibly dangerous electric currents, high pressures or high temperatures, and shows high potential for reducing the costs of fabrication.

Besides the obvious requirement that the branches need to be maneuverable, they should also have a certain stiffness in order to cope with external forces that will be present during, for example, tissue manipulation. In our search for a suitable cable-structure to achieve high maneuverability and stiffness, we have developed a cable-structure in which multiple cables are placed at different angles along the longitudinal axis. This structure has already shown great promise and is now in the process of further optimization.

Control

Dendritic instruments consist of many small joints and branches which the surgeon(s) needs to actively steer, in order to perform complex surgical tasks (e.g. suturing or tissue manipulation). The amount of joints in dendritic instruments are even so many, that currently existing prototypes require the cooperation of two surgeons to perform a task which is actually meant for only one surgeon. In other words, dendritic instruments have more Degrees of Freedom (DOF) than any  surgeon can control alone. However, the large amount of DOFs combined with an intuitive method of control is exactly what is required for dendritic instrumentation to become a reality.

The BITE research method to dendritic instrument control is one which is exploration driven. The optimal mechanical construction and DOF configuration are still being researched. Hence, the accompanying control interface or instrument handle cannot be designed yet. To investigate the best methods of control, virtual instruments are simulated in a Virtual Environment (VE). Physical hand movements and gestures are measured with RGB-D Kinect cameras, and mapped to virtual instrument movements. By playing with the coupling between hand DOF and instrument DOF, new control strategies are tested and reverse engineered to ultimately discover the best method for dendritic instrument control.

Dendritic_control_simulation_setup

Image adapted from  www.nimblevr.com (previously www.threegear.com)

I-Flex – Steering Towards Miniaturization Limits

Developed in 2007-2008, diameter 0.9 mm, steering range: ±90º in all directions.

The retina is a light-sensitive layer at the inside of the eye. The macula is the region at the center of the retina with the highest concentration of light-sensitive cells. Macula degeneration – a disease which is a major cause of blindness –  is caused by a disfunctioning choroid layer under the macula. A way to treat macula degeneration is to perform surgery to the choroid layer via a tiny incision in the retina near the macula.  Reaching the choroid layer under the macula is extremely difficult as the surgeon has to operate through the incision under an angle while avoiding damage to the extremely delicate macula layer.  A steerable instrument could potentially solve this issue by making it easier to steer the instrument through the incision.

The largest design and fabrication challenge of such an instrument is the extreme miniaturization of the steerable mechanism in the tip. Down-scaling our patented Cable-Ring mechanism, already applied in the Endo-Periscope III and MicroFlex, to a very small scale, resulted in the  I-Flex – world’s smallest steerable surgical instrument that can be steered in all directions. The compliant tip has a diameter of only  0.9 mm and is constructed from 7 steel cables and a spring. Being equipped with a tiny gripper, the tip can be steered in two Degrees of Freedom (DOF). The instrument contains a novel handle that combines intuitive steering with a fine and precise pincer grip.

Feedback of experienced eye-surgeons from the Eye Hospital in Rotterdam has led to the development of a second prototype which is currently under construction. This instrument incorporates a different handle, allowing further miniaturization of the steerable tip to a diameter of only 0.45 mm – three times the size of a human hair.

 

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MultiFlex – Tentacle from Steel

Developed in 2008-2009, diameter 5 mm, steering range: ±200º in all directions.

The MultiFlex is what we call a multi-steerable instrument. Based on the Cable-Ring mechanism applied in the Endo-Periscope III, the MultiFlex does not contain just one, but five steering segments serially stacked on top of each other. Each of these segments can be actuated in two Degrees of Freedom (DOF) by its own set of four steering cables, resulting in a total of 20 steering cables and a 10-DOF maneuverable tip capable of making a wide range of 3D shapes and curves. This level of maneuverability gives the instrument the ability to steer around anatomic strucures, making it world’s first instrument of this kind developed at 5 mm dimensions.

By using the Cable-Ring mechanism, all actuation cables could be positioned at the same diameter. Consequently, the increase in maneuverability does not affect the outer diameter of the instrument, which is still equal to Ø5 mm with a complexity similar to the Endo-Periscope III. The control handle of the MultiFlex has a  structure similar to the tip, yet its dimensions are scaled-up for a better fit to the surgeon’s hand.

 

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Steerable Guidewire – Maneuvering without Twisting

Developed in 2007-2008, diameter 0.9 mm, length 1 m, steering range: ±90º in all directions.

The Steerable Guidewire has been developed by spin-off DEAM in a very close collaboration with the BITE-group, using our patented Cable-Ring technology. Intended for easy steering through a network of blood vessels during catheter interventions, the guidewire contains a flexible shaft ending in a steerable tip with two Degrees of Freedom (DOF). The mechanism is novel as compared to existing guidewire designs in that it requires no need for twisting the guidewire body for re-directing the tip, which results in a much more stable and fluent 3D steering motion. The tip-mechanism is similar to the I-Fex and composed out of seven steering cables surrounded by a spring. The handle contains two joysticks, one at the proximal handle side and one at the distal handle side, that can both be used to control the 2-DOF tip. The Steerable Guidewire forms the basis for a series of new multi-steerable catheters designs currently being developed in the BITE-group.

 

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MicroFlex – Steering at a Micro-Scale

Developed in 2005-2006, diameter 1.3 mm, steering range: ±90º in all directions.

The MicroFlex is a steerable instrument for micro-surgery with a miniature Cable-Ring mechanism consisting of a ring of six steel cables (Ø0.2 mm) surrounded by a spring. The six cables are used for steering the tip, whereas the inner spring is replaced by a central cable that can be used to drive a miniature gripper on the tip (not yet incorporated in this prototype). The result is an instrument that realizes 3D-steering with only seven cables and a spring – smaller and at the same time simpler than existing steerable instruments.

 

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