HelicoFlex – advancing steering with 3D printing and minimal assembly

Developed in 2019-2020, diameter Ø8 mm

In minimally invasive surgery, instrument maneuverability is limited by the use of small incisions. Increasing the number of degrees of freedom (DOF) of the instrument shaft is beneficial for many surgical interventions. However, increasing DOF usually leads to high mechanical complexity, issues with sterilisation and too large cost price for disposable use.

In an attempt to reduce manufacturing time we propose the first fully 3D-printed handheld, multi-steerable instrument: the HelicoFlex. The instrument is mechanically actuated and is fitted with a compliant shaft containing five serially-controlled segments enabling high maneuverability in 10 degrees of freedom.

Our new, compliant segment design merges the functions of four helicoids and a continuum backbone combining high torsion and axial stiffness with low bending stiffness. Five such compliant segments were combined to form the shaft of the HelicoFlex. Following the control design strategy of our older MultiFlex and HelixFlex devices, a compliant control handle was designed that mimics the shaft structure.

The entire frame of the HelicoFlex consists of only three complex-shaped 3D printed components that are printed without a need for any support material in the compliant section. The use of minimal-assembly 3D printing drastically decreases assembly time. Our 3D printed shaft features four working channels that facilitate combined use with flexible instruments such as biopsy forcipes. With its 10 degrees of freedom, our HelicoFlex showed a fluid motion in performing single and multi-curved paths.

Video adapted from Culmone, C., et al. (2020). Plos one, 15(5), e0232952 licensed under CC BY 4.0

Publications

Culmone, C., Henselmans, P. W., van Starkenburg, R. I., & Breedveld, P. (2020). Exploring non-assembly 3D printing for novel compliant surgical devices. Plos one15(5), e0232952.

Culmone, C., Smit, G., & Breedveld, P. (2019). Additive manufacturing of medical instruments: A state-of-the-art review. Additive Manufacturing27, 461-473.

Self-Propelling Ovipositor Device

Developed in 2016 by MSc. student Perry Posthoorn

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 to 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 novel self-propelling Ovipositor Device designed for locomotion through the large intestine (colon). The device contains a miniature electric motor connected to a cylindrical cam. Six sliders are placed around the cam and move forward and backward following the path defined by the cam. Designed for motion through soft environments, the working principle of the propulsion mechanism is that multiple stationary sliders create sufficient friction to allow for a single slider to shuffle forward. In each step, one slider moves forward whereas the others remain stationary relative to the environment, generating a smooth and continuous motion at approximately 1/6 of the speed of a moving slider. The ovipositor mechanism allows a simple and robost construction that can be easily miniaturised to very small dimensions, see our research on self-propelled ovipositor needles.

Experiments were carried out with various flexible 3D-printed structures attached to the outer surface of each slider to generate direction-dependent friction for further enhancement of grip. Tests in plastic tubes showed fast and fluent self-propelled motion. Locomotion in a colon was succesfully achieved with an improved 3D-printed outer surface in which the tangential spacing between the sliding structures was decreased so that the colonic wall does not flex between them. The improved prototype was able to self-propel ex-vivo through a porcine colon without any visual damage to the colonic wall.

(Featured image adapted from “Braconid Wasp Ovipositing” by Katja Schulz is licensed under CC BY 2.0.)

Publications

Steerable bone drill

This research project is funded by the Netherlands Organization for Scientific Research NWO and conducted in collaboration with Philips Research, DEAM, Karolinska University Hospital in Sweden, Amsterdam University Medical Center and Reinier de Graaf Hospital in Delft.

Spinal fusion is the surgical procedure of stiffening parts of the spinal column with screws and rods to, among others, reduce back pain for patients affected by multiple diseases. Vertebrae have an outer layer of hard cortical bone surrounding the softer core that consists of cancelous bone. The strength of the connection between vertebra and screw mainly relies on the contact area with the cortical bone, but drilling close to this cortical bone layer is risky, as it can lead to cortical breaches. These breaches can have severe complications, especially since important neural and vascular structures run along the spinal column.

This research will focus on creating a better fixation of the screws and preventing complications that can arise due to cortical breaches by developing a steerable bone drill with an optical sensing system in the tip. This allows the surgeon to drill a curved path along the cortical bone layer while getting real time information about the location of the drill. Regular stiff screws will not fit this curved hole, thus a new anchoring device will be developed that is flexible when introduced to the curved hole and that can become rigid to generate the needed fixation.

PROJECT INSPIRATION

Our aim in ‘Project Inspiration’ is to quickly develop an emergency mechanical ventilator, inspired by a mechanical ventilator from the 60’s. A team of staff members and students, led by Gerwin Smit, has developed a new ventilator, that can be manufactured anywhere in the world. More information can be found at: https://www.projectinspiration.nl.

Media

Miniature Biopsy Needle for Ductoscopy

In ductoscopy, the milk ducts of the breast are investigated using a so-called ductoscope. The ductoscope consists of a handle with three canals: (1) for insertion of the micro-endoscope, (2) for insertion of a tool, and (3) the irrigation canal to expand the milk duct, and a hollow tube that is inserted in the milk duct.

In case a lesion is found during this procedure, a biopsy procedure is performed using a biopsy basket. Unfortunately, this procedure is very unreliable and difficult to perform, often resulting in the need for a follow-up procedure.

In an effort to overcome this challenge, we have developed a biopsy needle that can be used during the ductoscopy procedure. The biopsy needle consists of two concentric cutting blades with a rectangular cut-out at the distal tip. By counter-rotating the cutting blades, a biopsy can be obtained, similar to the way a scissor works. The cutting blades are actuated using a handle in which the counter-rotating motion of the blades is transferred to an axial translation (see below).

In a proof-of-principle experiment, a milk duct phantom was manufactured out of gelatin. The biopsy needle was able to reliably obtain biopsy samples from this phantom. Furthermore, the biopsy needle was also successfully combined with the ductoscope.

Publications

  • Sakes A., Snaar K., Smit G., Witkamp A.J., and Breedveld P. (2018). Design of a Novel Miniature Breast Biopsy Needle for Ductoscopy. Biomedical Physics & Engineering Express. Accepted.

Devices for autonomous intraluminal surgery

This research is part of the AuTonomous intraLuminAl Surgery Innovative Training Network ( ATLAS-ITN) and has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 813782 .

The goal of this project is to develop smart, flexible robots that autonomously propel themselves through complex, deformable, tubular structures. This calls for seamless integration of sensors, actuators, modelling and control.

Two early-stage researchers, Fabian Trauzettel (ESR 1) and Chun-Feng Lai (ESR 12), will be based at TU Delft, while two others, Di Wu (ESR 11) and Zhen Li (ESR 13) will have TU Delft as their secondary institution. They will focus on multi-steerable catheter technology, follow-the-leader control, control of multi-DOF catheters in unknown environments, and path planning / real-time re-planning. Details of their projects can be found here.

Research in the network will be conducted at KU Leuven, TU Delft, University of Strasbourg, Politecnico di Milano, Università di Verona, Scuola Superiore Sant’Anna Pisa, and UPC Barcelona.

SIGMA Catheter – steering inside the Heart

Developed in 2016-2017, diameter Ø3 mm, lumen Ø1 mm

In recent years, steerable catheters have been developed to combat the effects of the dynamic cardiac environment. However, current solutions are bound to a number of limitations: (1) low torsion, (2) shaft shortening, (3) high unpredictable friction, and (4) coupled tip-shaft movements. These effects make it very hard to steer in tortuous blood vessel and inside the heart.

In order to tackle these limitations we developed a novel multi-steerable catheter prototype with four degrees of freedom. The tip has two steering segments that can be steered in all directions, controlled by two joysticks on the handle: one for the thumb and one for the index finger. The prototype features automatic lock of the steering angle once the joystick is released.

To solve the four limitations mentioned above we used eight miniature Bowden-cables inside of the flexible shaft for independent omnidirectional steering of each tip segment. As each segment can steer in all directions, twisting the shaft is not needy for directing the catheter tip, which solves the issue with low torsion (1). The issue with shaft shortening (2) is solved with the Bowden-cables which are axially incompressible. The Bowden cables generate very low predictable friction (3) and coupled tip-shaft movements (4) are absent as the Bowden-cables transfer the joystick motions directly to the tip without influencing the shaft.

The ability to steer inside the heart with a variety of complex shapes and curves opens great possibilities for complex catheter interventions. We evaluated our SIGMA catheter in a transparent 3D printed heart, based on MRI-images and created by the company Materialize, as well as ex-vivo in a beating porcine heart at the LifeTec Group. Both evaluations show very promising results and superior behaviour as compared to conventional steerable catheters.

Publications:

Ali A., Sakes A., Arkenbout E.A., Henselmans P., Starkenburg R. van, Szili-Torok T., Breedveld P. (2019). Catheter steering in interventional cardiology: mechanical analysis and novel solution. Proc. Inst. Mech. Eng. Part H: Journal of Engineering in Medicine, 12 p.

Media

https://www.materialise.com/en/blog/how-a-modular-testbed-helps-medical-device-developers

MemoFlex 1 – Mechanical Surgical Snake

Developed in 2016-2017, diameter Ø5 mm

During complex surgical procedures such as in skull-base surgery, there is a need to reach difficult-to-reach locations via narrow anatomic corridors. Performing surgery along complex 3D pathways requires a snake-like instrument that memorizes the 3D shape of the followed pathway and shifts the shape backward as the instrument moves forward. This snake-like method of locomotion is called “follow-the-leader locomotion”, in which the head is the “leader” and the body follows the pathway of the head, see the following animations:

Follow-the-leader locomotion requires a segmented multi-steerable instrument as well as a memory in which the angles of the segments can be stored and shifted. In robotic approaches, the actuation usually occurs locally, within the segments, by miniature electric motors controlled by a computer. This will, however, result in a device much too large for surgical applications. Alternatively, the actuators can be stored in a handle so that larger motors can be used in combination with steering cables that transfer the motion to the snake-like tip. Although feasible, using electric actuators controlled by a computer will result in a complex and expensive system requiring additional safety measures to ensure reliability during surgery.

In a desire to create a simpler system that combines high safety with small dimensions, we explored an alternative follow-the-leader approach by using a mechanical memory. Following the design approach of our MultiFlex, the MemoFlex contains a 12 cm long, Ø5 mm multi-steerable tip with 14 segments that can be controlled individually in 28 Degrees of Freedom. Using 56 steering cables, the tip is connected to a bendable handle. When the handle is bent in a certain shape, the shape is mirrored and replicated by the tip.

The shape memory is a pre-bent stainless steel rod that slides through the bendable handle, driven by a crank. As the rod slides through the handle, its shape is detected by a 3D-printed compliant helicoid insert that makes the handle follow the shape of the rod precisely. The mechanism replicates the handle-shape to the tip which will then maneuver along a curved pathway equivalent to the shape of the pre-bent rod. The shape of the pre-bent rod can be derived from CT or MRI-images.

Our novel copy-and-replication mechanism shows promising results. Yet, the prototype has a high mechanical complexity and the pathway is fixed in the pre-bent shape and therefore not adjustable. In parallel with the development of our MemoSlide, we therefore continued this research with an improved prototype, the MemoFlex 2, which solves these issues with an entirely different shape memory mechanism. We will keep you posted about this new development!

Publications

Octopus-based Instrument used for first time in OR

The ‘mechanical octopus’, a steerable laparoscopic instrument used for minimally invasive surgery in the abdominal cavity, has been used for the first time in an operating room.

Surgeons at the Haags Medisch Centrum are positive about the benefits that the innovative technology in the LaproFlex gave them during a gynaecological operation. The technology behind the instrument was conceived by Paul Breedveld, professor of Medical Instruments & Bio-Inspired Technology. Jules Scheltes, who also obtained his PhD at TU Delft in the field of medical product development and who co-founded the Dutch company DEAM, has been working these past two years to market the product. Following an exciting period, he received CE certification earlier this summer for the LaproFlex and is producing and selling it in Europe.

Paul Breedveld
‘The LaproFlex is an example of research at a university finding its way into industry.’

Jules Scheltes
‘Co-founder Wimold Peters and I are especially proud that we have managed to pull this off with our team. Surgeons have indicated that the instrument is providing them with a better view of the organ they are operating on, and that they can access it from an optimal approach route and are not inconvenienced by intersecting instruments in their field of operation anymore. This is great news. This is exactly what we’ve been working towards.’

What makes this instrument special is that it has a flexible tip. This is made possible by an ingenious steering system based on the anatomy of an octopus’ tentacle, the so-called cable crane mechanism, which ensures that the scissors or grasper can be steered in every direction. Paul Breedveld and the researchers in his Bio-Inspired Technology Group (BITE) have further developed this technology, which has now been globally patented, into a large number of prototypes of steerable surgical instruments. DEAM is a spin-off company of the BITE group that develops steerable precision instruments for minimally invasive interventions. DEAM collaborates with a number of universities of technology and university medical centres. The LaproFlex is the first commercially available instrument using a cable crane mechanism and is considered to be a particularly affordable, disposable alternative for the extremely pricey Da Vinci operation robot.

Media

Pulze Hammer II: Catheter

Developed in 2017-2018, diameter 2 mm

We want to go deeper into the human body, using incisions that are smaller or even non existent. For this purpose we need small flexible tools that are able to deliver sufficient forces without buckling.

In an effort to facilitate high force delivery in a small flexible medical instrument, the pulze catheter prototype (2 mm) has been developed. Buckling is prevented by using a dynamic loading method, in which a high-speed indenter collides with the non-moving target. The flexible prototype consists of a distal spring-loaded indenter, which is manually actuated using a compliant (re)load mechanism, allowing for loading, locking, and (re)loading of the prototype while inserted in the body.

We are currently testing this catheter ex-vivo. Further development of this crossing prototype may in time allow for performing surgery deep inside the body.

Publications