The team is currently investigating prospects for Australian
production of the needle, which is the first of its kind to be
visible to ultrasound.
Image courtesy of Photolibrary.com

It is not what a patient awaiting surgery needs to hear, that hypodermic needles – used in the increasingly common ‘nerve block anaesthetics’ – become invisible to the ultrasound scans used to find the nerve, requiring the anaesthetist to literally ‘take a stab’ at positioning it correctly.

While skill and experience make this reasonably accurate, being able to see the needle would make the procedure far more reliable, and this has been achieved by two Swinburne University of Technology research faculties and St Vincent’s Hospital in Melbourne.

It is a valuable development because nerve blocks are considered safer than general anaesthetics, which carry a higher risk of complications during and after surgery. Complete recovery after a ‘general’ can take days or even weeks for some patients.

For procedures on arms and legs, such as orthopaedic and plastic surgery, a local nerve block is often now the preferred form of anaesthetic. However, it requires the anaesthetic to be placed next to the major nerve in the limb being operated on.

Anaesthetists need to bring the needle tip right up to the target nerve without entering it and, until now, without being able to see the needle. Standard needles are invisible using the ultrasound imaging that anaesthetists use to ‘see’ the nerve because ordinary needles do not reflect or ‘echo’ the ultrasound waves directly back to the imaging apparatus. No return echo means no image, forcing the anaesthetist to judge the needle’s position from subtle displacements of the tissue as it is penetrated.

However, Swinburne’s needle is visible on the ultrasound image. It has an intricately textured tip developed by Dr Rowan Deam, from Swinburne’s Faculty of Engineering and Industrial Sciences, and Dr David Liley, from the Faculty of Life and Social Sciences.

Dr Deam was alerted to the ‘invisible needle’ problem by his sister, Dr Roberta Deam, an anaesthetist at St Vincent’s. He accepted the sibling challenge and eventually, with Dr Liley, came up with a laser-based method to modify the tips of conventional needles.

"It’s as if the tip is etched with myriads of minute mirrors," Dr Deam says. "Some of these tiny facets are always angled correctly for echoing the ultrasound back to the sensor, whatever the angle of the needle." Swinburne is in the process of patenting the design.

So far the needle has been tested only in a standard synthetic material that mimics human tissue. Regulatory and ethics approvals for clinical trials, which will be held at St Vincent’s, are now being sought.

Needles for the laboratory tests and a batch for the forthcoming clinical trials were made by MiniFAB, a micro-manufacturing foundry that designs and manufactures micro- and nano-scale devices in low volumes for proof-of-concept and product development. The only facility of its type in Australia, MiniFAB was established by Swinburne in conjunction with commercial partners Michael Wilkinson and the Dalmore Group.

While many companies around the world have built micro-fabrication plants, often based on silicon, MiniFAB has unique capabilities to manufacture micro-engineered parts in plastics and metals, as well as silicon. MiniFAB has earned an international reputation for innovative design, creative microengineering, and its ability to translate research outcomes to commercial products.

The facility provides the infrastructure for researchers to take their designs and concepts out of the laboratory and on to the next stage toward commercialisation, encouraging investors’ confidence. MiniFAB is equipped with a multi-million dollar infrastructure to support a wide range of research and development activities in the microsystems area, including photonics, chemistry, biosensing and nanotechnology.

Professor Erol Harvey is the head of MiniFAB. He says that often researchers and scientists come up with an idea and succeed in getting it to work in the laboratory. But the next step usually needs significant investment, which requires industry to be convinced that it will work practically.

"Because of the element of risk, intellectual property is often sold too cheaply, but if researchers can take their designs and concepts to the next step and show that they actually understand how to make the product at a competitive price, investors will have much greater confidence in signing up to the project," Professor Harvey says.

Manufacturing at MiniFAB is the antithesis of old ‘smokestack’ industry: the fabrication areas are ‘clean room’ grade, the air filtered and the occupants clad in full-cover, surgical-type gowns and headwear. The 20 staff have advanced skills in design and fabrication of microdevices, and in controlling the sophisticated machines that perform these tasks.

The facility’s expertise extends to electroforming, in which metal layers are built onto micro and nano-engineered polymers, and to the bonding of intricately formed polymer surfaces without destroying the elaborate patterns and structures created in them.

MiniFAB is doing groundbreaking work on small devices dubbed ‘laboratory-on-a-chip’. An example is biosensors for environmental monitoring and cancer diagnosis. Each of these miniature sensors integrates all the functions for a particular test. The biosensor might react with material in water, blood or urine, depending on its purpose, then carry out the chemical test and transmit a report.

As the only non-European member of an international consortium, MiniFAB is working on biosensor tests for colorectal, breast and cervical cancer, under the European Union’s SmartHEALTH project.

In 2005, MiniFAB’s evolution took a new direction, when it became the nucleus for a Small Technology Cluster (STC), which has gathered an array of micro-technology businesses under one roof. STC was set up with a $3.5 million grant from the Victorian Government under its Science and Technology Innovation program.

Chief executive officer Clive Davenport says the STC’s mission is to build a high-growth, interactive business environment where researchers can demonstrate a product’s potential to investors, or advance beyond that stage to the point where a product is ready for commercial production.

Currently, the STC hosts 29 micro-technology companies, ranging in size from one-person consultancies and start-ups, to more mature ventures with 10 to 20 employees. All members share an interest in the development and application of micro-, nano- and biotechnology – the so-called ‘small technologies’ – in a wide range of economic activities.

Mr Davenport says many STC members are in the early stages of commercialisation. "Some were formed by Swinburne students. Others are start-ups emerging from Swinburne, the University of Melbourne, CSIRO, Griffith University and private organisations."

Their products include drug delivery and packaging systems, brain monitoring and photonics applications, radio frequency identification, global positioning and wireless technology, polymer implants, and water-quality sensing.

As the STC grows it is able to broaden its services, offering further support to members. For example, a recent arrival at the STC is the Australian Product Realisation Centre, also assisted by the Victorian Government’s Science and Technology Innovation program. The Centre will make available cost-effective, industry-based product development skills for members of the STC, as well as early-stage commercialisers in the broader small technologies community.

Under the STC’s Access Program, members can apply for small grants to pay for design and fabrication work at MiniFAB. These funds are awarded competitively, typically with values of $5000 to $20,000. The Swinburne needle developed by Dr Deam and Dr Liley received two of these STC Access Grants. Both grants went to Neurotech Medical Services Pty Ltd for the development of manufacturing methods at MiniFAB. Neurotech also supplied blank needles and staff time.

Swinburne funded the cost of getting approval from the Therapeutic Goods Administration as well as provisional patenting, and supported Dr Deam and Dr Liley during the time they spent on development. St Vincent’s Hospital invested the time of at least four of its senior staff to evaluate the needle and prepare the proposal for a clinical trial.

MiniFAB, together with Dr Deam and Dr Liley, is now working on methods for scaling up production of the modified needle and further reducing production costs. Professor Harvey is confident the streamlined techniques will allow MiniFAB to manufacture needles commercially.

At present, all local-nerve-block needles are made overseas, including a type designed by an anaesthetist at St Vincent’s that was once made in Australia. The needle-development team is investigating prospects for Australian production of the needle if the clinical trials go well. Australian hospitals use about 20,000 needles a year, each valued at about $25; the rest of the world uses about 400,000 needles annually.

Dr Deam is hopeful the Swinburne needle will eventually make life easier for anaesthetists and their local-nerve-block patients around the world.