The two basic devices that are the current focus for development activity are the Ankle Foot Orthosis (AFO) and the Hip Spica Cast.
Development progress on the AFO
1. The torc material has been successfully converted into 1.75 mm filament for 3-D printing. This was carried out at The University of Warwick’s International Institute for Product and Service Innovation (IIPSI) over a 3 day event using their laboratory twin screw extruder. We engaged the additional services of a Consulting Extrusion Engineer with 30 years’ experience of extruder design and processing to obtain independent confirmation that the material was fully suitable for standard single screw filament extrusion equipment. Additional thermal testing was also carried out by IIPSI confirming that the temperature at which manipulation of the torc material to alter the shape can be done without harming the patient is 55-59 degrees Centigrade, thus allowing for on-patient refits should the need arise.
2. Collaboration with a Company in Leeds (KORA Ltd) who have a recently entered into the manufacture of 3-D printing equipment is proceeding with a trial run booked of the torc filament using a modified print head suitable for use with very flexible filament. This should occur over the next 1-2 weeks and they will produce test piece models for determining layering efficiency and mechanical properties.
3. Agreement to submit an EPSRC project has been reached with Professor James Shippen who heads up the Motion Capture Laboratory at Coventry University. This project aims to produce the software needed to take patient gait analysis data and link it with a program to create a virtual patient model that will allow the attending clinician to apply a virtual AFO and study both the finite analysis detail and the gait correction result before finally downloading the AFO design in an STL (stereo lithographic) file format to a 3-D printer for bespoke manufacture of the AFO. A process that will ultimately take 1-3 days to complete instead of the current delay of between 6 and 12 weeks.
4. As part of our association with a leading Orthopaedic Surgeon a Case Study for the setting up of a centre of Excellence Gait Analysis Suite at The University Hospital Coventry and Warwickshire NHS Trust has been proposed and received the go-ahead from the orthopaedics department. The use of torc material to produce AFOs by 3-D printing will be developed alongside this project and clinical trials will be commissioned later this year. The commissioning of this unit and the implementation of the torc system for AFOs will have a dramatic impact on the quality and experience of care afforded to children with walking difficulties which could quickly be rolled out across the UK.
Development Progress on the Hip Spica Cast
1. A 5 day design program has been granted from the Health and Design Technology Institute at Coventry University Enterprises Ltd of which half a day has been used so far.
2. A Birmingham based neoprene sheet stockist has supplied suitable sheet material for the Spica vest and pockets; and a local re-upholsterer will be sewing the first prototype together for concept approval shortly once the heater pads arrive.
3. Flexible silicone heater pads with the proposed heating capacity, thermocouple control and low voltage DC supply are awaited from a UK based supplier.
4. Oven tests on a neoprene vest have shown that when a section of torc material is raised to 60 degrees Centigrade, the skin side of the neoprene only reaches a maximum of 52 degrees due to the inherent low heat conductivity rates of both the torc material and the neoprene foam layer.
5. Recent tests carried out at University Hospital Coventry and Warwickshire by Professor Charles Hutchison, Head of Imaging, have revealed that the presence of a silicone heater pad encased in a neoprene pocket has little effect on the quality of X-ray scanning, which means that the hip joints can be checked through the torc spica vest without the need to remove it.
I/P Asset Management:
1. Patent applications are in place for the basic system and the use of Additive Layer Manufacturing is also now fully covered.
2. A Patent Cooperation Treaty (PCT) is also in place which gives notice of our intention to file in a number of Countries within 18 months of the date of application (mid 2016).
3. A grant towards the cost of the PCT was obtained from Coventry University’s IPAM project (Intellectual Property Asset Management).
4. A number of possible prior art filings have been raised in early examinations and dismissed as being of insignificant similarity.
Commercial Potential for Additive Layer Manufacturing Using Torc Materials:
1. The torc material is also being assessed by the Leeds based company for use in Printers aimed at schools/colleges where the very low printing temperature and low thermal manipulation temperature will present vastly lower Health and Safety risks. This will give the company, Kora, a unique selling point (USP) over competitors in this market.
2. Material in filament form will also be available to owners of 3-D printers to offer a flexible coating on parts needing impact protection or a decorative layer.
3. A provisional patent application has been registered for a novel additive layer manufacturing method using a peristaltic pump system operating in a temperature range that some currently available pump tubing types will work within. This will allow the 3-D manufacture of models from torc granules without the need to first extrude filament and will increase deposition rates for much faster model production. It is expected that the pump system will be adaptable to existing 3-D printer linear motion drives thus offering a less expensive starting material than filament reels, with the added ability to introduce additives such as colours, re-odorants, anti microbials, and fillers into the feed system without the need to compound and extrude each new blend into filament.
4. In conjunction with the collaboration with Spica neoprene vest manufacturers we will be introducing a range of thermally manipulatable hand and wrist splints offering users the ability to adjust the splint for best fit and comfort at a temperature that is easily tolerated.
5. A sample strip of torc material is being evaluated as a dressing protector/retainer following minor facial surgical procedures