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Content archived on 2024-04-30

Development of a novel range of instruments for minimal invasive surgery applications

Objective


Task 1. Report issued that compares the properties of potentially competitive materials for the foreseen application. Super-elastic nickel-titanium alloy was found to be the most suitable choice.
Task 2. Mechanical property data measured under tension and compression, both as single tests and under cyclic conditions at room and body temperatures. Report issued to partners and technical paper accepted for publication.
Task 3. Data measured on tubular material in both bending and torsion modes at two temperatures. Data reported at partner meetings and transferred from Nottingham to Huddersfield University.
Task 4. A software material model of Ni-Ti has been completed and has now been integrated into the FE code.
Task 5 Preliminary design specification developed after discussions between partners and end-users.
Task 6. Parametric FE models for predicting slotted tube deformations under a range of loading conditions have been developed.
Task 7. Tube machining has been undertaken by laser cutting. Plasma-assisted CVD coatings of DLC have been successfully deposited onto Ni-Ti tubular substrates and have been examined in terms of mechanical and biocompatibility properties. An environmentally-friendly process has been developed for electro-polishing the super-elastic alloy.
Task 8. Static torsion measurements have been performed on trial slotted tubes and the results found to give good agreement with FE predictions (Task 6). The measurement of dynamic behaviour has been identified as being of benefit during the course of the work programme and will be undertaken after the formal completion date.
Task 9. FE models of torsional behaviour of slotted tubes have been shown to agree with experimental observations. This is a good test of the model and provides validation of it.
Task 10. Designs for two prototype instruments have been produced, based on information from the FE modelling and rapid prototyping activities.
Task 11. Two prototype instruments have been produced for demonstration.
Task 12. Performance of demonstration instruments included in final report.
1. Endoscope development. The partners have been in contact with instrument purchasers and clinicians to confirm the functional requirements of the novel instruments. The first application is for a high volume, orthopaedic instrument.
2. It is intended that the final instrument designs will be patented as a pre-cursor to wider exploitation. The intellectual property will be based on the material, surface treatments, slot geometries and articulating systems employed.
3. Surface finish will be an integral part of the instrument designs. To assist sterilisability and improve mechanical properties, the tubes have been electro-polished and, subsequently, a biocompatible coating of diamond-like carbon applied. Both of the processes adopted carry their own IPR that will be independently exploited for other applications, particularly in the biomedical sector.
4. Data generated that relate to the mechanical properties of the super-elastic Ni-Ti alloy will be disseminated by technical publications and by conference/seminar presentations. A paper has been prepared by Nottingham University, approved by the SME partners, and accepted for publication.
5. The implementation of the super-elastic material model within the finite element code will be disseminated by technical publications and by conference/seminar presentations. Papers will be prepared by Huddersfield University and approved by the SME partners.
6. The structural and finite element mesh optimisation methods will be disseminated by technical publications and conference/seminar presentations. Papers will be prepared by Huddersfield University and approved by the SME partners.
The objective of this project is to develop a range of endoscopic instruments for use in minimal invasive surgery (MIS) that will give surgeons improved operating benefits gained from the ability to utilise ancillary systems such as light fibres, cutting devices, localised drug deployment etc incorporated within the single instrument, thereby reducing patient trauma and speeding up recovery. This will be achieved by manufacturing the instruments from metal alloy tubes that can be actuated within the body to achieve 'round the corner' bending whilst carrying ancillary devices in the hollow lumen, so that damage to surrounding tissue is minimised. The technical hurdles that this project must overcome are to obtain high rigidity in the actuated tubes which must be of a sufficient diameter to allow the secondary devices to be deployed. The research approach will be to use computer modelling based on specific mechanical property data for the tube material to produce a design for a precisely manufactured geometry that gives a rigid structure when actuated. Fabrication and surface engineering techniques will be developed that will allow low cost manufacturing and the use of reusable handles or actuating mechanisms, and assist sterilisation procedures. Whilst there is a medium degree of risk in achieving the project objectives, it is believed that this is justified by the potential benefits to the quality of life of patients and the increased market opportunities for the industrial partners. Refinement of the instrument designs for different applications will need to be carried out after the 24 month research period. This is expected to take a further 18 months after which it is forecast that the cost of the project will be recovered in one year.

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CRS - Cooperative research contracts

Coordinator

Surgical Innovations Ltd
EU contribution
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Address
Clayton Park
LS16 6RF Clayton Wood Rise
United Kingdom

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Total cost

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Participants (8)

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