CLIENT: Clear Surgical
THE EXISTING EXPERIENCE
To perform their job well, Surgeons need a sufficient level of task lighting. Achieving this can be difficult when the incision is deep or the treatment area well hidden. Additionally, the surgical staff may block out the useful light from overhead lamps with their hands, heads or torso.
HOW HAS IT CHANGED?
A localised light source, integrated into the surgeon's retractors, creates a well lit surgical zone that is unimpaired by the bodies of the surgical staff. The result is improved surgical conditions and better overall patient care.
The light can be switched on and off as desired and, if the battery diminishes, the lighting module can be easily replaced.
Since the light is emitted from within the surgical cavity, and not from an external source, smaller incisions may be possible, with the potential for reduced scarring for the patient.
The creation of unique, marketable intellectual property. A design that can be adapted for different shapes and sizes of retractor, allowing Clear Surgical to capitalise on their IP by reaching a wider market. A proprietary disposable component, creating the potential for ongoing revenue through the supply of replacements.
A Design History File, with verification documentation to support CE marking. The early establishment of manufacturing partners and a validation proposal, along with the management of initial production samples and manufacturing refinements.
A leading light for surgical devices.
Despite modern advances in laparoscopic or keyhole surgery, many operations are still performed using open surgical methods. The success of these procedures is supported when the surgical cavity is well lit, at the specific area of treatment, allowing the surgeon to see their finer details of their task.
Most theatres come with powerful overhead lamps that can be repositioned to provide sufficient illumination. However, theatre staff may find that their own hands, heads or torsos are a problem; casting shadows on their area of focus. Further lighting issues may also occur when the incision is necessarily deep, due to excess body fat, or when the treatment area is hidden behind other internal body parts.
Partial solutions to this problem exist in the form of head lamps and fibre-optic torches. The heads lamps, although powerful, may also be obstructed by the surgeon's hands and are less useful for illuminating more hidden areas within the body, requiring the surgeon to hold their head at a certain angle. The mains powered, fibre-optic torches resolve some of these issues, but they require an assistant to hold them in place and have trailing cables that can get in the way.
Ultimately, the most effective way to illuminate the working area is to position a light source inside the surgical cavity itself; one that is self contained and self-powered. Such a solution would be unimpeded by the bodies of the surgical staff, and could be manipulated to illuminate even hard-to-reach areas. Also, with a light source internal to the cavity, the incision could be smaller, leading to less scarring for the patient.
The Oplight S, as it came to be know, had to provide these benefits in a slimline, unobtrusive package and maintain the familiarity of a standard pair of steel retractors. To this end, design work focussed on creating a low-cost, low-profile, battery operated lighting module, and a modified steel retractor in which to house it.
Collaborating with a neighbouring laser etching facility at TWB, Fearsome created near production level light guides, with quick turnarounds and minor costs. This method of prototyping proved invaluable, allowing for rapid optimisation and a streamline conversion to the moulded version.
As each light guide was prototyped, its illumination was measured and evaluate on 3D printed rigs that represented various surgical scenarios. And once optimised, the light guide configuration was transferred directly to the mould tool for initial production samples.
A particularly memorable part of this project - and not one for the faint of heart - was visiting and making use of the Theil Cadaver Facility at Dundee University. Theil Cadavers, unlike their traditional counterparts, are preserved in a way that the skin remains soft, and their internal organs remain intact. Here the project benefited from the unique features of this method, as Fearsome and Clear Surgical worked with local surgeons to evaluate prototypes and provide invaluable feedback for the design.
From Clear Surgical's point of view, a significant outcome of this work was the creation of a low-cost, mouldable lighting solution embodied in a replaceable lighting module. The basic design is simple enough to be adapted for other shapes and sizes of retractor, allowing them to capitalise on their IP by targeting a wider market or creating licensing arrangements. And, since the module is disposable, it creates the potential for a business model augmented by the supply of refills.