A colonoscopy device
Inspiration came through the practical difficulties in a conventional colonoscopy, including the colonoscope slipping back, the forces required to push can be quite high causing patient discomfort, the tip can move during procedure and is difficult to stabilise and current scopes can miss legions that hide behind colon folds and there is no way to view behind folds. These factors created the design challenge that DesignEdge needed to meet on a technical and aesthetic level, effectively these medical problems were the basis to the inspiration and an eventual solution.
UNIQUE PROPERTIES / PROJECT DESCRIPTION:
Endocuff is an innovative disposable device that slips onto the end of conventional colonoscopes to improve mucosal vision and enhance tip control. EndoCuff features soft flexible projections which gently support the tip of the colonoscope in the centre of the colonic lumen providing stability and reducing sudden slip back, looping and patient discomfort. The projections evert large folds and flatten small folds so more mucosa can be visualised. Colonoscopists use the flexible arms to manipulate folds and polyps. Each soft projection moves independently, rotating on a hinge at its base providing an improved position. During forward motion the hairs fall flush with the body.
OPERATION / FLOW / INTERACTION:
The EndoCuff slips onto the end of conventional colonoscopes using a friction grip fit. During extubation the Endocuff improves the Physician’s ability to visualise and examine the mucosa in four unique and innovative ways:
The Endocuff gently supports the tip of the instrument within the centre of the lumen providing an improved position for a panoramic view. During withdrawal, the flexible arms reduce the risk of sudden slippage so the physician experiences better control and feedback enabling a more thorough examination to be performed. The arms of the Endocuff open the bowel for inspection using a concertina motion, everting large mucosal folds and providing clear views of mucosa previously difficult to visualize. Experienced colonoscopists can use the flexible arm to manipulate folds, polyps or debris to gain a better view without vision being lost.
PROJECT DURATION AND LOCATION:
The project started in February 2009 in Cambridge and was launched early in 2012.
FITS BEST INTO CATEGORY:
Scientific Instruments, Medical Devices and Research Equipment Design
PRODUCTION / REALIZATION TECHNOLOGY:
EndoCuff’s unique industrial design uses advanced polymer technology to provide a rigid support structure combined with flexible projections which gently open the colon wall. The design language reflects a compact, high quality, technically detailed device suitable for the medical environment. There are a number of size variants available in different medically compatible colours designed to fit various colonoscope sizes and models. The design uses a twin shot moulding process and DesignEdge selected Boddingtons Plastics a specialist in developing technical medical mouldings for volume manufacture. Working closely with Boddingtons the part was detailed to include 8 side actions to manufacture the two layers of flexible hairs in a circular arrangement. The hard outer shell allows the part to be rigid for application to the endoscope whilst the soft moulding ensures hairs remain flexible ensuring minimum trauma during the procedure. This allows the inside of the cap to protect the colonoscope during application. The flexible feature also allows the EndoCuff to fit a number of different size scopes, with DesignEdge developing four different sizes which are colour coded to fit the wide variety of scopes and ensure that the fit is perfect for every scope.
SPECIFICATIONS / TECHNICAL PROPERTIES:
The Endocuff comes in different sizes to fit most Olympus, Fujinon and Pentax colonoscopes. Size is approx. Diameter 17mm x Length 24mm with projections in flush position. EndoCuffs are radio opaque and disposable. They fit onto the tip of the colonoscope distal to the bending section so will not interfere with the mechanics of the instrument. The hinged projections fall flush with the colonoscopes so will not interfere with forward motion.The EndoCuff does not include any latex. Patents Pending. EndoCuff is a sterile product and is for single use only.
EndoCuff, Colonoscopy, Cancer Screening, Medical Device, Disposable, Colonoscope, Endoscopic Procedures, Flexible Projections
Early research explored the natural world including animal skins and fish scales for forward friction traction. Hydroscopic and nano-coatings were explored to improving colonscope movement and reducing the forces involved. Materials were fundamental to the success of the project and explored super stretchy silicon materials, friction levels of rubber and hard soft material balance. Supplier research and selection was key to the project success as was meeting medical ethics and regulations. Early practical test were conducted using pig colons using a custom designed test jig to simulate the human colon. Research objectives included determining the best mechanical design in terms of function, materials and processes, coatings, aesthetics, testing and packaging.
The challenge was to create a simple, flexible retrofit cap to improve the colonoscopy procedure in terms of visibility, detection, speed (it is currently a 25-30 minute procedure) and patient comfort. The product also had to be able to attach to a number of colonoscope sizes and be mass produced.
TEAM MEMBERS (4) :
DesignEdge - Alasdair Barnett, DesignEdge - Bruce Hutchison, Arc Medical Design Ltd and
Alasdair Barnett, Bruce Hutchison, 2012.