The Challenge Our Approach Value Created

The Challenge

Catheter ablation is widely used to treat a range of abnormal heart rhythms. It involves passing a thin, flexible catheter through the blood vessels to the heart, where it pinpoints the arrhythmia and uses ablation to block the abnormal electrical signals. A more dexterous catheter increases success rates for patients and retains greater cardiac function.

King’s College London invented a technology that enabled ‘three degrees of freedom’ steerability to improve the precision of treatments and facilitated robotic augmentation. They asked us to develop their intellectual property to demonstrate commercial viability.

Our approach

We first engaged with cardiologists to identify user needs, which led us to improve the catheters capacity for therapy delivery. The technology is based around unique flexible segments so we integrated these into an overall catheter design that was practical to use and mitigated any major risks. In addition, we designed for manufacturing and assembly and selected new materials for strength, flexibility, biocompatibility and sterilization.

Our mechanical engineering team then designed, built using micro molding, and finally tested integrated prototypes that demonstrated advanced performance and reliability.

Micro injection moulding is used extensively in the new desig

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Computer aided engineering helps predict the performance of system components.

Precision engineering ensures high performance.

The value we created

In just nine months, ten full-length catheters were manufactured and tested. Their performance exceeded the key regulatory requirements of ISO 10555 and we proved key manufacturing and assembly steps. Our work enabled King’s College London to plan clinical trials and showcase their catheter technology to potential acquirers.

ablation-catheter-technology-cardiology-surgeon-operating-theatre

“We have been delighted with the results of Cambridge Design Partnership’s work on this project, their engineering approach and the practical improvements they managed to incorporate. They delivered fully moulded parts, and specified other components and the assembly route which fully met our aspirations for the project”

Professor Kawal Rhode, Professor of Biomedical Engineering, King’s College London

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The Challenge Our Approach Value Created

The Challenge

Whilst others have shown 3D printing of injection mold tooling is feasible for simple parts, we wanted to mold real world, complex components.

So we developed a fresh approach using industry standard polymer 3D printers to create complex mold tools in hours. Realizing that making the tool is only part of the time required, we also made sure to fast track tool design and verification.

First the design is sketched to develop the geometry of the major components.

The printed tool insert splits to allow the molding to be removed.

Precision 3D scanning is used to verify the accuracy of the finished part.

Our Approach

Others had shown that 3D-printed tooling could work for simple parts, so we started from a clean sheet to handle complex components. Printed polymers are weaker than tool steel and handle heat poorly, so our tooling design works around those limits.

We print only a small insert and fit it into a standard metal mold plate. Prototype tools don’t need to run automatically, so the insert is split into pieces and opened by hand, with no moving parts. Supported by rigid metal, the insert stays mostly in compression during injection, which keeps it accurate. For higher-temperature plastics, we fill it with a low-melting-point alloy to add heat capacity.

Every step is digital, from 3D CAD to printer to our BOY 22-tonne molding machine, with high-resolution 3D scanning to verify both the insert and the finished part. We proved the process on a precision multi-dose syringe made from ABS moldings.