Description:

Feedback suggested need for an improved patient support to immobilise the head during image guided therapies, especially strokes. There were a selection of products available for this purpose but none were widely accepted for Interventional Neuroradiology, some consisting of basic foam form, others with metallic components inducing radio shadow. Placing a patient under anesthesia adds another layer of cost / risk to these procedures and if there were a better solution to immobilise an awake patient, it would be widely adopted.
The design needed to:
Immobilise the patients head still for the numerous Angiographies required to diagnose and treat Strokes and other vascular malformations. A 3D model of the cerebral vascular system is acquired via CT and this is also overlaid with the 2D Angiography image to assist with navigation, making immobilisation critical.
Be radiolucent allowing clear imaging of the cerebral vascular system when viewed from multiple angles.
Comfortably accommodate different head shapes and sizes.
Offer some positioning versatility to accommodate the multitude of angiography imaging angles the user requires to complete the procedures, but also accommodate the patient body types, including partial side paralysis and muscle contraction induced by strokes.
Be quick and easy to install and remove in emergencies.
Not restrict C-arm X-ray camera procedural coverage requirements.
Be durable for repeat use and easy to clean.
Conform to ISO13485 device design guidelines for a Class 1 device.
Have a professional design and finish, easily placed amongst international design peers such as Philips healthcare.
The design of the Head Immobiliser presents as a well proportioned clean and simple solution for the required application. The innovation of the vacuum hood provides an effective solution for versatile head immobilisation in the most radiolucent materials.
Highlights of bright blue intuitively inform both patient and clinician of elements to interact with. The colour usage and materials form part of a suite of solutions in the field of Image guided medicine and are key components to the companies’ brand language.
Production of the soft hood proved extensively challenging, with spray moulding, rotational moulding, dip moulding all being tried, before arriving at the thermoforming and welding process.
The carbon fibre has rich appeal due to the depth of the visible cloth weave and is a material associated with high performance. It is used for its excellent radiolucency, strength and weight.
The strength allows the cantilevered head support to remain thin and radiolucent. The weight can be kept to a minimum with the carbon skin structure surrounding the aerated foam core, ensuring ease of handling by the nursing team responsible for set up.
The product addresses each of these stakeholders needs well due to the involvement they each had in the product development. Designers spent hours observing different procedures hearing the pain points first hand from Drs locally and abroad and visited Philips HQ in Holland. These became critical markers of success for the product.
It was released in May 2023.