Pre-clinical development and validation of mixed reality for intraoperative guidance in sentinel lymph node resection

Our commercial partner s digital platform translates standard clinical imaging into 3-D representations of anatomical structures (www.holocare.com).

Superimposed within 3-D space using Microsoft s class I CE marked medical device (HoloLens), this is presented to Augment Reality (AR) in the clinical setting, enabling users to see structures in front of them, i.e., holograms.

Applications include patient consultation and surgical planning; however, commercial viability will likely be dependent on mapping AR directly on to patients, to enable surgeons to visualise patient anatomy intra-operatively.

This could reduce pre-surgical planning, speed up operations and provide greater precision, particularly where surgeons have limited experience. This could confer better patient outcomes, greater efficiency and help ameliorate NHS surgical backlogs. Augmented reality software and algorithms have been developed for several pathologies and procedures (1).

However, within surgical guidance this has been limited.

To de-risk the HoloCare platform for AR guided surgery, we have selected a procedure commonly performed in the NHS, Sentinel Lymph node biopsy (SLNB).

In the UK, approximately 70,000 are performed annually for Melanoma and Breast cancer (2); which have a combined worldwide incidence of 2.5M annually (3). Localising the SLN within the surgical field is laborious but critical to guiding subsequent treatment (4,5). Currently, surgery is planned by variously combining, blue dye, radioactive material, skin marking and imaging.

This requires 1-2 hours of pre-operative technical activities and produces variable outcomes. AR guidance would negate the need for all but standard imaging, drastically reducing labour and procedure duration. Patient acceptance for AR guided surgery has not been fully evaluated, but is likely to be supported (6).

Patients views are critical to further develop and implement this technology.

During the FAST award, we will draw on extensive PPI infrastructure/networks to gain patient/public insight into acceptability of both the technology and co-design future work requiring testing with patients.