Sensor-enabled surgical guidance

FlexDetect captures real-time mechanical signals from the implantable device, and Sixth Sense Surgical turns that into real-time event detection and guidance to aid during delicate procedures, starting with cochlear implantation.

>75%
Reduction in excess impulse with real-time alerts
0.28 mm
ML reconstruction accuracy, in simulation
10×
Thinner than a human hair
Macro view of serpentine FlexDetect sensor traces running along a cochlear implant electrode.
FlexDetect traces on a cochlear implant electrode
FlexDetect

Meet FlexDetect.

FlexDetect is a microfabricated thin film, 10× thinner than a human hair, integrated with the cochlear implant electrode array. It is made of biocompatible materials already used in cochlear implants: silicone, Parylene C, platinum and gold. Capacitive sensing elements spaced along the array capture the real-time strain distribution as it traverses the cochlea.

A sensor on the array must not change how the array bends. In three-point bend testing FlexDetect adds 7.2 nN·m² of bending stiffness, under 3% of commercial electrode arrays.

Bending stiffness added by the sensor beside two commercial arrays · three-point bend test

Advanced Optronics holds an exclusive, perpetual, worldwide license to the underlying Carnegie Mellon University research, developed with support from UPMC Enterprises.

A flexible FlexDetect probe threaded between the bearings of a three-point bend fixture, bowing under load.
FlexDetect probe in a three-point bend fixture
Sixth Sense Surgical

Meet Sixth Sense Surgical.

Sixth Sense Surgical reads and interprets sensor data in real time from readout electronics outside the surgical field, so no active electronics stay implanted. An audible alert sounds when the insertion force crosses an alert threshold.

3D reconstruction

A machine-learning model reconstructs a digital twin of the electrode array’s shape and position inside the cochlea, without imaging. In finite-element simulation the reconstruction accuracy is 0.28 mm.

Software-rendered view of a cochlea with an electrode array inserted through its basal turn: the true array position and the machine-learning reconstruction from the sensors lie almost on top of each other along the whole insertion; a 5 millimeter scale bar.
ML reconstruction of the array from strain alone
The impact

Surgical technique improves with guidance.

Greater than 75 percent

Reduction in excess impulse with real-time alerts

In a usability study in 3D-printed cochlea models, audible alerts from the Sixth Sense Surgical prototype reduced excess impulse: the magnitude and duration of the force above the 50 mN alert threshold. This effect held among practicing cochlear implant surgeons and trainees (residents and a fellow).

Excess impulse per insertion, unassisted and assisted, for surgeons and trainees

Rapid skill acquisition

Guided insertions with real-time alerts from Sixth Sense Surgical taught atraumatic surgical technique. Assisted insertions (blue) led to dramatically reduced insertion force compared to unassisted insertions (purple). Benefits persisted in subsequent insertions, even once guidance was removed.

Surgeon A-002, ten consecutive insertions

Pre-clinical data; not derived from human clinical use.

Application

Cochlear implant surgery first.

The same thin-film approach extends to other flexible instruments: catheters, endoscopes and electrodes.


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