Integra LifeSciences Cusa Clarity Ultrasonic Tissue Ablation System

Integra Life Sciences, the leader in ultrasonic tissue ablation, chose Farm to collaborate on developing their next generation ablation system. Used during neuro, liver, and spinal surgery, CUSA Clarity delivers radio frequency energy to the tip of a surgical probe to precisely ablate tissue. Farm designed and engineered two ergonomic handpieces, a smaller and quieter console, and a simplified disposable cartridge for fluid and suction management.

Farm observed live brain tumor procedures at Tufts Medical Center, St. Joseph’s Hospital and Medical Center, and Barrow Neurological Institute (BNI) to gain insights into user interface and ergonomic improvements for the headpieces and console.

The team built mockups of the handpieces and various fluid and suction cartridge concepts, and they were tested with users to drive the selection decision. The team then built a full-size functional model of the console with the chosen cartridge and latching scheme for key opinion leaders preference testing. The patented cartridge design eliminated steps with a simple one-handed placement of both peristaltic and aspiration line tubing.

Farm established an intuitive information architecture for the GUI touchscreen, designed new iconography, and created a bold, easy-to-read visual design for the display.

Farm refined the component architecture, sourced critical components, breadboarded mechanical subsystems, and engineered all of the enclosure parts. Farm delivered full production CAD databases to Integra’s PDM system and worked with Integra’s manufacturing resource in Ireland on design transfer. Electronics and software development were conducted by our development partner, Sunrise Labs.

Key improvements include:

• A re-configurable console system which can be used as both a benchtop and mobile mounted cart.
• Improved the workflow with an intuitive Graphical User Interface which controls tip energy, irrigation flow rate, and vacuum level, for a specific surgery.
• Simplified tubing management for faster setup by creating a one-handed disposable cartridge for fluid and vacuum tubing management.
• Two integrated handpieces with different frequencies, each with improved handle ergonomics for safety and comfort.
• Significantly reduced the handpiece torque felt by the surgeon compared to previous tubing and cable management schemes.
• Created an ergonomic, disposable nosecone for the handpiece with integrated sealing features to eliminate o-rings.
• Streamlined tip attachment and setup.
• Visual design and brand language that complements Integra Camino/Licox neuromonitors.