Rapid, responsive, and active dissection insertion device for large-bore chest tubes
Unmet Need
Tube Thoracostomy, a critical procedure for removing fluids and/or air from around the lungs to restore breathing, has a high complication rate of 30%, with complications increasing cost by up to 21x. This procedure, performed in over 900,000 US patients annually, evacuates the fluid and/or air by inserting a large chest tube into the pleural cavity. Complications, which include organ punctures and tube malfunctions, primarily result from the difficulty in accurately navigating the chest tube into the body, through the dense tissue of the chest wall, and into the pleural cavity at a safe trajectory. There is a need for a device which assists in the insertion of large-bore chest tubes during tube thoracostomy by providing real-time navigational support and by eliminating high-risk procedural steps.
Technology
Developed by Duke engineers in collaboration with practicing clinicians, the SlipSpeed large-bore chest tube inserter is a single-use device designed to address this unaddressed procedural challenge through a novel mechanism which provides physicians greater control over their tube insertion trajectory than the current procedural technique while providing reliable active blunt dissection through tissue. This mechanism maintains unobstructed access into the pleural cavity along this trajectory for safe tube navigation and insertion. These features have generated excitement from physicians, and the device has performed successfully in proof-of-concept testing in both phantom and ex-vivo porcine models. With all device components designed for scalable manufacturing, this device can be sold to hospitals as part of a chest tube kit with a price within existing hospital reimbursement and comparable to existing chest tube kit prices.
Advantages
- Reduces the number of steps required for placing a chest tube
- Removes the steps that have the highest complication rate
- Provides real time feedback for pleural space insertion