A device for clinical wet-to-wet connections that alleviates healthcare provider anxiety and enhances patient quality of care

Unmet Need

Extracorporeal membrane oxygenation (ECMO) is a rapidly growing method of providing life-saving support to a patient suffering from heart or lung failure. Between 2010 and 2021 ECMO runs in the United States grew at over 16% CAGR. Given the ever-increasing prevalence of cardiac and respiratory conditions, this remarkable growth is forecasted to continue. An ECMO device acts as an external lung, adding oxygen and removing carbon dioxide from the blood. The device must be replaced every 8-10 days to maintain efficiency and avoid complications or failure. This procedure, called a circuit change, involves transferring the patient from the old ECMO circuit to a new one. Circuit changes are becoming ever more common as ECMO run durations increase. In 2021, the estimated number of circuit changes was nearly equal to the number of ECMO runs overall (13000 changes in 14000 runs). Although necessary, circuit changes are highly stressful for perfusionists as their patient is off life-support. In particular, the most challenging and stressful aspect of the circuit change is widely recognized as the wet-to-wet connection (WWC). Simplifying the WWC presents an opportunity to deliver value to patients, perfusionists, and hospitals. There is a need for a device to facilitate WWCs during an ECMO circuit change, to enhance patient quality of care and improve perfusionist wellbeing.

Technology

Duke inventors have developed a single-use sterile device that facilitates a WWC during an ECMO circuit change. This is intended to be used by a single perfusionist to perform a circuit change with increased safety, confidence, and efficiency. Specifically, the standalone device facilitates WWCs by providing a transparent saline-filled chamber in which the connection is made. The extracorporeal circuit (ECC) lines are inserted into the chamber through opposing fluid-tight ports and connected while submerged in saline. Sealed ports ensure the retention of saline within the chamber, while allowing maneuverability of ECC lines. Following connection, the device can be freed from the line by a pull tab. Safety is achieved by the submerged setting – in which any air in the tubing is automatically displaced by saline. Confidence is delivered by the continuous, unobstructed view of the connection throughout the entire process. In addition to this visibility, the device also increases efficiency via features that enable the procedure to be front-loaded before taking the patient off support and by reducing personnel requirements by half.

This has been demonstrated in feature testing of an initial prototype, and development has progressed to outsourced production of a high-fidelity prototype. The newer prototype will be used for design verification and validation based on bench testing and animal testing. These efforts will culminate in clinical trials and FDA approval, with full product launch anticipated in 2026.

Other Applications

This technology could also be used for other procedures that involve WWCs – such as circuit changes during cardiopulmonary bypass (CPB) surgery, as well as initiation of ECMO or CPB.

Advantages

• Improves patient quality of care – more efficient and safer WWC procedure
• Improves perfusionist wellbeing – minimizes technical challenges and patient risk
• Enables a single perfusionist to perform the WWC procedure