Application

Device that provides continuous renal replacement therapy (CRRT) for neonates and children with acute kidney injury, which is adjustable to treat adults as well.

Key Benefits

• Can be used in children - currently no CRRT device is approved for pediatric use.
• Improved accuracy over currently available devices due to novel pump and control system design.
• Easily integrated with other extracorporeal therapies.
• Reduced size of device and more user-friendly interface compared to other current therapy devices.
• Reduced risk of infection, bradykinin release syndrome, and transfusion reactions by reducing extracorporeal volume, thus reducing number of blood exposures.

Market Summary

Acute kidney injury is common in critically ill children and some form of adjunct support is often vital to provide fluid and electrolyte clearance until native renal function improves. Currently, there are no CRRT devices approved for pediatric use. Instead, devices used in adults must be adapted for use in children. Because these devices were not designed for or tested in children, they may have negative effects during pediatric care. Currently available devices have multiple problems when used on pediatric patients, including an imbalance between the amounts of ultrafiltrate produced and replacement fluid delivered, inaccurate pump delivery leading to dehydration, and reduced extracorporeal volume leading to additional blood exposures, which put the patient at risk of infection, antibody development, bradykinin release syndrome, and other transfusion reactions.

Technical Summary

This novel pediatric-specific CRRT device increases safety, improves fluid accuracy, reduces extracorporeal blood volume, and eliminates other problems associated with the current practice of using during pediatric care adapted CRRT devices that were originally designed and have been approved for treating adults. The unique mechanical design consists of a closed loop system that provides a means to safely control the blood that is drawn, filtered, supplemented, and returned to the patient; and a fluid balance system that resolves the inaccuracy between the amount of ultrafiltrated produced and replacement fluid delivered compared to currently available devices. Because clinicians sometimes need to impose a positive or negative state of fluid balance, there is an offset loop to provide adjustability to the balanced fluid exchange. The device is designed with a user-friendly interface. The interface can be used with a touch screen, is programmed to communicate and be compatible with electronic medical records, and has a number of additional features. Finally, this device is smaller than current designs that require a large amount of bedside space and has been designed to be quieter through the elimination of operating valves, which may be particularly beneficial for use with neonates and small children.

Developmental Stage

Prototype has been constructed and bench tested. Proof of principle studies in vivo are planned.