Abstract No. 346 Preventing Inadvertent Removal of Percutaneous Drains Using a Coiled Catheter Securement Device (DrainStay)

Percutaneous catheters have provided a minimally invasive solution to a wide range of problems from abscess drainage to enteral feeding solutions. These drains have a high rate of dislodgement of up to 30%, resulting in emergency room visits, repeat hospitalizations, and catheter repositioning/replacement procedures, all of which incur significant morbidity and mortality. Using ex vivo and in vivo models, a force body diagram was utilized to determine the forces experienced by a drainage catheter during dislodgement events. Common drainage catheter securement components were collected. Prototypes of a coiled skin level catheter securement and valved quick release system, between the drain and drainage bag tubing, were then developed using computer aided design (CAD) software and 3D printing technology. The DrainStay device was tested in a porcine model. Ex vivo, the force of failure for a 2-0 polypropylene drainage suture was 32.0 ± 5.9 N for (n=4), 16.5 ± 3.6 N for a standard pigtail catheter (n=3), and 64.3 ± 11.7 N for a medical grade skin adhesive (ostomy appliance) (n=4). A coiled friction model (DrainStay) was compared to a currently available linear friction model. With one revolution around a spool, the coiled model was able to resist 78.5 ± 8.4 N (n=5). Conversely, a linear fixation system failed at a force of 19.1 ± 1.8 N (n=3). Separately, the quick release mechanism decoupled at 17.5 ± 2.7 N (n=4), providing an adequate (∼5×) safety margin compared to the securement device adhesive. A catheter secured with a drain stitch and internal pigtail was dislodged with a peak force of 47.7± 4.6 N (n=4). The drainage catheter fully secured by the DrainStay device did not dislodge, with the breakaway detaching at 15.1 ± 0.7 N (n=3). In a suprapubic catheter model, urine continued to drain from the bladder while the catheter was coiled within the skin level securement device, which was engineered to prevent catheter kinking. Coiling of a drain around a central column safely placed at the skin entry site coupled with an external breakaway significantly increases the safety factor for percutaneous drain retention. The system was inspired by the capstans used in boating for increasing friction of a line around a central spool and quick release mechanisms used in electronics such as the Apple MagSafe computer charger. The prototype demonstrated that the miniaturized versions of technologies used in boating and electronics industries were able to meet the needs of preventing dislodgement of patient drainage catheters.