2399. A Novel 3D Printed Securement Device for Preventing Dislodgement of Drainage Catheters
Authors * Denotes Presenting Author
  1. John Di Capua; Massachusetts General Hospital
  2. Mario Russo *; Harvard Medical School
  3. Marc Succi; Massachusetts General Hospital
  4. Raul Uppot; Massachusetts General Hospital
  5. Dania Daye; Massachusetts General Hospital
  6. Avik Som; Massachusetts General Hospital
  7. Ashraf Thabet; Massachusetts General Hospital
Over 3.2 million percutaneous drainage catheters are placed in the US annually. Incidence of accidental catheter dislodgement ranges between 5% to 15%, depending on the type of percutaneous device and indwell time1,2. Patients who experience catheter dislodgement are affected by interruptions in care, costly returns to the emergency room, and often are subjected to the risk of a repeat procedure for catheter reinsertion or repositioning1. We developed an experimental catheter securement system designed to reduce incidence of accidental dislodgement.

Materials and Methods:
Computer-aided design (CAD) software and the Form 2 SLA 3D printer were utilized in the design and production of the device. To test the device, 16 10.2 Fr Dawson-Mueller drainage catheters were inserted in serial into the peritoneal cavity of a swine model using standard Seldinger technique. These drains were secured to the skin in three ways: without any securement, with a 2-0 prolene drain suture, and with the described securement system adhered to the pig’s skin. Once the catheter was secured, placement was visualized with CT or fluoroscopy. A Mark-10 digital force gauge was utilized to record tensile forces. The catheter hub was attached to the force gauge and pulled to dislodgement/failure and reimaged.

The design of the securement system is two-fold: a low-profile catheter securement device that adheres to the skin and manages excess external catheter length, and a quick-release component interposed between the luer fitting of the drainage catheter and drainage bag tubing. The quick-release is calibrated to detach during a dislodgement event while the skin securement device holds the drainage catheter in place. The design was deemed successful if it prevented partial or complete drainage catheter dislodgement. Without any securement (i.e. drain stitch), migration of a drainage catheter was seen with <1N of traction. Catheter drain stitches failed at 67.1 N +/- 5.1 SD , snapping the drain suture as it became dislodged. When utilizing the 3D printed securement system without a drain stitch, the quick release detached after application of 17.5 N +/- 2.4 SD of traction, well below the force required to remove a standardly secured drainage catheter, resulting in 0 partial or complete dislodgements as visualized fluoroscopically. The low-profile coil was adhered to the skin using a skin-safe adhesive.

Catheter dislodgement represents a patient safety risk and significant cost burden to healthcare systems, costing over $3 billion to manage in the US alone. The encouraging results from testing the experimental catheter securement system demonstrate that it is a possible solution to improving this pervasive problem. Future applications include vascular percutaneous devices.