Three-Dimensional Printing of Surgical Clips: An In Vitro Pilot Study and Trial of Efficacy

Abstract

Introduction and Objective:

Three-dimensional (3D) printing applications have increased over the past decade. Our objective was to test rapid prototyping of a 3D printed surgical clip for intraoperative use.

Materials and Methods:

Our prototype was modeled after the 10 mm Weck^® Hem-o-lok^® polymer clip (Teleflex, Inc., Wayne, PA). A 3D computer-aided design model of the Hem-o-lok clip was reverse engineered using commercial microscopy and printing was done using an Objet Connex500 multijetting system (Stratasys, Eden Prairie, MN). The initial polymer was Objet VeroWhitePlus RGD835; the addition of Objet TangoBlackPlus FLX980 during the design process improved hinge flexibility. The 3D printed clips were then pressure tested on rubber Penrose tubing and compared in vitro versus commercial Hem-o-lok clips.

Results:

Initial 3D printed clips were not functional as they split at the hinge upon closure of the clip jaws. Design changes were made to add Objet TangoBlackPlus FLX980 at the hinge to improve flexibility. Additional modifications were made to allow for clips to be compatible with the Hem-o-lok endoscopic clip applier. A total of 50 clips were tested. Fracture rate for the printed clips using a clip applier was 54% (n = 27), whereas none of the commercial Hem-o-lok clips broke upon closure. Of the 23 printed clips that closed, mean leak was at 20.7 κPa (range 4.8–42.7). In contrast, none of the commercial clips leaked, and fill continued until Penrose rupture at mean 46.2 κPa (44.8–47.6).

Conclusions:

This pilot study demonstrates feasibility of 3D printing functional surgical clips. However, the performance of our first generation clips is poor compared with commercial grade product. Refinement in printers and materials available may allow for customization of such printed surgical instruments that could be economically competitive to purchasing and stocking product.