Successful application of the innovation process to a case of Floyd Type I tracheal agenesis

Alicia Greene; Yiqi Zhang; Onur Asan; Joseph B Clark; Barry Fell; Kevin Harter; Thomas Samson; Dino Ravnic; Robert E Cilley; Peter Dillon; Donald Mackay; Anthony Y Tsai

doi:10.1016/j.sopen.2022.11.005

Successful application of the innovation process to a case of Floyd Type I tracheal agenesis

Surg Open Sci. 2022 Dec 5:11:73-76. doi: 10.1016/j.sopen.2022.11.005. eCollection 2023 Jan.

Authors

Alicia Greene¹, Yiqi Zhang², Onur Asan³, Joseph B Clark⁴, Barry Fell¹, Kevin Harter⁵, Thomas Samson⁶, Dino Ravnic⁶, Robert E Cilley⁷, Peter Dillon⁷, Donald Mackay⁶, Anthony Y Tsai⁷

Affiliations

¹ Division of General Surgery, Penn State Children's Hospital, Hershey, PA, USA.
² Department of Industrial and Manufacturing Engineering, Penn State University, University Park, PA, USA.
³ School of Systems and Enterprises, Stevens Institute of Technology, Hoboken, NJ, USA.
⁴ Division of Pediatric Cardiac Surgery, Penn State Children's Hospital, Hershey, PA, USA.
⁵ Center for Medical Innovation, Penn State College of Medicine, Hershey, PA, USA.
⁶ Division of Plastic Surgery, Penn State Children's Hospital, Hershey, PA, USA.
⁷ Division of Pediatric Surgery, Penn State Children's Hospital, Hershey, PA, USA.

Abstract

Background: Innovation is broadly defined as the act of introducing a new product, idea, or process. The field of surgery is built upon innovation, revolutionizing technology, science, and tools to improve patient care. While most innovative solutions are aimed at problems with a significant patient population, the process can also be used on orphan pathologies without obvious solutions. We present a case of tracheal agenesis, a rare congenital anomaly with an overwhelming mortality and few good treatment options, that benefited from the innovation process and achieved survival with no ventilator dependence at three years of age.

Methods: Utilizing the framework of the innovation process akin to the Stanford Biodesign Program, 1) the parameters of the clinical problem were identified, 2) previous solutions and existing technologies were analyzed, newly invented solutions were brainstormed, and value analysis of the possible solutions were carried out using crowd wisdom, and 3) the selected solution was prototyped and tested using 3D modeling, iterative testing on 3D prints of actual-sized patient parts, and eventual implementation in the patient after regulatory clearance.

Results: A 3D-printed external bioresorbable splint was chosen as the solution. Our patient underwent airway reconstruction with "trachealization of the esophagus": esophageotracheal fistula resection, esophagotracheoplasty, and placement of a 3D-printed polycaprolactone (PCL) stent for external esophageal airway support at five months of age.

Conclusions: The innovation process provided our team with the guidance and imperative steps necessary to develop an innovative device for the successful management of an infant survivor with Floyd Type I tracheal agenesis.

Article summary: We present a case of tracheal agenesis, a rare congenital anomaly with an overwhelming mortality and few good treatment options, that benefited from the innovation process and achieved survival with no ventilator dependence at three years of age.The importance of this report is to reveal how the innovation process, which is typically used for problems with significant patient population, can also be used on orphan pathologies without obvious solutions.

Keywords: Innovation process; Needs finding; Pediatric surgery; Surgical innovation; Tracheal agenesis.