Date on Master's Thesis/Doctoral Dissertation

4-2019

Document Type

Master's Thesis

Degree Name

M. Eng.

Department

Bioengineering

Committee Chair

Keynton, Robert S.

Committee Co-Chair (if applicable)

Metzinger, Daniel

Committee Member

Metzinger, Daniel

Committee Member

Roussel, Thomas

Committee Member

Williams, Stuart

Author's Keywords

Trocar; Suture-less Closure; Trocar Site Closure Techniques; Laparoscopic Surgery; Post-operative Hernia; Hernia Prevention

Abstract

Introduction: Following laparoscopic surgery, there is a need, in many cases, to close trocar sites to prevent hernias. Currently, devices that exist on the market are suture based, but the lack of standardization in the suturing techniques together with the time-consuming nature of the procedure leads to the need for improvement in trocar site closure products. Trocar closure sites do not need to be fully closed on the fascial layer; rather, sufficiently blocking the hole at the abdominal wall can significantly reduce post-operative herniation. A retrospective study on trocar site herniation (TSH) after laparoscopic surgery indicates a TSH incidence of ~5.2% out of a total of 30,568 adult and 1,098 child procedures [7]. Specifically, trocar sizes greater than 10mm, failure to suture the fascia, and fast absorbable suture were found to be linked to TSH. Thus, the purpose of this study is to present a new, rapid deployment, biodegradable device for trocar site closures.

Methods: The Trocar Site Closure Clip (TSCC) is a biodegradable clip to be inserted into the abdominal cavity through a 12mm trocar and retracted to pierce into the peritoneum and fascia. The TSCC will be inserted via an applicator through the trocar to the abdominal cavity. The trocar will be extracted from the patient. The TSCC will be pulled upward into the peritoneum and fascia. The applicator will be released leaving the TSCC to be separated and left in the patient to seal the trocar site. The TSCC is composed of polylactic acid and tested in various manufacturing modifications for optimization. TSCC prototypes completed bench top testing in dragon skin silicone, porcine belly, cadaver, and in a chronic swine model study.

Results: The results of this study demonstrate proof of concept for a biodegradable trocar site closure clip as a potential solution as a reliable trocar site closing and postoperative hernia prevention device in laparoscopic surgery. This study shows that the biocompatible poly-lactic acid-based device can plug and seal 12mm trocar site openings along with in animal peritoneal tissue.

Conclusion: This study successfully fabricated biocompatible TSCC prototypes using commercially-available manufacturing techniques. This study demonstrated the efficacy of the TSCC to be inserted into/through a trocar and engage the abdominal wall to plug the hole and prevent postoperative herniation.

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