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Development of an Endoluminal Colorectal Stent to Facilitate Healing and Prevent/Treat Anastomotic Leak

Sung G Lee, MD1, Jenna LaColla2, Rachel Slappy2, Elizabeth Barker, PhD2, Andrew Russ, MD, FACS, FASCRS1. 1University of Tennessee Medical Center at Knoxville, 2University of Tennessee Department of Mechanical, Aerospace, and Biomedical Engineering

Background: More than 600,000 colon resections are performed each year in the United States to treat a wide variety of colon diseases and complications, and it is estimated that up to 10% of these procedures result in patients developing anastomotic leaks at the site of resection. Anastomotic leak is perhaps the most dreaded complication after intestinal resection and is associated with mortality rates as high as 22%. Moreover, anastomotic leak is associated with increased healthcare cost by increasing length of stay, repeated imaging studies, and often requiring multiple interventions such as percutaneous drainage or re-operation with potential creation of a permanent or temporary stoma. Several options have been explored to prevent and treat anastomotic leaks, but the efficacy of these incremental advances varies widely and currently does not show significant improvement in patient outcomes. At the University of Tennessee, collaborators within the department of surgery and the college of engineering are developing a combination device to prevent/treat anastomotic leakage/dehiscence subsequent to colorectal anastomoses and potentially obviate the need for temporary fecal diversion.

Description: We are developing a multi-layered malleable colorectal stent to be placed at the time of anastomotic creation, as well as potentially placed endoscopically when an anastomotic disruption is diagnosed.  The device design includes an endoluminal stent with a mesh-like structure to promote tissue ingrowth and healing in the intestinal wall and is intended to be deployed directly to the anastomosis site endoscopically. In order to prevent migration of device during peristalsis, the device design includes structures at each end that are configured to anchor the device to the tissue and prevent migration. The design also includes a multilayer polymeric coating for local drug delivery allowing for immediate and sustained release of therapeutic agents that will aid in the soft tissue healing process. Currently available colorectal stents have been designed for treatment of stricture and consist of an expandable nitinol construction. We intend to build on a malleable construct with application of a mucoadhesive polymer to prevent migration as well as timed release layers of antibiotics and growth factors to create a mechanical barrier but also an environment which promotes anastomotic maturation and healing. 

Results: To optimize the device design, additive manufacturing has been employed for rapid prototyping. Additive manufacturing of medical device prototypes poses many advantages over manual assembly. These advantages allow for quick and accurate prototyping to expedite the design process. Additive manufacturing allows for a high level of flexibility when altering designs, and iterative designs can be easily modified in programs like SolidWorks and prototyped within minutes. Several iterations and/or replicates have been manufactured in a very short period of time.

Conclusion/Future Directions: With this prototype, we started mechanical and in vitro testing. As development continues, the device will be tested in vivo with an animal model to assess its efficacy in both prevention and treatment of colorectal anastomotic leakage. We are currently seeking industry partners to play a key role in the decision making process on the pathway to commercialization.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 91002

Program Number: ETP835

Presentation Session: Emerging Technology iPoster Session (Non CME)

Presentation Type: Poster

39

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