Development of a microinvasive, highly-scalable, biosensitive anastomosis system for visceral surgery

• Applicants: Professorin Dr. Petra Mela; Professor Dr. Dirk Wilhelm
• Subject Area: Biomaterials ; General and Visceral Surgery ; Engineering Design, Machine Elements, Product Development
• Term: since 2018
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 386233407

Anastomosing two intestinal segments, for example after the resection of a tumor, is one of the most critical procedures in visceral surgery. Trauma minimization and continuous improvement of the post-operative healing process is a major goal of research in surgery (laparoscopy, robotics, etc.). To this end, a purely endoluminal intervention, or measures that help to reduce abdominal wall incisions represent highly welcome solutions. With this in mind, research was conducted within the DFG project CONNECT to develop a microinvasive, patient-adaptive, endoscopic anastomosis technique in the gastrointestinal tract. Using additive manufacturing techniques, a modular, size-scalable, single-use demonstrator was developed for this purpose, comprising an applicator and a two-part implant. Based on the successful completion of CONNECT and the findings of the first funding period, further topics emerged, that were not in the focus of the first implementation and will therefore be developed in a second funding phase. In order to perform the entire anastomotic procedure endoluminally, the following research areas need to be specifically addressed: - Elimination of external (laparoscopic) support by the integration of endoscopic end-effectors optimized for tissue manipulation. - Endoscope-independent guidance through the intestine and implant application using an actively navigating overtube device - Reduction of complexity and system dimensions by implementing miniaturized hydraulic approaches and integrating efficient kinematics - Integration of a degrading, biosensitive implant that responds to the physiological healing behavior of the anastomosis, thereby ensuring optimal healing conditions for an adaptive and leak-tight compression anastomosis - In vivo evaluation of the new system (CONNEXT) The aim of the second funding period is to use additive manufacturing to create a fully adaptable anastomosis system, called CONNEXT, and ultimately a versatile platform to perform the complete intervention endoluminally. The innovations we will adress within this consecutive application show, besides the application in CONNEXT, a high exploitation potential and should be of highest relevance not only for medicine. In order to test our concept, we will create in a first step a suitable in-vitro environment for testing all functionalities including those of the implant (tightness, compression adaptation, degradation) and furthermore perform a validation of the adaptable anastomosis system in an animal study with 8 pigs.

• DFG Programme: Research Grants