Novel implant for transcervical sterilization

Abstract

Compared to laparoscopic surgery for interval tubal sterilization, the transcervical approach is an effective method of female sterilization which obviates the requirement of general anesthesia and surgical incision. However, current methods of transcervical sterilization are unable to provide an instant occlusion. This paper focuses on the design, development and testing of a novel implant (James E., Coleman, Christy Cummins, 2009. Anastomosis Devices and Method. US Patent 20090105733A1) to achieve instant permanent female sterilization via the transcervical approach. The implant is designed to be deployed under hysteroscopic visualization into the ostium of the fallopian tube and relies on instant mechanical occlusion. The implant includes two sets of wings that penetrate into the ostium and uterine muscle tissue and trap the tissue in between thus plugging the entrance of the fallopian tube. In order to design the shape of implant wings and to investigate the mechanical behavior of the implant, a three-dimensional (3D) model was developed and Finite Element Method (FEM) was used for simulations. The implant was validated by a number of successful deployments in bench testing, animal tissue and explanted human uteri. During the deployments in animal tissue and explanted uteri, it was observed that the two sets of wings completely trapped the tissue in between and the hydraulic pressure testing of the explanted uteri using saline solution and methylene blue proved the instant occlusion of the fallopian tubes. Initial results suggest that this novel implant provides a safe and effective method of female sterilization. Further development work is ongoing in preparation for "first-in-man" clinical trials.