Design, Development and Validation of a Novel Mechanical Occlusion Device for Transcervical Sterilization

摘要

The use of contemporary medical devices in the human body, such as dilation balloons, closure devices, stents, coils, stent-grafts, etc. are gaining more importance to preclude surgical incisions and general anaesthesia. An analogous procedure for permanent female sterilization is the transcervical approach that does not require either general anaesthesia or surgical incision and uses a normal body passage. Various contemporary technologies have improved the strategies for permanent female sterilization. However, current methods of transcervical sterilization are unable to provide an instant occlusion. This work presents the design, development and validation of a novel mechanical occlusion device (Rehan et al. 2010, Lecture notes in engineering and computer science: proceedings of the world congress on engineering 2010, WCE 2010, 30 June-2 July London, UK, vol I. pp 566-571), which achieve both instant and permanent female sterilization via a transcervical approach. The device is designed to provide an instant mechanical occlusion by deploying, under hysteroscopic visualization an implant into the intramural segment of the fallopian tube. The design of the device has been accomplished through computer aided design (CAD), finite element method (FEM) and experimental testing. Validation has been performed following a number of successful bench-top in-air and in vitro deployments on animal tissue and explanted human uteri. The efficacy of the device and the instant occlusion of the fallopian tubes were proved by hydraulic pressure testing of the implanted uteri using saline and methylene blue solution. Initial results suggest that the device provides a safe, effective and instant method of permanent female sterilization. Further development work is ongoing in preparation for first-in vivo clinical trials.