Design, development and validation of a novel mechanical occlusion device for transcervical sterilization
Rehan, Muhammad (2010) Design, development and validation of a novel mechanical occlusion device for transcervical sterilization. PhD thesis, Dublin City University.
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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. However, current methods of transcervical sterilization are unable to provide an instant occlusion of fallopian tubes. This work aims at the design, development and validation of a novel mechanical occlusion device, which achieve both instant and permanent female sterilization via the 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 transcervical sterilization devices comprises of three major systems, an occlusion implant, a guiding system and a delivery actuator. All three systems were designed, developed and validated in this research work. The design of the device has been accomplished through Computer Aided Design (CAD), Finite Element Method (FEM) and experimental testing. Validation of device was performed following a number of successful bench-top in-air deployments and invitro deployments in 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 work is ongoing for in-vivo clinical trials and, if these are successful, it will be mass-produced and introduced into the market.
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