A new male contraceptive: the Intra Vas Device

描述（由申请人提供）：随着世界人口持续急剧增长，迫切需要增加男性的避孕选择。目前的男性避孕技术依赖于避孕套和输精管切除术;由于文化或宗教原因，许多男性不接受这些方法。虽然“男性避孕药”可能被证明是一种有效和可逆的避孕方法，但可能有许多男性更喜欢副作用较少的非激素产品。硅胶输精管装置（Intra Vas Device; IVD）已开发多年，并在商业化方面取得了相当大的进展。IVD的设计目的是提供与输精管切除术相同的受益，并且创伤较小，因为IVD植入不需要损伤输精管来实现输精管阻塞。此外，与输精管切除术逆转相比，IVD有望提供更简单、更快和更便宜的逆转手术。在初步临床试验中，IVD显示出可提供有效的输精管阻断。在灵长类动物中，IVD输精管阻塞和IVD去除后精子通道完全恢复。在为期两年的大鼠研究和初步人体研究中显示了IVD的安全性。IVD相对于之前测试的其他输精管器械（包括注入输精管的硅胶）的优势是由于IVD是预先形成的。IVD的优点包括：1）它可以通过相对简单的程序快速植入和取出，2）它可以适合匹配输精管腔的大小，以更好地阻塞。Shepherd Medical在急性人体研究中开发了一种改进的IVD设计，并打算进行将这种改进的IVD设计推向市场所需的所有研究。本项目包括两个特定目的，以确保在I1期人体研究之前的患者安全性。本I期提案的安全性试验包括：1）人体植入前体外血管内器械灭菌方法的体外评价; 2）体外血管内器械机械性能的体外评价（7项实验）。该项目的成功结果将使第二阶段的人体研究成为可能。

DESCRIPTION (provided by applicant): With the world population continuing its steep rise, a serious need exists to increase the contraceptive options for men. Present male contraceptive technology relies on the condom and vasectomy; methods that are not acceptable to many men for cultural or religious reasons. Although the "male pill" may prove to be one solution for effective and reversible contraception when fully developed, there are likely to be many males who prefer non-hormonal products with fewer side effects. A silicone vas deferens device (the Intra Vas Device; IVD) has been under development for a number of years and has made considerable progress towards commercialization. The IVD has been designed to provide the same benefits as a vasectomy and be less traumatic, since IVD implantation does not require damaging the vas deferens to achieve vas obstruction. In addition, the IVD is expected to provide a simpler, faster and cheaper reversal procedure, compared to a vasectomy reversal. The IVD was shown to provide effective vas blockage in pilot clinical trials. IVD vas obstruction and complete recovery of sperm passage with IVD removal occurred in the primate. IVD safety was shown in two-year rat studies and in the pilot human studies. The advantages of the IVD over other vas devices tested previously (including silicone injected into the vas) are due to the IVD being preformed. IVD advantages include 1) it can be implanted and removed quickly by a relatively simple procedure, and 2) it can be fit to match the size of the vas lumen for better obstruction. Shepherd Medical has developed an improved IVD design in acute human studies and intends to perform all studies required to bring this refined IVD design to the market. The present project consists of two Specific Aims to ensure patient safety prior to human studies in Phase I1. The safety testing of this Phase I proposal includes: 1) in vitro evaluation of IVD sterilization methods prior to human implantation; and 2) in vitro evaluation of IVD mechanical performance with seven experiments. The successful outcome of this project will make human studies possible in Phase II.