Beyond the pump: a novel shape memory alloy penile prosthesis

摘要 勃起功能障碍(ED)是一种影响约3900万人的多因素疾病 美国男性，而且随着糖尿病患病率的增加，这一比例还在继续增加。 高血压和心血管疾病。当一线和二线药物，如 磷酸二酯酶5抑制剂(PDE5I)类药物或直接注射失败，外科 阴茎假体的植入提供了一个永久性的解决方案。约1/3的男性有ED 治疗最终将失败，PDE5i将产生1000万男性的潜在市场。两个人 市面上可买到的阴茎假体种类很多，包括充气假体和 半刚性假体。充气阴茎假体依赖于封闭的蓄水池系统， 泵、阀门和液压，以产生足以插入的模拟安装 还有性交。可延展性是一种可弯曲的杆。这两种设备都不能提供理想的平衡 稳健、可靠、简单、离散的男性勃起功能障碍的治疗。病人和医生 对这些设备解决方案的看法过于复杂、不可靠，而且不符合生理和 美容的外表也是外科手术的适度普及的部分原因。 植入假体治疗勃起功能障碍的数量与 潜在的候选人。因此，需要一种简单、可靠的手术解决方案来治疗男性 顽固性勃起功能障碍，表现为尽可能生理性的，但仍是离散的和 权衡上述解决方案的各种风险和优势。Uronext产品是一个解决方案， 依靠金属合金的分子重排来产生模拟勃起。因此， 它的轮廓要小得多，非常离散，并且依赖于金属的固有属性 因此非常可靠。这样的设计有可能为更广泛的 接受假体治疗ED类似于更广泛地接受 隆胸手术(每年20万例)。此外，更简单和更快的是 手术将允许更多的泌尿科医生和内科医生提出这一解决方案 给他们的病人。

Abstract Erectile dysfunction (ED) is a multifactorial disease that affects approximately 39 million American men and is continuing to increase with the increasing prevalence of diabetes, hypertension and cardiovascular disease. When first line and second line medications such as the phosphodiesterase 5 inhibitor (PDE5i) class of medications or direct injections fail, surgical implantation of penile prostheses offers a permanent solution. Approximately 1/3 of men with ED will ultimately fail treatment with PDE5i yielding a potential market of 10 million men. The two broad classes of penile prostheses commercially available are: the inflatable prosthesis and the semi-rigid prosthesis. The inflatable penile prosthesis relies on a closed system of reservoirs, pumps, valves and hydraulic pressure to produce a simulated erection sufficient for intromission and coitus. The malleable is a bendable rod. Neither device offers the ideal balance of being a robust, reliable, simple and discrete treatment for male ED. The patient and physician perceptions on these device solutions are being too complex, not reliable, and not physiologic and the cosmetic appearance is partly responsible as well for the modest uptake of surgical implantation of prostheses as treatment of their erectile dysfunction compared to the number of potential candidates. Thus there is a need for a simple, robust surgical solution for men with refractory erectile dysfunction that appears as physiologic as possible, yet remains discrete and balances the various risks and benefits of the above solutions. Uronext product is a solution that relies on the molecular rearrangement of a metal alloy to produce a simulated erection. As such, it has a much smaller profile, is very discrete, and relies on the intrinsic properties of the metal and is thus very reliable. Such a design has the possibility to open the door to more widespread acceptance of prostheses for the treatment of ED similar to the more widespread acceptance of breast implants (200,000 procedures per year). Furthermore, the much simpler and faster procedure will allow a much greater number of urologists and physicians to propose this solution to their patients.