Beyond the pump: a novel shape memory alloy penile prosthesis

超越泵：新型形状记忆合金阴茎假体

• 批准号: 9909387
• 负责人: Alberto Colombo
• 金额: $ 26.69万
• 依托单位: URONEXT, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909387
• 关键词: Address; Affect; Alloys; American; Appearance; Behavior; Benefits and Risks; Biomechanics; Cadaver; Cardiovascular Diseases; Cardiovascular system; Coitus; Complex; Computer Simulation; Computer software; Cosmetics; Devices; Diabetes Mellitus; Disease; Equilibrium; Erectile dysfunction; Heating; Hypertension; Implant; Incidence; Injections; Internal Breast Prosthesis; Learning; Magnetism; Mechanics; Memory; Metals; Methodology; Nickel; Operative Surgical Procedures; Patients; Penile Prosthesis; Perception; Performance; Pharmaceutical Preparations; Phase; Physicians; Physiological; Prevalence; Procedures; Process; Production; Property; Prosthesis; Prosthesis Implantation; Public Health; Publications; Publishing; Pump; Radial; Refractory; Risk; Sexual Health; Shapes; Site; Speed; Stents; System; Technology; Temperature; Testing; Titanium; Urologist; Viagra; animal tissue; base; biomaterial compatibility; cost; design; erection; exoskeleton; experience; human tissue; implantation; improved; inhibitor/antagonist; innovation; male; mechanical properties; meetings; men; mimicry; molecular rearrangement; nitinol; novel; penis; phosphodiesterase V; pressure; prototype; retinal rods; satisfaction; titanium nickelide; uptake; user-friendly

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.

摘要 勃起功能障碍（艾德）是一种多因素疾病，影响约3900万 随着糖尿病患病率的增加， 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（PDE 5i）类药物或直接注射失败，手术 阴茎假体植入提供了永久性的解决方案。大约1/3的男性艾德 PDE 5i的治疗最终会失败，从而产生1000万男性的潜在市场。两 市售的阴茎假体有很多类：可膨胀假体和 半刚性假体。可膨胀阴茎假体依赖于封闭的储液器系统， 泵、阀门和液压，以产生足以注入的模拟勃起 和交媾可延展棒是一种可弯曲棒。这两款设备都没有提供理想的平衡， 男性ED的稳健、可靠、简单和离散治疗。患者和医生 对这些设备解决方案的看法过于复杂，不可靠，不符合生理学， 化妆品外观也是外科手术的适度吸收的部分原因。 植入假体治疗勃起功能障碍的人数与 潜在的候选人因此，需要一种简单、稳健的手术解决方案， 难治性勃起功能障碍，表现为尽可能的生理性，但仍然是离散的， 平衡了上述解决方案的各种风险和收益。Uronext产品是一种解决方案， 依靠金属合金的分子重排来产生模拟勃起。因此，在本发明的一个方面， 它的外形要小得多，非常离散，并且依赖于金属的固有特性 因此非常可靠。这样的设计有可能打开更广泛的大门 接受假体治疗艾德与更广泛接受的 乳房植入体（每年200，000例手术）。此外，更简单和更快的 程序将允许更多的泌尿科医生和内科医生提出这种解决方案 给他们的病人。