SBIR Phase I: Development of a device for permanent relief of urinary obstruction related to benign prostatic hyperplasia

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是最终完成一种基于办公室的植入物的设计，永久缓解与良性前列腺增生症(BPH或前列腺肥大)相关的尿路梗阻。这种疾病在美国影响了1400多万男性，并给生活质量带来了巨大的负担。现有的治疗方法只包括疗效有限的药物和并发症风险较高的手术。这种研究设备的目的是在局部麻醉下，在10分钟的程序中提供永久性症状缓解，成本远远低于所有现有的选择。基于已建立的报销代码的预期定价意味着每年30-40亿美元的市场机会。拟议的项目涉及完成上述植入型设备及其部署系统的设计。该装置必须易于部署，提供足够的周向力来阻止前列腺，安装在输送系统内而不会过度紧张或可能造成损害，并具有较低的不良事件风险。台架测试、身体研究和动物研究将推动设备设计，以确保满足这些目标。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to finalize the design of an office-based implant for permanent relief of urinary obstruction related to benign prostatic hyperplasia (BPH or enlarged prostate). This condition affects over 14 million men in the US and imposes a significant quality of life burden. Established treatments include only drugs, which have limited efficacy, and surgery, which has a high complication risk. The investigational device is intended to provide permanent symptom relief in a ten-minute procedure under local anesthesia, at a cost far lower than all existing options. Expected pricing based on established reimbursement codes suggests a $3-4 billion annual market opportunity.The proposed project involves finalizing design of the aforementioned implantable device and its deployment system. The device must be easily deployable, provide sufficient circumferential force to hold back the prostate, fit within the delivery system without excessive strain or the potential for damage, and carry a low risk of adverse events. Bench tests, cadaver studies, and animal studies will drive device design to ensure satisfaction of these aims.