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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是最终确定一种基于办公室的植入物的设计，用于永久缓解与良性前列腺增生（BPH或前列腺肥大）相关的尿路梗阻。这种情况影响了美国超过1400万男性，并对生活质量造成了重大负担。现有的治疗方法仅包括疗效有限的药物和并发症风险高的手术。该研究器械旨在局部麻醉下在10分钟的手术中提供永久性症状缓解，成本远低于所有现有选择。基于已建立的报销代码的预期定价表明，每年的市场机会为30 - 40亿美元。拟议项目涉及上述植入式设备及其部署系统的最终设计。该装置必须易于展开，提供足够的周向力以阻止前列腺，适合输送系统而没有过度应变或损坏的可能性，并且具有低的不良事件风险。台架试验、尸体研究和动物研究将推动器械设计，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.