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

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是最终确定一种用于永久性缓解良性前列腺增生（BPH或前列腺肥大）相关尿路阻塞的办公室植入物的设计。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。现有的治疗方法包括药物治疗和手术治疗，而药物治疗的效果有限，手术治疗的并发症风险很高。该研究装置的目的是在局部麻醉下，在10分钟的过程中提供永久性的症状缓解，其成本远低于所有现有的选择。基于既定报销代码的预期定价表明，每年有30亿至40亿美元的市场机会。拟建项目涉及上述植入式装置及其部署系统的最终设计。该装置必须易于部署，提供足够的周向力来抑制前列腺，适合于输送系统，没有过度的压力或潜在的损伤，并且不良事件的风险低。台架试验、尸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.