SBIR Phase I: Novel Laparoscopic Device for treatment of Varicocele

SBIR 第一阶段：治疗精索静脉曲张的新型腹腔镜装置

• 批准号: 2026272
• 负责人: Tushar Sharma
• 金额: $ 25.6万
• 依托单位: VIVIFI MEDICAL LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2026272&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Laparoscopic; Device

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to advance translation of a new procedure to address varicocele, the most common cause of male infertility. Varicocele affects approximately 30 million men in the US alone and is the direct cause of over 1.5 million involuntary infertile couples. It is also associated with testicular pain, erectile disfunction, and low free testosterone. Current treatments have varying success, with only 50% of patients noticing 50% improvement in sperm parameters and up to 37% of patients showing no change. The treatment for varicocele has not changed since 1929 and consists of ligation or occlusion of the internal spermatic vein, the primary route of drainage for the testis. This project will advance a new method of treatment. This Small Business Innovation Research (SBIR) Phase I project aims at leveraging a highly effective procedure proposed to treat Varicocele. Even though surgical ligation procedures have shown promising clinical efficacy, the technical difficulty and low success rates motivate other treatment modalities. This procedure was proposed in the 1980s based on an advanced understanding of hemodynamics responsible for the pathophysiology of varicocele. Preliminary tests suggest lower complication rates and complete elimination of hydrocele formation, recurrence rate of up to 0.2%, and faster recovery times. This project will advance a technology to simplify the procedure.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是推进一种新程序的翻译，以解决精索静脉曲张，男性不育的最常见原因。精索静脉曲张仅在美国就影响了大约3000万男性，并且是超过150万非自愿不孕夫妇的直接原因。它还与睾丸疼痛、勃起功能障碍和低游离睾酮有关。目前的治疗有不同的成功，只有50%的患者注意到精子参数改善了50%，高达37%的患者没有变化。精索静脉曲张的治疗自1929年以来没有改变，包括精索内静脉的结扎或闭塞，这是睾丸的主要引流途径。这个项目将提出一种新的治疗方法。这个小企业创新研究（SBIR）第一阶段项目旨在利用一个高度有效的程序提出治疗精索静脉曲张。尽管外科结扎手术已显示出有希望的临床疗效，但技术难度和低成功率促使其他治疗方式。该手术是在20世纪80年代基于对精索静脉曲张病理生理学的血流动力学的深入理解而提出的。初步测试表明并发症发生率较低，完全消除了鞘膜积液的形成，复发率高达0.2%，恢复时间更快。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。