SBIR Phase II: Laparoscopic Device for Treatment of Varicocele and Related Conditions

SBIR 第二阶段：用于治疗精索静脉曲张及相关病症的腹腔镜装置

• 批准号: 2212869
• 负责人: Tushar Sharma
• 金额: $ 100万
• 依托单位: VIVIFI MEDICAL LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2212869&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Laparoscopic; Device

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project seeks to develop of a safe and curative, minimally invasive procedure leading to long-lasting outcomes for patients with varicocele. Varicocele is the most common cause of male infertility and is also associated with testicular pain, erectile disfunction, and low free testosterone. Varicocele affects approximately 30 million men in the US alone and is the direct cause of over 1.5 million infertile couples. Current methods of treatment have low success rates, with only 50% of patients noticing 50% improvement in sperm parameters and up to 37% of patients showing no change after treatment. 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. Even though surgical ligation procedures have shown promising clinical efficacy, the technical difficulty in performing the procedures and low success rates leave room for improvement. This Small Business Innovation Research (SBIR) Phase II project seeks to leverage a highly effective procedure proposed to treat varicocele. This procedure was proposed in the 1980s and was based on an advanced understanding of hemodynamics responsible for pathophysiology of varicocele. Through initial studies, this procedure showed groundbreaking results and has been used in multiple independent studies to treat patients with close to 100% success rates. Additionally, the complication rates are significantly lower, with complete elimination of hydrocele formation, recurrence rates of 0.2% and faster recovery times. However, this procedure has not caught widespread adoption due to the high skill required to perform this procedure. This SBIR project seeks to develop a technology that will lower the barrier to perform the highly challenging procedure, thereby making the procedure a reality for patients of varicocele and infertility. The resulting device may afford patients the benefits of surgery, without the risk, ultimately reducing overall cost of care associated with patients of infertility.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）第二阶段项目的更广泛的影响/商业潜力旨在开发一种安全和治愈性的微创手术，为精索静脉曲张患者带来持久的结果。精索静脉曲张是男性不育的最常见原因，也与睾丸疼痛，勃起功能障碍和低游离睾酮有关。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150万不孕夫妇的直接原因。目前的治疗方法成功率较低，只有50%的患者注意到精子参数改善50%，高达37%的患者在治疗后没有变化。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。尽管外科结扎手术已显示出有希望的临床疗效，但执行手术的技术难度和低成功率仍有改进的余地。这个小企业创新研究（SBIR）第二阶段项目旨在利用一个高度有效的程序来治疗精索静脉曲张。该手术于20世纪80年代提出，基于对精索静脉曲张病理生理学的血流动力学的深入了解。通过初步研究，该手术显示出突破性的结果，并已用于多项独立研究，以接近100%的成功率治疗患者。此外，并发症发生率显著降低，完全消除了鞘膜积液形成，复发率为0.2%，恢复时间更快。然而，由于执行该程序所需的高技能，该程序尚未得到广泛采用。该SBIR项目旨在开发一种技术，降低执行高度挑战性手术的障碍，从而使精索静脉曲张和不孕症患者的手术成为现实。由此产生的设备可以为患者提供手术的好处，而没有风险，最终降低与不孕症患者相关的整体护理成本。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。