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

这项小企业创新研究（SBIR）二期项目旨在开发一种安全、可治愈的微创手术，为精索静脉曲张患者带来持久的治疗效果，其更广泛的影响/商业潜力。精索静脉曲张是男性不育的最常见原因，也与睾丸疼痛、勃起功能障碍和游离睾酮水平低有关。仅在美国，精索静脉曲张就影响了大约3000万男性，是150多万对夫妇不育的直接原因。目前的治疗方法成功率很低，只有50%的患者注意到精子参数有50%的改善，高达37%的患者在治疗后没有任何变化。精索静脉曲张的治疗自1929年以来一直没有改变，包括结扎或阻塞精索内静脉，这是睾丸的主要引流途径。尽管外科结扎手术已显示出良好的临床疗效，但手术的技术难度和低成功率仍有改进的空间。这项小企业创新研究（SBIR）二期项目旨在利用一种高效的治疗精索静脉曲张的方法。该手术是在20世纪80年代提出的，基于对精索静脉曲张病理生理的血液动力学的深入了解。通过初步研究，该方法显示出突破性的结果，并已在多个独立研究中使用，治疗患者的成功率接近100%。此外，并发症发生率显著降低，完全消除鞘膜积液形成，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。这个SBIR项目旨在开发一种技术，降低执行极具挑战性的手术的障碍，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总体护理成本。该奖项反映了美国国家科学基金会的法定使命，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。

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.