SBIR Phase I: A Minimally Invasive Transurethral Cryotherapy Catheter System for Benign Prostate Hyperplasia

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响是为良性前列腺增生（BPH）提供低成本，安全和持久的治疗选择，每年影响1290万美国人。 一线药物治疗是BPH最常见的治疗方法，但这些药物提供了适度的临床改善，并引起不良的，有时是永久性的，影响生活质量的副作用。这使得估计62-91%的患者在12个月后停止治疗。一线治疗失败的患者可以选择手术，但由于永久性并发症的高风险，痛苦的恢复或与当前手术技术相关的长期预后不良，每年只有1.1%的患者选择手术。因此，35%的BPH患者选择不接受药物治疗或手术。如果不及时治疗，这种观察等待的患者群体有不可逆的膀胱损伤的风险，据报道，在四年的时间内，约87%的BPH患者的症状恶化。重要的是，据估计，在所有患有BPH的男性中，有30%需要手术干预，这使得数百万美国人没有强有力的选择。 所提出的解决方案用微创导管系统治疗前列腺。拟议的项目推进翻译的系统提供局灶性冷冻消融到人类前列腺。通过一系列导管球囊实施定向和局部冷冻治疗，该装置可以去除肥大的前列腺组织，同时保留对保留性功能和生殖功能至关重要的相邻解剖结构。此外，可以利用超声成像来真实的实时监测治疗的前列腺组织，以增强安全性和治疗指导。该I期提案的目标是优化台式模型中的定向冷冻治疗系统，并验证其用于消融前列腺侧叶。为了优化冷冻消融剂量，将在体外前列腺组织模型中对温度等温线进行表征并在空间上绘制一系列操作参数。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。

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to provide a low-cost, safe, and durable treatment option for benign prostate hyperplasia (BPH), affecting 12.9 M Americans annually. First-line pharmacological therapy is the most common treatment for BPH, but these drugs provide modest clinical improvements and induce undesirable, and sometimes permanent, side effects that impact quality of life. This drives an estimated 62-91% of patients to discontinue treatment after 12 months. Patients who fail first-line therapy have the choice to pursue surgery, but due to the high risk of permanent complications, painful recovery, or a poor long-term prognosis associated with current surgical techniques, only 1.1% of all managed patients choose to have surgery each year. As a result, 35% of all managed BPH patients opt to not receive either medication or surgery. This watchful waiting patient population risks irreversible bladder damage if left untreated, where symptoms have been reported to worsen in ~87% of BPH patients over a four-year period. Importantly, it is estimated that sur gical intervention is necessary in 30% of all men afflicted with BPH, leaving millions of Americans without a robust option. The proposed solution treats the prostate with a minimally invasive catheter system. The proposed project advances translation of a system to provide focal cryoablation to the human prostate. By implementing directional and localized cryotherapy through a series of catheter balloons, the device can remove enlarged prostate tissue while preserving adjacent anatomical structures key for preservation of sexual function and continence. Moreover, treated prostate tissue can be monitored in real time with ultrasound imaging for enhanced safety and treatment guidance. The goal of this Phase I proposal is to optimize a directional cryotherapy system in a benchtop model and verify its use to ablate the prostate lateral lobes. To optimize cryoablative dosing, temperature isotherms will be characterized and spatially mapped in an in vitro prostate tissue model across a range of operating parameters.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.