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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛影响是为良性前列腺增生症(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，但这些药物可提供适度的临床改善，并会产生不良的、有时甚至是永久性的副作用，影响生活质量。这导致估计有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接受手术，但由于目前的手术技术存在永久性并发症、痛苦恢复或长期预后较差的高风险，所有接受一线治疗的患者中，每年只有1.1%选择手术。因此，所有接受治疗的BPH患者中，有35%选择不接受药物或手术。这一警惕的等待患者群体如果不接受治疗，就有可能造成不可逆转的膀胱损伤，据报道，在四年的时间里，约87%的BPH患者的症状会恶化。重要的是，据估计，在所有患有BPH的男性中，有30%的人有必要进行外科干预，这让数百万美国人没有可靠的选择。建议的解决方案是用微创导管系统治疗前列腺。拟议的项目推进了为人类前列腺提供焦点冷冻消融的系统的翻译。通过一系列导管气囊实施定向和局部冷冻治疗，该设备可以移除肥大的前列腺组织，同时保留对保存性功能和可控性至关重要的邻近解剖结构。此外，治疗后的前列腺组织可以通过超声成像进行实时监测，以增强安全性和治疗指导。这项第一阶段提案的目标是在台式模型中优化定向冷冻治疗系统，并验证其用于消融前列腺侧叶的用途。为了优化冷冻消融剂的剂量，温度等温线将在体外前列腺组织模型中根据一系列操作参数进行表征和空间映射。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.