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

SBIR I 期：治疗良性前列腺增生的微创经尿道冷冻治疗导管系统

• 批准号: 2049600
• 负责人: Bruce Addis
• 金额: $ 25.56万
• 依托单位: ALSUS MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2049600&HistoricalAwards=false
• 关键词: SBIR; Phase; Minimally; Invasive; Transurethral

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.

这项小企业创新研究（SBIR）第一阶段项目的广泛影响是为每年影响1290万美国人的良性前列腺增生（BPH）提供一种低成本、安全和持久的治疗选择。一线药物治疗是BPH最常见的治疗方法，但这些药物提供适度的临床改善，并诱发不良的，有时是永久性的，影响生活质量的副作用。据估计，这导致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，但由于目前的手术技术存在永久性并发症的高风险、痛苦的恢复或较差的长期预后，每年只有1.1%的患者选择手术。结果，35%的BPH患者选择不接受药物治疗或手术治疗。如果不及时治疗，这些警惕等待的患者可能会有不可逆的膀胱损伤，据报道，在四年的时间里，87%的BPH患者的症状会恶化。重要的是，据估计，30%的男性前列腺增生患者需要手术治疗，这使得数百万美国人没有一个强有力的选择。提出的解决方案是用微创导管系统治疗前列腺。提出的项目推进系统的翻译，以提供局灶冷冻消融到人类前列腺。通过一系列导管气球实施定向和局部冷冻治疗，该设备可以切除肿大的前列腺组织，同时保留对保存性功能和尿失禁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实时监测，以提高安全性和治疗指导。本I期建议的目标是在台式模型中优化定向冷冻治疗系统，并验证其在前列腺侧叶消融中的应用。为了优化低温消融剂量，温度等温线将在一系列操作参数下在体外前列腺组织模型中进行表征和空间映射。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。