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.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响是为每年影响 1290 万美国人的良性前列腺增生 (BPH) 提供低成本、安全且持久的治疗选择。 一线药物治疗是 BPH 最常见的治疗方法，但这些药物只能提供有限的临床改善，并会引起不良的、有时甚至是永久性的副作用，从而影响生活质量。这导致估计 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治疗，但由于目前手术技术带来的永久性并发症风险高、恢复过程痛苦或长期预后不良，每年只有 1.1% 的治疗患者选择手术。因此，所有接受治疗的 BPH 患者中有 35% 选择不接受药物治疗或手术。如果不及时治疗，这些警惕的等待患者群体将面临不可逆转的膀胱损伤的风险，据报道，约 87% 的 BPH 患者在四年内症状会恶化。重要的是，据估计，30% 患有 BPH 的男性需要手术干预，这使得数百万美国人没有可靠的选择。 所提出的解决方案通过微创导管系统治疗前列腺。拟议的项目推进了一种系统的转化，为人类前列腺提供局灶性冷冻消融。通过一系列导管球囊实施定向和局部冷冻治疗，该装置可以去除增大的前列腺组织，同时保留对保留性功能和节制至关重要的相邻解剖结构。此外，可以通过超声成像实时监测治疗后的前列腺组织，以增强安全性和治疗指导。该第一阶段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的用途。为了优化冷冻消融剂量，将在一系列操作参数的体外前列腺组织模型中对温度等温线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价值和更广泛的影响审查标准进行评估，被认为值得支持。