I-Corps: Low-cost, handheld, manual cataract surgery device

I-Corps：低成本手持式手动白内障手术设备

• 批准号: 2106140
• 负责人: Kunal Parikh
• 金额: $ 5万
• 依托单位: Johns Hopkins University
• 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: 2021-03-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2106140&HistoricalAwards=false
• 关键词: Corps; Low; cost; handheld; manual

The broader impact/commercial potential of this I-Corps project lies in its potential to address the leading cause of avoidable blindness. A total of 253 million people suffer from blindness or visual impairment, and 89% live in low- and middle-income countries (LMICs). Cataract surgery has been shown to improve physical and mental health, income, productivity, and quality of life, but it remains the leading cause of blindness globally. The limitations of phacoemulsification have prevented broad implementation across emerging markets, causing disadvantaged patients and those with mature cataracts to receive manual small incision cataract surgery (MSICS). MSICS involves removal of the whole, intact cataract through a large incision. This 6-7 mm incision leads to increased recovery time and astigmatism. Issues with affordability and acceptability of treatment delays care-seeking behavior, causing development of mature cataracts, and sometimes leading to blindness and significant functional limitations. By enabling non-ultrasonic fragmentation of even mature cataracts through a 3 mm incision in a time- and cost-efficient manner, the proposed technology has the potential to improve the acceptability and accessibility of cataract surgery in LMICs, increase the surgical volume and capacity of eye care systems, and provide improved visual and financial outcomes for the 21 million patients receiving cataract surgery annually in LMICs.This I-Corps project represents a novel approach to address vision loss and blindness due to cataracts. Globally, 12.6 million people are blind and 52.6 million have moderate-to-severe visual impairment due to cataracts. Cataract surgery is a simple, sight-restoring procedure where the clouded lens of the eye is removed and replaced with a synthetic lens. Cataract-related visual impairment is concentrated in low-and middle-income countries (LMICs), and is expected to grow dramatically with the aging population. The current phacoemulsification procedure involving ultrasonic cataract emulsification through a 3 mm incision is not ideal for emerging markets due to the length, cost, significant capital expense, recurring costs, and maintenance. Moreover, phacoemulsification is not optimal for treating ultra-hard, late-stage cataracts found in LMICs which require increased ultrasound power. The proposed technology consists of a low-cost, handheld, manual cataract surgery device which addresses the limitations of phacoemulsification and has the potential to achieve comparable or improved safety and efficacy. The device is deployed through a 3 mm incision and can capture and safely fragment all cataract sizes and hardnesses. It eliminates the need for capital equipment, maintenance, and electricity. Importantly, the device fits into the existing training and surgical workflow in emerging markets.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.

I-Corps项目更广泛的影响/商业潜力在于它有可能解决可避免失明的主要原因。共有2.53亿人患有失明或视力障碍，其中89%生活在低收入和中等收入国家。白内障手术已被证明可以改善身心健康、收入、生产力和生活质量，但它仍然是全球失明的主要原因。超声乳化术的局限性阻碍了其在新兴市场的广泛应用，导致弱势患者和成熟白内障患者接受人工小切口白内障手术（msic）。mscs包括通过大切口切除整个完整的白内障。这个6-7毫米的切口会增加恢复时间和散光。治疗的可负担性和可接受性问题会延迟求医行为，导致成熟白内障的发展，有时还会导致失明和严重的功能限制。通过时间和成本效益的方式，通过3毫米切口实现成熟白内障的非超声碎裂，所提出的技术有可能提高中低收入国家白内障手术的可接受性和可及性，增加眼科保健系统的手术量和容量，并为中低收入国家每年接受白内障手术的2100万患者提供改善的视力和经济结果。这个I-Corps项目代表了一种解决白内障导致的视力丧失和失明的新方法。在全球范围内，有1260万人失明，5260万人因白内障而患有中度至重度视力障碍。白内障手术是一种简单的恢复视力的手术，将浑浊的晶状体取出并用人工晶状体代替。白内障相关的视力损害主要集中在低收入和中等收入国家（LMICs），并将随着人口老龄化而急剧增长。目前的超声乳化手术包括通过3mm切口进行超声白内障乳化手术，由于手术时间长、费用高、资本支出大、重复费用和维护等原因，在新兴市场并不理想。此外，超声乳化术并不是治疗中低收入患者超硬、晚期白内障的最佳选择，因为这些患者需要更高的超声功率。提出的技术包括低成本、手持式、手动白内障手术装置，解决了超声乳化的局限性，并有可能达到相当或更高的安全性和有效性。该设备通过一个3毫米的切口部署，可以捕获和安全地分割所有白内障大小和硬度。它消除了对资本设备、维护和电力的需求。重要的是，该设备适合新兴市场现有的培训和手术工作流程。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。