SBIR Phase II: Low-cost needle guidance system for bedside lumbar puncture

SBIR第二期：用于床边腰椎穿刺的低成本针引导系统

• 批准号: 2112322
• 负责人: Cassidy Wang
• 金额: $ 100万
• 依托单位: ETHOS MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2112322&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Low; cost

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve the quality and efficiency of bedside spinal access procedures by developing a needle guidance system that interfaces with existing ultrasound machines. Lumbar punctures (LPs) are performed to diagnose and treat neurological conditions such as meningitis. The traditional LP technique requires practitioners to manually feel for spinal landmarks to form a mental image of the anatomy before blindly inserting the needle into the spine, aiming for a small target containing spinal fluid. This methodology can be challenging, costly, and time-consuming and is highly dependent on practitioner experience and patient body type. Up to 42% of procedures fail to access the target. Failed cases require radiological intervention, increasing the cost of care, lengthening patient stay, and exposing patients to radiation. Hospitals in the United States lose an estimated $2 billion annually due to inefficiencies and failures in LPs. The proposed needle guidance system will enable bedside spinal access procedures to be performed under real-time ultrasound imaging, significantly improving first-attempt success rates. The guidance technology can further be applied in other clinical segments, improving the quality of care across a variety of needle-based procedures.This Small Business Innovation Research (SBIR) Phase II project aims to accomplish two primary objectives: 1) Complete development of a needle guidance system designed to interface with existing ultrasound machines; and 2) Develop an AI-powered anatomy detection software feature for the guidance system. These combined objectives will generate a functional, intuitive, and accessible solution that minimizes barriers to adoption while maximizing clinical and operational value. The proposed research involves conducting an array of safety and reliability studies to investigate the performance of the guidance system under realistic conditions. In developing a robust anatomy detection software feature, a spinal ultrasound data set will be created from a variety of non-patient volunteers. The data will be analyzed, processed, and used to train a machine learning model for anatomy detection. It is anticipated that the results of this project will demonstrate a sufficiently safe and efficacious system that can consistently guide a needle to an intended target with an error of less than 3 millimeters. The anatomy detection feature is expected to perform with at least 93% sensitivity and 85% specificity in identifying five key spinal landmarks; this level of performance would significantly reduce the knowledge barrier to performing ultrasound-guided interventions.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.

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是通过开发与现有超声机器接口的针头引导系统来提高床边脊柱通路程序的质量和效率。腰椎穿刺（LPs）用于诊断和治疗神经系统疾病，如脑膜炎。传统的LP技术要求从业者在盲目地将针头插入脊柱之前，手动感觉脊柱地标以形成解剖结构的心理图像，瞄准含有脊髓液的小目标。这种方法可能具有挑战性，昂贵且耗时，并且高度依赖于医生的经验和患者的体型。多达42%的程序无法访问目标。失败的病例需要放射干预，增加了护理费用，延长了病人的住院时间，并使病人暴露在辐射下。由于效率低下和lp失败，美国的医院每年损失约20亿美元。所提出的针头引导系统将使床边脊柱通路手术能够在实时超声成像下进行，显著提高首次尝试的成功率。该指导技术可以进一步应用于其他临床领域，提高各种针基手术的护理质量。该小企业创新研究（SBIR）二期项目旨在实现两个主要目标：1)完成设计用于与现有超声机器接口的针头引导系统的开发；2)为制导系统开发基于人工智能的解剖检测软件功能。这些综合目标将产生一个功能性的、直观的、可访问的解决方案，最大限度地减少采用障碍，同时最大化临床和操作价值。提出的研究包括进行一系列的安全性和可靠性研究，以调查制导系统在现实条件下的性能。在开发健壮的解剖检测软件功能时，将从各种非患者志愿者中创建脊柱超声数据集。这些数据将被分析、处理，并用于训练用于解剖检测的机器学习模型。预计该项目的结果将证明一个足够安全有效的系统，可以始终如一地将针头引导到预定目标，误差小于3毫米。解剖检测功能预计在识别五个关键脊柱标志方面具有至少93%的灵敏度和85%的特异性；这种水平的表现将大大减少进行超声引导干预的知识障碍。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。