I-Corps Teams: Minimally Invasive Ultrasound approaches for brain oncology

I-Corps项目更广泛的影响和商业潜力是，与目前的替代方案相比，该项目可以切除脑肿瘤和其他颅软组织，感染更少，效果更好，成本更低。目前，美国约有70万人被诊断患有脑肿瘤，预计今年还会有8万人被诊断出患有脑肿瘤（National brain tumor Society, 2017）。近三分之二，即54000名患者将在美国5000个神经外科中心中的一个接受手术作为第一疗程。目前大多数患者采用有创颅瓣切除术治疗。此外，该技术可能为13000名高风险原发性恶性肿瘤患者提供一种治疗选择，这些患者可能被认为无法通过当前的手术方法进行手术。热消融医疗器械市场在美国代表着22亿美元的机会，超声热消融技术价值3.34亿美元，年市场增长率为13.5% （BCC Research, 2017）。这一创新将为神经外科医生提供一种独特的工具，除了颅外科导航工具，它在美国的市场价值为4.59亿美元，目前被认为是颅外科手术的标准护理。I-Corps项目将探索一种微创高强度聚焦超声（HIFU）设备，用于消融脑肿瘤和其他颅软组织，该设备具有混合换能器尖端，可将治疗性超声应用于目标解剖，同时使用超声成像来可视化手术部位。我们的仿真建模确定了初始原型的适当参数，以便在模拟脑脊液和脑组织的异质介质体积中使用柔性换能器相控阵精确聚焦超声并创建病变（Zhang等人，2017，AAPM年会）。这些数据表明，我们的系统可以提供相同的治疗效果，功率比无创经颅HIFU设备低两个数量级。然后，项目团队根据模拟结果构建了一个原型，并使用牛血清白蛋白模型展示了概念验证功能。该项目的主要挑战之一将是保持探头的声学性能，因为该项目正朝着技术小型化的方向发展，以适应脑室内的探头。该团队将进一步探索客户，以更深入地了解临床工作流程、收入流、报销和监管方面，目标是建立一个基于证据的商业计划。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。

The broader impact/commercial potential of this I-Corps project is to ablate brain tumors and other cranial soft tissues with less infection, better outcomes, and reduced cost compared to current alternatives. Currently, there are around 700,000 individuals diagnosed with brain tumor in the US, with another 80,000 expected to be diagnosed this year (National Brain Tumor Society, 2017). Nearly two thirds, or 54,000, of these patients will undergo surgery as a first course of treatment at one of 5,000 neurosurgical centers in the US. The majority of patients are currently treated with invasive cranial flap resection procedures. Furthermore, the proposed technology may offer a therapeutic option for the 13,000 patients with high-risk primary malignant tumors that may be considered inoperable with current surgical approaches. The thermal ablation medical device market represents a $2.2B opportunity in the US, with ultrasound thermal ablation technology valued at $334M with an annual market growth rate of 13.5% (BCC Research, 2017). This innovation would offer a unique tool for neurosurgeons apart from cranial surgical navigation tools with a $459M US market, which are currently considered the standard of care for cranial surgery.This I-Corps project will explore a minimally invasive high-intensity focused ultrasound (HIFU) device to ablate brain tumors and other cranial soft tissues, which features a hybrid transducer tip to apply therapeutic ultrasound to the targeted anatomy while simultaneously using ultrasound imaging to visualize the surgery site. Our simulation modeling determined the appropriate parameters for an initial prototype to precisely focus ultrasound and create a lesion using a flexible transducer phased array in a heterogeneous medium volume simulating cerebrospinal fluid and brain tissue (Zhang et al., 2017, AAPM Annual Meeting). These data showed that our system could provide the same efficacy of treatment with two orders of magnitude less power than non-invasive, transcranial HIFU devices. The project team then built a prototype based on the simulation results, and showed proof-of-concept functionality using a bovine serum albumin protein phantom. One of the primary challenges of this project will be to maintain the acoustic performance of the probe as the project moves toward miniaturization of the technology to fit the probe within the brain ventricles. The team will pursue further customer discovery to gain a deeper understanding of the clinical workflow, revenue streams, reimbursement, and regulatory aspects, with the goal to build an evidence-based business plan.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.