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

这个i-Corps项目的更广泛的影响/商业潜力是，与目前的替代方案相比，以更少的感染、更好的结果和更低的成本消融脑瘤和其他颅骨软组织。目前，美国约有70万人被诊断患有脑瘤，预计今年还将有8万人被诊断出脑瘤(全国脑瘤协会，2017年)。其中近三分之二，即5.4万名患者将在美国5000家神经外科中心之一接受手术，作为第一疗程的治疗。目前，大多数患者接受侵入性颅骨瓣切除手术。此外，拟议的技术可能会为1.3万名患有高危原发恶性肿瘤的患者提供一种治疗选择，这些患者可能被认为是目前的手术方法无法手术的。热消融医疗设备市场在美国代表着22亿美元的机会，其中超声波热消融技术价值3.34亿美元，年市场增长率为13.5%(BCC Research，2017)。这项创新将为神经外科医生提供一个独特的工具，除了拥有4.59亿美元的美国市场的颅脑手术导航工具，这些工具目前被认为是颅脑手术的标准护理。这个i-Corps项目将探索一种微创高强度聚焦超声(HIFU)设备，以消融脑瘤和其他颅骨软组织，其特点是混合换能器尖端，将治疗性超声波应用于目标解剖，同时使用超声成像来可视化手术部位。我们的仿真建模为初始原型确定了适当的参数，以使用灵活的换能器相控阵在模拟脑脊液和脑组织的不同介质体积中精确聚焦超声波并创建病变(Zhang等人，2017，AAPM年会)。这些数据表明，我们的系统可以以比无创、经颅HIFU设备低两个数量级的功率提供相同的治疗效果。然后，项目团队基于模拟结果构建了一个原型，并使用牛血清白蛋白模体展示了概念验证功能。该项目的主要挑战之一将是在该项目朝着将探头安装在脑室内的技术微型化的过程中保持探头的声学性能。该团队将寻求进一步的客户发现，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业务计划。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.