STTR Phase II: Automated system for creating custom three-dimensional radiofrequency ablation lesion geometries in post-lumpectomy margin ablation breast cancer treatment

STTR II 期：用于在肿块切除术后边缘消融乳腺癌治疗中创建定制三维射频消融病灶几何形状的自动化系统

基本信息

批准号：
1738541
负责人：
Robert Rioux
金额：
$ 48.62万
依托单位：
Innoblative Designs
依托单位国家：
美国
项目类别：
Standard Grant
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2020-02-29
项目状态：
已结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=1738541&HistoricalAwards=false
关键词：
STTR Phase II Automated system

项目摘要

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project will focus on the design of the first completely automated radio frequency ablation (RFA) system for breast tissue. Of the approximately 200,000 breast cancer patients in the US who elect lumpectomy annually, over 20% must undergo re-operation due to lack of clear margins. Furthermore, many breast cancer patients who are treated with lumpectomy require expensive adjuvant radiation therapy that can last up to 7 weeks causing time away from work and family. Fortunately, performing intraoperative RFA of the lumpectomy cavity has been shown to decrease the need for re-operations and radiation therapy by sterilizing tumor margins. However, no RFA devices are designed for post-lumpectomy breast cavities or breast tissue. The RFA system being developed in this project will automate post-lumpectomy RFA, accurately and precisely delivering energy based on local tissue properties and desired ablation depth in three dimensions thus customizing treatment for each patient. Eventual commercialization of this system could provide early stage breast cancer patients new treatment options that improve quality of life, reduce burdens of care, and costs while providing breast cancer recurrence control. The proposed project aims to develop a system (control unit and device) for optimal post-lumpectomy RFA. The proposed device is designed to mechanically fit the post-lumpectomy cavity for near-perfect tissue contact. The control unit includes advanced algorithms that utilize machine learning to create a three-dimensional ablation status map of each margin (ablation vs in-ablated) for controlling ablation. The combined system allows the surgeon to customize and monitor the three-dimensional ablation profile and automates therapy delivery to ensure accurate, precise ablation results. The objectives propose gathering device requirements, identifying critical tasks of an automated RFA procedure, and improving the system algorithm by collecting training data in cadaveric and prophylactic mastectomy specimens. The intellectual merits proposed are: (1) an automated ablation system implemented on an embedded microprocessor and co?]processor FPGA capable of ablation shape estimation and control; (2) a system that demonstrates clinical relevance through successful ablation in human tissue and surgeon usability.

这种小型企业技术转移（STTR）II期项目的更广泛的影响/商业潜力将集中在乳腺组织的第一个完全自动化的射频消融（RFA）系统上。在美国每年选择乳房切除术的大约200,000名乳腺癌患者中，由于缺乏明显的边缘，必须重新手术。此外，许多接受乳房切除术治疗的乳腺癌患者需要昂贵的辅助放射治疗，这可能持续7周，从而导致时间和家庭。幸运的是，已证明对肿瘤切除术腔内进行术中RFA可通过对肿瘤边缘进行灭菌，从而减少对重新操作和放射治疗的需求。但是，没有RFA设备设计用于倾斜后切除术乳房或乳房组织。该项目中开发的RFA系统将自动化倾斜后切除术RFA，准确，准确地基于局部组织特性传递能量，并希望在三个维度中消融深度，从而对每位患者进行定制治疗。该系统的最终商业化可能会为乳腺癌患者提供新的治疗选择，以改善生活质量，减轻护理负担和成本，同时提供乳腺癌复发。拟议的项目旨在开发一个系统（控制单元和设备），以实现最佳的倾斜后切除术RFA。该提出的装置旨在机械地拟合倾斜后切除术腔，以进行近乎完美的组织接触。控制单元包括高级算法，这些算法利用机器学习来创建每个边缘的三维消融状态图（消融与开放式）以控制消融。联合系统允许外科医生自定义和监视三维消融剖面，并自动化治疗递送，以确保准确，精确的消融结果。这些目标提出了收集设备要求，确定自动RFA程序的关键任务，并通过收集尸体和预防性乳房切除术标本中的训练数据来改善系统算法。提出的智力优点是：（1）在嵌入式微处理器和CO上实现的自动消融系统，可以进行消融形状估计和控制；（2）通过在人体组织和外科医生可用性中成功消融来证明临床相关性的系统。