Steerable MEMS Instruments for Precise Intracardiac Surgery

描述（由申请人提供）：在影响胎儿、儿科和成人患者的许多情况下，用于修复心脏内部结构的现有工具和技术导致介入时机和方法不佳。虽然基于导管的技术已经改变了某些病症的治疗，但是传统制造方法在毫米和亚毫米尺度上的崩溃已经严重限制了导管递送仪器的复杂性，并因此限制了它们的实用性。相比之下，开放性外科手术允许复杂的重建和患者定制的修复，但是，它们涉及大量的创伤和风险。所需要的是一种器械技术，其将微创手术的有限附带组织损伤与开放手术方法所提供的灵活性和定制配合相结合。我们建议开发这样一种技术，安装工具和植入物构造使用3D微机电系统（MEMS）技术的尖端上的高精度可控针。这些针由弯曲的超弹性管同心组合而成，能够蜿蜒穿过心脏的腔室到达手术部位。与传统的MEMS器件不同，我们将使用的EFAB MEMS工艺将使我们能够用金属构建完全组装的复杂毫米级机构，这些金属可以从其基底上移除以进行针安装。为工具提供动力的控制线可以穿过针的内腔，类似于现有的手持式和机器人微创器械。三维MEMS技术有可能彻底改变微创工具和植入物的设计。3D MEMS器件的多功能性可能实现新的微创手术并提高当前手术的精度。使用端口接入，可操纵针将提供用于将工具定位在心脏内的高度精确的平台，并且将足够坚硬以施加操纵组织所需的力。这个问题的复杂性非常适合BRP。PI组建了一个多学科团队，并在行业工程师（Microfabrica）、临床研究人员（波士顿儿童医院）和大学工程师（波士顿大学）之间建立了独特的合作伙伴关系。我们将通过解决以下具体目标共同开发这项技术：目标1 -开发用于小儿/成人心内组织切除的可控MEMS器械。目标2 -开发用于儿科/成人心内组织缝合的可操控MEMS器械。目标3 -开发用于胎儿心内组织切除的可操控MEMS器械。

DESCRIPTION (provided by applicant): In many situations affecting fetal, pediatric and adult patients, existing tools and techniques for repairing structures inside the heart result in suboptimal interventional timing and approach. While catheter-based techniques have transformed the treatment of certain conditions, the breakdown of traditional manufacturing methods at the millimeter and sub-millimeter scale has placed severe limitations on the complexity of catheter-delivered instruments and consequently on their utility. In contrast, open surgical procedures permit complex reconstruction and patient-tailored repairs, however, they involve substantial trauma and risk. What is needed is an instrument technology which combines the limited collateral tissue damage of a minimally invasive procedure with the dexterity and custom fit afforded by the open surgical approach. We propose to develop such a technology by mounting tools and implants constructed using 3D microelectromechanical systems (MEMS) technology on the tips of high-precision steerable needles. Constructed from the concentric combination of curved superelastic tubes, these needles will be able to snake their way through the heart's chambers to a surgical site. And unlike traditional MEMS devices, the EFAB MEMS process we will use will allow us to construct fully-assembled complex millimeter-scale mechanisms from metals which can be removed from their substrate for needle mounting. Control wires to power the tools can be run through the needle's lumen similar to existing handheld and robotic minimally invasive instruments. Three-dimensional MEMS technology has the potential to revolutionize the design of minimally invasive tools and implants. The versatility of 3D MEMS devices is likely to enable new minimally invasive procedures and to improve the precision of current procedures. Using port access, the steerable needles will provide a highly precise platform for positioning the tools within the heart and will be stiff enough to apply the forces necessary to manipulate the tissue. The complexity of this problem is well suited to a BRP. The PI has assembled a multidisciplinary team and established a unique partnership among industry-based engineers (Microfabrica), clinical investigators (Children's Hospital, Boston) and university-based engineers (Boston University). Together, we will develop this technology by addressing the following specific aims: Aim 1 - Develop Steerable MEMS Instruments for Pediatric / Adult Intracardiac Tissue Removal. Aim 2 - Develop Steerable MEMS Instruments for Pediatric / Adult Intracardiac Tissue Approximation. Aim 3 - Develop a Steerable MEMS Instrument for Fetal Intracardiac Tissue Removal.