A laparoscopically-deployable HIFU device for tissue ablation

描述（由申请人提供）：仅在美国，每年就进行数百万次外科手术，这些手术涉及切除组织或器官的一部分，因为涉及该组织的某些病理，特别是涉及良性和恶性肿瘤的那些病理。虽然这些组织和器官的显著百分比是用常规手术切除的，但是最近已经做出了重大努力来利用腹腔镜和其他微创技术，这些技术已经降低了发病率。然而，通过腹腔镜进行这种手术需要主治医生的大量培训和先进技能。腹腔镜手术最大的挑战可能是控制出血。本研究的目的是设计、构建和测试一种器械，该器械允许进行这些外科手术，特别是涉及肾部分切除术的手术，而无需担心失血。我们已经开发出一种技术，使用高强度超声，使临床医生或其他熟练的操作者进行腹腔镜组织消融，出血最少。该设备涉及使用高强度超声，从附接到腹腔镜器械的换能器的两个线源辐射，该腹腔镜器械可以通过常规套管针插入体内。该方法涉及使用高强度超声来诱导烧灼平面穿过组织，靠近感兴趣区域，包括血管的闭塞，从而将该区域与其血管供应隔离。因此，包含感兴趣区域的器官一旦被横断，将不会出血。这种微创技术有望大大扩展腹腔镜手术的使用，例如，允许广泛进行部分肾切除术，从而保留大量移植手术需要的肾脏和器官。这项工作的具体目标如下：（1）设计、构建和声学表征一种改进的HIFU夹，该夹将在猪肾模型中实现完全透壁消融;（2）在组织模体和离体组织中进行一系列实验，以测试我们的工程原型的有效性;（3）在猪动物模型中使用HIFU夹和Nussbaum夹进行一系列急性实验;以及（4）在猪动物模型中使用腹腔镜部署的HIFU夹进行一系列存活实验。这一努力的主要目标的成功完成提供了基本技术，将导致在器官和组织保留手术中增加腹腔镜手术的使用。

DESCRIPTION (provided by applicant): In the US alone, several million surgical procedures are performed each year that involve the removal of tissue, or a portion of an organ, because of some pathology involving this tissue, particularly those involving benign and malignant tumors. Although a significant percentage of these tissues and organs are removed with conventional surgery, a major effort has recently been made to utilize laparoscopic and other minimally invasive techniques that have reduced morbidity. However, performing this surgery through laparoscopes requires significant training and advanced skills of the attending physician. Perhaps the most severe challenge of laparoscopic surgery is in the control of bleeding. It is the purpose of this research effort to design, construct, and test a device that would permit these surgical procedures, particularly those involving a partial nephrectomy, to be performed without fear of blood loss. We have developed a technique, using high intensity ultrasound, that enables the clinician or other skilled operator to perform laparoscopic tissue ablation with minimal bleeding. The apparatus involves the use of high intensity ultrasound, radiated from two line sources of transducers that are attached to a laparoscopic instrument that can be inserted though a conventional trocar into the body. The method involves the use of the high intensity ultrasound to induce a plane of cauterization through the tissue, proximal to the region of interest, including the occlusion of blood vessels, thus isolating this region from its vascular supply. Consequently, the organ containing the region of interest, once transected, will not bleed. This minimally invasive technique has the promise of greatly expanding the use of laparoscopic procedures, permitting, for example the widespread practice of performing partial nephrectomies, thus preserving a large number of kidneys, organs that are in major demand for transplant surgeries. The specific aims of this effort are as follows: (1)To design, construct, and acoustically characterize an improved HIFU clamp that will achieve completely transmural ablation in a porcine kidney model; (2) To perform a series of experiments in tissue phantoms and ex vivo tissues to test the effectiveness of our engineering prototype; (3) To perform a series of acute experiments in a porcine animal model, both with the HIFU Clamp as well as the Nussbaum Clamp; and (4) To perform a series of survival experiments in a porcine animal model with the HIFU clamp deployed laparoscopically. The successful completion of the major goals of this effort provides the basic technology that would lead to increased use of laparoscopic procedures during organ and tissue sparing surgeries.