A laparoscopically-deployable HIFU device for tissue ablation

用于组织消融的腹腔镜可部署 HIFU 装置

• 批准号: 8240888
• 负责人: LAWRENCE A CRUM
• 金额: $ 21.96万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8240888
• 关键词: Ablation; Acoustics; Acute; Address; Animal Model; Animals; Benign; Blood Vessels; Cauterization - action; Clinical; Coagulative necrosis; Communities; Conventional Surgery; Data; Device Designs; Devices; Diagnosis; Diagnostic; Effectiveness; Engineering; Excision; Family suidae; Focused Ultrasound Therapy; Fright; Future; Goals; Heating; Hemorrhage; Hemostatic function; Histology; Image; Imaging technology; In Situ; Kidney; Laparoscopes; Laparoscopic Surgical Procedures; Laparoscopy; Lead; Malignant Neoplasms; Medicine; Methods; Modality; Modeling; Morbidity - disease rate; Nephrectomy; Operative Surgical Procedures; Organ; Pathology; Physicians; Procedures; Protocols documentation; Relative (related person); Research; Science; Series; Source; Study models; Surgeon; Techniques; Technology; Testing; Therapeutic; Time; Tissues; Training; Transducers; Transplantation; Trocars; Ultrasonography; Vascular blood supply; Width; Work; blood vessel occlusion; design; design and construction; improved; in vivo; innovation; instrument; interest; minimally invasive; novel; performance tests; prototype; research study; skills; technology development; tissue phantom; tool

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. PUBLIC HEALTH RELEVANCE: Non-invasive technologies such as image-guided High Intensity Focused Ultrasound (HIFU) have great promise for the treatment of a variety of benign and malignant tumors; accordingly, in order to evaluate the utility of this rapidly evolving, non-invasive technology for general clinical use, we shall investigate a novel, minimally-invasive High Intensity Ultrasound device of our own design. This device is integrated with a laparoscopic tool and inserted through a 1 cm trocar in order to perform tissue ablation. Successful development of this technology will permit laparoscopic bloodless surgery.

描述（由申请人提供）：仅在美国，每年就会进行数百万例涉及切除组织或器官一部分的外科手术，因为某些涉及组织的病理学，特别是涉及良性和恶性肿瘤的病理学。尽管这些组织和器官的很大一部分是通过传统手术切除的，但最近人们在利用腹腔镜和其他微创技术来降低发病率方面做出了重大努力。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高级技能。也许腹腔镜手术最严峻的挑战是控制出血。这项研究工作的目的是设计、构建和测试一种设备，使这些外科手术，特别是涉及部分肾切除术的手术，能够在无需担心失血的情况下进行。我们开发了一种使用高强度超声波的技术，使临床医生或其他熟练操作者能够以最少的出血进行腹腔镜组织消融。该装置使用高强度超声波，从两个传感器线源辐射，这些传感器连接到腹腔镜器械上，可以通过传统的套管针插入体内。该方法涉及使用高强度超声波来诱导穿过靠近感兴趣区域的组织的烧灼平面，包括血管闭塞，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切，就不会流血。这种微创技术有望大大扩展腹腔镜手术的使用，例如允许进行部分肾切除术的广泛实践，从而保留大量肾脏和移植手术所需的器官。这项工作的具体目标如下：（1）设计、构建和声学表征改进的HIFU钳，该钳将在猪肾模型中实现完全透壁消融； （2）在组织模型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) 使用HIFU钳和Nussbaum钳在猪动物模型上进行一系列急性实验； (4)使用腹腔镜下部署的HIFU钳在猪动物模型中进行一系列生存实验。这项工作主要目标的成功完成提供了基础技术，将导致在器官和组织保留手术中增加腹腔镜手术的使用。 公共健康相关性：图像引导的高强度聚焦超声 (HIFU) 等非侵入性技术对于治疗各种良性和恶性肿瘤具有广阔的前景；因此，为了评估这种快速发展的非侵入性技术在一般临床应用中的实用性，我们将研究我们自己设计的新型微创高强度超声设备。该装置与腹腔镜工具集成并通过 1 厘米套管针插入以进行组织消融。该技术的成功开发将使腹腔镜无血手术成为可能。