Automated retraction for thoracotomy: Improved recovery of respiratory function a

开胸手术自动回缩：改善呼吸功能的恢复

• 批准号: 7746190
• 负责人: HUGH CHARLES CRENSHAW
• 金额: $ 14.18万
• 依托单位: PHYSCIENT, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2010-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7746190
• 关键词: Absence of pain sensation; Age; Algorithms; Animals; Biomechanics; Biopsy; Cardiac; Cartilage; Chest; Chest wall structure; Chronic; Clinical Research; Clinical Trials; Computer software; Contracts; Development; Drops; Electronics; Ensure; Family suidae; Focus Groups; Fracture; Frequencies; Functional disorder; Goals; Hospitals; Human; Knowledge; Lead; Ligaments; Lung; Manuals; Manufacturer Name; Measurement; Measures; Mechanics; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Pain; Phase; Postoperative Period; Preclinical Testing; Procedures; Recovery; Research; Respiratory physiology; Rib Fractures; Robotics; Small Business Innovation Research Grant; Stainless Steel; Sternotomy; Sternum; Stress; Structure; Surgical Instruments; Surgical incisions; Technology; Testing; Thoracic Surgical Procedures; Thoracotomy; Tidal Volume; Time; Tissues; Training; Translating; Trauma; Universities; Video-Assisted Thoracic Surgery; Work; behavior measurement; clinically relevant; design; improved; instrument; medical attention; minimally invasive; new technology; percutaneous coronary intervention; preclinical study; prevent; prototype; public health relevance; respiratory; rib bone structure; surgical pain; technological innovation; technology development; tissue trauma

DESCRIPTION (provided by applicant): Thoracotomies are common approaches for thoracic surgery. In 2005, approximately 200,000 were performed in the US. Thoracotomy causes significant trauma of the thoracic tissues due to mechanical separation of the ribs to create surgical access. Immediately post-surgery, respiratory function is compromised, and pain is severe, requiring significant analgesia and other medical attention. These can frequently limit release from the surgical ICU and hospital, and, most importantly, can lead to further complications. Chronic post-thoracotomy pain is also common, sometimes lasting for months or years, and is a significant contributor to morbidity. There have been extensive efforts to replace thoracotomies with minimally invasive procedures. Acceptance of most of these procedures has been low in thoracic surgery. For example, despite more than 15 years of development, thoracoscopic procedures have seen wide use only in exploration and biopsy of the lungs. For all other procedures, thoracotomies are used. In fact, the number of thoracotomies has risen by 20% over the past decade and is expected to grow dramatically as baby boomers age. Most trauma from thoracotomy occurs during spreading of the ribs by an instrument known as a "thoracic retractor". Today's thoracic retractors have had little technological innovation for nearly 70 years. Physcient, Inc. is advancing new technology, first developed at NC State University, to develop a thoracic retractor that will reduce tissue trauma in thoracotomies. Preliminary results have been positive, demonstrating that these retractors can decrease rib fractures and retraction force, greatly smooth the force of retraction, and detect imminent fractures in time to prevent them. Physcient is currently building a new prototype that combines these technologies to automate retraction. The work proposed in Phase 1 of this SBIR is to test this automated retractor against current retractors in a porcine model of thoracotomy. Primary endpoints will be reduced frequency of rib fracture, faster recovery of respiratory function (tidal volume), and faster recovery from pain (behavioral measures). Phase II of this project will begin with additional preclinical studies to ensure appropriately powered studies and then proceed to clinical trials to demonstrate efficacy of Physcient's retractor in thoracotomies in humans. PUBLIC HEALTH RELEVANCE: There are approximately 200,000 thoracotomies in the US each year. These procedures frequently are followed by significant post-operative respiratory dysfunction and pain. The goal of this project is to develop a new surgical instrument that greatly decreases respiratory dysfunction and pain after thoracotomy.

描述（申请人提供）：开胸手术是胸外科手术的常用方法。2005年，大约有20万例手术在美国进行。由于机械分离肋骨以创造手术通路，开胸术会造成胸部组织的严重创伤。手术后，呼吸功能立即受损，疼痛严重，需要大量镇痛和其他医疗护理。这些通常会限制从外科ICU和医院的释放，最重要的是，可能导致进一步的并发症。慢性开胸术后疼痛也很常见，有时持续数月或数年，是导致发病率的重要因素。人们一直在努力用微创手术取代开胸手术。在胸外科手术中，这些手术的接受度一直很低。例如，尽管有超过15年的发展，但胸腔镜手术仅广泛用于肺部的探查和活检。其他手术均采用开胸手术。事实上，在过去十年中，开胸手术的数量增加了20%，随着婴儿潮一代的年龄增长，预计这一数字还会大幅增长。大多数开胸手术造成的创伤发生在用“胸牵开器”伸展肋骨的过程中。近70年来，今天的胸腔牵开器几乎没有什么技术创新。physient公司正在推进一项新技术，该技术最初是在北卡罗来纳州立大学开发的，旨在开发一种胸部牵开器，以减少开胸手术中的组织创伤。初步结果是积极的，表明该牵开器可以减少肋骨骨折和牵开力，极大地平滑牵开力，并及时发现即将发生的骨折以防止其发生。物理学家目前正在构建一个新的原型，它结合了这些技术来自动收回。该SBIR第一阶段提出的工作是在猪开胸模型中测试该自动牵开器与现有牵开器的对比。主要终点是肋骨骨折频率降低，呼吸功能恢复更快（潮气量），疼痛恢复更快（行为测量）。该项目的第二阶段将从额外的临床前研究开始，以确保适当的研究动力，然后进行临床试验，以证明physient的牵开器在人类开胸手术中的有效性。公共卫生相关性：美国每年大约有20万例开胸手术。这些手术后经常出现明显的术后呼吸功能障碍和疼痛。该项目的目的是开发一种新的手术器械，大大减少呼吸功能障碍和疼痛的开胸手术后。