A Laparoscopic Grasping Instrument for Robust and Atraumatic Tissue Manipulation in Minimally-Invasive Gastrointestinal Surgery

腹腔镜抓取器械，用于微创胃肠手术中稳健且无创伤的组织操作

• 批准号: 10006295
• 负责人: Michael Jaasma
• 金额: $ 22.5万
• 依托单位: THERANOVA, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-15 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006295
• 关键词: Abdomen; Address; Aging; Animals; Area; Blinded; Complication; Data; Development; Devices; Evaluation; Family; Family suidae; Future; Gallbladder; Gastrointestinal Surgical Procedures; Goals; Head; Hemorrhage; Iatrogenesis; Influenza; Injury; Jaw; Lampreys; Laparoscopic Cholecystectomy; Laparoscopic Surgical Procedures; Laparoscopy; Large Intestine; Lead; Length of Stay; Literature; Morbidity - disease rate; Muscle; Operative Surgical Procedures; Pathologist; Patients; Perception; Perforation; Phase; Postoperative Pain; Postoperative Period; Procedures; Property; Publications; Reporting; Research; Risk; Running; Safety; Secure; Series; Small Business Innovation Research Grant; Small Intestines; Stains; Stomach; Structure; Suction; Surgeon; System; Techniques; Testing; Time; Tissue Microarray; Tissue Sample; Tissues; Tooth Tissue; Tooth structure; Traumatic injury; Work; aging population; base; commercialization; design; experience; flexibility; grasp; iatrogenic injury; improved; in vivo; in vivo evaluation; instrument; minimally invasive; novel; older patient; patient population; surgery outcome; tissue injury; tool; usability

Abstract With up to 4.8 million procedures annually in the U.S., laparoscopy has rapidly become the surgical standard for a wide range of procedures. Compared to open procedures, laparoscopic approaches reduce muscle damage, blood loss, post-operative pain, complication rates, and length of hospital stay. However, laparoscopy has unique technique-specific limitations and complications, so the perception that minimally invasive surgery is minimally traumatic is imprecise. There is now evidence that the frail, aging population may benefit most from laparoscopic techniques. Thus, advances in laparoscopic techniques that reduce surgery-related complications would provide important benefits to the older patient population. Although laparoscopy has generally improved surgical outcomes, current instruments can contribute to procedure-related complications. To grasp and manipulate tissue, surgeons typically use the compressive grasper, a tool that pinches tissue between the teeth of two jaws. While compressive graspers are well-suited for grasping smaller structures, the typical V-shaped jaws only open to a maximum of 3.5-10 mm apart, so they are not optimized for grasping larger structures, particularly stiff structures like the inflamed gallbladder. As a result of the compressive grasper’s design, excessive grasping and retraction forces, long duration of grasps, and slippage of the tissue in the grasper jaws can all contribute to tissue injury and perforation. In turn, intraoperative tissue damage can lengthen operative time, result in conversion to traditional open surgery, and increase patient morbidity. In addition to immediately apparent damage, tissue injury during surgery can result in delayed perforations and significant patient morbidity. Therefore, the risk of iatrogenic tissue injury is a central and ubiquitous concern for surgeons. To address the need for a laparoscopic grasper capable of gripping a broad array of tissue types without the risk of slippage or iatrogenic injury, TheraNova is developing the Lamprey Grasper, a novel, atraumatic laparoscopic grasper. Our goal is to improve key functionalities within the grasper family, particularly in grasping larger, stiffer structures. In preliminary studies, we demonstrated that several Lamprey Grasper designs enable a strong, reliable tissue grasp while inducing less injury than a compressive grasper. The overall goals of this proposal are to build on this promising work to optimize and validate the Lamprey Grasper. In Specific Aim 1, we will conduct a benchtop evaluation to identify the optimal Lamprey Grasper design for robust grasping across a range of porcine abdominal tissues. In Specific Aim 1, we will use the optimal design from Aim 1 to conduct a comprehensive in vivo evaluation of the Lamprey Grasper vs. a conventional compressive grasper. Two experienced laparoscopic surgeons will perform a series of laparoscopic actions in Yorkshire pigs (n=6) to compare functionality, usability, and grasper-induced tissue injury between the two graspers. If this Phase I work is successful, in Phase II we will conduct a large, post-operative survival animal study to validate the functionality, usability, and safety of the Lamprey Grasper, which will support a 510(k) submission to the FDA.

摘要 美国每年有多达480万例手术，腹腔镜检查已迅速成为外科标准， 各种各样的程序。与开放手术相比，腹腔镜手术减少了肌肉损伤， 失血量、术后疼痛、并发症发生率和住院时间。然而，腹腔镜手术具有独特的 技术特定的局限性和并发症，因此认为微创手术 创伤是不精确的。现在有证据表明，虚弱，老龄化人口可能受益最多的腹腔镜手术 技术.因此，减少手术相关并发症的腹腔镜技术的进步将提供 对老年患者群体有很大好处。尽管腹腔镜检查总体上改善了手术效果 结果，目前的工具可能导致手术相关并发症。以抓紧和处理 对于组织，外科医生通常使用压缩抓钳，这是一种在两个钳口的齿之间夹紧组织的工具。 虽然压缩抓钳非常适合于抓持较小的结构，但典型的V形钳口仅打开 最大间距为3.5-10 mm，因此它们不适合抓取较大的结构，特别是刚性结构， 比如发炎的胆囊由于压缩抓钳的设计，过度抓持和 回缩力、长时间的抓取以及组织在抓取器钳口中的滑动都可能导致 组织损伤和穿孔。反过来，术中组织损伤会延长手术时间，导致 转换为传统的开放手术，并增加患者的发病率。除了立即明显的 手术期间的损伤、组织损伤可能会导致穿孔延迟和患者严重发病。 因此，医源性组织损伤的风险是外科医生普遍关注的中心问题。解决 需要一种腹腔镜抓钳，其能够抓持广泛的组织类型而没有滑动的风险， 为了避免医源性损伤，TheraNova正在开发Lamprey抓钳，这是一种新型的无创伤腹腔镜抓钳。我们 目标是改善抓钳系列的关键功能，特别是在抓持更大、更硬的结构方面。 在初步研究中，我们证明了几种七鳃鳗抓钳设计能够实现坚固、可靠的组织 抓持，同时比压缩抓持器引起更少的损伤。本提案的总体目标是： 这项有前途的工作，以优化和验证七鳃鳗抓钳。在具体目标1中，我们将进行一个实验台 评估以确定最佳七鳃鳗抓钳设计，用于在一系列猪中进行稳健抓钳 腹部组织在具体目标1中，我们将使用目标1中的最优设计进行全面的研究， Lamprey抓钳与传统压缩抓钳的体内评价。两名经验丰富的腹腔镜检查员 外科医生将在约克郡猪（n=6）中进行一系列腹腔镜操作，以比较功能性，可用性， 以及两个抓紧器之间的抓紧器引起的组织损伤。如果第一阶段的工作成功，在第二阶段， 将进行一项大型的术后存活动物研究，以验证 七鳃鳗抓钳，将支持向FDA提交510（k）申请。