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.

抽象的 美国每年进行多达 480 万例手术，腹腔镜手术已迅速成为手术标准 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长，但腹腔镜检查有其独特之处。 技术特定的限制和并发症，因此人们认为微创手术是最小的 目前有证据表明，体弱、老龄化人群可能从腹腔镜手术中受益最多。 因此，腹腔镜技术的进步将减少手术相关并发症。 尽管腹腔镜检查总体上改善了手术效果，但对老年患者群体有重要的好处。 结果，当前的仪器可能会导致与手术相关的并发症的掌握和操作。 对于组织，外科医生通常使用压缩抓紧器，这是一种将组织夹在两个钳口的牙齿之间的工具。 虽然压缩抓取器非常适合抓取较小的结构，但典型的 V 形钳口仅打开 最大间距为 3.5-10 毫米，因此它们并未针对抓取较大结构（特别是刚性结构）进行优化 由于压缩抓握器的设计，过度抓握和发炎的胆囊等结构。 回缩力、抓握持续时间长以及抓钳钳口中组织的滑动都会导致 组织损伤和穿孔反过来，术中组织损伤又会延长手术时间，导致手术时间延长。 转换为传统的开放手术，除了立即明显的增加患者发病率外。 组织损伤，手术期间的组织损伤可导致迟发性穿孔和显着的患者发病率。 因此，医源性组织损伤的风险是外科医生普遍关注的焦点。 需要一种腹腔镜抓紧器能够抓紧多种组织类型，而不会出现滑落或滑落的风险 针对医源性损伤，TheraNova 正在开发 Lamprey Grasper，这是一种新型的无创伤性腹腔镜抓取器。 目标是改进抓取器系列的关键功能，特别是在抓取更大、更坚硬的结构方面。 在初步研究中，我们证明了几种七鳃鳗抓取器设计能够实现坚固、可靠的组织 与压缩抓握器相比，抓握时造成的伤害更少 该提案的总体目标是建立在这种基础上的。 这项有望优化和验证 Lamprey Grasper 的工作在特定目标 1 中，我们将进行一次台式测试。 评估以确定最佳的七鳃鳗抓取器设计，以实现对一系列猪的稳健抓取 在具体目标1中，我们将利用目标1的优化设计进行全面的研究。 两位经验丰富的腹腔镜手术人员对七鳃鳗抓取器与传统压缩抓取器进行了体内评估。 外科医生将对约克夏猪（n = 6）进行一系列腹腔镜手术，以比较功能性、可用性、 如果第一阶段的工作成功，我们将在第二阶段进行。 将进行一项大型术后存活动物研究，以验证该设备的功能、可用性和安全性 Lamprey Grasper，将支持向 FDA 提交 510(k) 申请。