Low Insertion Force Epidural, Actuated Needle System for Enhanced Control and Tactile Feel During Epidural Insertion

低插入力硬膜外驱动针系统可增强硬膜外插入过程中的控制和触觉

• 批准号: 8904425
• 负责人: Maureen L. Mulvihill
• 金额: $ 89.89万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8904425
• 关键词: Absenteeism at work; Acceleration; Accounting; Activities of Daily Living; Anatomy; Anesthesia procedures; Anesthesiology; Award; Back; Birth; Blood specimen; Cadaver; Caring; Clinical; Clinical Research; Clinical Trials; Complication; Conduction Anesthesia; Cranial Nerve Injuries; Cyclic GMP; Development; Devices; Discipline of obstetrics; Dura Mater; Effectiveness; Electronics; Enteral Feeding; Epidural Anesthesia; Epidural Blood Patch; Family suidae; Feedback; Focus Groups; Goals; Grant; Guidelines; Hospitals; Hour; Human; Incidence; Infection; Injection of therapeutic agent; Injury; Leg; Litigation; Marketing; Medical; Medical Device; Medicare; Modeling; Motion; Muscle; Narcotics; Needles; Obesity; Outcome; Pain management; Patient-Focused Outcomes; Patients; Penetration; Pharmaceutical Preparations; Phase; Population; Post-Dural Puncture Headaches; Price; Procedures; Puncture procedure; Resistance; Risk; Rodent; Safety; Sales; Sensory; Sleep Apnea Syndromes; Small Business Innovation Research Grant; Spinal; Spinal Cord; Structure; Subdural Hematoma; System; Tactile; Technology; Testing; Time; Tissue Model; Tissues; United States National Institutes of Health; Vertebral column; Vision; aging population; base; clinically significant; commercial application; commercialization; cost; cost effective; density; design; epidural space; experience; farmer; improved; innovation; ligamentum flavum; meetings; prototype; public health relevance; research clinical testing; soft tissue; success; verification and validation

 DESCRIPTION (provided by applicant): In this NIH Phase IIB Competing Renewal SBIR project, Actuated Medical, Inc. will finalize and clinically test the "Low Insertion Force Epidural (LIFE), Actuated Needle Insertion System for Enhanced Control and Tactile Feel." LIFE uses closed-loop control of a vibrating needle to provide the clinician a more controlled entry through tough muscle and tissue, while improving tactile feel. Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly into the epidural space just outside the spinal cord. Epidural anesthesia is used in 2.49M births every year in the U.S. Single shot epidurals, routinely given for pain management in the lower back and legs, account for another ~5.2M epidural procedures in the Medicare population alone. Epidural procedures require significant clinician expertise for accurate and safe medication delivery, due in part to the complexity of anatomy and variety of tissue planes the needle must traverse before reaching the dura. The major complication from epidural anesthesia is overshooting the epidural space and puncturing the dural sheath. Since epidural procedures are `by feel' and human anatomies vary, it is difficult for the clinician to anticipate the exact plane in which the tissue resistance will chang. The overshoot can occur when the force applied to the needle while traversing from hard tissue density (high resistance - e.g., ligamentum flavum) into the soft tissue density (low resistance - e.g., dura sheath) leads to needle acceleration. This needle acceleration causes accidental dural punctures in ~6% of epidural needle insertions. Approximately 86% of dural punctures result in a Post Dural Puncture Headaches (PDPH), leading to an average increase of 17 hours in the hospital - and in 72% of cases, an epidural blood patch is given. Longer-term complications include temporary or permanent cranial nerve injuries, subdural hematoma, infection, inability to perform activities of daily living and missed work. PDPH is also the third highest reason for litigation in anesthesiology with an estimated $130M in settlements annually in obstetrics alone. The controlled insertion force and velocity through tissue provided by LIFE allows an increased ability to focus on tactile feel, resulting in smooth tissue transitions - minimizing the complications of PDPH and associated cost in epidural anesthesia. Phase IIB Hypothesis: LIFE improves procedural safety and effectiveness. LIFE procedures result in a clinically significant reduction in complication rate and a clinically significant reduction in onst time of sensory anesthesia. Hypotheses to be tested with a=0.05, ß=0.20. Specific Aims: Aim 1 Electronic Shut-off Development Validated with Safety and Clinical Bench Testing, Early Feasibility Clinical Study. Aim 2 Design Verification and Validation Testing. Aim 3 Pivotal Clinical Trial.

 描述（由适用提供）：在NIH阶段IIB竞争的续签SBIR项目中，Actieted Medical，Inc。将最终确定并在临床上测试“低插入力硬膜外硬膜外发作 生命使用振动针对振动针的闭环控制来为临床提供更受控的肌肉和组织，同时改善触觉。硬膜外麻醉是每种属性的脊髓触及脊柱，这是脊柱刺激的一种形式。单次射击性硬尿，通常用于下背部和腿部的疼痛管理，仅在医疗保险人群中进行了〜520次的硬膜外手术。程序是“通过感觉”和人类解剖学的变化，临床很难预测组织阻力会改变的确切平面。当力从硬组织密度（例如高电阻 - 例如韧带黄素）施加到软组织密度（例如低电阻 - 例如，硬脑膜鞘）导致针加速度时，可能会发生过度冲8。此针加速度在大约6％的硬膜外针插入中引起意外硬膜穿刺。大约86％的硬脑膜穿刺导致硬脑膜后头痛（PDPH），导致医院平均增加17小时 - 在72％的病例中，给出了硬膜外血液斑块。长期并发症包括临时或永久性颅神经损伤，硬膜下血肿，感染，无法进行日常生活和缺席的活动。 PDPH也是麻醉学诉讼的第三高理由，仅妇产科估计每年有1.3亿美元的定居点。通过生命提供的组织的受控插入力和速度可以提高专注于触觉感觉的能力，从而导致光滑的组织过渡 - 最小化PDPH的并发症以及硬膜外麻醉的相关成本。 IIB期假设：生活提高了程序的安全性和有效性。生命程序导致并发症发生率的临床显着降低和感觉麻醉时间的临床显着降低。用A = 0.05，ß= 0.20测试的假设。具体目的：AIM 1通过安全性和临床基准测试验证的电子关闭开发，早期可行性临床研究。 AIM 2设计验证和验证测试。 AIM 3关键临床试验。