Active Fine Gauge Spinal Needle with CSF Sensing to Minimize PDPH and Dura Damage

具有脑脊液感应功能的主动细规格脊柱针可最大程度地减少 PDPH 和硬脑膜损伤

• 批准号: 8930162
• 负责人: Maureen L. Mulvihill
• 金额: $ 65.42万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930162
• 关键词: Algorithms; Anesthesia procedures; Animal Model; Area; Bed rest; Biopsy; Blood; Blood specimen; Caring; Cerebrospinal Fluid; Clinical; Clinical Trials; Complication; Conduction Anesthesia; Cyclic GMP; Development; Devices; Discipline of obstetrics; Dura Mater; Early Diagnosis; Effectiveness; Electronics; Enteral Feeding; Extravasation; Family suidae; Feedback; Feeling; Focus Groups; General Anesthesia; Goals; Grant; Hospitalization; Hospitals; Hour; Human; Injection of therapeutic agent; International; Left; Life; Ligaments; Litigation; Medical; Medical Device; Modeling; Motion; Narcotics; Nausea and Vomiting; Needles; Nerve; Nerve Block; Obesity; Outcome; Pain; Pain management; Patients; Penetration; Peripheral; Peripheral Nerves; Pharmaceutical Preparations; Phase; Post-Dural Puncture Headaches; Procedures; Production; Puncture procedure; Residual state; Risk; Rodent; Safety; Sales; Signal Transduction; Sleep Apnea Syndromes; Small Business Innovation Research Grant; Space Models; Spinal; Spinal Anesthesia; Structure; Subarachnoid Space; System; Tactile; Techniques; Technology; Testing; Time; United States National Institutes of Health; Vertebral column; Vision; Visit; Visual; aging population; analog; base; bone; cerebrospinal fluid flow; commercial application; commercialization; cost; design; electric impedance; experience; improved; prototype; public health relevance; research clinical testing; tool; verification and validation

DESCRIPTION (provided by applicant): In this NIH SBIR Phase II, Actuated Medical, Inc. will finalize and clinically test the "Active Fine Gauge Spinal Needle with CSF Sensing to Minimize PDPH and Dura Damage." Phase I achieved all Specific Aims and demonstrated that the Smooth Insertion Spinal (SIS) System provided greater control for the clinician by reducing the buckling of 27G traumatic needles during insertion. Tip penetration into the subarachnoid space with cerebrospinal fluid (CSF) flow was electronically detectable 4 times faster compared to visual flashback. Clinician focus groups (N = 20) agreed that the SIS technology would be advantageous in placing 27G needles. Phase II Aims and goals are based on conversations with regulatory experts (CE Mark and FDA) and clinicians, and are structured to obtain regulatory clearance/approval. Spinal anesthesia is a form of regional anesthesia involving injection of drugs directly into the subarachnoid space. Spinal anesthesia provides many benefits over general anesthesia, including decreased post- anesthesia nausea and vomiting, and more effective post-op pain control. The most common complication is a Post Dural Puncture Headache (PDPH), caused by leakage of CSF through the residual hole in the dura left by the deliberate needle puncture. PDPH can last from hours to weeks and can require extended hospitalization, bed rest, medication, and/or possible treatment with a blood patch. In 2008, in the U.S., 30,324 PDPH cases resulted in extended hospital visits and 16,912 spinal blood patches. PDPH is one of the Top Three reasons for litigation against obstetric anesthesiologists. PDPH is reduced up to 65% by using fine gauge (e 25G) and more atraumatic (non-cutting) tipped needles. Unfortunately, finer atraumatic needles can buckle, deflect, or even break during the procedure. Repeated insertions and redirections, which increase PDPH risk, can result from a) the difficulty in feeling the 'pop' into the thin dural sheah, and b) the time needed to confirm CSF contact. A device is needed that can improve spinal anesthesia outcomes by allowing fine gauge (27G) atraumatic needles to be smoothly and accurately inserted with earlier confirmation of entry into subarachnoid space. SIS solves these clinical shortfalls. SIS will detect CSF flow in needles prior to CSF flashback in 91/96 (95%) insertions in porcine model, rate of 95% confirmed with a 'one-proportion' hypothesis test with =0.05. Additionally, SIS will be safe and effective for 27G atraumatic spinal needle insertions in 10 of 10 human patients. Aims: 1) Final Optimization and Verification of Sensing Electronics for CSF and Bone Contact and Pre-validate SIS Design (AMI, Mo. 1-12), 2) Demonstrate Safety and Effectiveness in Live Animal Model (AMI/HMC, Mo. 13-16), 3) Verification and Validation with Production of SIS Beta Prototype (AMI Mo. 14-18), 4) Pilot Human Clinical Evaluation (AMI/HMC, Mo. 18-24).

描述（由申请人提供）：在 NIH SBIR 第二阶段中，Actuated Medical, Inc. 将最终确定并临床测试“具有 CSF 传感功能的主动细规格脊髓针，以最大限度地减少 PDPH 和硬脑膜损伤”。第一阶段实现了所有具体目标，并证明平滑插入脊柱 (SIS) 系统通过减少 27G 创伤性针在插入过程中的弯曲，为临床医生提供了更好的控制。与视觉闪回相比，通过电子方式可检测到尖端通过脑脊液 (CSF) 流刺入蛛网膜下腔的速度快 4 倍。临床医生焦点小组 (N = 20) 一致认为 SIS 技术在放置 27G 针方面具有优势。第二阶段的目的和目标基于与监管专家（CE 标志和 FDA）和临床医生的对话，并旨在获得监管许可/批准。脊髓麻醉是区域麻醉的一种形式，涉及将药物直接注射到蛛网膜下腔。与全身麻醉相比，脊髓麻醉有许多好处，包括减少麻醉后恶心和呕吐，以及更有效地控制术后疼痛。最常见的并发症是硬脑膜穿刺后头痛 (PDPH)，这是由于故意针刺造成的硬脑膜残留孔中脑脊液渗漏所致。 PDPH 可持续数小时至数周，可能需要延长住院时间、卧床休息、药物治疗和/或可能使用血贴治疗。 2008 年，美国有 30,324 例 PDPH 病例需要延长住院时间，并导致 16,912 例脊髓血斑。 PDPH 是针对产科麻醉师提起诉讼的三大原因之一。通过使用细规格 (e 25G) 和更无损伤（非切割）的尖头针，PDPH 降低高达 65%。不幸的是，更细的无创针可能会在手术过程中弯曲、偏转，甚至断裂。重复插入和重定向会增加 PDPH 风险，原因可能是：a) 难以感觉到薄硬脑膜鞘中的“弹出”声，b) 确认脑脊液接触所需的时间。我们需要一种装置，通过允许细规格 (27G) 无创伤针顺利、准确地插入并尽早确认进入蛛网膜下腔，从而改善脊椎麻醉效果。 SIS 解决了这些临床缺陷。 SIS 将在猪模型中的 91/96 (95%) 插入中在 CSF 闪回之前检测针中的 CSF 流量，通过 =0.05 的“比例”假设检验证实了 95% 的比率。此外，SIS 对于 10 名人类患者中的 10 名进行 27G 无创伤脊柱针插入是安全有效的。目标：1) 最终优化和验证脑脊液和骨接触的传感电子器件，并预先验证 SIS 设计（AMI，第 1-12 期），2) 展示活体动物模型的安全性和有效性（AMI/HMC，第 13-16 期），3) 生产 SIS Beta 原型进行验证和验证（AMI，第 14-18 期），4) 试点人体临床评估（AMI/HMC，第 14-18 期）莫。 18-24）。