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

描述(由申请人提供)：在NIH SBIR第二阶段，Actuated Medical，Inc.将完成并临床测试“带有脑脊液传感的主动式细针，以最大限度地减少PDPH和硬脑膜损害。”第一阶段实现了所有特定目标，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，脑脊液(CSF)血流的尖端穿透蛛网膜下腔的电子检测速度快4倍。临床医生焦点小组(N=20)一致认为，SIS技术在放置27G针方面将是有利的。第二阶段的目的和目标基于与监管专家(CE Mark和FDA)和临床医生的对话，并旨在获得监管部门的批准/批准。脊麻是区域麻醉的一种形式，直接向蛛网膜下腔注射药物。与全身麻醉相比，脊麻有许多优点，包括减少麻醉后的恶心和呕吐，以及更有效的术后疼痛控制。最常见的并发症是硬脑膜穿刺术后头痛(PDPH)，这是由于故意针刺导致脑脊液从硬脑膜残留孔渗漏而引起的。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/或可能的血贴治疗。2008年，在美国，30,324例PDPH病例导致延长了医院就诊时间和16,912个脊椎血块。PDPH是对产科麻醉师提起诉讼的前三大原因之一。通过使用细针(E 25g)和更无损伤(非切割)的针尖，PDPH可降低高达65%。不幸的是，在手术过程中，细微的非创伤性针可能会弯曲、偏转，甚至断裂。重复插入和重定向会增加PDPH的风险，其原因可能是a)难以感觉到‘Pop’进入薄薄的硬脑膜鞘，以及b)确认脑脊液接触所需的时间。需要一种装置，通过允许细长(27G)无创针平稳而准确地插入，并及早确认进入蛛网膜下腔，从而改善脊柱麻醉结果。SIS解决了这些临床上的不足。在猪模型中，SIS将在脑脊液闪回之前检测到针头中的脑脊液流动，91/96(95%)的插入率为95%，经=0.05的‘一比例’假设检验证实。此外，对于10名人类患者中的10名患者，SIS将安全有效地进行27G无创性脊椎穿刺术。目标：1)最终优化和验证脑脊液和骨接触的传感电子设备，并预验证SIS设计(密苏里州急性心肌梗塞)。1-12)，2)在活体动物模型(密苏里州AMI/HMC)中展示安全性和有效性。13-16)，3)通过生产SIS Beta原型进行验证和确认(AMI Mo.14-18)，4)试点人类临床评估(AMI/HMC，密苏里州18-24)。

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).