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

描述（由申请人提供）：在本NIH SBIR II期中，Actuated Medical，Inc.将最终确定并临床测试“带CSF传感功能的活动式细规格脊柱穿刺针，以最大限度地减少PDPH和硬膜损伤。“第一阶段实现了所有特定目标，并证明了平滑插入脊柱（SIS）系统通过减少插入过程中27 G创伤性针的屈曲，为临床医生提供了更好的控制。与视觉闪回相比，通过电子检测头端穿透蛛网膜下腔并伴有脑脊液（CSF）流的速度快4倍。临床医生焦点小组（N = 20）一致认为SIS技术在放置27 G针头方面具有优势。第II阶段的目的和目标基于与监管专家（CE认证和FDA）和临床医生的对话，并旨在获得监管许可/批准。脊髓麻醉是一种区域麻醉的形式，涉及将药物直接注射到蛛网膜下腔。与全身麻醉相比，脊髓麻醉提供了许多益处，包括减少麻醉后恶心和呕吐，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后头痛（PDPH），这是由于故意针刺留下的硬脑膜残留孔导致CSF泄漏。PDPH可持续数小时至数周，并可能需要延长住院时间，卧床休息，药物治疗和/或可能的血液贴片治疗。2008年，在美国，30，324例PDPH病例导致住院时间延长和16，912例脊柱血液补片。PDPH是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 25 G）和更无创伤（非切割）的针头，PDPH减少了65%。不幸的是，更细的无创针可能在手术过程中弯曲、偏转甚至断裂。重复插入和重新定向会增加PDPH风险，这可能是由于a）难以感觉到"弹出“到薄硬脑膜鞘中，以及B）确认CSF接触所需的时间。需要一种器械，通过允许细规格（27 G）无创针顺利准确插入并提前确认进入蛛网膜下腔，从而改善脊髓麻醉效果。SIS解决了这些临床缺陷。SIS将在猪模型中的91/96（95%）次插入中检测到CSF闪回前针头中的CSF流量，通过=0.05的“单比例”假设检验证实了95%的比率。此外，SIS对于10/10例人类患者的27 G无创脊椎穿刺针插入安全有效。目的：1）用于CSF和骨接触的传感电子器件的最终优化和验证以及SIS设计的预确认（AMI，Mo. 1-12），2）在活体动物模型中证明安全性和有效性（AMI/HMC，Mo. 13-16），3）SIS Beta原型生产的验证和确认（AMI Mo. 14-18），4）初步人体临床评价（AMI/HMC，Mo. 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).