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二期研究中，Actuated Medical, Inc.将完成并临床测试“具有脑脊液传感的主动细径脊髓针，以尽量减少PDPH和硬脑膜损伤”。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27G创伤性针头在插入过程中的屈曲，为临床医生提供了更好的控制。脑脊液（CSF）流的尖端穿透蛛网膜下腔的电子检测速度是视觉闪回的4倍。临床焦点小组（N = 20）同意SIS技术在放置27G针时是有利的。II期的目的和目标是基于与监管专家（CE标志和FDA）和临床医生的对话，并以获得监管许可/批准为基础。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），这是由于故意穿刺针在硬脑膜上留下的残余孔漏出脑脊液引起的。PDPH可以持续数小时到数周，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病例导致了延长住院时间和16,912例脊髓血补。PDPH是起诉产科麻醉师的三大原因之一。通过使用细径（25G）和更多的自动（非切割）尖端针头，PDPH减少了65%。不幸的是，更精细的自动针头在手术过程中会弯曲、偏转甚至断裂。反复插入和重定向会增加PDPH的风险，这可能是由于a)难以感觉到“弹出”进入薄的硬脑膜，b)确认脑脊液接触所需的时间。需要一种能够改善脊髓麻醉结果的装置，使细径（27G）无创性针头能够顺利、准确地插入，并及早确认进入蛛网膜下腔。SIS解决了这些临床缺陷。在猪模型中，在91/96（95%）的针头插入中，SIS将检测到脑脊液在脑脊液闪回之前的脑脊液流量，95%的比率通过“一比例”假设检验（=0.05）得到证实。此外，SIS对于10名患者中的10名患者的27G无创性脊髓针插入是安全有效的。目的：1)CSF和骨接触传感电子器件的最终优化和验证以及SIS设计的预验证（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)生产SIS Beta原型的验证和验证（AMI, Mo. 14-18）， 4)试点人体临床评估（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).