Actuated Fine-Gauge Spinal Needle Insertion to Reduce Dura Damage and PDPH Risk

驱动细规格脊柱针插入可减少硬脑膜损伤和 PDPH 风险

• 批准号: 8394330
• 负责人: Maureen L. Mulvihill
• 金额: $ 25.39万
• 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 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8394330
• 关键词: Adverse effects; Anesthesia procedures; Anesthesiology; Animal Model; Animals; Arachnoid mater; Bed rest; Blood; Cerebrospinal Fluid; Clinical Research; Conduction Anesthesia; Critical Care; Dependence; Detection; Developing Countries; Development; Devices; Discipline of obstetrics; Distal; Doctor of Medicine; Dura Mater; Effectiveness; Electronics; Extravasation; Family suidae; Feedback; General Anesthesia; Guatemala; Hand; Headache; Health system; Healthcare Systems; Hemorrhage; Hospitalization; Hospitals; Hour; Human; Injection of therapeutic agent; Knowledge; Learning; Left; Length of Stay; Letters; Licensing; Life; Litigation; Manufacturer Name; Marketing; Medical; Medical Device; Modeling; Motion; Nausea and Vomiting; Needles; Nerve Block; Outcome; Pain; Pain management; Patients; Pharmaceutical Preparations; Phase; Post-Dural Puncture Headaches; Procedures; Puncture procedure; Residual state; Resistance; Risk; Rural Community; Rural Hospitals; Safety; Sales; Secure; Small Business Innovation Research Grant; Spinal; Spinal Anesthesia; Spinal Cord; Subarachnoid Space; Surgeon; System; Systems Integration; Technology; Testing; Tissues; Training; Transducers; United States National Institutes of Health; Vertebral column; Virginia; cerebrospinal fluid flow; cost; experience; improved; innovation; interest; programs; response; safety testing; success; tool; underserved rural area; vibration

DESCRIPTION (provided by applicant): In this NIH SBIR program, Actuated Medical, Inc. (AMI), (formerly Piezo Resonance Innovations, Inc) will develop and test the Actuated Spinal Anesthesia (SIS or 'Smooth Insertion Spinal') Needle Insertion Tool to Reduce Dural Damage and Post Dural Puncture Headache (PDPH). The system will eliminate buckling and steering difficultly in thin (27G) spinal needles and electronically sense entry into the sub-arachnoid space. 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 blood loss, decreased post-anesthesia nausea and vomiting, and better post-op pain control. The most common side effect is a debilitating PDPH, caused by leakage of cerebrospinal fluid (CSF) through a residual hole in the dura. PDPH is incapacitating to the patient and is one of the leading causes of litigation against obstetric anesthesiologists. PDPH is reduced 60 - 65% by using high gauge (25 Gauge and thinner) needles and atraumatic / non-cutting tipped needles. Unfortunately, thinner 25-27 gauge, atraumatic needles can buckle or break during the procedure. Atraumatic needles also require an unsafe level of force to insert, particular in the upper spine. An introducer can be used with these needles, but limits the ability to steer the needle without partially retracting the needle and creating another puncture, increasing the chance of PDPH. A device is needed that allows atraumatic, high-gauge (25-27G) needles to be smoothly and accurately inserted without the need for an introducer. Reduced insertion force will allow the safe and simple use of both atraumatic needles and thinner needles (27G) for spinal anesthesia. Sensing of the subarachnoid space by the SIS system will provide immediate feedback of successful needle placement. Ultimately, the SIS system will allow access to spinal anesthesia in developing nations by making the procedure simpler and safe. AMI will manufacture the device in its FDA compliant, ISO 13485-certified facility in Bellefonte, PA. AMI is in discussions with a strategic partner in the Spinal Anesthesia market for sales/marketing/distribution. Phase I Hypothesis: The SIS System will accurately and safely achieve needle placement into the subarachnoid space with a 27G atraumatic spinal needle without an introducer at a first-attempt success proportion e 0.8. Overall proportion of successful placement of a 27G needle, with SIS, is significantly higher (¿ = 0.05) than 25G standard cutting needle. Tissue damage from the 27G needle, with the SIS, is less than the tissue damage from the manually-inserted 25G. In addition, the SIS will provide automatic confirmation of entry into subarachnoid space in 5 seconds or less in 18 out of 20 attempts in a live animal model. Phase I Specific Aims: Aim 1 - Optimize SIS transducer to eliminate buckling for 27G atraumatic needle insertion. Aim 2 - Integrate electronic confirmation of subarachnoid space entry into the SIS device. Aim 3 - Demonstrate safety and effectiveness in live animal model with anesthesiologist. PUBLIC HEALTH RELEVANCE: Spinal anesthesia is a form of regional anesthesia involving injection of drugs directly into the spinal cord. The most common side effect is a debilitating headache, caused by leakage of cerebrospinal fluid (CSF) through a residual hole after injection. The risk of headaches and other complications is reduced significantly by using thinner needles. Unfortunately, thinner gauge can buckle or break during the procedure. In this NIH SBIR program, Actuated Medical, Inc. (AMI) will develop and conduct preliminary testing for safety and efficacy of the Smooth Insertion Spinal (SISTM) Needle System that reduces buckling of thin 25-27 gauge needles, and electronically senses successful needle placement. The device will also enable access to spinal anesthesia in developing nations where less-experienced clinicians are available to perform the procedure.

描述（由申请人提供）：在该NIH SBIR计划中，Actuated Medical，Inc. (AMI)，（前身为Piezo Resonance Innovations，Inc）将开发和测试用于减少硬膜损伤和硬膜穿刺后头痛（PDPH）的致动脊髓麻醉（SIS或“平滑插入脊髓”）针插入工具。该系统将消除薄（27 G）脊柱针的弯曲和转向困难，并以电子方式感知进入蛛网膜下腔。 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，脊髓麻醉具有许多优点，包括减少失血，减少麻醉后恶心和呕吐，以及更好的术后疼痛控制。最常见的副作用是使人衰弱的PDPH，由脑脊液（CSF）通过硬脑膜中的残留孔渗漏引起。PDPH使患者丧失能力，是对产科麻醉师提起诉讼的主要原因之一。PDPH是 通过使用高规格（25号和更薄）针头和无创伤/非切割针头，减少了60 - 65%。不幸的是，更薄的25-27号无创针可能在手术过程中弯曲或断裂。无创针还需要不安全的力水平来插入，特别是在上脊柱中。导引器可与这些针一起使用，但限制了 在不部分回缩针头并造成另一次穿刺的情况下操纵针头，从而增加PDPH的机会。 需要一种允许无创伤的、高规格（25- 27 G）针在不需要导引器的情况下平稳且准确地插入的装置。减小的插入力将允许安全和简单地使用无创针和更薄的针（27 G）进行脊髓麻醉。SIS系统对蛛网膜下腔的感知将提供成功置针的即时反馈。最终，SIS系统将通过使手术更简单和安全，使发展中国家能够获得脊髓麻醉。AMI将在其位于宾夕法尼亚州贝莱丰特的FDA合规、ISO 13485认证工厂生产该器械。AMI正在与脊髓麻醉的战略合作伙伴进行讨论 销售/营销/分销市场。第一阶段假设：在首次尝试成功率e 0.8的情况下，SIS系统将使用27 G无创脊椎穿刺针在不使用导引器的情况下准确安全地将穿刺针置入蛛网膜下腔。使用SIS成功置入27 G针的总体比例显著高于（<$= 0.05）25 G标准切割针。使用SIS的27 G针头造成的组织损伤小于手动插入的25 G针头造成的组织损伤。此外，SIS将在活体动物模型中的20次尝试中的18次中在5秒或更短时间内提供进入蛛网膜下腔的自动确认。第I阶段具体目标：目标1 -优化SIS探头，以消除27 G无创穿刺针插入的屈曲。目的2 -将蛛网膜下腔进入的电子确认集成到SIS设备中。目的3 -证明麻醉师在活体动物模型中的安全性和有效性。 公共卫生相关性：脊髓麻醉是一种区域麻醉形式，涉及将药物直接注射到脊髓中。最常见的副作用是使人衰弱的头痛，这是由注射后脑脊液（CSF）通过残留孔渗漏引起的。使用更细的针头可以显著降低头痛和其他并发症的风险。不幸的是，较薄的规格可能会在手术过程中弯曲或断裂。在NIH SBIR项目中，Actuated Medical，Inc. (AMI)将开发并对光滑插入脊柱（SISTM）针系统的安全性和有效性进行初步测试，该系统可减少25-27号细针的屈曲，并以电子方式感知针的成功放置。该设备还将使发展中国家能够获得脊髓麻醉，在这些国家，经验较少的临床医生可以进行手术。