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

DESCRIPTION provided by applicant In this NIH SBIR Phase II Actuated Medical Inc will finalize and clinically test the andquot Active Fine Gauge Spinal Needle with CSF Sensing to Minimize PDPH and Dura Damage andquot 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 G traumatic needles during insertion Tip penetration into the subarachnoid space with cerebrospinal fluid CSF flow was electronically detectable times faster compared to visual flashback Clinician focus groups N agreed that the SIS technology would be advantageous in placing G 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 in the U S PDPH cases resulted in extended hospital visits and spinal blood patches PDPH is one of the Top Three reasons for litigation against obstetric anesthesiologists PDPH is reduced up to by using fine gauge e G 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 andapos popandapos 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 G 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 insertions in porcine model rate of confirmed with a andapos one proportionandapos hypothesis test with Additionally SIS will be safe and effective for G atraumatic spinal needle insertions in of human patients Aims Final Optimization and Verification of Sensing Electronics for CSF and Bone Contact and Pre validate SIS Design AMI Mo Demonstrate Safety and Effectiveness in Live Animal Model AMI HMC Mo Verification and Validation with Production of SIS Beta Prototype AMI Mo Pilot Human Clinical Evaluation AMI HMC Mo PUBLIC HEALTH RELEVANCE In this Phase II NIH SBIR Actuated Medical Inc will finalize and clinically test the andquot Active Fine Gauge Spinal Needle with CSF Sensing to Minimize PDPH and Dura Damage andquot The Smooth Insertion Spinal system uses closed loop control of a vibrating needle to reduce buckling in fine gauge spinal needles which are extremely challenging to insert The use of finer gauge needles reduces post dural puncture headache PDPH due to the smaller hole made in the spinal sheath Flow of cerebrospinal fluid CSF into the needle tip is electronically detected providing immediate confirmation of successful needle placement The need for regional anesthesia including spinal anesthesia is projected to increase due to an aging population obesity and the desire to avoid narcotics particularly in patients with sleep apnea