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

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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.