In this NIH Phase IIB Competing Renewal SBIR project, Actuated Medical, Inc. will finalize and clinically test the Low Insertion Force Epidural (LIFE), Actuated Needle Insertion System for Enhanced Control and Tactile Feel. LIFE uses closed-loop control of a vibrating needle to provide the clinician a more controlled entry through tough muscle and tissue, while improving tactile feel. Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly into the epidural space just outside the spinal cord. Epidural anesthesia is used in 2.49M births every year in the U.S. Single shot epidurals, routinely given for pain management in the lower back and legs, account for another ~5.2M epidural procedures in the Medicare population alone. Epidural procedures require significant clinician expertise for accurate and safe medication delivery, due in part to the complexity of anatomy and variety of tissue planes the needle must traverse before reaching the dura. The major complication from epidural anesthesia is overshooting the epidural space and puncturing the dural sheath. Since epidural procedures are `by feel' and human anatomies vary, it is difficult for the clinician to anticipate the exact plane in which the tissue resistance will chang. The overshoot can occur when the force applied to the needle while traversing from hard tissue density (high resistance - e.g., ligamentum flavum) into the soft tissue density (low resistance - e.g., dura sheath) leads to needle acceleration. This needle acceleration causes accidental dural punctures in ~6% of epidural needle insertions. Approximately 86% of dural punctures result in a Post Dural Puncture Headaches (PDPH), leading to an average increase of 17 hours in the hospital - and in 72% of cases, an epidural blood patch is given. Longer-term complications include temporary or permanent cranial nerve injuries, subdural hematoma, infection, inability to perform activities of daily living and missed work. PDPH is also the third highest reason for litigation in anesthesiology with an estimated $130M in settlements annually in obstetrics alone. The controlled insertion force and velocity through tissue provided by LIFE allows an increased ability to focus on tactile feel, resulting in smooth tissue transitions - minimizing the complications of PDPH and associated cost in epidural anesthesia. Phase IIB Hypothesis: LIFE improves procedural safety and effectiveness. LIFE procedures result in a clinically significant reduction in complication rate and a clinically significant reduction in onst time of sensory anesthesia. Hypotheses to be tested with a=0.05, =0.20.
Specific Aims :
Aim 1 Electronic Shut-off Development Validated with Safety and Clinical Bench Testing, Early Feasibility Clinical Study.
Aim 2 Design Verification and Validation Testing.
Aim 3 Pivotal Clinical Trial.
In this Phase IIB Competing Renewal NIH SBIR, Actuated Medical, Inc. will finalize and clinically test the Low Insertion Force Epidural (LIFE), Actuated Needle Insertion System for Enhanced Control and Tactile Feel. Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly into the epidural space just outside the spinal cord. The LIFE system uses closed-loop control of a vibrating needle to provide the clinician a more controlled entry through tough muscle and tissue, while improving tactile feel for epidural anesthesia - reducing the risk of injury to the dural sheath around the spine. The need for regional anesthesia is projected to increase due to an aging population, obesity, and the desire to avoid narcotics, particularly in patients with sleep apnea.