LIFE, Low Insertion Force Epidural to Reduce Insertion Force

DESCRIPTION (provided by applicant): This Phase I NIH SBIR, will design and demonstrate the Low Insertion Force Epidural (LIFE) insertion tool. Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly into the epidural spa ce and is used in 2.4 million births every year in the U.S. alone. A needle is placed within the epidural space, through which a catheter is usually passed. Local anesthetics are injected into the epidural space causing temporary loss of sensation and pain by blocking the transmission of pain signals through nerves in or near the spinal cord. The procedure can be unpleasant to the patient because of the high force levels required to penetrate the supraspinous ligament, interspinous ligament and ligamentum f lavum. One of the most common complications is an accidental dural puncture. The epidural space is only a few millimeters deep and provides comparatively little resistance to the needle. A cerebrospinal fluid to leak into the epidural space results can cause a post dural puncture headache. Headaches can be severe and last from weeks to years. Significant leakage can cause enough intracranial hypotension as to tear veins causing a subdural hematoma, and can cause traction injuries to the cranial nerve s resulting in tinnitus, hearing loss, dizziness, facial droop, or double vision. The LIFE device will enable the clinician a more controlled entry into the epidural space eliminating the over-shooting that often punctures the Dura accidentally from the cu rrent high force required. The device will utilize an innovative sharps motion control technology with lightweight, low-cost piezoelectric transducers. Phase I Specific Aims are: 1) Design and build a prototype LIFE epidural insertion tool, including piezo electric elements and motion constraint to minimize heating that can reduce force required to penetrate muscle by 75% with less than 5xC temperature rise. 2) Perform preliminary tests to optimize design for muscle penetration, balance, and ease of use, and build second-generation prototype. 3) Evaluate the LIFE concept prototype with clinical experts in regional anesthesiology to determine clinical value and approach for Phase II program. These aims will test the hypothesis that a commercially viable reduction in force tool can be developed to aid penetrating the ligamentum flavum for epidural insertion. The long-term objective of this work is to commercialize the catheter tool via a large medical OEM partner. Based on the numbers above, for th e global market, roughly 5 million epidural kits are sold annually. The LIFE device should be able to take 10% of the market, due to ease of use and reduction of patient complications. PRII will develop and set up a manufacturing operation to produce the L IFE device. PUBLIC HEALTH RELEVANCE: Epidural anesthesia is used in 2.4 million births every year in the U.S. One of the most common complications is an accidental dural puncture. A cerebrospinal fluid to leak into the epidural space results, which can cau se a post dural puncture headache and other painful complications. Development of low force epidural insertion tool will provide clinicians with a new technique to reduce the risk of dural puncture and other epidural complications.