In this Phase II NIH SBIR, the Low Insertion Force Epidural (LIFE) device will be further optimized and efficacy measured on human cadavers and live porcine models. Piezo Resonance Innovations, Inc. successfully designed and demonstrated the Phase I LIFE device insertion tool in various tissue models, including trials by senior anesthesiologists. The Phase II developments will lead to a Phase III human study and commercialization in collaboration with a major medical company. With a global market of epidural kits near $219M, a device that will increase safety and comfort, enhance training, and raise penetration success rate by clinicians has commercial viability. The improvements derived from the LIFE device could allow less experienced providers, such as interventional radiologists or non-anesthesia trained pain physicians, to perform epidural procedures. Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly into the epidural space. Epidural anesthesia is used in 2.4 million births annually in the United States, in addition to a wide range of other pain-management procedures as far up the spine as the neck. The procedure can be unpleasant to the patient and difficult to perform because of the high force levels required to penetrate the supraspinous ligament, interspinous ligament and ligamentum flavum. One of the most common complications is an accidental dural puncture. If the dura is punctured accidentally, the chance for a cerebrospinal fluid leak causing a post dural puncture headache is quite high. 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 nerves resulting in tinnitus, hearing loss, dizziness, facial droop, or double vision. Over-insertion is even more dangerous for epidurals inserted in the neck. The LIFE device will enable the clinician a more controlled entry into the epidural space, eliminating the excessive force that results in 'over-shooting'and dural punctures. This Phase II project will advance a commercially viable LIFE System to aid penetrating the ligamentum flavum, while also minimizing dural puncture """"""""wet taps"""""""" during epidural insertion procedures.
Epidural anesthesia insertion is a difficult procedure, due in large part to the force required to insert a needle through tough ligament and muscle, and into the epidural space. When the needle 'pops-through'the tougher tissue into the epidural space, it is difficult to control the depth of penetration. An error in the procedure is referred to as a 'wet-tap'or dural puncture. The puncture may cause cerebrospinal fluid to leak into the epidural space, often resulting in a post dural-puncture headache and other painful complications. The development of a low force epidural insertion tool will provide clinicians with improved control to decrease pop-through and minimize dural puncture. This new technique will also enhance resident training, and with a reduction in risk, may allow less experienced providers, such as interventional radiologists or non-anesthesia trained pain physicians, to perform epidural insertion. For 2008, the global market for epidural kits is projected to be $219M.