Smart sensor for guiding safe delivery of anesthetic and pain drugs through epidurals

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Project Summary/Abstract Physical Sciences Inc. (PSI), in collaboration with anesthesiologists from Beth Israel Deaconess (BID) Hospital and Brigham and Women’s Hospital (BWH), who will act as consultants in Phase I and clinical investigators in Phase II, proposes to develop a novel approach for guiding safer delivery of pain and/or anesthetic drugs during epidural procedures (EPs). Epidural injections are typically used to treat pain from herniated discs, spinal stenosis, chemical discs, chronic pain secondary to post-cervical surgery syndrome, and chronic neck pain of discogenic origin. They are also regularly used to alleviate pain related to birth. However, when not properly performed, the epidural injections can have negative side effects, such as severe headache, infection, and even nerve damage. Serious side effects may also occur, including stroke, paralysis, or loss of vision. A new technology based on a novel optical sensing technique is proposed to assess tissue composition and optimize the force applied to the needle to guide its safe insertion into the epidural space, while the monitoring of the pulsatile pressure in the epidermal space is proposed for evaluating proper positioning of the drug delivery catheter. The Phase I effort will focus on development of a laboratory prototype that will be initially tested and optimized ex vivo on animal tissue specimens, and then preliminarily evaluating its efficacy in vivo in swine. Based on the Phase I findings, the technology will be further improved during Phase II and validated on humans at BWH.