SBIR Phase II: Tactile sensing for spinal-needle placements

Intuitap Medical, Inc., Chicago IL

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to support needs in emergency medicine, neurology, and anesthesiology for a low-cost, non-radiative device that allows for accurate, efficient, and intuitive placement of needles in the spine. By reducing the number of required injection attempts, the device reduces patient pain, number of complications, and the need for radiation. The device could also be employed as a training tool to improve physician skill and familiarity with lumbar punctures, thus reducing errors. While the currently proposed device is limited to use in the lumbar region, future versions will expand its use to other regions on patients’ spine, greatly impacting injections for pain management. In the future, the device can also offer an imaging option for the current blind techniques in other clinical procedures such as joint injections. This Small Business Innovation Research Phase II project will expand functionality of the first device. A prototype device has been shown to improve the accuracy and efficiency of lumbar punctures. However, in response to clinician needs, the functionality will further be expanded as follows: The first objective adds external needle position tracking by adding full needle insertion and lateral adjustment functionalities to the needle guide. Tracking mechanisms will be developed to detect and display the needle’s position on the image. These modifications will be tested on a bench model by clinicians and compared to the previous device. The second objective incorporates feature detection into the image. Physician feedback will drive the selection of necessary features and propriety algorithms will be developed to highlight the features on the image. This project will test algorithms on existing data and then incorporated into a bench model. The third objective incorporates an external digital pressure sensing mechanism to alert the user of entry of needle into epidural space to prevent complications from inadvertent punctures beyond the epidural layer. The accuracy of this design will then be tested by clinicians on a bench model. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.