SBIR Phase II: Tactile sensing for spinal-needle placements

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是支持急诊医学、神经病学和麻醉学对低成本、非辐射设备的需求，这种设备可以准确、高效和直观地在脊柱中放置针头。通过减少所需的注射次数，该装置减少了患者的疼痛，并发症的数量，并减少了放射治疗的需要。该设备还可以作为一种培训工具来提高医生的技能和对腰椎穿刺的熟悉程度，从而减少错误。虽然目前提出的设备仅限于在腰椎区域使用，但未来的版本将扩展到患者脊柱的其他区域，极大地影响疼痛治疗的注射。在未来，该设备还可以为其他临床程序（如关节注射）中当前的盲技术提供成像选择。这个小企业创新研究二期项目将扩展第一个设备的功能。一个原型装置已被证明可以提高腰椎穿刺的准确性和效率。然而，根据临床医生的需要，功能将进一步扩展如下：第一个目标是通过在导针器上添加完整的针插入和横向调节功能来增加外部针位跟踪。将开发跟踪机制来检测和显示针在图像上的位置。这些改进将由临床医生在台架模型上进行测试，并与以前的设备进行比较。第二个目标是对图像进行特征检测。医生的反馈将推动必要特征的选择，适当的算法将被开发以突出图像上的特征。该项目将在现有数据上测试算法，然后将其纳入bench模型。第三个目标包括一个外部数字压力传感机制，提醒使用者针头进入硬膜外空间，以防止意外刺穿硬膜外层引起的并发症。这种设计的准确性将由临床医生在实验台上进行测试。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.