SBIR Phase II: Tactile sensing for spinal-needle placements

这一小型企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力是支持急诊医学、神经病学和麻醉学对低成本、无辐射设备的需求，该设备允许在脊柱中准确、高效和直观地放置针头。通过减少所需的注射尝试次数，该装置减少了患者的疼痛、并发症的数量和对辐射的需求。该装置还可以用作培训工具，以提高医生的技能和熟悉腰椎穿刺，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，但未来的版本将扩大其在患者脊柱其他区域的使用，极大地影响疼痛管理的注射。未来，该设备还可以为其他临床程序（如关节注射）中的当前盲法技术提供成像选项。这个小型企业创新研究第二阶段项目将扩展第一个设备的功能。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，为了响应临床医生的需求，该功能将进一步扩展如下：第一个目标是通过向针导向器添加完整的针插入和横向调节功能来添加外部针位置跟踪。将开发跟踪机制，以检测并在图像上显示针的位置。这些改进将由临床医生在台架模型上进行测试，并与之前的器械进行比较。第二个目标将特征检测结合到图像中。医师反馈将驱动必要特征的选择，并将开发适当算法以突出显示图像上的特征。该项目将在现有数据上测试算法，然后将其纳入实验台模型。第三个目的是采用外部数字压力传感机制，提醒用户针头进入硬膜外腔，以防止意外穿刺硬膜外层引起的并发症。该奖项反映了NSF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.