New Access Kit for Lymphatic Interventions

摘要 尽管淋巴系统(LS)在生理上很重要，但它一直是最被忽视的部分 这主要是因为缺乏强有力的成像和介入方法。传统踏板 淋巴管造影术(PL；即直接插入淋巴管)具有显著的技术、时间、成本和 图像质量挑战。最近，淋巴成像和介入领域由于 结内淋巴管造影术(IL)和胸导管栓塞术(TDE)的进展。IL是作为一种 技术简单，可替代踏板淋巴管造影术。IL是通过用一种 脊椎穿刺针使用超声波引导。它提供了优于PL的成像，现在是领先的方法 全球淋巴系统成像的最新进展。尽管IL技术比PL有许多优势，但在 仍然存在问题，因为脊椎针不是专门为这种应用而设计的。的限制 IL包括：1)由于淋巴结内移动性的原因，难以将针插入淋巴结内 皮下组织松动；2)难以将针准确定位在LN的中央部分；3)缺乏 在介入和病人转移过程中，LN中针的稳定机制。上一期的结果 针头频繁移位，严重影响成像质量，降低成功率 淋巴系统的程序。TDE是一种用于治疗肺淋巴管的微创技术。 精神错乱。在TDE中，经腹使用一根长的21-22G针即可进入TD。类似 对于上面列出的IL问题，该针不是专门为TD干预而设计的，并导致 以下缺点：1)针不够锋利，不能穿过顺应性组织的长路线； 针头刚性不够，针尖难以精确控制；3)针尖锋利 接触TD的通道使操作TD中的电线变得困难，从而导致频繁的剪切；以及4) 针头长度的选择非常有限。淋巴成像和TD介入都很耗时 而且在技术上具有挑战性，仍然是检测和治疗淋巴疾病的主要障碍。 因此，创新的LS通路工具对淋巴介入治疗的进展至关重要。世界银行的目标是 建议确定新型LN和TD针在猪体内的安全性和有效性 上述问题。一种创新的淋巴专用工具包比现有的访问工具包具有优势，后者是 我们的初步数据表明。由于其访问LS的简单性、安全性和有效性，我们的新 工具包将具有广泛的实用价值，使诊断和治疗在LS中得到更广泛的使用。这个特别的 设计新颖的工具包将大大提高淋巴成像和介入的成功率，增强 通过提高效率和疗效，提高患者舒适度，提高医生效率，降低医疗成本。

SUMMARY Despite the physiologic importance of the lymphatic system (LS), it has been arguably the most neglected part of circulatory system, primarily because of a lack of robust imaging and interventional methods. Traditional pedal lymphangiography (PL; i.e., direct cannulation of the lymphatic vessels), has significant technical, time, cost, and image quality challenges. Recently, the field of lymphatic imaging and intervention underwent revival due to the development of intranodal lymphangiography (IL) and thoracic duct embolization (TDE). IL was developed as a technically simple alternative to pedal lymphangiography. IL is performed by accessing the lymph nodes with a spinal needle using ultrasound guidance. It provides imaging that is superior to PL and is now the leading method of imaging of the lymphatic system worldwide. Although the IL technique has many advantages over PL, there are remaining problems because a spinal needle is not designed specifically for this application. Limitations of IL include: 1) Difficulty of introducing needle into lymphatic node (LN), because of mobility of the LN within the loose subcutaneous tissue; 2) Difficulty in positioning the needle precisely in the central part of the LN; 3) Lack of a stabilization mechanism of the needle in LN during intervention and patient transfer. The last issue results in frequent dislodgement of the needle, greatly impairing the quality of the imaging and decreasing the success of the lymphatic procedures. TDE is a minimally invasive technique developed to treat the pulmonary lymphatic disorders. During TDE, the access to the TD is obtained transabdominally using a long 21-22 G needle. Similarly to the issues with IL listed above, the needle is not specially designed for TD intervention and leads to the following shortcomings: 1) The needles are not sharp enough to traverse the long route of compliant tissue; 2) The needle is not sufficiency rigid, so it is difficult to have fine control of the tip of the needle; 3) The sharp angle of access to the TD makes it difficult to manipulate the wire in the TD, resulting frequently in shearing; and 4) The choice of needle length is very limited. Lymphatic imaging and TD interventions are both time-consuming and technically challenging and remain a major hurdle to the detection and treatment of lymphatic disorders. Therefore, innovative LS access tools are critical to the progress of lymphatic intervention. The goals of the proposal are to determine the safety and effectiveness of novel LN and TD needles in vivo in swine to address the issues above. An innovative lymphatic-specific toolkit has advantages over existing access kits, which is demonstrated by our preliminary data. Due to its simplicity, safety, and effectiveness to access the LS, our new toolkit will have broad utility to enable wider use of diagnostic access and treatments in the LS. This specially designed novel toolkit will considerably improve the success of lymphatic imaging and intervention, enhance patient comfort, increase physician efficiency, and lower medical costs by improving efficiency and efficacy.