New Access Kit for Lymphatic Interventions

总结 尽管淋巴系统（LS）的生理重要性，它一直被认为是最被忽视的部分 这主要是因为缺乏强大的成像和介入方法。传统踏板 淋巴管造影术（PL;即，淋巴管的直接插管）具有显著的技术、时间、成本，并且 图像质量的挑战。最近，淋巴成像和干预领域经历了复苏，由于 结内淋巴管造影（IL）和胸导管栓塞（TDE）的发展。IL是作为一种 技术上简单的替代足部淋巴管造影术。IL是通过用一个淋巴结进入淋巴结来进行的。 使用超声引导的脊椎穿刺针。它提供了比PL更上级的成像，现在是领先的方法 淋巴系统成像的最大成就。虽然IL技术比PL具有许多优点， 因为脊椎穿刺针不是专门为此应用而设计的。局限性 IL包括：1）由于LN在淋巴结内的移动性，难以将针引入淋巴结（LN）。 松散的皮下组织; 2）难以将针精确定位在LN的中心部分; 3）缺乏 在介入和患者转移期间，LN中的针的稳定机制。最后一期结果 在针的频繁移位中，极大地损害了成像质量并降低了成功率 淋巴程序的一部分TDE是一种微创技术，用于治疗肺淋巴结转移， 紊乱在TDE过程中，使用21-22 G长针经腹进入TD。类似地 对于上面列出的IL问题，针不是专门为TD干预设计的， 以下缺点：1）针不够锋利，不能穿过顺应性组织的长路径; 2） 针的刚性不够，难以对针尖进行精细控制; 3）锐角 难以接近TD使得难以操纵TD中的线材，导致频繁剪切;以及4） 针头长度的选择非常有限。淋巴成像和TD干预都很耗时 并且在技术上具有挑战性，并且仍然是淋巴疾病检测和治疗的主要障碍。 因此，创新的LS入路工具对于淋巴介入的进展至关重要。的目标 建议是确定新型LN和TD针在猪体内的安全性和有效性，以解决 上面的问题。一个创新的特定于医疗器械的工具包比现有的访问工具包有优势， 我们的初步数据显示。由于其简单，安全，有效地访问LS，我们的新 该工具包将具有广泛的实用性，能够在LS中更广泛地使用诊断访问和治疗。这种特殊 设计的新型工具包将大大提高淋巴成像和干预的成功率， 患者舒适度，提高医生效率，并通过提高效率和功效降低医疗成本。

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.