Gage Shawn M, Lawson Michael, Nichols Craig, Sycks Dalton, Manson Roberto J, Knight Joseph A
InnAVasc Medical, Inc., Durham, NC, USA.
Duke University, Durham, NC, USA.
J Vasc Access. 2020 May;21(3):328-335. doi: 10.1177/1129729819874987. Epub 2019 Sep 16.
No technology has been specifically developed with the intent to reduce needle-related vascular access injuries; a significant source of complications and abandonment. We present the initial pre-clinical study results of a novel, self-sealing, immediate cannulation dialysis graft that aims to prevent needle-related complications; to promote safe, reliable needle access; to reduce catheter use; and could facilitate home hemodialyisis.
The innovative graft design consists of two cannulation chambers with self-sealing properties and materials that prevent side and back wall needle puncture. Study and control grafts (expanded polytetrafluoroethylene) were implanted in one pig and 10 sheep in two studies over the course of 1 year. First cannulation occurred immediately post implant for all study grafts. Post-cannulation time to hemostasis, hematoma and seroma formation, infection, and patency were recorded.
The two studies account for nearly 60 weeks (average 6.4 weeks/graft) of study graft follow-up. In the ovine study, average study graft time to hemostasis was 27.3 s (standard deviation = 26.3, range = 0-120), and the control averaged 177.2 s (standard deviation = 113.4, range = 60-600), p < 0.0001. Secondary patency was 75% and 67% for the study and control grafts, respectively. Neither study nor control groups experienced seroma, graft infections, or deaths.
All novel grafts in the studies were implanted successfully and functioned as intended. There were no complications related to tunneling of the study graft and the chamber prevented back/side wall needle injury. This novel technology may help to mitigate these needle-related complications, while allowing for early/immediate cannulation which could also reduce catheter contact time.
目前尚未专门研发出旨在减少与针头相关的血管通路损伤的技术，而这种损伤是并发症和通路废弃的一个重要来源。我们展示了一种新型自密封即时插管透析移植物的初步临床前研究结果，该移植物旨在预防与针头相关的并发症，促进安全、可靠的针头通路，减少导管使用，并有助于家庭血液透析。
这种创新的移植物设计包括两个具有自密封特性的插管腔以及防止侧壁和后壁被针头穿刺的材料。在为期1年的两项研究中，将研究移植物和对照移植物（膨体聚四氟乙烯）分别植入1头猪和10只绵羊体内。所有研究移植物在植入后立即进行首次插管。记录插管后止血时间、血肿和血清肿形成情况、感染情况以及通畅情况。
两项研究对研究移植物的随访时间总计近60周（平均每个移植物6.4周）。在绵羊研究中，研究移植物的平均止血时间为27.3秒（标准差=26.3，范围=0 - 120），而对照移植物的平均止血时间为177.2秒（标准差=113.4，范围=60 - 600），p<0.0001。研究移植物和对照移植物的二级通畅率分别为75%和67%。研究组和对照组均未出现血清肿、移植物感染或死亡情况。
研究中的所有新型移植物均成功植入并按预期发挥功能。未出现与研究移植物隧道相关的并发症，且该腔室可防止后壁/侧壁被针头损伤。这项新技术可能有助于减轻这些与针头相关的并发症，同时允许早期/即时插管，这也可以减少导管接触时间。
