Author + information
- Rex Teeslink1
EnSite Medical has designed a large bore closure device, SiteSeal, simulating external compression,removing associated variables, leaving nothing behind.
SiteSeal utilizes a number 2 Vicryl suture making Z stitch, holding SiteSeal device in place, closing the arteriotomy site in a linear fashion. Z stitch is placed by entering soft tissue at skin insertion site of sheath. First entrance is 1cm east of sheath, passing under sheath exiting 1 cm west of sheath. The second entrance is 1cm above skin insertion of sheath and 1cm to east. Needle crosses up and over sheath back down into soft tissue exiting 1 cm west of sheath. The two ends of Z stitch form a double half know, which when closed, creates a “X” over arteriotomy site. Bioseal powder is placed around sheath and half knot. The device is cocked by turning cross bar horizontally, applying pressure, which loads springs. It is centered over sheath at arteriotomy site with incline plane facing north. The dilator is removed from sheath. The two suture ends are pulled tight against sheath as pressure is applied to device, closing Z stitch into an “X” over arteriotomy site, and sheath is removed. Suture ends are pulled up through designed slots and tied into notched slot of cross bar. Loaded springs are released by turning cross bar back to vertical position. Once device is activated, pressure created by the Z stitch continues to elevate artery and folds in soft tissues surrounding arteriotomy site, closing site in a linear fashion. Roof is placed. Tegaderm is applied for stabilization.
45 EVAR and 23 Impella procedures have been performed without any hematoma formation at discharge, 24 hours, 7day and 30 day follow up.
SiteSeal will close large bore sheaths with a single device, leaving nothing behind. Associated advantages are: not limited by sheath size, including EVAR, TEVAR, TAVAR no patient limitation: size, anti-coagulation, calcification, etc. simple and rapid deployment allows immediate re-access minimizes patient discomfort, allowing immediate head elevation to 30° with no restriction to leg movement early ambulation nothing left behind…the potential of minimal risk of vessel wall injury, infection, or embolization
ENDOVASCULAR: Peripheral Vascular Disease and Intervention