Patent ID: 8728153
Filing Date: 2014-05-20
Classification: A61F,A61M

Abstract:
1. An introducer sheath adapted for access to a treatment site within the heart or major blood vessels via a transmyocardial access comprising: an axially elongate sheath tube having a proximal end, a distal end, and a lumen extending therethrough, wherein the sheath tube comprises a collapsible region and further wherein the sheath working length is sufficiently long that the sheath tube can extend from the outside of a myocardium of a patient's heart, through the myocardium, and through the cardiac chambers to a point residing within or proximate the heart, further wherein the collapsible region comprises a first, smaller cross-sectional area, and a second, larger cross-sectional area in response to dilation; a hub affixed to the proximal end of the axially elongate sheath tube, wherein the hub further comprises a hemostasis valve operably connected to the lumen extending through the sheath tube; a dilator pre-inserted through the lumen in the axially elongate sheath tube, wherein the dilator comprises a length of dilator tubing, a dilator hub comprising a balloon inflation port and a guidewire access port further comprising a hemostasis valve, and a non-compliant balloon, which is deflated and folded about the dilator tubing to form a minimum profile; and a reverse dilator, removably placeable within the lumen of the axially elongate sheath tube following expansion of the collapsible region by the dilator, wherein the reverse dilator comprises proximal and distal balloons, a reverse dilator tube further comprising inflation lumens for the proximal and distal balloons, a vacuum lumen operably connected to the region between the two balloons by vacuum ports in the reverse dilator tube, and a reverse dilator hub affixed to the proximal end of the reverse dilator further comprising ports for infusion or removal of pressurized fluid into the inflation lumens of the reverse dilator and for generating a vacuum between the proximal and distal balloons; wherein the dilator is operable to expand the sheath collapsible region from the first, smaller cross-sectional area to the second, larger cross-sectional area; and wherein the reverse dilator is configured to have its proximal and distal balloons expanded to seal against the lumen of the sheath tube such that the vacuum drawn between the proximal and distal balloons of the reverse dilator causes re-collapse of the collapsible region of the sheath from the second, larger cross-sectional area to a third, smaller cross-sectional area.