Guidewire introducer sheath

#The present invention relates to systems and methods for positioning guidewires in a body lumen, and to catheter systems for delivering stents.

#A type of endoprosthesis device, commonly referred to as a stent, may be placed or implanted within a vein, artery or other tubular body organ for treating occlusions, stenoses, or aneurysms of a vessel by reinforcing the wall of the vessel or by expanding the vessel. Stents have been used to treat dissections in blood vessel walls caused by balloon angioplasty of the coronary arteries as well as peripheral arteries and to improve angioplasty results by preventing elastic recoil and remodeling of the vessel wall. Two randomized multicenter trials have recently shown a lower restenosis rate in stent treated coronary arteries compared with balloon angioplasty alone (Serruys, P W et al., New England Journal of Medicine 331: 489-495 (1994) and Fischman, D L et al. New England Journal of Medicine 331:496-501 (1994)). Stents have been successfully implanted in the urinary tract, the bile duct, the esophagus and the tracheo-bronchial tree to reinforce those body organs, as well as implanted into the neurovascular, peripheral vascular, coronary, cardiac, and renal systems, among others. The term “stent” as used in this Application is a device which is intraluminally implanted within bodily vessels to reinforce collapsing, dissected, partially occluded, weakened, diseased or abnormally dilated or small segments of a vessel wall.

#One of the drawbacks of conventional stents is that they are generally produced in a straight tubular configuration. The use of such stents to treat diseased vessels at or near a bifurcation (branch point) of a vessel may create a risk of compromising the degree of patency of the main vessel and/or its branches, or the bifurcation point and also limits the ability to insert a branch stent into the side branch if the result of treatment of the main, or main, vessel is suboptimal. Suboptimal results may occur as a result of several mechanisms, such as displacing diseased tissue, plaque shifting, vessel spasm, dissection with or without intimal flaps, thrombosis, and embolism.

#FIG. 1A is an illustration of a dual lumen guidewire introducer;

#FIG. 1B is an illustration of an alternative embodiment of a dual lumen guidewire introducer according to the present invention;

#FIG. 2 is a sectional view of the system of FIG. 1A, taken along line 2—2;

#The present invention provides a dual lumen guidewire introducer and methods of use for the dual lumen guidewire introducer for introducing guidewires into main and branch vessels at a vessel bifurcation. As such, the present invention enables the positioning of guidewires such that main and branch stents can be deployed in the vessel bifurcation after the guidewire introducer has been removed. Alternatively, a main stent can be positioned such that a side opening in the stent is positioned in registry with the ostium of a branch vessel.

#Referring first to FIGS. 1 and 2, a guidewire introducer 10 is provided. Guidewire introducer 10 has two lumens 12 and 14 passing therethrough. As can be seen, lumen 12 has a distal end opening 13 which is preferably disposed at the distal end of the introducer. Lumen 14 has a distal end opening 15 which is preferably disposed at a location some distance from the distal end of the introducer.

#As will be explained in conjunction with the preferred method, a first guidewire 25 is received through lumen 12 and a second guidewire 27 is received through lumen 14.