This application is related to subject matter disclosed in:
U.S. Pat. No. 6,319,278 entitled “Low profile device for the treatment of vascular abnormalities” issued Nov. 20, 2001 in the name of Stephen F. Quinn, said patent being hereby incorporated by reference as if fully set forth herein;
U.S. non-provisional application Ser. No. 10/277,641 entitled “Bifurcated side-access intravascular stent graft” filed Oct. 22, 2002 in the name of Stephen F. Quinn, said application being hereby incorporated by reference as if fully set forth herein;
U.S. non-provisional application Ser. No. 09/734,987 entitled “Bifurcated side-access intravascular stent graft” filed Dec. 11, 2000 in the name of Stephen F. Quinn (now U.S. Pat. No. 6,645,242), said application being hereby incorporated by reference as if fully set forth herein; and
Stephen F. Quinn MD et al, “Percutaneous Placement of a Low-profile Stent-Graft Device for Aortic Dissections”, J. Vasc. Interv. Radiol., Vol. 13(8) pp. 791–798 (August 2002).
This application is also related to subject matter disclosed in:
U.S. Pat. No. 5,282,824 entitled “Percutaneous stent assembly” issued Feb. 1, 1994 to Gianturco;
U.S. Pat. No. 5,316,023 entitled “Method for bilateral intra-aortic bypass” issued May 31, 1994 to Palmaz et al;
U.S. Pat. No. 5,443,496 entitled “Intravascular radially expandable stent” issued Aug. 22, 1995 to Schwartz et al;
U.S. Pat. No. 5,562,697 entitled “Self-expanding stent assembly and methods for the manufacture thereof” issued Oct. 8, 1996 to Christiansen;
U.S. Pat. No. 5,571,170 entitled “Method and apparatus for bilateral intra-aortic bypass” issued Nov. 5, 1996 to Palmaz et al;
U.S. Pat. No. 5,591,195 entitled “Apparatus and method for engrafting a blood vessel” issued Jan. 7, 1997 to Taheri et al;
U.S. Pat. No. 5,628,787 entitled “Clad composite stent” issued May 13, 1997 to Mayer;
U.S. Pat. No. 5,693,084 entitled “Expandable transluminal graft prosthesis for repair of aneurysm” issued Dec. 2, 1997 to Chuter;
U.S. Pat. No. 5,755,778 entitled “Anastomosis device” issued May 26, 1998 to Kleshinski;
U.S. Pat. No. 5,824,040 entitled “Endoluminal prostheses and therapies for highly variable body lumens” issued Oct. 20, 1998 to Cox et al;
U.S. Pat. No. 5,851,228 entitled “Implantable intraluminal prosthesis” issued Dec. 22, 1998 to Pinheiro;
U.S. Pat. No. 5,855,598 entitled “Expandable supportive branched endoluminal grafts” issued Jan. 5, 1999 to Pinchuk;
U.S. Pat. No. 5,893,887 entitled “Stent for positioning at junction of bifurcated blood vessel and method of making” issued Apr. 13, 1999 to Jayaraman;
U.S. Pat. No. 5,906,641 entitled “Bifurcated stent graft” issued May 25, 1999 to Thompson et al;
U.S. Pat. No. 5,957,974 entitled “Stent graft with braided polymeric sleeve” issued Sep. 28, 1999 to Thompson et al;
U.S. Pat. No. 5,972,023 entitled “Implantation device for an aortic graft method of treating aortic aneurysm” issued Oct. 26, 1999 to Tanner et al;
U.S. Pat. No. 6,093,203 entitled “Stent or graft support structure for treating bifurcated vessels having different diameter portions and methods of use and implantation” issued Jul. 25, 2000 to Uflacker;
U.S. Pat. No. 6,129,756 entitled “Biluminal endovascualr graft system” issued Oct. 10, 2000 to Kugler et al;
U.S. Pat. No. 6,210,429 entitled “Extendible stent apparatus” issued Apr. 3, 2001 to Vardi et al;
U.S. Pat. No. 6,344,056 entitled “Vascular grafts for bridging a vessel side branch” issued Feb. 5, 2002 to Dehdashtian;
U.S. Pat. No. 6,355,056 entitled “Implantable intraluminal prosthesis” issued Mar. 12, 2002 to Pinheiro;
Shoiji Sakaguchi MD et al, “Twin-tube Endografts for Aortic Aneurysms: An Experimental Feasibility Study”, J. Vasc. Interv. Radiol., Vol. 10(8) pp. 1092–1098 (1999).
In many instances of vascular disease, a damaged, weakened, and/or enlarged portion of a blood vessel must be protected from intravascular fluid pressure. Continued exposure to such fluid pressure may result in progression of damage to the affected area and/or vessel failure, accompanied by significant morbidity or even sudden death. A well-established technique for treating such vascular damage is the use of transluminal stent grafts, many different types of which are described in the above-cited references. Stent grafts are typically introduced into intravascular space at an introduction site remote from the repair site, moved through the vascular system to the repair site, and then deployed. In this way vessels may be repaired at sites deep within the body via an introduction site that is more readily accessible, i.e., through a vessel near the body surface, thereby avoiding a major surgical procedure. In many cases access to the intravascular space at the introduction site may be established percutaneously, while in other cases access to the vessel at the introduction site must be established surgically. Primary factors determining whether such remote access may be employed are: the cross sectional sizes of the vessels to be navigated between the introduction site and the repair site relative to the cross sectional sizes of the stent graft and any necessary deployment hardware; and the tortuousness of the vessels to be navigated between the introduction site and the repair site relative to the flexibility and maneuverability of the stent graft and any necessary deployment hardware.
Briefly, a stent graft comprises two major components, a stent and a graft. The stent (one or more) typically takes the form of a somewhat stiff tube-like structure, often comprising perforated or mesh material, inserted into an affected vessel and fixed in place. The stent may serve to maintain a patent vessel lumen, may serve as structural support for the vessel, and/or may serve as an attachment/seal for a graft. A graft typically takes the form of a flexible tube or sleeve which is at least somewhat fluid-tight (although varying degrees of permeability may be desirable for a variety of reasons). When secured within a vessel using stent(s) (a single stent the length of the graft, a pair of stent segments at the ends of the graft, multiple stent segments spaced along the length of the graft, or other suitable arrangement), the graft becomes a surrogate vessel-within-a-vessel, and bears the brunt of the intravascular fluid pressure. It has become common practice to bridge damaged vessel segment using a sufficiently long graft secured within the vessel with one or more stent segment(s).
Difficulties may arise when vessel damage occurs near a vessel branch point. More elaborate, multi-component devices are required to both shield the damaged vessel portion while maintaining blood flow through the main and branch vessels, as described in several of the above-cited references. Further difficulties may arise in areas where multiple branch points lie near one another. Difficulties may arise in accurately securing the stent graft at a particular vessel location, particularly in the vicinity of one or more branch points. Difficulties may arise if the cross-sectional size of the stent graft (and the necessary deployment hardware) is too large and/or too stiff for ready introduction into and navigation through the vascular system, delivery to the repair site, and/or deployment at the repair site. Under the latter conditions, surgical access to the intravascular introduction site may be required, surgical access to the repair site may be required, or deployment of the stent graft may be ruled out entirely. It is often the case that the cross sectional sizes of the vessels is smaller at the introduction site than at the repair site.