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US 2007/0203566A1 Arbefeuille Et Al US 20070203566A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0203566A1 Arbefeuille et al. (43) Pub. Date: Aug. 30, 2007 (54) NON-CIRCULAR STENT (60) Provisional application No. 60/499,652, filed on Sep. 3, 2003. Provisional application No. 60/500,155, filed on Sep. 4, 2003. (75) Inventors: Samuel Arbefeuille, Hollywood, FL (US); Humberto Berra, Cooper City, Publication Classification FL (US) (51) Int. Cl. Correspondence Address: A6IF 2/86 (2006.01) MAYBACK & HOFFMAN, P.A. (52) U.S. Cl. .......................................... 623/1.13; 623/1.15 5722 S. FLAMINGO ROAD #232 (57) ABSTRACT FORT LAUDERDALE, FL 33330 (US) A vascular repair device includes a tubular graft body having (73) Assignee: Bolton Medical, Inc., Sunrise, FL a central longitudinal axis and a structural framework having at least one stent connected to the graft body in a partially (21) Appl. No.: 11/699,700 compressed state, the stent having Substantially linear Struts and apices between adjacent pairs of the Struts, each of the (22) Filed: Jan. 30, 2007 apices being in the same plane as the adjacent pairs of the struts. Also provided is a vascular repair device where the Related U.S. Application Data stent defines a cross plane orthogonal to the longitudinal axis and has a cross profile having a polygonal shape parallel to (62) Division of application No. 10/784,462, filed on Feb. the cross-sectional plane and viewed along said longitudinal 23, 2004. aX1S. Patent Application Publication Aug. 30, 2007 Sheet 1 of 21 US 2007/0203566A1 g Patent Application Publication Aug. 30, 2007 Sheet 2 of 21 US 2007/020356.6 A1 N g LL CO CN S O N CN N s O O CD S - Patent Application Publication Aug. 30, 2007 Sheet 3 of 21 US 2007/0203566 A1 Patent Application Publication Aug. 30, 2007 Sheet 4 of 21 US 2007/020356.6 A1 Patent Application Publication Aug. 30, 2007 Sheet 5 of 21 US 2007/020356.6 A1 Patent Application Publication Aug. 30, 2007 Sheet 6 of 21 US 2007/020356.6 A1 Patent Application Publication Aug. 30, 2007 Sheet 7 of 21 US 2007/0203566 A1 $ $ 3 S. Patent Application Publication Aug. 30, 2007 Sheet 8 of 21 US 2007/020356.6 A1 869 uZCZ NSSSSSSSSSRSzzz/ R OZ9 Patent Application Publication Aug. 30, 2007 Sheet 9 of 21 US 2007/020356.6 A1 639 Patent Application Publication Aug. 30, 2007 Sheet 10 of 21 US 2007/020356.6 A1 638 /1 636 F.G. 32 Patent Application Publication Aug. 30, 2007 Sheet 11 of 21 US 2007/020356.6 A1 S. 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F.G. 49 Patent Application Publication Aug. 30, 2007 Sheet 17 of 21 US 2007/020356.6 A1 989 Patent Application Publication Aug. 30, 2007 Sheet 18 of 21 US 2007/020356.6 A1 3-| Patent Application Publication Aug. 30, 2007 Sheet 19 of 21 US 2007/020356.6 A1 Z09 Patent Application Publication Aug. 30, 2007 Sheet 20 of 21 US 2007/020356.6 A1 Patent Application Publication Aug. 30, 2007 Sheet 21 of 21 US 2007/020356.6 A1 • STAN.ANNOE Z99 89"SDI 889 029 US 2007/020356.6 A1 Aug. 30, 2007 NON-CIRCULAR STENT as the diameter and/or circumference of the vessel into which the graft will be inserted so that there is no possibility CROSS-REFERENCE TO RELATED of blood flowing around the graft (also referred to as APPLICATION endoleak) to either displace the graft or to reapply hemo 0001. This application is a divisional of co-pending U.S. dynamic pressure against the diseased portion of the blood patent application Ser. No. 10/784,462, filed Feb. 23, 2004, vessel. Accordingly, to so hold the graft, self-expanding which application claims the benefit under 35 U.S.C. S frameworks are attached typically to the graft material, 119(e) of U.S. Provisional Applications Nos. 60/499,652, whether on the interior or exterior thereof. Because blood filed Sep. 3, 2003, and 60/500,155, filed Sep. 4, 2003, the flow within the lumen of the graft could be impaired if the complete disclosures of which are each hereby incorporated framework was disposed on the interior wall of the graft, the by reference herein in their entirety. framework is connected typically to the exterior wall of the graft. The ridges formed by such an exterior framework help BACKGROUND OF THE INVENTION to provide a better fit in the vessel by providing a sufficiently uneven outer Surface that naturally grips the vessel where it 0002) 1. Field of the Invention contacts the vessel wall and also provides areas around 0003) The invention lies in the field of endoluminal blood which the vessel wall can endothelialize to further secure the vessel repairs. The invention specifically relates to a non stent graft in place. circular stent, which can be used to endoluminally repair aneurysm and/or dissections of the thoracic transverse aortic 0010. One of the significant dangers in endovascular graft arch, thoracic posterior aortic arch, and the descending technology is the possibility of the graft migrating from the thoracic portion of the aorta. desired position in which it is installed. Therefore, various devices have been created to assist in anchoring the graft to 0004 2. Description of the Related Art the vessel wall. 0005. A stent graft is an implantable device made of a tube-shaped Surgical graft covering and an expanding or 0011. One type of prior art prosthetic device is a stent self-expanding frame. The stent graft is placed inside a graft made of a self-expanding metallic framework. For blood vessel to bridge, for example, an aneurismal, dis delivery, the stent graft is, first, radially compressed and sected, or other diseased segment of the blood vessel, and, loaded into an introducer system that will deliver the device thereby, exclude the hemodynamic pressures of blood flow to the target area. When the introducer system holding the from the diseased segment of the blood vessel. stent graft positioned in an appropriate location in the vessel 0006. In selected patients, a stent graft advantageously and allowed to open, the radial force imparted by the eliminates the need to perform open thoracic or abdominal self-expanding framework is helpful, but, sometimes, not Surgical procedures to treat diseases of the aorta and elimi entirely sufficient, in endoluminally securing the stent graft nates the need for total aortic reconstruction. Thus, the within the vessel. patient has less trauma and experiences a decrease in hos pitalization and recovery times. The time needed to insert a 0012 U.S. Pat. No. 5,824,041 to Lenker et al. (hereinaf stent graft is Substantially less than the typical anesthesia ter “Lenker') discloses an example of a stent graft delivery time required for open aortic bypass Surgical repair, for system. Lenker discloses various embodiments in which a example. sheath is retractable proximally over a prosthesis to be released. With regard to FIGS. 7 and 8, Lenker names 0007 Use of surgical and/or endovascular grafts have components 72 and 76, respectively, as “sheath” and “pros widespread use throughout the world in vascular Surgery. thesis-containment sheath.” However, the latter is merely There are many different kinds of vascular graft configura the catheter in which the prosthesis 74 and the sheath 72 are tions. Some have Supporting framework over their entirety, held. With regard to FIGS. 9 and 10, the sheath 82 has inner Some have only two stents as a Supporting framework, and and outer layers 91.92 fluid-tightly connected to one another others simply have the tube-shaped graft material with no to form a ballooning structure around the prosthesis P. This additional Supporting framework, an example that is not ballooning structure inflates when liquid is inflated with a relevant to the present invention. non-compressible fluid medium and flares radially outward when inflated. With regard to FIGS. 13 to 15, Lenker 0008 One of the most commonly known supporting stent discloses the “sheath’ 120, which is merely the delivery graft frameworks is that disclosed in U.S. Pat. Nos. 5.282, catheter, and an eversible membrane 126 that “folds back 824 and 5,507,771 to Gianturco (hereinafter collectively over itself (everts) as the sheath 120 is retracted so that there referred to as "Gianturco). Gianturco describes a Zig-Zag are always two layers of the membrane between the distal shaped, self-expanding stent commonly referred to as a end of the sheath 120 and the prosthesis P. Lenker at col. Z-stent. The stents are, preferably, made of nitinol, but also 9, lines 63 to 66. The eversion (peeling back) is caused by have been made from stainless steel and other biocompatible direct connection of the distal end 130 to the sheath 120. The materials. Lenker delivery system shown in FIGS. 19A to 19D holds 0009.
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