Branched internal prosthetic organ systems, devices, and methods

Abstract

To provide branched vascular endoprosthetic systems.SOLUTION: Bifurcated endoprosthetic devices, systems and methods are disclosed herein for treating disease of human vasculature. In various embodiments, a bifurcated endoprosthesis includes a trunk portion and a plurality of legs, where the legs are constrained to maintain alignment with one another. In some examples, the legs and bifurcation of an endoprosthetic device may be formed by cutting a tubular graft component along a portion of less than its entire circumference in a longitudinally central region, and then folding the tubular graft component along the uncut portion to define two legs, where the uncut portion defines the bifurcation. In some of such examples, the folded tubular graft component can be coupled with a tubular trunk component to form the bifurcated endoprosthetic device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to a system and method for manufacturing an endovascular prosthesis system for branched vessels.

Background Art

[0002] There is a need for advanced devices, tools, systems and methods for the endovascular treatment of vascular diseases in the region of branched and main vessel junctions, including diseases affecting the aorta, including the descending aorta, the internal and external iliac arteries and the femoral arteries.

Summary of the Invention

[0003] Various examples related to endovascular prostheses and methods of manufacturing related endovascular prostheses are disclosed. The various concepts disclosed relate to an endovascular prosthesis having a first leg, a second leg and a bifurcation. According to one example ("Example 1"), the manufacturing method includes providing a mandrel having a first section and a second section, wherein the second section includes a first elongate element and a second elongate element. The method also includes providing a first tubular graft element having a first end and a second end.

[0004] The method also includes folding the first tubular graft element to define a folded region. The first leg is defined between the first end of the first tubular graft element and the folded region, and the second leg is defined between the second end of the first tubular graft element and the folded region. The method also includes applying the first tubular graft onto the second section such that the second elongate element extends through the second leg of the first tubular graft from the second end of the first tubular graft, and such that the folded region is positioned between the first leg and the second leg to define a bifurcation.

[0005] This method also includes forming the trunk portion of the internal prosthesis along a mandrel such that the trunk portion extends along a portion of the first section of the mandrel. The trunk portion includes a tab that extends across the branch of the first tubular graft element. This method also includes fixing the trunk portion and the first tubular graft element together to form the internal prosthesis.

[0006] In addition to Example 1, according to another example ("Example 2"), the trunk portion is formed as a second tubular graft element, which is then applied onto the first section of the mandrel and fixed to the first tubular graft element.

[0007] In addition to Example 1 or 2, according to another example ("Example 3"), the method also includes applying graft material to the outside of the internal prosthesis such that the graft material extends along at least portions of the first and second legs to maintain the alignment of the first and second legs.

[0008] In addition to one of the preceding examples, another example ("Example 4") shows that the longitudinal axis of the first leg is parallel to the longitudinal axis of the second leg.

[0009] In addition to one of the preceding examples, according to another example ("Example 5"), a first cutting line is defined around the tubular graft in a first region between the first end and the second end. The graft element is incised along the first cutting line in portions shorter than the entire first cutting line, defining a first incised portion and a first unincised portion.

[0010] In addition to Example 5, another example ("Example 6") shows that the first tubular graft element is folded along the first unincised portion, defining the folded area.

[0011] In addition to Examples 5 or 6, according to yet another example ("Example 7"), a second cutting line is defined around the tubular graft in a second region between the first and second ends, longitudinally offset from the first region. The graft element is incised along the second cutting line around a portion shorter than the entire second cutting line, defining a second incised portion and a second unincised portion. A third cutting line extends between the first and second cutting lines, and the graft element is incised along the third cutting line.

[0012] In addition to Example 7, according to another example ("Example 8"), the method also comprises folding a first tubular graft element along a second non-incisional portion, the folded region comprising a folded first non-incisional portion and a folded second non-incisional portion.

[0013] In addition to Example 7 or 8, according to another example ("Example 9"), the first tubular graft is applied to the second section such that the folding portion extends between the first leg and the second leg to define a branch.

[0014] According to one of Examples 7-9, plus another example ("Example 10"), the surplus section is defined in the region bounded between the first and second cutting lines. A third cutting line bisects the surplus section. The first tubular graft is applied over the second section such that at least a portion of the surplus section extends along the first portion of the mandrel away from the branch.

[0015] In addition to Example 10, according to another example ("Example 11"), the portion of the surplus section extending along the first part of the mandrel includes a first flap and a second flap opposite the first flap. The free ends of the first and second flaps are defined by a third cutting line.

[0016] In addition to the preceding example, according to another example ("Example 12"), the method also includes applying a support structure to the internal prosthesis along the trunk portion.

[0017] In addition to Example 12, another example ("Example 13") shows that the support structure is a stent.

[0018] In addition to Example 12 or 13, according to another example ("Example 14"), the support structure is located between the trunk portion and the graft material surrounding the trunk portion.

[0019] According to one of Examples 1-11, plus another example ("Example 15"), the method also includes applying a support structure to the internal prosthesis along one or more of the first and second legs.

[0020] In addition to Example 15, another example ("Example 16") shows that the support structure is a stent.

[0021] In addition to Example 15 or 16, according to another example ("Example 17"), the support structure is located between the first tubular graft element and the graft material surrounding the first tubular graft element.

[0022] In addition to one of the preceding examples, according to another example ("Example 18"), the first tubular graft is applied to the second section such that the first elongated element extends from the first end of the first tubular graft through the first leg of the first tubular graft.

[0023] In addition to one of the preceding examples, another example ("Example 19") shows that the tab extends between the first and second long elements.

[0024] Various examples related to a multi-lumen graft device and related methods of constructing the same are also disclosed. The various concepts disclosed relate to a multi-lumen graft device having a main graft body and at least two graft legs. According to one example ("Example 20"), the method includes providing a mandrel having a main mandrel body and at least two mandrel legs, applying a single tubular structure on the mandrel that includes at least one tab covering each of the two mandrel legs and covering at least a portion of the main mandrel body, and forming a main graft body on the main mandrel body, the main graft body being coupled to the at least one tab and disposed to cover at least a portion of both of the two graft legs.

[0025] In addition to Example 20, according to another example ("Example 21"), at least one stent element is attached to the graft device.

[0026] In addition to Example 20 or 21, according to another example ("Example 22"), the single tubular structure includes at least two tabs, each tab being coupled to the graft body.

[0027] In addition to any one of Examples 20 - 22, according to another example ("Example 23"), the main mandrel body includes at least one flat taper toward the two mandrel legs, the flat taper defining a transition between the main mandrel body and the mandrel legs.

[0028] In addition to Example 23, according to another example ("Example 24"), at least one tab is aligned on the flat taper during construction.

[0029] Although multiple embodiments are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description which illustrates exemplary examples. Therefore, the drawings and detailed description should be considered to be essentially exemplary and not limiting.

Brief Description of the Drawings

[0030] The features and advantages of the present disclosure will become more apparent from the detailed description set forth below when taken in conjunction with the drawings.

[0031] [Figure 1] FIG. 1 is a perspective view of an intraluminal device according to some embodiments.

[0032] [Figure 2] FIG. 2 is another perspective view of the intraluminal device of FIG. 1.

[0033] [Figure 3] FIG. 3 is a first end view of the intraluminal device of FIG. 1 according to some embodiments.

[0034] [Figure 4] FIG. 4 is a second end view of the intraluminal device of FIG. 1 according to some embodiments. <00​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

[0039] [Figure 9A] Figure 9A shows various intermediate configurations of the trunk section of an intraluminal device under construction, according to several embodiments. [Figure 9B] Figure 9B shows various intermediate configurations of the trunk section of an intraluminal device under construction, according to several embodiments. [Figure 9C] Figure 9C shows various intermediate configurations of the trunk section of an intraluminal device under construction, according to several embodiments.

[0040] [Figure 9D] Figure 9D is a diagram of the trunk section of the intraluminal device shown in Figure 9C, laid flat, according to several embodiments.

[0041] [Figure 10A] Figure 10A shows various intermediate configurations of the gate section of an intraluminal device under construction according to several embodiments. [Figure 10B] Figure 10B shows various intermediate configurations of the gate section of an intraluminal device under construction, according to several embodiments. [Figure 10C] Figure 10C shows various intermediate configurations of the gate section of an intraluminal device under construction according to several embodiments.

[0042] [Figure 11A] Figure 11A shows various intermediate configurations of the gate section of an intraluminal device under construction according to several embodiments. [Figure 11B] Figure 11B shows various intermediate configurations of the gate section of an intraluminal device under construction according to several embodiments. [Figure 11C] Figure 11C shows various intermediate configurations of the gate section of an intraluminal device under construction according to several embodiments. [Figure 11D] Figure 11D shows various intermediate configurations of the gate section of an intraluminal device under construction according to several embodiments.

[0043] [Figure 12A] Figure 12A shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Figure 12B] Figure 12B shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Figure 12C] Figure 12C shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Figure 12D] Figure 12D shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Figure 12E] Figure 12E shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Figure 12F] Figure 12F shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Figure 12G] Figure 12G shows various intermediate configurations of intraluminal devices under construction according to several embodiments. [Figure 12H] Figure 12H shows various intermediate configurations of an intraluminal device under construction according to several embodiments. [Modes for carrying out the invention]

[0044] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by various methods and apparatus configured to perform the intended functions. It should also be noted that not all accompanying drawings referenced herein are drawn to a fixed scale and may be exaggerated to illustrate various aspects of this disclosure; in this respect, the drawings should not be construed as limiting. Finally, while this disclosure may be described in relation to various principles and beliefs, this disclosure should not be bound by theory.

[0045] Terms such as internal prosthesis devices, internal prostheses, vascular devices, and intraluminal devices may, throughout the specification and claims, refer to any medical device that can be implanted and / or deployed within a body lumen. In various embodiments, internal prostheses may include stents, stent grafts, grafts, and the like.

[0046] Throughout this specification and the claims, the term “distal” refers to a location further downstream with respect to blood flow than another part of an intraluminal device (such as a stent graft) when implanted, or to a part of an intraluminal device (such as a stent graft). Similarly, the term “distal” refers to the direction of blood flow, or further downstream in the direction of blood flow.

[0047] The term "proximal" refers to a location or part of an intraluminal device that is further upstream in relation to blood flow than other parts of the intraluminal device when an implant is placed. Similarly, the term "proximal" refers to a direction opposite to the direction of blood flow, or upstream from the direction of blood flow.

[0048] With regard to the terms proximal and distal, this disclosure should not be interpreted narrowly with respect to these terms. Rather, the devices and methods described herein may be modified and / or adapted to the patient's anatomical structure. Therefore, where expressly indicated, the terms “distal” and “distal” may refer to a relative location far from the internal location where the medical device is introduced, or a relative location far from the physician operating the medical device. Similarly, where expressly indicated, the terms “proximal” and “proximal” may refer to a relative location close to the internal location where the medical device is introduced, or a location close to the physician operating the medical device.

[0049] As used herein, the term “conduit” refers to any lumen or tubular structure within the body that can utilize these structures. This includes, but is not limited to, blood vessels, arteriovenous malformations, vascular defects such as aneurysms, lymphatic conduits, anatomical structures of the esophagus and intestines, tortuous lumens, the genitourinary system, or other such systems or anatomical features.

[0050] Intraluminal devices, such as those discussed herein, are used to treat the vascular systems of mammalian patients. These treatments or procedures are generally referred to as intraluminal or endovascular procedures. Such intraluminal devices, including stents and stent grafts, can generally be tubular structures that define one or more lumens and are inserted into the vascular system to open and / or maintain the vascular structure in order to prevent or address local flow narrowing, weakening of the vascular structure, aneurysms, etc. Thus, in various embodiments, intraluminal devices have dimensions appropriate for the desired vascular treatment and sufficient strength to provide structural support for the flexible walls of the intraluminal device and / or vascular structure.

[0051] In some examples, the intraluminal device includes a proximal end and a distal end and has a single lumen extending from the proximal end to the distal end. In some other examples, the intraluminal device may include a proximal end and a distal end, where multiple lumens are defined at one or more of the proximal and distal ends. In some examples, the intraluminal device may include a bifurcation such that the lumen of the intraluminal device transitions into multiple lumens or is otherwise divided into multiple lumens. In some examples, the intraluminal device may include multiple lumens, each containing such a bifurcation.

[0052] Figures 1-4 show the intraluminal device 100 according to the present disclosure. The intraluminal device 100 can have various configurations and generally includes, for example, a graft component 102 and a support component 104, the support component 104 being configured to provide support to the graft component 102. The support component 104 and the graft component 102 may be coupled together substantially coaxially. The intraluminal device 100 includes a proximal end 106 and a distal end 108 and generally includes a trunk section 110 and a gate section 112. The intraluminal device 100 may be a balloon-expandable device or may have another configuration including a self-expanding device, as will be understood by those skilled in the art.

[0053] As will be discussed in more detail below, in various examples, the trunk section 110 includes a single lumen, such as a trunk lumen, and the gate section 112 includes a branch so that the gate section 112 includes multiple lumens, where the multiple lumens of the gate section 112 are fluidly connected to the lumen of the trunk section 110. Figure 2 is a perspective view of the intraluminal device 100 showing a distal end 108 containing multiple lumens, the multiple lumens including a first gate lumen 114 and a second gate lumen 116. As shown, the first gate lumen 114 is at least partially defined by a first gate 118, while the second gate lumen 116 is at least partially defined by a second gate 120. Thus, the gate section 112 includes a first gate 118 and a second gate 120.

[0054] The graft components 102 of the intraluminal device 100 may consist of any material suitable for use as a graft in a selected body cavity. Many graft materials are known, particularly those used as vascular graft materials. For example, natural materials such as collagen can be introduced into the inner surface of a stent and fixed in place. Synthetic polymers such as polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, mixtures, blends, copolymers, and other materials are also suitable. This class includes polyesters such as polyethylene terephthalate such as DACRON and MYLAR, polyaramids such as KEVLAR®, polyfluorocarbons, and porous or non-porous polyurethanes. Classes of fluoropolymers include polytetrafluoroethylene (PTFE) with and without copolymerized hexafluoropropylene, stretched or unstretched PTFE, fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoro(propyl vinyl ether) (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE) and its TFE, copolymers with ethylene-chlorotrifluoroethylene (ECTFE), ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF) and polyvinylidene fluoride (PVF).

[0055] Furthermore, one or more radiopaque metal fibers, such as gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals, can be incorporated into the device, particularly into grafts, to enable fluorescence visualization of the device.

[0056] The graft material can also be reinforced using a network of small-diameter fibers. The fibers may be random, braided, knitted, or woven.

[0057] FEP and other adhesive materials known in the art can be used as adhesives for graft materials. For example, a porous stretched polytetrafluoroethylene (ePTFE) graft component 102 can be formed by bonding layers of ePTFE together using an FEP adhesive. For example, the ePTFE may be coated with FEP, or the FEP may be in the form of a bonding member (e.g., a flat ribbon) placed between layers of graft material. As will be discussed further below, FEP and other adhesive materials known in the art can be used as additional or substitute materials to bond the support component 104 and the graft component 102 together.

[0058] In various examples, the support component 104 may include steel such as stainless steel or other alloys. In some examples, the support component 104 may include shape memory alloys such as nitinol. In yet another example, the support component may include nonmetallic materials such as polymer materials. It should be understood that the support component 104, including one or more distinct parts, may be permanent (i.e., non-biodegradable) or biodegradable.

[0059] In some examples, the support component 104 is generally made of a moderately high-strength material, such as a material that resists plastic deformation when stressed. The support component 104 may include a wire wound around a pinned mandrel so as to simultaneously form a helical winding and undulations. Other structures may also be used. For example, a suitable shape may be formed from a flat material and wound around a cylinder or tube of a certain length that has been processed into the suitable shape. Other suitable manufacturing methods include support components cut from a continuous tube (e.g., laser-cut nitinol tube).

[0060] In some cases, suitable materials include those that maintain adequate elasticity even when processed into very thin sheets or small-diameter wires. For example, as consistently with the above, a variety of materials, including metals and superelastic alloys, are suitable for use in support components 104. Various stainless steels that can be treated physically, chemically, and otherwise to produce high springability are also suitable, as are other metal alloys such as cobalt-chromium alloys (e.g., ELGILOY), platinum / tungsten alloys, and nickel-titanium alloys commonly known as "nitinol." In some cases, other materials suitable as support components include certain polymer materials, particularly engineering plastics such as thermotropic liquid crystal polymers ("LCPs").

[0061] Continuing to refer to Figures 1 to 4, in various examples, the support component 104 includes one or more elements arranged along the trunk section 110, and one or more components arranged along the gate section 112.

[0062] For example, as shown, the support component 104 includes a plurality of annular stent elements 122 arranged along the trunk section 110 and a plurality of annular stent elements 124 arranged along the gate section 112. The annular stent elements 122 and 124 may include a plurality of individual continuous cylindrical components arranged adjacent to each other along the longitudinal axis of the intraluminal device, or may include one or more helical windings, or may include a combination thereof.

[0063] In some examples, one or more of the adjacent annular stent elements 122 and 124 can be interconnected with one another via, for example, an interconnecting component (e.g., an interconnecting wire). In some such examples, the interconnecting wire may include a wire extending longitudinally between a first annular stent element and a second annular stent element located adjacent to it. Any number of adjacent annular stent elements can be joined together via such an interconnecting wire. In some other examples, instead of or in addition to such an interconnecting wire, one or more vertices 132 of annular stent elements can be connected by contact with one or more vertices 132 of adjacent annular stent elements.

[0064] The annular stent elements 122 and 124 can be arranged at uniform intervals from each other along the longitudinal axis (i.e., uniformly distributed along the longitudinal axis), or at different intervals from each other along the longitudinal axis (i.e., non-uniformly distributed along the longitudinal axis), or a combination thereof (for example, as shown in Figure 1). Therefore, it should be understood that any arrangement of the annular stent elements 122 and 124 is within the scope of this disclosure, as long as they are adapted to provide support to the trunk section and gate sections 110 and 112.

[0065] In various embodiments, the various annular stent elements 122 and 124 can have different stiffnesses. For example, one or more annular stent elements 122 and 124 with increased stiffness can be positioned at the distal and / or proximal ends of the intraluminal device 100. Furthermore, one or more annular stent elements 122 and 124 with reduced stiffness can be positioned away from the distal and / or proximal ends of the intraluminal device 100.

[0066] Furthermore, while the annular stent elements 122 and 124 of the intraluminal device 100 shown in Figures 1-4 include a substantially sinusoidal configuration having multiple peaks and multiple varries, it should be understood that other configurations are conceivable, including annular stent elements having any pattern that provides sufficient elasticity and flexibility to the intraluminal device 100. For example, the annular stent elements 122 and / or 124 may include polygons, such as parallelograms. In various examples, the annular stent elements 122 and / or 124 may be diamond-shaped. In other embodiments, the annular stent elements 122 and / or 124 may include square or rectangular shapes. Therefore, it should be understood that any shape of the annular stent elements 122 and / or 124, including non-polygonal shapes (such as oval or rounded shapes) or shapes that include undulations or bends, is within the scope of this disclosure.

[0067] In line with the above discussion, in various examples, the annular stent elements 122 and / or 124 may include metallic materials such as steel, including stainless steel, or other alloys, including shape memory alloys such as Nitinol. In yet another embodiment, the annular stent elements 122 and / or 124 may include non-metallic materials such as polymer materials. Thus, the annular stent elements 122 and / or 124 may, if desired, be cut from a single metal or polymer tube according to known methods. Additionally or alternatively, the annular stent elements 122 and / or 124 may be formed by using other known stent-forming devices, such as a plurality of pins arranged in a configuration corresponding to a desired pattern, through which the wire is wound.

[0068] In some examples, the support component 104 is arranged concentrically around the graft component 102. In some other examples, the graft component 102 is arranged concentrically around the support component 104. In several other examples, the support component 104 can be positioned between multiple graft material layers of the graft component 102.

[0069] Therefore, in some examples, the graft material can define the luminal surface 126 of the trunk section 110 and / or the luminal surface 128 of the first gate 118 and / or the luminal surface 130 of the second gate 120. Here, such luminal surfaces are adapted to come into contact with the blood flow within the tubule once the intraluminal device 100 is implanted within the vascular structure.

[0070] Continuing to refer to Figures 1-4, in various examples, the intraluminal device 100 is configured such that the first gate and the second gates 118 and 120 are fixed against substantial movement of each other. In some examples, such fixation involves directly joining the first gate and the second gates 118 and 120 to each other by means of sutures or adhesive, etc., so that the first gate and the second gates 118 and 120 are attached to each other. Alternatively, in some examples, the first gate and the second gates 118 and 120 can be fixed (and thus effectively joined) against movement of each other without requiring direct joining between them. That is, in some examples, the first gate and the second gates 118 and 120 can be joined together while maintaining separation between them along their longitudinal length.

[0071] For example, as shown in Figures 1-4, the intraluminal device 100 includes a sleeve portion 134 extending along the outside of the first gate and the second gates 118 and 120, respectively. In some examples, the sleeve portion 134 is integrated with the graft component 104 of the intraluminal device 100, as will be discussed in more detail below. In various examples, the sleeve portion 134 includes graft material wrapped around the first gate and the second gates 118 and 120. Thus, the wrapped graft material contacts less than all of the first gate and the second gates 118 and 120 and extends between the gap 136 between the first gate 118 and the second gate 120, as shown in Figure 3, forming a webbing that spans the gap 136 between them. In various examples, the gap 136 extends along the length of the first gate and the second gates 118 and 120 from the bifurcation 138 to the distal end 108 of the intraluminal device 100. In various examples, the bifurcation 138 may be understood to be located at the distal end of the trunk component 110 and at the proximal ends of the first and second gates 118 and 120, respectively (the location of the bifurcation 138 along the intraluminal device 100 is shown in Figure 1). In various examples, the bifurcation 138 may define one or more of the distal end of the trunk component 110 and the proximal ends of the first and second gates 118 and 120, respectively. Those skilled in the art will understand that the bifurcation 138 defines the division where the lumen of the trunk component 110 transitions to the first and second gate lumens 114 and 116, respectively.

[0072] It should be understood that the sleeve 134 is fitted to maintain the alignment of the first gate and second gates 118 and 120, including the first and second gate lumens 114 and 116, which can help facilitate the intubation of one or more of the first and second gate lumens 114 and 116. Furthermore, in some examples, the sleeve 134 can also increase the strength of the intraluminal device 100, for example, by increasing the rupture strength of the graft components 104 during deployment of its branches (e.g., the first gate 118 and the second gate 120) into branch vessels. Also, in some examples, the sleeve 134 facilitates the process of deploying the intraluminal device 100 into a vessel because multiple annular stent elements 124 are sandwiched between layers of graft material. In this example, the sleeve 134 is on the outside and the graft components 102 are on the inside, reducing friction that could result from the annular stent elements 124 directly contacting the surrounding tissue wall.

[0073] Next, referring to Figure 5, an exemplary method for manufacturing the intraluminal device 100 is shown. However, it should be understood that the manufacturing method illustrated in Figure 5 is not intended to be limiting. Therefore, it should be understood that the sequence of steps, or the detailed steps discussed below, can be rearranged or completed in other ways.

[0074] As shown, in step 502, a mandrel is provided having a first section and a second section, the second section having a plurality of elongated parallel members. An exemplary mandrel 200 is shown in Figures 6A–6C. As shown, the mandrel 200 has a first section 202 and a second section 204. The second section 204 has a first elongated element 206 and a second elongated element 208, the second elongated element 208 extending parallel to the first elongated element 206. The first elongated element and the second elongated elements 206 and 208 extend from the distal end 210 of the first section 202, which is located opposite the proximal end 212 of the first section 202. The first elongated element 206 has a proximal end 214 and a distal end 216. Similarly, the second elongated element 208 has a proximal end 218 and a distal end 220. The first and second elongated elements 206 and 208 each include substantially cylindrical body sections 222 and 224, respectively. Similarly, the first section 202 is cylindrical as shown in the figure.

[0075] As shown in Figure 6B, the proximal ends 214 and 218 of the first and second elongated elements 206 and 208 are joined to the distal end 210 of the first section 202. In various examples, the first and second elongated elements 206 and 208 are joined to the first section 202 such that they are separated from each other transversely. For example, as shown in Figure 6B, the first and second elongated elements 206 and 208 are joined to the first section 202 such that they are separated from each other transversely, as evidenced by the gap 230 between the first and second elongated elements 206 and 208 along their lengths. In other words, the first and second elongated elements 206 and 208 are positioned such that the distance between their longitudinal axes exceeds half the diameter of the first elongated element 206, half the diameter of the second elongated element, and the sum of the thicknesses of the first gate 118 and the second gate 120. In some examples, the first and second gates 118 and 120 have the same thickness. In some examples, the first and second elongated sections 206 and 208 have the same diameter. It should also be understood that the diameters of the first and second sections 206 and 208 correspond to the lumen diameters of the first and second gates 118 and 120, respectively. In some examples, the first gate and the second gates 118 and 120 are offset from each other in the longitudinal direction by having a first elongated element 206 with a different length from the second elongated element 208, so that when viewed from the side, the first gate and the second gates 118 and 120 do not align with each other.

[0076] The gap 230 coincides with the gap 136 formed between the first gate 118 and the second gate 120 described above. That is, the first and second elongated elements 206 and 208 are coupled to the first section 202 so that the gap 136 between the first and second gates 118 and 120 of the intraluminal device 100 may be formed during the manufacture of the intraluminal device 100, as will be discussed further below.

[0077] In various examples, the first section 202 of the mandrel 200 is configured to include a first tapered section 226 and a second tapered section 228 opposite the first tapered section 226, where the first and second tapered sections 226 and 228 are located at the distal end 210 of the first section 202. In various examples, the first and second tapered sections 226 and 228 located at the distal end 210 of the first section 202 provide a transition from the trunk portion 110 of the intraluminal device 100 to the gate portion 112 of the intraluminal device 100. Such a transition provides hemodynamics through the intraluminal device 100 that help minimize areas of stagnation that could lead to thrombus formation. As shown in Figures 6A-6C, the first tapered section and the second tapered sections 226 and 228 are at an angle of approximately 21 degrees with respect to the longitudinal axis of the mandrel 200, but it should be understood that any suitable angle between 0 and 90 degrees can be implemented.

[0078] As shown in Figure 5, in step 504, the trunk section 110 and gate section 112 of the intraluminal device 100 are provided. Figure 7 provides an exemplary diagram of the trunk section 110 in its pre-assembly configuration, and Figure 8 provides an exemplary diagram of the gate section 112 in its pre-assembly configuration. As shown in Figure 7, the trunk section 110 in its pre-assembly configuration includes a substantially tubular body 140 having a distal end 142 and a proximal end 144. In various examples, the proximal end 144 of the tubular body 140 generally corresponds to the proximal end 106 of the intraluminal device 100. At the distal end 142, the trunk section 110 in its pre-assembly configuration includes a tail portion 146, a first overlapping region 148, and a second overlapping region 150. In some examples, the trunk section 110 includes a relief portion 152 located opposite the tail portion 146 (see, for example, Figure 9C). As will be discussed in more detail below, the relief portion 152 is configured such that the tail portion 146 can pass through it in order to form a saddle that extends across the distal end 142 of the trunk section 110 in order to help connect the gate section 112 to the trunk section 110.

[0079] As shown in Figure 7, in various examples, the tubular body 140 of the trunk section 110 can be formed by arranging graft material consistent with the graft material discussed herein along a mandrel. The graft material can be arranged around the mandrel by spirally winding and / or longitudinally winding the graft material around the mandrel. Once the tubular body 140 is formed, it can be further processed to form the tail portion 146 and the first and second overlapping regions 148 and 150.

[0080] Referring here to Figures 9A-9D, the trunk section 110 is shown in its pre-assembly configuration in various manufacturing processes. Figure 9A shows the trunk section 110 after the tubular body 140 has been formed and before the tail portion 146 and the first and second overlapping regions 148 and 150 have been formed. Figure 9B shows an exemplary cut pattern on the trunk section 110 consistent with the formation of the tail portion 146 and the first and second overlapping regions 148 and 150. Figure 9C shows an exemplary trunk section 110 after the formation of the tail portion 146 and the first and second overlapping regions 148 and 150, which is consistent with the example of the trunk section 110 shown in Figure 7. Figure 9D is a representation of the trunk section 110 shown in Figure 9C, which is cut longitudinally, opened, and laid flat to better illustrate the features of the trunk section 110. Please understand that the longitudinal cut extends from the proximal end 144 to the relief portion 152, and that the longitudinal cut bisects the width of the relief portion 152.

[0081] As shown in Figures 9C and 9D and previously mentioned, in its pre-assembly configuration, the trunk section includes a tail portion 146, a first overlapping region 148, and a second overlapping region 150. In some cases, in certain examples, the trunk section 110 further includes a relief portion 152, which is located opposite the tail portion 146. In some examples, the tail portion 146, as well as the first and second overlapping regions 148 and 150, are formed by cutting the tubular body 140 of the trunk section 110 along cutting lines 154a, 154b, and 156 shown in Figure 9B. As shown, cutting lines 154a and 154b are longitudinal cutting lines extending along the tubular body 140 for a length "L", while cutting line 156 is a circumferential cutting line made in the tubular body 140, which is shorter than approximately the entire circumference of the tubular body 140 of the trunk section 110. As shown, the cutting line 156 is made in the tubular body 140 around the tubular body 140 and is shorter than the width "W" of the tail portion 146. That is, the cutting line 156 does not cross the width "W" of the tail portion 146. Cutting lines 158a and 158b are also shown in Figure 9B, and these may be made in the tubular body 140 of the trunk section 110 to form a relief 152, as may be further described below.

[0082] In some examples, the tail portion 146 is formed by cutting the tubular body 140 along cutting lines 154a and 154b, and also along cutting line 156, and removing the excess section 160. As shown, the excess section 160 is defined as the region bounded between the distal end 142 and cutting lines 156 and 154a and 154b.

[0083] Figure 9C shows the trunk section 110 in its pre-assembly configuration with the excess section 160 removed. As shown, the cutting lines 154a and 154b extend proximal to a distance "X" equal to the difference between "L" and "D". Therefore, it should be understood that the cutting lines 154a and 154b extend proximal to the first and second overlapping regions 148 and 150, such that the base of the tail section 146 (for example, where the tail section 146 terminates within the tubular body 140) is proximal to the first and second overlapping regions. With such a configuration, the first and second overlapping regions may be located distal to the tail section 146 when the tail section 146 folds across the tubular body 140 and passes through the relief section 152 to connect the trunk section 110 to the gate section 112, as will be discussed further below. Furthermore, as shown, once the excess section 160 is removed, the tail portion 146 extends distally to the first overlapping region and the second overlapping regions 148 and 150. In some examples, the distal end of the tail portion 146 defines the distal end 142 of the trunk section 110 in the pre-assembly configuration (see, for example, Figure 9D).

[0084] As described above, in some examples, cutting lines 158a and 158b may be created on the tubular body 140 of the trunk section 110 on the opposite side of cutting lines 154a and 154b. For example, as shown in Figure 9B, cutting line 158a can be created 180 degrees opposite cutting line 154b, and cutting line 158b can be created 180 degrees opposite cutting line 154a. In some examples, cutting lines 158a and 158b may have a length equal to the difference between the length "L" of the tail portion 146 and the depth "D" of the excess portion 160. Thus, it should be understood that cutting lines 158a and 158b, like cutting lines 154a and 154b, extend substantially the same amount proximal from cutting line 156 along the tubular body 140 of the trunk section 110.

[0085] In various examples, cutting lines (not shown) are made between cutting lines 158a and 158b at their proximal ends. Thus, the relief portion 152 is formed by removing excess material defined between cutting line 156 and the proximal ends of cutting lines 158a and 158b, and between cutting lines 158a and 158b. In various examples, cutting lines 158a and 158b are separated by a width "W" substantially the same as that of cutting lines 154a and 154b, such that the relief portion 152 has a width "W" substantially the same as that of the tail portion 146.

[0086] It should be understood that the tubular body 140 may be cut along the above cutting lines, including cutting lines 154a, 154b, 156, 158a, and 158b, according to known methods such as laser cutting.

[0087] It should be understood that the width "W" can be any desired width smaller than the circumference of the tubular body 140 of the trunk section 110. It should also be understood that the length "L" can be any desired length shorter than the longitudinal length of the trunk section 110, measured from the proximal end 144 to the distal end 142. It should also be understood that the depth "D" can be any desired depth less than or equal to the difference between the length "L" and the diameter of the cutting lines 154a and 154b.

[0088] Referring here to Figures 10A-10C, an exemplary gate section 112 is shown in its pre-assembly configuration for various manufacturing processes. Figure 10A shows the gate section 112 after the tubular body 162 has been formed, before the tubular body 162 is partially divided to form the first gate and the second gates 118 and 120. Figure 10B shows an exemplary cut pattern on the gate section 112 consistent with the formation of the first gate portion and the second gate portions 118 and 120. Figure 10C shows an example of the gate section 112 after the tubular body 162 has been partially divided and folded to form the first gate and the second gates 118 and 120.

[0089] In various examples, the tubular body 162 of the gate section 112 may be formed by arranging graft material consistent with the graft material discussed herein along a mandrel. The graft material can be arranged around the mandrel by known methods such as spirally winding and / or longitudinally winding the graft material around the mandrel. Once the tubular body 162 is formed, it can be further processed to form the gate section 112.

[0090] As shown in Figure 10C, in its pre-assembly configuration, the gate section 112 includes a first gate and second gates 118 and 120. In some examples, the first gate and second gates 118 and 120 are formed by cutting the tubular body 162 of the gate section 112 along a cutting line 168 shown in Figure 10B. As shown, the cutting line 168 is a cut made transversely to the longitudinal axis of the tubular body 162. The cutting line 168 is made as a circumferential cut in the tubular body 162 and is shorter than approximately the entire circumference of the tubular body 162 of the gate section 112. It should be understood that any suitable length of cut can be used as long as the tubular body 162 can be folded to define the first gate and second gates 118 and 120, consistent with the following discussion. In some examples, the circumferential cut corresponds to a cut length that corresponds to at least half the circumference of the tubular body 162 in the area of ​​the cutting line 168. As shown, the first gate 118 is defined as a region bounded by the proximal end 166 and the cutting line 168, while the second gate 120 is defined as a region bounded by the distal end 164 and the cutting line 168.

[0091] Figure 10C shows the gate portion 112 of the pre-assembly configuration after the tubular body 162 has been cut to define the first gate and the second gates 118 and 120. As shown, after cutting the tubular body 162 along the cutting line 168 to define the first gate and the second gates 118 and 120, the tubular body 162 is folded along the cutting line 168, and the distal end 164 and proximal end 166 are pulled toward each other until the first gate and the second gates 118 and 120 extend substantially parallel to each other while being offset transversely. That is, after folding the tubular body 162 along the cutting line 168, the first gate and the second gates 118 and 120 do not share a common axis, or are not coaxial with each other. In various examples, even though they are not coaxial with each other, the axes of the first gate and the second gates 118 and 120 can extend substantially parallel to each other, as shown in Figure 10C.

[0092] Furthermore, as described above, the cutting line 168 is a circumferential cut in the tubular body 162 and is shorter than approximately the entire circumference of the gate section 112 around the tubular body 162. When folded into the pre-assembly configuration shown in Figure 10C, the first and second gates 118 and 120 remain joined via the uncut portion 170 of the graft material of the tubular body 162. In various examples, the uncut portion 170 defines a saddle or other support structure extending between the first and second gates 118 and 120 on opposite sides of the proximal end 166 and distal end 164 in the folded configuration shown in Figure 10C. As will be discussed in more detail below, this saddle or uncut portion 170 provides a support structure that helps to join the gate section 112 to the trunk section 110.

[0093] It should be understood that the tubular body 162 can be cut along the above-mentioned cutting line, including the cutting line 168, according to known methods such as laser cutting.

[0094] Referring here to Figures 11A–11D, another exemplary gate section 112 is shown in pre-assembly configurations for various manufacturing processes. Figure 11A shows the gate section 112 after the tubular body 162 has been formed, before the tubular body 162 is partially divided to form the first gate and the second gates 118 and 120. Figure 11B shows an exemplary cut pattern on the gate section 112 consistent with the formation of the first gate and the second gate portions 118 and 120. Figure 11C shows the tubular body 162 with the cut graft material portions unfolded before the tubular body 162 is folded into the configuration shown in Figure 11D. Figure 11D shows an example of the gate section 112 after the tubular body 162 has been folded to form the first gate and the second gates 118 and 120, which is consistent with the diagram of the gate section 112 shown in Figure 8.

[0095] As described above, the tubular body 162 of the gate section 112 can be formed by arranging graft material consistent with the graft material discussed herein along a mandrel. The graft material can be arranged around the mandrel by known methods such as winding the graft material helically and / or longitudinally around the mandrel. Once the tubular body 162 is formed, it can be further processed to form the gate section 112 shown in Figures 11B–11D.

[0096] As shown in Figure 11C, in its pre-assembly configuration, the gate section 112 includes a first gate and second gates 118 and 120. In some examples, the first gate and second gates 118 and 120 are formed by cutting the tubular body 162 of the gate section 112 along various cutting lines 168a to 168c shown in Figure 11B. As shown, the cutting lines 168a and 168b correspond to cuts made so as to traverse the longitudinal axis of the tubular body 162. In the diagram shown in Figure 11B, the cutting lines 168a and 168b are substantially perpendicular to the longitudinal axis of the tubular body 162. However, in some examples, the cutting lines 168a and 168b may be formed at an angle to the longitudinal axis, as desired, which would have the effect of generating an excess section (e.g., excess section 172) that tapers from its free end. The cutting lines 168a and 168b are offset longitudinally from each other by a distance "D", as shown in Figure 11B. The distance "D" can be any desired distance. These cutting lines 168a and 168b are made as circumferential cuts of the tubular body 162 and are shorter than approximately the entire circumference of the gate section 112 of the tubular body 162. It should be understood that any suitable length of cut can be used, as long as the tubular body 162 can be folded to define the first and second gates 118 and 120, as will be further described below. In some examples, the circumferential cuts correspond to a cut length that corresponds to at least half the circumference of the tubular body 162 in the area of ​​the cutting line 168. As shown, the first gate 118 is defined as the area bounded between the proximal end 166 and the cutting line 168a, while the second gate 120 is defined as the area bounded between the distal end 164 and the cutting line 168b.

[0097] The excess section 172 is defined as the region bounded by cutting lines 168a and 168b, with cutting line 168c bisecting the excess section 172. In some examples, as will be discussed further below, the excess section 172 defines a saddle region of the gate section 112, which provides a support structure to assist in joining the gate section 112 to the trunk section 110. In such examples, the saddle region is formed by cutting the tubular body 162 along cutting lines 168a, 168b, and 168c, and folding and opening the excess section 172, as shown in Figure 11C. In particular, as described above, cutting lines 168a and 168b are partial circumferential cuts, not complete circumferential cuts. Therefore, the first gate and the second gates 118 and 120 remain connected via the uncut portions 174a and 174b of the tubular graft, which are defined as uncut regions between the excess portion 172 and the first gate and the second gates 118 and 120, respectively, as shown in Figure 11C.

[0098] Figure 11D shows the gate section 112 in its pre-assembly configuration after the tubular body 162 has been cut to define the first and second gates 118 and 120. As shown, after the tubular body 162 has been cut along the cutting lines 168a, 168b and 168c to define the first and second gates 118 and 120, the tubular body 162 is folded so that the distal end 164 and the proximal end 166 are drawn toward each other until the first and second gates 118 and 120 extend substantially parallel to each other while being offset transversely from each other. That is, after the tubular body 162 has been folded as shown in Figure 11D, the first and second gates 118 and 120 do not share a common axis, or are otherwise not coaxial with each other. In various examples, even though they are not coaxial with each other, the axes of the first and second gates 118 and 120 can still extend substantially parallel to each other, as shown in Figure 11D. In some examples, the first gate and the second gates 118 and 120 have different lengths. For example, when the cutting line 168 in Figure 10B or the cutting lines 168a-168c in Figure 11B are shifted toward the proximal end 166, the first gate 118 becomes shorter longitudinally than the second gate 120. On the other hand, when the cutting line 168 or the cutting lines 168a-168c are shifted toward the distal end 164, the second gate 120 becomes shorter longitudinally than the first gate 118.

[0099] Furthermore, as described above, the cutting lines 168a and 168b are partial circumferential cuts of the tubular body 162, respectively, and are shorter than the approximately entire circumference of the tubular body 162 of the gate section 112. Thus, when folded into the pre-assembly configuration shown in Figure 11D, the first gate and the second gates 118 and 120 remain joined via the excess portion 172. In various examples, the excess portion 172 defines a saddle or other support structure extending between the first gate and the second gates 118 and 120 on the opposite side of the proximal and distal ends 166 and 164 in the folded configuration shown in Figure 11D. In various examples, the excess portion defines tabs 176a and 176b (see, for example, Figures 11C and 11D). Tabs 176a and 176b correspond to regions of the surplus portion 172 that extend away from the non-cut regions of the surplus portion 172 (for example, regions where the surplus portion 172 remains coupled to the first gate and the second gates 118 and 120).

[0100] It should be understood that the tubular body 162 can be cut along the above-mentioned cutting lines, including cutting lines 168a, 168b, and 168c, according to known methods such as laser cutting.

[0101] Referring back to Figure 5, in step 506, the gate section 112 is positioned along the second section 204 of the mandrel 200 in its pre-assembly configuration. Referring now to Figures 12A and 12B, the gate section 112 is shown positioned along the second section 204 of the mandrel 200. Figure 12A shows the mandrel 200 without the gate section 112, and Figure 12B shows the mandrel 200 with the gate section 112 positioned on the second section 204 adjacent to the first section 202. In some examples, the gate section 112 may be positioned on the second section 204 adjacent to the distal end 210 of the first section 202 of the mandrel 200 (for example, as shown in Figures 6A and 6C). As shown in Figure 12B, the gate section 112 is positioned along the second section 204 of the mandrel 200, so that the first elongated element 206 extends through the lumen 114 of the first gate 118, and the second elongated element 208 extends through the lumen 116 of the second gate 118. Furthermore, as shown, the tab 176a is positioned along the first tapered section 226 of the first section 202 of the mandrel 200. Although not shown in the drawing, it should be understood that the tab 176b is similarly positioned along the second section 228.

[0102] Additionally or alternatively, in some examples, before placing tabs 176a and 176b along the first and second tapered portions 226 and 228 (see, for example, Figure 12B), a separate length of graft material may be applied to the mandrel, so that it extends from the first tapered portion 226 to the second tapered portion 228, and across the portion of the distal end 210 between the first and second tapered portions 226 and 228 and between the first and second long elements 206 and 208 (e.g., within the gap 230), with tabs 176a and 176b at least partially placed on top of the separate length of graft material already applied to extend across the distal end 210. In some examples, the excess graft material may be configured such that its width in the region of gap 230 is consistent with the width between the first and second elongated elements 206 and 208, and the excess graft material is substantially flat (e.g., essentially wrinkle-free) with respect to the distal end 210 of the first section 202 of the mandrel 200 in the region of gap 230. Such a configuration helps minimize the possibility of wrinkles or uneven surface structures along the internal region of the intraluminal device in the region of the bifurcation 128 of the intraluminal device 100. For example, in a configuration where the distance "D" of the cutting line 168c (see, for example, Figure 11B) exceeds the width of the gap 230 between the first and second elongated elements 206 and 208 (see, for example, Figure 6B), the excess section 172 may be compressed longitudinally when the gate section 112 is placed on the second section 204 of the mandrel 200 (for example, the cutting lines 168a and 168b are compressed toward each other). This compression of the excess section 172 can cause wrinkles in the excess section 172.

[0103] Figure 12C shows a configuration similar to that shown in Figure 12B, but with the addition of annular stent elements 124 applied to the first gate and second gates 118 and 120 of gate section 112. In various examples, the annular stent elements 124 are applied to gate section 112 before it is placed on the mandrel 200. In some other examples, the annular stent elements 124 are applied to gate section 112 after it has been placed on the mandrel 200. As described above, the annular stent elements 124 can be coupled to gate section 112 according to known methods.

[0104] Referring again to Figure 5, in step 508, the trunk section 110 in its pre-assembly configuration is positioned along the first section 202 of the mandrel 200. Now referring back to Figure 12D, the trunk section 110 is shown positioned along the first section 202 of the mandrel 200. Figure 12D shows the trunk section 110 positioned with the tail portion 146 extending distally. Furthermore, as shown, the trunk section 110 is positioned along the mandrel 200 such that the trunk section 110 at least partially overlaps the gate section 112. For example, as shown in Figure 12D, the trunk section 110 overlaps with the gate section 112, and as a result, the first and second overlapping regions 148 and 150 overlap at least partially with the first and second gates 118 and 120 (hidden by the first and second overlapping regions 148 and 150 in Figure 12D).

[0105] Referring again to Figure 5, in step 510, the trunk section 110 and the gate section 112 are joined. Referring now to Figure 12E, the trunk section 110 is shown with the tail portion 146 wrapped around through the gap 230. Although not shown in the figure, it is understood that the tail portion 146 is wrapped around through the gap 230 and is positioned along the second tapered section 228 of the mandrel 200, either inside or outside the trunk section 110, or the other. With this configuration, the uncut portion (e.g., 170 or 172) of the tubular body 162 extending between the first gate 118 and the second gate 120 is located between the distal end 210 of the first section 202 of the mandrel 200 and the tail portion 146. The wound portion of the tail section 146 can be fixed or joined to one or more pieces of the trunk section 110, the gate section 112, and / or any element of the graft material in the region of the second tapered section 228 of the mandrel 200. The fixing or joining of the tail section 146 can be done by one or more adhesives or by other known methods. By winding the tail section 146 in this manner, the trunk section 110 and the gate section 112 can be joined together in at least the region of the branch 138. In various examples, the first overlapping region and the second overlapping regions 148 and 150 can be fixed to the first gate and the second gates 118 and 120 to further join the trunk section 110 and the gate section 112 to form the intraluminal device 100. At this stage, it should be understood that the first overlap region and the second overlap region 148 and 150 can be fixed to the first gate and the second gate 118 and 120 using one or more adhesives or according to other known methods.

[0106] Referring again to Figure 5, in step 512, the graft mounting member is applied along the trunk section 110 and the gate section 112. Figure 12F provides an illustrative diagram showing the graft mounting member 178 wound around the trunk section and the gate sections 110 and 112. The graft mounting member 178 can be any suitable graft material as described above. It should be understood that other suitable methods can be used to position the graft mounting member around the trunk section 110 and the gate sections 112. For example, a prefabricated tubular graft mounting member can be advanced over the trunk section and the gate sections 110 and 112 and positioned along them. In some examples, when assembled on the mandrel 200, measuring from the proximal end 144 of the trunk section 110 to the ends 164 and 166 of the first and second gate sections 110 and 112, the graft mounting member 178 has a longitudinal length that exceeds the longitudinal length of the trunk section 110 and the gate sections 112. A typical example of such a configuration is shown in Figure 12G, where the graft attachment member 178 is applied so as to extend from the proximal end 144 of the trunk section 110 to the distal ends 164 and 166 of the first gates 118 and 120.

[0107] In various examples, after the graft mounting member 178 is applied, an assembly including at least the graft mounting member 178, the trunk section 110, and the gate section 112 is joined together. This can be achieved by known methods such as heating, pressurizing, compression, or a combination thereof.

[0108] In various cases, after joining the graft attachment member 178 and one or more of the trunk section and gate sections 110 and 112 together, the resulting assembly can be trimmed to a desired length to define the proximal end 106 and distal end 108 of the intraluminal device 100. Trimming can be performed before or after removing the assembly from the mandrel 200.

[0109] Figure 12H shows the intraluminal device 100 mounted on the mandrel 200. The intraluminal device 100 is shown together with an annular stent element 122. The annular stent element 122 can be applied to the trunk section 110 before it is mounted on the mandrel 200, or it can be applied to the trunk section 110 after it has been mounted on the mandrel 200. For example, the annular stent element 122 can be applied to the trunk section 110 after the graft attachment member 178 has been attached to the trunk section and gate sections 110 and 112. In such a configuration, as shown in Figure 12H, the annular stent element 122 is positioned around the outside of the graft attachment member 178, while the graft attachment member 178 is positioned around and outside the annular stent element 124. In some examples, one or more additional coatings of graft material can be applied around and outside the intraluminal device 100 such that the annular stent element 124 is positioned between the graft attachment member 178 and the additional coating of graft material.

[0110] It will be apparent to those skilled in the art that various modifications and changes can be made to the present invention without departing from the spirit or scope of the invention. Accordingly, the present invention is intended to encompass modifications and changes to the invention as long as they fall within the scope of the appended claims and equivalent forms thereof.

Claims

1. A branching portion comprising a first tubular graft element having a first leg, a second leg, and a folding region located between the first leg and the second leg that defines the branch, The first leg portion is defined between the first end of the first tubular graft element and the folding region. The second leg portion is defined between the second end of the first tubular graft element and the folding region, and The folding region defines a branch portion which includes at least one tab extending away from the folding region, and A trunk portion extending from the aforementioned branch and fixed to the tab of the branch portion to form an intraluminal device, An intraluminal device comprising the above.

2. The intratubular device according to claim 1, wherein the trunk portion is formed as a second tubular graft element fixed to the first tubular graft element.

3. The intraluminal device according to claim 1, further comprising graft material applied at least partially to the outside of the trunk portion and the branch portion such that the graft material extends along at least a portion of the first leg and the second leg to maintain the alignment of the first leg and the second leg.

4. The intraluminal device according to claim 1, wherein the longitudinal axis of the first leg is parallel to the longitudinal axis of the second leg.

5. The intraluminal device according to claim 1, wherein a first cutting line is defined around the first tubular graft element in a first region between the first end and the second end, where the first tubular graft element is cut along the first cutting line around a portion shorter than the entire first cutting line defining a first incised portion and a first unincised portion.

6. The intraluminal device according to claim 5, wherein the first tubular graft element is folded along the first non-incisional portion to define the folded region.

7. In a second region between the first end and the second end, which is longitudinally offset from the first region, a second cutting line is defined around the first tubular graft element, where the first tubular graft element is cut along the second cutting line around a portion shorter than the entire second cutting line defining a second incised portion and a second unincised portion, and a third cutting line extends from the first cutting line to the second cutting line, and the first tubular graft element is cut along the third cutting line, according to claim 5.

8. The intraluminal device according to claim 7, wherein the first tubular graft element is folded along the second non-incisional portion, where the folded region includes the folded first non-incisional portion and the folded second non-incisional portion.

9. The intraluminal device according to claim 7, wherein the folding region is defined as the boundary region between the first cutting line and the second cutting line, and the third cutting line divides the folding region longitudinally from the first cutting line to the second cutting line.

10. The intraluminal device according to claim 9, wherein the folding region defines a first tab and a second tab opposite to the first tab, and the free ends of the first tab and the second tab are defined by the third cutting line.

11. The intraluminal device according to any one of claims 1 to 10, further comprising a support structure applied along the trunk portion.

12. The intraluminal device according to claim 11, wherein the support structure is at least one stent.

13. The intraluminal device according to claim 11, wherein the support structure is located between the trunk portion and the graft material surrounding the trunk portion.

14. The intraluminal device according to any one of claims 1 to 10, further comprising a support structure applied along one or more of the first and second legs.

15. The intraluminal device according to claim 14, wherein the support structure is at least one stent.

16. The intratubular device according to claim 14, wherein the support structure is located between the first tubular graft element and the graft material surrounding the first tubular graft element.

17. Main graft body, and Single tubular structure A multi-lumen graft device comprising, The aforementioned single tubular structure is Multiple graft legs defining multiple lumens, A folding region located between the graft legs and defining the branching portion, A plurality of tabs extending away from the aforementioned folding region, the tabs overlapping with at least a portion of the main graft body, A multi-lumen graft device comprising a defined area, wherein the main graft body is coupled to the plurality of tabs and overlaps with at least a portion of the plurality of graft legs.

18. The multi-lumen graft device according to claim 17, wherein at least one stent element is attached to the main graft body and the single tubular structure.

19. The multi-lumen graft device according to claim 17 or 18, wherein the plurality of tabs form a flat taper at the transition between the plurality of graft legs of the single tubular structure and the main graft body.

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