Patent Publication Number: US-2023157805-A1

Title: Aortic graft assembly

Description:
RELATED APPLICATIONS 
     This application is a continuation U.S. patent application Ser. No. 16/528,267, filed Jul. 31, 2019, which is a continuation of U.S. patent application Ser. No. 15/417,467, filed Jan. 27, 2017, which is a divisional of U.S. patent application Ser. No. 13/788,724, filed Mar. 7, 2013, which is a continuation of International Application No. PCT/US2012/065622, filed on Nov. 16, 2012, which claims the benefit of U.S. Provisional Application No. 61/560,517, filed on Nov. 16, 2011. The entire teachings of the above applications are incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     Aortic aneurysms are life-threatening conditions. Surgical interventions used to treat aortic aneurysms include endovascular repair by transluminal placement of one or more endografts across the longitudinal extent of the lesion. The endograft is placed in the aorta with the intention of bridging the aneurysmal sac to exclude it from the high-pressure of aortic blood flow, which can permit remodeling of the aortic wall in and around the aneurysm site. In certain regions of the aorta accurate placement of the endograft is critical to maintain blood flow to vessels branching from the aorta to minimize compromised blood flow to organs. For example, currently, if aortic devices are placed within the aortic arch in a manner that offsets the aperture for the left carotid artery, the artery can be occluded, which can result in ischemia to the brain. Most surgical methods of treating aneurysms at or near the aortic arch generally involve sternotomy or thoracotomy and may require cardio-pulmonary bypass, often resulting in high morbidity rates. Thus, there is a need to develop new and useful devices and methods of treating aortic aneurysms by endovascular methods. 
     SUMMARY OF THE INVENTION 
     The present invention relates to vascular repair systems, delivery systems and methods of using the delivery systems and its components to treat aortic vascular damage, in particular, vascular damage associated with aortic disease, such as, aneurysms, penetrating atherosclerotic ulcers and dissection. 
     In an embodiment, the invention is an aortic graft assembly that includes a tubular aortic component having a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends. The aperture has a proximal end that extends perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis. A tunnel graft is connected to the wall of the tubular aortic component and extends from the wall aperture toward the proximal end of the tubular aortic component. The tunnel graft has a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component. A proximal stent abuts the proximal end of the aperture, and a distal stent abuts a distal end of the aperture. 
     In yet another embodiment, the invention is an aortic graft assembly, comprising a tubular aortic component that includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis; a tunnel graft connected to the wall of the tubular aortic component and extending from the wall aperture toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component; a proximal stent that supports the proximal end of the tubular aortic component; a distal stent that supports the distal end of the tubular aortic component; a clasping stent at the proximal end of the tubular aortic component, the clasping stent including at least two exposed proximal apices proximate to the proximal end of tubular component and attached to an interior wall of the tubular aortic component; and a crown stent between the clasping stent and the proximal end of the tubular aortic component, the crown stent attached to an interior surface of the tubular aortic component. 
     In a further embodiment, the invention is an aortic graft assembly, comprising a tubular aortic component that includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis; a tunnel graft connected to the wall of the tubular aortic component and extending from the wall aperture toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component; a proximal stent that abuts the proximal end of the tubular aortic component; a distal stent that supports the distal end of the tubular aortic component; an abutting distal stent that includes at least one proximal apex that abut the distal end of the wall aperture; a clasping stent at the proximal end of the tubular aortic component, the clasping stent including at least two exposed proximal apices proximate to the proximal end of tubular component and attached to an interior wall of the tubular aortic component; and a crown stent between the clasping stent and the proximal end of the tubular aortic component, the crown stent attached to an interior surface of the tubular aortic component. 
     In another embodiment, the invention is a method for implanting a prosthesis, including delivering a tubular aortic component defining a wall aperture through an aorta of a patient to an aneurysm site of the patient, the tubular aortic component being radially and releasably constrained by a distal clasp at a distal end of an outer control tube of a delivery device, and releasably attached by a retention component to a proximal clasp at the outer control tube proximal to the proximal clasp, the tubular aortic component further supported by a control catheter of the delivery device extending within the outer control tube. The wall aperture is aligned over at least one vessel ostium at the aneurysm site of the patient. The outer tube is retracted, thereby releasing the tubular aortic component from the distal and proximal clasps, thereby deploying the tubular aortic component at the aneurysm site. 
     In an additional embodiment, the invention is a method for implanting a prosthesis, comprising the steps of delivering a tubular aortic component defining a wall aperture through an aorta to an aneurysm site of a patient, the tubular aortic component being radially and releasably constrained by a distal clasp at a distal end of an outer control tube of a delivery device, and releasably attached by a retention component to a proximal clasp at the outer control tube proximal to the proximal clasp, the tubular aortic component further supported by a control catheter of the delivery device extending within the outer control tube; aligning the wall aperture over at least one vessel ostium at the aneurysm site of the patient; retracting the outer control tube, thereby releasing the tubular aortic component from the distal and proximal clasps, thereby deploying the tubular aortic component at the aneurysm site in the patient, wherein at least one supporting wire extends from the control tube, said supporting wire extending through a suture loop inside the proximal end of the tubular aortic component to thereby prevent collapse of the proximal end of the tubular component during deployment. The method can further includes the step of partially retracting an inner sheath from around the tubular aortic component, whereby the supporting wire at least partially restricts longitudinal movement of the proximal end of the tubular aortic component until the proximal end of the tubular aortic component is secure within the aorta, to thereby prevent collapse of the proximal end of the tubular aortic component at an inferior portion of the aorta, wherein the inner sheath is releasably secured to a distal end within a cavity defined by a proximal end of the nose cone, wherein the steps of the method include partially retracting an inner sheath from around the tubular aortic component to release the distal end of the inner sheath from the nose cone and thereby cause partial deployment of the tubular aortic component; partially retracting the control catheter to thereby release the clasping stent from the distal apex clasp and the retention component from the proximal clasp; further retracting the control catheter to at least partially retract the nose cone to within the tubular aortic component while retaining the suture loops on the supporting wires; advancing the tubular aortic component to a final position in the aorta of the patient spanning the aneurysm; fully retracting the inner sheath from the tubular aortic component; and fully retracting the nose cone and supporting wires to release the suture loops from the supporting wires, thereby fully deploying the tubular aortic component within the aorta of the patient. 
     In an embodiment, a stent defining the aperture permits blood flow into the ostium of the target vessel, unlike other systems that rely on a narrowing or dog-bone shape of the body of the tubular aortic component of an aortic graft system to permit blood flow outside and around the tubular graft component if the surgeon is unable to align the aperture with the ostium of the target vessel. 
     The aortic graft assembly of the invention does not require precise radial or longitudinal alignment in the aorta and permits approximate alignment, which is beneficial in reducing the manipulation of the aortic arch and resulting stroke in the patient. The claimed systems can be fully deployed before the surgeon completes the endovascular procedure by deployment of the first tunnel or second tunnel graft, unlike current aortic components that are in a “dogbone” configuration to guard against unintentional obstruction of the target ostium. The delivery device employed with the graft assembly aids in proper alignment of the assembly in the aorta by, for example, use of a curved guidewire catheter, proximal clasp and distal clasp. 
     The aortic assembly systems and methods of the invention can be employed to treat aortic aneurysms, such as aortic aneurysms at, near or around the arch of the aorta, or branches from the abdominal aorta (e.g., celiac artery, superior mesenteric artery and renal arteries). The aortic assembly systems of the invention have a relatively large aperture tapered into a tunnel graft that provides the surgeon with a relatively large margin of error in placement of the system, facilitates cannulation and permits alignment of a single aperture for at least one blood vessel. Aortic assembly systems of the invention that include a tunnel graft having one aperture extending proximally with two openings permit for easy alignment in the aorta, particularly in regions of the aorta that branch to peripheral and major vessels. The size of the aperture allows blood to flow to target vessels during the procedure. The aortic graft assembly of the invention generally does not restrict blood flow acutely or chronically, in part, because of a relatively large diameter of the tunnel graft and the stent or stents supporting the tunnel graft. 
     Barbs in the interior of the tunnel grafts of the branched graft assembly have the advantage of securing connection of the tubular component to the tunnel graft. The telescoping ability of the graft assembly systems of the invention, for example, the length and different configurations of the tunnel graft, allow the tubular component to be positioned in-situ to ensure maximum use of a “landing zone” inside the target vessel. A relatively long tunnel length can ensure adequate overlap with the tubular component into the tunnel grafts to ensure a sufficient seal. 
     The delivery device of the invention also has the advantage of allowing the proximal end of the stent graft to be aligned perpendicular to the center line axis of the “landing zone.” This is of key concern when the landing zone is in Zone 0 ( FIGS.  15 ,  16 ,  17   ) of the ascending aorta. When landing in this area much care must be taken to avoid accidental coverage of the coronary arteries, typically the left coronary artery. 
     Thus, the aortic graft assembly, delivery systems, and methods of the invention can be used to treat various aortic pathologies, including aortic aneurysms, penetrating atherosclerotic ulcers, dissections and, therefore, avoid complications and death consequent to life-threatening vascular conditions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS.  1 A,  1 B and  1 C  represent an embodiment of an aortic assembly system of the invention. 
         FIGS.  2 A and  3 A  represent cross sectional views of the aortic assembly system of the invention, shown in  FIG.  1 A , taken along line  2 A. 
         FIGS.  2 B and  3 B  represent a longitudinal view of  FIGS.  2 A and  3 A  of an aortic assembly system of the invention. 
         FIGS.  4 A and  4 B  represent embodiments of an aortic assembly system of the invention, taken from views  4 A and  4 B of  FIGS.  2 A and  2 B . 
         FIG.  5    is a perspective view into the proximal end of one embodiment of the invention. 
         FIG.  6    represents another embodiment of an aortic assembly system of the invention. 
         FIGS.  7 A and  8 A  represent additional embodiments of an aortic assembly system of the invention. 
         FIGS.  7 B and  8 B  represent additional embodiments of an aortic assembly system of the invention taken along lines  7 B and  8 B of  FIGS.  7 A and  8 A , respectively. 
         FIGS.  9 A and  10 A  represent additional embodiments of an aortic assembly system of the invention. 
         FIGS.  9 B and  10 B  represent further embodiments of an aortic assembly system of the invention taken along lines  9 B and  10 B of  FIGS.  10 A and  10 B , respectively. 
         FIG.  11    is a perspective view of one embodiment of an aortic assembly system of the invention mounted on one embodiment of a delivery system of the invention. 
         FIG.  12    represents placement of an embodiment of an aortic graft assembly of the invention in the ascending aorta, aortic arch and a portion of the descending aorta of a subject. 
         FIG.  13    represents zones (0, 1, 2, 3 and 4) of the aorta and major vessels branching from the aorta (prior art). 
         FIG.  14    represents zones (0, 1, 2, 3 and 4) of the aorta, an aortic aneurysm, a right carotid artery to left carotid artery bypass, a left carotid artery to left subclavian artery bypass and ligation of the left carotid and left subclavian arteries (prior art). 
         FIG.  15    represents zones (0, 1, 2, 3 and 4) of the aorta, an aortic aneurysm, a left carotid artery to left subclavian artery bypass and ligation of the left subclavian artery (prior art). 
         FIGS.  16 A- 16 F  are a representation of one embodiment of an aortic assembly system of the invention of one embodiment of a delivery system of the invention. 
         FIGS.  17 A- 17 C  are side, cross-sectional and perspective views of one embodiment of the invention, respectively. 
         FIG.  18    is a perspective view of a nose cone, and inner sheath tucked into a proximal cavity of the nose cone of one embodiment of the invention. 
         FIGS.  19 A and  19 B  represent alterative embodiments of an inner sheath of an embodiment of a delivery system of the invention. 
         FIG.  20    represents an alterative embodiment of an inner sheath of an embodiment of a delivery system of the invention. 
         FIGS.  21 A and  21 B  represent additional alterative embodiments of an inner sheath of an embodiment of a delivery system of the invention. 
         FIG.  22    represents an embodiment of a portion of a delivery system employed by the invention. 
         FIGS.  23 A- 23 D  represent additional views of an aortic assembly system and branch graft of the invention. 
         FIGS.  24 A- 24 E  represent method steps of one embodiment of a method of the invention. 
         FIGS.  25 A and  25 B  represent alterative embodiments of an inner sheath component of one embodiment of the invention. 
         FIGS.  26 A- 26 C  represent method steps of one embodiment of an alternative method of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the invention. 
     “Proximal” means, when reference is made to a delivery system or a component of a delivery system, such as an apex clasp and a nose cone, closest to the clinician using device. Likewise, “distal” means, when reference is made to a delivery system or a component of a delivery system, such as an apex clasp and a nose cone, away from the clinician using the device. 
     When reference is made to a prosthesis to be delivered, such as an aortic graft assembly, tubular aortic component, tunnel graft, branch graft and stent, the word “proximal” means that portion of the prosthesis or component of the prosthesis that is towards the heart of the patient and “distal” means that portion of the prosthesis or component of the prosthesis that is away from the heart of the patient. For clarity, the word “proximate” means close to as opposed to “proximal” or “distal.” 
     Aortic graft assemblies of the invention can be implanted, for example, by transfemoral access. Tubular branch components can be implanted, for example, by supraaortic vessel access (e.g., brachial artery), or by transfemoral or transapical access. 
     The invention is generally directed to an aortic graft assembly and a method for deploying the aortic graft assembly. The invention is also directed to methods of implanting at least one tubular branch graft into a patient and the aortic graft assembly. In one embodiment of the aortic graft assembly of the invention, represented in  FIG.  1 A  through  FIG.  1 C , aortic graft assembly  10  includes tubular aortic component  12  having proximal end  14  and distal end  16  connected by wall  18 . Wall  18  defines wall aperture  20  that is between proximal end  14  and distal end  16 . Wall aperture  20  has proximal end  22  that extends perpendicular to a major longitudinal axis  24  of tubular aortic component  12  when viewed orthogonally to major longitudinal axis  24 . Wall aperture  20  also defines distal end  26  of wall aperture  20 . 
     Tunnel graft  28 , shown, for example, in  FIGS.  2 A,  2 B,  3 A,  3 B,  4 A and  4 B  is connected to wall  18  of tubular aortic component  12  and extends from wall aperture  20  toward proximal end  14  of the tubular aortic component  12 . Tunnel graft  28  includes proximal end  30  and distal end  32 . Distal end  32  of tunnel graft  28  is at wall aperture  20  of tubular aortic component  12 . 
     Referring back to  FIGS.  1 A- 1 C , proximal stent  34  supports proximal end  14  of tubular aortic component  12 . Distal stent  36  supports distal end  16  of tubular aortic component  12 . Similarly, distal stent  36  can be attached to an interior wall to tubular aortic component  12 . 
     Optionally, radiopaque markers  38  are located along a line parallel to major longitudinal axis  24  of tubular aortic component  12 . In one embodiment, radiopaque marker  38  is at a proximal apex of wall aperture distal stent  50  abutting wall aperture  20 . Another radiopaque marker is at a distal apex  48  of proximal stent  34 . Further, radiopaque marker  38  is at least one of proximal end  14  and distal end  16  of tubular aortic component  12 . Also optionally, radiopaque markers  40  extend about the circumference of wall aperture  20  at tubular aortic component  12 . Radiopaque markers  38 ,  40  can be made of any suitable material such as platinum, iridium, gold, etc. Examples of radiopaque markers are described in the U.S. Pat. No. 8,062,345 and U.S. Published Patent Application No.: US 2010/0030255, the entire teachings of which are incorporated herein by reference. 
     Proximal stent  34  in one embodiment, shown in  FIGS.  1 A,  1 B and  1 C , includes proximal apices  46  and distal apices  48 . In one embodiment, at least a portion of distal apices  48  abut proximal end  22  of wall aperture  20 . Wall aperture distal stent  50  includes proximal apices  52  and distal apices  54 , a portion of proximal apices  52  of wall aperture distal stent  50  abut distal end  26  of wall aperture  20 . Clasping stent  56  at proximal end  14  of tubular aortic component  12  includes at least two exposed proximal apices  58  proximate to proximate end  14  of tubular aortic component  12 . In one embodiment, clasping stent  56  is attached to an interior wall of tubular aortic component  12 . 
     Crown stent  60  is located between clasping stent  56  and proximal end  14  of tubular aortic component  12 . As can be seen in  FIG.  5   , at least two support wire sutures  62  are located within tubular aortic component  12  at proximal end  14  of tubular aortic component  12 , distal to proximal apices  58  of clasping stent  56 . Support wires sutures  62  are separated by at least one distal apex  61  of clasping stent  56 . In one embodiment, proximal apices  59  of crown stent  60  are blunted, as shown in  FIG.  1 A . Crown stent  60  and clasping stent  56  can be nested, as shown in  FIG.  1 A . Crown stent  60  and clasping stent  56  are attached to interior wall  76  of tubular aortic component  12 . 
     At least one stent  64  is located at tubular aortic component  12  between proximal stent  34  and distal stent  36 . At least a portion of stents  64  include proximal apices  66  and distal apices  68  connected by struts  70 . At least one partial stent  72  is located at tubular aortic component  12  between stents  34 ,  50  abutting proximal  22  and distal  26  ends of wall aperture  20 , respectively, as shown in  FIGS.  1 B and  1 C . 
     Stents employed in the invention are constructed of a suitable material. In one embodiment, the stents employed by the invention include a suitable shape memory alloy, such as nitinol. Further description of suitable materials for construction of stents for use in the invention can be found in U.S. Pat. Nos. 7,763,063 and 8,062,345, the teachings of which are incorporated herein by reference in their entirety. 
     In one embodiment, the arc length of proximal end  22  of wall aperture  20  is equal to or less than one-half the circumference of tubular aortic component  12 . Examples of suitable arc lengths of proximal end  22  of wall aperture  20  include arc lengths equal to one member selected from the group consisting of about 6 mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm. In one embodiment, a longitudinal length of wall aperture  20  is equal to or less than about 90 mm. In another embodiment, the longitudinal length of wall aperture  20  is equal to or greater than about 14 mm. 
     Referring to  FIGS.  2 A,  2 B,  3 A and  3 B , the distance between proximal end  22  of wall aperture  20  and proximal end  14  of tubular aortic component  12  can be in a range of between about 10 mm and about 80 mm. In a typical embodiment, the distance between proximal end  22  of wall aperture  20  and proximal end  14  of tubular aortic component  12  is one member selected from the group consisting of about 20 mm, about 40 mm, about 60 mm, about 80 mm or about 90 mm. In one embodiment, the distance between proximal end  22  of wall aperture  20  and proximal end  12  of tubular aortic component  12  is about 40 mm, as shown in  FIGS.  2 A and  2 B . In another embodiment, the distance between proximal end  22  of wall aperture  20  and proximal end  14  of tubular aortic component  12  is about 60 mm, as shown in  FIGS.  3 A and  3 B . 
     In one embodiment, shown in  FIG.  1 A , retention component  78  is located at tubular aortic component  12  distal to wall aperture  20  and within tubular aortic component  12  (only external portion of retention component  78  is shown in  FIG.  1 A ). In one embodiment, retention component is a suture loop. In another embodiment, retention component  78  is at least one of a magnet or a stent apex. In still another embodiment, retention component  78  is radiopaque. In one embodiment, retention component  78  is at a proximal apex  52  of stent  50  abutting distal end  26  of wall aperture  20 . 
     In another embodiment, shown in  FIG.  6   , circumferential stent  80  is located at tubular aortic component  12  and surrounds wall aperture  20 . In one embodiment, a circumferential stent  80  surrounding wall aperture  20  defines, at least in part, wall aperture  20 . In one embodiment, the diameter of proximal end  14  of tubular aortic component  12  is greater than the diameter of distal end  16  of tubular aortic component  12 , as shown in  FIG.  1 B . 
     In one embodiment, shown in  FIGS.  7 A,  8 A,  9 A and  10 A , the interface between tubular aortic component  12  and wall aperture  20 , when viewed orthogonally to major longitudinal axis  24  of tubular aortic component  12  is a polygon, such as is shown in the referenced figures, a polygon having four sides. In various embodiments, the polygon can be a square, a rectangle, a parallelogram, or a rhombus (not shown). 
     In a specific embodiment, inferior portion  83  is on one side of tubular aortic component  12  opposite wall aperture  20  and is essentially parallel to major longitudinal axis  24  of tubular aortic component  12 , shown in  FIG.  1 B . Exposed apices  58  of clasping stent  56 , when collapsed will cause at least partial collapse of proximal end  14  of tubular aortic component  12  at clasping stent  56 , as can be seen in  FIG.  11   . At least one of support wire sutures  62  are at inferior portion  83  within tubular aortic component  12 . In a specific embodiment, support wire sutures  62  are at apices of clasping stent  56 . Preferably, support wire sutures  62  are separated by at least one proximal apex of clasping stent. 
     In one embodiment, distal end  32  of tunnel graft  28  has a diameter greater than that of proximal end  30  of tunnel graft  28 , as can be seen in  FIGS.  2 A and  3 A . In another embodiment, proximal end  30  of tunnel graft  28  is between the most proximal edge of proximal end  14  of tubular aortic component  12  and proximal end  22  of wall aperture  20 , as shown in  FIGS.  2 A,  2 B,  3 A,  3 B,  4 A and  4 B . As shown in  FIGS.  4 A and  4 B , tunnel graft  28  is secured to an interior wall of tubular aortic component  12  by a suitable means, such as by sutures  29 . 
     As can be seen in  FIGS.  1 B,  1 C,  2 A,  2 B,  3 A and  3 B , tunnel graft  28  includes open portion  84  at wall aperture  20 . Tubular portion  86  extends proximally from open portion  84 , as shown in  FIGS.  2 A,  2 B,  3 A and  3 B . In one embodiment, tubular portion includes stents  88 ,  90  at each of a proximal  92  and distal end  94  of tubular portion  86 , as shown in  FIGS.  2 B and  3 B . Preferably, stents  88 ,  90  at proximal  92  and distal  94  ends of tubular portion  86  includes proximal and distal apices connected by struts. Preferably, stent  88  at proximal end  92  of tubular portion  86  includes at least one barb  96  ( FIG.  2 B ). In another embodiment shown in  FIG.  3 B , barbs  96  extend for distal apices of stent  98  of tubular portion  86 . Optionally, tubular portion  86  further includes at least one stent  98  between stents  88 ,  90  at proximal  92  and distal  94  ends, respectively, of tubular portion  86 . Preferably, at least one of stents  98  between stents  88 ,  90  at proximal end  92  and distal end  94  includes at least one barb. Most preferably, stents of tubular portion  86  include nitinol. 
     As can also be seen in  FIGS.  2 A and  2 B and  3 A and  3 B,  4 A and  4 B , distal end  94  of tubular portion  86  is generally conical, whereby distal end  94  of tubular portion  86  essentially matches proximal end  92  of tunnel graft  28  at proximal end  22  of wall aperture  20 , as a continuum or, optionally, at a seam, not shown. In one embodiment, a maximum diameter of proximal end of tunnel graft  28  is equal to or less than the diameter of distal end of tubular portion  94 . Examples of suitable maximum diameters of proximal end  30  of tunnel graft  28  include, for example, diameters equal to or greater than a diameter selected from the group consisting of about 6 mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm. 
     Preferably, tubular portion  86  has a major longitudinal axis that is parallel to major longitudinal axis  24  of tubular aortic component  12 . Proximal end  92  of tubular portion  86  is distal to the most proximal edge of proximal end  14  of tubular aortic component  12 . In one embodiment, not shown, proximal end  92  of tubular portion  86  is coterminous with the most proximal edge of proximal end  14  of tubular aortic component  12  or, alternatively, as shown in  FIGS.  2 A and  2 B and  3 A and  3 B,  4 A and  4 B , is distal to proximal end  14  of tubular aortic component  12 . In another embodiment, tubular portion  86  has a major axis at an angle A  81  relative to major longitudinal axis  24  of tubular aortic component  12 , as shown in  FIG.  9 A . In one embodiment, the angle is in the range of at least one of between about 0° and about 90°, such as 10°, 20°, 30°, 45°, 60°, and 90° C. 
     Further, as shown in  FIGS.  9 A and  9 B , proximal end  92  of tubular portion  86  has geometric center  150  that is distinct from a geometric center  152  of tubular aortic component  12 , wherein line  154  defined by geometric center  150  of proximal end  92  of tubular portion  86  and geometric center  152  of tubular aortic component  12  in a plane defined by proximal end  92  of tubular portion  86 , taken along line  9  B of  FIG.  9 A , is at a positive angle B from line  156  defined by geometric center  152  of tubular aortic component  12  and point  158  along centerline  160  bisecting wall aperture  20  and parallel to major longitudinal axis  24  ( FIG.  1 A ) of tubular aortic component  12 , point  158  being in the same plane as the geometric centers  150 ,  152  of proximal end  92  of tubular portion  86  and tubular aortic component  12 , respectively. Examples of suitable positive angles B can be at least one member selected for the group consisting of ±10°, ±20°, ±30°, ±45°, ±60°, ±90°, ±120°, ±135°, ±160°, ±170° and 180°. 
     In one embodiment, at least one radiopaque marker  99  is located at at least one of proximal end  92  of tunnel graft  28  and distal end  94  of tubular portion  86  of tunnel graft  28 , as shown in  FIGS.  2 B,  3 B and  4 B . Another embodiment includes tubular portion  100  and further includes second tubular portion  102  of tunnel graft  28  extending proximal to open portion  84  of the tunnel graft  28 , wherein second tubular portion  102  has distal end  104  and proximal end  106  as shown in  FIGS.  7 A,  7 B,  8 A and  8 B . In one embodiment, not shown, second tubular portion  102  is of unequal length to that of first tubular portion  100 . In another embodiment, shown in  FIGS.  7 A and  7 B , second tubular portion  102  is parallel to first tubular portion  100 . First tubular portion  100  and second tubular portion  102  are each a distinct, and integrally complete tubular portion. In another embodiment, shown in  FIGS.  8 A and  8 B , tubular portions share common wall of a first graft material  108  that partition a conduit of the second graft material  110 . In this embodiment, first  108  and second  110  graft materials define, at least in part, first tubular portion  100  and second tubular portion  102 . As shown in  FIGS.  10 A and  10 B , tubular portions  112  and  114  extend away from each other and proximally from open portion  84 . 
     In still another embodiment, shown in  FIGS.  2 A,  2 B,  3 A,  3 B,  4 A and  4 B , proximal end  92  of tunnel graft  28  has a diameter in a range between about 5 mm and about 10 mm, or between about 5 mm and about 15 mm, or between about 8 mm and about 15 mm. Generally, tubular portion  86  has a length in a range of between about 20 mm and about 60 mm, or between about 20 mm and about 100 mm. Most commonly, tubular portion  86  has a length in a range between about 30 and 50 mm. Preferably, proximal end  92  of tunnel graft  28  is within at least about 5 mm, about 10 mm, and about 15 mm or about 20 mm of proximal end  14  of tubular aortic component  12 . 
       FIG.  12    shows one embodiment of aortic graft assembly  10  of the invention fully deployed within aorta  117  of a patient.  FIGS.  13 - 15    show various stages of an aortic bypass operation (prior art). 
     As shown, in  FIGS.  16 A- 16 F , aortic graft assembly  200  ( FIG.  16 A ) includes delivery component  202  ( FIG.  16 B ) to which tubular aortic component  12  ( FIG.  16 A ) is attached ( FIGS.  16 A and  16 C ). Delivery component  202  includes control catheter  204  ( FIG.  16 B ), about which tubular aortic component  12  ( FIG.  16 C ) extends, nose cone  206  ( FIGS.  16 B and  16 C ) is fixed at a distal end of control catheter  204  ( FIGS.  17 A and  17 B ). 
     In one embodiment, shown in  FIGS.  17 A,  17 B and  17 C , delivery component  202  further includes inner sheath  210  extending about control catheter  204 . A distal opening at distal end  214  of inner sheath  210 , can be tucked into nose cone  206  ( FIGS.  17 A,  17 B and  18   ). In still another embodiment, shown in  FIGS.  19 A and  19 B , inner sheath  210  includes inferior portion  82 , said inferior portion  82  having fluted portion  85  as can be seen in  FIG.  20   . Optionally, as can be seen in  FIGS.  21 A and  21 B , inner sheath  210  can be tapered to narrow toward distal end  211  or of essentially constant diameter. In one embodiment, inner sheath  210  defines at least one through hole  280  at proximal end  282  of inner sheath  210 , as shown in  FIGS.  25 A and  25 B . 
     As can be seen in  FIGS.  17 A and  17 B , introducer sheath  216  extends about inner sheath  210  and about tubular aortic component  12 , wherein introducer sheath  216  is retractable relative to inner sheath  210  to thereby release distal end  214  of inner sheath  210 . Nose cone  206  can thereafter be retracted within inner sheath  210 . 
     Delivery component  202 , shown in  FIGS.  17 A,  17 B,  17 C and  22   , further includes at least one supporting wire  230  fixed at proximal end  224  to support base  235 , substantially parallel to a major longitudinal axis of outer control tube  232  and free at the distal end  228 , wherein free end  228  of at least one of supporting wire  230  and internal sutures  62  ( FIG.  17 B ) at the proximal end  14  of tubular aortic component  12  releasably secures proximal end  14  of tubular aortic component  12  to at least one of supporting wires  230 . Outer control tube  232  is slidable along control catheter  204 . Supporting wires  230  are fixed at proximal ends  224  to support base  235  at outer control tube  232  distal to proximal apex clasp  240 . Free ends  228  of support wires  230  are proximate to proximal end  14  and to nose cone  206 . Proximal portion  252  of distal apex clasp  238  and outer control tube  232  are slidable along the control catheter  204  with movement of outer control tube  232  ( FIGS.  16 B and  22   ). Distal apex clasp  238  fixes proximal end  14  of tubular aortic component  12  by securing exposed apices  58  ( FIG.  16 C ) of clasping stent  56  at proximal end  14  of tubular aortic component  12 . As shown in  FIG.  16 B , distal portion  248  of distal apex clasp  238  mates with of teeth  252  of proximal portion  250  of distal apex clasp  238  in a closed position that secures exposed apices  58  of clasping stent  56  of tubular aortic component  12 . 
     Proximal apex clasp  240  is at outer control tube  232  ( FIG.  17 B ). Proximal apex clasp  240  includes teeth  246  ( FIG.  16 B ) extending distally from proximal portion  244  of proximal clasp  240 . Teeth  246  extend distally through retention component  78  of tubular aortic component  12 , as shown in  FIG.  17 B . 
     As shown in  FIGS.  23 A- 23 D , tubular branch component  254  includes proximal end  256  and distal end  258 , wherein proximal end  256  of tubular branch component  254  is configured to engage proximal end  30  of tunnel graft  28 . In an embodiment, the engagement is by interfering relation between tubular branch component  254  and tunnel graft  28 . When aortic graft assembly  10  is implanted in the aorta of a patient, a seal forms with at least one member of the group consisting of the proximal end of at least one of the tubular aortic component  12 , tubular branch component  254  and second tubular branch component  260 , and the distal end of at least one of tubular aortic component  12 , tubular branch component  254  and second tubular component  260 . A “seal” as defined herein, means that essentially no fluid will seep between the wall of a first conduit and the wall of a second conduit within which the first conduit is located. Such seals typically will be at the most proximal portion of a juncture between nested first and second conduits. 
     In one embodiment, supporting wire  230  has at least one stop  274  ( FIG.  11   ), wherein stop  274  limits movement of suture loop  62  along supporting wire  230 . 
     In another embodiment, tubular aortic component  12  includes radiopaque sutures  18  and inner sheath  210  includes radiopaque markers  276 , all of which are longitudinally aligned along a path of relative movement of inner sheath  210  ( FIGS.  16 A- 16 F and  17 A- 17 C ) and tubular aortic component  12  during deployment of tubular aortic component  12 , and are spaced apart from each other, whereby partial retraction of inner sheath  210  will cause overlap of radiopaque markers  276  with radiopaque markers  38 . In one embodiment, radiopaque markers  38  are also, or alternatively, on superior portions of inner sheath  210  and tubular aortic component  12 . Preferably, radiopaque markers  38 ,  276  are asymmetric, wherein a shape of radiopaque markers  38 ,  276  changes as radiopaque markers  38 ,  276  are aligned with a surgical site. Preferably, radiopaque markers  38 ,  276  of tubular aortic component  12  are elongated and are substantially aligned with the major longitudinal axis  24  of inner sheath  210 . 
     In a preferred embodiment, referring back to  FIGS.  16 A- 16 F and  17 A- 17 C , tubular aortic component  12  is further constrained at at least one end by a clasp, such as distal apex clasp  238  or proximal apex clasp  240 , and the method includes the step of releasing the clasp with retraction of supporting wire  230  from suture loop  62  of tubular aortic component  12 . In this embodiment, preferably, tubular aortic component  12  further includes at least one radiopaque marker  38 , wherein, preferably, radiopaque marker  38  is located on tubular aortic component  12  facing away from cavity  284  ( FIG.  18   ) of the curve  286  ( FIG.  18   ) defined by control catheter  204 . Preferably, inner sheath  210  further includes at least one radiopaque marker  276 , wherein radiopaque marker  276  of inner sheath  210  overlaps at least one radiopaque marker  276  of tubular aortic component  12  when tubular aortic component  12  is partially deployed. In still another embodiment, tubular aortic component  12  is further constrained by proximal clasp  240  and proximal fixed end  234  of supporting wire  230 . 
     A method for implanting a prosthesis of the invention includes the steps of delivering tubular aortic component  12  within introducer sheath  216  along guidewire  320  through an aorta  262  to aneurysm  270  of the patient, shown in  FIGS.  24 A- 24 E . Tubular aortic component  12  is radially constrained and supported at least in part by control catheter  204  ( FIGS.  16 B,  16 C,  16 D ), which is slidable along guidewire  320  ( FIGS.  24 A- 24 E ). As shown in  FIGS.  16 A- 16 F and  17 A- 17 C , tubular aortic component  12  is further longitudinally constrained by at least one supporting wire  230  extending from support base  235  at outer control tube  232  extending about and slidable along control catheter  204 . Free end  228  of at least one of supporting wire  230  is arcuate and extends through suture loop  62  ( FIG.  17 B ), within proximal end  14  of tubular aortic component  12 . 
     Referring back to  FIGS.  24 A- 24 E , tubular aortic component  12  is guided to aneurysm  270  along guidewire  320 . Inner sheath  210  ( FIG.  17 B ), is partially retracted from tubular aortic component  12 , whereby supporting wire  230  at least partially restricts longitudinal movement of proximal end  14  of tubular aortic component  12  until proximal end  14  of tubular aortic component  12  is secure within aorta  262  ( FIGS.  24 A- 24 E ) of the patient to thereby prevent collapse of proximal end  14  of tubular aortic component  12  at an inferior portion  264  of aorta  262 . 
     In one embodiment, inner sheath  210  is releasably secured at distal end  214  within a cavity defined by the proximal end of nose cone  206  ( FIG.  18   ). In this embodiment, as shown in  FIGS.  24 A- 24 E , optional inner sheath  210  is partially retracted to release the distal end of the inner sheath  210  from nose cone  206  and thereby cause partial expansion of tubular aortic component  12 . Wall aperture  20  is aligned over at least one vessel ostium  290 ,  292 ,  294  at aneurysm site  263  of the patient. Optionally, in embodiments of the invention that employ inner sheath  210 , inner sheath  210  is then partially retracted to expose the proximal end  14  of tubular aortic component  12 , including crown stent  56  and the clasping stent  60  ( FIG.  1 A ). Control tube  232  is then partially extended to release bare apices  58  ( FIG.  1 A ) of clasping stent  56  from distal clasp  238  and to release retention component  78  from proximal clasp  240  ( FIGS.  16 B and  17 B ), while retaining suture loops  62  on ends  228  of support wires  230  ( FIGS.  16 A- 16 F and  17 A- 17 C ). Nose cone  206  is then partially retracted into proximal end of tubular aortic component  12  and the delivery assembly and tubular aortic component  12  are then advanced to a final position within aorta  262  spanning aneurysm  263  of the patient. Control tube  232  is then further retracted to release suture loops  62  from ends  228  of support wires  230 . Inner sheath  210  is then fully retracted (in embodiments of the invention that employ inner sheath  210 ) and then nose cone  206  and supporting wires  230  are fully retracted to complete deployment of tubular aortic component  12 . 
     In an embodiment, the method of the invention includes the step of implanting at least one tubular branch component  254  in at least one of an innominate artery (also referred to as “brachiocephalic artery”)  290 , a left subclavian artery  292 , a left common carotid artery  294 , or right common carotid artery  296  of the patient into wall aperture  20  and tunnel graft  28  within tubular aortic component  12 , as shown, with respect to the prior art, in  FIGS.  13 - 15   , and in  FIGS.  24 A- 24 E . In a preferred embodiment, the method of the invention includes the steps of implanting tubular branch component  254  into innominate artery  290 , and another tubular branch component, into the left common carotid artery  294  ( FIG.  24 E ). 
     Implantation of the aortic graft assemblies of the invention can include implantation in at least one of a portion of the ascending aorta, the aortic arch, the descending aorta and abdominal aorta (see  FIGS.  12 ,  24 A- 24 E and  26 A- 26 C ). Implantation near, around or at the arch of the aorta, can include a right common carotid to left common carotid artery bypass with ligation of the left common carotid inferior to the point of the bypass and a left common carotid artery to left subclavian artery bypass with ligation inferior to the bypass. In another embodiment, for example, an aortic graft assembly of the invention that includes two tubular branch components (e.g., one into the right common carotid, another into the left common carotid) can include a left common carotid artery to left subclavian artery bypass, with ligation of the left subclavian artery inferior to the bypass (see  FIGS.  16  and  17   ). Alternatively, as shown in  FIGS.  26 A- 26 C , aortic assembly systems can be implanted in the abdominal aorta  300 . Opening  84  can be placed in abdominal aorta proximate to celiac artery  302 , superior mesenteric artery  304  or renal artery  306 , thereby spanning aneurysm  308 . Tubular branch component  254  can then be implanted into at least one of celiac artery  302 , superior mesenteric artery  304  or at least one renal artery  306 . 
     In another embodiment, shown in  FIGS.  25 A and  25 B , inner sheath  210  about tubular aortic component  12 , includes proximal perforated portion  280  that defines through-holes  282 . Through-holes  282  can be defined by a mesh or fabric of perforation portion  280 , as shown in  FIG.  25 A , or as distinct openings, such as longitudinal through-hole opening  284  shown in  FIG.  25 B . The through-holes permit relatively continuous blood flow during implantation of the prosthesis, as further described in U.S. Published Patent Application No.: 2010/0234932, the teachings of which are incorporated herein by reference in their entirety. 
     Suitable systems, delivery devices and components of systems, stent grafts as described in U.S. application Ser. No. 11/449,337, filed on Jun. 8, 2006; Ser. No. 11/699,700, filed on Jan. 30, 2007; Ser. No. 11/700,609, filed on Jan. 31, 2007; Ser. No. 11/701,867, filed on Feb. 1, 2007; Ser. No. 11/828,653, filed on Jul. 26, 2007; Ser. No. 12/137,592, filed on Jun. 12, 2008; Ser. No. 11/701,876, filed on Feb. 1, 2007; 61/164,545, filed on Mar. 30, 2009; Ser. No. 12/459,387, filed on Jun. 30, 2009; and U.S. Pat. Nos. 7,763,063; 8,007,605; 8,062,345; 8,062,349; 8,070,790; 8,292,943 and 8,308,790, the teachings of all of which are hereby incorporated by reference in their entirety, can be employed to deliver the aortic graft assembly of the invention by the method of the invention. 
     The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. 
     Example 1 
     A 74 year old male with penetrating atherosclerotic ulcer (PAU) of the aorta located on the interior side of the thoracic arch at the level of the left common carotid was treated. A model of the patient&#39;s anatomy was made based on computer tomography (CT) scanning. A right carotid to left carotid bypass was performed initially without ligating the left carotid. A tubular aortic component of an aortic graft assembly (46 mm-42 mm×80 mm) was deployed at the sinotubular junction. The ascending aorta of this patent had a graft diameter of about 44 mm. A tubular aortic component having a diameter of 46/42 mm×80 mm was employed to provide a smaller healthy neck. The proximal end of the tubular aortic component of the aortic graft assembly was released to optimize apposition with the wall of the ascending aorta. 
     A tunnel graft (46 mm-34 mm×220 mm) was used in the aortic graft assembly. The tunnel graft was 15 mm in diameter. The aperture of the tubular aortic component was 30 mm×30 mm. A graft of a size of 15 mm-17 mm×100 mm or 15 mm-17 mm×110 mm) was employed to bridge the graft tunnel with the brachial cephalic trunk and a wire-catheter was positioned prior to implantation as a precautionary bailout. An angiogram was performed to confirm profusion to the and left common carotid arteries. The tunnel graft was advanced to the proximal portion of the aperture of the tubular aortic component with the distal end of at least one tubular branch component. The graft was aligned to allow cannulation of the tunnel graft through the innominate or the left common carotid arteries based on movement of the tubular aortic component. The tunnel graft was cannulated via the right common carotid. A relatively short tubular branch component was selected in this patient because the tunnel graft was deployed more distally. The distal end of the branch graft was aligned with the brachial cephalic trunk bifurcation and the tubular branch graft deployed without complication. An angiogram showed exclusion of the aneurysm with flow to the innominate artery and left common carotid artery via a carotid-carotid bypass. 
     Example 2 
     An 81 year old male with an aneurysm at the arch of the aorta was treated. A CT scan was employed to model the patient&#39;s anatomy. The thoracic aneurysm was in a region of the aortic arch and at least a portion of the descending aorta. The tunnel graft had a diameter of about 15 mm. 
     While this invention has been particularly shown and described with references to example embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.