Abstract:
An endograft includes a main body having a wall separating interior and exterior surfaces and adapted to be inserted within the vessel. The main body is characterized by a single proximal opening and two distal openings and at least one aperture extending through the wall. At least one stent is secured to the main body that upon expansion pressure fits the main body into the vessel. An open tunnel is secured to the interior surface of the main body around the main body aperture and secured somewhere along the tunnel length to provide fluid communication between the interior and exterior surfaces of the main body through the aperture and with the vascular branch in proximity to the main body aperture. The insertion of a sleeve positioned partly within the tunnel and extending beyond the exterior surface of the main body into the vascular branch assures to the vascular branch.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. Utility application Ser. No. 14/035,574 filed Sep. 24, 2013 (Patent Pending), which in turns is a continuation of U.S. Utility application Ser. No. 11/425,872 filed Jun. 22, 2006 (now U.S. Pat. No. 8,808,358), which in turn is a continuation-in-part of U.S. Utility application Ser. No. 11/337,303 filed Jan. 23, 2006 (now U.S. Pat. No. 7,828,837), which claims priority of U.S. Provisional Patent Application Ser. No. 60/653,793 filed Feb. 17, 2005, which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention in general relates to a vascular endograft and method for surgical deployment thereof, and in particular to a vascular endograft facilitating revascularizing branching vessels. 
     BACKGROUND OF THE INVENTION 
     Stent grafts have become a popular treatment option for aneurysms. Typically, a stent graft is delivered to a treatment site through endovascular insertion via an introducer or catheter. Subsequent radial expansion retains the graft in position relative to the vessel wall. In instances where an aneurysm is located along a length of vessel on which branch vessels are not present, a simple tubular cylindrical stent graft is suitable. Additionally, stent grafts are known to the art for treatment of aneurysms in aortic regions where the distal end of the graft bifurcates to define two lumens so as to extend into arterial branches. Such bifurcated stent grafts are well known for the treatment of ascending thoracic and abdominal aortic aneurysms. Exemplary stents of this kind are embodied in U.S. Pat. Nos. 6,695,875 B2 and 6,814,752 B1 and U.S. Patent Application Publication 2004/0230287 A1. 
     Currently, aneurysms in certain anatomic regions of the aorta have proved difficult to properly repair with a stent graft. In particular, treatment of suprarenal aortic aneurysms has proved problematic. In such locales, the lack of a neck above the aneurysm precludes attachment of a conventional endovascular graft. Additionally, in the treatment of an aneurysm in such a locale, the preoperative measurement of arterial and aortic dimensional variables necessary to form a suitable endograft has proven to be complex. Any misfit in preparing a conventional stent graft to treat an aneurysm in this region results in lumenal obstruction or collapse, or material fatigue, resulting in continued blood flow into the aneurysm. 
     WO 03/082153, FIGS. 7-11, is representative of the stent grafts for the treatment of suprarenal aortic aneurysms. This graft includes a single lumen containing a Gianturco type zigzag Z stent tube in communication at a distal end with an aperture in the lumen and free floating at the proximal end within the lumen. Unfortunately, the free-floating tube proximal end is prone to damage during insertion of a sleeve therefrom into an artery in registry with the aperture, as well as under hemodynamic operating conditions. 
     Thus, there exists a need for a vascular endograft capable of treating an aneurysm in a vessel having adjacent vessel branches. 
     SUMMARY OF THE INVENTION 
     An endograft for a vessel having a vascular branch extending from the vessel is provided. The endograft includes a main body having a wall separating interior and exterior surfaces and adapted to be inserted within the vessel. The main body is characterized by a single proximal opening and two distal openings and at least one aperture extending through the wall. At least one stent is secured to the main body that upon expansion pressure fits the main body into the vessel. An open tunnel is secured to the interior surface of the main body around the main body aperture and secured somewhere along the tunnel length to provide fluid communication between the interior and exterior surfaces of the main body through the aperture and with the vascular branch in proximity to the main body aperture. Through the addition of further apertures and tunnels, an endograft is well suited for revascularizing the celiac, superior mesenteric artery and renal arteries for the treatment of a suprarenal aortic aneurysm. The insertion of a sleeve positioned partly within the tunnel and extending beyond the exterior surface of the main body into the vascular branch assures continued fluid flow to the vascular branch. The two distal openings are adapted to engage the iliac arteries. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a plan view of an inventive endograft depicted within a partial cutaway of the superior mesenteric and renal artery region of the descending aorta; 
         FIG. 2  is a top view of the inventive stent graft depicted in  FIG. 1  absent the expandable stents for visual clarity; 
         FIG. 3  is a magnified cross-sectional view through a tunnel connecting the endograft depicted in  FIG. 1  to the superior mesenteric artery and containing a sleeve therein; 
         FIG. 4  is a plan view of an inventive endograft proportioned and apertured for revascularization of the celiac, superior mesenteric, and two renal arteries, the tunnels are depicted interior to the endograft as dashed lines; the expandable Z stents are not shown for visual clarity; 
         FIGS. 5A-5D  are a schematic depiction of a possible surgical process for revascularizing celiac, superior mesenteric, and renal arteries, as part of the deployment of an inventive endograft to treat a suprarenal aortic aneurysm; and 
         FIG. 6  is a plan view of an inventive endograft proportioned to distally secure to the right and left common iliac arteries. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention has utility as a vascular endograft well suited for the treatment of aneurysms. While the present invention is detailed herein with respect to an endograft having revascularization tunnels positioned for use in the aortic region encompassing the superior mesenteric artery (SMA) and renal arteries, it is appreciated that an inventive endograft has application in a variety of vascular settings where vessels branch from a main lumen. In addition, the inventive endograft is appreciated to be suitable for the treatment of an aneurysm alone, or in combination with a conventional stent graft depending upon the relative position and size of a vascular aneurysm. 
     An inventive endograft has a main body including at least one deployable, expanding stent and an open tunnel secured within the main body to a main body sidewall aperture to ensure reliable fluid communication between fluid passing through the main body and a vascular branch overlying an open tunnel terminus. The tunnel is secured somewhere along the tunnel length to the interior of the main body and lacks a stent expander along the length thereof. Preferably, the tunnel is secured to the main body along the majority of the tunnel length. Through the use of a sleeve that extends from the tunnel into the overlying vascular branch, a predefined percentage of the fluid flow through the main body of an inventive endograft is shunted into the vascular branch. While an open tunnel used in an inventive endograft is cylindrical in general shape in a first embodiment, it is appreciated that a bifurcated tunnel having an inverted “Y” shape is operative in situations where vascular branch bifurcates proximal to the central vessel are desired to have assured fluid flow. 
     The present invention is further illustrated with respect to the following non-limiting embodiments depicted in the figures. Referring now to  FIGS. 1-3 , an inventive endograft is shown generally at  10 . The endograft  10  has a main body  12  having at least one proximal opening  14  and at least one distal opening  16 . As used herein, it is appreciated that proximal and distal are defined relative to the direction of fluid flow through the vessel lumen in which an inventive endograft is secured. At least one stent  18  is secured about the circumference of the main body  12  on the external surface  20  of the main body wall  15 . A Gianturco zigzag stent is representative of stent types operative herein. The main body  12  has an interior surface  22  through which fluid communication within the vessel is maintained. An open tunnel  24  has a mouth  26  and a terminus  28 . The tunnel  24  is formed of a material that will not become obstructed or collapse under prolonged exposure to physiologic fluid transport. Materials suitable for the construction of a main body  12  and a tunnel  24  independently in each case include polymeric materials such as those sold under the trade names Dacran®, Gortex®, Teflon® and implant grade silicones. In order to preclude obstruction and/or collapse of a tunnel  24  subsequent to placement, the tunnel  24  is formed independent of an extendable stent associated with the tunnel circumference. The terminus  28  of the tunnel  24  is sealed around an aperture  30  within the main body  12  and is flush with the exterior surface  20 . As a result, the tunnel  24  does not extend beyond the dimensions of the main body  12 ; this attribute facilitates placement of an inventive endograft  10  within the central vessel denoted at V. The aperture  30  and terminus  28  of the tunnel  24  are positioned within the main body  12  so as to overlie a vascular branch B extending from the vessel V in which the main body  12  is placed. The tunnel  24  is secured to the interior surface  22  at at least one point along the tunnel length. A single point securement is ideally proximal to the mouth  28 . Preferably, the tunnel is secured along the majority of the tunnel length. More preferably, the entire tunnel length is secured to the interior surface  22 . Securement of the tunnel  24  to the interior surface  22  is accomplished with conventional fastening techniques illustratively including sutures, contact adhesives, sonic welding, thermal welding, and combinations thereof. A securement anchoring the tunnel  24  to the interior surface  22  is critical to the longevity of an inventive endograft in assuring that the tunnel  24  does not kink during placement or under the strong pulsatile flow dynamics experienced within the aorta. It is appreciated that each vascular branch requiring perfusion that overlies an inventive endograft is provided with an open tunnel as described herein to assure fluid communication therewith. 
     With an inventive endograft  10  placed within a vessel V, fluid communication with a vascular branch B is provided through the placement of a separate sleeve  32  in part within the tunnel  24  and extending beyond the terminus  28  into the vascular branch B as shown in  FIG. 3 . A sleeve  32  is conventional to the art and typically is formed of materials such as those used for the formation of the main body  12  or the tunnel  24 . A sleeve  32  typically includes multiple circumferential stents  34  in order to retain the sleeve  32  in a preselected position relative to the tunnel  24  and the vascular branch B. 
     The inventive embodiment depicted in  FIGS. 1-3  corresponds to an endograft spanning the suprarenal portion of the aorta and as such the vessel V is the aorta and the vascular branch B is the superior mesenteric artery. The additional vascular branches depicted at C and D correspond to the right and left renal arteries, respectively. As blood flow to the renal arteries C and D must necessarily be maintained in a successful aneurysm treatment, tunnel  24 ′ is placed within the main body  12  in order to assure fluid communication between the aorta and the right renal artery C, where lice primed numerals correspond to those detailed above with respect to tunnel  24 . Tunnel  24  is secured to the interior surface  22  as detailed above with respect to tunnel  24 . The left renal artery D is depicted with the uncommon phenotype of an immediate bifurcation in order to illustrate that a bifurcated tunnel  36  optionally replaces a cylindrical tunnel as depicted with reference to numeral  24  in instances where patient anatomy so dictates. Bifurcated tunnel  36  has a mouth  38  of a preselected diameter and a bifurcation  40  so as to define a first terminus  42  and a second terminus  44 . The termini  42  and  44  are sealed to apertures  46  and  48  formed through the wall  15  of the main body  12 . Tunnel  36  is secured to the interior surface  22  as detailed above with respect to tunnel  24 . Sleeves  50  and  52  are similar to sleeve  32  as described with respect to tunnel  24  and serve to assure a preselected percentage of blood flow to each of the left renal arterial branches. 
     It is appreciated that the relative percentage of fluid exiting through an inventive tunnel relative to the percentage of fluid exiting the distal opening of an inventive endograft is controlled by the effective diameter of the tunnel as compared to the endograft diameter at the position of the tunnel mouth. The effective diameter of an inventive tunnel is appreciated to be equivalent to the internal diameter of the tunnel mouth in the theoretical instance where the tunnel wall and sleeve are of infinitesimal thickness. Actual flow to a vascular branch is readily modeled with standard fluid dynamic equations. In the embodiment depicted in  FIGS. 1-3 , tunnels  24 ,  24 ′ and  36  have lengths ranging from 10 to 25 millimeters with each tunnel having a diameter of from between 6 and 12 millimeters. The internal surface diameter at the proximal opening  14  is typically between 35 and 45 millimeters while the internal diameter about the distal opening  16  ranges from 20 to 30 millimeters. The overall length of the endograft  10  for an adult human ranges from 60 to 120 millimeters. While the above dimensional ranges associated with an inventive endograft  10  are those associated with a suprarenal endograft for an adult human subject, it is appreciated that human child, veterinary endografts, as well as those used to treat differently positioned aneurysms within an adult human, or to accommodate peculiar subject anatomy will vary in any, or all of these dimensions. 
     An inventive endograft in addition to itself precluding fluid flow to an aneurysm is appreciated to be suitable for the joinder of a secondary stent  60  to the distal opening  16  thereof in order to function as an anchoring neck for a conventional stent graft. Joinder of a secondary stent  60  to an inventive endograft is accomplished through a variety of techniques including the use of a vascular cuff  62 . 
     In selecting an endograft for a particular individual, the principal variables include measurement of the internal diameter of the vessel that provides the outer diameter of an inventive endograft, as well as the tunnel terminus internal diameter derived from a measurement of vascular branch internal diameter. Compared to existing stent grafts, the present invention represents a simplification of the design modifications and overall preoperative measurements associated with stent graft design. 
     The placement of an inventive endograft optionally results in the sacrifice of the celiac artery in the instance where the inventive endograft is in a suprarenal position. While an inventive endograft is extended to provide a tunnel for the celiac artery, the celiac artery sacrifice is compensated for by continued flow through the superior mesenteric artery to prevent adverse events. Sacrifice of the celiac artery provides a considerably longer sealing zone proximal to mouth  26  of the tunnel  24 . The suprarenal endograft  10  depicted in  FIGS. 1-3  is an indicated treatment for individuals with pararenal or suprarenal abdominal aortic aneurysms, as well as those individuals suffering failure of a conventional endograft repair secondary to aortic neck deterioration. 
     An endograft maintaining flow to an overlying celiac artery is depicted in plan view generally at  70 , where like numerals correspond to those detailed with respect to  FIG. 1 . The endograft  70  has tunnels  24  and  24 ′ having termini  28  and  28 ′ that are spaced to overlie the aortic junctions with the superior mesenteric and right renal arteries, respectively, upon implantation. Additional tubular tunnels  24 ″ and  24 ′″ are provided with termini  28 ″ and  28 ′″ that are spaced to overlie the left renal and celiac arteries, respectively, upon implantation. Each of the tunnels  24 ,  24 ′,  24 ″, and  24 ′″ has a mouth  26 ,  26 ′,  26 ″, and  26 ′″, and are secured to the interior surface of the main body wall  72 , as described with respect to  FIGS. 1-3 . A portion of the fluid entering the proximal opening  74  relative the direction of fluid flow through the vessel lumen in which an inventive endograft is secured is communicated through the main body  12 , past at least one stent  18  and into one of the tunnels  24 ,  24 ′,  24 ″, or  24 ′″ and expelled via one of the apertures  30 ,  30 ′,  30 ″, or  30 ′″ extending through the main body wall  72 . The fluid not transiting the wall  72  is expelled via distal opening  76 . 
     Referring now to  FIG. 6 , an inventive endograft is shown generally at  200 . Endograft  200  has a main body  202  having a proximal opening  204  and a bifurcated pair of distal openings  206  and  207 . At least one stent  208  is secured about the circumference of the main body  202  on the external surface  210  of the main body wall  205 . A Gianturco zigzag stent is representative of stent types operative herein. The main body  202  has an interior surface  212  in which fluid communication within the vessel is maintained. An open tunnel  214  has a mouth  216  and a terminus  218  with the main body  202  and tunnel  214  being formed of materials as previously described with respect to  FIGS. 1-3 . The tunnel  214  is formed independent of an extendable stent associated with the tunnel circumference. Terminus  218  of the tunnel  214  is sealed around an aperture  220  within the main body  202  and is flush with the exterior surface  210 . As a result, the tunnel  214  does not extend beyond the dimensions of the main body  202  so as to facilitate placement of the endograft  200  within a primary vessel. The aperture  220  and the terminus  218  of the tunnel  214  are positioned within main body  202  so as to overlie vascular branches to which blood flow must necessarily be maintained upon placement of the main body  202 . Tunnel  214  is secured to the interior surface  212  at at least one point along the tunnel length. A single point securement is ideally proximal to the mouth  218 . Preferably, the tunnel is secured along the majority of the tunnel length. More preferably, the entire tunnel length is secured to the interior surface  212 . Securement of the tunnel  214  to the interior surface  212  is accomplished with conventional fastening techniques as detailed with respect to  FIGS. 1-3 . To facilitate fluid communication between the interior  212 , the endograft  200  and a vascular branch overlying the aperture  220 , a sleeve  222  is placed in part within the tunnel  214  and extending beyond the terminus  218  into the vascular branch. The system is of a composition and form as previously described with respect to  FIGS. 1-3 . The endograft  200  has additional tunnels  214 ′,  214 ″ and  214 ′″ with respective mouths  26 ′- 26 ′″, termini  28 ′- 28 ′″, and apertures  30 ′- 30 ′″. With the appropriate aperture spacing, the sleeves are readily deployed to maintain fluid communication to superior mesenteric, left renal, right renal and celiac arteries and deploying sleeves through tunnels  24 - 24 ′″, respectively. Subsequent to revascularization of overlying vessels by a procedure as detailed with respect to  FIGS. 5A-5D , distal ends  206  and  207  are directed into the right common iliac artery and left common iliac artery, respectively, with distal stents  236  and  237  fully deployed within the right and left iliac arteries to afford a sealing zone without resort to a secondary stent coupled to an inventive endograft with resultant anxiety as to the joint between the inventive endograft and a secondary stent leaking. 
     A procedure for repair of a renal aneurysm is preferably performed in a staged fashion to decrease the overall time of the procedure, fluoroscopy contrast agent exposure, and radiation dosage. An exemplary procedure for placement of an inventive endograft as a repair includes the following steps. 
     1. CT Assessment: Identify patient candidates and obtain diameter and length measurements. Initial assessment with high resolution helical CT scans will identify patients that are candidates for this procedure. The CT protocol will be similar to infrarenal stent graft assessments, but extend from the distal descending thoracic aorta to the common femoral arteries. In patient candidates aortic diameters and lengths will be determined. 
     2. Angiography and visceral artery covered stent placement. Diagnostic angiography will provide further anatomic definition, also covered stents will be deployed in the SMA and the right and left renal arteries. Patient candidates identified with CT will proceed to angiography to assess the status of the SMA and renal arteries. In addition, any stenotic lesions of the visceral arteries will be treated at this time. 
     3. Endo-graft deployment, mesenteric revascularization, conventional endograft aneurysm repair. The delivery and deployment of the aortic endograft will utilize the current methods used with infrarenal aneurysm endograft repair. Bilateral femoral artery exposure and left brachial artery access will be used. The patient will be anticoagulated once artery exposure is obtained. 
     Endograft deployment: A stiff guide wire is advanced under fluoroscopy into the proximal descending thoracic aorta from the femoral artery being used for delivery of the main aortic component. The main component is then delivered into the distal descending thoracic aorta for deployment above the SMA, using the previously placed SMA covered stent as a landmark. The endograft will be oriented by unique radio-opaque markers for the renal and SMA branches. Once in position the supra mesenteric component will be partially deployed for a length of about 2.5 centimeters or otherwise to expose the celiac and SMA upstream apertures  30 ′″ and  30 , respectively, as shown in lateral view in  FIG. 5A . The infrarenal portion of the endograft will not be deployed until mesenteric revascularization is complete to avoid compromising guide wire access to the native mesenteric arteries. 
     4. Visceral revascularization. Placing the mesenteric endografts will optimally be performed from the left brachial approach. This will take advantage of the visceral artery anatomy relative to the aorta. Using standard guide wire techniques a 90 centimeter brachial catheter  90  sheath is advanced to the aorta proximal to the endograft. The SMA tunnel will be accessed within the endograft by a marking catheter  92  having gradations to assess the required sleeve length needed to extend within the endograft and into the branching vessel to which fluid communication is to be maintained. The marking catheter  92  will be advanced through the tunnel into the native aortic lumen and into the native SMA. A stent is then fed into position spanning a portion of the tunnel  24  through aperture  30  and into the native SMA before sleeve stent expansion  94  in  FIG. 5B . In  FIG. 5A  the celiac artery is shown having already been spanned by a sleeve stent  93  expanded in tunnel  24 ′″ and extending through aperture  30 ′″ into the native celiac artery by a process as detailed above for the SMA. The order of SMA and celiac artery revascularization is appreciated to be immaterial. Typically, a stent has at least 1.5 centimeter coverage into the native artery. Alternatively, the celiac and/or SMA spanning stents are transported up the given artery into the appropriate sleeve. Proximity to an aneurysm or an involved arterial juncture are instances that are indications that may justify the added complexity of arterial stent delivery. The positioning of the endograft or the sleeve stent is guided with contrast injections from the brachial catheter  90 . 
     Subsequent to SMA and optional celiac artery revascularization, as the visceral first stage of endograft deployment, longitudinal expansion of the endograft main body occurs distal from aperture  30 . It is noted that revascularizing the SMA and optional celiac artery affords a measure of fixation to the endograft against torsion associated with succeeding renal artery revascularization. 
     This procedure will be repeated for the right and left renal arteries. Once SMA and renal endovascular revascularization is completed the infrarenal component of the SRE will be deployed. This completes SRE deployment and visceral revascularization. 
     5. Renal revascularization.  FIGS. 5C and 5D  are rotated views relative to the lateral views of  FIGS. 5A and 5B  to schematically illustrate renal artery revascularization. The brachial catheter  90  and the marking catheter  92  are employed as detailed above for visceral SMA revascularization to successively revascularize the right and left renal arteries with sleeves  96  and  98 , respectively. Preferably, the distal 2.5 centimeter section of the endograft main body is retained in a collapsed state during positioning and expansion of sleeves  96  and  98 . Thereafter, as shown in  FIG. 5D , the distal docking end of the endograft is expanded. 
     6. Distal joinder. Additional joinder of a secondary conventional stent to the distal end of the endograft then occurs in instances where additional length is required to span an aneurysm. A secondary stent is deployed directly to the distal end or with resort to a vascular cuff. 
     Patent documents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These documents and publications are incorporated herein by reference to the same extent as if each individual document or publication was specifically and individually incorporated herein by reference. 
     The foregoing description is illustrative of particular embodiments of the invention, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the invention.