Abstract:
Devices, systems, and methods for implanting prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

Description:
RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation,” which is incorporated herein by reference. This application also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/692,283, filed Oct. 23, 2003, and entitled “Prosthesis Delivery Systems and Methods,” which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/488,753, filed Jul. 21, 2003, and entitled “Endoprosthesis Delivery Systems and Methods.” This application also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/786,465, filed Feb. 25 2004, and entitled “Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ.” This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 11/693,255, filed Jun. 24, 2005, entitled “Multi-Lumen Prosthesis Systems and Methods,” which is a division of U.S. patent application Ser. No. 10/693,255, filed 24 Oct. 2003 (now U.S. Pat. No. 6,929,661), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/489,011, filed Jul. 21, 2003, and entitled “Bifurcated Prosthesis Systems and Methods.” This application also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/307,226, filed 29 Nov. 2002, and entitled “Intraluminal Prosthesis Attachment Systems and Methods.” This application is also a continuation-in-part of copending U.S. patent application Ser. No. 10/669,881, entitled “Catheter-Based Fastener Implantation Apparatus and Methods with Implantation Force Resolution.” This application is also a continuation-in-part of copending U.S. patent application Ser. No. 11/166,411, filed Jun. 24, 2005, entitled “Endovascular Aneurysm Repair System,” which is a division of U.S. patent application Ser. No. 10/271,334, filed 15 Oct. 2002 (now U.S. Pat. No. 6,960,217), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/333,937, filed 28 Nov. 2001, and entitled “Endovascular Aneurysm Repair System.” Each of the preceding applications is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention relates generally to devices, systems, and methods for the delivery and implantation of a prosthesis to a targeted site within the body, e.g., for the repair of diseased and/or damaged sections of a hollow body organ and/or blood vessel.  
       BACKGROUND OF THE INVENTION  
       [0003]     The weakening of a vessel wall from damage or disease can lead to vessel dilatation and the formation of an aneurysm. Left untreated, an aneurysm can grow in size and may eventually rupture.  
         [0004]     For example, aneurysms of the aorta primarily occur in the abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation. Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. The rupture of an aortic aneurysm results in massive hemorrhaging and has a high rate of mortality.  
         [0005]     Open surgical replacement of a diseased or damaged section of vessel can eliminate the risk of vessel rupture. In this procedure, the diseased or damaged section of vessel is removed and a prosthesis, made either in a straight or bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthesis for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The prosthesis are longitudinally unsupported so they can accommodate changes in the morphology of the aneurysm and native vessel. However, these procedures require a large surgical incision and have a high rate of morbidity and mortality. In addition, many patients are unsuitable for this type of major surgery due to other co-morbidities.  
         [0006]     Endovascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair. The aneurysm is bridged with a vascular prosthesis, which is placed intraluminally. Typically these prostheses for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These prostheses are usually designed with a fabric material attached to a metallic scaffolding (stent) structure, which expands or is expanded to contact the internal diameter of the vessel. Unlike open surgical aneurysm repair, intraluminally deployed prostheses are not sutured to the native vessel, but rely on either barbs extending from the stent, which penetrate into the native vessel during deployment, or the radial expansion force of the stent itself is utilized to hold the prosthesis in position. These prosthesis attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.  
         [0007]     Accordingly, there is a need for improved prosthesis delivery devices, systems, and methods that deliver a prosthetic graft to a body lumen, the prosthesis being able to adapt to changes in aneurysm morphology and able to be deployed safely and without damage to the native vessel.  
       SUMMARY OF THE INVENTION  
       [0008]     One aspect of the invention provides a system comprising a guide defining an access path into a vessel or hollow body organ and a fastener applier comprising a catheter sized and configured for introduction along the access path to a site targeted for implantation of at least one fastener. The guide includes a distal region with terminus. The fastener applier includes an actuated member that is selectively operable to generate an implantation force to implant the at least one fastener within tissue at the site. According to this aspect of the invention, the catheter includes indicia visible to a naked eye to mark when the actuated member rests at a desired distance along the access path short of the terminus of the distal region and is therefore still out of contact with tissue. The visible indicia makes it possible for the physician, without resort to fluoroscopic visualization or other visualizations techniques that augment human sight, to always know whether the fastener is within or outside the guide.  
         [0009]     This aspect of the invention also provides instructions for using the guide and fastener applier in which, as the actuated member is being introduced along the access path toward the terminus, the operator or physician is instructed to view the indicia with a naked eye, to detect when the actuated member rests at a desired distance along the access path short of the terminus of the distal region.  
         [0010]     Another aspect of the invention provides for a fastener applier an electrically powered drive member coupled to the driven member and a controller coupled to the drive motor. According to this aspect of the invention, the controller includes a LOAD state. In the LOAD state, the controller operates in response to an input command for delivering electrical current to the drive member to drive the driven member in a first direction to load a fastener onto the driven member. The controller senses electrical current delivered to the drive member while loading the fastener onto the driven member. The controller terminates delivery of electrical current to the driven member when a prescribed amount of current is delivered to the drive member, thereby terminating the LOAD state.  
         [0011]     On one embodiment, the controller also includes an UNWIND state that follows the LOAD state. In the UNWIND state, which is operative after termination of the LOAD state, the controller delivers electrical current to the drive member to drive the driven member in a second direction. The controller senses a period of operation of the driven member in the second direction which is sufficient to reduce torque windup on the driven member created during the LOAD state. The controller terminates delivery of electrical current to the driven member after the period of operation, thereby terminating the UNWIND state. According to this aspect of the invention, the fastener applier enters a READY TO APPLY state with a minimum of torque windup associated with the driven element.  
         [0012]     Another aspect of the invention provides a fluid seal assembly usable in association with, e.g., a catheter assembly including an operative element that, in use, is exposed to a body fluid, a control element, a control filament coupled at one end to the control element and to an opposite end to the operative element. In this arrangement, the seal assembly is positioned between the control element and the operative element, and the control filament passes through the seal assembly to prevent contact between the body fluid and the control element.  
         [0013]     According to this aspect of the invention, the seal assembly comprises a first seal component with at least one guide tube formed therein, and a second seal component with at least one guide tube formed therein. The second seal component registers with the first seal component with at least one guide tube in the second component coaxially aligned with at least one guide tube in the first component. A septum is sandwiched between the first and second seal components. The septum accommodates passage of the control filament from one the coaxially aligned guide tubes, through the septum, to the other one of the coaxially aligned guide tubes, thereby providing a fluid seal for the control filament that prevents the control element from contacting body fluid to which the operative element is exposed during use.  
         [0014]     Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]      FIG. 1  is a view of the components of a system for repairing an endovascular aneurysm.  
         [0016]      FIG. 2  is a view of the components of the system shown in  FIG. 1  consolidated for use in a multiple piece kit, along with instructions for their use.  
         [0017]      FIG. 3A  is a view of the main body of the endovascular graft that forms a part of the system shown in  FIG. 1 .  
         [0018]      FIG. 3B  is a view of a lumen extension of the endovascular graft that forms a part of the system shown in  FIG. 1 .  
         [0019]      FIG. 3C  is an anatomic view of the main body and lumen extensions of the graft assembly assembled within an abdominal aortic aneurysm.  
         [0020]      FIG. 4A  is a view of the delivery system for the main body of the endovascular graft, which forms a part of the system shown in  FIG. 1 .  
         [0021]      FIGS. 4B and 4C  are views of the top and bottom of the control handle of the main body delivery system shown in  FIG. 4A .  
         [0022]      FIG. 4D  is a view of the distal end of the main body delivery system shown in  FIG. 4A , with parts broken away to show the attachment of the main body of the endovascular graft to the delivery system and the release wire and jacket controls that are coupled to the handle to affect a controlled stepwise release of the main body from the delivery system.  
         [0023]      FIG. 4E  is a view of the distal end of the main body delivery system showing the retracted and advanced positions of the slidable release jacket.  
         [0024]      FIG. 5A  is a view of the handle of the main body delivery system shown in  FIG. 4A , with portions broken away to show a hemostatic seal assembly within the housing.  
         [0025]      FIGS. 5B and 5C  are, respectively, exploded and assembled views of the hemostatic seal assembly shown in  FIG. 5A .  
         [0026]      FIG. 5D  is an enlarged view of the hemostatic seal assembly within the handle of the main body delivery system, showing the passage of the release wires through the seal assembly between the control mechanisms and the distal end of the main body delivery system (as shown in  FIG. 4D ).  
         [0027]      FIG. 6A  is a view of the delivery system for a lumen extension of the endovascular graft, which forms a part of the system shown in  FIG. 1 .  
         [0028]      FIGS. 6B and 6C  are views of the top and bottom of the control handle of the lumen extension delivery system shown in  FIG. 6A .  
         [0029]      FIG. 6D  is a view of the distal end of the lumen extension delivery system shown in  FIG. 6A , with parts broken away to show the attachment of a lumen extension of the endovascular graft to the delivery system and the release wire and jacket controls that are coupled to the handle to affect a controlled release of the lumen extension from the delivery system.  
         [0030]      FIG. 7A  is a view of the steerable endovascular guide and obturator that form a part of the system shown in  FIG. 1 .  
         [0031]      FIG. 7B  is an enlarged view of the handle of the steerable endovascular guide shown in  FIG. 7A .  
         [0032]      FIG. 8A  is a view of a endovascular fastener or staple that forms a part of the system shown in  FIG. 1 .  
         [0033]      FIGS. 8B and 8C  are views of a cassette to hold the a plurality of endovascular fasteners, as shown in  FIG. 8A , and to present the fasteners for loading in the staple applier, which also forms a part of the system shown in  FIG. 1 .  
         [0034]      FIG. 9A  is a view of a fastener applier for implanting a fastener as shown in  FIG. 8A , which forms a part of the system shown in  FIG. 1 .  
         [0035]      FIG. 9B  is an enlarged view of the handle of the fastener applier shown in  FIG. 9A .  
         [0036]      FIG. 10A  is a view showing the manipulation of the fastener applier shown in  FIG. 9A  in loading a fastener from the cassette shown in  FIGS. 8B and 8C .  
         [0037]      FIGS. 10B and 10C  are anatomic views showing the actuated element at the distal end of the fastener applier being driven to implant a fastener in a graft and adjacent tissue, to secure the position of the graft.  
         [0038]      FIG. 11A  is a view showing a fastener applier of a type shown in  FIG. 9A , which includes indicia visable to a naked eye.  
         [0039]      FIG. 11B  is a view showing the fastener applier shown in  FIG. 11A  in association with a steerable endovascular guide of a type shown in  FIG. 7A , showing how the indicia, which is visible to a naked eye, marks when the actuated member rests at a desired distance within the guide short of the terminus of the guide and therefore out of contact with tissue.  
         [0040]      FIG. 11C  shown the distal end of the guide when the indicia visible at the proximal end of the guide marks when the actuated member rests at a desired distance within the guide short of the terminus of the guide and therefore out of contact with tissue.  
         [0041]      FIGS. 12A  to  12 P are anatomic views of manipulation of the components of the system shown in  FIG. 1  in placing a prosthesis in an abdominal aortic aneurism, which manipulations can be incorporated within an instruction for use associated with a kit like that shown in  FIG. 2 .  
         [0042]      FIG. 13A  is a schematic view of the motor control functions of a representative control circuit for the fastener applier shown in  FIG. 9A .  
         [0043]      FIG. 13B  is a schematic flow diagram of the operational states of the control circuit shown in  FIG. 13A . 
     
    
     DETAILED DESCRIPTION  
       [0044]     This Specification discloses various catheter-based devices, systems, and methods for delivering and implanting radially expandable prostheses in the body lumens. For example, the various aspects of the invention have application in procedures requiring the repair of diseased and/or damaged sections of a hollow body organ and/or blood vessel. The devices, systems, and methods that embody features of the invention are also adaptable for use with systems and surgical techniques that are not necessarily catheter-based.  
         [0045]     The devices, systems, and methods are particularly well suited for treating aneurysms of the aorta that primarily occur in the abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation, as well as aneurysms that also occur in the thoracic region between the aortic arch and renal arteries. For this reason, the devices, systems, and methods will be described in this context. Still, it should be appreciated that the disclosed devices, systems, and methods are applicable for use in treating other dysfunctions elsewhere in the body, which are not necessarily aorta-related.  
         [0046]     When referring to an endovascular graft or its components that are intended to be implanted in a vessel or body organ, the terms “proximal” and “distal” will be used to describe the relation or orientation of the graft with respect to the heart after implantation. Therefore, the term “proximal” will be used to describe a relation or orientation of the graft that, when implanted, is toward the heart, and the term “distal” will be used to describe a position or orientation of the graft that, when implanted, is away from the heart, i.e., toward the feet.  
         [0047]     When referring to implantation apparatus or devices that are manipulated by a physician or operator in order to implant the endovascular graft or its components, the terms “proximal” and “distal” will be used to describe the relation or orientation of the apparatus or device with respect to the operator as it is used. Therefore, the term “proximal” will be used to describe a relation or orientation of the apparatus or device that, when in use, is positioned toward to the operator (i.e., at the handle end of the device), and the term “distal” will be used to describe a position or orientation of the apparatus or device that, when in use, is positioned away from the operator (i.e., at the other end of a catheter or the like away from the handle).  
         [0000]     I. System Overview  
         [0048]      FIG. 1  shows a system  10  for repairing an endovascular aneurysm, which is well suited for the repair of an abdominal aortic aneurysm (AAA). The system  10  comprises three primary components  12 ,  14 , and  16 .  
         [0049]     The first component  12  comprises an endovascular graft assembly. In use, the endovascular graft assembly  12  is placed within a vessel at the site of the aneurysm. In the illustrated embodiment, the endovascular graft assembly  12  includes a main body  18  that is placed within the aorta adjacent the renal arteries (see  FIG. 3C ), and lumen extensions  20  and  22  that extend into the contralateral and ipsilateral branches of the iliac artery, as  FIG. 3C  shows.  
         [0050]     The second component  14  comprises an endovascular delivery system for introducing and deploying in sequence the main body  18  and lumen extensions  20  and  22  of the endovascular graft assembly  12  using an endovascular approach. In the illustrated embodiment, in which the endovascular graft assembly  12  comprises three modular portions—the main body  18 , the ipsilateral lumen extension  20 , and the contralateral lumen extension  22 —there are three corresponding endograft delivery components  24 ,  26 , and  28 .  
         [0051]     The third component  16  comprises an endovascular stapling system. In use, the endovascular stapling system  16  attaches one or more regions of the endovascular graft assembly to the vessel wall with one or more endovascular staples. In the illustrated embodiment, the endovascular stapling system  16  comprises a steerable endovascular guide  30 , an obturator  32 , a cassette  34  holding a plurality of endovascular staples  36 , and an endovascular staple applier  38 . In use, the steerable endovascular guide  30  establishes an endovascular path to the targeted site where the endovascular graft assembly  12  has been partially or fully deployed. The steerable endovascular guide  30  is manipulated by flexure and rotation to successive sites where individual endovascular staples  36  are to be implanted, to penetrate the endovascular graft assembly  12  and adjacent vessel wall. The endovascular staple applier  38 , carrying one or more endovascular staples  36 , is guided by the steerable endovascular guide  30  to the successive sites. The endovascular staple applier  38  is actuated to implant individual endovascular staples  36  into selected region or regions of the endovascular graft assembly  12  and adjacent vessel wall, to attach the endovascular graft assembly  12  to the vessel wall.  
         [0000]     II. The Kit  
         [0052]     As  FIG. 2  shows, the various tools and devices as just described, comprising the system  10 , can be consolidated for use in a multiple piece functional kit  40 .  
         [0053]     The kit  40  can take various forms. In the illustrated embodiment, the kit  40  comprises an assemblage of individual packages  42 ,  44 ,  46 ,  48 ,  50 ,  52 ,  54 , and  56 , each comprising a sterile, wrapped, peel-open assembly. One or more the packages may include an interior tray made, e.g., from die cut cardboard, plastic sheet, or thermo-formed plastic material, which hold the contents. The kit  40  also preferably includes instructions or directions  58  for using the contents of the packages to carry out a desired procedure. A desired procedure using the contents of the kit  40  shown in  FIG. 2  will be described in greater detail later.  
         [0054]     The instructions for use  58  can, of course vary. The instructions for use  58  can be physically present in one or more of the packages, but can also be supplied separately. The instructions for use  58  can be embodied in separate instruction manuals, or in video or audio recordings. The instructions for use  58  can also be available through an internet web page.  
         [0055]     A. The Component Packages  
         [0056]     The arrangement and contents of the packages can vary.  
         [0057]     For example, as shown in  FIG. 2 , the kit  40  comprises eight packages  42 ,  44 ,  46 ,  48 ,  50 ,  52 ,  54 , and  56 . Five of these packages  42 ,  44 ,  46 ,  48 , and  50  provide the main components of the endovascular repair system  10  as described. The remaining packages  52 ,  54 , and  56  provide ancillary components used in the deployment of the system  10 , e.g., conventional vascular access sheaths (in package  52 ); conventional 0.035 inch guide wires (in package  54 ); and bags containing heparinized saline for catheter flushing and contrast for angiography (in package  56 ).  
         [0058]     In package  42 , the main body  18  of the endovascular graft assembly  12  is preloaded into the main body endograft delivery components  24 . In package  44 , the ipsilateral lumen extension  20  of the endovascular graft assembly  12  is preloaded into the ipsilateral extension endograft delivery component  26 . In package  46 , the contralateral lumen extension  22  of the endovascular graft assembly  12  is preloaded into the contralateral extension endograft delivery component  28 . Housed within the packages  42 ,  44 , and  46 , the components of the endovascular graft assembly  12  and the corresponding delivery components  24 ,  26 , and  28  for the endograft components are supplied sterile to the user.  
         [0059]     As further shown in  FIG. 2 , the kit  40  comprises an additional package  50  that provides the steerable endovascular guide  30  and at least one associated components; namely, the obturator  32 . The kit  40  also comprises an additional package  48  that provides the endovascular staple applier  38  and at least one associated component; namely, a cassette  34  holding a plurality of endovascular staples  36 . Housed within the packages  48  and  50 , the steerable endovascular guide  30  and the endovascular staple applier  38  and their associated components are supplied sterile to the user.  
         [0060]     Further details of a representative construction of the contents of the packages will now be described.  
         [0061]     1. The Endovascular Graft  
         [0062]     a. The Main Body  
         [0063]     In a representative embodiment (see  FIG. 3A ), the main body  18  of the endovascular graft is a multi-lumen endograft comprising two primary components: a graft  60  made of a biocompatible material, e.g., polyester, ePTFE, etc.; and one or more stents or scaffolds  62  made of a biocompatible metal or plastic material, e.g., Stainless steel, nickel-titanium (Nitinol), etc.  
         [0064]     In a representative embodiment, the preferred length of the main body  18  is between 5 cm and 14 cm and most preferably between 7 cm and 10 cm. Desirably, different dimensions for the diameter of the main body  18  are provided to accommodate different anatomic dimensions of patients.  
         [0065]     As illustrated, the multi-lumen endograft is a tube at the proximal end, which separates into two distal ipsilateral and contralateral lumens  64  and  66 . The ipsilateral and contralateral lumens  64  and  66  are separated by a septum  68  or “shared wall” between them. The septum  68  extends the length of the ipsilateral lumen  64  (in the representative embodiment, approximately 3 cm).  
         [0066]     The main body  18  includes a proximal sealing stent  70 , e.g., with diamond or “V” shaped cells, which is sewn to the inside proximal end of the graft e.g., with braided or monofilament suture. The proximal sealing stent  70  is sized and configured to ensure secure apposition to the vessel wall just below the renal arteries. The stent  70  preferably extends beyond the fabric 0 mm to 15 mm and most preferably extends 1 mm to 10 mm .  
         [0067]     The main body  18  includes a distal locking stent  72  located in each of the two lumens  64  and  66  at the distal end of the main body  18 . The stents  72  are sewn to the graft, e.g., with braided or monofilament suture. The distal locking stents  72  of the main body  18  engage with the tape covering the proximal spiral stent  86  on the lumen extensions  20  and  22  (see  FIG. 3B ) to help prevent component separation and provide support to the lumen openings of the main body  18 .  
         [0068]     Predetermined arrays of radiopaque markers made from biocompatible materials with high radiopacity (e.g, tantalum, platinum or gold) are desirably attached to the main body  18  to assist with visualization under fluoroscopy. The markers, like the stents, are sewn to the graft, e.g., with braided or monofilament suture or can be attached to the stent. The arrays can vary. In the illustrated embodiment, there are two (2) long contralateral side markers  74 ; three (3) short ipsilateral side markers  76 ; four (4) proximal stent marker bands  78 ; five (5) distal locking stent marker bands  80 ; and an insertion depth marker  82  near the proximal end of the septum  68  for positioning of the lumen extension.  
         [0069]     Further details of representative constructions of the main body  18  of the endovascular graft assembly  12  can be found in co-pending, commonly owned U.S. patent application Ser. No. 11/254,444, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation, Including a Prosthesis Assembly,” which is incorporated herein by reference.  
         [0070]     b. The Lumen Extensions  
         [0071]     In a representative embodiment (see  FIG. 3B ), each lumen extension  20  and  22  is sized and configured to be inserted into the corresponding ipsilateral and contralateral lumens of the main body  18 , to complete the assembly of the endovascular graft  12  (see  FIG. 3C ). The lumen extensions  20  and  22  can be provided in various lengths and diameters to different anatomic dimensions of patients.  
         [0072]     In a representative embodiment, each lumen extension comprises a biocompatible material  84 , e.g., polyester, ePTFE, etc, and two stent or scaffold components  86  and  88  made of a biocompatible metal or plastic material, e.g., Stainless steel, nickel-titanium (Nitinol), etc.  
         [0073]     The first stent component  86  comprises a continuous, spiral sinusoidal stent that runs the length of the lumen extension  20  and  22 . The spiral stent component  86  is sized and configured to prevent kinking and maintain patency of the graft. The stent component can be sewn to the graft, e.g., with braided or monofilament suture. The proximal region of the spiral stent is further covered with material, e.g., polyester, ePTFE, etc. The covered proximal region  90  is sized and configured to engage the locking stent  72  in the main body  18  (see  FIG. 3C ) to prevent separation of the lumen extension from the main body  18 . The covered proximal region  90  also serves to prevent the metallic stent components from coming into contact with one another.  
         [0074]     The other stent component  88  of each lumen extension comprises a distal sealing stent. The stent component  88  can be sewn to the graft, e.g., with braided or monofilament suture. The distal sealing stent  88  is sized and configured to ensure good apposition of the lumen extension to the wall of the iliac artery. The distal sealing stent  88  preferably extends beyond the distal end of the fabric portion of the lumen extension 0 mm to 15 mm and most preferably extends 1 mm to 10 mm .  
         [0075]     Predetermined arrays of radiopaque markers made from biocompatible materials with high radiopacity (e.g, tantalum, platinum or gold) are desirably attached to each lumen extension to assist with visualization under fluoroscopy. The markers, like the stents, can be sewn to the graft, e.g., with braided or monofilament suture or can be attached to the stent. The arrays can vary. In the illustrated embodiment ( FIG. 3B ), there is a proximal insertion depth marker  92  at the proximal end of the graft material and a distal marker  94  at the distal end of the graft material.  
         [0076]     Further details of representative constructions of the lumen extensions  20  and  22  of the endovascular graft assembly can be found in co-pending, commonly owned U.S. patent application Ser. No. 11/254,444, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation, Including a Prosthesis Assembly,” which is incorporated herein by reference.  
         [0077]      2 . Endovascular Graft Delivery Components  
         [0078]     a. The Main Body Delivery System  
         [0079]     i. General Overview  
         [0080]     The main body  18  of the endovascular graft assembly  12  is preloaded into the main body delivery system  24  (see  FIG. 4A ), which is a single use component that is supplied to the user within its package  42  in a sterile condition (see  FIG. 2 ). The main body delivery system  24  is sized and configured to facilitate accurate placement of the main body  18  of the endovascular graft assembly  12  and to allow the physician to maintain control of the main body  18  while the endovascular staples  36  are applied.  
         [0081]     In the illustrated embodiment (see  FIG. 4A ), the main body delivery system  24  comprises a delivery catheter  96  and a control handle  98  coupled to the proximal end of the delivery catheter  96 . The delivery catheter  96  (see  FIG. 4D ) comprises a flexible inner assembly  100  and an outer graft retention jacket  102 . The inner assembly  100  carries at its distal-most end a flexible radiopaque tracking nosecone  104 .  
         [0082]     When preloaded (see  FIG. 4D ), the main body  18  of the endovascular graft assembly  12  is attached to the inner assembly  100  in three locations. Just proximal of the nosecone  104  (i.e., toward the handle  98 ), the main sealing stent  70  of the main body  18  is secured by a releasable suture S 1  to the inner assembly  100 . Also just proximal of the nosecone  104 , the inner assembly  100  includes a set of main body stabilizing arms  106 . In the illustrated embodiment, there are three stabilizing arms  106 . The proximal end of the preloaded main body  18  of the endovascular graft assembly is attached to the three stabilizing arms by three releasable pull wires S 2 , each threaded through eyelets in a respective one of the distal ends of the stabilizing arms  106  and through adjacent graft material. The distal end of the ipsilateral lumen  66  of the preloaded main body  18  is also attached to the inner assembly  100  by a releasable suture S 3 . These sutures and release wires S 1 , S 2 , and S 3  secure the main body  18  of the endovascular graft assembly  12  to the inner assembly  100  for deployment to the targeted implantation site.  
         [0083]     Separate wires  108 ,  110 , and  112  extend from the handle  98  along the inner assembly  100 . The separate release wires  108  and  112  are independently coupled to the sutures S 1  holding the proximal sealing stent  70  (release wire  108 ) and the suture S 3  at the distal end of the ipsilateral lumen  66  (release wire  112 ). The release wires  110  are continuations of the release wires S 2  threaded through the stabilizing arms  106  (as previously described), so that, in the illustrated embodiment, there are actually three release wires  110 , one for each arm  106 . Controls  114 ,  116 , and  118  on the handle  98  are coupled to the separate release wires  108 ,  110  (commonly coupled to the three wires), and  112 , as will be described in greater detail later, to independently release the sutures or release wires at one location, without necessarily releasing the sutures or release wires at another location. The separate and independently controllable release wires  108 ,  110 ,  112  and make it possible to release of the main body  18  of the endovascular graft assembly  12  in a prescribed order, to deploy the main body  18  of the endovascular graft assembly  12  in a desired sequence during the graft deployment process, as will be described in greater detail later.  
         [0084]     The graft retention jacket  102  is sized and configured to slide over and along the inner assembly  100  from an advanced position over the main body  18  of the preloaded endovascular graft assembly  12  (shown in phantom Lines in  FIG. 4E ) to a retracted position spaced away from the main body  18  of the preloaded endovascular graft assembly  12  (shown in solid lines in  FIG. 4E ). A radiopaque marker  120  is positioned at the leading edge of the graft retention jacket  102  to assist in visualization under fluoroscopy. A jacket control mechanism  122  coupled to controls  124  and  126  on the handle  98  affects retraction of the graft retention jacket  102  in a stepwise fashion—using first control  124  and then control  126 , as will be described later—as well as the re-advancement of the retention jacket  102  using the single control  126  after the main body  18  has been fully deployed and it is time to withdraw the delivery system.  
         [0085]     When in its advanced position, the graft retention jacket  102  protects the preloaded main body  18  of the endovascular graft assembly  12  as it is advanced through the patient&#39;s vasculature. When in its retracted position, the graft retention jacket  102  frees the preloaded main body  18  of the endovascular graft assembly  12  for deployment by operation of the controls  124  and  126  on the handle  98  during the graft deployment process.  
         [0086]     The actuating components on the control handle  98  (see  FIGS. 4B and 4C ) include a jacket retraction knob  124  and a jacket retraction slide  126 , which are coupled to the jacket control mechanism  122  just described (as shown in  FIG. 4D ). The jacket retraction knob  124  is actuated by rotation and is coupled to a rack and pinion component of the jacket control mechanism  122  within the handle  98 . The rack and pinion component applies a mechanical advantage in response to rotation of the knob  124  sufficient to overcome the initial resistance of the graft retention jacket  102  to axial movement beyond the proximal sealing stent  70  of the main body  18  of the endovascular graft assembly  12 . Once free of the proximal sealing stent  70 , the rack and pinion component of the jacket control mechanism  122  is automatically released from the jacket retraction knob  124  (the knob  124  will accordingly spin freely), and subsequent control passes to the jacket retention slide  126 . Pulling on the jacket retention slide  126  (which does not provide a mechanical advantage) suffices to complete the retraction of the jacket  102 . This control sequence provides the physician with tactile feedback during the retraction of the jacket  102 . After retracted in this manner, the jacket  102  can be advanced back toward the nosecone  104  using the jacket slide  126  when it is time to withdraw the delivery system.  
         [0087]     The actuating components on the control handle (see  FIGS. 4B and 4C ) also include a proximal sealing stent release slide  114 , a graft release slide  116 , and an ipsilateral lumen release slide  118 . The proximal sealing stent release slide  114  is coupled to the release wire  110  for the proximal sealing stent  70  (see  FIG. 4D ). The graft release slide  116  is coupled to the three separate release wires  110  for the stabilizing arms  106  (also shown in  FIG. 4D ). The ipsilateral lumen release slide  118  is coupled to the separate release wire  112  for the distal end of the ipsilateral lumen  66  (as further shown in  FIG. 4D ).  
         [0088]     Once the graft retention jacket  102  is retracted (as just described), pulling on the proximal sealing stent release slide  114  opens the proximal sealing stent  70 . Despite opening the proximal sealing stent  70 , the proximal and ipsilateral ends of the main body  18  of the endovascular graft assembly  12  remain attached to the inner assembly  100  of the endovascular graft delivery system. The physician maintains control of the main body  18  of the endovascular graft assembly  12  for further final positioning and for the application of the staples  36 , as will be described in greater detail later.  
         [0089]     Once positioned in a desired location and/or after insertion or implantation of staples to secure the main body  12  to the vessel wall, pulling on the graft release slide  116  releases the proximal end of the main body  18  of the endovascular graft assembly  12  from the stabilizing arms  106 . Despite opening the proximal sealing stent  70  and the stabilizing arms, the physician still maintains control of the ipsilateral end of the main body  18  of the endovascular graft assembly, which remains attached to the inner assembly  100 . Next pulling on the ipsilateral lumen release slide  118  opens and releases the ipsilateral lumen  66  from the delivery catheter  96 .  
         [0090]     If desired, and as shown in phantom lines in  FIG. 4A , a stationary outer jacket  220  may be provided that extends for a distance from the proximal end of the handle  98  over the delivery catheter  96  (the jacket  102 ) slides within the stationary outer jacket  220 ). The stationary jacket  220  provides a seal interface with a hemostatic valve of the introducer sheath at the access site. The stationary jacket  220  can be made of a suitable medical grade plastic, such as Fluroinated Ethylene Propylene (FEP) as non-limiting example. The stationary outer jacket  220  provides column strength and lubricity to reduce friction during sliding actuation of the jacket  102 .  
         [0091]     The delivery catheter  96  is desirably sized to present a minimum diameter according to the diameter of the main body  18  of the endovascular graft assembly  12  it carries. The delivery catheter  26  is desirably sized and configured with a lumen accommodating conventional over-the-wire delivery within a patient&#39;s vasculature, e.g., using a conventional 0.035 or 0.038 inch guide wire. In representative embodiment, the overall length of the delivery catheter is preferably between 40 and 120 cm and most preferably between 50 and 90 cm.  
         [0092]     Further details of representative constructions of a main body delivery system  24  can be found in co-pending, commonly owned U.S. patent application Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation,” which is incorporated herein by reference.  
         [0093]     ii. Hemostasis Control  
         [0094]     In a representative embodiment (see  FIG. 5A ), the proximal end of the handle  98  (near the sliding controls  114 ,  116 , and  118  just described) includes a hemostatic seal assembly  128 . As  FIG. 5D  shows, a flush passage  130  (for conveying heparinized saline to flush the delivery catheter  96  prior to deployment) communicates with the space between the inner assembly  100  and jacket  102  through the hemostatic seal assembly  128 . As  FIG. 5D  also shows, the individual release wires  108 ,  110 , and  112  for the proximal sealing stent release slide  114 , the graft release slide  116  (one release wire  110  for each stabilizing arm  106 ), and the ipsilateral lumen release slide  118 , as previously described, also pass from the slide controls  114 ,  116 , and  118  within the handle in a sealed fashion through the hemostatic seal assembly  128  for passage along the inner assembly  100  to the distal end of the delivery catheter  96 , where they connect to their respective components, as previously described. The hemostatic seal assembly  128  allows flushing to occur and prevents blood, which can enter the space between the outer jacket  102  and the inner assembly  100  catheter tube during use, from entering the interior of the handle  98 .  
         [0095]     In the illustrated embodiment (see  FIGS. 5B and 5C ), the hemostatic seal assembly  128  includes first and second substantially rigid seal components  132  and  134 , made e.g. of an inert material. The first seal component  132  comprises a center post  136  and a collar  138  that extends radially from an end of the post  136 . The collar  138  forms a mount for coupling the hemostatic seal assembly  128  within the confines of the handle  98 , as  FIG. 5D  shows.  
         [0096]     The center post  136  defines a passage that sealingly engages the flush passage  130  of the delivery catheter  96 , to provide a fluid seal.  
         [0097]     The second seal component  134  comprises an annular ring that fits about the post. As further shown in  FIGS. 5B and 5C , the hemostatic seal assembly  128  further includes an annular septum or gasket  140  that also fits about the post  136 . When assembled, the gasket  140  is sandwiched between the second seal component  134  and the collar  138  of the first seal component  132 . The gasket  140  is made of a soft material, like silicone rubber. The collar  138  and the second seal component  134  include coaxial through-holes or guide tubes  142  to accommodate passage of the various release wires  108 ,  110 , and  112  through the annular gasket  140 . The through-holes  142  act as bearing surfaces or guides for the release wires  108 ,  110 , and  112  on opposite sides of the annular gasket  140 .  
         [0098]     The gasket  140  provides a dynamic fluid seal for the release wires  108 ,  110 , and  112 . The fluid seal is maintained even if a release wire becomes tensioned during use in a non-axial direction. The length and diameter of the bearing surfaces of the through holes  142  and the thickness of the annular gasket  140  can vary depending upon the diameter of the release wires  108 ,  110 , and  112  and direction or angle the release wires  108 ,  110 , and  112  make as they exit the bearing through holes  142 , to prevent tear out or sawing of the material of the gasket  140 .  
         [0099]     b. The Lumen Extension Delivery System  
         [0100]     Each lumen extension  20  and  22  of the endovascular graft assembly is preloaded into a lumen extension delivery system, respectively  26  and  28 (see  FIG. 6A ), each of which is a single use component that is supplied to the user within its package  44  and  46  in a sterile condition. Each lumen extension delivery system  26  and  28  is sized and configured to facilitate accurate placement of its lumen extension  20  and  22  of the endovascular graft assembly  12 .  
         [0101]     In the illustrated embodiment (see  FIG. 6A ), each lumen extension delivery system  26  and  28  comprises a delivery catheter  144  and a control handle  146  coupled to the proximal end of the delivery catheter  144 . The delivery catheter  144  (see  FIG. 6D ) comprises a flexible inner assembly  148  and an outer graft retention jacket  150 . The inner assembly  148  carries at its distal-most end a flexible radiopaque tracking nosecone  152 .  
         [0102]     When preloaded (see  FIG. 6D ), the lumen extension  20  or  22  of the endovascular graft assembly is attached to the inner assembly  148  by a releasable suture S 4  at the proximal end of the spiral stent  86 . A release wire  154  extends from the handle  98  along the inner assembly  148  and is coupled to the suture S 4  holding the proximal end of the spiral stent  86 . A sliding control  156  on the handle  146  is coupled to the release wire  154  (as will be described in greater detail later), to release the suture S 4  and thereby release of the lumen extension  20  or  22  of the endovascular graft assembly  12  from the inner assembly  148  during the graft deployment process, as will be described in greater detail later.  
         [0103]     The graft retention jacket  150  is sized and configured to slide over and along the inner assembly  148  from an advanced position over the preloaded lumen extension  20  or  22  of the endovascular graft assembly  12  (shown in phantom Lines in  FIG. 6D ) to a retracted position spaced away from the preloaded lumen extension  20  or  22  of the endovascular graft assembly  12  (shown in solid lines in  FIG. 6D ). A radiopaque marker  158  is positioned at the distal end of the graft retention jacket  150  to assist in visualization under fluoroscopy. A control mechanism  160  coupled to a sliding control  162  on the handle  146  affects advancement and retraction of the graft retention jacket  150 , as will be described later.  
         [0104]     When in its advanced position, the graft retention jacket  150  protects the preloaded lumen extension  20  or  22  of the endovascular graft assembly  12  as it is advanced through the patient&#39;s vasculature. When in its retracted position, the graft retention jacket  150  frees the preloaded lumen extension  20  or  22  of the endovascular graft assembly  12  for deployment by operation of the sliding control  162  on the handle  98  during the graft deployment process.  
         [0105]     The actuating components on the control handle  146  (see  FIGS. 6B and 6C ) include a jacket retraction knob  162  (coupled to the jacket control mechanism  160 ) and a proximal spiral stent release slide  156  (coupled to the release wire  154  just described (as shown in  FIG. 6D ). Pulling on the jacket retraction slide  162  suffices to retract the jacket  150 . Once the graft retention jacket  150  is retracted (as just described), pulling on the proximal spiral stent release slide  156  opens and releases the lumen extension  20  or  22  from the inner assembly  148 .  
         [0106]     A stationary outer jacket  220  may also be provided for the lumen extension delivery systems  26  and  28  (as shown in phantom lines in  FIG. 6A ). As previously described with respect top the main body delivery system  24 , the stationary outer jacket  220  extends for a distance from the proximal end of the handle  146  over the delivery catheter  144  (the jacket  150 ) slides within the stationary outer jacket  220 ). The stationary jacket  220  provides a seal interface with a hemostatic valve of the introducer sheath at the access site. As previously described, the stationary jacket  220  can be made of a suitable medical grade plastic, such as Fluroinated Ethylene Propylene (FEP) as non-limiting example. The stationary outer jacket  220  provides column strength and lubricity to reduce friction during sliding actuation of the jacket  150 .  
         [0107]     Each lumen extension delivery catheter  144  is desirably sized to present a minimum diameter according to the diameter of the lumen extension  20  or  22  of the endovascular graft assembly  12  it carries. The delivery catheter  144  is desirably sized and configured with a lumen accommodating conventional over-the-wire delivery within a patient&#39;s vasculature, e.g., using an appropriately sized guide wire. In representative embodiment, the over-all length of the lumen extension delivery catheter  144  is preferably between 40 and 120 cm and most preferably between 50 and 90 cm.  
         [0108]     The lumen extension delivery catheter can include a hemostatic valve assembly of the type previously described and as shown in  FIGS. 5A  to  5 D.  
         [0109]     Further details of representative constructions of a lumen extension delivery system can be found in co-pending, commonly owned U.S. patent application Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation,” which is incorporated herein by reference.  
         [0110]     C. Endovascular Stapling System  
         [0111]     The endovascular stapling system  16  comprises steerable endovascular guide  30  and a companion obturator  32  (see  FIGS. 7A and 7B ) for over-the-wire, intravascular deployment of the steerable endovascular guide  30 . The endovascular stapling system  16  also comprises a plurality of endovascular staples  36  ( FIG. 8A ) and, desirably, a cassette  34  for holding the staples  36  (see  FIG. 8B ), as well as an endovascular staple applier  38  (see  FIGS. 9A and 9B ).  
         [0112]     d. Steerable Endovascular Guide and Companion Obturator  
         [0113]     The steerable endovascular guide  30  is a single use component that is supplied with a companion obturator  32  to the user within its package  50  in a sterile condition. The steerable endovascular guide  30  is sized and configured to direct the endovascular staple applier  38  to the desired location for implantation of one or more endovascular staples  36 .  
         [0114]     The steerable endovascular guide  30  (see  FIGS. 7A and 7B ) includes a guide tube  164  and a handle  166  coupled to the proximal end of the guide tube  164 . The guide tube defines an open interior lumen  168  accommodating passage of the obturator  32  (during deployment) and the endovascular staple applier  38  (during use).  
         [0115]     The distal portion of the guide tube  164  can be deflected in one direction (as shown in phantom lines in  FIG. 7A ) and straightened by a steering wire (not shown) coupled to a rotational deflector knob  170  on the handle  166 . In a representative embodiment, the over-all length of guide tube  164  and handle  166  is preferably between 40 and 120 cm and most preferably between 50 and 90 cm, and the length of the deflectable tip is preferably between 1 and 10 cm and most preferably between 2 and 5 cm. A C-shaped radiopaque marker  172  is located at the distal tip of the guide tube  164  to aid in orientation under fluoroscopy.  
         [0116]     In a representative embodiment, the obturator  32  is desirably sized and configured with a lumen  174  accommodating conventional over-the-wire delivery within a patient&#39;s vasculature, e.g., using an appropriately sized guide wire.  
         [0117]     Further details of representative constructions of a steerable endovascular guide  30  can be found in co-pending, commonly owned U.S. patent application Ser. No. 11/254,619, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Guiding an Operative Tool into an Interior Body,” and co-pending, commonly owned U.S. patent application Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation,” which are both incorporated herein by reference.  
         [0118]     B. The Endovascular Staple and Companion Cassette  
         [0119]     The endovascular staple  36  (see  FIG. 8A ) is a single use component that is supplied, desirably in a companion cassette, to the user within a package in a sterile condition. The endovascular staple  36  is sized and configured to attach the endovascular graft assembly  12  to a vessel wall.  
         [0120]     In the illustrated embodiment (see  FIG. 8A ) the endovascular staple  36  comprises a main staple body  176  that is helical-shaped. The helical-shape allows the endovascular staple  36  to pierce and engage tissue in response to rotation of the main staple body  176 , thereby securing attachment of the endovascular graft assembly  12  to a vessel wall.  
         [0121]     In a representative embodiment, the main staple body  176  is manufactured from medical grade wire having a diameter of from 0.1 mm to 1 mm . In a representative embodiment, the endovascular staple  36  is approximately between 2 mm to 12 mm in over-all length and approximately from approximately 1 mm to 10 mm in maximum diameter. The leading end  178  of the main staple body  176  is desirably sharpened to facilitate atraumatic deployment through the graft materials and vessel wall. The proximal end  180  of the main staple body  176  is desirably closed to prevent over-penetration of the endovascular staple  36 .  
         [0122]     Desirably, a plurality of staples  36  (e.g., ten) are provided in a cassette  34  (see  FIG. 8B ), to allow easy and accurate loading into the endovascular staple applier  38 . The cassette  34  includes a base  208  having a plurality of spaced apart staple ports or stations  210 , each sized to house a staple  36 . A cover  212  rotates on the base  208  (see  FIG. 8C ). The cover  212  overlies the ports  210 , closing them, except for an open notch region  214 , which permits access to a single one of the ports  210 . In use, an operator rotates the cover  212  to expose one port  210  and the staple  36  it contains. The operator operates the staple applier  38  to load the staple  36  from the exposed port  210 , as will be described in greater detail. After implanting the withdrawn staple  36 , the operator rotates the cover  212  to expose another one of the ports  210  and the staple  36  it contains. The operator again operates the staple applier  38  to load the staple  36  from the exposed port  210  for implantation. In this way, the cassette  34  aids the operator in loading individual staples on the staple applier  36  for implantation in a single fire (one at a time) fashion.  
         [0123]     Further details of representative constructions of an endovascular staple  36  and companion cassette  34  can be found in co-pending, commonly owned United States patent application Ser. No. 11/255,116, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation,” which is incorporated herein by reference.  
         [0124]     C. Endovascular Staple Applier  
         [0125]     1. Overview  
         [0126]     The endovascular staple applier  38  (see  FIGS. 9A and 9B ) is a single use component that is supplied to the user within a package  48  in a sterile condition. In the illustrated embodiment, the endovascular staple applier  38 , a supply of endovascular staples  36 , and the staple cassette  34  are provided, for the sake of convenience, in a single package  48 . The endovascular staple applier  38  is sized and configured to pass through the lumen  168  of the steerable endovascular guide tube  164  and to be selectively operated to implant one or more endovascular staples  36  through the graft materials and vessel wall.  
         [0127]     In the illustrated embodiment, the endovascular staple applier  38  comprises an applier catheter  182  and a control handle  184  coupled to the end of the applier catheter  182 . The applier catheter  182  carries a rotationally driven member  186  at its distal end. A battery powered motor  188  enclosed within the handle  184  is coupled to the driven member  186 , to selectively rotate the driven member  186  either in a forward (e.g., clockwise) direction and reverse (e.g., counterclockwise) direction. A control circuit  190  in the handle  184  is coupled to the motor  188  and to a forward control button  192  and a reverse control button  194  on the handle. The control circuit  190  governs operation of the operation of the motor  188  according to pre-programmed operating parameters in response to user commands received by manipulation of the buttons  192  and  194 .  
         [0128]     In use (see  FIGS. 10A  to  10 H), an endovascular staple  36  is loaded into the driven member  186  from the cassette  34 , e.g., by placing the distal end of the applier catheter  182  into an exposed staple port  210  in the cassette  34  and pressing the reverse control button  194  ( FIG. 10A ). The now loaded endovascular staple applier  38  is passed through the guide tube  164  of the endovascular guide  30  ( FIG. 10B ), which has been manipulated beforehand to be at an intended implantation site for the endovascular staple  36 .  
         [0129]     Once the endovascular staple applier  38 , loaded with a staple, is positioned at the desired location ( FIG. 10C ), the physician presses the forward control button  192  to command rotation of the endovascular staple  36  in the forward direction (i.e., into tissue).  
         [0130]     The control circuit  190  is desirably pre-programmed to require a two-stage implantation process. The first stage commands only a partial implantation of the staple  36 . In the first stage, the physician is allowed to ascertain whether the staple  36  is placed correctly at the desired location and that the desired located is suitable for implantation of the staple  36 . While in the first stage, the physician is allowed to retract the staple  36  (by pressing the reverse control button  194 ) and to re-position the staple  36 .  
         [0131]     The control circuit  190  commands a full final deployment of the staple  36  only after a deliberate entry of the second stage. In the first and second stages, the control circuit  190  generates audible tones and visual indicators e.g., blinking lights, during operation of the motor  188 , to indicate the position of the staple and available direction of motion.  
         [0132]     Once the staple  36  is implanted, the endovascular staple applier  38  is withdrawn through the endovascular guide. The cassette cover  212  is rotated to reveal another staple port  210  and the staple  36  it contains. The staple applier  38  is reloaded. The endovascular guide  30  is manipulated to another desired implantation site, and the endovascular staple applier  38  (reloaded with another staple  36 ) is redeployed and operated in the manner just described. The endovascular staple applier  38  is intended to be loaded, deployed, and reloaded in this way multiple times for a single patient.  
         [0133]     Further details of representative constructions of an endovascular staple applier  38  and methods of its use can be found in co-pending, commonly owned U.S. patent application Ser. No. 11/254,950, filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Prosthesis Delivery and Implantation, Including the Use of a Fastening Tool” which is incorporated herein by reference.  
         [0134]     2. Tracking the Relative Position of the Endovascular Staple Applier in the Endovascular Guide  
         [0135]     Desirably, the endovascular staple applier  38  includes indicia  196 , which is visible to a naked eye (i.e., without resort to fluoroscopic visualization or other visualization techniques that augment human vision) the indicates the extent to which the driven distal end  186  of the applier catheter  182 , which carries the endovascular staple  36 , resides within the guide tube  164  of the steerable endovascular guide  30 . In particular, the visible indicia  196  indicates when the driven distal end  186  of the applier catheter  182  and the staple  36  it carries have arrived at a predetermined location within the guide tube near to but still within the distal end of the guide tube  164 . In this way (see  FIG. 11C ), the physician can quickly and accurately ascertain, without resort to fluoroscopic visualization, that the distal end of the applier catheter  182 , and the endovascular staple  36  it carries, are positioned wholly within the confines of the guide tube  164 , ready for final deployment, once the guide tube  164  is placed at the intended implantation site. The visible indicia  196  can also indicate to extend to which the driven distal end  186  of the applier catheter  182  has been extended outside the distal end of the guide tube  164 .  
         [0136]     In the illustrated embodiment (see  FIG. 11A ), the indicia  196  comprises visible material or markings on the most proximal section of the applier catheter  182 , adjacent the handle  184 , that is marked or colored differently or is otherwise differentiated from the remainder of the applier catheter  182 . In a representative example, a prescribed length of contrast-colored tubing  198  can be placed at the most proximal end of the applier catheter  182 , where it exits the handle  184 .  
         [0137]     The contrast-color tubing  198  has a prescribed length. The distal end of the tubing  198  marks a line of differentiation between the tubing  198  and the remainder of the applier catheter  182 . The length is selected so that the distal end of the tubing  198  registers with the insertion port/hemostatic seal  200  on the handle  166  of the steerable endovascular guide  30  (see  FIG. 11B ) when the driven distal end  186  of applier catheter  182  rests at a desired inset distance d within the distal end of the guide tube  164  (see  FIG. 11C ).  
         [0138]     In this way, the indicia  196  indicates when the applier catheter  182  has reached a desired insertion depth within the guide tube, and is ready to be further advanced beyond the guide tube  164  to implant the endovascular staple  36 . The contrast-color tubing  198  may further include additional markings M along its length by which the physician can gauge advancement of the applier catheter  182  beyond the endovascular guide  20 .  
         [0139]     The indicia  196  makes it possible for the physician, without resort to fluoroscopic visualization, to always know whether the endovascular staple  36  is within or outside the endovascular guide  30 .  
         [0140]     3. The Motor Control Circuit  
         [0141]     In a representative embodiment (see  FIG. 13A ), the control circuit  190  for the motor includes an optical encoder  250  coupled to a counting function  252 , to enable counting the revolutions of the battery powered motor  188 . The control circuit  190  also includes a sensing function  254  that senses the magnitude of current being drawn by the motor  188 , for deriving torque that the motor  188  is encountering. The control circuit  190  also includes a comparison function  256  that compares the magnitude of the sensed torque (current) with set torque limits in either the forward or reverse direction, to change the state of operation should excess torque conditions be encountered.  
         [0142]     The control circuit  190  carries embedded code, which expresses pre-programmed rules or algorithms under which different operation states are entered and motor command signals are generated in response to input from the external control sources and the counting, sensing, and comparison functions. The pre-programmed rules or algorithms of the control circuit  190  are designed to conserve power consumption, placing the circuit into a standby (wait) mode between staple loading and deployment cycles. This makes it possible to power up the staple applier just once and to leave the staple applier on during an entire procedure, avoiding time consumed in repeated power ups and power downs. The pre-programmed rules or algorithms of the control circuit also dictate that a desired sequence of steps is faithfully followed in loading, deploying, and reloading the staples, prompting the physician at the initiation of each step and not allowing any short-cuts or deviations along the way.  
         [0143]     Features of the pre-programmed rules or algorithms of a representative control circuit  190  for the staple applier will now be described in greater detail.  
       Power Up/System Self-Check  
       [0144]     In a representative implementation (see  FIG. 13B ), the pre-programmed rules or algorithms of the control circuit  190  enter a POWER UP state when an operator enters a prescribed power up command, e.g., when the operator presses and holds the reverse control button  194  for a prescribed amount of time. In the POWER UP state, the pre-programmed rules or algorithms of the control circuit  190  first check battery voltage against a set minimum. The POWER UP state proceeds if the battery voltage exceeds the set minimum. Otherwise, the pre-programmed rules or algorithms of the control circuit  190  enter a LOW BATTERY FATAL state.  
         [0145]     Absent a LOW BATTERY FATAL state, the pre-programmed rules or algorithms of the control circuit  190  enable the optical encoder and drive the motor  188  in a forward direction for a set period of time. The counting and sensing functions of the control circuit  190  count the number of revolutions and sense forward current. If the forward current exceeds a set maximum current level (as determined by the comparison function), the pre-programmed rules or algorithms of the control circuit  190  enter a FORWARD TORQUE FATAL state. Otherwise, the sensed forward current is registered by the pre-programmed rules or algorithms of the control circuit  190  as a base line for forward torque.  
         [0146]     Absent a FORWARD TORQUE FATAL state, the pre-programmed rules or algorithms of the control circuit  190  enable the optical encoder and counting function, and drive the motor  188  in a reverse direction for a set period of time. The counting function of the control circuit  190  counts the number of revolutions, while the sensing function senses reverse current. If the reverse current exceeds a set maximum current level (as determined by the comparison function), the pre-programmed rules or algorithms of the control circuit  190  enter a REVERSE TORQUE FATAL state. Otherwise, the sensed reverse current is registered by the pre-programmed rules or algorithms of the control circuit  190  as a base line for reverse torque.  
         [0147]     Audible tones and visual indicators (e.g. blinking lights) coupled to the control circuit  190  desirably accompany the POWER UP state as the system self-check is accomplished. If no fatal states are encountered during the POWER UP sequence, the pre-programmed rules or algorithms of the control circuit  190  enter a READY TO LOAD state. The pre-programmed rules or algorithms of the control circuit  190  enable a ready to load prompt, e.g., blinking a reverse green arrow  202  (see  FIG. 9B ), to indicate to the user that the endovascular staple applier  38  is ready to load the first endovascular staple. If a fatal state is encountered, the pre-programmed rules or algorithms of the control circuit  190  enable a different prompt, e.g., illuminating a red error light  204  (see  FIG. 9B ), indicating that the endovascular staple applier  38  has encountered an error.  
         [0148]     In addition, there are other checks that can be performed during the POWER UP state, including checking the encoder and the watchdog function for operation.  
         [0149]     In a representative implementation, the pre-programmed rules or algorithms of the control circuit  190  allow the operator to clear the error state one time, e.g., by pressing the forward control button  192 . After the error has been cleared, the self-check sequence of the POWER UP state will reinitiate. If during the second self check sequence, a fatal state is again encountered, the pre-programmed rules or algorithms of the control circuit  190  either disable the endovascular staple applier  38  from use, or again enable the error prompt. In the latter instance, the instructions for use  58  desirably will inform the operator not to use an endovascular staple applier  38  that has encountered a start-up error twice.  
       Ready to Load State: Load Staple  
       [0150]     After the staple applier has been powered up and is in the READY TO LOAD state, the operator is able to load the endovascular staple by initiating a prescribed input command, e.g., by pushing the reverse control button  194 . The distal end of the endovascular staple applier catheter  182  is intended to be inserted into a staple port of the cassette at the time the input command is given.  
         [0151]     When the prescribed input command is received, the pre-programmed rules or algorithms of the control circuit  190  command the motor  188  to rotate in a reverse direction for a set time period and generates a confirmation output with visual indicators (e.g., blinking the reverse green arrow  202 ). The endovascular staple  36  will be drawn from the cassette  34  into the distal end of the staple applier  38 .  
         [0152]     The sensing function of the control circuit  190  senses the magnitude of the current drawn by the motor  188  as the staple  36  is being loaded onto the distal end of the staple applier  38 . Once a prescribed amount of current has been reached, the pre-programmed rules or algorithms of the control circuit  190  consider the staple applier to have completed the loading state. The pre-programmed rules or algorithms of the control circuit  190  then automatically go into a UNWIND sequence, to reduce or eliminate amount of torque windup in the staple applier catheter and drive shaft developed during the LOAD state. The pre-programmed rules or algorithms of the UNWIND sequence run the motor in the reverse direction from the load direction a set number of turns and wait for a command input.  
         [0153]     After the UNWIND sequence, the endovascular staple is presumed loaded, and the pre-programmed rules or algorithms of the control circuit  190  enter a READY TO APPLY state. The pre-programmed rules or algorithms of the control circuit  190  generate a confirmation output, e.g., audible and visual indicators (e.g., two short beeps and a forward green arrow  206  will blink (see  FIG. 9B ) to prompt the next step, which is to deploy the staple  36 .  
         [0154]     The endovascular staple  36  is now loaded in the staple applier  38 , and the applier  38  can be removed from the cassette  34 . The physician is desirably urged by the instructions for use  58  to verify that the endovascular staple  36  is in place by visually inspecting the distal end of the applier  38 .  
         [0155]     When the staple applier  38  has been powered up and is in the READY TO LOAD state, the pre-programmed rules or algorithms of the control circuit  190  desirably do not accept any command other than the command prescribed for loading (e.g., pushing the reverse control button  194 ). If an operator provides a contrary command, e.g., by pushing on the forward command button  192 , the pre-programmed rules or algorithms of the command circuit will ignore the command. In this way, the pre-programmed rules or algorithms of the command circuit require an operator to follow a prescribed sequence in operating the staple applier.  
       Ready to Apply State: Deploy Staple  
       [0156]     When the pre-programmed rules or algorithms of the control circuit  190  have entered the READY TO APPLY state, and the operator is ready to deploy the staple  36 , the operator is able to deploy the endovascular staple  36  by initiating a prescribed input command, e.g., by pressing the forward control button  192 . When the forward control button  192  is pushed, the pre-programmed rules or algorithms of the control circuit  190  command the motor  188  to rotate in a forward direction for a set number of rotations (sensed by the counting function), which, according to the pre-programmed rules or algorithms, are less than the number of rotations required to fully implant the staple. The pre-programmed rules or algorithms of the control circuit  190  suspend operation of the motor  188  at this point and await another input command. Thus, the pre-programmed rules or algorithms of the control circuit  190  only partially deploy the staple and generate a confirmation output, e.g., four beeps and/or alternatively blinking the forward and reverse arrows  202  and  206 , prompting the operator to make a choice. This indicates that the operator may chose to continue deployment or to withdraw the endovascular staple back into the applier.  
         [0157]     If the operator inputs a prescribed withdraw command, e.g., by pushing the reverse control button  194 , the pre-programmed rules or algorithms of the control circuit  190  drive the motor  188  in the reverse direction for a set number of rotations (sensed by the counting function), to withdraw the staple  36 . The pre-programmed rules or algorithms of the control circuit  190  then return to the READY TO APPLY state.  
         [0158]     If the operator inputs a prescribed complete the implantation command, e.g. by pushing the forward control button  192 , the pre-programmed rules or algorithms of the control circuit  190  will drive the motor  188  in the forward direction for a set number of rotations (monitored by the counting function), to complete the implantation of the staple. The pre-programmed rules or algorithms of the control circuit  190  generate a confirmation output, e.g., audio and visual indicators. The pre-programmed rules or algorithms of the control circuit  190  return to the READY TO LOAD state.  
         [0159]     During the different operational states, the pre-programmed rules or algorithms of the control circuit  190  continue to check battery voltage against a set minimum. The operational states proceed as described as long as the battery voltage exceeds the set minimum. If, during an operational state the battery voltage falls below the set minimum, the pre-programmed rules or algorithms of the control circuit  190  enter a LOW BATTERY FATAL state.  
         [0160]     D. The Instructions for Use  
         [0161]     The instructions for use  58  can direct use of catheter-based technology via a peripheral intravascular access site, such as in the femoral artery, optionally with the assistance of image guidance. Image guidance includes but is not limited to fluoroscopy, ultrasound, magnetic resonance, computed tomography, or combinations thereof.  
         [0162]      FIGS. 12A  to  12 P show a representative embodiment of the steps that a representative instructions for use  58  can incorporate or direct.  
         [0163]     In a representative embodiment, the instructions for use  58  may include the achievement of percutaneous vascular access by conventional methods into the femoral artery, for example. In this arrangement, the patient is placed on an imaging table, allowing fluoroscopic visualization from the aortic arch to the femoral artery bifurcations. Access is secured to both contralateral and ipsilateral branches by standard techniques using introducer sheaths (which can be supplied as part of the kit  40 ). Using fluoroscopic guidance, access to the patient&#39;s abdominal aorta can be achieved with an appropriately sized guide wire through each femoral access sites.  
         [0164]     1. Position the Main Body Graft Assembly in the Targeted Endovascular Treatment Site  
         [0165]     In this arrangement, the instructions  58  for use may include positioning of the main body  18  of the endovascular graft assembly to be deployed. The instructions may include a series of steps that can be followed to carry out this portion of the procedure. These steps may include:  
         [0166]     (i) after flushing the main body delivery system  24  with heparinized saline, positioning the main body delivery system  24  within an aortic aneurysm over the guide wire via the ipsilateral femoral access site, which has been previously established in conventional fashion ( FIG. 12A );  
         [0167]     (ii) visualizing the proper rotation and orientation of the main body  18  using the ipsilateral and contralateral radiopaque markers on the main body  18 . As previously described, the main body  18  includes three (3) short markers  76  on the ipsilateral side and two (2) long markers  74  on the contralateral side for this purpose. The two rows of markers  74  and  76  should be parallel to each other and not cross. The main body delivery system  24  can be rotated for re-alignment of the main body  18  of the graft assembly  12 .  
         [0168]     (ii) withdrawing the graft retention jacket  102  of the main body delivery system  24  by rotating the jacket retraction knob  124 , until the knob  124  spins freely (which indicates that the rack and pinion mechanism has been released). This step only partially retracts the jacket  102  (about 63 mm ), unsheathing the proximal stent  70 , with the remaining portion of the main body  18  still constrained within the jacket  102 . The instructions may note that the proximal sealing stent  70  will not open during retraction of the jacket  102 .  
         [0169]     (iii) completing the retraction of the graft retention jacket  102  by sliding the jacket retention slide  126  away from the patient. The instructions may note that the contralateral lumen of the main body  18  is now fully open, while the proximal sealing stent  70  and ipsilateral lumen remain collapsed and connected to the main body delivery system  24  ( FIG. 12B );  
         [0170]     (iv) verifying the position and orientation of the main body  18  using the radiopaque markers  74  and  76 , to ensure that blood flow to the renal arteries is not obstructed and the main body  18  of the graft assembly  12  is not twisted; and  
         [0171]     (v) opening the proximal sealing stent  70  by retracting the proximal sealing stent release slide  114  ( FIG. 12C ). The instructions may note that the proximal and distal ends of the main body  18  of the endovascular graft assembly  12  still remain secured to the main body delivery system  24 . The physician thereby maintains control of the position and orientation of the main body  18  of the graft assembly  12 .  
         [0172]     2. Deploy Endovascular Staples to Secure the Position of the Main Body of the Graft Assembly  
         [0173]     The instructions for use  58  may next instruct securing of the position of the proximal end of the main body  18  of the endovascular graft assembly using endovascular staples  36 . The instructions may include a series of steps that can be followed to carry out this portion of the procedure. These steps may include:  
         [0174]     (i) placing an exchange length appropriately sized guide wire via the contralateral femoral access site into the abdominal aorta ( FIG. 12D ). The main body  18  of the endovascular graft assembly includes distal end radiopaque markers that outline the opening of the contralateral lumen of the main body  18 . The guide wire is to be placed through this opening and its position verified using standard endovascular techniques.  
         [0175]     (ii) inserting the obturator  32  into the lumen  168  of the steerable endovascular guide  30 .  
         [0176]     (iii) using fluoroscopic guidance, advancing the steerable endovascular guide  30  with the obturator  32  over the guide wire into a position within the proximal neck of the aortic aneurism ( FIG. 12E ). The C-shaped radiopaque marker  172  located at the distal tip of the steerable endovascular guide  30  will aid in fluoroscopic visualization.  
         [0177]     (iv) removing the guide wire.  
         [0178]     (v) removing the obturator  32  to open the lumen  168  of the steerable endovascular guide  30  for passage of the endovascular staple applier  38 .  
         [0179]     (vi) deflecting the distal end of the steerable endovascular guide  30  toward the first intended staple implantation area by rotating the deflector knob, while observing with fluoroscopic guidance. The instructions may note that the C-shaped fluoroscopic marker  172  will appear as a straight line when the catheter is oriented laterally, as a right curve “(” when oriented anteriorly, and as a left curve “)” when oriented posteriorly.  
         [0180]     (vii) turning on the endovascular staple applier  38  by pressing and holding the reverse control button  194  for at least five (5) seconds. This initiates a self-checking sequence with audible tones and blinking lights. At the end of this sequence, the reverse green arrow  202  will be blinking, indicating that the endovascular staple applier  38  is ready to load the first endovascular staple  36 . The instructions may note that, if at the end of the self check sequence, the red error light  204  is illuminated, the endovascular staple applier  38  has encountered an error. The error can be cleared by pressing the forward control button  192 . After the error has been cleared, the self check sequence will initiate. If at the end of the second self check sequence, the red error light  202  is still illuminated, the endovascular staple applier  38  is not functional and should not be used.  
         [0181]     (viii) after flushing the inner lumen of the endovascular staple applier  38  with heparinized saline via the flush port, loading the staple by pressing the reverse command button  194  on the handle. While the motor  188  is running, insert the distal end of the endovascular staple applier catheter  182  into the open staple port of the cassette  34 . The reverse green arrow  202  will blink, and the endovascular staple will be drawn from the cassette into the distal end of the staple applier  38 . When the endovascular staple  36  is loaded, an audible tone (e.g., two short beeps) will be heard, and the forward green arrow  206  will blink. This indicates that the endovascular staple  36  is now preloaded in the staple applier  38 , and the applier  38  can be removed from the cassette  34 . The instructions may urge the physician to verify that the endovascular staple  36  is in place by visually inspecting the distal tip of the applier  38 .  
         [0182]     (ix) while stabilizing the control handle  166  of the endovascular guide  30  relative to the patient, inserting the now-loaded endovascular staple applier  38  through the hemostatic seal at the proximal end of the steerable endovascular guide control handle  166 . The instructions may direct the physician to observe the location of the visible contrast-color tubing  198  or other indicia on the proximal end of the applier catheter  182  and to halt further insertion of the staple applier  38  when the end of the contrast-color tubing  198  registers with the insertion port/hemostatic seal on the handle of the steerable endovascular guide (as shown in  FIG. 11B ). This indicates that the distal end of applier catheter  182  rests in a desired short inset distance within the distal end of the guide tube  164  (as shown in  FIG. 11C ).  
         [0183]     (x) inserting and positioning the steerable endovascular guide  30  at the desired location for endovascular staple implantation within a desired stapling zone, e.g., between the marker bands on the proximal sealing stent  70  and the bottom edge of the proximal sealing stent  70 . The instructions may note that the endovascular staples should be evenly distributed around the circumference of the proximal sealing stent  70 , typically about 4 to 6 endovascular staples per graft.  
         [0184]     (xi) under fluoroscopic guidance, advancing the endovascular staple applier  38  through the steerable endovascular guide  30  until the endovascular staple applier  38  emerges from the distal end and contacts the endovascular graft assembly  12 . Slowly, continue to advance the endovascular staple applier  38  until resistance is felt, indicating that the endovascular staple applier  38  is firmly pushing against the main body  18  of the endovascular graft assembly  12  against the vessel wall.  
         [0185]     (xii) using the control handle  184  of the endovascular staple applier  38 , pressing the forward control button  192  for achieving the first stage of endovascular staple deployment. The endovascular step will partially deploy and pause. An audible tone is heard (e.g., four beeps) and the forward and reverse arrows  202  and  206  will alternatively blink, indicating that the operator may continue deployment or withdraw the endovascular staple  36  back into the applier  38 . The instructions may note that, in the event of a power loss when the staple  36  is partially deployed, the staple may be removed by manually rotating the handle  184  and catheter  182  in a counter-clockwise direction until the staple  36  disengages from the graft and tissue. The staple applier  38  can be removed from the endovascular guide  30  in this condition.  
         [0186]     (xiii) If the endovascular staple  36  is not in the desired location, pressing the reverse control button  194  to re-house the staple inside the staple applier  38  for re-positioning.  
         [0187]     (xiv) If the endovascular staple  36  is in the desired position, completing the final stage of staple deployment by pressing the forward control button  192  ( FIG. 12F ). When complete, an audible tone (e.g., three beeps) is heard and the reverse green arrow  202  will be blinking.  
         [0188]     (xv) using fluoroscopy, carefully and slowly retracting the endovascular staple applier  38  away from the graft wall to ensure it is released from the deployed staple.  
         [0189]     (xvi) removing the endovascular staple applier  38 , leaving the steerable endovascular guide  30  in place.  
         [0190]     (xvii) using fluoroscopy, visually confirming that the endovascular staple  36  is in place.  
         [0191]     (xviii) as needed, flush the steerable endovascular guide and the staple applier with heparinized saline to prevent clotting in the lumens.  
         [0192]     (xix) rotating the head of the cassette  34  (as shown in  FIG. 8C ) clockwise to expose the next endovascular staple port. Load the next endovascular staple in the manner described above.  
         [0193]     (xx) repositioning the steerable endovascular guide  30  to the next desired implantation site for an endovascular staple  36 . Desirably, the physician straightens the steerable endovascular guide  30  between rotating in within the main body  18 , to prevent accidental dislodgment or movement of the main body  18 .  
         [0194]     (xxi) deploying the next endovascular staple  36  through the steerable endovascular guide  30  in the manner described above. Typically, 4 to 6 endovascular staples, evenly distributed about the circumference of the main body  18 , will serve to secure the position of the main body  18  within the vessel ( FIG. 12G ).  
         [0195]     (xxii) after deployment of the last endovascular staple, removing the endovascular stapler applier  38  from the steerable endovascular guide  30 .  
         [0196]     (xxiii) re-advancing the obturator  32  and then the guide wire into the steerable endovascular guide.  
         [0197]     (xxiv) removing the steerable endovascular guide  30  and the obturator  32 , leaving the guide wire in position.  
         [0198]     3. Deploy the Contralateral Lumen Extension  
         [0199]     The instructions for use  58  may next include the deployment of the contralateral lumen extension  22  of the endovascular graft assembly. The instructions may include a series of steps that can be followed to carry out this portion of the procedure. These steps may include:  
         [0200]     (i) after flushing with heparinized saline, advancing the contralateral lumen extension delivery system  28  over the guide wire in the contralateral femoral access site ( FIG. 12H ).  
         [0201]     (ii) using fluoroscopic guidance, aligning the proximal marker  94  on the lumen extension  22  with the insertion depth marker  92  located medially on the main body  18 .  
         [0202]     (iii) holding the lumen extension deliver system  28  stable relative to the patient, retracting the jacket retraction slide  162  away from the patient to unsheath the lumen extension  22  ( FIG. 12I ). The distal end of the lumen extension  22  will deploy. The proximal end of the lumen extension  22  will remain collapsed and secured to the delivery system  28 .  
         [0203]     (iv) retracting the proximal stent release slide  156  to release the proximal end of the lumen extension  22  and complete the deployment of the lumen extension ( FIG. 12J ).  
         [0204]     (v) rejacketing the lumen extension delivery system by holding the jacket retention slide  162  and slowly retracting the delivery system  28 , until the nosecone seals into the proximal end of the jacket  150 .  
         [0205]     (vi) maintaining forward pressure on the jacket retention slide  162 , removing the lumen extension delivery system  28  from the patient, leaving the guide wire and femoral access introducer sheath in place.  
         [0206]     4. Complete the Deployment of the Main Body  
         [0207]     The instructions for use  58  may next include the completion of the deployment of the main body  18  of the endovascular graft assembly, which remains in a secured but partially deployed condition during the deployment of the contralateral lumen extension  22 , as above described. The instructions may include a series of steps that can be followed to carry out this portion of the procedure. These steps may include:  
         [0208]     (i) moving to the ipsilateral femoral access site, where the main body delivery system  24  resides.  
         [0209]     (ii) releasing the stabilizing arms  106  from the graft by retracting the graft release slide  116  on the handle of the delivery system away from the patient ( FIG. 12K ).  
         [0210]     (iii) releasing the main body ipsilateral lumen from the delivery system by retracting the ipsilateral release slide  118  on the handle away from the patient ( FIG. 12L ). The main body  18  is now fully released ( FIG. 12K ).  
         [0211]     (iv) rejacketing the main body delivery system  24  by holding the jacket retention slide  126  and slowly retract the main body  18  delivery system, until the nosecone seals into the proximal end of the jacket  102 .  
         [0212]     (vi) maintaining forward pressure on the jacket retention slide  126 , remove the main body delivery system  24  from the patient ( FIG. 12L ), leaving the guide wire and femoral access introducer sheath in place.  
         [0213]     5. Deploy the Ipsilateral Lumen Extension  
         [0214]     The instructions for use  58  may next include the deployment of the ipsilateral lumen extension  20  of the endovascular graft assembly  12 . The instructions may include a series of steps that can be followed to carry out this portion of the procedure. These steps may include:  
         [0215]     (i) after flushing with heparinized saline, advancing the ipsilateral lumen extension delivery system  26  over the guide wire in the ipsilateral femoral access site ( FIG. 12M ).  
         [0216]     (ii) using fluoroscopic guidance, aligning the proximal marker  92  on the lumen extension  20  with the insertion depth marker  82  located medially on the main body  18 .  
         [0217]     (iii) holding the lumen extension deliver system stable relative to the patient, retracting the jacket retraction slide  162  away from the patient to unsheath the lumen extension  20  ( FIG. 12N ). The distal end of the lumen extension  20  will deploy. The proximal end of the lumen extension  20  will remain collapsed and secured to the delivery system  26 .  
         [0218]     (iv) retracting the proximal stent release slide  156  to release the proximal end of the lumen extension  20  and complete the deployment of the lumen extension ( FIG. 120 ).  
         [0219]     (v) rejacketing the lumen extension delivery system  26  by holding the jacket retention slide  162  and slowly retracting the delivery system  26 , until the nosecone seals into the proximal end of the jacket  150 .  
         [0220]     (vi) maintaining forward pressure on the jacket retention slide  162 , removing the lumen extension delivery system  26  from the patient, leaving the guide wire and femoral access introducer sheath in place.  
         [0221]     6. Completion of the Procedure  
         [0222]     The instructions for use  58  may next include the completion of the procedure. The instructions may include a series of steps that can be followed to carry out this portion of the procedure. These steps may include:  
         [0223]     (i) performing post-implant aortic angiography to evaluate the implantation.  
         [0224]     (ii) checking for endovascular leaks around the endovascular graft assembly. If a leak is observed, standard endovascular techniques can be used to resolve. Additional staples may be placed, in the manner described above.  
         [0225]     (iii) checking for proper location, blood flow, and patency of the endovascular graft assembly.  
         [0226]     (iv) removing the guide wires and femoral access sheaths and close the femoral arteriotomies according to standard practice ( FIG. 12P ).  
         [0227]     It is to be appreciated that the general steps just described do not necessarily need to follow the order in which they were described. It is also to be appreciated that fasteners may be applied to the lumen extensions as well to connect the lumen extensions to the iliac arteries.  
         [0228]     It will also be appreciated that the components and/or features of the preferred embodiments described herein may be used together or separately, while the depicted methods and devices may be combined or modified in whole or in part. It is contemplated that the components of the guiding device, fastener device, and helical fastener may be alternately oriented relative to each other, for example, offset, bi-axial, etc. Further, it will be understood that the various embodiments may be used in additional procedures not described herein, such as vascular trauma, arterial dissections, artificial heart valve attachment and attachment of other prosthetic device within the vascular system and generally within the body.  
         [0229]     The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.  
         [0230]     The desired embodiments of the invention are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.