Abstract:
Systems and methods suture within a body organ region. The systems and methods advance into the body organ region a catheter tube having a distal region that carries a suture applicator. The systems and methods operate the suture applicator from a location external to the body to apply a suture to an interior wall in the body organ region.

Description:
RELATED APPLICATION  
       [0001]     This application is a divisional of co-pending U.S. patent application Ser. No. 10/915,864, filed Aug. 11, 2004, which is a divisional of U.S. patent application Ser. No. 10/099,149 filed 15 Mar. 2002 (now U.S. Pat. No. 6,800,081), which is a divisional of application Ser. No. 09/787,135, filed Sep. 17, 1999, entitled “Endovascular Fastener Applicator,” which claims the benefit of U.S. Provisional Application Ser. No. 60/101,050 filed Sep. 18, 1998. This application also claims the benefit of U.S. patent application Ser. No. 09/640,554, filed Aug. 18, 2000, entitled “Endovascular Device for Application of Prosthesis with Sutures” (now U.S. Pat. No. 6,336,933), which is incorporated herein by reference, which is a continuation of U.S. patent application Ser. No. 09/266,200, filed Mar. 10, 1999, entitled “Endovascular Device for Application of Prosthesis with Sutures” (now abandoned), and which further claims the benefit of Argentine Patent Application Serial No. P19980101145, filed Mar. 13, 1998, entitled “Endovascular Device for Application of Prosthesis with Sutures.” 
     
    
     FIELD OF THE INVENTION  
       [0002]     This disclosure relates generally to vascular grafts for intraluminal delivery, and in particular, to a method and apparatus for repairing diseased or damaged sections of a vessel by fastening a prosthesis within the vessel.  
       BACKGROUND OF THE INVENTION  
       [0003]     Diseased or damaged blood vessels often cause weakening of the vessel wall resulting in an aneurysm whereby a blood vessel and especially an artery have a section of abnormal blood-filled dilation. For example, an abdominal aortic aneurysm is a sac caused by an abnormal dilation of the wall of the aorta, a major artery of the body as it passes through the abdomen.  
         [0004]     The abdominal aortic aneurysm usually arises in the infrarenal portion of the arteriosclerotically diseased aorta, for example, below the kidneys. Left untreated, the aneurysm will eventually cause rupture of the sac with ensuing fatal hemorrhaging in a very short time. High mortality associated with rupturing led the state of the art into trans-abdominal surgical repair of abdominal aortic aneurysms.  
         [0005]     Surgery involving the abdominal wall, however, is a major undertaking with associated high risks. This type of surgery, in essence, involves replacing the diseased and aneurysmal segment of blood vessel with a prosthetic device which typically is a synthetic tube, or graft, usually fabricated of either DACRON™, TEFLON™, or other suitable material.  
         [0006]     The present state of the art for intraluminal repair of a vessel does not fasten a prosthesis to the remaining aortic wall. For example, U.S. Pat. Nos. 5,571,171 and 5,571,173 disclose a method and apparatus for treating an abdominal aortic aneurysm by supplying a prosthesis or an aortic graft for intraluminal delivery that does not fasten the graft to the remaining aortic wall.  
         [0007]     Presenting an aortic graft through the aorta by intraluminal delivery avoids major invasive surgery. The &#39;171 and &#39;173 patents disclose an aortic graft that is delivered intraluminally to the aneurysm site. The aortic graft is secured to the remaining aortic wall by a balloon that is inflated thereby causing the graft to contact and adhere to the remaining aortic wall.  
         [0008]     The major disadvantages related to the combination of endovascular expanders, such as a balloon or stent, and prosthesis is the dilation of the natural artery with consequent migrations and periprosthetic losses. Upon withdrawal of the expander, the tissue is caused to collapse and the prosthesis disengages from the remaining aortic wall and tends to migrate to a location away from the aneurysm site to be repaired. The migration and movement of the disengaged aortic graft would then obstruct the affected vessel. The migration and movement of the aortic graft requires further treatment on the patient to remove the failed attempt to attach the aortic graft to the remaining aortic wall.  
         [0009]     Further treatment may include major surgery that is hazardous and traumatic to the patient. Major surgery to remove the aortic graft defeats the benefits of intraluminal delivery of the aortic graft. The current state of the art does not disclose a fastener applicator that intraluminally delivers a vascular graft and endoluminally applies internal fasteners to fasten a prosthesis in place.  
         [0010]     Accordingly, there is a present need for a fastener applicator that intraluminally delivers a vascular graft to a site within a vessel and applies fasteners to pass through both a prosthesis and the thickness of a vessel wall. The fastened prosthesis should also have the capability of following dilation of a vessel.  
       SUMMARY OF THE INVENTION  
       [0011]     The invention provides systems and methods for suturing within a body organ region, such as a blood vessel lumen. The systems and methods advance into the body organ region a catheter tube having a distal region that carries a suture applicator. The systems and methods operate the suture applicator from a location external to the body to apply a suture to an interior wall in the body organ region.  
         [0012]     Other features and advantages of the invention will be pointed out in, or will be apparent from, the drawings, specification and claims that follow. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  is a perspective view of one embodiment of an endovascular fastener applicator in accordance with the present disclosure;  
         [0014]      FIG. 2  is a cross-sectional view, in part elevation, of an aortic graft placed at the site of all abdominal aortic aneurysm within the aorta;  
         [0015]      FIG. 3  is an enlarged detail view of a portion of  FIG. 2  illustrating the aortic graft secured to the remaining aortic wall and maintained in position by helical fasteners;  
         [0016]      FIG. 4  is a cross-sectional view, in part elevation, of an aortic graft for treating an aortic aneurysm affecting the aorta and both ileac arteries;  
         [0017]      FIG. 5  is a perspective view of a helical fastener;  
         [0018]      FIG. 6  is a side elevation view of a helical fastener;  
         [0019]      FIG. 7  is a bottom perspective view taken along line  7 - 7  of  FIG. 6  of a helical fastener having a rectangular configuration at its limiting end for cooperating with a rectangular drive assembly;  
         [0020]      FIG. 8  is a cross-sectional view taken along line  8 - 8  of  FIG. 7  of a helical fastener;  
         [0021]      FIG. 9  is a cross-sectional view, in part elevation, of an endovascular fastener applicator;  
         [0022]      FIG. 10  is a cross-sectional view, in part elevation, of a distal portion of the applicator at the aneurysm site;  
         [0023]      FIG. 11  is a cross-sectional view of the control assembly;  
         [0024]      FIG. 12  is a cross-sectional view, in part elevation, of the applicator at the aneurysm site showing an expandable portion causing a prosthesis to contact a vessel wall;  
         [0025]      FIG. 13  is a cross-sectional view of the control assembly;  
         [0026]      FIG. 14  is a cross-sectional view, in part elevation, of the applicator at the aneurysm site showing advance of a delivery tube;  
         [0027]      FIG. 15  is a cross-sectional view of the control assembly;  
         [0028]      FIG. 16  is a cross-sectional view, in part elevation, of the applicator at the aneurysm site showing advance of a drive assembly;  
         [0029]      FIG. 17  is a top view of a helical fastener defining a rectangular configuration at its limiting end for cooperating with a rectangular drive assembly, as shown in cross-section;  
         [0030]      FIG. 18  is a cross-sectional view of the control assembly;  
         [0031]      FIG. 19  is a cross-sectional view, in part elevation, of the delivery assembly showing rotation for insertion of a helical fastener;  
         [0032]      FIG. 20  is a cross-sectional view, in part elevation, of an alternate embodiment of the applicator showing the delivery assembly at the aneurysm with fastener guides;  
         [0033]      FIG. 21  is an enlarged detail view of a portion of  FIG. 20  illustrating a helical fastener guided over a drive attached to a fastener guide;  
         [0034]      FIG. 22  is a cross-sectional view, in part elevation, of a helical fastener taken along line  22 - 22  of  FIG. 21 ;  
         [0035]      FIG. 23  is a plan view, in part cross-section, taken along line  23 - 23  of  FIG. 20  showing the applicator with fastener guides,  
         [0036]      FIG. 24  is a perspective view of one embodiment of a fastener guide in accordance with the present disclosure;  
         [0037]      FIG. 25  is a perspective view, in part cross-section, showing movement of the helical fastener over a drive prior to collapsing the fastener guide;  
         [0038]      FIG. 26  is a perspective view, in part cross-section, showing the drive after the fastener guide is collapsed and the helical fastener deployed;  
         [0039]      FIG. 27  is a perspective view, showing retraction of the drive and fastener guide;  
         [0040]      FIG. 28  is a perspective view of an alternate embodiment of the control assembly;  
         [0041]      FIG. 29  is a perspective view of the distal end of an alternate embodiment of the drive assembly loaded with a plurality of helical fasteners;  
         [0042]      FIG. 30  is a perspective view showing a helical fastener for loading with a channel of the drive assembly;  
         [0043]      FIG. 31  is a perspective view of an alternate embodiment of a helical fastener;  
         [0044]      FIG. 32  is a perspective view of an applicator head and helical fasteners prior to deployment into a prosthesis;  
         [0045]      FIG. 33  is a perspective view of the helical fastener deployed into the prosthesis and artery;  
         [0046]      FIG. 34  is a perspective view of an alternate embodiment of the applicator showing the expandable portion in an expanded state;  
         [0047]      FIG. 35  is a perspective view of the expandable portion shown in  FIG. 34  in a relaxed state;  
         [0048]      FIG. 36  is an exploded view of the delivery assembly shown in  FIG. 34 ;  
         [0049]      FIG. 37  is an exploded view of the drive assembly shown in  FIG. 34 ;  
         [0050]      FIG. 38  is a perspective view of the drive assembly shown in  FIG. 34 ;  
         [0051]      FIG. 39  is a perspective view of an embodiment of an ejection mount;  
         [0052]      FIG. 40  is a perspective view of the ejection mount showing a set screw and cam divider for cooperating with the drive assembly;  
         [0053]      FIG. 41  is a cross-sectional view of the applicator with the expandable portion in a relaxed state and a prosthetic having a sealing gasket;  
         [0054]      FIG. 42  is a cross-sectional view, in part elevation, of the distal end of the applicator;  
         [0055]      FIG. 43  is a cross-sectional view, in part elevation, with the expandable portion in an expanded state;  
         [0056]      FIG. 44  is an enlarged cross-sectional view, in part elevation, of the distal end of the applicator;  
         [0057]      FIG. 45  is a perspective view of the expandable portion in an expanded state and the ejection mount loaded with helical fasteners;  
         [0058]      FIG. 46  is a cross-sectional view, in part elevation, with the ejection mount pivoted for deployment of helical fasteners;  
         [0059]      FIG. 46A  is a perspective view, in part cross-section, an alternate embodiment of the ejection mount pivoted for deployment of helical fasteners;  
         [0060]      FIG. 47  is a cross-sectional view, in part elevation, of the ejection mount engaging the aortic graft prior to deployment of helical fasteners;  
         [0061]      FIG. 48  is a perspective view, in part cross-section, showing deployment of helical fasteners;  
         [0062]      FIG. 49  is a perspective view, in part-cross-section, showing retraction of the ejection mount;  
         [0063]      FIG. 50  is a cross-sectional view, in part elevation, showing the ejection mount subsequent to deployment of a helical fastener; and  
         [0064]      FIG. 51  is a top view of the applicator, showing movement of the ejection mount prior to deployment of a helical fastener. 
     
    
       [0065]     The invention is not limited to the details of the construction and the arrangements of parts set forth in the following description or shown in the drawings. The invention can be practiced in other embodiments and in various other ways. The terminology and phrases are used for description and should not be regarded as limiting.  
       DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0066]     As illustrated in  FIG. 1 , the present disclosure relates to an endovascular fastener applicator, generally referred to as numeral  50 . Endovascular fastener applicator  50  delivers aortic graft  100 , as shown in  FIGS. 2 and 3 , for repairing an abdominal aortic aneurysm  120  in aorta  124  having two iliac arteries  126 L and  126 R associated therewith, as well as a plurality of renal arteries  130  located above aneurysm  120  in fluid communication with aorta  124 . Repairing the aneurysm includes fastening an aortic graft  100  to an aortic wall  132  by fasteners  80 . Aortic graft  100 , as well as other prostheses, may be utilized in the thoracic aorta, and can be used to repair thoracic aneurysms or thoracic dissecting aneurysms. Further, the fastener applicator  50  may also treat vascular trauma and other obstructive diseases with various prostheses. Accordingly, use of the term aortic aneurysm in this specification and claims is intended to relate to and mean both abdominal aortic aneurysms, thoracic aneurysms and related vessel diseases.  
         [0067]     Endovascular fastener applicator  50  has a delivery assembly  60  and a control assembly  140 . Delivery assembly  60 , as illustrated in  FIG. 9 , includes a tubular body, such as, for example, an outer sleeve  64 , an elongate control  68 , a delivery tube  72  and a drive assembly  76 , each having a proximal and distal end relative to control assembly  140 . Outer sleeve  64  defines a channel  65  and is adapted for insertion within aorta  124  (as shown in  FIG. 10 ) and has an expandable portion  66  operatively connected at its distal end. Elongate control  68  is coaxially positioned within channel  65  of outer sleeve  64  and is operatively connected to expandable portion  66  at its distal end. Delivery tube  72  defines a channel  71  and is coaxially positioned within channel  65  of outer sleeve  64  and adapted for advancing a helical fastener  80  to the abdominal aortic aneurysm site. Drive assembly  76  is coaxially positioned within channel  71  of delivery tube  72  and adapted for advancing, in cooperation with delivery tube  72 , and deploying helical fastener  80  into aortic graft  100  and aorta wall  132 . It is contemplated that the components of the delivery assembly may be alternately oriented relative to each other, such as, for example, bi-axial, offset, etc. It is further contemplated that the components of delivery assembly  60  are flexible and may be constructed from a shape memory material.  
         [0068]     Operation of endovascular fastener applicator  50  is controlled by control assembly  140 . As shown in  FIGS. 1 and 9 , control assembly  50  includes outer sleeve push bar  146 , expandable portion control  150 , delivery tube push bar  148  and handle  144 . Outer sleeve push bar  146  is operatively connected to the proximal end of outer sleeve  64  for regulating movement of outer sleeve  64 . Expandable portion control  150  is operatively connected to the proximal end of elongate control  68 , which in turn is connected to expandable portion  66 . Correspondingly, expandable portion control  150  controls the expansible force AA (shown in  FIG. 12 ) exerted by expandable portion  66  for supporting aortic graft  100  in contact with aortic wall  132 . Outer sleeve push bar  146  may also be adapted to influence expansible force AA.  
         [0069]     Delivery tube push bar  148  is operatively connected to the proximal end of delivery tube  72  for regulating movement of delivery tube  72 . Handle  144  is operatively connected to the proximal end of drive assembly  76 , for controlling axial and rotational movement of drive assembly  76 , described in detail below.  
         [0070]     As shown in  FIG. 9 , drive assembly  76  includes a drive  78 . Drive  78  at its distal end has a curved portion  79  oriented at substantially  90 ′ to the longitudinal axis of outer sleeve  64  and delivery tube  72  (similarly shown in  FIGS. 10 and 12 ). It is contemplated that the curved portion may be positioned at various angular orientations. Drive assembly  76  transmits rotational motion from its proximal end to its distal end and through its curved portion  79  to facilitate deployment of helical fasteners  80  into the aortic graft  100  and aortic wall  132 .  
         [0071]     In one embodiment, as illustrated in  FIGS. 5-8 , helical fasteners  80  have a sharpened distal end  81  and a penetration limit end  82 . Helical fastener  80  has an outer diameter  83  and an inner diameter  84 . Outer diameter  84  facilitates penetration of sharpened distal end  81  into aortic graft  100  and aortic wall  132 . The surface of inner diameter  84  cooperatively engages drive assembly  76  and delivery tube  72  at their distal ends to facilitate loading of helical fastener  80  into endovascular fastener applicator  50 . Preferably, inner diameter  84  and penetration limit end  82  have a rectangular configuration for cooperative engagement with drive assembly  76 , drive assembly  76  also having a rectangular configuration at its distal end. Although a helical fastener is disclosed it is contemplated that fastener  80  may have various configurations, such as, for example, cylindrical, triangular, etc. It is further contemplated that fasteners  80  are of the metallic fastener staple type and are preferably made from stainless steel but may be constructed from a polymeric material.  
         [0072]     In the embodiment illustrated in  FIG. 9 , drive  78  is made from a shape memory alloy whereby drive  78  assumes the curved configuration of curved portion  79  upon exiting delivery tube  72 . Delivery tube  72  may also include an applicator head  73  at its distal end having a curved orientation to facilitate deployment of helical fasteners  80 , as shown in  FIGS. 14, 16  and  19 . Helical fasteners  80 , as shown in  FIG. 3 , are deployed into aortic graft  100  and aortic wall  132  for fastening.  
         [0073]     In an alternate embodiment, repair of abdominal aortic aneurysm  120 , as shown in  FIG. 10 , proceeds by insertion of endovascular fastener applicator  50  into aorta  124  and advancing to the abdominal aortic aneurysm site by manipulation by a surgeon of control assembly  140 . Endovascular fastener applicator  50  delivers aortic graft  100  to abdominal aortic aneurysm  120  by advancing the aortic graft  100  so that a sufficient portion of aortic graft  100  is brought in contact with aortic wall  132 . Aortic graft  100  is a conventional tubular graft made of DACRON®, TEFLONV (polytetrafluoroethylene) and the like and is of a length sufficient to span the abdominal aortic aneurysm  120 .  
         [0074]     With reference to  FIGS. 11-19 , delivery assembly  60  and aortic graft  100  are delivered to the abdominal aneurysm site by manipulation of outer sleeve push bar  146 , as shown by arrows A in  FIG. 11 . Aortic graft  100  is positioned at the abdominal aneurysm site. Expandable portion  66  is caused to expand, shown by arrows AA in  FIG. 12 , in response to cooperative manipulation of outer sleeve push bar  146  and elongate control  68 . Outward radial force AA supports aortic graft  100  in contact with aortic wall  132 . Expandable portion  66  facilitates fastening of aortic graft  100  with aortic wall  132  by deployment of helical fasteners  80 . In this embodiment, expandable portion  66  includes support members  67  that define interstitial regions  70  therebetween. Helical fasteners  80  are deployed through interstitial regions  70  and into aortic graft  100 . It is contemplated that helical fasteners  80  may be deployed at various locations about the circumference of aortic graft  100  relative to the number of support members  67  and spacing of interstitial regions  70 .  
         [0075]     Delivery tube push bar  148  is manipulated to axially advance delivery tube  72  within outer sleeve  64 , as shown by arrows B in  FIG. 13 . At its distal end, delivery tube  72  has an applicator head  73  configured to have a substantially perpendicular orientation to the longitudinal axis of delivery tube  72 . Drive  78  follows the substantially perpendicular orientation of delivery tube  72  to facilitate deployment of helical fasteners  80 . It is contemplated that applicator head  73  may have various configurations and orientations to facilitate deployment of helical fasteners  80 .  
         [0076]     With reference to  FIG. 14 , delivery tube  72  is advanced to a location where aortic graft  100  will be fastened to aortic wall  132 . A loaded helical fastener  80  is oriented for deployment by applicator head  73 , as shown by arrows C. Applicator head  73  is articulable in a clockwise and a counter-clockwise direction about the inner surface of graft  100 .  
         [0077]     The surface of inner diameter  84  and penetration limit end  82  of helical fastener  80  have a rectangular configuration for cooperative engagement with drive assembly  76 , drive assembly  76  also having a rectangular configuration at its distal end( FIG. 17 ).  
         [0078]     It is contemplated that the remainder of drive assembly  76  may not be in cooperative engagement with the surface of inner diameter  84 .  
         [0079]     Helical fastener  80  has a substantially circular cross-section. It is envisioned that other cross-sectional configurations may be used that are suitable for fastening.  
         [0080]     With reference to  FIG. 15  and  16 , handle  144  is manipulated to advance drive assembly  76 . A torque is applied to handle  144  transmitting a rotational force from the proximal end to the distal end of drive assembly  76 . The rectangular configuration of drive assembly  76  cooperates with the rectangular configuration of the surface of inner diameter  84  causing rotational movement of helical fastener  80 . The sharpened distal end  81  of helical fastener  80  contacts the interior wall  102  of aortic graft  100  thereby facilitating deployment of fastener  80  into aortic graft  100  and aortic wall  132 . Helical fastener  80  penetrates aortic graft  100  and aortic wall  132  to penetration limit end  82  thereby fastening aortic graft  100  to aortic wall  132 .  
         [0081]     In the embodiment shown in  FIG. 19 , delivery tube  72  cooperates with elongate control  68  at junction  69 . Junction  69  facilitates rotation of delivery tube  72  and drive assembly  76  positioned coaxially therewithin, to a location for deployment of helical fasteners  80 , as shown in  FIG. 19  by arrow D. Junction  69  rotates by manipulation of expandable portion control  150 , as shown in  FIG. 18 . Delivery tube  72  is retracted from the fastening site and loaded with another helical fastener  80  for subsequent deployment at another location along the diameter of aortic graft  100 . As many helical fasteners  80  may be deployed as are necessary to adequately fasten aortic graft  100  to aortic wall  132 . Fastening in this manner prevents periprosthetic losses and accidental migration of aortic graft  100 . It is contemplated that multiple helical fasteners  80  may be loaded into endovascular fastener applicator  50 .  
         [0082]     In another embodiment, as shown in  FIGS. 20-27 , endovascular fastener applicator  50  positions aortic graft  100  at the aneurysm site and in contact with aortic wall  132 . Referring to  FIG. 20  aortic graft  100  includes band  104  having anchor pads  107  implanted therewithin.  
         [0083]     As shown in  FIG. 23 , anchor pads  107  are implanted circumferentially about band  104 . Band  104  may be fabricated from, such as, for example, polytetrafluoroethylene. Anchor pads  107 , are implanted within band  104  corresponding to interstitial regions  70  located between support members  67  of expandable portion  66 . Referring to  FIG. 23 , pads  107  have a substantially circular configuration. It is envisioned that the pads may have other configurations such as, for example, rectangular, elliptical, etc.  
         [0084]     Anchor pads  107  cooperatively engage fastener guides  106  positioned at the distal end of drive assembly  76 . Anchor pads  107  and fastener guides  106  cooperate to provide a guided deployment of helical fasteners  80  and facile release of drive assembly  76  from the aneurysm site. Referring to  FIGS. 21 and 22 , drive assembly  76  further includes multiple guide wires  77  releasably attached to fastener guides  106 . Guide wires  77  facilitate guided travel of fasteners  80 .  
         [0085]     Referring back to  FIG. 24 , fastener guides  106  include anchor legs  108 . Anchor legs  108  are resiliently biased so that upon deployment of helical fastener  80 , anchor legs  108  are caused to collapse and release from band  104 . Anchor legs  108  are connected to multiple guide wires  77  so that after collapse and release of anchor legs  108 , multiple guide wires  77  are retracted from the fastening site. Anchor pad  107  is retained within band  104  after helical fastener  80  is deployed.  
         [0086]     As shown in  FIG. 25 , expandable portion  66  supports aortic graft  100  in contact with aortic wall  132 . Applicator head  73  of delivery tube  72  is configured and dimensioned to cooperate with inner diameter  84  to advance a helical fastener  80  over multiple guide wires  77 , as shown by arrows E. As helical fastener  80  is deployed, anchor legs  108  are caused to collapse, shown by arrows F in  FIG. 26 . Delivery tube  72  causes rotational movement of helical fastener  80  and corresponding penetration of band  104 , aortic graft  100  and aortic wall  132 , facilitating fastening.  
         [0087]     Delivery tube  72  is retracted subsequent to deployment of helical fastener  80  and multiple guide wire  77  is also retracted, as shown in  FIG. 27 , with helical fastener  80  in a deployed position. Delivery tube  72  is subsequently loaded with another helical fastener  80  for deployment from another of multiple guide wires  77 . As many helical fasteners  80  may be deployed as are necessary to adequately fasten aortic graft  100  to aortic wall  132 . It is contemplated that at least a portion of the fastener guides and/or guide wires may remain fixed to the prosthetic upon deployment of a fastener.  
         [0088]     In another embodiment as shown in  FIG. 28 , control assembly  140  includes a handle  110  and a trigger  120  for controlling operation of endovascular fastener applicator  50 . In this embodiment, handle  110  controls advancement of delivery tube  72  (not shown) and trigger  120  controls advancement of drive assembly  76  (not shown) and deployment of helical fasteners  80  (not shown).  
         [0089]     In another embodiment, as illustrated in  FIGS. 29-33 , a plurality of helical fasteners  80  are loaded in endovascular fastener applicator  50  for deployment. As shown in  FIG. 30 , drive assembly  76  defines a channel  75  for accepting helical fasteners  80  ( FIG. 31 ). In particular, penetration limit end  82  of helical fastener  80  slidably engages channel  75  providing a plurality of helical fasteners  80  for deployment, as shown in  FIG. 29 . Applicator head  73  of delivery tube  72  engages band  104 , as shown in  FIG. 32 , and drive assembly  76  advances helical fasteners  80  to penetrate band  104 , aortic graft  100  and aortic wall  132 , shown by arrows G. As shown in  FIG. 33 , aortic graft  100  is fastened to aortic wall  132  of aorta  124  by helical fastener  80 . After deployment of a helical fastener  80 , delivery tube  72  is rotated to deploy another of the plurality of helical fasteners  80 , consequently reloading is not required.  
         [0090]     In another embodiment, as illustrated in  FIGS. 34-51 , expandable portion  66  is capable of moving between two extreme positions. A relaxed position, as shown in  FIG. 35 , and an expanded position, as shown in  FIG. 34 . In the embodiment illustrated in  FIG. 34 , expandable portion  66  includes support members  67  that define open interstitial regions  70 .  
         [0091]     As best shown in  FIG. 36 , outer sleeve  64  operatively engages with expandable portion  66  for controlling operation between the two extreme positions. Expandable portion  66  has an atraumatic head  200  attached to opening  210  defined at the distal end of expandable portion  66  and opening  212  defined at its proximal end for receiving applicator head  73  of delivery tube  72 . Applicator head  73  includes ejection mount  250  for deployment of a plurality of helical fasteners  80  from drive assembly  76 .  
         [0092]     Ejection mount  250 , as shown in  FIG. 36 , includes yoke  256  and ejection head  260 . Yoke  256  engages penetration head  200  for coaxial positioning within expandable portion  66 . Ejection head  260  is pivotally positioned within yoke  256 . Ejection head  260  includes a cam divider  262  and a saw-toothed face  264 . Ejection head  260  is capable of rotational movement relative to delivery tube  72  and pivotal movement between two extreme positions. A first extreme position is coaxial with delivery tube  72  and a second extreme position is perpendicular to the longitudinal axis of delivery tube  72  and in position to deploy a helical fastener  80 .  
         [0093]     With reference to  FIGS. 37 and 38 , drive assembly  76  includes distal drive  280 , proximal drive  284 , outer drive  285 , ratchet assembly  286 , spring  294  and washer  296 . Distal drive  280  defines a slot  281  for receiving penetration limit end  82  for loading a plurality of helical fasteners  80 . The plurality of helical fasteners  80  are spring loaded onto drive assembly  76  and separated from spring  294  by washer  296 .  
         [0094]     Distal drive  280  is operatively connected to ratchet assembly  286  which is operatively connected to proximal drive  284  and outer drive  285 . Ratchet assembly  286  includes ratchet sleeve  287  which defines opening  288  for receipt of distal drive  280 . Manipulation of proximal drive  284  causes movement of distal drive  280  to facilitate deployment of helical fasteners  80 . Ratchet sleeve  287  also defines opening  289  for receipt of proximal drive  284 . Ratchet sleeve  287  is slidably received within ratchet retainer  290  for cooperative engagement with outer drive  285 . Ratchet retainer  290  defines opening  291  for receiving ratchet arm  292 .  
         [0095]     As shown in  FIGS. 39 and 40 , ratchet arm  292  engages ejection head  260 . Ratchet arm  292  is positioned within cam divider  262  in ejection head  260  and secured therein by set screw  298 . It is contemplated that ratchet arm  292  is crimped in place within ejection head  260  and that no set screw is required. It is further contemplated that ratchet arm  292  may be fixed within ejection head  260  as is known by one skilled in the art. Manipulation of outer drive  285  engages ratchet retainer  290  and ratchet arm  292  causing pivotal movement of ejection head  260  relative to delivery tube  72 .  
         [0096]     As illustrated in  FIGS. 41 and 42 , delivery assembly  60  is positioned at the aneurysm site of abdominal aortic aneurysm  120 . Aortic graft  100  is positioned for fastening to aortic wall  132  of aorta  124 . Aortic graft  100  has band  104 . Aortic graft  100  may also have gasket  105 , as shown in  FIG. 41 , sewn to the outside diameter of aortic graft  100  to prevent leakage of fluid.  
         [0097]     Expandable portion  66  is in a relaxed state, as shown in  FIGS. 41 and 42 . Aortic graft  100  is positioned at the abdominal aneurysm site and expandable portion  66  is caused to expand by axial motion of outer sleeve  64 , shown by arrows I in  FIG. 44  and by arrows H in  FIG. 43 , illustrating the outward force of support members  67  used to support aortic graft  100  in contact with aortic wall  132 . Expandable portion  66  facilitates fastening of aortic graft  100  with aortic wall  132  for deployment of helical fasteners  80  by securing aortic graft  100  in contact with aortic wall  132 . It is contemplated that helical fasteners  80  may be deployed from ejection mount  250  through interstitial regions  70  between support members  67 . The helical fasteners  80  arc deployed about the circumference of aortic graft  100  relative to the number of support members  67  and spacing of interstitial regions  70 .  
         [0098]     As shown in  FIG. 45 , drive assembly  76  is loaded with a plurality of helical fasteners  80 . Referring to  FIG. 46 , delivery tube  72  has an ejection arm  310  positioned at its distal end facilitating pivotal movement of ejection mount  250 . An arm  292  functions as an ejection arm to ejection head  260 . This provides extra holding force on the graft which pivots ejection head  260  positioned at its distal end. Ejection arm  310  includes a slider  312  received within a cam slot  300  defined by ejection head  260 . Cam slot  300  further defines the relative movable limits of slider  312  and thus ejection arm  310 .  
         [0099]     Delivery tube  72  is manipulated advancing ejection arm  310  axially causing pivotal movement of ejection head  260 , shown by avow J, and positioning ejection head  260  for deployment of helical fasteners  80 . Ejection head  260  is positioned in a substantially perpendicular orientation to the longitudinal axis of delivery tube  72 .  
         [0100]     It is contemplated that ejection arm  310  has alternate orientations for causing movement of ejection head  260 . For example, in an alternate embodiment shown in  FIG. 46A , ejection head  260  pivots within expandable portion  66  and is positioned at the center of expandable portion  66 . Saw-toothed face  264  is positioned at a closer proximity to the inner surface of graft  100  for accurate deployment of a fastener. At the center position, ejection head  260  spans a diameter that expandable portion  66  supports aortic graft  100  in contact with aortic wall  132 . In this embodiment, ejection arm  310  is fixed at a maximum angle relative to delivery tube  72 .  
         [0101]     Drive assembly  76  is manipulated so that ejection head  260  engages band  104  of aortic graft  100  for deployment of helical fasteners  80 , as illustrated in  FIG. 47 . Outer drive  285  and proximal drive  284  are advanced, shown by arrows K. Ejection arm  292  correspondingly axially positions saw-tooth face  264  of ejection head  260  to contact band  104  of aortic graft  100 , as shown by arrow L. Ejection arm  292  may also cause rotational movement of ejection head  260  and saw-tooth face  264  for engaging aortic graft  100 .  
         [0102]     With reference to  FIG. 48 , distal drive  280  advances and is rotated causing helical fasteners  80  to penetrate and fasten aortic graft  100  and aortic wall  132 , as shown by arrow M.  
         [0103]     As shown in  FIG. 49 , delivery tube  72  is manipulated so that ejection arm  310  pivotally retracts ejection head  260  to a position substantially parallel to the longitudinal axis of delivery tube  72 , as shown by arrows MM.  
         [0104]      FIG. 50  illustrates a retracted ejection mount  250  subsequent to deployment of one of a plurality of helical fasteners  80 . A rotational force is transmitted from the proximal end to the distal end of drive assembly  76 , shown by arrows N, thereby driving and axially advancing another of the plurality of helical fasteners  80 , shown by arrows P, for deployment by ejection head  260  at a new deployment site.  
         [0105]      FIG. 51  shows ejection head  260  positioned in a substantially perpendicular orientation to the longitudinal axis of delivery tube  72  (not shown). Ejection head  260  is rotated to a new deployment site to deploy another of the plurality of helical fasteners  80  (not shown). As many helical fasteners  80  may be deployed as are necessary to adequately fasten aortic graft  100  to aortic wall  132 .  
         [0106]     It will be understood that various modifications may be made to the embodiments disclosed herein. For example, while specific preferred embodiments of the endovascular fastener applicator have been described in detail, structures that perform substantially the same function in substantially the same way to achieve substantially the same result may also be used. For example, the expandable portion may include expanding wires for supporting a prostheses in contact with a vessel wall. Also the fastener guide may be implanted completely through the thickness of the aortic graft. Further, the helical fasteners may be constructed from various suitable materials or may embody one continuous fastener that is severable at the point of insertion. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments, those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.  
         [0107]     Features and advantages of the invention are set forth in the following claims.