Patent Publication Number: US-2002007193-A1

Title: Method and apparatus for the surgical repair of aneurysms

Description:
CROSS REFERENCE TO RELATED PATENT APPLICATIONS  
     [0001] This application claims priority to U.S. Provisional Application Ser. No. ______, entitled “METHOD AND APPARATUS FOR THE SURGICAL REPAIR OF ANEURYSMS” filed on Jun. 30, 1997. 
    
    
     
       BACKGROUND OF THE INVENTION  
       [0002] 1. Field of the Invention  
       [0003] The present invention relates to methods and apparatus for the repair of abdominal aortic aneurysms using a novel prosthetic tube graft within the abdominal aorta.  
       [0004] 2. Description of Related Art  
       [0005] An aneurysm is a ballooning of the wall of an artery resulting from the weakening of the artery due to disease or other conditions. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.  
       [0006] Aortic aneurysms are the most common form of arterial aneurysm and are life threatening. The aorta is the main artery which supplies blood to the circulatory system. The aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen. Among other arterial vessels branching off the aorta along its path, the abdominal aorta supplies two side vessels to the kidneys, the renal arteries. Below the level of the renal arteries, the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries. The iliac arteries, in turn, supply blood to the lower extremities and perineal region.  
       [0007] It is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on aneurysms smaller than 5 cm because no statistical benefit exists in performing such procedures.  
       [0008] Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal wall to the location of the aneurysm to reinforce or replace the diseased section of the aortic aneurysm. A prosthetic device, typically a synthetic tube graft, is used for this purpose. The graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.  
       [0009] Repair of an aortic aneurysm by surgical means is a major operative procedure. Substantial morbidity accompanies the procedure, resulting in a protracted recovery period. Further, the procedure entails a substantial risk of mortality. While surgical intervention may be indicated and the surgery carries attendant risk, certain patients may not be able to tolerate the stress of intra-abdominal surgery. It is, therefore, desirable to reduce the mortality and morbidity associated with intra-abdominal surgical intervention.  
       [0010] In recent years, methods have been developed to attempt to treat an aortic aneurysm without the attendant risks of intra-abdominal surgical intervention. Among them are inventions disclosed and claimed in Kornberg, U.S. Pat. No. 4,562,596 for Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair; Lazarus, U.S. Pat. No. 4,787,899 for Intraluminal Graft Device, System and Method; and Taheri, U.S. Pat. No. 5,042,707 for Intravascular Stapler, and Method of Operating Same.  
       [0011] Kornberg discloses an aortic graft comprising a flexible tubular material having a plurality of struts to lend the graft stability and resiliency. The struts have angled hooks with barbs at their upper ends which are securely attached to the inside of the aorta above the aneurysm. Kornberg&#39;s graft is inserted using a tubular device also disclosed in his patent. Kornberg, however, only anchors the proximal end of the graft. Kornberg claims that the downward flow of blood holds the distal graft securely in place, so that no mechanical attachment is necessary distally. The blood pressure in the abdominal aorta, however, is typically in the magnitude of 130 mm of mercury (Hg). In spite of the direction of flow of blood through the graft, proximal to distal, substantial back pressure within the aneurysm will result unless the distal end is also mechanically attached to the aorta in a manner that prevents substantial leakage of blood between the graft and the aorta. Without distal attachment, the device of Kornberg will not effectively exclude the weakened arterial wall at the site of the aneurysm from the forces and stress associated with the blood pressure.  
       [0012] Lazarus discloses a grafting system that employs a plurality of staples mounted in the proximal end of the graft. Lazarus&#39;s staples are forced through the aorta wall by means of a balloon catheter. As does Kornberg, Lazarus discloses staples mounted only in the proximal end of the graft. There is no teaching or suggestion in Lazarus, U.S. Pat. No. 4,787,899 as to the desirability of, let alone means for, mechanically attaching the graft to the distal aorta below the level of the aneurysm.  
       [0013] Taheri discloses an articulatable stapler for implanting a graft in a blood vessel. The stapler is in the form of an elongated catheter with a plurality of segments mounted on the distal end of the catheter. The segments have beveled faces and are connected to each other by hinges. A stylet runs through the catheter to the most distal segment. The most distal segment is moved, in conjunction with the other segments, into a firing position that is substantially perpendicular to the main catheter body by the action of pulling on the stylet. The staple is implanted by using two other stylets which act as fingers to bend the staple into its attachment position.  
       [0014] Taheri, however, appears to be a single-fire design which can only implant one staple at a time. After each stapler is implanted, Taheri&#39;s design apparently requires that the catheter be removed before another staple is loaded. In addition, Taheri&#39;s does not teach or suggest an appropriate density of staples to secure a graft against the pulsatile blood flow of the aorta. Pressures within the aorta range from 120 mm Hg pressure to 200 mm Hg pressure. Without adequate attachment, the graft may leak around the edges continuing to allow life threatening pressures to develop in the aneurysm, and may not even remain in place.  
       [0015] Hence, although in recent years certain techniques have been developed that may reduce the stress, morbidity, and risk of mortality associated with surgical intervention to repair aortic aneurysms, none of the systems that have been developed effectively treat the aneurysm and exclude the affected section of aorta from the pressures and stresses associated with circulation. None of the devices disclosed in the references provide a reliable and quick means to reinforce an aneurysmal artery. In addition, all of the prior references require a sufficiently large section of healthy aorta surrounding the aneurysm to ensure attachment of the graft. The neck of the aorta at the cephalad end (i.e., above the aneurysm) is usually sufficient to maintain a graft&#39;s attachment means. However, when an aneurysm is located near the iliac arteries, there may be an ill-defined neck or no neck below the aneurysm. Such an ill-defined neck would have an insufficient amount of healthy aortic tissue to which to successfully mount a graft. Furthermore, much of the abdominal aorta wall may be calcified which may make it extremely difficult to attach the graft to the wall.  
       [0016] There are a number of shortcomings with the presently available graft products and their fixation within the abdominal aorta. Although sizing of “tube” or “bifurcated” grafts is radiographically assessed prior to surgery, it is necessary for the surgeon to have a large selection of graft lengths and diameters on hand to ensure an appropriate surgical outcome. Additional shortcomings include the placement of a “circular” profile graft with an associated fixation device within an essentially “ovoid” profile vessel and the use of attachment means which fasten only to the insubstantial, structurally compromised (diseased) intima and media levels of the vessel wall. Research has exposed yet another problem which indicates that the necks of the post-surgical aorta increase in size for approximately twelve months, regardless of whether the aneurysm experiences dimensional change. This phenomenon can result in perigraft leaks and graft migration.  
       [0017] There are a number of currently available scanning technologies that facilitate the pre-surgical assessment of abdominal aortic aneurysms. These include: computed tomography; magnetic resonance angiography; computed angiography; sonography including Doppler, and color flow; abdominal aortography; contrast arteriography; magnetic resonance imaging (i.e., MRI); and echocardiography. T he images gained by these scanning technologies are informative, but are open to multiple interpretations as they do not provide direct viewing of the portion of the aorta to be repaired. Furthermore, the performance of the procedures for these technologies may be injurious to the patient and in other instances impractical.  
       OBJECTS OF THE INVENTION  
       [0018] It is therefore an object of the present invention to provide a new and improved method of repairing an abdominal aorta aneurysm.  
       [0019] It is another object of the present invention to provide an apparatus for facilitating the repair of an abdominal aneurysm.  
       [0020] It is another object of the present invention to provide a graft for the repair of an abdominal aneurysm.  
       [0021] It is an object of the present invention to provide an apparatus for the repair of the aneurysm that facilitates direct viewing of the area of the aneurysm to be repaired.  
       [0022] It is another object of the present invention to reduce the amount of damage to the aorta and associated vasculature while repairing the aneurysm.  
       [0023] It is another object of the present invention to facilitate direct viewing of the vessel wall surface to assist the medical practitioner (i.e., surgeon or interventional radiologist) in the repair of vessel.  
       [0024] It is an object of the present invention to exclude an aneurysm from the circulatory system.  
       [0025] It is an object of the present invention to create a device for the repair of an aneurysm that can, without negative consequences, navigate the vessels extending to and from the aorta.  
       [0026] It is another object of the present invention to localize a graft within the abdominal aorta between the proximal and distal ends of the aorta.  
       [0027] It is an object of the present invention to firmly fasten a graft to the adventitia of the vessel wall to prevent migration of the graft.  
       [0028] It is another of object of the present invention to create a device to clearly visualize the surgical site during repair of the aneurysm.  
       [0029] It is another object of the present invention to create a uniform universal graft that is sized for use in a range of patients.  
       [0030] It is another object of the present invention to create a graft whose performance is not adversely effected by post surgical dimensional changes in the aortic necks.  
       [0031] It is another object of the present invention to create a device for the repair of the abdominal aortic aneurysm which may in addition to the classic femoral/common iliac introduction, also may be introduced via the axillary and/or brachial artery, which has not previously been contemplated.  
       [0032] It is another object of the present invention to provide a seal detail within an introducer sheath device that will significantly reduce blood loss during the repair procedure.  
       [0033] It is another object of the present invention to provide fastener assemblies that replace sutures.  
       [0034] It is another object of the present invention to provide a device that is capable of on board storage of a procedure specific quantity of fasteners so that it is not necessary to remove the device to reload during the repair procedure.  
       [0035] It is another object of the present invention to create a graft and a device for the repair of an aneurysm that reduces the invasiveness of current surgical procedures.  
       [0036] It is another object of the present invention to create a graft that is not dimension dependent (i.e., diameter/length) which is adaptable to the patient environment.  
       SUMMARY OF THE INVENTION  
       [0037] The present invention is directed to an attachment assembly for securing a graft to repair a vessel having an aneurysm therein. The vessel has a proximal neck or end and a distal neck or end. The graft has a proximal end and a distal end. The attachment assembly comprises attachment means for securing the distal end of the graft to the distal end of the vessel. The attachment assembly also comprises graft attachment means for securing the distal end of the graft to the attachment means. The attachment means permits expansion of the vessel necks and/or ends without negatively impacting the connection between the graft and the vessel wall. The attachment assembly may comprise a radially extending cuff. The attachment means may comprise at least one graft attachment tube for receiving the distal end of the graft. The attachment assembly is preferably formed from a flexible material.  
       [0038] The present invention is also directed to a repair graft assembly for repairing a vessel having an aneurysm therein. The repair graft assembly comprises a graft assembly for creating a passageway within the vessel to reinforce the aneurysm. The graft assembly has a proximal end and a distal end. The repair graft assembly also comprises an attachment assembly. The attachment assembly comprises attachment means for securing the distal end of the graft to the distal end of the vessel. The attachment assembly also comprises graft attachment means for securing the distal end of the graft to the attachment means. The attachment means permits expansion of the vessel without negatively impacting the connection between the distal end of the graft and the vessel. The attachment assembly may comprise a radially extending cuff. The attachment means may comprise at least one graft attachment tube for receiving the distal end of the graft. The repair graft assembly is preferably formed from a flexible material. The attachment means of the repair graft assembly preferably comprises at least one graft attachment tube for receiving the distal end of the graft assembly.  
       [0039] The repair graft assembly comprises proximal attachment means for securing the proximal end of the graft to the proximal neck or end of the vessel. The proximal attachment means comprises a radially extending cuff.  
       [0040] The present invention is also directed to a visualization apparatus for viewing the interior of a vessel prior to, during and following a surgical procedure. The visualization apparatus comprises a housing and image creating means for creating an image of the interior of the vessel from within the vessel. The image creating means is located within the housing. The image creating means comprises illumination means for illuminating an area within the vessel for viewing by a user. The image creating means also comprises diverting means for temporarily diverting blood away from the viewing area. The image creating means also comprises optical viewing means for viewing the area within the vessel.  
       [0041] The illumination means may comprise at least one optical fiber for illuminating the area within the vessel.  
       [0042] The visualization means comprises means for supplying a fluid to the area to direct the flow of blood away from the viewing area, and return means for draining the fluid from the area to permit the return of blood.  
       [0043] The optical viewing means comprises an optical fiber. The optical viewing means may alternatively comprise scanning means for scanning an area of the vessel for creating a non optical image of the area. The scanning means may produce an ultrasound image. The scanning means may comprise a scanning catheter.  
       [0044] The present invention is also directed to a penetration apparatus for use in creating a plurality of treatment specific holes in the sometimes calcified vessel wall to aid in the attachment of a graft. The penetration apparatus comprises a housing, and penetration means for use in creating a plurality of treatment specific holes in the sometimes calcified vessel wall. The penetration means is located within the housing. The penetration means may comprise a laser. The laser may be an acousto optical laser or a Holmium-Yag laser. Alternatively, the penetration means may comprise a piezoelectric penetrating device. The penetration apparatus may also comprise insertion means for inserting a fastener through the opening in the vessel to secure a surgical component (e.g., graft and prosthesis) to the vessel. The penetration apparatus may also comprise secondary penetration means for forming at least one opening adjacent the opening in the sometimes calcified vessel wall. The secondary penetration means may comprise a laser or piezoelectric device. The secondary penetration means stabilizes the penetration apparatus as the insertion means inserts a fastener in the opening. The penetration apparatus may further comprise visual tracking means for identifying the location of the penetration apparatus within the vessel.  
       [0045] The present invention is also directed to repair apparatus for repairing a vessel during a surgical procedure. The apparatus comprises a housing and at least one of a penetration apparatus for use in forming an opening in a vessel having a calcified portion and a visualization apparatus for viewing an interior of a vessel during a surgical procedure. The penetration apparatus comprises a penetration housing, and penetration means for forming treatment specific holes in the sometimes calcified vessel wall. The visualization apparatus comprises a visualization housing, and image creating means for creating an image of the interior of the vessel from within the vessel.  
       [0046] The present invention is also directed to a fastener for use in a surgical procedure for securing a surgical component to a vessel. The fastener comprises fastening means for securing the surgical component to the vessel under a compressive force. The fastening means is either a wire fabrication or a coil spring fabrication.  
       [0047] The present invention is also directed to an introducer sheath device for use during a surgical procedure for introducing surgical components into a vessel. The introducer sheath device comprises a housing having a passageway that permits the passage of the surgical components therein. The introducer sheath device also comprises sealing means at the proximal end for preventing the loss of blood from the vessel during the insertion and subsequent removal of surgical components during the surgical procedure. The sealing means comprises a sealing cavity. The sealing cavity is filled with a sealing material, which forms a seal around the surgical components as they are inserted and removed from the introducer sheath device during the surgical procedure. The introducer sheath device further comprises positioning means for maintaining the position of the introducer sheath device within the vessel. The positioning means preferably comprises an inflatable cuff positioned at the distal end of the introducer sheath device. 
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0048] The invention will now be described in conjunction with the following drawings in which like reference numerals designate like elements and wherein:  
     [0049]FIG. 1A is a perspective view of a prosthetic bifurcated tube graft and bifurcated cuff according to a preferred embodiment of the present invention;  
     [0050]FIG. 1B is a perspective view of a prosthetic bifurcated tube graft and bifurcated cuff according to another embodiment of the present invention;  
     [0051]FIG. 2A is a perspective view of the prosthetic bifurcated tube graft and bifurcated cuff of FIG. 1A secured within the abdominal aorta;  
     [0052]FIG. 2B is a perspective view of the prosthetic bifurcated tube graft and bifurcated cuff of FIG. 1B secured within the abdominal aorta;  
     [0053]FIG. 3 is a perspective view of a prosthetic tube graft and cuff according to another embodiment of the present invention;  
     [0054]FIG. 4 is a perspective view of the prosthetic tube graft and cuff of FIG. 3 secured within the abdominal aorta;  
     [0055]FIG. 5 is a perspective view of the connection between the prosthetic tube graft and the cuff;  
     [0056]FIG. 6 is a side view of the prosthetic tube graft of FIG. 4 secured to a secondary cuff;  
     [0057]FIG. 7 is an exploded view of the connection between the prosthetic tube graft and secondary cuff as shown in FIG. 6;  
     [0058]FIG. 8 is a perspective view of attachment cuffs according to another embodiment of the present invention;  
     [0059]FIG. 9 is a perspective view of the flexible attachment cuff according to embodiments of the present invention;  
     [0060]FIG. 10 is a perspective view of the attachment cuffs of FIG. 8 having a prosthetic tube graft secured between the attachment cuffs;  
     [0061]FIG. 11 is a perspective view of an IntraVascular Endoscopy (IVE) based repair system according to an embodiment of the present invention containing an embodiment of a visualization device according to the present invention;  
     [0062]FIG. 12 is an end view of the IntraVascular Endoscopy (IVE) based repair system according to the embodiment of FIG. 11;  
     [0063]FIG. 13 is an end view of the visualization device depicted in FIG. 11;  
     [0064]FIG. 14 is another perspective view of the IntraVascular Endoscopy (IVE) based repair system illustrating the guide wire and articulation cables exiting the housing of the repair system;  
     [0065]FIG. 15A is a perspective view of an IntraVascular Endoscopy (IVE) based repair system according to an embodiment of the present invention containing an embodiment of a penetration device according to the present invention and an embodiment of a fastener cartridge according to the present invention;  
     [0066]FIG. 15B is a perspective view of an IVE based repair system according to another embodiment of the present invention containing a penetration device and fastener cartridge according to the present invention;  
     [0067]FIG. 15C is a perspective view of an IVE based repair system according to the embodiment of FIG. 15B containing a penetration device and fastener cartridge according to another embodiment of the present invention;  
     [0068]FIG. 15D is a perspective view of an IVE based repair system according to another embodiment of the present invention containing a penetration device and fastener cartridge according to the present invention;  
     [0069]FIG. 16 is an end view of the penetration device according to an embodiment of the present invention;  
     [0070]FIG. 17 is an end view of the penetration device according to another embodiment of the present invention;  
     [0071]FIG. 18 is an end view of the fastener cartridge according to the embodiment of FIG. 15  
     [0072]FIG. 19 is a perspective view of an advancing mechanism of a penetration device according to an embodiment of the present invention;  
     [0073]FIG. 20 is a schematic view of another advancing mechanism of a penetration device and fastener cartridge according to another embodiment of the present invention;  
     [0074]FIGS. 21 and 22 are perspective views of an IntraVascular UltraSound (IVUS) based repair apparatus according to another embodiment of the present invention containing a visualization device and a penetration device;  
     [0075]FIG. 23 is a cross sectional view of a housing according to an embodiment of the present invention;  
     [0076]FIG. 24 is an end view of a penetration device depicted in FIG. 21;  
     [0077]FIGS. 25 and 26 are perspective views of a wire fastener for securing the cuff detail of a surgical cuff to a vessel wall according to an embodiment of the present invention;  
     [0078]FIGS. 27 and 28 are perspective views of a wire fastener according to another embodiment of the present invention for securing the cuff detail of a surgical cuff to a vessel wall;  
     [0079]FIGS. 29 and 30 are perspective views of a wire fastener according to another embodiment of the present invention for securing the cuff detail of a surgical cuff to a vessel wall;  
     [0080]FIGS. 31, 32 a ,  32   b ,  32   c ,  32   d  and  32   e  are perspective views of a fastener according to another embodiment of the present invention for securing the cuff to a vessel wall;  
     [0081]FIG. 33 is a schematic view of an embodiment of the penetration device according to the present invention having fasteners, as shown in FIGS. 31, 32 a ,  32   b  and  32   c  stored thereon;  
     [0082]FIG. 34 is a schematic view of an another embodiment of the penetration device according to the present invention having fasteners, as shown in FIGS. 31, 32 a ,  32   b  and  32   c  stored therein;  
     [0083]FIGS. 35 and 36 are perspective views illustrating the fastener attachment of the cuff detail to the vessel wall using a fastener as shown in FIGS. 29 and 30 according to an embodiment of the present invention;  
     [0084]FIG. 37 is a perspective view of another embodiment of an IntraVascular Endoscopy (IVE) based repair system according to an another embodiment of the present invention;  
     [0085]FIG. 38 is a perspective view on an introducer sheath device according to the present invention; and,  
     [0086]FIG. 39 is a cross sectional view of a seal assembly for the introducer sheath device according to an embodiment of the present invention. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
     [0087] The following descriptions of the preferred embodiments of the present invention are described, for purpose of example, in connection with the repair of an abdominal aortic aneurysm. The inventors of the present subject matter contemplate that the embodiments described herein are capable of use in the repair of other vessels and in other procedures. Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they come within the scope of the appended claims and their equivalents.  
     Repair Graft  
     [0088] Reference will now be made in detail to preferred embodiments of grafts according to the present invention for repair of abdominal aortic aneurysms, an example of which is illustrated in FIGS.  1 - 9 .  
     [0089]FIGS. 1A and 2A depict a preferred embodiment of the repair graft assembly of the present invention directed to a proximal graft assembly  10  and distal graft assembly  20  for repair of a vessel  1 . The proximal graft assembly  10  and distal graft assembly  20  are secured to a wall  2  of the vessel  1  to exclude the aneurysm from the circulatory system of the patient. In the preferred embodiment of the present invention, the proximal graft assembly  10  is a bifurcated tube graft.  
     [0090] The distal graft assembly  20  preferably comprises an attachment cuff  21 . The attachment cuff  21  is sized to secure the distal graft assembly  20  to the wall  2  of the vessel  1  at the distal end of the vessel  1 . The distal graft assembly  20  also comprises at least one graft attachment leg, tube or branch  22 . The attachment cuff  21  is secured to the wall  2  of the vessel  1  out to the adventitia using a suitable fastener, described in detail below.  
     [0091] The distal graft assembly  20  is positioned within the distal end of the vessel  1 , as shown in FIG. 1A using a guide wire, not shown, that extends between and through both common iliacs. The attachment cuff  21  is then secured to distal end of the vessel  1  out to the adventitia using a repair apparatus, described below. After the attachment cuff  21  is firmly secured to the wall  2 , attachment tubes  22  are invaginated to the position shown in FIG. 2A. A proximal graft assembly  10  is then secured to the attachment legs  22  using suitable connectors, such as, a self-expanding stent  30 , as shown in FIG. 5.  
     [0092] The bifurcated proximal graft assembly  10  comprises a pair of tubular legs  11 . The tubular legs  11  are sized to be received within/without the graft attachment tubes  22 . The bifurcated proximal graft assembly  10  may also comprise an attachment cuff  12  for attachment to the wall  2  of the vessel  1 . The attachment cuff  12  has a similar structure to the attachment cuff  21  of attachment device  20 . The tubular legs  11  are invaginated following the process of securing the attachment cuff  12  to the wall  2 . The attachment legs  22  may be positioned within the tubular legs  11 , as shown in FIG. 2A. Alternatively, the tubular legs  11  may be positioned within the attachment legs  22 , as shown in the embodiment of FIG. 4.  
     [0093] It is also contemplated that the distal graft assembly  20  may be used with a standard tube graft  3 , as shown in FIGS. 1B and 2B. In this variation, the tube graft  3  is secured to the wall  2  of the vessel  1  while in an inverted position, as shown in FIG. 1B using fasteners, described below, and a self-expanding stent  30 , if desired. The tube graft  3  is then invaginated and secured to the distal graft assembly  20 , as described above. The benefit of the invagination of the graft  3  is that the fasteners securing the graft  3  to the vessel  1  are not in direct contact with the blood within the vessel  1 . This will reduce the possible build up of thrombus at the point of attachment and thereafater the creation of emboli.  
     [0094] The proximal graft assembly  10  and distal graft assembly  20  will enable the creation of a cross sectional area ratio between the common iliacs and the distal aorta that exists only at childhood. The ratio may be 1.1 to 1.0. This ratio minimizes the reflected wave that is instrumental in the creation of plaque deposits at the distal bifurcation.  
     [0095]FIGS. 3 and 4 depict another embodiment of a repair graft for repair of an abdominal aortic aneurysm  1  according to the present invention. The proximal graft assembly  100  is secured to a wall  2  of the abdominal aorta to exclude the aneurysm  1  from the circulatory system of the patient. The proximal graft assembly  100  is used in connection with the distal graft assembly  20 , described above. In this embodiment, the distal graft assembly  20  comprises a single attachment leg or tube  22 . The proximal graft assembly  100  comprises a tube graft assembly  110  for forming a passageway within the vessel  1 .  
     [0096] The radially extending attachment cuff  121  provides a greater surface area for securing the proximal graft assembly  100  to the wall  2 . Additionally, the radially extending portion  121  is flexible, which permits some positioning adjustment of the proximal graft assembly  100  in the event the size of the passageway within the abdominal aorta changes after the surgical procedure. FIG. 9 illustrates the flexibility of the attachment cuff  21  which is similar to attachment cuff  121 . Like the embodiment of FIGS. 1A and 2A, the proximal graft assembly  100  is secured to the vessel wall  2  in an invaginated manner, as shown in FIG. 3. After the attachment cuff  121  is secured to the vessel wall  2 , the proximal graft assembly  100  is invaginated to the position shown in FIG. 4. The tubular leg assembly  110  is then secured to the distal graft assembly  20 , as shown in FIG. 5. In a preferred embodiment, a self-expanding stent  30  is used to secure it to the attachment leg  22  of the distal graft assembly  20 . The self-expanding stent  30  applies radial pressure against an inner surface of tube graft assembly  110  to secure the tube graft assembly  110  to the distal graft assembly  20 .  
     [0097] The self-expanding stent  30  is a preferred method of securing the proximal tube assemblies  10  or  100  to the distal graft assembly  20 . However, it will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, surgical staples, sutures, adhesives or other methods may be used to secure the proximal graft assembly  10  to the distal graft assembly  20 . Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     [0098] As described above in connection with FIGS. 1B and 2B, it is also contemplated that the distal graft assembly  20  may be used with a standard tube graft, not shown. The tube graft will also be secured to the wall  2  of the vessel  1  while in a cephalad position using either fastener devices, described below, or a self-expanding stent  30 . The tube graft is then invaginated and secured to the distal graft assembly  20 , as described above.  
     [0099]FIGS. 6 and 7 depict a proximal attachment assembly  150  according to the present invention for securing the proximal graft assembly  10  or  100  to the proximal end of the vessel  1 . It is preferred that the proximal attachment assembly  150  be used in connection with securing the proximal graft assemblies  10  or  100  to the vessel wall  2  according to preferred embodiments of the present invention as shown, for example, in FIGS. 3, 4,  6  and  7 . The proximal attachment assembly  150  comprises a cuff attachment portion  151  and a vessel attachment portion  152 . The attachment cuff  12  or  121  is secured to the cuff attachment portion  151 , by sewing, for example. The vessel attachment portion  151  is then secured to the vessel  1  using, for example, a fastener or a self-expanding stent  30  and fasteners, if necessary. Alternatively, the proximal attachment assembly  150  may be invaginated and secured to the vessel  1  in the manner described above in connection with FIGS. 1B and 2B. The cuff attachment portion  151  and the attachment cuff  12  or  121  interact in a manner such that the proximal graft assembly  10  or  100  are not impacted by the expansion of the neck of vessel  1  after the surgical procedure.  
     [0100] Another embodiment of the repair grafts according to the present invention are disclosed in FIGS. 8 and 10. The embodiment of FIGS. 8 and 10 utilizes a pair of distal graft assemblies  20 , which are secured at the proximal and distal ends of the vessel. A proximal graft assembly  1000 , which forms a passageway within the vessel  1  interconnects the distal graft assemblies  20 . As described above, the proximal graft assembly  1000  is secured to the attachment legs  22  of the distal graft assemblies  20  using a self-expanding stent  30  or other suitable fastening means. The attachment legs  22  may be inserted in the proximal graft assembly  1000 . Alternatively, the proximal graft assembly  1000  may be inserted in the attachment legs  22 , as shown in FIG. 10.  
     [0101] The above described repair grafts facilitates repair of a vessel in a manner that is neither profile nor dimension dependent. This is especially helpful in view of the fact that the necks of the post-surgical aorta typically increases in size for approximately twelve months. The above-described repair grafts accommodate such expansion without allowing leaks or graft migration. The attachment cuffs are capable of accommodating dimensional changes in the necks of the abdominal aorta. Furthermore, the use of the distal graft assembly  20  permits distal attachment removing the need for iliac/femoral attachment.  
     [0102] In the above described embodiments, the proximal graft assemblies  10 ,  100  and  1000 , distal graft assembly, and proximal attachment assembly  150  are preferably formed from Gore-Tex® or equivalent biocompatible material. It will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, in the embodiments mentioned above, various other suitable materials such as, Dacron®, and other biocompatible graft materials may be used to form the repair grafts. Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     [0103] Similar to other graft procedures, the proximal graft assemblies  10 ,  100 , or  1000  according to the present invention require attachment to the wall  2  of the vessel. Often, it is necessary to attach the distal end of the graft into material which is routinely calcified and therefore difficult to penetrate. When paired with the absence of a distal neck in the vessel, the presence of the plaque has forced others to promote the use of a bifurcated graft in which the graft limbs are fastened by stents within the common iliac or femoral arteries. This procedure may potentially damage the femoral arteries. Furthermore, the presence of a graft and stent within the iliac or femoral arteries potentially restricts the flow of blood within the vessels. This is unnecessary when utilizing the repair grafts according to the present invention.  
     IntraVascular Endoscopy (IVE) Based Repair System  
     [0104] Reference will now be made in detail to preferred embodiments of an apparatus according to the present invention for facilitating the repair of abdominal aortic aneurysms using above described grafts. An example of an intravascular endoscopy based system is depicted in FIGS.  11 - 17 .  
     [0105] The repair apparatus  5  comprises a housing  200  for alternately receiving a visualization apparatus  6  and a penetration apparatus  7 , as shown in FIG. 15D. It, however, is contemplated by the inventors of the present invention that the visualization apparatus  6  and penetration apparatus  7  may be combined into a single assembly within the repair apparatus  5 . The housing  200  has a hollow construction, as illustrated in FIG. 12, which permits insertion of the visualization apparatus  6  or the penetration apparatus  7 , described in detail below. The housing  200  is divided into two primary portions: static housing portion  210 ; and flexible housing portion  220 . The housing  200  has a sufficient length such that it extends from the repair site within the vessel  1  through the appropriate or chosen artery to a point outside the patient.  
     [0106] The housing  200  has a hollow interior  211  to permit passage of one of the interchangeable apparatus  6  and  7 . An inner surface of the hollow interior  211  comprises rotation prevention means  212  for properly orienting the interchangeable apparatus  6  and  7  within the housing  200 . In a preferred embodiment, the rotation prevention means  212  is a ridge, as shown in FIG. 12, that extends along the inner surface of the hollow interior  211 . It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the rotation prevention means  211  mentioned above, may be located at different radial positions within the housing and may also be a ridge, a groove, a plurality of grooves, or other devices capable of preventing rotation of the interchangeable apparatus  6  and  7  within the housing  200 . Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     [0107] Positioned within the housing  200  is an apparatus guide means  214  for guiding the repair apparatus  5 , as shown in FIGS. 11 and 15A, within the vessel  1  during use. The guide means  214  preferably is a passageway or lumen extending within the housing wall through the static portion  210 . A guiding means  160  cooperates with guide means  214  to guide the apparatus  5  during use. The guiding means  160  is preferably a guide wire which is capable of extending from the femoral artery to the axillary artery. In a preferred embodiment, the guide wire  160  is a filament (e.g., stainless steel, titanium or a Kevlar®). It, however, will be apparent to those skilled in the art that various other materials having similar properties of physical integrity, high strength, flexibility, and minimal thermal expansion may be used to form the guide wire  160 . The guide wire  160  projects from the flexible housing portion  220  through an aperture  226  in the housing  200 , as shown in FIG. 14.  
     [0108] Housing  200  also comprises an apparatus manipulation means  215  to aid in manipulating and orienting the apparatus  5  within the vessel  1  during the repair operation. The manipulation means  215  preferably comprises at least one passageway extending within the housing wall through the static housing portion  210  and terminating in the flexible housing portion  220 . A manipulating means  170  cooperates with manipulation means  215  to guide the apparatus  5  during use. The manipulating means  170  is preferably comprises at least one guide wire that is capable of extending from outside the patient through the housing  200 . The guide wires  170  extend through the manipulating means  215 . In a preferred embodiment, the guide wires  170  are filaments (e.g., stainless steel, titanium or a Kevlar®). It, however, will be apparent to those skilled in the art that various other materials having similar properties of physical integrity, high strength and flexibility may be used to form the guide wires  170 .  
     [0109] The guide wires of the manipulating means  170  terminate within the flexible housing portion  220 . Operation of the manipulating means  170  results in the articulation of an end portion of the flexible housing portion  220 . The guide wires  170  maintain the flexible housing portion  220  in an articulated position, as shown in FIGS. 11 and 14, such that the visualization apparatus  6  and the penetration apparatus  7  can be interchanged without altering the orientation of the repair apparatus  5  with respect to the surgical site.  
     [0110] The wall of the static housing portion  210  comprises an outer surface formed from silicone and an inner surface formed from Teflon®. It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the housing wall may be formed from a suitable polymer (e.g., Pebax®) or other material having similar properties including, but not limited to biocompatability, flexural strength, low coefficient of friction. Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     [0111] The flexible housing portion  220  may be formed in a manner similar to static housing portion  210 . For example, the housing may comprise an outer surface formed from silicon and an inner surface formed from Teflon®. It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the lining may be formed from a suitable polymer or other material having similar properties including, but not limited to biocompatability, flexural strength, low coefficient of friction. Alternatively, the flexible housing portion  220  may comprise a coiled metallic spring outer casing  224  that surrounds a lining. The lining may be formed from Teflon®. The coiled metallic spring outer casing  224  may be formed from a biocompatible stainless steel or titanium. Furthermore, the spring outer casing  224  may be formed from other suitable spring materials. It is not necessary that the outer spring casing  224  extend along the entire length of the flexible housing portion  220 . Rather, the outer spring casing  224  may be positioned along the portion of the flexible housing portion  220  that is subject to bending. However, it is contemplated that an outer spring casing that extends along the entire length of the flexible housing portion  220  be within the scope of the present invention.  
     [0112] The flexible housing portion  220  and the static housing portion  210  are manufactured as separate components. It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the static housing portion  210  and the flexible housing portion  220  may be formed as a single component. In a preferred embodiment, the static housing portion  210  is permanently secured to the flexible housing portion  220 . However, it is contemplated that the housing portions  210  and  220  may also be removably attached.  
     [0113]FIGS. 15B and 15C illustrates another repair apparatus  500  for alternatively receiving a visualization apparatus  6  and a penetration apparatus  7  according to another embodiment of the present invention. The repair apparatus  500  comprises a housing  2000  for alternatively receiving a visualization apparatus  6  and a penetration apparatus  7 . The housing  2000  is flexible and has a sufficient length such that it extends from the repair site within the vessel  1  through the appropriate artery to a point outside the patient.  
     [0114] The housing  2000  is hollow, as described above in connection with housing  200 , to permit passage of one of the interchangeable apparatus  6  or  7 . The housing  2000  includes at least one guide means  2140  positioned at the exterior of the housing  2000  for guiding the repair apparatus  500  within the vessel  1  during use. The guide means  2140  preferably is a passageway extending along the exterior of the housing wall to a point adjacent the distal end  2001  of the housing  2000 .  
     [0115] Guide wires  160  extend within the guide means  2140 . The guide wires  160  extend from the end of guide means  2140  and are secured to the distal end  2001  of the housing  2000 , as shown in FIGS. 15B and 15C. Adjustment of the guide wires  160  manipulates the position of the repair apparatus  500  within the vessel  1 . The above described arrangement permits a wide range of articulation of the repair apparatus  500  within the vessel  1 .  
     [0116] An additional guide wire  161  is secured to the distal end  2001  of the housing  2000 . The guide wire  161  extends through the vessel  1  and appropriate artery to permit the positional adjustment of the repair apparatus  500  within the vessel.  
     [0117]FIG. 15D illustrates another repair apparatus  5000  for alternatively receiving a visualization apparatus  6  and a penetration apparatus  7  according to another embodiment of the present invention. The repair apparatus  5000  comprises a flexible hollow housing  2010  and has a sufficient length such that it extends from the repair site within the vessel  1  through the appropriate artery to a point outside.  
     [0118] The housing  2010  includes at least one guide wire  162  extending along the exterior of the housing  2010 , as shown in FIG. 15D. The housing  2010  includes an inflatable portion  2011 , located adjacent the distal end  2001 . Inflation of the inflatable portion  2011  permits articulation of the repair apparatus  5000  within the vessel  1 . A passageway, not shown, extends within the housing  2010  to permit inflation of the inflatable portion  2011  with a suitable fluid, such as, saline or suitable liquid polymers or air. An additional guide wire  161  is secured to the distal end  2001  of the housing  2010 . The guide wire  161  extends through the vessel  1  and appropriate artery to permit the positional adjustment of the repair apparatus within the vessel.  
     [0119] The overall dimensions of the repair apparatus  5  allows axillary access. This previously was not possible. In this regard, the repair apparatus used in connection with the visualization apparatus  6  or penetration apparatus  7  is capable of being used in other surgical procedures not previously contemplated. The apparatus size permits insertion through an introducer sheath device  900 , described below. The apparatus  5  may also be introduced into a vessel percutaneously. This procedure is less invasive and/or intrusive when compared to other repair surgical procedures.  
     IntraVascular Endoscopy (IVE) Visualization Apparatus  
     [0120] Reference will now be made in detail to preferred embodiments of the interchangeable apparatus  6  and  7  for use with the repair apparatus  5  according to the present invention for facilitating the repair of abdominal aortic aneurysms. The visualization apparatus  6  will now be described in connection with FIGS. 11 and 13.  
     [0121] A visualization apparatus  6  may be inserted within the repair apparatus  5  to illuminate and permit real time direct viewing of the abdominal aorta to aid and the diagnosis and repair of the aneurysm. The visualization apparatus  6  is an intravascular endoscope based system that comprises a housing  300  for housing various illuminating and viewing components. The housing  300  is preferably formed as a conduit that is sized to slide within housing  200 . In a preferred embodiment, the housing  300  is an extrusion of silicon, Teflon® or polymer or other material having similar properties.  
     [0122] The housing  300  extends through the hollow interior  211  of the housing  200 . The housing  300  may comprise orientation means  310  for orienting the visualization means  300  within the housing  200 . The orientation means  310  cooperates with rotation prevention means  212 . In a preferred embodiment, the orientation means  310  is a channel that extends along an outer surface of the housing  300 . It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the orientation means  310  mentioned above may be located at different radial positions within the housing  300 . The orientation means  310 , may be a ridge, a groove, a plurality of grooves, or other devices that are complementary with the rotation prevention means  212  to prevent rotation of the visualization apparatus  6  within the housing  200 .  
     [0123] As shown in FIG. 13, housing  300  comprises a plurality of passageways  311 ,  312 ,  313 ,  314 , and  315  formed therein. The passageways  311 ,  312 ,  313 ,  314 , and  315  extend along the entire length of the housing  300 . Central passageway  311  is provided for the passage of optical viewing means  320  for viewing an abdominal aorta. In a preferred embodiment, the optical viewing means  320  is a fiber optic system. The system incorporates a fiber optic bundle. It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the optical viewing means  320  mentioned above, may be any flexible optical system that is sized for use in surgical applications. The optical viewing means  320  permits real time direct viewing of the area of repair in the vessel  1 . The optical viewing means  320  may be connected to a video camera and monitor, not shown, that permits the surgeon to view the repair area The images may be stored and recalled as desired by using either a video printer or video cassette recorder. The penetration apparatus  7  will be located at the same position as the visualization apparatus  6 . The penetration apparatus  7  incorporates a radio opaque marker that will indicate the precise position of the penetration apparatus  7  on the monitor. This allows the surgeon to monitor and track the adjustments of the repair apparatus  5 .  
     [0124] Peripheral illumination passageways  312  and  313  are provided for the passage of illuminating means  330  for illuminating the abdominal aorta for viewing by the optical viewing means  320 . In a preferred embodiment, the illuminating means  330  is a fiber optic system including a fiber optic bundle. It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the illuminating means  330  mentioned above, may be any system that is sized for use in surgical applications and capable of illumination within the aorta. Although a pair of passageways are illustrated, it is contemplated that a single illumination passageway will provide sufficient illumination. Additionally, more than two passageways may also be provided.  
     [0125] Peripheral fluid inflow passageway  314  and peripheral fluid outflow passageway  315  are provided for the passage of fluid lens media to and from the visualization tip  340 . The peripheral fluid inflow passageway  314  supplies a stream of optically clear fluid lens media from the visualization tip  340  in the area in front of the optical viewing means  320 . A control means, not shown, may be incorporated into passageway  314  to control the flow volume and velocity of the fluid lens media to the visualization tip  340 . The control means may be a valve or other suitable flow control devices. The control means controls the optically clear fluid lens media such that blood within the aortic cavity and the fluid lens media are pressure balanced. As a result, blood that is typically within the aorta is temporarily diverted away by the fluid lens media to a point adjacent the area of the wall  2  to be viewed by the optical viewing means  320 . The infusion of fluid lens media will dilute blood to an appropriate transparency in the immediate surgical site to exclude blood between the visualization tip  340  and the surgical site on the wall  2 . This permits the surgeon to clearly view the wall  2  through the optical viewing means  320 . In a preferred embodiment, the fluid lens is a transparent fluid to permit viewing of the wall  2 . The fluid lens media may be a saline solution. It is preferred that the solution be used for a single application (i.e., it is not reused). Other media, such as CO 2  gas and GreenX liquid fluorocarbon are contemplated to be within the scope of the present invention. The peripheral fluid outflow passageway  315  acts as a return duct for the fluid lens media within the aorta. Alternatively, the fluid lens media may then be filtered using an appropriate filtering means and recirculated using a pumping means through the peripheral fluid inflow passageway  314 .  
     [0126] In a preferred embodiment, it is contemplated that the visualization apparatus  6  be used in combination with the introducer sheath devices  900 , described below. The introducer sheath devices  900  and in particular the positioning assembies  920  permit the isolation of a portion of the vessel during the repair procedure. Specifically, the positioning assemblies  920  within the common iliacs and femoral artery permit the control of blood within the vessel. With this arrangement, it is then possible to more readily divert blood away from a viewing area with the flow of fluid lens media from the fluid inflow passageway  314 .  
     [0127] A visualization tip  340  is securely mounted to the end of housing  300  in a fluid tight manner. The tip  340  may be snap fitted or permanently mounted to the housing  300 . It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the visualization tip  340  mentioned above, may be secured to the housing  300  by means other than the above described snap and permanent fittings. The visualization tip  340  may be formed by injection molding or other suitable manufacturing methods in silicone or similar polymer.  
     [0128] The visualization tip  340  comprises apertures  341 ,  342 ,  343 ,  344 , and  345  that correspond to passageways  311 ,  312 ,  313 ,  314 , and  315 , respectively. Aperture  341  contains a lens positioned therein to facilitate viewing of the wall  2  with the optical viewing means  320 . Apertures  342  and  343  may include windows therein whereby light from the illuminating means  330  passes through the windows to illuminate the wall  2 , although it is not necessary. Apertures  344  and  345  act as gates for the peripheral fluid inflow passageway  314  and peripheral fluid outflow passageway  315 . The aperture  344  may be inwardly tapered, such that the inside diameter of the aperture adjacent the inflow passageway  314  is greater than the diameter on the outer surface of the tip  340  to concentrate the stream of fluid lens media from the fluid inflow passageway  314 . The aperture  345  may be outwardly tapered, such that the inside diameter of the aperture adjacent the inflow passageway  315  is less than the diameter on the outer surface of the tip  340 . It is contemplated that the tip  340  is optional.  
     Penetration Apparatus  
     [0129] A penetration apparatus  7  will now be described in connection with FIGS.  15 - 20 . The penetration apparatus  7  may be inserted within the repair apparatus  5 ,  500 ,  5000 , as shown in FIGS.  15 A-D, for fastening a repair graft to the vessel wall  2 . The penetration apparatus  7  comprises several components for fastening a repair graft including penetration means  420 , secondary penetration means  430 , tracking means  440  and insertion means  450 . The penetration apparatus  7  comprises housing  410  for housing the penetration means  420 , secondary penetration means  430 , tracking means  440  and insertion means  450 . In a preferred embodiment, the housing  410  has a thin walled tri-limbed profile, as shown in FIGS. 15C, 16, and  17 . In a preferred embodiment for increased flexibility, the housing  410  is positioned within the repair apparatus  5  such that two of the three limbs of the housing  410  are spaced from the side of housing  200  containing the guide wire  160 . It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the housing  410  mentioned above, may have more than three limbs. Alternatively, the housing  410  may be cylindrical having a plurality of inwardly projecting limbs. An alternative configuration for housing  4100  is depicted in FIGS. 15B and 15D. The housing  4100  comprises a central passageway  4110  containing penetration means  420 . Additional passageways  4210  and  4130  are provided for other components such as secondary penetration means, tracking means and insertion means.  
     [0130] The housing  410  is preferably formed from an extrusion of silicone, Teflon®, or polymer having similar properties. Housing  410  comprises a plurality of passageways  411 ,  412 ,  413 , and  414 , formed therein as shown in FIG. 16. An alternative arrangement is shown in FIG. 17. The passageways  411 ,  412 ,  413 , and  414  extend along the entire length of the housing means  410 . Primary passageway  411  is provided for the passage of the penetration means  420 . The penetration means  420  is provided to create a treatment specific hole in the wall  2  of the abdominal aorta for securing the graft thereto with a suitable fastener device, described below. The penetration means  420  penetrates the potentially calcified vessel wall  2  to securely fasten the repair graft to the wall  2 . The penetration means  420  may be either a laser penetrating device or a piezoelectric penetrating device. It, however, is contemplated by the inventors of the present invention that other penetration means including but not limited to CO 2  penetration, micro electromechanical systems, and intraluminal suturing are considered to be within the scope of the present invention. The laser penetrating device  420  preferably is an IR fiber optic based system using laser energy to create treatment specific holes in the aorta wall  2 . The fused silica/quartz fibers that are utilized are in the 200-600 micron size range. Suitable lasers comprise but are not limited to an acousto optical laser having a wavelength of about 1.35 μm, and a Holmium-Yag laser having a wavelength of about 2.1 μm. The selected wavelength allows transition of laser energy through the fiber in the passageway  411 . The laser fiber will be in direct contact with the surgical site such that the fiber projects from the end of the housing  410 . It is contemplated that a single, or tri-pronged hole pattern will be created using penetration means  420  and secondary penetration means  430 .  
     [0131] The piezoelectric penetrating device preferably is a catheter based system, which utilizes acoustic vibrations to create treatment specific suture holes to aid in graft/tissue attachment. The piezoelectric penetrating device applies an “acoustic wave” effect to create holes in the graft and vessel wall. In this variation, the passageway  411  preferably contains a super elastic titanium catheter, in rod or tube form, which enables transmittance of energy through the sometimes tortuous vessels to the surgical site. The catheter will be in direct contact with the surgical site such that the catheter projects from the end of the housing  410  into the formed treatment specific hole. The secondary penetration means  430  creates one or more temporary hole(s). The piezo-electronic device preferably operates at a frequency of 20 KHz. Other frequencys, both higher and lower, are contemplated to be within the scope of the present invention. The primary penetration means  420  is coaxial with the fastener devices such that the fastener devices may be inserted through the treatment specific hole created by the primary penetration means  420 .  
     [0132] Secondary passageway  412  is provided for the passage of the secondary penetration means  430 . The secondary penetration means  430  is also provided to create one or more temporary holes in the vessel wall  2 , in a manner similar to the primary penetration means  420 . Similarly, the secondary penetration means  430  may be either a laser penetrating device or a piezoelectric penetrating device, as described above in connection with the penetration means  420 . The secondary penetration means  430  serves to anchor and orient the penetration apparatus  7  while a fastener is inserted within the treatment specific hole formed by the primary penetration means  420 . After the secondary penetration means  430  is removed, the temporary holes will seal with blood that will coagulate.  
     [0133] Passageway  413  is provided within the housing  410  for passage of the insertion means  450 , described below. Passageway  414  is provided within the housing means  410  for passage of the tracking means  440 . In a preferred embodiment, the tracking means  440  is a radiopaque marker, which is utilized for the purpose of identifying the location of the penetration apparatus  7  within the image on the monitor. It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the tracking means  440  mentioned above, may be a tip-tracking device or a fiber optic aiming beam.  
     [0134] Insertion means  450  for securing the repair graft to the wall  2  during repair of the aneurysm will be described in connection with FIG. 19. The insertion means  450  preferably comprises a mechanism that drives an individual fastener from a fastener cartridge  460 , shown in FIGS. 15 and 18, into and through the treatment specific holes created by the penetration means  420  in the repair graft and wall  2 . The fastener cartridge  460  is capable of holding a plurality of fasteners such that more than one fastener may be sequentially displaced from the cartridge  460  to secure the repair graft to the abdominal aorta wall  2 . Fastener cartridge  460  is preferably detachably connected to housing  410 . The fastener cartridge  460  is a hollow housing, as shown in FIG. 18, preferably formed of injection molding HDPE or Liquid Crystal, manufactured by the RTP Co. of MN. The penetration means  420  and  430 , the tracking means  440  and the insertion means  450  are appropriately accommodated within the interior of the cartridge structure  460 . The cartridge  460  is positioned about the housing  410 .  
     [0135] The insertion means  450  illustrated in FIG. 19 comprises a driving means  451  for driving the fastener devices to secure the repair graft to the vessel wall  2 . A gear  452  and fastener advancing means  453  are positioned within an opening  454  in housing  410 . In a preferred embodiment, the gear  452  is a worm gear. However, other suitable gear assemblies are contemplated to be within the scope of the present invention. The gear  452  is connected to the driving means  451 . The fastener advancing means  453  interacts with the gear  452  to advance a fastener device to secure the repair graft to the vessel wall  2 . In a preferred embodiment, the fastener advancing means  453  is an internally geared drive plate assembly. The drive plate assembly may be capable of limited angular adjustment. Operation of the insertion means  450  is controlled by a control device, not shown, such that upon actuation by the control device, the fastener advancing means  453  is advanced to eject a fastener device from fastener cartridge  460 . Alternatively, the insertion means  450  may be hand operated. The insertion means  450  is used, for example, in the embodiment illustrated in FIG. 15C.  
     [0136] Another embodiment of the insertion means  4500  is illustrated in FIG. 20. An insertion cartridge  4510  is secured to the distal end of the repair apparatus  5 . The insertion cartridge  4510  may be snap fitted to the housing  200 . The insertion cartridge  4510  comprises a cavity  4511 . A spring means  4520  is positioned within the cavity  4511 . A fastener cartridge  460  is also located within the cavity  4511 . An opening  4530  is located at one end of the insertion housing  4510 . The housing  410  of the penetration apparatus  7  normally prevents the spring means  4520  from ejecting a fastener device through the opening  4530 . The insertion means  4500  comprises retraction means  4540  which retracts the housing  410  away from the opening  4530  which permits the fastener to be ejected into the treatment specific hole created by the primary penetration means  420 . The retraction means  4540  may be a cable that acts to retract the housing  410  away from opening  4530 . The release of the retraction means  4540  causes the housing  410  to return to the position adjacent the opening  4530  to prevent the discharge of a subsequent fastener device.  
     IntraVascular UltraSound (IVUS) Repair System  
     [0137] Reference will now be made in detail to preferred embodiments of an apparatus according to the present invention for facilitating the repair of abdominal aortic aneurysms using above described repair grafts. An example of an intravascular ultrasound based system is depicted in FIGS.  21 - 24 .  
     [0138] The repair apparatus  50  comprises housing  800 . The housing  800  comprises a major guide wire portion  810 , a cross-section of which is shown in FIG. 23, a spacer portion  820 , and a minor guide wire portion  830 .  
     [0139] Positioned within the housing  800  is an apparatus guide means  214  for guiding the repair apparatus  50  within the vessel  1  during use. The guide means  214  preferably is a passageway or lumen extending the length of the housing  800  through major guide wire portion  810 , the spacer portion  820 , and the minor guide wire portion  830 . A guiding means  160  cooperates with guide means  214  to guide the apparatus  50  during use. The guiding means  160  is preferably a guide wire which is capable of extending from the femoral artery to the axillary artery. In a preferred embodiment, the guide wire  160  is a filament (e.g., stainless steel, titanium or Kevlar® cable). It, however, will be apparent to those skilled in the art that various other materials having similar properties of physical integrity, high strength, flexibility, and minimal thermal expansion may be used to form the guide wire  160 .  
     [0140] Housing  800  also comprises an apparatus manipulation means  215  to aid in manipulating and orienting the penetration apparatus  700  within the vessel  1  during the repair operation. The manipulation means  215  preferably comprises at least one passageway extending within the housing  810 . The manipulation means  215  mates with complimentary passageways formed in housing  710 . A manipulating means  170  cooperates with manipulation means  215  to guide the apparatus  50  during use. The manipulating means  170  is preferably comprises at least one guide wire that is capable of extending from outside the patient through the housings  810  and  710 . The guide wire  170  extends through the manipulating means  215 . In a preferred embodiment, the guide wire  170  is a super elastic metal filament. It, however, will be apparent to those skilled in the art that various other materials having similar properties of physical integrity, high strength and flexibility may be used to form the guide wire  170 .  
     [0141] Operation of the manipulating means  170  results in the articulation of an end portion of the housing  710 . The guide wire  170  maintains the housing  710  in an articulated position, as shown in FIG. 21, during the repair operation.  
     [0142] The penetration apparatus  700  will now be described in connection with FIGS.  21 - 24 . The penetration apparatus  700  comprises several components for fastening a repair graft including penetration means  420 , secondary penetration means  430 , tracking means  440 , and insertion means  450 . The penetration apparatus  700  comprises housing  710  for housing the penetration means  420 , secondary penetration means  430 , and insertion means  450 . In a preferred embodiment, the housing  410  has a thin walled tri-limbed profile, as shown in FIGS. 21, 22 and  24 . It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention.  
     [0143] The housing  710  is preferably formed from an extrusion of silicone, Teflon®, or polymer having similar properties. Housing  710  comprises a plurality of passageways  711 ,  712 ,  713 ,  714 , and  715  formed therein as shown in FIG. 24. The passageways  711 ,  712 ,  713 ,  714  and  715  extend along the entire length of the housing  710 . Primary passageway  711  is provided for the passage of the penetration means  420 . The penetration means  420  is provided to create an treatment specific hole in the wall  2  of the abdominal aorta for securing the graft thereto with a suitable fastener device. The penetration means  420  penetrates the calcified portions of the wall  2  to securely fasten the repair graft to the wall  2  in the same manner as described above in connection with the endoscopic based system. The penetration means  420  may be either a laser penetrating device or a piezoelectric penetrating device.  
     [0144] Secondary passageway  712  is provided for the passage of the secondary penetration means  430 . The secondary penetration means  430  is also provided to create one or more openings in the vessel wall  2 , in a manner similar to the primary penetration means  420 , as described above.  
     [0145] Passageway  713  is provided within the housing  710  for passage of the insertion means  450 . Passageway  714  is provided within the housing  710  for passage of the guide wire  170 . Passageway  715  is provided for tracking means  440 . The insertion means  450  preferably comprises a mechanism that drives an individual fastener from a fastener cartridge  470 , shown in FIGS. 21 and 22, into and through the treatment specific holes created by the penetration means  420  in the repair graft and wall  2 . The fastener cartridge  470  is capable of holding a procedure specific quantity of fasteners such that more than one fastener device may be sequentially displaced from the cartridge  470  to secure the repair graft to the wall  2 . Fastener cartridge  470  is preferably detachably assembled to housing  710 . The fastener cartridge  470  has a hollow housing  471 , as shown in FIG. 21. The penetration means  420  and  430 , and the placement/fastener means  450  are appropriately accommodated within the interior of the cartridge structure  460 . The cartridge structure  470  and associated fastener device are complimentary with the spacer portion  820  of the housing  800  such that the penetration apparatus  700  has a flush profile, as shown in FIG. 22.  
     [0146] A visualization apparatus  600  for viewing the abdominal aorta to repair the aneurysm is positioned within housing  800  adjacent the minor guide wire portion  830 . The visualization apparatus  600  is an intravascular ultrasound (IVUS) based system produced, for example, by Endosonics of Rancho Cordova, Calif., that comprises a housing  601  for housing radial scanning components. The housing  601  may comprise a scanning window  602 , however, it is not essential for the effective operation of the visualization apparatus  600 . The visualization apparatus comprises scanning catheter positioned within the housing  601  such that it scans the area of the abdominal aorta. The housing  601  is an extrusion of silicon, Teflon® or polymer or other material having similar properties. The scanning catheter extends through the minor guide wire portion  830  of housing  800 . The scanning catheter creates an image of the repair that can be viewed on an external monitor, not shown.  
     [0147] The housing  800  also comprise transition portions  801  and  802  located on opposite ends of the penetration apparatus  700  to provide the repair apparatus  50  with a smooth profile, as shown in FIG. 22. This improves the movement of the repair apparatus  50  within the vessel  1  and adjacent arteries.  
     Fasteners  
     [0148] Reference will now be made in detail to preferred embodiments of a fastener device, as depicted in FIGS.  25 - 32 , according to the present invention for securing the attachment device  20  to the distal end of the vessel  1 . Although the fastener devices are described in connection with the repair of an aneurysm in a vessel, the use of the fastener devices in other surgical procedures as a replacement for sutures is contemplated to be within the scope of the present invention.  
     [0149]FIGS. 25 and 26 depict a fastener  510  according to an embodiment of the present invention. The fastener  510  comprises a pair of normally splayed fastening legs  512  and  513 . The fastener  510  also comprises an anchoring portion  514 . The fastener  510  is preferably formed from a wire-like material. The anchoring portion  514  may be formed from a coil of the wire-like material. The legs  512  and  513  are temporarily reoriented, as shown in FIG. 25, for storage on a fastener cartridge  460  and for enabling the attachment of the attachment device  20  to the wall  2 . As the legs  512  and  513  are inserted through the attachment device  20  and the wall  2 , the legs  512  and  513  return to a normal, as manufactured, splayed position, as shown in FIG. 26. When the fastener  510  is in a fastened position within the vessel, the anchoring portion  514  is positioned on one side of the attachment device  20  and wall  2  (intima/graft) adjacent the attachment device  20 . The splayed legs  512  and  513  are positioned on the opposite side of the attachment device  20  and wall  2  (adventia) adjacent the wall  2 . The anchoring portion  514  and splayed legs  512  and  513  apply compressive forces to the wall  2  and the attachment device  20  to securely fastening the attachment device  20  to the vessel  1 .  
     [0150] The fastener  510  is preferably formed from a stainless steel, such that the legs  512  and  513  return to the splayed position to secure the attachment device  20  to the wall  2 . It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the fastener  510  may be formed from other suitable materials including but not limited to superelastic titanium, or other procedure/performance-appropriate materials having similar properties including, but not limited to biocompatability, elasticity, and flexural strength. Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     [0151]FIGS. 27 and 28 depict a fastener  520  according to an another embodiment of the present invention. The fastener  520  comprises a pair of normally splayed fastening legs  522  and  523 . The fastener  520  also comprises an anchoring portion  524 . The fastener  520  is also preferably formed from a wire-like material. The anchoring portion  524  may be formed from at least one coil of the wire-like material (i.e., a wound portion). The legs  522  and  523  are temporarily compressed, as shown in FIG. 27, for storage in a fastener cartridge  460  and for facilitating the attachment of the attachment device  20  to the wall  2 . Similar to the embodiment described above in connection with FIGS. 25 and 26, as the legs  522  and  523  are inserted through the attachment device  20  and the wall  2 , the legs  522  and  523  return to a normally splayed position, as shown in FIG. 27. When the fastener  520  is in a fastened position within the vessel, the anchoring portion  524  is positioned on one side of the attachment device  20  and wall  2  adjacent the attachment device  20 . The splayed legs  522  and  523  are positioned on another side of the attachment device  20  and wall  2  adjacent the wall  2 . The anchoring portion  524  and splayed legs  522  and  523  apply compressive forces to the wall  2  and the attachment device  20  to securely fastening the attachment device  20  to the vessel  1 .  
     [0152]FIGS. 29 and 30 depict a fastener  530  according to another embodiment of the present invention. Fastener  530  is a spring type fastener, which may comprise a coil spring. The fastener  530  is also formed from a wire-like material. The fastener  530  comprises a plurality of coils, as shown in FIG. 29. The end portions  531  and  532  of the wire-like material are preferably located on the same end of the fastener  530 , as shown in FIGS. 29, 30, and  34 - 36 . Unlike fastener  510  and  520 , the fastener  530  is temporarily elongated for storage in the fastener cartridge  535 , as shown in FIGS. 33, 34, and  37 . As the fastener  530  is inserted through the attachment device  20  and wall  2  using the insertion means  450  on the penetration device  7 , as shown in FIG. 35, the fastener  530  remains in an elongated position until the insertion means  450  is removed from the treatment specific hole  3  created in the wall  2  of the vessel  1  and the attachment device  20  formed by the penetration apparatus  7 . The fastener  530  then assumes a collapsed position, as shown in FIG. 30. When the fastener  530  is in a fastened position within the vessel  1 , the end portions  531  and  532  are positioned on one side of the attachment device  20  and wall  2  adjacent the attachment device  20 , as shown in FIG. 36. The remaining portion of the fastener  530  is positioned on another side of the attachment device  20  and wall  2  adjacent the wall  2 . The fastener  530  apply compressive forces to the wall  2  and the attachment device  20  to securely fastening the attachment device  20  to the vessel  1 . Fastener  530  may be formed from a suitable shape memory alloy, stainless steel, titanium, a superelastic alloy, or any other procedure/performance-appropriate materials.  
     [0153]FIGS. 31, 32 a ,  32   b , and  32   c  depict a fastener  540  according to another embodiment of the present invention. Fastener  540  is a coil spring type fastener. Fastener  540  comprises a mid-section  541 , and semi-knotted end portions  542  and  543 . The fastener  540  is also formed from a coil spring using materials, as described above. The fastener  540  is substantially linear, as shown in FIG. 31, for storage in a fastener cartridge, not shown. As the fastener  540  is inserted through the attachment device  20  and wall  2 , the fastener  540  returns to its normally coiled position, as shown in FIG. 32 a  The fastener  540  applies compressive forces to the wall  2  and the attachment device  20  to securely fastening the attachment device  20  to the vessel  1  such that one semi-knotted end portion  542  is positioned adjacent the attachment device  20  and the other semi-knotted end portion  543  is positioned adjacent the wall  2  of the vessel  1 , as shown in FIGS. 32 b  and  32   c . FIG. 32 b  depicts an axially wound fastener  540 . FIG. 32 d  depicts the fastener  540  of FIG. 32 b  secured to the wall  2 . FIG. 32 c  depicts a radially wound fastner  540 . FIG. 32 e  depicts the fastener  540  of FIG. 32 c  secured to the wall  2 .  
     [0154] It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. For example, the fastening means mentioned above, may be pop-rivet fasteners, screw-type fasteners, rapid hardening plastic extradites, and other suitable fasteners are contemplated to be within the scope of the present invention. Thus, it is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     Introducer Sheath Devices  
     [0155] Reference will now be made to a preferred embodiment of an introducer sheath device according to the present invention of use in the repair of abdominal aneurysms, an example of which is illustrated in FIGS. 38 and 39. The introducer sheath devices create a protective passageway through the vessel through which the graft and repair devices are inserted. The introducer sheath devices protect the arteries from damage that may occur when the repair apparatus and other device are passed through the tortuous artery passageways during a surgical procedure.  
     [0156] Existing methods for repairing aneurysms utilize introducer sheath devices only in the femoral and common iliac arteries. Typically, guide wires extend from a femoral arteriotomy to an occlusion balloon placed within the proximal neck of the aorta at a point cephalad with respect to the abdominal aorta. Typically, others have gained access to the abdominal aorta via a femoral or common iliac arteriotomy into which is inserted an introducer sheath device of between 18-28 Fr. diameter. The size of these devices may cause damage to the vessels through which they pass.  
     [0157] By contrast, the inventors of the present invention contemplate the use of more than one unique introducer sheath device  900 , as shown in FIG. 33. The sheaths  900  are introduced over a femoral/axillary guide wire. One introducer sheath device  900  extends from either an axillary incision or a brachial incision to the proximal neck of the vessel  1 . Another introducer sheath device  900  extends from a femoral incision to the distal neck of the vessel or common iliac/distal aorta transition. The introducer sheath devices according to the present invention that extend through the axillary vessel and through the femoral artery have similar constructions. However, the introducer sheath device that extends through the axillary artery has a smaller size in the range between 9-12 Fr. and is able to navigate the arteriotomy/distal aorta passageway without problem. The smaller size will permit access to the aorta via either the left brachial or axillary artery, both of which are significantly smaller than the femoral or common iliac arteries. This procedure, previously, beyond consideration, may now significantly benefit these vascular surgeries.  
     [0158] Each introducer sheath device  900  comprises a housing  910  having a hollow interior  911  that permits the passage of the tube graft and other repair apparatus through the introducer sheath device to the vessel  1 . The repair apparatus are introduced through the an opening  912  in the end portion of the housing  910 . In a preferred embodiment, the housing  910  is a thin walled co-extrusion having an outer surface formed, for example, from silicon and an inner surface formed, for example, from Teflon®. Alternatively, the housing  910  may be formed of a suitable polymer having similar properties.  
     [0159] The introducer sheath device  900 , also, comprises positioning assembly  920  for maintaining the sheath  900  in proper orientation within the vessel. In a preferred embodiment, the positioning assembly  920  comprises an inflatable cuff  921  located at one end of housing  910 . The positioning assembly  920  further comprises an inflation device  922  for inflating the cuff  921 . The inflation device  922  in a preferred embodiment comprises a plurality of passageways  923  formed within the wall of housing  910 . A suitable fluid, such as saline, is supplied from an external source through the passageways  923  to fill the cuff  921 . The passageways  923  terminate at inflatable cuff  921 , as shown in FIG. 38.  
     [0160] Prior introducer sheath devices have not been able to control the loss of significant amounts of blood through the open end of the introducer sheath device that is positioned outside of the body. Others have attempted to prevent this blood loss through the use of complex clamping systems. The present invention provide a unique seal arrangement to prevent significant blood loss. A seal  930  located at one end of the housing  910  adjacent opening  912  will prevent significant blood loss. The seal  930  comprises an expanded housing assembly  931 . A self-sealing gel-like material  932  is located within the expanded housing assembly  931 . The material  932  permits the insertion of the repair apparatus through the material  932 , which forms a seal around the repair apparatus. As a the repair apparatus is removed from the introducer sheath device  900 , the material  932  forms a seal behind the repair apparatus as it is removed through opening  912 .  
     [0161] It, however, will be apparent to those skilled in the art that various modifications and variations can be made in the construction and configuration of the present invention without departing from the scope or spirit of the invention. It is intended that the present invention cover the modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.  
     Method of Repairing an Aneurysm  
     [0162] Reference will now be made in detail to a preferred embodiment of the method of repairing an aneurysm utilizing the above described components according to the present invention.  
     IntraVascular Endoscopy (IVE) Based Repair Method  
     [0163] The IntraVascular Endoscopy (IVE) based repair method will be described in connection with the use of a proximal graft assembly  10  and distal graft assembly  20 . Introducer sheath devices  900  are placed by femoral arteriotomy in both common iliacs under radiological guidance such that the positioning assembly  920  is positioned at the common iliac/aortic bifurcation transition. A guide wire is fed from one femoral incision to the other, also under guidance. A distal graft assembly  20  is fed over the guide wire until the attachment cuff  21  appears directly above the carina at the bifurcation, as shown in FIG. 1A.  
     [0164] A second guide wire  160  is now fed under radiological guidance between one femoral incision and the left axillary incision. Another introducer sheath device  900  is fed from the axillary until the positioning assembly  920  reaches the infrarenal aorta at which time it is inflated. The repair apparatus  5  is then fed through the introducer sheath device  900  over guide wire  160  from either the femoral or axillary access to the midpoint of the aortic aneurysm. The visualization apparatus  6  is then fed through the hollow interior  211  of housing  200  to the area of the wall  2  to which the attachment cuff  22  is to be attached. The guide wires  170  are then manipulated to adjust the orientation of the visualization apparatus  6  to permit viewing of the wall  2  as described above, such that an image appears on the monitor. An image of the wall  2  appears on the monitor. The visualization apparatus  6  is then removed and the penetration apparatus  7  is then inserted through the hollow interior  211 . The guide wires  170 , as described above, permit the penetration apparatus to be positioned in the same position as the visualization apparatus  6 . The tracking means  440  pinpoints the location of the penetration means  420  with respect to the wall  2  and attachment cuff  22  as viewed on the monitor. The primary and secondary penetration means  420  and  430  are then operated to form treatment specific holes within the cuff  22  and wall  2 , as described above. The primary penetration means  420  is then retracted and a fastener is then inserted within the treatment specific hole using the insertion means  450 . The location of the penetration apparatus  7  is then adjusted to repeat the process over the area previously viewed by the visualization apparatus  6 . The penetration apparatus  7  is then removed and the visualization apparatus  6  is reinserted. The viewing and fastening process is alternately repeated until the attachment cuff  22  is firmly attached to the wall  2 .  
     [0165] The repair apparatus  5  is removed once the attachment cuff  22  is secured to the wall  2 . The proximal graft assembly  10  is then inserted in an inverted manner through the femoral arteriotomy over the guide wire  160  to the position shown in FIG. 1A. The repair apparatus  5  is then fed through the introducer sheath device  900  over the guide wire  160  from either a femoral or axillary access to a position adjacent the attachment cuff  12 . The visualization apparatus  6  and the penetration apparatus  7  are then alternately inserted in the manner described above to secure the attachment cuff  12  to the wall  2 . In the event that a standard graft  3  is used, the inverted graft  3  is secured directly to the wall  2  in a similar manner. Alternatively, a self-expanding stent  30  may be used in combination with fasteners to secure the graft  3  to the wall  2 . The repair apparatus  5  is then removed.  
     [0166] Once the proximal graft assembly  10  or  3  are secured in place, the first guide wire is removed and the graft  3  or  10  is invaginated. The tubular legs  11  are then inserted into the attachment tubes  22 . Self-expanding stents  30  are then used to secure the attachment tubes  22  and tubular legs  11  firmly together. The guide wire  160  is then removed. The positioning assemblies  920  are deflated and the introducer sheath device  900  are removed from the femoral and axillary arteries. The incisions are then closed completing the repair process. The outlined procedure according to the present invention is far less intrusive than current known techniques. As a result, a patient&#39;s recovery period should decrease.  
     IntraVascular Ultrasound Repair Method  
     [0167] The intravascular ultrasound repair method will be described in connection with the use of a proximal graft assembly  10  and distal graft assembly  20 . Introducer sheath device  900  are placed by femoral arteriotomy in both common iliacs under radiological guidance such that the positioning assembly  920 , as described above in connection with the IntraVascular Endoscopy (IVE) based repair method. A distal graft assembly  20  is fed over a guide wire, as described above, until the attachment cuff  21  appears directly above the carina at the bifurcation, as shown in FIG. 1A.  
     [0168] A second guide wire  160  is now fed under guidance between one femoral incision and the left axillary incision. Another introducer sheath device  900  is fed from the axillary until the positioning assembly  920  reaches the infrarenal aorta at which time it is inflated. The repair apparatus  50  is then fed through the introducer sheath device  900  over guide wire  160  to the midpoint of the aortic aneurysm. The visualization apparatus  600  is then positioned adjacent the area of the wall  2  to which the attachment cuff  22  is to be attached. The scanning catheter is drawn caudad providing images of the distal aortal common iliac transition on an external monitor. The repair apparatus  50  is then oriented such that the penetration apparatus  700  is adjacent the area where the attachment cuff  21  is to be attached to the wall  2 .  
     [0169] The primary and secondary penetration means  420  and  430  are then operated to form treatment specific holes within the cuff  22  and wall  2 , as described above. The primary penetration means  420  is then retracted and a fastener is then inserted within the treatment specific hole using the insertion means  450 . The location of the penetration apparatus  700  is then adjusted to repeat the process over the area previously viewed by the visualization apparatus  600 . The repair apparatus  50  is then oriented such that the visualization apparatus  600  may scan another portion of the wall  2 . The viewing and mounting process is alternately repeated until the attachment cuff  22  is firmly attached to the wall  2 .  
     [0170] The repair apparatus  50  is removed once the attachment cuff  22  is secured to the wall  2 . The proximal tube graft assembly  10  is then inserted in an inverted manner over the guide wire  160  to the position shown in FIG. 1A. The repair apparatus  50  is then inserted through a femoral incision over the guide wire  160  to a position adjacent the attachment cuff  12 . The visualization apparatus  600  and the penetration apparatus  700  are then alternately operated in the manner described above to secure the attachment cuff  12  to the wall  2 .  
     [0171] Once the proximal graft assembly  10  is secured in place, the first guide wire and the repair apparatus  50  are removed and the proximal graft assembly  10  is invaginated. The tubular legs  11  are then inserted into the attachment tubes  22  or vice verse. Self-expanding stents  30  are then used to secure the attachment tube  22  and tubular legs  11  firmly together. The guide wire  160  is then removed. The positioning assemblies  920  are deflated and the introducer sheath devices  900  are removed from the femoral and axillary arteries. The incisions are then closed completing the repair process.  
     [0172] While this invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the preferred embodiments of the invention as set forth herein are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention as defined in the following claims.