Patent Abstract:
A system and method for exclusion of an aneurysm of an aortic arch region using a graft delivery system capable of maneuvering around an aortic arch, an aortic arch graft, and an occluder system for isolating an aneurysm while occluding one or more corresponding arteries, and with bypass of those arteries being performed using one or more selected bypass grafts. The graft may be branched or branchless. The graft delivery system has a flexible sheath that is manipulated manually with the aid of a guidance system. A hoist delivery system may also be provided. The occluder system may comprise independent occluders with one or more anchor members adjacent to one end. Alternatively, the occluders can be provided as part of the aortic arch graft, either as a built-in singular self-deploying occluder or as built-in multiple occluders. A kit is also provided containing a graft, stents, occluders, and optional delivery system.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 60/347,250, filed on Jan. 14, 2002. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to cardio vascular disease and the treatment thereof. More particularly, the invention pertains to a method and apparatus for treating an aneurysm of the ascending/descending aorta and/or aortic arch. 
     2. Description of the Prior Art 
     By way of background, existing techniques for exclusion of an aneurysm in the ascending/descending aorta and/or the aortic arch require the use of a heart lung machine and drastic reductions in patient body temperature, followed by excision and replacement of the diseased aortic arch section. These techniques are associated with a high rate of complications, morbidities, and mortalities. It would be desirable if an exclusion of an aortic arch region could be performed without entering the chest or mediastinum, as by use of a transfemoral or other percutaneous technique, and preferably requiring only local anesthesia and sedation. 
     SUMMARY OF THE INVENTION 
     The foregoing problems are solved and an advance in the art is obtained by a novel system and method for the exclusion of an aneurysm of the ascending/descending aorta and/or the aortic arch using an aortic arch graft and a graft delivery system capable of maneuvering around an aortic arch. An occluder system may also be provided for occluding one or more of the left subclavian artery, the left common carotid artery and the right innominate artery, and with bypass of one or more of those arteries being performed using selected bypass lumina. 
     In one embodiment of the invention, the aortic arch graft has branches and in another embodiment the aortic arch graft is branchless. The grafts may be stented or stentless, and they may have various additional features, such as connection members adapted for use during graft deployment, for stent restraint, for graft positioning or for other purposes. 
     In one implementation of a branchless aortic arch graft, the aortic graft has a built-in singular self-deploying occluder that provides the occluder system. The occluder is preferably sized to be larger than the distance in an aortic arch between a left subclavian artery and a right innominate artery. The occluder may contain an optional support ring sewn internally at the base of the occluder. 
     In another implementation of a branchless aortic arch graft, the graft has built-in multiple deployable occluders providing the occluder system. The occluders are preferably sized to respectively correspond to the diameters of a left subclavian artery, a left common carotid artery, and a right innominate artery. The occluders can be self-deploying or can be manually deployed by use of a guide member attached to the top of each occluder. 
     The graft delivery system of the invention may include a flexible tubular sheath surrounding a plunger mechanism, a catheter with a shaped tip, and a flexible guide wire. The sheath preferably has a flexible end that is capable of bending and maneuvering in any direction, up and around an artery or vessel. Manipulation of the flexible end can be performed with the aid of a guidance mechanism running end to end along the sheath. The guidance mechanism is adapted to be manipulated manually at the distal end of the sheath. 
     In an alternative implementation of the graft delivery system, a hoisting system is used to introduce the aortic arch graft. The graft has two or more connection members at one end, which can be attached with hoisting elements to an eyelet formed on the flexible guide wire. The hoisting elements and the guide wire extend internally through the graft. They are used to position the graft in an aortic arch and/or ascending/descending aorta by pulling on the hoisting elements after positioning the guide wire, and pulling the graft up towards the eyelet on the guide wire. 
     The occluder system of the invention may include individual occluders adapted to occlude one or more of a left subclavian artery, a left common carotid artery, and a right innominate artery. Each occluder may have one or more protruding anchor members adjacent to one end thereof. The anchor members are sized to anchor themselves to the wall of an artery. 
     The invention further contemplates an aortic arch aneurysm repair kit having an aortic arch graft, stents, occluders for occluding one or more of a left subclavian artery, a left common carotid artery, and a right innominate artery, and an optimal delivery system. 
     The invention further contemplates methods for repair of an ascending/descending aorta or aortic arch aneurysm. One method is for use with a branchless aortic arch graft. According to this method, a left carotid-subclavian bypass between the left common carotid artery and the left subclavian artery is performed, together with a bilateral femoral-axillary bypass between the right femoral artery and the right subclavian artery, and between the left femoral artery and the left subclavian artery. Next, the left subclavian artery, the left common carotid artery, and the right innominate artery are occluded proximate to the aortic arch. A branchless aortic arch graft is then introduced via a percutaneous approach and positioned in the ascending/descending aorta and/or aortic arch. Another method in accordance with the invention is for use with a branched aortic arch graft. According to this method, a left carotid-subclavian bypass between the left common carotid artery and the left subclavian artery is performed. Next, the left carotid artery is occluded proximate to the aortic arch. A branched aortic arch graft is then introduced via a percutaneous approach and positioned in the ascending/descending aorta and/or aortic arch and respective branches. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The foregoing and other features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying Drawings, in which: 
     FIG. 1 is a diagrammatic view showing an outline of the human body and a portion of the circulatory system, and further illustrating a left carotid-subclavian bypass, a right femoral-axillary bypass, and a left femoral-axillary bypass. 
     FIG. 2 a  is a side view of a branchless aortic arch graft of the present invention with a built-in self-deploying occluder in a non-deployed condition; 
     FIG. 2 b  is a top view of the graft of FIG. 2 a  in a non-deployed condition; 
     FIG. 2 c  is a side view of the graft of FIG. 2 a  in a deployed condition; 
     FIG. 3 a  is a side view of an alternate branchless aortic arch graft of the present invention with multiple built-in occluders; 
     FIG. 3 b  is a top view of the graft of FIG. 3 a  in a non-deployed condition; 
     FIG. 3 c  is a side view of the graft of FIG. 3 a  in a deployed condition; 
     FIGS. 4 a  and  4   b  are cross sectional centerline views of the proximal end of a graft delivery system in accordance with the present invention in which FIGS. 4 a  and  4   b  show alternative constructions of a sheath introducer; 
     FIG. 5 is a perspective view showing the delivery system of FIG. 4 a  deployed within an aortic arch and advancing into an ascending aorta; 
     FIG. 6 is a perspective view of the branchless graft of FIG. 2 a  showing the graft deployed in an aortic arch; 
     FIG. 7 a  is a perspective view of the branchless graft of FIG. 3 a  showing the graft deployed in an aortic arch, but prior to deployment of occluders; 
     FIG. 7 b  is a perspective view of graft of FIG. 3 a  with occluders being deployed using strings in the branches of an aortic arch. 
     FIGS. 8 a  and  8   b  are perspective views of an alternate delivery system of the present invention for use with a branched or branchless aortic arch graft with multiple loop connection members at its proximal end, and with the graft being stented and FIGS.  8   a  and  8   b  respectively showing alternative methods for compressing the stents during graft introduction; 
     FIGS. 9 a  and  9   b  are perspective views showing deployment of a modified version of the graft of FIG. 3 a  using the delivery system of FIG. 8 a;    
     FIG. 10 is a side view of an occluder with integral anchor members; 
     FIG. 11 is a perspective view showing three occluders according to FIG. 10 deployed in the branches of an aortic arch. 
     FIG. 12 is a diagrammatic view showing an aortic arch, and further illustrating a left carotid brachial bypass lumen. 
     FIG. 13 is a perspective view of a branched aortic arch graft of the present invention, and a graft delivery system in accordance with the present invention. 
     FIGS. 14 a ,  14   b , and  14   c  are perspective views of the graft of FIG. 13 being prepared for introduction into the delivery system of FIG.  13 . 
     FIG. 15 is a perspective view of the delivery system of FIG. 13 deployed within an aortic arch and advancing into an ascending aorta. 
     FIG. 16 is a two-part perspective view of the graft of FIG. 13 being deployed in an ascending aorta. 
     FIG. 17 is a perspective view of the branches of the graft of FIG. 13 being deployed in the branches of an aorta. 
     FIG. 18 is a perspective view of the graft of FIG. 13 being secured with stents in an aortic arch region and the branches of an aorta. 
     FIG. 19 is a perspective view of the graft of FIG. 13 secured in an aortic arch region and branches of an aorta and the delivery system of FIG. 13 being removed. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     A. Introduction 
     The system and method of the invention will now be described by way of exemplary embodiments shown by the drawing figures, in which like reference numerals indicate like elements in all of the several views. The terms distal and proximal are used herein and will be understood to indicate position relevant to the heart, with proximal indicating a position closer to the heart and distal indicating a position farther away from the heart. 
     As summarized above, the invention represents a departure from the conventional techniques for repairing an aneurysm of the aortic arch or ascending/descending aorta in which the diseased section is excised and replaced. The invention contemplates the insertion of the aortic arch graft to isolate the diseased section from blood flow. This presents a challenge because the aortic arch has three branches connected to the left subclavian artery, left common carotid artery and a right innominate artery. The present invention proposes two solutions, one being the use of an aortic arch graft with branches and the other being the use of a branchless aortic arch graft with occlusion of the aortic branches. 
     B. Branchless Aortic Arch Graft 
     As indicated, one solution to the aortic arch repair challenge is to implant a branchless aortic arch graft without cutting off blood supply to the arteries leading from the aortic branches. This is can be done by performing an arterial bypass procedure prior to graft introduction, as shown in FIG.  1 . First and second surgical teams using arterial bypass grafts  2  can implement the bypass procedure. The bypass grafts are conventional in design and material and may be of the same type used for femoral-axillary bypass procedures. A first surgical team performs a left carotid-subclavian bypass  5 , in which a bypass graft  2  is placed between the left carotid artery  6  and the left subclavian artery  8 . A second surgical team performs a bilateral femoral-axillary bypass  7  in which bypass grafts  2  are respectively placed between the right subclavian artery  4  and the right femoral artery and between the left subclavian artery  8  and the left femoral artery. The left common carotid artery  6 , left subclavian artery  8 , and right innominate artery  9  may then be occluded proximate to an aortic arch either prior to or part of the graft deployment procedure. 
     Following the bypass procedure, an aortic arch graft can be deployed in the aortic arch and/or ascending aorta to exclude the aneurysm, followed by occlusion of the branches of the aortic arch. FIGS. 2 a  and  2   b  show an exemplary branchless aortic arch graft  10  that may be used for this purpose. The graft  10 , which can be constructed of dacron or other suitable biocompatible material, has a tubular shape when in its expanded state and is capable of being folded or twisted for loading into a sheath introducer (See FIGS. 4 a  and  4   b ). The graft  10  has a first open end  18  and second open end  19 . Each end may have a stent  12  mounted thereto by sewing or the like. Alternatively, stents may be inserted following graft deployment. The graft  10  further includes a single self-deploying occluder  14 . The occluder  14  is preferably made from additional graft material that is sewn or otherwise attached to the wall of the graft  10 . Sufficient material is used so that the occluder  14  is capable of deploying laterally outward beyond the nominal tubular shape of the graft  10 . The occluder  14  is preferably elliptical in shape, but other shapes could be used. It extends along the partial length of the graft  10  and is preferably sized to be larger than the distance in an aortic arch between a left subclavian artery and a right innominate artery. An opening is formed in the wall of the graft  10  that allows blood to flow into the occluder  14  from the main body of the graft (see below). A support ring  13  may be provided at a base  17  of the occluder  14  to help define the opening. The support ring  13  can be made of nitonol and is preferably 1-2 mm larger than the base  17  of the occluder  14 . As described in more detail below relative to FIG. 6, the graft  10  can be positioned by using one or more iodinated radio-opaque markers  15 . 
     In FIG. 2 c , the occluder  14  of the graft  10  is seen from a side view in a deployed state. Deployment occurs as blood flow  16  forces the wall of the occluder  14  to move laterally beyond the girth of the graft  10 . 
     The stents  12  can be formed as conventional spring stent members made from a shape memory material such as nitonol (nickel-titanium alloy) that self deploy upon insertion. Alternatively, they may be formed as non-self deploying stents. In either case, the stents  12  must be sized for use in the ascending/descending aorta or aortic arch. Note that only two stents are desirable because of the curved shape of the aortic arch. 
     Turning to FIGS. 3 a  and  3   b , another embodiment of an aortic arch graft  20  is similar in construction to the graft  10 , but is provided with multiple occluders  24  instead of a single occluder. The occluders  24  may include loop members  26  located externally at the end of each occluder  24 . The loop members  26  may be closed or partially open such that strings/filaments or other occluder deployment members  28  may be threaded or otherwise attached for manual deployment of the occluders  24 . FIG. 3 c  shows a side view of the graft  20  with the occluders  24  in a deployed state. By way of example only, the strings  28  can be threaded through loop members  26  and pulled to expand the occluders  24  from the main body of the graft  20 . In an alternative construction, the occluders  24  can be adapted to be self-deployable by virtue of blood flow  27 . As described in more detail below in FIG. 6, the graft  20  is positioned using iodinated radio-opaque markers  29 . 
     Turning now to FIG. 4 a , a delivery system  40  for positioning any of the aortic graft assemblies herein includes a sheath introducer  42  surrounding a plunger assembly  45 , which itself surrounds a catheter  50 . The sheath introducer  42 , which can be made from biocompatible plastic or any other biocompatible, substantially flexible material, is a generally tubular member with a proximal end  43  and distal end (not shown), each end being provided with an opening. To provide the flexibility required to negotiate the aortic arch, the sheath  42  can be constructed with flexible ribs  60  running from the proximal end  43  down the shaft of the sheath introducer about one to three inches. By way of example only, the flexible ribs  60  can be configured as shown in the inset of FIG. 4 a . The plunger assembly  45  is of standard construction. It includes a central lumen  44  for passage over the catheter  50 , and a plunger head  46  located at the most proximal part of the plunger assembly. The plunger head  46  preferably has a substantially flat proximal surface for contacting a graft assembly as described herein so that the plunger assembly  45  is able to push the graft in a proximal direction relative to the sheath introducer  42  during graft deployment. The catheter  50  is substantially tubular with two hollow interior passages  51  and  53 . A proximal end of the catheter  50  is equipped with a hydraulic inflatable tip  54  that is adapted to be filled with a liquid  58 , preferably saline. A suitable injection device, such as an attachable syringe  47 , is used to force solution up through the hydraulic passage  51  of the catheter  50  and into the catheter tip  54 . The catheter passage  53  is conventionally adapted to receive a guide wire  56  to direct the delivery system  40  through appropriate arteries as part of a transfemoral approach. 
     An optional internal guidance mechanism  55  can be provided to enable the proximal end  43  of the sheath  42  to bend and maneuver multi-directionally, up and around an artery or vessel. The guidance mechanism  55  can be implemented in a variety of ways, but is shown by way of example only in FIG. 4 a  as including a wire/filament  57  attached to the proximal end  43  of the sheath  42 . The wire/filament  57  runs end to end along the inside of the sheath  42 , and is activated manually at the distal end thereof. If desired, a suitable control device, such as a knob or lever (not shown) could be attached to allow manipulation of the wire/filament  57 . 
     FIG. 4 b  illustrates an alternative way in which a sheath introducer can be constructed with the required flexibility to allow its use in the delivery system  10 . In particular, a sheath introducer  58  is formed with a hollow wall  59  that is adapted to be filled with a liquid, preferably saline, to provide various states of rigidity by controlling the hydraulic pressure within the wall  59 . A suitable injection device, such as an attachable syringe  47 , is used to force solution up through the wall  59  of the sheath introducer  58  until the sheath introducer  58  is of a desired rigidity. Note that all other structure shown in FIG. 4 b  is identical to that shown in FIG. 4 a , and its description will not be repeated. 
     The delivery system  40  can be used to deploy an aortic arch graft (such as the grafts  20  and  40 ) according to the following procedure: After opening a femoral artery (right or left), the guide wire  56  is inserted therein and passed through the descending aorta, around the aortic arch, through the ascending aorta, and into the aortic valve of the heart. Note that the guide wire  56  has a relatively blunt tip so that it does not damage any blood vessel walls. Next, the proximal end of the catheter  50  of the delivery system  40  is inserted over the distal end of the guide wire  56 . The delivery system  40  will have been previously loaded with an aortic arch graft inside of the sheath introducer  42 . After inflating the catheter tip  54  with the liquid to a desired pressure, the delivery system  40  is inserted into the femoral artery and passed through the descending aorta  61 , the aortic arch  62 , and into the ascending aorta  64  as depicted in FIG.  5 . As the catheter tip  54  reaches the aortic arch  62 , the guidance mechanism  55  (if present) is used to bend the sheath introducer  42  (or  58 ) to direct the delivery system  40  to the ascending aorta  64 , where it is positioned using iodinated radio-opaque markers on graft. With the delivery system  40  in position, the graft  65  is deployed from the sheath introducer  42  (or  58 ) using the plunger  45 . With the proximal end of the graft sufficiently secured to the vessel wall by virtue of its proximal stent, the sheath introducer  42  (or  58 ) is withdrawn from the ascending aorta  64  and the descending aorta  61  as the plunger  45  simultaneously deploys the remaining length of the graft around the aortic arch  62  and down to the descending aorta  61 . With the distal end of the graft sufficiently secured in position by virtue of its distal stent, the catheter tip  54  is deflated and pulled through the interior of the graft until it reaches the proximal end of the sheath introducer  42  (or  58 ). The delivery system  40  is then removed from the body, followed by the removal of the guide wire  56 . 
     If the delivery system  40  is used to implant the aortic arch graft  10  of FIG. 2 a , the implantation procedure described above will result in the graft  10  being deployed in the aortic arch in the manner shown in FIG.  6 . As blood flows through the graft  10 , (shown at  16 ) the wall of the single occluder  14  will be forced laterally outward by the force of the blood flow  16  at least the distance between the right innominate artery  92  and left subclavian artery  94 . Due to pressure differential, this force will be greater than the force asserted from blood flow within the occluded arteries. The occluder  14  will thus be retained in position. 
     If the delivery system  40  is used to implant the aortic arch graft  20  of FIG. 3 a , the implantation procedure described above will result in the graft  10  being deployed in the aortic arch in the manner shown in FIGS. 7 a  and  7   b . Although the graft  20  is introduced in the manner described above relative to FIG. 5, delivery of this type of graft includes the additional step of temporarily attaching occluder deployment members, such as strings/filaments  101 , to the occluders  24  before the graft  20  is loaded into the sheath introducer  42  (or  58 ). The strings/filaments  101  can be respectively inserted into the right innominate artery, left carotid artery, and left subclavian artery and pulled from their point of entry, passed through the descending aorta, into the femoral artery, and out of the vessel at the groin. Next, the strings/filaments  101  are temporarily attached to the loop members  26  of the corresponding occluders  24  of the graft  20 . The graft  20  is then loaded into the sheath introducer  42  (or  58 ). As the delivery system  40  is inserted into the femoral artery and advanced for positioning in the aortic arch  64 , the strings/filaments  101  are simultaneously pulled, remaining relatively taut and forward of the delivery system  40  to prevent entanglement within the arterial vessels. FIG. 7 a  shows the graft  20  in position and ready for the occluders  24  to be deployed by way of a final pulling of the strings/filaments  101  temporarily attached to the loop members  26 . One at a time (or simultaneously), the attached strings/filaments  101  are pulled to assist movement of the occluders  24  up into a corresponding artery  106 , blocking blood flow and occluding the artery as seen in FIG. 7 b . Because the force of the blood flow  27  within the graft  20  is greater than the force being asserted from blood flow  109  within the occluded arteries  106  the occluders  24  will remain in a deployed state. After the occluders  24  are sufficiently secured, the strings/filaments  101  are detached from the loop members  26  of the occluders  24  by pulling one end until the opposing end is fully withdrawn from the body. Although not shown, a modified version of the graft  20  wherein the occluders  24  do not have loop members  26  and are not deployed with strings/filaments  101  could also be used. In this instance, the occluders  24  would be deployed by the blood flow  27  alone, which forces the occluders  24  to expand out from the graft  20  and into position in the arteries  106 , which are thereby occluded. The occluders  24  will then remain in a deployed state due to blood flow pressure differential, as described above. Alternatively, each occluder  24  could be stabilized with a stent (not shown). 
     Turning now to FIGS. 8 a  and  8   b , an alternate delivery system  200  featuring a graft hoisting arrangement can be used to position an aortic arch graft  202  in an ascending/descending aorta and/or an aortic arch. The delivery system  200  includes a flexible guide wire or catheter  204 , made of plastic or other suitable material, with an eyelet  206  at or near its proximal end  207  (which is preferably blunt tipped), and hoisting elements, such as strings  208 . The graft  202  includes a first open proximal end  210  and second open distal end  212 , each end having a stent  214  mounted thereto by sewing or the like. Alternatively, stents may be inserted following graft deployment. The graft  202  can be constructed with one or more occluders, as shown in FIGS. 9 a  and  9   b , which depict the graft  202  in a deployed position. With or without occluders, the graft  202  is constructed with two or more loop members  216  (or other suitable attachment elements) at the proximal end  210  thereof. To deploy the delivery system  200 , the strings  208  are temporarily threaded through the loop members  216  and through the eyelet  206  of the guide wire  204 . Both the strings  208  and the guide wire  204  are placed internally through the graft  202  and out the distal end  212  of graft  202 . Either prior to or after the foregoing threading procedure, the graft  202  is inserted into a proximal end  218  of a very thin-walled sheath introducer  219  by radially compressing the stents  214  (if present). The graft  202  will remain seated in the sheath introducer  219  by virtue of the radial outward force imparted by the stents  214 . As such, the sheath introducer  219  should be made of a material that is capable of resisting the expansive pressure of the compressed stents  214 , yet should also have good bending compliance. Contemplated materials include very thin-walled polypropylene or polyethylene sheet stock e.g. having a thickness of about 1-5 mil. which will act as an outer skin-like barrier and stent retainer for the graft until placement. This arrangement is shown in FIG. 8 a.    
     After the delivery system  200  is readied for deployment in the above-described manner, the proximal end  207  of the guide wire  204  is inserted into the femoral artery. It is advanced to the descending aorta, around the aortic arch, and then to the ascending aorta where the eyelet  206  of the guide wire  204  is positioned using an imaging device, such as an image amplifier, such that the proximal end  207  enters the aortic valve. The attached strings  208  are allowed to continuously pass through the loop members  216  of the graft  202  so that the graft  202  and the sheath introducer  219  remain in a stable position outside of the body during insertion and positioning of the guide wire  204  in the ascending aorta. With the guide wire  204  in position, the sheath introducer  219  with the graft  202  installed therein is inserted into the femoral artery. The guide wire  204  is held in constant position as the strings  208  are pulled. This movement of the strings  208  causes the sheath introducer  201  and the graft  202  to be hoisted towards the eyelet  206  of the guide wire  204 . This moves the sheath introducer  219  and the graft  202  through the femoral artery, up to the descending aorta, around the aortic arch, and into the ascending aorta, until they are properly positioned. The sheath introducer  219  is then separated from the graft  202  and removed by pulling on its distal end while holding the strings  208  to keep the graft  202  in position. As the sheath introducer  219  is removed, the graft  202  is revealed, thus allowing stents  214  (if present) to expand and secure the graft  202  in position. After the sheath introducer  201  is completely removed, the strings  208  are detached from the loop members  203  of the graft  202  and the eyelet  206  of the guide wire  204  by pulling one end of each string until the opposing end is fully withdrawn from the body. After the strings  208  are removed, the guide wire  204  is also removed from the body. 
     FIG. 8 b  shows how the delivery system  200  in FIG. 8 a  can be used with an alternate aortic arch graft  251  and without a sheath introducer  219 . The alternate graft  251  includes multiple loop members  252  placed around the outside of the graft and positioned near the center of expandable stents  254 . Before deployment of the graft  251  in a body, the stents  254  are wrapped tightly by stent retaining members such as filament/strings  256 , causing them to compress. Other stent retaining members, such as springs, could also be used. With the stents  254  in a compressed state, the filament/strings  256  are tied in a releasable slipknot  258  or the like, with its remaining length running along the outside of graft  251 . The graft  251  is positioned in the aortic arch using the hoisting method as described above in FIG. 8 a . The stents  254  are released by pulling one end of the filament/strings  256  until the slipknot  258  is released, thus allowing the stents  254  to expand. The filament/strings are then detached from the loop members  252  by pulling one end of each string until the opposing end is fully withdrawn from the body. 
     As previously stated, FIGS. 9 a  and  9   b  show how a modified version  220  of the aortic arch graft  20  of FIG. 3 a  can be deployed using the delivery system  200 . The modification refers to the fact that the modified version  220  has loop members on its proximal end for hoisting. It should be noted that the guide wire  204  and the strings  208  could also be used to hoist a stentless version of the graft  202  with or without the use of the sheath introducer  219 . In that case, stents would be inserted to secure the graft following its deployment in the aortic arch region. 
     Turning to FIGS. 10 and 11, an exemplary occluder  300  is shown for use with a tubular aortic arch graft  302  that has no integral occluders. The occluder  300  has a tubular shape when in its expanded state and is capable of being folded or twisted for loading into a sheath introducer, such as the introducer  42  (or  58 ) of FIGS. 4 a  and  4   b . The occluder  300  can be constructed of a suitable stent graft material, such as dacron. As shown in FIG. 10, the occluder  300  has a first closed (proximal) end  304  and a second closed (distal) end  305 , with each end having a stent  308  secured thereto by sewing or the like. Alternatively, a single stent could be used. The occluders  300  are of a size to adequately block blood flow through an aortic arch artery when positioned therein. The occluder  300  further includes one or more (two are shown) integral anchor members  310 , such as spikes, at one end thereof. The anchor members  310  are preferably sized to be long enough to enter the wall of an artery without piercing through the wall. FIG. 11 shows the positioned graft  302  in an aortic arch and three occluders  300  with anchor members  310  respectively positioned in the right innominate artery  314 , the left carotid artery  316  and the left subclavian artery  318 . The anchor members  310  are located at the proximal ends  304  of the occluders  300  and are anchored in the arterial walls  325 . The occluders  300  may be introduced and properly positioned in accordance with a delivery system as seen in FIGS. 4 a  or  4   b , using carotid and subclavian approaches. Note that the three occluders  300  and the graft  302  shown in FIGS. 10 and 11 can be provided in kit form for use by a medical practitioner to exclude an aortic arch aneurysm. The kit could further include a sheath introducer as shown in FIGS. 4 a  or  4   b.    
     C. Branched Aortic Arch Graft 
     As indicated, one solution to the aortic arch repair problem is to implant a branched aortic arch graft without cutting off blood supply to the arteries leading from the aortic branches. Preferably, to avoid possible complications associated with deploying a branch using a carotid approach, the graft will only have two branches, one for the right innominate artery and the other for the left subclavian artery. As such, the left common carotid artery will be blocked from blood supply. Therefore, a carotid-subclavian bypass procedure and an occlusion of the left common carotid artery proximate to the aortic arch must be done to reintroduce blood flow to the left common carotid artery prior to graft introduction, as shown in FIG.  12 . The entire exclusion operation, including bypass and graft deployment procedure, can be implemented by two teams of surgeons. A first surgical team performs a left carotid-subclavian bypass, in which a bypass graft  402  is placed between the left carotid artery  406  and the left subclavian artery  422 . This is followed by an occlusion of the left common carotid artery  406  proximate to an aortic arch  408  by tying  410  or use of an occluder (see FIG.  10 ). A second surgical team exposes a femoral artery (not shown in FIG. 12) and a right brachial artery  430  and a left brachial artery  431  (see FIG.  13 ). The second surgical team introduces a guide wire  414   a  through a femoral artery, to the descending aorta  418 , and around the aortic arch to the ascending aorta  419 . Similar procedures are performed relative to the two non-occluded aortic branches. Guide wire  414   b  is introduced through a femoral artery to the descending aorta  418 , to the right innominate/right subclavian artery  420  and to the opening previously exposed in the right brachial artery  430 . A guide wire  414   c  is introduced through a femoral artery to the descending aorta  418 , to the left subclavian artery  422 , and to the opening previously exposed in the left brachial artery  431 . The second surgical team introduces deployments members such as strings/filaments  415  through the body to the openings in the right and left brachial arteries  430  and  431  using the same procedure as described above for the guide wires  414   b  and  414   c . The guide wires  414   a-c  and strings/filaments  415  may all then be passed through a sheath introducer  460  so that the strings/filaments  415  can be attached to corresponding parts of a branched aortic arch graft  440  and the guide wires  14   a-c  can be used to guide the delivery system with the graft, as will now be described. 
     Turning to FIG. 13, a branched aortic arch graft  440  is shown with a delivery system  442  for positioning the graft  440 . As indicated above, the graft  440  is constructed with two branches  444 , one for the right innominate artery the other for the left subclavian artery. The graft may also have loop members  447  at a proximal end  450 . The loop members  447  may be closed or partially open such that deployment members, such as strings/filaments  452  may be threaded or otherwise attached for the purpose of closing the proximal end  450  during graft deployment, as described below. The branches  444  each have an open ends  448 . The end  448  may have loop members  447  mounted thereon so that strings/filaments  415  may be threaded or otherwise attached for the purpose of closing the open ends  448  during graft deployment. The delivery system  442  comprises a sheath introducer  460  and a catheter  462 . The catheter  462  includes a tip  464  and first and second proximal expandable portions  466  and  468 . 
     With reference now to FIGS. 14 a ,  14   b , and  14   c , loading of the graft  440  into the sheath introducer  460  is shown. First, the guide wires  414   a-c  and the strings  415  are passed through a sheath introducer  460  (see FIG. 14 c ). Next, a non-self deploying stent  469  is placed around the second proximal expandable portion  468  of the catheter  462  as seen in FIG. 14 a . FIG. 14 b  shows the guide wires  414   b  and  414   c  from the brachial arteries placed through the open ends  448  of the branches  444  of the graft  440 . FIG. 14 b  also shows the guide wire  414   a  from the ascending aorta being passed through the tip  464  of catheter. Next, the strings/filaments  415  are threaded through the loop members  447  at the distal ends of the branches  444  of the graft  440  and secured (e.g. with a releasable slipknot), and a string/filament  452  is threaded through the loop members  447  at the proximal end of the graft  440 . The graft  440  is then placed over the catheter  462  until its proximal end reaches the first proximal expandable portion  466 . FIG. 14 c  shows the next step where the string/filament  452  is pulled tightening the proximal end of the graft  440  around the proximal expandable portion  466  of the catheter  462 . As shown in FIG. 14 c , the catheter  462  and the graft  440  are then slid into the sheath introducer  460  until the catheter tip  464  reaches the proximal end of the sheath introducer  460 . 
     FIG. 15 shows the sheath introducer  460 , loaded as depicted in FIG. 14 c  following advancement into the aortic arch  408 . This can be done in the manner described above by inserting the loaded sheath introducer  460  into the open femoral artery, passing it through the descending aorta  418 , and then around the aortic arch  408  into the ascending aorta  419 . 
     Turning to FIG.  16  and FIG. 17, the graft  440  is extracted from the sheath  460 . Note that the first proximal expandable portion  466  of the catheter  462  is expanded tightly against the proximal end of the graft  440 , which is closed by maintaining tension on the string/filament  452  threaded through the loop members  447 . The graft  440  is pushed out of the sheath introducer  460  and into the ascending aorta  419  by proximally advancing the catheter  462  relative to the sheath introducer  460 . When the graft  440  is in a desired position, the string/filament  452  is released and the first proximal expandable portion  466  of the catheter  462  is expanded until the graft  440  is tight against an arterial wall. This temporarily secures the graft  440  as the sheath introducer  460  is pulled down the descending aorta  418  until the graft  440  is fully exposed. Next, each branch  444  of the graft  440  is positioned into their respective aortic branch by pulling on the distal ends of the strings/filaments  415  threaded through the loop members  447  of the branch  444 . 
     As shown in FIG. 18, with the graft  440  in position, the first proximal expandable portion  466  of the catheter  462  is deflated. The catheter  462  is pushed further until the second most proximal expandable portion  468  of the catheter  462  with the stent  469  is positioned at the end of the proximal end of the graft  440 . The second proximal expandable portion  468  is then expanded, causing the stent  469  to open and secure the proximal end of the graft  440 . The stent  469  may also be self-releasing, expanding as it is released from the sheath introducer  460 . The branches  444  of the graft  440  are then secured in their respective aortic branches and the distal end  477  of the graft  440  in similar fashion as will now be described. 
     With reference to FIGS. 18 and 19, the branches of the graft are deployed using the same procedure as described above for the main body of the graft. The guide wires  414   b  and  414   c  are each passed through the catheter tip  503  of a respective delivery system  502 . One of delivery systems  502  is then inserted into the open right brachial artery until it reaches the branch  444   a  of the graft  440  in a right innominate artery. The other delivery system  502  is inserted into the open left brachial artery until it reaches the branch  444   b  of the graft  440  in a left subclavian artery. Catheters  504  are pushed until the second most proximal expandable portions  505  thereof, each carrying a stent  508 , are respectively positioned at the distal end of the branches  444   a  and  444   b . The second proximal expandable portions  505  of each catheter  504  are then expanded causing the stents  508  to open and secure the respective distal end of the branches  444   a  and  444   b . The delivery systems  502  are then removed from the body. Then, with the graft  440  secured by stents  469  and  508 , the sheath introducer  460  is removed from the body, along with the strings/filaments  415  and  452 , and the guide wires  414  by pulling on the distal ends. 
     Accordingly, a system and method for exclusion of an aneurysm of the ascending/descending aorta and/or the aortic arch have been disclosed. While various embodiments of the invention have been shown and described, it should be apparent that many variations and alternative embodiments could be implemented in accordance with the teachings herein. It is understood, therefore, that the invention is not to be in any way limited except in accordance with the spirit of the appended claims and their equivalents.

Technology Classification (CPC): 0