Abstract:
A prosthesis, introducer device and a method for repair of an aortic aneurysm which is positioned at least partially in the ascending aorta ( 62 ). The prosthesis ( 3 ) has a proximal end ( 15 ) and a distal end ( 5 ) and is formed from a biocompatible material, the proximal end is adapted to be surgically fastened adjacent and around the aortic heart valve ( 60 ) of a patient and the distal end is adapted to extend into the descending aorta ( 66 ). The distal end has a distally extending exposed self-expanding stent ( 9 ). The introducer device can be deployed through an incision ( 75 ) in the thoracic arch ( 64 ) and extend down the descending aorta to place the distal end of the prosthesis first and then removed so that the proximal end of the prosthesis can be sutured in place around the aortic heart valve ( 60 ).

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims priority of provisional application Serial No. 60/430,821, filed Dec. 4, 2002. 
     
    
     
       TECHNICAL FIELD  
         [0002]    This invention relates to a device and method for treating the thoracic aorta of a patient.  
         BACKGROUND OF THE INVENTION  
         [0003]    Endovascular methods have been proposed for treatment of aneurysm of the aorta particularly where the aneurysm is adjacent the aorta bifurcation but when an aneurysm occurs higher up in the aorta, in the region of the descending aorta adjacent the thoracic arch or in the ascending aorta, endovascular techniques for treating these aneurysms are somewhat more difficult because of the arched nature of the thoracic arch, the occurrence of major arteries in the region and the proximity to the heart.  
           [0004]    Generally operations to treat aneurisms of the aorta in this region have been done by open chest surgery by surgical replacement of the aorta with a tubular prosthesis. It is proposed in this invention to use a combination of open chest surgery and endovascular deployment to deploy a prosthesis to treat aneurysms and the like in the thoracic arch area of the aorta.  
           [0005]    For this purpose a particular construction of prosthesis is proposed as well as a deployment device and a method and deploying the device into the aorta.  
           [0006]    Throughout this specification the term distal with respect to a portion of the aorta, a deployment device or a prosthesis is the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart and the term proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart.  
         SUMMARY OF THE INVENTION  
         [0007]    In one form the invention is said to reside in a prosthesis for repair of an aortic aneurysm which is at least partially in the ascending aorta, the prosthesis being tubular and having a proximal end and a distal end and being formed from a biocompatible material, the proximal end being adapted to be surgically fastened adjacent and around the aortic heart valve of a patient and the distal end being adapted to extend into the descending aorta, the distal end including at least one self-expanding stent.  
           [0008]    Preferably the distal end of the prosthesis has an internal self expanding stent and a further uncovered self expanding stent extending therefrom.  
           [0009]    There may be provided barbs on the uncovered self expanding stent.  
           [0010]    The tubular prosthesis may be formed from a corrugated biocompatible material and be of varying diameter depending on what portion of the aorta it is intended to be deployed into. The prosthesis may also include side branches or a portion adapted for connecting side branches where other major arteries extend from the aorta particularly in the region of the aortic arch.  
           [0011]    In a further form the invention is said to reside in a deployment device for an aortic prosthesis adapted to repair an aneurysm at least partially within the ascending aorta, the prosthesis being as described above, the deployment device including a central catheter extending from a proximal end to a distal end, the proximal end being adapted to remain outside a patient and the distal end being adapted to be inserted into the descending aorta of a patient, a nose cone on the distal end of the central catheter, the nose cone including means to retain the distal end of the prosthesis with the assistance of a trigger wire, and a deployment catheter coaxially around the central catheter and slidable longitudinally with respect to the central catheter and means to lock the movement of the deployment catheter with respect to the central catheter, the deployment catheter extending from adjacent the nose cone to a position which in use is outside the patient.  
           [0012]    Preferably the deployment device further includes a manipulator sheath coaxially around the deployment catheter and slidable therealong, the manipulator sheath including a fixing boss at a distal end thereof adapted to retain the proximal end of the prosthesis and a grip at a proximal end thereof which is adapted to remain outside the patient in use, the grip being provided to enable manipulation of the manipulation sheath with respect to the deployment catheter.  
           [0013]    The trigger wire arrangement may include a first and second trigger wire system and be adapted to retain the distal end of the prosthesis to the deployment catheter and the external stent within the nose cone of the deployment device.  
           [0014]    The first trigger wire system may also be adapted to retain the internal self-expanding stent in a retracted position about the deployment catheter.  
           [0015]    The second trigger wire system is adapted to prevent movement of the distal end of the prosthesis with respect to the deployment catheter so that while removing the nose cone from the external stent the prosthesis as a whole does not move distally. There is a problem that the barbs could catch within the nose-cone and the prosthesis be moved with the nose cone if it was not retained.  
           [0016]    Preferably the nose cone is in the form of a proximally opening capsule which is adapted to retain the uncovered stent in a contracted condition and thereby also retain the barbs within the capsule before the uncovered stent is released.  
           [0017]    Preferably the prosthesis tube is held at the distal end of the deployment device to extend back over the catheter and then is turned back inside itself to be fastened to the fixing boss on the manipulation sheath.  
           [0018]    There may be provided on the manipulator sheath and slidable therealong a proximal retainer to retain the proximal folded portion of the prosthesis. The proximal retainer may have a grip to enable manipulation of the proximal retainer. The proximal retainer may be funnel shaped and include an annular groove on its outer surface to receive a suture fastening for holding the proximal end of the graft out the retainer.  
           [0019]    The suture may extend inside the retainer so that after suturing the proximal folded portion to the aortic arch as discussed later the suture can be cut within the funnel portion to enable it to be removed.  
           [0020]    Preferably the means to lock the deployment catheter with respect to the central catheter is a pin vice.  
           [0021]    There may be means on the proximal end of the deployment catheter to retain the external end of each of the trigger wire systems and release the trigger wire as required.  
           [0022]    There may be provided a haemostatic seal between the deployment catheter and the manipulation sheath at its proximal end.  
           [0023]    In a further form the invention is said to reside in a method of deploying a prosthesis within the thoracic arch area of the aorta to repair an aortic aneurysm at least partially within the ascending aorta, the prosthesis being as discussed above and using a deployment device of the type discussed above, the method including the steps of  
           [0024]    (1) revealing the aorta and making an incision therein in the region of the aortic arch,  
           [0025]    (2) inserting the deployment device into the incision and extending the deployment device into the descending aorta to a required distance,  
           [0026]    (3) surgically joining the prosthesis intermediate its ends circumferentially to the aorta distally adjacent of the incision,  
           [0027]    (4) releasing the distal end of the prosthesis to enable it to engage with the wall of the descending aorta,  
           [0028]    (5) withdrawing the deployment device and releasing the proximal end of the prosthesis from the deployment device,  
           [0029]    (6) feeding the prosthesis into the ascending aorta through the incision and surgically fastening the proximal end of the prosthesis around the aortic heart valve and fastening the prosthesis around the branch arteries.  
           [0030]    Preferably the step of releasing the distal end of the prosthesis includes the steps of withdrawing a trigger wire to release the internal self-expanding stent while holding the external self-expanding stent within the nose cone of the deployment device, releasing the locking means and advancing the nose cone distally to release the external stent from the nose cone capsule to enable the external stent to expand so that the barbs engage the walls of the descending aorta and retracting the nose cone to the deployment catheter tip.  
           [0031]    The step of advancing the nose cone distally to release the external stent from the nose cone capsule may include the step of retaining the internal self-expanding stent during the advancing.  
           [0032]    The step of withdrawing the deployment device may include the step of moving the manipulator sheath proximally with respect to the deployment catheter.  
           [0033]    In a further form the invention id said to reside in a prosthesis mounted on a deployment device, the prosthesis being tubular and having a proximal end and a distal end and being formed from a biocompatible material, the proximal end being adapted to be surgically fastened adjacent and around the aortic heart valve of a patient and the distal end being adapted to extend into the descending aorta, the distal end including at least one self-expanding stent, the prosthesis being everted and the proximal and distal ends of the prosthesis being fastened to the distal end of the deployment device with the proximal end within the distal end and a central portion of the prosthesis extending proximally. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0034]    This then generally describes the invention but to assist with understanding reference will now be made to the accompanying drawings which show a preferred embodiment of the invention including the prosthesis, the deployment device and the method of deploying the prosthesis with the assistance of the accompanying drawings.  
         [0035]    In the drawings:  
         [0036]    [0036]FIG. 1 shows a part cross sectional view of an embodiment of an deployment device according to this invention for deploying a prosthesis into the thoracic aorta;  
         [0037]    [0037]FIG. 2 shows a schematic view of the thoracic aorta showing regions of aneurysm to be treated according to the present invention;  
         [0038]    [0038]FIG. 3 shows a first stage in the deployment of the prosthesis into the descending aorta;  
         [0039]    [0039]FIG. 4 shows the next stage in the deployment;  
         [0040]    [0040]FIG. 5 shows the next stage of deployment where the portion of the prosthesis folded back inside itself is withdrawn;  
         [0041]    [0041]FIG. 6 shows the next stage in which the distal end of the prosthesis is partially released;  
         [0042]    [0042]FIG. 7 shows the next stage in the deployment where the distal end of the prosthesis is fully released;  
         [0043]    [0043]FIG. 8 shows a still further stage with withdrawal of the trigger wire retaining the stented portion of the prosthesis;  
         [0044]    [0044]FIG. 9 shows withdrawal of the nose portion of the deployment device;  
         [0045]    [0045]FIG. 10 shows removal of the deployment device; and  
         [0046]    [0046]FIG. 11 shows the final suturing in of the prosthesis according to this invention around the aortic valve and the branching arteries. 
     
    
     DETAILED DESCRIPTION  
       [0047]    Now looking more closely at the drawings and in particular FIG. 1 it will be seen that the deployment device  1  has a prosthesis generally shown as  3  mounted onto it. The prosthesis  3  is of generally corrugated form and formed from a biocompatible material. The distal end  5  of the prosthesis has an internal zig-zag stent  7  and a distally extending external stent  9 . The external stent  9  has barbs  11  on it but when the prosthesis  3  is loaded onto the deployment device  1  the barbs  11  are contained within nose cone  22  of the deployment device as will be discussed below.  
         [0048]    A central portion  13  of the prosthesis  3  extends back over the deployment device and is folded back inside itself until it is mounted at its proximal end  15  to a fixing boss  32  of the deployment device  1  by means of knotted suture  16  as will be discussed later.  
         [0049]    The deployment device  1  includes a central guide wire catheter  20  which extends from a nose cone  22  at a distal end of the deployment device to a nose cone actuator  24  at a proximal end of the device. The central catheter  20  is sufficiently flexible to be guided down the descending aorta as will be discussed later. In use, the nose cone actuator  24  is intended to remain outside the patient.  
         [0050]    Surrounding the central catheter  20  is a deployment catheter  26 . The deployment catheter  26  can be moved longitudinally with respect to the central catheter  20  and can be locked into position with respect to the central catheter by means of pin vice arrangement  28  at the proximal end of a handle  25 . The pin vice arrangement  28  and handle  25  is also intended, in use, to remain outside a patient. The handle  25  is at the proximal end of the deployment catheter  26 .  
         [0051]    Surrounding the deployment catheter  26  is a manipulator sheath  30  which extends from a proximal prosthesis end  15  fixing boss  32  to a proximal end manipulator  34 . In use the proximal end manipulator  34  is intended to remain outside a patient. The proximal end manipulator  34  includes a haemostatic seal  36  which engages against the outside of the deployment catheter  26 . The haemostatic seal  36  is intended to prevent blood loss between the deployment catheter and the manipulator sheath but also provides frictional engagement and feel between these components.  
         [0052]    At the distal end of the deployment device  1  the nose cone  22  includes a recess  40  which provides a capsule into which the external stent  9  of the prosthesis is received and which encloses the barbs  11  on the external stent  9  during deployment.  
         [0053]    After release of the pin vice arrangement  28  the nose cone actuator  24  can be moved distally to in turn move the nose cone  22  distally to release the external stent  9  as will be discussed later.  
         [0054]    A first trigger wire arrangement is provided to retain the external stent within the nose cone and to hold the internal zig-zag stent in a compressed condition during deployment.  
         [0055]    The first trigger wire  44  extends from a trigger wire boss  42  which is mounted onto the handle  25  at the proximal end of the deployment catheter and which in use remains external of the patient to the distal end of the deployment device between the central catheter  20  and the deployment catheter  26  in the lumen of the deployment catheter. Towards the distal end of the deployment device  1  the first trigger wire  44  extends out through a side aperture  46  in the deployment catheter to engage and to retain the internal stent  7  in a retracted condition. This may be done with the assistance of a suture or mooring loop  44  which holds the internal stent in a contracted condition. The suture or mooring loop  44  may remain with the internal stent after deployment or remain with the deployment device.  
         [0056]    After the trigger wire  44  engages the internal stent it re-enters a further aperture  48  in the deployment catheter and then extends further distally out of the distal end of the prosthesis  5  and into an aperture  41  in the nose cone  22  to exit the nose cone  22  and re-enter through aperture  43  to engage with the external stent  9  and then exit out a further aperture  52  in the nose cone. The aperture  52  retains the distal end of the trigger wire and prevents it fouling with other objects during deployment.  
         [0057]    When the thumb screw  54  in the trigger boss  42  is released the trigger boss  42  can be completely withdrawn which in turns pulls the trigger wire  44  so that it no longer engages the external stent  9  and the internal stent  7 . The external stent, however, is still retained within the recess  40  in the nose cone  22  until such time as this is moved distally as will be discussed below and with respect to the drawings showing the various stages of deployment.  
         [0058]    A second trigger wire arrangement is provided to retain the internal stent  7  with respect to the deployment catheter during movement of the nose cone  22 .  
         [0059]    The trigger wire  31  extends from a trigger wire boss  33  which in use remains external of the patient to the distal end of the deployment device between the central catheter  20  and the deployment catheter  26  in the lumen of the deployment catheter. Towards the distal end of the deployment, the catheter trigger wire  31  extends out through a side aperture  35  in the deployment catheter to engage and to retain the internal stent  7 .  
         [0060]    After the trigger wire  31  engages the internal stent  7  it re-enters a further aperture  37  in the deployment catheter.  
         [0061]    When the thumb screw  39  in the trigger boss  33  is released the trigger wire boss  33  can be completely withdrawn which in turns pulls the trigger wire  31  so that it no longer engages the external stent as will be discussed with respect to the drawings showing the various stages of deployment.  
         [0062]    A proximal retainer  45  for the prosthesis is mounted coaxially on the manipulator sheath  30  and has a grip  47 . The proximal end  51  of the folded prosthesis  13  is retained onto the proximal retainer  45  by means of a loop of suture  49 . The proximal retention allows for control of the proximal end of the sheath during deployment as will be discussed later.  
         [0063]    [0063]FIG. 2 shows a schematic view of the thoracic arch region of an aorta of a patient. The aorta extends from an aortic valve  60  of a patient via the ascending aorta  62  to the thoracic arch  64  before proceeding down the descending aorta  66 . An aneurysm  68  has been depicted in the ascending aorta as well as adjacent the thoracic arch  64  in the descending aorta. In the arch region  64  major arteries, the innominate artery  69 , the left common carotid artery  70  and the subclavian artery  72  exit from the aorta. Any deployment of a prosthesis into the aorta must allow blood to still get to these arteries.  
         [0064]    As can be seen in FIG. 3 an incision  75  has been made in the side of the thoracic arch  64  of the aorta and the deployment device  1  with the prosthesis mounted onto it has been inserted so that it extends down the descending aorta  66 . The deployment device has been deployed to the extent that the nose cone  22  is well past the aneurysm region  68 . The central portion of the prosthesis  13  extends back along the deployment device  1  so that it is still visible in the incision  75 . The central portion  13  is then fastened circumferentially to the aortic arch as is shown in FIG. 4 just distally of the subclavian artery  72 . The prosthesis is sutured or stapled or otherwise fastened completely around its circumference at this point to the wall of the aorta. The proximal retainer  45  assists in holding the proximal end  51  of the folded prosthesis during this fastening.  
         [0065]    In the next stage the suture  49  is cut and the grip  47  is moved distally to remove the proximal retainer  45 .  
         [0066]    The prosthesis can then be straightened out by pulling on the proximal end manipulator  34  while holding the handle  25  stationary so that the manipulator sheath  30  withdraws the fixing boss  32  until the position shown in FIG. 5 is attained.  
         [0067]    In the next stage the first trigger wire boss  42  is completely removed from the handle  25  by releasing the thumb screw  54  and withdrawing the trigger wire boss  42  over the nose cone actuator  24 . By this means, trigger wire  44  is removed completely from the nose cone  22  and from retaining the external and internal stents  9 ,  7 . At this stage then as shown in FIG. 6 it will be seen that the internal stent  7  has partially expanded but that the external stent  9  is still retained within the nose cone  22 .  
         [0068]    In the next stage as shown in FIG. 7 the pin vice  28  is released and the nose cone activator  24  advanced distally so that by moving the catheter  20  fixed to the activator  24  the nose cone  22  moves distally and releases the external stent  9  from the recess  40  which enables the external stent  9  to expand to the wall of the descending aorta  66  and the barbs  11  to engage into the wall of the aorta to hold the distal ends of the prosthesis  3  in the descending aorta.  
         [0069]    At this stage the internal stent  7  is retained by the trigger wire  31 . This prevents the prosthesis moving distally while the nose cone is being moved distally.  
         [0070]    Next the second trigger wire boss  33  is completely removed from the handle  25  by releasing the thumb screw  39  and withdrawing the trigger wire boss  33  over the nose cone actuator  24 . By this means, trigger wire  31  is removed completely and the internal stent  7  can fully expand to engage the wall of the aorta. This is shown in FIG. 8.  
         [0071]    The nose cone  22  and catheter  20  and deployment device  1  are then retracted towards the fixing boss  32  as shown in FIG. 9 leaving part of the prosthesis deployed in the descending aorta from the central portion  13  sutured into the aortic arch down to the distal end  5  of the prosthesis  3  retained by the internal stent  7  and external stent  9  and barbs  11 .  
         [0072]    At this stage of the withdrawal the end  15  of the prosthesis  3  fastened to the graft fixing boss  32  is exposed and the fastening  16  which fastens the graft end  15  to the fixing boss  32  is removed and the deployment device is completely removed from the prosthesis  3  as shown in FIG. 10.  
         [0073]    In the next stage of the procedure the proximal end  15  of the prosthesis  3  is fed back into the incision  75  in the aortic arch and directed down the ascending aorta towards the aortic valve  60 . The proximal end of the graft  15  is then sutured circumferentially at  80  around the aortic valve  60  so that blood can flow out of the valve and into the prosthesis end  15 .  
         [0074]    In the region of the branching arteries an incision  82  is made in the side of the prosthesis  3  and the prosthesis  3  is sutured around the branch arteries so the blood can flow into them as well. The incision  75  is then closed up as shown in FIG. 11 and the chest cavity closed.  
         [0075]    Throughout this specification, various indications have been given as to the scope of the invention but the invention is not limited to any one of these but may reside in two or more of these combined together. The examples are given for illustration and not for limitation.