Abstract:
A stent graft introducer for intraluminal deployment of a stent graft ( 26 ), the introducer comprising a stent graft release mechanism ( 6 ) to allow partial release of the stent graft ( 26 ) when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft from at least one end of the stent graft. The partial release can comprise partial release of one end of the stent graft.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority of provisional application Ser. No. 60/580,161, filed Jun. 16, 2004, and provisional application Ser. No. 60/679,305 filed May 10, 2005. 
    
    
     TECHNICAL FIELD 
     This invention relates to a medical device and more particularly to a medical device for the introduction of a stent graft into a human or animal body. 
     BACKGROUND OF THE INVENTION 
     This invention will be generally discussed in relation to deployment of stent grafts into the aorta but it is not so limited and can be applied to other vasculature or other body lumens. 
     The introduction of endovascular techniques for the placement of stent grafts into the vascular of human or animal patient has revolutionized the treatment of vascular diseases. As treatment techniques have improved there is a requirement for deployment devices which can provide a physician with more flexibility and control in placement of stent grafts. 
     The object of this invention is to provide an introducer for a stent graft which will give a physician more control or at least provide the physician with a useful alternative. 
     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. When applied to other vessels similar terms such as caudal and cranial should be understood. 
     Throughout this discussion the term “stent graft” is intended to mean a device which has a tubular body of biocompatible graft material and at least one stent fastened to the tubular body to define a lumen through the stent graft. The stent graft may be bifurcated and have fenestrations, side arms or the like. Other arrangements of stent grafts are also within the scope of the invention. 
     SUMMARY OF THE INVENTION 
     In one form, the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, the introducer comprising a stent graft retention and release mechanism to allow selective release of each end of the stent graft when carried on the introducer, an indwelling catheter extending from a distal end of the introducer to a proximal end of the introducer and passing through the stent graft when retained on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft by use of the indwelling catheter. 
     Preferably the release mechanism includes a fastening between the stent graft and introducer at both proximal and distal ends of a stent graft retained on the introducer. 
     The stent graft introducer may have a sheath surrounding the deployment catheter and preferably the sheath is a highly flexible sheath. 
     In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, an introducer having: 
     a guide wire catheter extending from a proximal to a distal end, 
     a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end and a longitudinal groove therein, 
     a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter, 
     a first retention arrangement at the proximal end of the deployment catheter to retain the distal end of a stent graft thereon, 
     a second retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon, 
     a release arrangement associated with the handle to separately release the first retention arrangement and the second retention arrangement, and 
     an indwelling catheter extending from the handle to the groove in the nose cone dilator. 
     Preferably, each release arrangement includes a trigger wire extending from the retention arrangement to a respective trigger wire grip on the handle, and the trigger wire grips are arranged on the handle so that they can only be released in a selected order. 
     In a preferred form of the invention the stent graft has a distally extending exposed stent and the first retention arrangement for the distal end of the stent graft includes a capsule covering the exposed stent and acting as the first retention arrangement and a trigger wire associated with the capsule which prevents the exposed stent from being released from the capsule until the trigger wire has been removed as discussed earlier. 
     There can be further diameter reducing ties associated with the stent graft when retained on the introducer and the handle including a release arrangement for the diameter reducing ties. The diameter reducing ties comprise loops of suture or other thread material which extend around part of the periphery of the stent graft and are located by a trigger wire and are tightened to reduce the circumference of the stent graft. When released, the stent graft can expand to its full diameter. 
     In a preferred form the stent graft has at least one fenestration such that when the stent graft is deployed in the body lumen such as an aorta fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen. For instance in the case of a stent graft deployed in the aorta of a patient then the fenestration may allow access to the renal, mesenteric or coeliac axis arteries. In the case of a stent graft deployed into the descending aorta the fenestration may be at or adjacent the distal end of the stent graft to allow access to a branch artery. The indwelling catheter would allow access from the thoracic arch such as by a brachial or carotid access. Such a fenestration may be in the form of a scallop at the distal end of the stent graft or may be an aperture in the body of the stent graft. The aperture may be reinforced with a resilient wire ring around its periphery. When the stent graft has been at least partially released the resilient wire ring will cause the fenestration to open to assist with access through the fenestration. 
     Preferably the introducer further comprises an indwelling catheter extending from a distal end of the introducer to a proximal end of the introducer and passing through the stent graft when retained on the introducer. Preferably the indwelling catheter extends through the deployment catheter to the nose cone dilator to be received in the groove therein. Preferably the indwelling catheter extends through the fenestration. 
     In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, an introducer having: 
     a guide wire catheter extending from a proximal to a distal end, 
     a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end, 
     a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter, 
     a distal retention arrangement a the proximal end of the deployment catheter to retain the distal end of a stent graft thereon and an associated distal release arrangement, 
     a proximal retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon and an associated proximal release arrangement, the proximal retention arrangement including multiple fastenings between the stent graft and the release mechanism, 
     a first release arrangement associated with the handle to release the distal retention arrangements, 
     a second release arrangement associated with the handle to release the proximal fastenings, 
     each release arrangement including a trigger wire extending from the respective retention arrangement to a trigger wire grip on the handle, 
     the trigger wire grips being arranged on the handle so that they can only be released in a selected order. 
     There can be further diameter reducing ties associated with the stent graft when retained on the introducer and the handle including a release arrangement for diameter reducing ties on the stent graft. 
     In a preferred form of the invention the stent graft has a distally extending exposed stent and the distal retention arrangement includes a capsule to cover the exposed stent and the distal release arrangement includes means to withdraw the capsule from the exposed stent. There can be further included a capsule trigger wire associated with the capsule which engages with the exposed stent within the capsule and prevents the capsule from being removed from the exposed stent until the capsule trigger wire has been removed and there is a respective trigger wire grip on the handle. 
     In a preferred form the stent graft has at least one fenestration at a distal end thereof such that when the stent graft is deployed in the body lumen, such as an aorta, fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen. For instance, in the case of a stent graft deployed in the aorta of a patient then the fenestration may allow access to the renal, mesenteric or coeliac axis arteries. 
     The fenestration may be an aperture through the wall of the stent graft or may be a cut out in an end of the stent graft. 
     The stent graft may comprise a tubular body of a biocompatible graft material and a plurality of stents to define in use a lumen through the stent graft. 
     In an alternative form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, the introducer comprising a stent graft release mechanism to allow partial release of at least one end of the stent graft when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft through the partially released at least one end of the stent graft. 
     Preferably the release mechanism includes a fastening between the stent graft and introducer at both proximal and distal ends of a stent graft retained on the introducer and the partial release releases at least part of the fastening at either the proximal or distal end. 
     Preferably the partial release is only a part of the total fastening at either the proximal or distal end and hence because there is still some retention at both the proximal and distal ends of the stent graft, control of the positioning of the stent graft within a body lumen is still possible. 
     In a preferred embodiment retention of either the proximal or distal ends of the stent graft includes at least three fastenings between the stent graft and a release mechanism with the fastening spaced around the periphery of the stent graft and the partial release releases at one of these at least three fastenings thereby releasing part of the end of the stent graft to allow the access as discussed above. 
     In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, the introducer having proximal and distal stent graft release mechanisms, the proximal release mechanism having at least two fastenings between the stent graft and at least two release mechanisms for the fastenings at the proximal end to allow partial release of part of the proximal end of the stent graft when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft from the partially released proximal end of the stent graft. 
     In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, an introducer comprising: 
     a guide wire catheter extending from a proximal to a distal end, 
     a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end, 
     a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter, 
     a first retention arrangement at the proximal end of the deployment catheter to retain the distal end of a stent graft thereon, 
     a second retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon, 
     a release arrangement associated with the handle to separately release the first retention arrangement and the second retention arrangement, 
     either the first or the second retention arrangement including multiple fastenings between the stent graft and the release mechanism and wherein one of the multiple fastenings can be released independently of the others of the multiple fastenings, 
     a stent graft retained on the introducer, the stent graft comprising at least one fenestration whereby when the stent graft is deployed in a body lumen fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen through the fenestration, 
     an indwelling catheter extending from a distal end of the introducer through the deployment catheter to a proximal end of the stent graft when retained on the introducer, 
     and the indwelling catheter extending through the fenestration. 
     In one embodiment the fenestration comprises a scallop at the distal end of the stent graft. Alternatively the fenestration is an aperture in the body of the stent graft and being reinforced with a resilient wire ring around its periphery. 
     The graft material may be a woven or non-woven fabric such as Dacron or may be a polymeric material such as expandable PTFE. The graft material may alternatively be a naturally occurring biomaterial, such as collagen, particularly a specially derived collagen material known as an extracellular collagen matrix (ECM), such as small intestinal submucosa (SIS) that causes remodelling of host tissue coming into contact therewith. Besides SIS, examples of ECM&#39;s include pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater. 
     The plurality of stents may be self-expanding zig zag stents or may be balloon expandable stents or other forms of stent. 
     U.S. Pat. No. 5,387,235 entitled “Expandable Transluminal Graft Prosthesis For Repair Of Aneurysm” discloses apparatus and methods of retaining grafts onto deployment devices. These features and other features disclosed in U.S. Pat. No. 5,387,235 could be used with the present invention and the disclosure of U.S. Pat. No. 5,387,235 is herewith incorporated in its entirety into this specification. 
     U.S. Pat. No. 5,720,776 entitled “Barb and Expandable Transluminal Graft Prosthesis For Repair of Aneurysm” discloses improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Pat. No. 5,720,776 could be used with the present invention and the disclosure of U.S. Pat. No. 5,720,776 is herewith incorporated in its entirety into this specification. 
     PCT Patent Publication No. WO 98/53761 entitled “A Prosthesis And A Method And Means Of Deploying A Prosthesis” discloses an introducer for a prosthesis which retains the prosthesis so that each end can be moved independently. These features and other features disclosed in PCT Patent Publication No. WO 98/53761 could be used with the present invention and the disclosure of PCT Patent Publication No. WO 98/53761 is herewith incorporated in its entirety into this specification. 
     U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262 entitled “Endoluminal Aortic Stents” disclose a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262 could be used with the present invention and the disclosure of U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262 is herewith incorporated in its entirety into this specification. 
     U.S. patent application Ser. No. 10/280,486, filed Oct. 25, 2002 and published on May 8, 2003 as U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 entitled “Prostheses For Curved Lumens” discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in U.S. patent application Ser. No. 10/280,486, and U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 could be used with the present invention and the disclosure of U.S. patent application Ser. No. 10/280,486, and U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 is herewith incorporated in its entirety into this specification. 
     U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and other features disclosed in U.S. Pat. No. 6,206,931 could be used with the present invention and the disclosure of U.S. Pat. No. 6,206,931 is herewith incorporated in its entirety into this specification. 
     U.S. Provisional Patent Application Ser. No. 60/392,682, filed Jun. 28, 2002, U.S. patent application Ser. No. 10/447,406, filed May 29, 2003, and Published on Dec. 18, 2003, as U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 entitled “Trigger Wires” disclose release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,682, U.S. patent application Ser. No. 10/447,406, and U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/392,682, U.S. patent application Ser. No. 10/447,406, and U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 is herewith incorporated in its entirety into this specification. 
     U.S. Provisional Patent Application Ser. No. 60/392,667, filed Jun. 28, 2002, and U.S. patent application Ser. No. 10/609,846, filed Jun. 30, 2003, and Published on May 20, 2004, as US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 entitled “Thoracic Deployment Device” disclose introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,667, U.S. patent application Ser. No. 10/609,846, and US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/392,667, U.S. patent application Ser. No. 10/609,846, and US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 is herewith incorporated in its entirety into this specification. 
     U.S. Provisional Patent Application Ser. No. 60/392,599, filed Jun. 28, 2002, and U.S. patent application Ser. No. 10/609,835, filed Jun. 30, 2003, entitled “Thoracic Aortic Aneurysm Stent Graft” disclose stent grafts that are useful in treating aortic aneurysms particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,599 and U.S. patent application Ser. No. 10/609,835, filed Jun. 30, 2003 could be used with the present invention, and the disclosure are herewith incorporated in their entirety into this specification. 
     U.S. Provisional Patent Application Ser. No. 60/392,599, filed Jun. 28, 2002, and U.S. patent application Ser. No. 10/609,835, filed Jun. 30, 2003, and published on Jun. 3, 2004, as U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 entitled “Thoracic Aortic Aneurysm Stent Graft” disclose stent grafts that are useful in treating aortic aneurysms particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,599, U.S. patent application Ser. No. 10/609,835, and U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 could be used with the present invention, and the disclosure of U.S. Provisional Patent Application Ser. No. 60/392,599, U.S. patent application Ser. No. 10/609,835, and U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 is herewith incorporated in its entirety into this specification. 
     U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003, and published on Apr. 15, 2004, as U.S. Patent Application Publication No. US-2004-0073289-A1, and PCT Patent Publication No. WO 2004/017868 entitled “Asymmetric Stent Graft Attachment” disclose retention arrangements for retaining onto and releasing prostheses from introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003, and U.S. Patent Application Publication No. US-2004-0073289-A1, and PCT Patent Publication No. WO 2004/017868 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003, and U.S. Patent Application Publication No. US-2004-0073289-A1, and PCT Patent Publication No. WO 2004/017868 is herewith incorporated in its entirety into this specification. 
     U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 and published as U.S. Patent Application Publication No. U.S. 2003-0120332, and PCT Patent Publication No. WO 03/053287 entitled “Stent Graft With Improved Adhesion” disclose arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 and published as U.S. Patent Application Publication No. U.S. 2003-0120332, and PCT Patent Publication No. WO 03/053287 could be used with the present invention and the disclosure of U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 and published as U.S. Patent Application Publication No. U.S. 2003-0120332, and PCT Patent Publication No. WO 03/053287 is herewith incorporated in its entirety into this specification. 
     U.S. Provisional Patent Application Ser. No. 60/405,769, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/645,095, filed Aug. 23, 2003, and published on Apr. 29, 2004, as U.S. Patent Application Publication No. US-2004-0082990-A1, and PCT Patent Publication No. WO 2004/017867 entitled “Composite Prostheses” discloses prostheses or stent grafts suitable for endoluminal deployment. These prostheses and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/405,769, U.S. patent application Ser. No. 10/645,095, and U.S. Patent Application Publication No. US-2004-0082990-A1, and PCT Patent Publication No. WO 2004/017867 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/405,769, U.S. patent application Ser. No. 10/645,095, and U.S. Patent Application Publication No. US-2004-0082990-A1, and PCT Patent Publication No. WO 2004/017867 is herewith incorporated in its entirety into this specification. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       This then generally describes the invention but to assist with understanding reference will now be made to the accompanying drawings which show preferred embodiments of the invention. 
       In the drawings: 
         FIG. 1  shows a general view of a deployment device according to one embodiment of the invention; 
         FIG. 2  shows a longitudinal cut-away view of the embodiment shown in  FIG. 1  but with the device rotated through 90 degrees on a longitudinal axis; 
         FIG. 3  shows part of the deployment device as shown in  FIG. 1  after a first stage of deployment and with a fenestrated stent graft retained thereon; 
         FIG. 3A  shows the same view as  FIG. 3  except that it shows the other side of the stent graft and deployment device; 
         FIG. 4  shows part of the deployment device as shown in  FIG. 1  with an alternative stent graft retained thereon with a scalloped fenestration and an apertured fenestration; 
         FIG. 5  shows a longitudinal cross sectional view showing detail of the sliding handle mechanism of the deployment device of  FIG. 1 ; 
         FIG. 6  shows a similar view to that of  FIG. 5  except that the handle has been retracted; 
         FIG. 7  shows a detailed view of one embodiment of proximal fastening arrangement for a stent graft onto the deployment device of  FIG. 1 ; 
         FIG. 8  shows a cross sectional view along the line  8 - 8 ′ in  FIG. 7 ; 
         FIG. 9  shows a detailed view of one embodiment of a distal retention arrangement for a stent graft onto the deployment device of  FIG. 1 ; 
         FIG. 10  shows one embodiment of a stent graft suitable for use with a deployment device according to one embodiment of the invention; 
         FIG. 11  shows a longitudinal cross sectional view of the stent graft of  FIG. 10 ; 
         FIG. 12  shows a detail view of the proximal end fastenings of a stent graft onto a deployment device according to one embodiment of the invention; 
         FIG. 13  a detail view of an alternative embodiment of proximal end fastenings of a stent graft onto a deployment device according to the invention; 
         FIG. 14  shows a detail of the proximal end of a stent graft fastened onto a deployment device according to one embodiment of the invention; 
         FIG. 15  shows a detail of the proximal end of a stent graft fastened onto a deployment device according to an alternative embodiment of the invention; 
         FIG. 16  shows the detailed fastening of  FIG. 15  but with the stent graft partially released; 
         FIG. 17  shows an alternative embodiment of a stent graft with a scalloped fenestration suitable for use with a deployment device according to one embodiment of the invention; 
         FIG. 18  shows detail of an alternative embodiment of scalloped fenestration; 
         FIG. 19  shows an alternative embodiment of a stent graft with a scalloped fenestration and an apertured fenestration suitable for use with a deployment device according to the invention; 
         FIG. 20  shows a perspective view of one embodiment of stent graft mounted onto a deployment device according to the present invention; 
         FIG. 21  shows the other side of the stent graft mounted onto a deployment device shown in  FIG. 18 ; and 
         FIG. 22  shows a general view of an alternative embodiment of deployment device according to the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  shows a general view of a deployment device according to one embodiment of the invention and  FIG. 2  shows a longitudinal cut-away view of the embodiment shown in  FIG. 1  but rotated through 90 degrees on a longitudinal axis. 
     In  FIGS. 1 and 2 , it will be seen that the deployment device  1  generally consists of a guide wire catheter  2  which extends the full length of the device from a Luer lock connector  3  for a syringe at the far distal end of the device to and through a nose cone dilator  4  at the proximal end. The nose cone dilator  4  is fixed to the guide wire catheter  1  and moves with it. To lock the guide wire catheter with respect to the deployment device in general a pin vice  5  is provided. 
     Trigger wire release mechanisms generally shown as  6  on a fixed handle  10  includes three trigger wire release mechanisms as will be discussed below. The trigger wire release mechanisms  6  slide on a portion of the fixed handle  10  and hence until such time as they are activated the trigger wire mechanisms  6  which are fixed by thumbscrews  11  remain fixed with respect to the fixed portion of the fixed handle  10 . 
     The trigger wire release mechanisms generally shown as  6  includes three trigger wire mechanisms  7 ,  8  and  9  for three different stages of release of the stent graft from the deployment device. The three stages of release generally comprise:
     (1) release of the distal end of the stent graft;   (2) release of diameter reducing ties; and   (3) release of the proximal retention arrangements.   

     The trigger wire release mechanism  9  has a trigger wire  48  (see  FIG. 3A ) which extends to the capsule  21  and engages one of the loops of the exposed stent  29 . When the thumb screw  11  on the retention mechanism  9  is removed, the trigger wire mechanism  9  and trigger wire  48  can be removed and the capsule  21  can be removed from the exposed stent. 
     The trigger wire release mechanism  8  extends a trigger wire  45  (see  FIG. 3A ) to diameter reducing ties  43  on the stent graft. When the thumb screw  11  on the trigger wire mechanism  8  is removed, the trigger wire mechanism  8  and trigger wire  45  can be completely removed from the deployment device which releases the diameter reducing ties  43 . 
     The trigger wire mechanism  7  has three trigger wires  76  (see  FIG. 7 ) connected to it and when this trigger wire release mechanism  7  and trigger wires  76  are removed the proximal retention fastenings  90 ,  91  and  92  (see  FIG. 12 ) can be released to release the proximal end of the stent graft as is discussed in relation to  FIGS. 7 ,  8  and  12  to  14 . 
     Immediately proximal of the trigger wire release mechanisms  6  on the fixed handle  10  is a sliding handle mechanism generally shown as  15 . The sliding handle mechanism  15  generally includes a fixed handle extension  16  and a sliding portion  17  the sliding portion  17  slides over the fixed handle extension  16 . A thumbscrew  18  fixes the sliding portion with respect to the fixed portion. The fixed handle portion  16  is affixed to the trigger wire mechanism handle  10  by a screw threaded nut  24 . More detail of the sliding and fixed handle mechanisms is shown in  FIGS. 5 and 6 . 
     The sliding portion of the handle  17  is fixed to the deployment catheter  19  by a mounting nut  20 . The deployment catheter  19  extends through to a capsule  21  at the proximal end of the deployment catheter  19 . 
     Over and around the deployment catheter  19  is a sheath manipulator  22  and a sheath  23  which slides with respect to the deployment catheter  19  and in the ready to deploy situation extends forward to the nose cone dilator  4  to cover the stent graft  26 . The sheath  23  is preferably a highly flexible sheath. 
     In the ready to deploy condition as shown in  FIGS. 1 and 2  the sheath  23  assists in retaining the stent graft  26 , which includes self-expanding stents  26 , in a compressed condition. The proximal covered stent  27  is retained at proximal end  28  by a retention mechanism as will be discussed in detail with reference to  FIGS. 7 ,  8  and  12  to  16  and the distal exposed stent  29  on the stent graft  26  is retained within the capsule  21  on the deployment catheter  19  and by the distal retention mechanism as will be discussed in relation to  FIG. 9 . 
     An indwelling catheter  50  extends from the distal end of the deployment device along a groove  51  in the fixed handle  10  and under the trigger wire release mechanisms  7 ,  8  and  9 . As can be seen particularly in  FIG. 2  the indwelling catheter  50  then extends through an aperture  55  into the lumen between the guide wire catheter  2  and the fixed handle  10  to extend through the sliding handle mechanism as discussed below and then extends through the lumen between the guide wire catheter  2  and the deployment catheter to a further aperture  57  just distal of the capsule  21 . The indwelling catheter  50  then exits the deployment catheter  19 , passes over the capsule  21  and enters the fenestration  59  in the stent graft  26  and extends proximally through the lumen of the stent graft  26  to exit at the proximal end  28  and extend along the nose cone dilator  4  in a longitudinal groove  61  in the nose cone dilator  4 . 
     The indwelling catheter  50  has a auxiliary guide wire  53  extending through it. This auxiliary guide wire  53  can be extended through the indwelling catheter to be snared to enable trans-brachial access for placement of branch stents through the fenestrations in the stent graft. 
       FIG. 3  shows a detailed view of a portion of the deployment device shown in  FIGS. 1 and 2  after a first stage of deployment and with a fenestrated stent graft retained thereon and  FIG. 3A  shows the same view as  FIG. 3  except that it shows the other side of the stent graft and deployment device. In  FIGS. 3 and 3A  the stents on the stent graft are not shown for clarity. 
     In  FIGS. 3 and 3A  the sheath  23  has been withdrawn distally to expose the stent graft  26  and the capsule  21 . The stent graft  26  is retained on the deployment device between the nose cone dilator  4  and the deployment catheter  19 . The proximal end  28  of the stent graft  26  is retained onto the deployment device distally of the nose cone dilator  4  by a retention arrangement as discussed below. The distal exposed stent  29  is retained in the capsule  21  and is locked in place using a trigger wire  48  as will be discussed below. The indwelling catheter  50  exits the deployment catheter  19  through aperture  57 , passes over the capsule  21  and enters the fenestration  59  in the stent graft  26  and extends proximally through the lumen of the stent graft  26  to exit at the proximal end  28  and extend along the nose cone dilator  4  in a longitudinal groove  61 . 
     The other side of the stent graft  26  as shown in  FIG. 3A  has a number of diameter reducing ties  43  retained by a release mechanism as will be discussed below. 
       FIG. 4  shows part of the deployment device as shown in  FIG. 1  with an alternative stent graft retained thereon with a scalloped fenestration  66  and an apertured fenestration  67 . In  FIG. 4  the stents on the stent graft are not shown for clarity. In  FIG. 4  the sheath  23  has been withdrawn to expose the stent graft  26  and the capsule  21 . In this case there are two indwelling catheters  63  and  65  with the indwelling catheter  63  extending through scalloped fenestration  66  and the indwelling catheter  65  extending through the apertured fenestration  67 . The two indwelling catheters  63  and  65  extend forward to the nose cone dilator  4  and are received in grooves  68  and  69  respectively in the nose cone dilator  4 . 
     Now looking more closely at  FIGS. 5 and 6  the detailed construction of a particular embodiment of a sliding handle mechanism according to this invention is shown.  FIG. 5  shows the sliding handle mechanism in the ready to deploy condition and  FIG. 6  shows the mechanism when the deployment catheter and hence the capsule has been withdrawn by moving the sliding handle with respect to the fixed handle. The retraction of the capsule releases the distally extending exposed stent  29  on the stent graft  26  (see  FIG. 2 ). 
     The fixed handle extension  16  is joined to the trigger wire mechanism handle  10  by screw threaded nut  24 . 
     The sliding handle  17  is fixed to the deployment catheter  19  by screw threaded fixing nut  20  so that the deployment catheter moves along with the sliding handle  17 . The sliding handle  17  fits over the fixed handle extension  16  and in the ready to deploy situation is fixed in relation to the fixed handle by locking thumbscrew  18  which engages into a recess  30  in the fixed handle extension  16 . On the opposite side of the fixed handle extension  16  is a longitudinal track  31  into which a plunger pin  32  spring loaded by means of spring  33  is engaged. At the distal end of the track  31  is a recess  34 . 
     A guide tube  35  is fixed into the proximal end of the sliding handle  17  at  36  and extends back to engage into a central lumen in the fixed handle extension  16  but able to move in the central lumen. An O ring  37  seals between the fixed handle extension  16  and guide tube  35 . This provides a hemostatic seal for the sliding handle mechanism. The trigger wire  38  which is fixed to the trigger wire releasing mechanism  8  by means of screw  39  passes through the annular recess  42  between the fixed handle extension  16  and the guide wire catheter  2  and then more proximally in the annular recess  44  between the guide wire catheter  2  and the guide tube  35  and forward to extend through the annular recess  46  between the guide wire catheter  2  and the deployment catheter  19  and continues forward to the proximal retaining arrangement. Similarly the distal trigger wire (not shown in  FIGS. 5 and 6 ) extends to the distal retaining arrangement and the diameter reducing release wire (not shown in  FIGS. 5 and 6 ) extends to the diameter reducing ties. 
     The indwelling catheter  50  extends from the distal end of the deployment device along the groove  51  in the fixed handle  10  and under the trigger wire release mechanism  8 . The indwelling catheter  50  extends through the aperture  55  into the lumen  42  between the guide wire catheter  2  and the fixed handle  10  to extend through the sliding handle mechanism. 
     A further hemostatic seal  70  is provided where the guide wire catheter  1  enters the trigger wire mechanism handle  10  and the trigger wires  38  and the indwelling catheter  50  pass through the hemostatic seal  40  to ensure a good hemostatic seal. 
     As can be seen in  FIG. 6  the locking thumbscrew  18  has been removed and discarded and the sliding handle  17  has been moved onto the fixed handle  16  and the plunger pin  32  has slid back along the track  31  to engage into the recess  34 . At this stage the sliding handle cannot be moved forward again. 
     As the trigger wire release mechanisms  7 ,  8  and  9  are on the trigger wire mechanism handle  10  which is fixed with respect to the fixed handle  16  then the proximal trigger wire  38  is not moved when the deployment catheter  19  and the sliding handle  17  is moved so that it remains in position and does not prematurely disengage. 
     In  FIGS. 7 and 8  a proximal part of the stent graft deployment device is shown and includes the guide wire catheter  2  which extends the length of the deployment device and at the proximal end of the guide wire catheter  2  is the nose cone dilator  4 . Extending back from the nose cone dilator  4  and surrounding the guide wire catheter  2  is a trigger wire guide  72 . The trigger wire guide  72  is coaxial with the guide wire catheter  2  and defines a lumen  74  between them through which, in use, pass trigger wires  76 . 
     Just distal of the nose cone dilator  4  there are apertures  78  in the trigger wire guide  72  extending into the lumen  74  and out of which apertures  78  extend the trigger wires  76  in a loop  80  so that it can engage the zig zag stents of a stent graft (see  FIG. 13 ) or sutures can be engaged around the loops  80  and into a stent graft (see  FIG. 12 ). The trigger wires  76  continue along the lumen  74  to terminate within the region of the nose cone dilator  4 . When it is desired to release the proximal end of the stent graft the trigger wires  76  are pulled out. 
       FIG. 8  shows a cross sectional view along the line  8 - 8 ′ in  FIG. 7 . It will be noted that the trigger wires  76  extend in the lumen  74  between the guide wire catheter  2  and the trigger wire guide  72 . The groove  61  in the nose cone  4  to receive the indwelling catheter  50  (see  FIG. 3 ) can be seen in this drawing. 
       FIG. 9  shows a detailed view of one embodiment of distal retention of a stent graft onto the deployment device of  FIG. 1 . In this view it will be noted that the stent graft  26  has a tubular body  80  supported by stents  25  and having a distally extending exposed stent  29 . The distally extending exposed stent  29  is received in a proximally opening capsule  21  at the proximal end of the deployment catheter  19 . A locking wire  48  extends from the trigger wire release mechanism  6  (see  FIG. 1 ) and engages a strut  29   a  of the exposed stent  29  before exiting through an aperture  49  in the capsule  21  and being passed into the lumen of the stent graft  26 . A diameter reducing tie release wire  40  passes through the lumen between the guide wire catheter  2  and the deployment catheter  19  and through the capsule  21  and extends to the stent graft  26  where it is stitched in and out of the graft material at intervals, such as at  47 , longitudinally along the graft as is shown in  FIG. 3A  and as is discussed below in relation to  FIG. 21  to engage the diameter reducing ties. The indwelling catheter  50  exits the deployment catheter  19  through aperture  57  in the deployment catheter and passes through scalloped fenestration  66  into the lumen of the stent graft  26  forward to the nose cone dilator as is discussed in relation to  FIG. 3 . 
     The capsule  21  is smaller in diameter than the deployment catheter  19  and is mounted off centre from the deployment catheter  19  so that sufficient space is provided beside the capsule on the side that the aperture  57  is in the deployment catheter  19  so that the indwelling catheter  50  can pass beside the capsule when the sheath (not shown) extends over the capsule  21 . 
       FIGS. 10 and 11  show an arrangement of a stent graft including a fenestration of the type suitable for the present invention. The stent graft  100  comprises a tubular body  102  of biocompatible graft material with a lumen  104  therethrough. The stent graft  100  has a distal end  106  and a proximal end  105 . The proximal end  105  has barbs  107  to assist with retention when the stent graft  100  is deployed into the thoracic aorta, for instance. The distal end  106  of the stent graft has distally extending exposed stent  108  and within the tubular body  102  there are proximal and distal internal stents  110  and several external stents  112  intermediate the proximal and distal ends. A fenestration  114  is provided towards the distal end  106  of the stent graft  100 . In this embodiment the fenestration  114  is in the form of an aperture. 
     Radiopaque or MRI opaque markers  116  are provided each side of the fenestration to enable visualisation of the fenestration to an accurate position with respect to a branch vessel. 
     A retention arrangement to hold the proximal end of the stent graft  26  onto the deployment device in this embodiment is a multiple retention system with multiple fastenings and is shown in detail in  FIG. 12 . At three points around the periphery of the stent graft  26 , fastenings  90 ,  91  and  92  respectively pull the material of the stent graft to fasten onto trigger wires  76 . The trigger wires  76  extend through a lumen  74  of the trigger wire guide  72  which fits around guide wire catheter  2  as discussed in relation to  FIGS. 7 and 8  back to the trigger wire release mechanism generally shown as  6  in  FIGS. 1 and 2 . 
       FIG. 13  shows a different retention arrangement in which the three points around the periphery of the stent graft  26  are directly engaged to the trigger wires  76  by the trigger wires  76  being passed through the material of the stent graft and more preferably around a bend of a stent of the stent graft as well as through the material of the stent graft. For clarity the stents are not shown in  FIG. 13 . The trigger wires extend through a lumen  74  of the trigger wire guide  72  which fits around guide wire catheter  2  as discussed in relation to  FIGS. 7 and 8  back to the trigger wire release mechanism generally shown as  6  in  FIGS. 1 and 2 . 
       FIG. 14  shows a general view of a proximal end of a stent graft  26  when retained by the mechanism as discussed above. It will be seen that there are three lobes  95  of graft material around the trigger wire guide  72  and guide wire catheter  2 . The indwelling catheter can easily pass through one of these to the groove  61  in the node cone dilator  4  (see  FIG. 3 ). 
       FIGS. 15 and 16  show an end on view of the proximal end of the stent graft  26  when mounted in an alternative manner onto a deployment device.  FIG. 15  shows detail of the stent graft tubular body  26  constricted at three places by ties  90   a ,  91   a  and  92   a . As shown in  FIG. 16  when the tie  91   a  is released by removing the trigger wire  76   a , the end of the stent graft can open up to enable entry into the lumen of the stent graft. It will be noted that the loop of suture thread  91   a  remains on the end of the stent graft  26 . 
       FIG. 17  shows an alternative arrangement of a stent graft of the type suitable for the present invention and including a scalloped fenestration. The stent graft  120  comprises a tubular body  122  of graft material with a lumen  124  therethrough. The distal end  126  of the stent graft has distally extending exposed stent  128  and within the tubular body  122  there are proximal and distal internal stents  130  and three external stents  132  intermediate the proximal distal ends. A fenestration  134  is provided at the distal end  126  of the stent graft  100 . In this embodiment the fenestration  134  is in the form of a scallop or cut out extending from the distal end  126  of the stent graft  120 . The fenestration  134  is aligned with the struts  136  of the distal, internal, self expanding, zig zag stent  130  so that the sides of the fenestration  134  can be stitched by stitching  138  to the struts  136  along at least part of their length. 
       FIG. 18  shows an alternative arrangement of scalloped fenestration on a stent graft. In this embodiment the scallop  140  is at the distal end of the tubular body  142  and the struts  144  and  145  of the distal self expanding stent either side of the scallop are shaped to give a more arch-like shape to the aperture. The edge of the scalloped fenestration  140  is stitched as at  146  to the strut to ensure that the scalloped fenestration  140  opens when the stent graft is released upon deployment. 
       FIG. 19  shows an alternative arrangement of a stent graft of the type suitable for the present invention including both a fenestration and a scalloped fenestration. The stent graft  150  comprises a tubular body  152  of graft material with a lumen  154  therethrough. The distal end  156  of the stent graft  150  has distally extending exposed stent  158  and within the tubular body  152  there are proximal and distal internal stents  160  and at least one external stent  162  intermediate the proximal distal ends. A fenestration  164  is provided towards the distal end  156  of the stent graft  150 . In this embodiment the fenestration  164  is in the form of an aperture. A scalloped fenestration  166  is also provided towards the distal end  156  of the stent graft  150 . This fenestration  166  is in the form of a scallop or cut out extending from the distal end  156  of the stent graft  68 . The fenestration  82  is aligned with the struts of the distal, internal, self expanding, zig zag stent  160  so that the sides of the fenestration  90  can be stitched by stitching to the struts along at least part of their length. 
       FIGS. 20 and 21  show two views of a stent graft mounted onto a delivery device according to an embodiment of the present invention and in particular in  FIG. 21  showing the side of the stent graft upon which are the diameter reducing ties. 
     The part of the delivery device  170  shown includes part of a nose cone dilator  172  and a guide wire catheter  174  with a guide wire lumen  175  therethrough. A proximal fastening for a stent graft  176  of the type shown in  FIG. 13  is used which gives a clover leaf type pattern at the proximal end  177  of the stent graft  176  such as that shown in  FIG. 15 . At the distal end of the stent graft  176  a capsule  180  is mounted in an off set manner on a deployment catheter  182 . The capsule  180  receives a distally extending exposed stent  184  which is fastened to the stent graft  176 . The stent graft  176  includes internal stents at each end and external stents  185  intermediate the ends. 
     As can be seen in  FIG. 20  an indwelling catheter  188  extends from an aperture  190  in the deployment catheter  182  and over the capsule  180  and into a fenestration  192  in the stent graft  176 . The indwelling catheter  188  extends through the lumen of the stent graft  176  and out of the proximal end  177  thereof and to the nose cone dilator  172 . A longitudinal groove  194  in the nose cone dilator  172  receives the indwelling catheter  188 . 
     An anchor trigger wire  200  extends along the lumen (not shown) of the deployment catheter  182  and engages a bend of the exposed stent  184  within the capsule  182  and exits the capsule  182  through aperture  201  and then extends along the outside of the capsule and is inserted into the graft material of the stent graft  176 . 
     The other side of the stent graft  176  is shown in  FIG. 21 . On this side the diameter reducing ties  196  are provided to draw together some of the struts of the internal and external stents  185  so that the circumference and hence the diameter of the stent graft can be reduced to enable maneuverability after partial release of the stent graft after withdrawal of the sheath (not shown). The diameter reducing ties are placed on the side of the stent graft opposite to the fenestration or fenestrations. The diameter reducing ties are fastened to a release wire  198  which extends out of the capsule  180  and is stitched in and out of the graft material. As the diameter reducing ties  196  are tightened the struts of the stents  185  are drawn together and the graft material is corrugated between them. 
       FIG. 22  shows a general view of an alternative embodiment of deployment device according to the invention. In this drawing the same reference numeral will be used for corresponding components to those of  FIG. 1 . 
     In  FIG. 22  it will be seen that the deployment device  200  generally consists of a guide wire catheter  2  which extends the full length of the device from a Luer lock connector  3  for a syringe at the far distal end of the device to and through a nose cone dilator  4  at the proximal end. The nose cone dilator  4  is fixed to the guide wire catheter  2  and moves with it. To lock the guide wire catheter  2  with respect to the deployment device in general a pin vice  4  is provided. 
     The trigger wire release mechanism generally shown as  6  on a fixed handle  10  includes four trigger wire release mechanisms as will be discussed below. The trigger wire release mechanisms  6  slide on a portion of the fixed handle  10  and hence until such time as they are activated the trigger wire mechanisms  6  which are fixed by thumbscrews  11  remain fixed with respect to the fixed portion of the fixed handle  10 . 
     Immediately proximal of the trigger wire release mechanisms  6  is the sliding handle mechanism generally shown as  15 . The sliding handle mechanism  15  generally includes a fixed handle extension  16  and a sliding portion  17  the sliding portion  17  slides over the fixed handle extension  16 . A thumbscrew  18  fixes the sliding portion with respect to the fixed portion. 
     The fixed handle portion  16  is affixed to the trigger wire mechanism handle  10  by a screw threaded nut  24 . 
     The sliding portion of the handle  17  is fixed to the deployment catheter  19  by a mounting nut  20 . The deployment catheter  19  extends through to a capsule  21  at the proximal end of the deployment catheter  19 . 
     Over the deployment catheter  19  is a sheath manipulator  22  and a sheath  23  which slides with respect to the deployment catheter  19  and in the ready to deploy situation extends forward to the nose cone  3  to cover the stent graft  26 . 
     In the ready to deploy condition shown in  FIG. 22  the sheath  23  assists in retaining the stent graft  26  which includes self-expanding stents  25  in a compressed condition. The proximal covered stent  27  is retained at  28  by a retention mechanism as will be discussed later and the distal exposed stent  29  on the stent graft  26  is retained within the capsule  21  on the deployment catheter  19  and by a distal retention mechanism. 
     For this release mechanism the handle include four trigger wire release grips  7 ,  8   9  and  12 . The first grip  12  is fastened to the trigger wire  76   a  (see  FIG. 15 ) and by removal of the thumb screw  11  on release trigger wire release mechanism  12 , the trigger wire  76   a  (see  FIG. 15 ) can be completely withdrawn from the deployment device which releases the fastening  91   a  so that the retention of the proximal end of the stent graft changes from that shown in  FIG. 15  to that shown in  FIG. 16 . 
     The trigger wire release mechanism  9  has a trigger wire which extends to the capsule at the proximal end of the deployment catheter and engages one of the loops of an exposed stent  29  of the stent graft  26 . When the thumb screw  11  on the retention mechanism  9  is removed, that trigger wire can be removed and the capsule can be removed from the exposed stent. 
     The trigger wire release mechanism  8  extends a trigger wire  45  to diameter reducing ties  43  on the stent graft  26  (see  FIG. 3A ). When the thumb screw  11  on the trigger wire mechanism  8  is removed, the trigger mechanism  8  can be completely removed from the deployment device which releases the diameter reducing ties as discussed in detail in relation to  FIG. 21 . 
     The trigger wire mechanism  7  has two trigger wires  76  connected to it and when this trigger wire release mechanism is removed the remaining proximal retention fastenings  90   a  and  92   a  can be released to release the proximal end of the stent graft as is discussed in relation to  FIGS. 15 and 16 . 
     As can be seen in  FIG. 16  the proximal end of the stent graft is partially open and a guide wire can be introduced through the larger lobe  97  via a cranial or brachial entry into the aorta so that it can extend into the lumen within the stent graft  26  and by careful manipulation extend out through a fenestration in the stent graft. To assist with placement of the guide wire the rotational, longitudinal position of the stent graft  26  can still be adjusted because the diameter reducing ties prevent the stent graft from fully expanding against the walls of the vessel. 
     An indwelling catheter  50  extends from the distal end of the deployment device along a groove  51  in the fixed handle  10  and under the trigger wire release mechanisms  7 ,  8 ,  9  and  12 . The indwelling catheter  50  has a auxiliary guide wire  53  extending through it. The indwelling catheter  50  and auxiliary guide wire  53  can be extended out of the stent graft after the stent graft has been partially released at its proximal end as discussed in relation to  FIGS. 15 and 16 . The auxiliary guide wire  53  can then be extended through the indwelling catheter to be snared to enable trans-brachial access for placement of branch stents through the fenestrations in the stent graft. 
     It will be seen that by this invention there is provided a deployment device which ensures good control of the stent graft during deployment is possible by the use of an indwelling catheter and separate release mechanisms. In particular for fenestrated stent grafts a partial retention removal stage will assist with ensuring that access to the lumen of the stent graft to enable placement of a catheter through the stent graft and fenestration into a branch vessel is possible. 
     Throughout this specification various indications have been given as to the scope of the invention but the invention not limited to any one of these but may reside in two or more of these combined together. The examples are given for illustration only and not for limitation.