Delivery system and method for bifurcated graft

Abstract

A flexible low profile delivery system for delivery of an expandable intracorporeal device, specifically, an endovascular graft, which has at least one belt circumferentially disposed about the device in a constraining configuration. The belt is released by a release member, such as a release wire, by retracting the wire from looped ends of the belt. Multiple belts can be used and can be released sequentially so as to control the order of release and placement of the endovascular graft. An outer protective sheath may be disposed about the endovascular graft while in a constrained state which must first be retracted or otherwise removed prior to release of the graft from a constrained state. The delivery system can be configured for delivery over a guiding device such as a guidewire. The delivery system can also be configured for delivery of bifurcated intracorporeal devices.

1 . A delivery system for a bifurcated intracorporeal device comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section comprising: 
 an elongate primary belt support member;  
 at least one primary belt secured to the primary belt support member configured to be circumferentially disposed about a bifurcated intracorporeal device so to at least partially constrain the device;  
 a primary release member configured to engage and releasably secure the primary belt in a constraining configuration;  
 at least one elongate secondary belt support member disposed adjacent the elongate primary belt support member;  
 at least one secondary belt secured to the secondary belt support member configured to be circumferentially disposed about a bifurcated intracorporeal device so to at least partially constrain the device; and  
 a secondary release member configured to engage and releasably secure the secondary belt in a constraining configuration.  
   
     
     
         2 . The delivery system of  claim 1  wherein the primary belt support member is an elongate tubular member and the bifurcated intracorporeal device is a bifurcated endovascular graft in a constrained state.  
     
     
         3 . The delivery system of  claim 1  wherein the primary belt and secondary belt each comprise a length of wire having a first end and a second end with each of said first and second wire ends secured to the primary belt support member, and secondary belt support member respectively.  
     
     
         4 . The delivery system of  claim 1  wherein one or both of the primary belt and the secondary belt comprise first and second opposed ends and wherein the first opposed end has a different cross-sectional area than the second opposed end.  
     
     
         5 . The delivery system of  claim 4  wherein each of the first and second opposed ends form an end loop.  
     
     
         6 . The delivery system of  claim 3  wherein the wire comprises nickel titanium.  
     
     
         7 . The delivery system of  claim 1  wherein the release members comprise release wires moveably disposed within opposed looped ends of the respective belts.  
     
     
         8 . The delivery system of  claim 1  wherein the belts in the constraining configuration form a plane that is substantially orthogonal to a longitudinal axis of the elongate shaft.  
     
     
         9 . The delivery system of  claim 1  wherein at least two belts are configured to be releasable by a single release member.  
     
     
         10 . The delivery system of  claim 1  comprising a plurality of primary release members wherein the proximal ends of at least two of the primary release members are color-coded.  
     
     
         11 . The delivery system of  claim 1  comprising a plurality of primary release members wherein proximal ends of the primary release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment sequence for a plurality of belts.  
     
     
         12 . The delivery system of  claim 11  wherein the plurality of primary release members comprise a distal primary release wire handle and a proximal primary release wire handle disposed in a nested configuration.  
     
     
         13 . The delivery system of  claim 1  wherein the primary release member comprises a branched release wire.  
     
     
         14 . The delivery system of  claim 1  further comprising a secondary belt support member housing secured to the primary belt support member wherein the secondary belt support member is configured to move axially within the housing and the housing and secondary belt support member are configured to prevent relative rotational movement therebetween.  
     
     
         15 . A delivery system for a bifurcated graft comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section comprising: 
 a portion having disposed thereon the bifurcated graft, the graft having a main body portion, an ipsilateral leg and a contralateral leg;  
 an elongate primary belt support member disposed adjacent the main body portion and ipsilateral leg;  
 at least one primary belt secured to the primary belt support member and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft;  
 a primary release member which releasably secures the primary belt in the constraining configuration;  
 at least one secondary belt support member disposed adjacent the contralateral leg;  
 at least one secondary belt secured to the secondary belt support member and circumferentially disposed about the bifuircated graft and which constrains at least a portion of the graft; and  
 a secondary release member which releasably secures the secondary belt in the constraining configuration.  
   
     
     
         16 . The delivery system of  claim 15  additionally comprising a first proximal self-expending member secured to a proximal end of the contralateral leg and a second proximal self-expanding member secured to a proximal end of the ipsilateral leg, and wherein the legs have a different length and the first and second proximal self-expanding members are axially offset from each other when the graft is in a constrained state within the delivery system.  
     
     
         17 . The delivery system of  claim 15  additionally comprising a first proximal self-expanding member secured to a proximal end of the contralateral leg and a second proximal self-expanding member secured to a proximal end of the ipsilateral leg and wherein the legs have substantially the same length and one of the legs is axially compressed or folded such that the first and second proximal self-expanding members are axially offset from each other when the graft is in a restrained state within the delivery system.  
     
     
         18 . The delivery system of  claim 15  wherein the primary belt constrains a distal self-expanding member disposed at a distal end of the bifurcated graft main body portion.  
     
     
         19 . The delivery system of  claim 16  wherein the distal self-expanding member is a tubular stent.  
     
     
         20 . The delivery system of  claim 17  wherein the stent comprises a circumferential groove configured to accept at least a portion of the primary belt.  
     
     
         21 . The delivery system of  claim 15  wherein the primary belt and the secondary belt comprise at least one length of wire having a first end and a second end and configured in a loop with each of said first and second wire ends secured to the primary belt support member and secondary belt support member, respectively.  
     
     
         22 . The delivery system of  claim 15  wherein the primary belt and secondary belt comprise at least one length of wire having opposed end loops having differing diameters.  
     
     
         23 . The delivery system of  claim 21  wherein the wire comprises nickel titanium.  
     
     
         24 . The delivery system of  claim 15  wherein the release members comprise release wires moveably disposed within opposed looped ends of the respective belts.  
     
     
         25 . The delivery system of  claim 15  wherein the belts in the constraining configuration form a plane that is substantially orthogonal to a longitudinal axis of the elongate shaft.  
     
     
         26 . The delivery system of  claim 15  wherein at least two primary belts are configured to be releasable by the same release member.  
     
     
         27 . The delivery system of  claim 15  wherein the primary belt support member comprises a guidewire tube.  
     
     
         28 . The delivery system of  claim 26  wherein the distal section further comprises an outer protective sheath disposed about the endovascular graft while the graft is in a constrained state.  
     
     
         29 . A delivery system for a bifurcated graft having a main body portion, an ipsilateral leg, contralateral leg and a plurality of self-expanding members secured to the graft, comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising: 
 a portion having disposed thereon the bifurcated graft;  
 an elongate primary belt support member disposed within the main body portion and ipsilateral leg of the bifurcated graft;  
 a plurality of primary belts secured to a primary belt support member comprising a guidewire tube adjacent self-expanding members of the graft, the belts being circumferentially disposed about adjacent self-expanding members in a configuration that at least partially constrains the respective self-expanding members;  
 a primary release wire that engages and releasably secures at least one of the primary belts in a constraining configuration;  
 a secondary belt support member disposed within the contralateral leg of the bifurcated graft;  
 a secondary belt secured to the belt support member adjacent self-expanding members of the graft, the belt being circumferentially disposed about an adjacent self-expanding member in a configuration that at least partially constrains the adjacent self-expanding member; and  
 a secondary release wire that engages and releasably secures the secondary belt in a constraining configuration.  
   
     
     
         30 . A delivery system for a bifurcated intracorporeal device comprising: 
 an elongate shaft means having a proximal section and a distal section with the distal section comprising: 
 an elongate primary constraint support means;  
 at least one primary constraint means secured to the primary constraint support means configured to be circumferentially disposed about a bifurcated intracorporeal device so to at least partially constrain the device;  
 a primary release means configured to engage and releasably secure the primary constraint means in a constraining configuration;  
 at least one elongate secondary constraint support member disposed adjacent the elongate primary constraint support means;  
 at least one secondary constraint means secured to the secondary constraint support means configured to be circumferentially disposed about a bifurcated intracorporeal device so to at least partially constrain the device; and  
 a secondary release means configured to engage and releasably secure the secondary constraint means in a constraining configuration.  
   
     
     
         31 . The delivery system of  claim 30  wherein the primary constraint support means is an elongate tubular means and the bifurcated intracorporeal device is a bifurcated endovascular graft in a constrained state.  
     
     
         32 . The delivery system of  claim 30  wherein one or both of the primary constraint means and the secondary constraint means comprise first and second opposed ends and wherein the first opposed end has a different cross-sectional area than the second opposed end.  
     
     
         33 . The delivery system of  claim 30  wherein the constraint means in the constraining configuration form a plane that is substantially orthogonal to a longitudinal axis of the elongate shaft means.  
     
     
         34 . The delivery system of  claim 30  wherein at least two of the constraint means are configured to be releasable by a single release means.  
     
     
         35 . The delivery system of  claim 30  comprising a plurality of primary release means wherein the proximal ends of at least two of the primary release means are color-coded.  
     
     
         36 . The delivery system of  claim 30  comprising a plurality of primary release means wherein proximal ends of the primary release means are in a linear spatial configuration that corresponds to a desired deployment sequence for a plurality of constraint means.  
     
     
         37 . A delivery system for a bifurcated graft comprising: 
 an elongate shaft means having a proximal section and a distal section with the distal section comprising: 
 a portion having disposed thereon the bifurcated graft, the graft having a main body portion, an ipsilateral leg and a contralateral leg;  
 an elongate primary constraint support means disposed adjacent the main body portion and ipsilateral leg;  
 at least one primary constraint means secured to the primary constraint support means and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft;  
 a primary release means which releasably secures the primary constraint means in the constraining configuration;  
 at least one secondary constraint support means disposed adjacent the contralateral leg;  
 at least one secondary constraint means secured to the secondary constraint support means and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft; and  
 a secondary release means which releasably secures the secondary constraint means in the constraining configuration.  
   
     
     
         38 . The delivery system of  claim 37  wherein the primary constraint means constrains a distal self-expanding member disposed at a distal end of the bifurcated graft main body portion.  
     
     
         39 . The delivery system of  claim 37  wherein the constraint means in the constraining configuration form a plane that is substantially orthogonal to a longitudinal axis of the elongate shaft means.  
     
     
         40 . A delivery system for a bifurcated graft having a main body portion, an ipsilateral leg, contralateral leg and a plurality of self-expanding members secured to the graft, comprising: 
 an elongate shaft means having a proximal section and a distal section with the distal section of the elongate shaft comprising: 
 a portion having disposed thereon the bifurcated graft;  
 an elongate primary constraint support means comprising a guidewire tube means disposed within the main body portion and ipsilateral leg of the bifurcated graft;  
 a plurality of primary constraint means secured to the primary constraint support means adjacent respective self-expanding members of the graft, the primary constraint means being circumferentially disposed about the adjacent self-expanding members in a configuration that at least partially constrains the respective self-expanding members;  
 a primary release means that engages and releasably secures at least one of the primary constraint means in a constraining configuration;  
 a secondary constraint support means disposed within the contralateral leg of the bifurcated graft;  
 a secondary constraint means secured to the secondary constraint support means adjacent respective self-expanding members of the graft, the secondary constraint means being circumferentially disposed about the adjacent self-expanding members in a configuration that at least partially constrains the adjacent self-expanding members; and  
 a secondary release means that engages and releasably secures the secondary constraint means in a constraining configuration.  
   
     
     
         41 . A delivery system for an expandable intracorporeal device comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising: 
 a portion having disposed thereon the expandable intracorporeal device;  
 an elongate belt support member disposed adjacent a portion of the expandable intracorporeal device;  
 a belt secured to the belt support member and circumferentially disposed about the expandable intracorporeal device and which constrains at least a portion of the expandable intracorporeal device; and  
 a release member which releasably secures the belt in the constraining configuration.  
   
     
     
         42 . The delivery system of  claim 41  wherein the belt constrains a self-expanding portion of the expandable intracorporeal device.  
     
     
         43 . The delivery system of  claim 42  wherein the self-expanding portion is a tubular stent.  
     
     
         44 . The delivery system of  claim 43  wherein the stent comprises a cicumferential groove configured to accept at least a portion of the belt.  
     
     
         45 . The delivery system of  claim 41  wherein the belt support member is an elongate tubular member and the expandable intracorporeal member is an endovascular graft in a constrained state.  
     
     
         46 . The delivery system of  claim 41  wherein the belt comprises at least one length of wire having a first end and a second end.  
     
     
         47 . The delivery system of  claim 46  wherein the at least one length of wire is configured in at least one loop with each of said first and second wire ends secured to the belt support member.  
     
     
         48 . The delivery system of  claim 46  wherein the wire comprises a shape memory alloy.  
     
     
         49 . The delivery system of  claim 48  wherein the wire comprises nickel titanium.  
     
     
         50 . The delivery system of  claim 41  wherein the release member comprises a release wire releasably secured to at least one end of the belt.  
     
     
         51 . The delivery system of  claim 50  wherein the release wire is moveably disposed within opposed looped ends of the belt.  
     
     
         52 . The delivery system of  claim 41  wherein the belt in the constraining configuration forms a plane which is substantially orthogonal to a longitudinal axis of the elongate shaft.  
     
     
         53 . The delivery system of  claim 41  wherein a plurality of belts are secured to various axial positions on the belt support member and circumferentially disposed about the expandable intracorporeal device and have a configuration that constrains the expandable intracorporeal device, and 
 at least one release member that releasably secures the belts in the constraining configuration.    
     
     
         54 . The delivery system of  claim 53  wherein the number of belts is three.  
     
     
         55 . The delivery system of  claim 53  wherein at least two belts are configured to be releasable by the same release member.  
     
     
         56 . The delivery system of  claim 53  wherein all the belts are configured to be releasable by the same release member.  
     
     
         57 . The delivery system of  claim 55  wherein the order in which the at least two belts are released is determined by the axial position of the at least two belts and the direction of movement of the at least one release member.  
     
     
         58 . The delivery system of  claim 57  wherein the at least one release member comprises a release wire moveably disposed within opposed looped ends of each belt and wherein the delivery system is configured such that a distal-most belt will be released first when a distal end of the release wire is retracted in a proximal direction so as to move past the looped ends of the distal-most belt, and belts located more proximally are released sequentially thereafter as the distal end of the release wire passes the respective looped ends thereof.  
     
     
         59 . A delivery system for an endovascular graft with a flexible tubular body portion and at least one self-expanding member secured to the flexible tubular body portion, comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising:    a portion having disposed thereon the self-expanding endovascular graft;    an elongate belt support member disposed adjacent the self-expanding member of the endovascular graft;    a belt secured to the belt support member adjacent the self-expanding member and circumferentially disposed about the self-expanding member and which has a configuration which constrains the self-expanding member; and    a release wire releasably securing ends of the belt in the constraining configuration.    
     
     
         60 . The delivery system of  claim 59  wherein the belt support member comprises a guidewire tube.  
     
     
         61 . The delivery system of  claim 59  wherein the belt comprises nickel titanium.  
     
     
         62 . The delivery system of  claim 59  wherein the endovascular graft comprises a plurality of self-expanding members and wherein a plurality of belts are secured to various axial positions on the belt support member adjacent the plurality of self-expanding members, and circumferentially disposed about the self-expanding members and having a configuration which constrains the self-expanding members.  
     
     
         63 . The delivery system of  claim 62  wherein the release wire is moveably disposed within opposed looped ends of the belts and configured such that a distal-most belt will be released first when a distal end of the release wire is retracted in a proximal direction so as to move past the looped ends of the distal most belt, and belts located more proximally in an axial direction are released sequentially thereafter as the distal end of the release wire passes the respective looped ends thereof.  
     
     
         64 . The delivery system of  claim 62  wherein the distal section of the delivery system comprises at least two release wires configured to release different belts.  
     
     
         65 . The delivery system of  claim 59  wherein the distal section further comprises an outer protective sheath disposed about the endovascular graft while the graft is in a constrained state, the belts being in their constraining configuration and at least a portion of the release wire being disposed at the belts.  
     
     
         66 . A delivery system for an endovascular graft with a flexible tubular body portion and a plurality of self-expanding members secured to the tubular body portion, comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising:    a portion having disposed thereon a self-expanding endovascular graft;    an elongate guidewire tube disposed within the endovascular graft with the endovascular graft being in a constrained state;    a plurality of shape memory wire belts secured to the guidewire tube adjacent the respective self-expanding members, the belts being circumferentially disposed about the respective self-expanding members and which have a configuration that constrains the respective self-expanding members;    a first release wire that releasably secures ends of the belts disposed about the self-expanding members at the distal end of the endovascular graft in the constraining configuration; and    a second release wire that releasably secures ends of the belts disposed about the self-expanding members at the proximal end of the endovascular graft in the constraining configuration.    
     
     
         67 . A delivery system for an expandable intracorporeal device comprising: 
 an elongate shaft having a proximal section and a distal section with the distal section comprising:    an elongate belt support member disposed adjacent a portion of the distal portion configured to receive an expandable intracorporeal device;    at least one belt secured to the belt support member and which is configured to be circumferentially disposed about the expandable intracorporeal device to constrain the expandable intracorporeal device; and    a release member which releasably secures the belt in the constraining configuration.    
     
     
         68 . The delivery system of  claim 67  wherein the belt support member is an elongate tubular member and the expandable intracorporeal member is an endovascular graft in a constrained state.  
     
     
         69 . The delivery system of  claim 67  wherein the belt comprises at least one length of wire having a first end and a second end.  
     
     
         70 . The delivery system of  claim 69  wherein the at least one length of wire is configured in at least one loop with each of said first and second wire ends secured to the belt support member.  
     
     
         71 . The delivery system of  claim 69  wherein the wire comprises a shape memory alloy.  
     
     
         72 . The delivery system of  claim 71  wherein the wire comprises nickel titanium.  
     
     
         73 . The delivery system of  claim 67  wherein the release member comprises a release wire releasably secured to loop ends of the belt.  
     
     
         74 . The delivery system of  claim 73  wherein the release wire is moveably disposed within opposed looped ends of the belt.  
     
     
         75 . The delivery system of  claim 67  wherein the belt in the constraining configuration forms a plane which is substantially orthogonal to a longitudinal axis of the elongate shaft.  
     
     
         76 . The delivery system of  claim 67  wherein the delivery system comprises a plurality of belts.  
     
     
         77 . The delivery system of  claim 76  wherein at least two belts are configured to be releasable by the same release member.  
     
     
         78 . The delivery system of  claim 76  wherein all the belts are configured to be releasable by the same release member.  
     
     
         79 . The delivery system of  claim 77  wherein the order in which the at least two belts are released is determined by the axial position of the at least two belts and the direction of movement of the at least one release member.  
     
     
         80 . The delivery system of  claim 79  wherein the at least one release member comprises a release wire moveably disposed within at least one end of each belt and wherein the delivery system is configured such that a distal-most belt will be released first when a distal end of the release wire is retracted in a proximal direction so as to move past the at least one end of the distal-most belt, and belts located more proximally are released sequentially thereafter as the distal end of the release wire passes the respective ends thereof.  
     
     
         81 . The delivery system of  claim 76  further comprising a plurality of release members wherein at least a portion of the proximal end of at least two of the release members are different colors.  
     
     
         82 . The delivery system of  claim 81  wherein the release members comprise release wire handles secured to proximal ends of release wires and at least a portion of at least two of the release wire handles are of different colors.  
     
     
         83 . The delivery system of  claim 76  further comprising a plurality of release members wherein proximal ends of the release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment order for the plurality of belts.  
     
     
         84 . The delivery system of  claim 76  wherein the release member comprises a branched release wire.