Methods and devices for percutaneous implantation of arterio-venous grafts
Methods, devices, and kits for implanting a vascular graft to perform hemodialysis treatments on patients with renal failure are disclosed. The kits can include access devices comprised of an access catheter having a guidewire lumen and stylet lumen, a guide tube having a curved distal end, a stylet, an actuator handle and a vascular graft. The methods describe techniques for using the described kits and devices for performing vascular procedures, such as percutaneous implantation of the vascular graft.
1 . A method of percutaneously implanting an arterio-venous graft, comprising:
advancing a first guidewire into a lumen of a first artery from a second artery; advancing a second guidewire into a lumen of a first vein from a second vein;
advancing a first access catheter over the first guidewire into the lumen of the first artery;
advancing a second access catheter over the second guidewire into the lumen of the first vein;
operating a first guide tube actuator to advance a first guide tube from the first access catheter toward a portion of a wall of the first artery;
operating a second guide tube actuator to advance a second guide tube from the second access catheter toward a portion of a wall of the first vein;
operating a first stylet actuator to advance a first stylet along a curved path through the first guide tube and through the wall of the first artery to form an arterial exit site;
operating a second stylet actuator to advance a second stylet along a curved path through the second guide tube and through the wall of the first vein to form a venous exit site; and
forming a subcutaneous tunnel between the arterial exit site and the venous exit site, wherein the subcutaneous tunnel is located in an arm of a patient.
2 . The method of claim 1 , further comprising: advancing a guide catheter over the second stylet; wherein the guide catheter passes through the venous exit site and through the subcutaneous tunnel; and wherein a distal end of the guide catheter is disposed adjacent the arterial exit site.
3 . The method of claim 2 , further comprising:
threading the first stylet through the guide catheter, wherein the first stylet forms a loop comprising an arterial leg, a venous leg, and a tunnel leg.
4 . The method of claim 3 , further comprising: threading a delivery catheter comprising the arterio-venous graft over the venous leg and the tunnel leg of the loop of the first stylet; and deploying the arterio-venous graft such that a distal end of the arterio-venous graft is coupled to the first artery, a body is disposed within the subcutaneous tunnel, and a proximal end of the arterio-venous graft is coupled to the first vein.
5 . The method of claim 4 , wherein the arterio-venous graft comprises a plurality of anchors disposed about a periphery of the distal end and the proximal end.
6 . The method of claim 5 , wherein the plurality of anchors comprise at least one hook member.
7 . The method of claim 6 , further comprising:
forming a sutureless anastomosis at the arterial exit site between the distal end of the arterio-venous graft and the first artery, wherein the hook member is embedded into the wall of the first artery adjacent the arterial exit site; and
forming a sutureless anastomosis at the venous exit site between the proximal end of the arterio-venous graft and the first vein,
wherein the hook member is embedded into the wall of the first vein adjacent the venous exit site.
8 . The method of claim 7 , wherein blood flows from the first artery, through the arterio-venous graft and into the first vein.
9 . The method of claim 5 , wherein each anchor of the plurality of anchors includes a pair of struts that are partially disposed outside the arterio-venous graft and extend radially outward substantially perpendicular to the arterio-venous graft and form an apex disposed outside the arterio-venous graft.
10 . The method of claim 9 , wherein a hook member extends from each apex.
11 . The method of claim 10 , wherein each hook member forms an acute angle relative to the pair of struts.
12 . The method of claim 9 , wherein the pair of struts of each anchor forms a 90 degree angle between the struts.
13 . The method of claim 4 , wherein the arterio-venous graft is configured as a self-expanding, covered stent graft.
14 . The method claim 1 , wherein the first artery is a brachial artery and the second artery is a femoral artery.
15 . The method of claim 1 , wherein the first vein is an axillary vein and the second vein is a femoral vein.
16 . The method of claim 1 , wherein the first stylet advances through subcutaneous tissue and skin adjacent to the first artery.
17 . The method of claim 1 , wherein the second stylet advances through subcutaneous tissue and skin adjacent to the first vein.
18 . The method of claim 1 , wherein a middle portion of the subcutaneous tunnel is more superficial than end portions of the subcutaneous tunnel disposed at the arterial exit site and the venous exit site, respectively.