Systems and methods for percutaneous intravascular access for arteriovenous fistula

Abstract

A device for extending, elongating, or repairing a previously created arteriovenous fistula between a first blood vessel and an adjacent second blood vessel includes a main body having a primary lumen and an articulating jaw member disposed at the distal end of the main body. The jaw member is configured with two elements to allow rotation of one element about a pivot point to grasp tissue while being rotated. The jaw member is also configured to allow thermal energy delivery to one or both elements of the jaw member that allow tissue welding and cutting with DC, RF, Laser or Ultrasonic energy. A second lumen located within one element of the jaw member is configured to allow advancement over a guidewire into the second vessel while the other element of the jaw member remains within the first blood vessel at the position where the arteriovenous fistula, or aperture, exists between the first and second blood vessel.

What is claimed is: 
     
         1 . A device for elongating, extending, or repairing a tissue aperture, comprising:
 a handle;   a body connected to and extending distally from the handle, comprised of a flexible material and having a primary lumen;   a rigid jaw member connected to and extending distally from the flexible body; and   a tissue cutting element disposed on the jaw member.   
     
     
         2 . The device as recited in  claim 1 , wherein the flexible material comprising the body is a polymer. 
     
     
         3 . The device as recited in  claim 2 , wherein the polymer comprising the body has a Shore A hardness of 70-90. 
     
     
         4 . The device as recited in  claim 1 , wherein the rigid jaw member is fabricated of a rigid material comprising either a metal or a rigid polymer having a Shore A hardness greater than 90. 
     
     
         5 . The device as recited in  claim 1 , wherein the jaw member comprises two elements, each having distal ends, wherein one of the elements is pivotable relative to the other element to create a spacing of varying sizes between the two elements at their respective distal ends. 
     
     
         6 . The device as recited in  claim 5 , wherein one of the elements is a stationary element and the other element is an articulating element, the articulating element being pivotable about a pivot point disposed on a proximal end thereof. 
     
     
         7 . The device as recited in  claim 5 , wherein both of the elements are articulating elements. 
     
     
         8 . The device as recited in  claim 1 , wherein the tissue cutting element comprises an electrode for energizing the tissue to be cut. 
     
     
         9 . The device as recited in  claim 8 , and further comprising a power supply and an activation switch disposed on the handle for activating said electrode. 
     
     
         10 . The device as recited in  claim 5 , and further comprising a lever on the handle for moving at least one of the jaw member elements relative to the other one to increase or decrease the spacing between the distal ends of the elements, thereby opening or closing the jaws of the jaw member. 
     
     
         11 . The device as recited in  claim 10 , and further comprising a wire connecting the lever to the jaw member for opening or closing the jaw member. 
     
     
         12 . The device as recited in  claim 11 , and further comprising a ratcheting mechanism on said lever for applying variable incremental pressure to the jaw member. 
     
     
         13 . The device as recited in  claim 9 , and further comprising a conductor for electrically connecting the power supply and activation switch to the electrode. 
     
     
         14 . The device as recited in  claim 5 , wherein the jaw member has a closed orientation wherein both jaw elements are substantially aligned with a longitudinal axis of the primary lumen, and open orientations wherein at least one of the jaw elements is disposed at a substantial angle of varying sizes from the longitudinal axis of the primary lumen. 
     
     
         15 . The device as recited in  claim 5 , and further comprising a secondary lumen disposed in one of the jaw elements. 
     
     
         16 . A method of extending, elongating, or repairing a fistula between adjacent first and second vessels, comprising:
 inserting a main body of a device into the first vessel so that a distal end thereof lies within a blood flow passage of the first vessel;   opening a jaw member disposed at a distal end of the main body;   disposing the open jaw member so that a portion of tissue adjacent to the fistula is disposed between elements thereof;   closing the elements of the jaw member to clamp the portion of tissue therebetween;   energizing an electrode on said jaw member to cut and weld the tissue to extend the fistula; and   withdrawing the device.   
     
     
         17 . The method as recited in  claim 16 , wherein the inserting step comprises aligning a lumen in the device over a guidewire, and sliding the device over said guidewire to the desired location. 
     
     
         18 . The method as recited in  claim 16 , wherein the energizing step comprises applying thermal energy of about 10-50 watts to the clamped tissue. 
     
     
         19 . The method as recited in  claim 18 , wherein the tissue temperature is increased to about 100-400 degrees C. to cut and weld an extended aperture of about 1-5 mm from the primary blood vessel to the secondary blood vessel. 
     
     
         20 . The method as recited in  claim 16 , wherein imaging guidance is used to insert the device into a procedural site and monitor the cutting and welding step.