Suturing graft tubes to lumen walls percutaneously

A device for suturing a first circular cuff and a second circular cuff attached to ends of a graft tube, to lumen walls when concentrically located in the lumen after entering the vascular system through a skin puncture comprising,

• a. a first and a second circular cuff having a shape like a wide ring or cuff on a sleeve, being continuous with or attached to one or more tunnel housing sections, with the length of said tunnel housing sections being parallel to the centerline through said first and said second circular cuffs and said first and said second circular cuffs being made of a non-biodegradable polymer which may include undulating wire of stainless steel, nickel titanium or other metal alloy such that said first and said second circular cuff will expand in response to a force exerted by an expanding balloon on the inside of said circular cuff and will return to a circumference of a predetermined size dependent on the material of which it is made.
• b. one or more tunnel housing sections made of a non-biodegradable polymer, stainless steel, nickel titanium alloy or other biocompatible metal, with length greater than depth and depth greater than width, containing a first tunnel and second tunnel of the same cross-section, said first and said second tunnels being lined with stainless steel, nickel titanium alloy, or other biocompatible metal alloy, or non-biodegradable polymer, with said first tunnel having a flared entry port, on a longitudinal end of said tunnel housing section and coursing straight along the length, for a distance greater than the length of a short suture to be placed in said first tunnel, then curving through the depth to an exit port on a plane at approximately a right angle with respect to the plane of said entry port, and said second tunnel having a through port opening which may be flared, at a short distance from and on the same side of said tunnel housing section as said exit port and coursing in a curved path to an end port in said tunnel housing section, and with said exit port and said through port being on the outside circumference of said circular cuff,
• c. one or more short sutures of non-biodegradable biopolymer or stainless steel, nickel titanium alloy, or other biocompatible metal, being of the same cross-section, and slidably smaller than said first and said second tunnels, having a blunt proximal end and sharp distal end, with said short suture being biased in a curved shape during manufacture to which said short suture will return after being released from any other shape forced on said short suture by being forced into said first tunnel,
• d. a graft tube tapered throughout its length thus producing different circumference on proximal and distal ends and points between, made of a non-biodegradable polymer, with removable or non-removable reinforcing rings or spirals that tend to prevent said graft tube from changing circumference when stretched, and said graft tube being capable of being covered of lined with a heparin bioactive surface, ePTFE, endothelial growth factor, and/or a tissue-engineered vessel,
• e. a first and a second shroud, continuous with or attached to said first and said second circular cuff, but not blocking said entry ports, being of a material that is the same as or will bond with said graft tube, of slidably larger circumference than said graft tube where said shroud is attached by an overlapping joint made with adhesive.
• f. a first and a second push rod balloon made of compliant and/or non-compliant material of a size that push rods mounted on the circumference of said push rod balloons will be in line with said entry ports on said first and said second circular cuffs when said first and said second push rod balloons are fully inflated and which will pass through said circular cuffs when uninflated, and said first and said second push rod balloons having a keyway,
• g. a plurality of push rods of stainless steel, or other biocompatible metal, mounted on the circumference of a first and a second push rod balloon and extending in a proximal or distal direction a sufficient distance to enter said first tunnel and push said short suture to said end port, with said push rods being equal in number and equally spaced to be in line with said entry portswhen said first and said second push rods are fully inflated,
• h. a first push rod catheter of material such as silicone elastomer or other amorphous polymer, to which said first push rod balloon is attached on its distal end where there is also a keyway in the form of a longitudinal dent in said push rod catheter under said first push rod balloon, where a key mounted on a holding balloon catheter can enter and be withdrawn from said keyway by moving said holding balloon catheter located concentrically inside said push rod catheter,
• i. a second push rod catheter of material such as silicone elastomer or other amorphous polymer, to which said second push rod balloon is attached on its distal end where there is also a key which can enter or be withdrawn from a keyway on a second holding balloon catheter by moving said holding balloon catheter located concentrically outside said push rod catheter,
• j. a first holding balloon sized to correspond to the size of said first circular cuff, thus having a semi-inflated circumference smaller than, and fully-inflated diameter larger than, the inner diameter of said first circular cuff, and thus capable of increasing the circumference of said first circular cuff, and said first holding balloons being made of compliant and/or non-compliant material, and having one or more grooves in the outside circumference, equal in number, equally spaced to, and slidably larger than said tunnel housing sections protruding into the inner diameter of said circular cuff to which it is applied, and being concentrically mounted on said first holding balloon catheter,
• k. a second holding balloon sized to correspond to the size of said second circular cuff catheter thus having a semi-inflated circumference smaller than, and fully-inflated diameter larger than, the inner diameter of said second circular cuff, and thus capable of increasing the circumference of said second circular cuff, and said second holding balloon being made of compliant and/or non-compliant material, and having one or more grooves in the outside circumference, equal in number, equally spaced to, and slidably larger than said tunnel housing sections protruding into the inner diameter of said second circular cuff to which it is applied, and being concentrically mounted on said second holding balloon catheter,
• whereby, after entry into a vessel lumen through a skin puncture or other opening, a circular cuff with tunnel housing sections protruding into its central opening is advanced through the lumen by an operator outside the body pushing a catheter with a holding balloon rotated to engage said tunnel housing sections until reaching a predetermined distal site where said circular cuff is to be attached to said lumen wall, and where said circular cuff may not be contiguous with said lumen wall, whereupon said holding balloon is inflated inside the inner diameter of said circular cuff to increase its circumference while aligning groves in said holding balloon with said tunnel housing sections protruding into said circular cuff and thus aligning a key on said holding balloon catheter to a keyway on said push rod balloon catheter, causing push rods to be aligned with and enter said entry ports whereupon said holding balloon is advanced to the distal side of said circular cuff and rotated to engage said tunnel housing sections protruding into said circular cuff so pushing said push rods while pulling said holding balloon with opposite and equal force will cause each said short suture to move through said first tunnel, leave through said exit port, enter and curve through the adjacent lumen wall, and re-enter through said through port to continue through said second tunnel to said end port, thereby connecting said circular cuff to said lumen wall whereupon the circular cuff may relax to its original circumference on deflation of holding balloons or remain at any predetermined circumference depending on the materials used in manufacture. The tapered distal end of the graft tube is attached to the first circular cuff during manufacture so is attached while the circular cuff is so disposed, but the proximal second cuff is not attached during manufacture so now that the required length of the graft tube has been determined it is cut to length and attached with a shroud in an overlapping joint with adhesive. The procedure is essentially repeated on the larger proximal end of said graft tube which is tapered, causing said graft tube to be sutured to the lumen wall of the vascular system in which the procedure is performed. The graft tube, circular cuffs, sutures and shrouds may be covered with ePTFE, a heparin bioactive surface, endothelial growth factor, and/or tissue engineered vessels.