Patent ID: 8409224
Filing Date: 2013-04-02
Classification: A61B

Abstract:
1. 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 circular cuff and a second circular cuff each having a shape of a wide ring or cuff on a sleeve, each 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 material with shape memory such that said first and said second circular cuff will remain at shape of memory or will expand in response to an outside force and after said outside force is removed will remain at a circumference of a predetermined size as a function of the shape memory material of which it is made, b. said one or more tunnel housing sections made of a material compatible with material of which said first and said second circular cuffs are made with length greater than depth and depth greater than width, and length parallel to the centerline of and equal to width of said first and said second cuffs, and depth extending beyond inside circumference of said first and said second circular cuffs, containing a first tunnel and second tunnel of the same cross-section, said first and said second tunnels being lined with material of which said one or more tunnel sections are made with said first tunnel having a flared entry port, on a longitudinal end of said tunnel housing section and coursing approximately 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 with curve being same as that of said short suture when unconfined to an out port on a plane at a right angle with respect to the plane of said entry port, and said second tunnel having a through port opening on the same side of said tunnel housing section as said out port, at a distance equal to diameter of and in location corresponding to original unconfined shape of said short suture as it emerges from said out port and said second tunnel coursing in same curved path to an end port in said second tunnel of said tunnel housing section and with said out port and said through port being on the outside circumference of said circular cuff, c. one or more short sutures of material having a shape memory 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 circular shape during manufacture so said proximal and said distal ends are touching in same or adjacent planes 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 having a proximal and a distal end where said first and said second circular cuffs are respectively attached, and circumferences on said proximal and distal ends and points fit against lumen walls when said graft tube is concentrically located in said lumen after entering the vascular system through a skin puncture, made of a flexible material with reinforcing rings that spiral tending to prevent said graft tube from changing said circumferences when stretched, and said graft tube being capable of being covered or lined with materials that encourage bioactive endothelial growth, 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 but having no reinforcing rings, of slidably larger circumference than said graft tube to which said shroud is attached by a joint, f. a first and a second push rod support member mounted on a push rod catheter, and of a circumference such that a plurality of push rods mounted on said circumference of said push rod support members will be in line with said entry ports in said tunnel housings on said first and said second circular cuffs, but when said first and said second push rod support members are not so aligned said support members will pass through said first and said second circular cuffs, g. said plurality of push rods mounted on the circumference of said first and said second push rod support members extending away from said first and said second push rod support members a sufficient distance to enter said first tunnel and push said proximal blunt end of said short suture a sufficient distance for said distal sharp end of said short suture to enter said end port, with said plurality of push rods being equal in number and equally spaced to be in line with said entry ports when said first and said second push rod support members are so aligned, h. said push rod catheter of strong flexible material having said second support member mounted distal to said first support member with push rods pointed distally and said first of said support members mounted proximal to said second support member with push rods pointed proximally and there is also one of two keyways both in the form of a longitudinal dent, one being in said push rod catheter under said second push rod support member, and two keys, both being in the form of a longitudinal protrusion shaped to fit in said keyways, one being located on said push rod catheter just proximal to ends of said pushrods, i. an inside and an outside holding catheter, made of strong flexible material and each having a distal and proximal end with said distal end of said inside holding catheter having a second holding member attached and having one of said two keys attached just proximal to said second holding member, and said distal end of said outside holding catheter having a first holding member attached and having one of said two keyways being located under said first holding member, j. said first and said second holding members sized to correspond to the size of said first and said second circular cuff, thus having a circumference smaller than the inner diameter of said first and said second circular cuff, and having one or more grooves in said 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, and said first holding member being concentrically mounted on said distal end of said outside holding catheter and said second holding member being concentrically mounted on said distal end of said inside holding catheter, and when moved to opposite side of said circular cuffs said keys and said keyways are moved a sufficient distance to disengage allowing rotation which engages said tunnel housing sections between said grooves to hold said tunnel housing sections against force from said push rods, k. a first expansion balloon mounted on said distal end of said inside catheter and a second expansion balloon mounted on said distal end of said outside catheter, being a means of delivery and a means of expanding said circular cuff, each having said one or more grooves in said outside circumference, equal in number, equally spaced to, and slidably larger than said tunnel housing sections protruding into the inner diameter of said first and said second circular cuff to which it is applied and having an uninflated circumference smaller than, a semi-inflated circumference equal to, and fully-inflated diameter larger than said inner diameter of said first and said second circular cuff, and thus capable of gripping, holding, and increasing the circumference of said first and said second circular cuff, and aligning said keys and said keyways on said outside and said inside holding catheters, whereby, said first and second expansion balloons when placed within said central openings of said first and said second circular cuff and inflated to grip said first and said second circular cuff enables operator to advance said inside and said outside catheter with said first and second expansion balloons on their distal ends causing said first and said second circular cuff to advance by pulling and pushing said shrouds, said graft tube and said first and said first and said second circular cuff through said vasculature until reaching a predetermined distal site where said second circular cuff is to be attached to said lumen wall, and where said first circular cuff is located at a preselected proximal site thus accomplishing delivery, whereupon said expandable balloons is inflated to a preselected size to make said first and said second circular cuff contiguous, then deflated and either removed from body and be replaced with an alternative holding member or remain and be used as said first and second holding member, such that said holding members and said push rod support members are advanced through said graft tube so that grooves in said holding members are thus aligned with said tunnel housing sections protruding into the inner diameter of said circular cuffs and said keys and said keyways are engaged thus causing said push rods to be aligned with said entry ports whereupon operator moves said holding members out of said circular cuffs to opposite side and rotates them to engage protruding tunnel housing sections, then operator by pulling and pushing said holding catheters and said push rod catheters with opposite and equal force will cause said push rods to enter said tunnels and cause each said short suture to move through said first tunnel, leave through said exit port, resume its original circular shape when no longer in said first tunnel, enter and curve through the adjacent lumen wall, and enter said second tunnel through said through port to continue through said second tunnel to said end port, thereby connecting said circular cuffs to said lumen wall whereupon said circular cuffs remain at any predetermined circumference depending on the materials used in manufacture graft tube, circular cuffs, sutures and shrouds are capable of being covered with a bioactive endothelial growth factor.