Device and Method for Atraumatic and Percutaneous Formation of an Arteriovenous Fistula

1 . An implant for the creation of a fistula between a first and a second blood vessel, the implant having a longitudinal axis from a distal to a proximal end, the implant comprising

a sutureless anastomosis device comprising a first set of hands and a second set of hands;

wherein each hand comprises a body extending at an angle from the longitudinal axis of the implant;

wherein each hand comprises a resilient material such that the hand may be deflected under tension to a compact orientation substantially parallel to the longitudinal axis of the implant;

wherein each of the first set of hands and the second set of hands is connected to and arranged around an annular structure such that the first set of hands forms a first flange and the second set of hand forms a second flange, wherein the flanges are separated by a space along the longitudinal axis of the implant;

wherein the implant further comprises a conduit comprising a tubular structure comprising a lumen, connected at its distal end circumferentially around the proximal end of the annular structure, wherein the conduit comprises a scaffolding material enclosed in or surrounded by a covering of biocompatible material.

2 . The implant of claim 1 , wherein

the sutureless anastomosis device comprises 4-12 hands.

3 . The implant of claim 1 , wherein

the hands are substantially perpendicular to the longitudinal axis of the implant.

4 . The implant of claim 1 , wherein

the hands comprise a material selected from the group consisting of nitinol, stainless steel, and cobalt-chrome.

5 . The implant of claim 1 , wherein

the hands comprise loops of wire.

6 . The implant of claim 1 , wherein

the annular structure comprises a radially expandable structure.

7 . The implant of claim 1 , wherein

the conduit is tapered, being widest at its proximal end and narrowest at its distal end where it connects to the annular structure.

8 . The device of claim 1 , wherein

the covering of the conduit comprises PTFE film.

9 .- 16 . (canceled)

17 . A system for deploying a sutureless anastomosis device comprising,

a sutureless anastomosis device comprising:

first set of hands and a second set of hands; wherein each hand comprises a body extending at an angle from the longitudinal axis of the implant; wherein each hand comprises a resilient material such that the hand may be deflected under tension to a compact orientation substantially parallel to the longitudinal axis of the implant; wherein each of the first set of hands and the second set of hands is connected to and arranged around an annular structure such that the first set of hands forms a first flange and the second set of hand forms a second flange, wherein the flanges are separated by a space along the longitudinal axis of the implant; wherein the implant further comprises a conduit comprising a tubular structure comprising a lumen, connected at its distal end circumferentially around the proximal end of the annular structure, wherein the conduit comprises a scaffolding material enclosed in or surrounded by a covering of biocompatible material; and

a catheter comprising a proximal end, the proximal end comprising a control assembly and a distal end comprising an implant housing;

wherein the sutureless anastomosis device is contained within the implant housing and is configured such that the hands are in the compact position;

wherein the implant housing comprises a deployable cutting element, a deployable guide wire; and a means of controllably and incrementally advancing the implant from the opening;

wherein the deployable cutting element, the deployable guide wire; and the means for controllably and incrementally advancing the implant from the opening are controlled by means of control elements in the control housing.

18 . The crossing device of claim 17 , wherein

the implant housing comprises one or more echogenic and/or radiopaque markings at its distal tip for visualization of the distal tip of the crossing device when deployed in the body of a subject.

19 . The delivery tool of claim 17 , wherein

the implant housing comprises one or more magnetic elements.

20 . A method of forming a fistula in a subject wherein the fistula comprises a connection between a first and a second blood vessel in a subject, comprising the steps:

creating an access at a selected entry site of the subject;

introducing a crossing device into the vascular system of the subject via the access, wherein the crossing device comprises an implant housing which houses an implant, wherein the implant may be controllably deployed from the implant housing; wherein the implant comprises a sutureless anastomosis device comprising an annular structure comprising a first set of hands and a second set of hands wherein the each of the first set of hands and second set of hands are circumferentially arranged around the outer diameter of the annular structure; wherein the each set of hands may be separately released from the implant housing; wherein upon release from the implant housing, each set of hands spontaneously assumes a configuration which creates a flange; wherein the implant further comprises a conduit portion extending from the proximal end of the annular structure; wherein the implant housing further comprises a deployable cutting element;

advancing the implant housing of the crossing device through the vascular system to the target site, the target site being a site in the first blood vessel which is in proximity to the second blood vessel;

deploying the cutting element to create a puncture in the first blood vessel and the second blood vessel;

advancing the implant from the implant housing to create the first and the second flange in a manner that sandwiches the walls of the first blood vessel and the second blood vessel between the first and second flanges and such that such that the lumen of the annular structure of the implant creates a channel for the flow of blood between the first and the second blood vessels;

withdrawing the implant housing from the target site, such that the conduit portion of the implant is deployed in the first blood vessel.

21 . The method of claim 20 , wherein

the fistula is an arteriovenous fistula.

22 . The method of claim 20 , wherein

the first blood vessel is the median cubital perforator, either the medial cubital vein, cephalic vein or basilic vein of the arm and the second blood vessel is the brachial artery at its terminus or the proximal radial or proximal ulnar artery.

23 . The method of claim 20 , wherein

the arteriovenous fistula is created in a subject in need of hemodialysis treatment.

24 . The method of claim 20 , wherein

the conduit is deployed such blood flowing from the conduit bypasses the deep venous system and flows into the superficial venous system.