Abstract: A method of creating an AV fistula between adjacent first and second vessels includes inserting a guidewire from the first vessel into the second vessel. Inserting a catheter including a proximal member and a distal member over the guidewire such that a distal tip of the distal member comes into contact with a selected anastomosis site. Moving the distal member and the proximal member together to clamp tissue surrounding the aperture between the distal face of the proximal member and a proximal face on the distal member. Applying energy to an active heating member on the proximal member to cut and form the aperture, and to weld the edges thereof in order to create a desired fistula between the two vessels. Using a passive heating member disposed on the distal member to create a heating gradient across a tissue contacting surface of the distal member.

Abstract: A power controller device and system allows verification, monitoring, and control of an arteriovenous (AV) fistula creation catheter which comprises a main housing having a power supply, an embedded electronic controller and a user interface display, and which is configured to allow connection to an intravascular catheter. When activated, the device verifies that a valid catheter is connected, downloads stored manufacturing calibration data from the catheter, and provides a user interface to allow initiation of AV fistula creation. Once creation of the AV fistula is initiated, the device provides closed loop control of the catheter heating element and provides a means of monitoring the catheter temperature and tip position to a prescribed parameter to automate the arteriovenous fistula creation procedure.

Abstract: A device for creating a fistula between blood vessels operates in conjunction with a guidewire to locate and position itself so that it straddles both vessels and is able to draw them together. A fixing agent is released either from within the device or from an external needle, or both, into the procedural site. The fixing agent functions to hold the relative position of the two vessels, to seal the surrounding tissue so that any leaks that do occur don't spread into the tissue to create a hematoma, and to limit expansion of the fistula. After the vessels are in close proximity to each other and the fixing agent is applied, the device of the invention employs a cutting mechanism which opens a portal between the two vessels.

Abstract: A catheter system for creating an arteriovenous (AV) fistula includes a proximal base having a distal end surface. A distal tip is connected to the proximal base and is movable relative to the proximal base. The distal tip has a proximal end surface. The distal end surface and the proximal end surface are adapted to contact opposing sides of a tissue portion to create the fistula. A peripheral edge defines the distal end surface of the proximal base. A stop is formed in the peripheral edge and is configured to limit movement of the distal tip in a proximal direction.

Abstract: A device and method for creating an arteriovenous (AV) fistula includes a proximal base having a distal diagonal end surface and a distal tip connected to the proximal base and movable relative to the proximal base. The distal tip has a proximal diagonal end surface. A heating assembly, including an energized heating element, is disposed one of the distal diagonal end surface and the proximal diagonal end surface. A passive heating assembly is disposed on the mating diagonal end surface. The distal diagonal end surface and the proximal diagonal end surface are adapted to contact opposing sides of a tissue portion to create a fistula. The angle of the proximal diagonal end surface matches the angle of the distal diagonal end surface, so that the two surfaces match one another during deployment.

Abstract: A power controller device and system allows verification, monitoring, and control of an arteriovenous (AV) fistula creation catheter which comprises a main housing having a power supply, an embedded electronic controller and a user interface display, and which is configured to allow connection to an intravascular catheter. When activated, the device verifies that a valid catheter is connected, downloads stored manufacturing calibration data from the catheter, and provides a user interface to allow initiation of AV fistula creation. Once creation of the AV fistula is initiated, the device provides closed loop control of the catheter heating element and provides a means of monitoring the catheter temperature and tip position to a prescribed parameter to automate the arteriovenous fistula creation procedure.

Abstract: A catheter having opposed tissue contacting surfaces for creating an anastomosis between two blood vessels is utilized to facilitate a method for percutaneously placing a biologic graft at a procedural site. The method may comprise steps of inserting a guidewire into a blood vessel, placing a sheath over the guidewire, advancing a biologic graft over the guidewire into the blood vessel at a biologic graft attachment site, advancing a catheter over the guidewire, pushing a distal tip of the catheter through the biologic graft, a vessel wall of the blood vessel, and into a lumen of the blood vessel, and creating an anastomosis between the biologic graft and the blood vessel by activating the catheter to apply energy to the vessel wall and to a wall of the biologic graft.

Abstract: A system for creating an arteriovenous (AV) fistula comprises a vessel access sheath having a hollow interior and an exit port, a side access needle catheter configured to fit within the hollow interior of the sheath, a needle configured to be inserted into a blood vessel through the side access needle catheter, a toggle delivery catheter configured to fit within the hollow interior of the sheath, and a toggle apparatus configured to be delivered into a vessel through the toggle delivery catheter. The toggle apparatus comprises a shaft and a toggle member pivotably attached to a distal end of the shaft. A source of RF energy or resistive heat energy may be provided for application to the toggle member and/or to a heater insert in the toggle delivery catheter, for the purpose of creating the fistula.

Abstract: A catheter and tissue cutting system percutaneously permits the creation of an anastomosis between a first and second anatomical structure, such as a vein and an artery. The system comprises a catheter having a main body with a lumen and tapered distal tip, configured to be moved distally into the first anatomical structure over a primary guidewire. A cutting electrode is nested in the main body, with a lumen which tracks over a secondary guidewire, and is insertable into the secondary anatomical structure. An energy supply is operative to energize the cutting electrode in order to cut a tissue wall defining the first anatomical structure.

Abstract: A method of creating an anastomosis includes steps of advancing a distal tip of a catheter device through a first blood vessel into a second blood vessel, while simultaneously advancing a proximal base of the device into the first vessel, contacting a wall of the first vessel with a distal blunt surface on the proximal base. A further step is to retract the distal tip so that a proximal blunt base of the distal tip contacts a wall of the second vessel, thereby capturing the two vessel walls between the blunt surfaces of the proximal base and the distal tip. A controlled pressure is applied between the two blunt surfaces to compress and stabilize the captured tissue and approximate the vessel walls. A clip is deployed through the captured tissue to hold the tissue in place during the anastomosis procedure. The anastomosis is created by applying cutting energy to the captured tissue.

Abstract: Methods for creating and maintaining an anastomosis between two adjacent blood vessels using percutaneous techniques, for use in hemodialysis procedures are disclosed and described.

Abstract: A method of producing an arteriovenous (AV) fistula includes producing an anastomosis between a primary blood vessel (e.g., a vein) and a secondary blood vessel (e.g., an artery). A collateral (or competing) blood vessel in fluid communication with one of the primary blood vessel or the secondary blood vessel is identified. A reversible flow restrictor is then applied to the collateral blood vessel to reduce a blood flow rate through the collateral blood vessel. In some embodiments, the anastomosis can be produced percutaneously. In some embodiments, the reversible flow restriction (or a portion thereof) can be removed from the collateral blood vessel. In other embodiments, the reversible flow restriction (or a portion thereof) can be adjusted to allow increased blood flow therethrough while within the collateral blood vessel.

Abstract: A device for creating an arteriovenous (AV) fistula includes a proximal base having a distal tapered end surface and a distal tip connected to the proximal base and movable relative to the proximal base. The distal tip has a proximal tapered end surface. A first heating assembly, including an energized heating element, is disposed on at least one of the distal tapered end surface and the proximal tapered end surface. A second heating assembly, comprising a passive non-energized heat spreader, is disposed on the other one of the distal tapered end surface and the proximal tapered end surface. The distal tapered end surface and the proximal tapered end surface are adapted to contact opposing sides of a tissue portion to create the fistula. The taper of the proximal tapered end surface matches the taper of the distal tapered end surface, so that the two surfaces match one another.

Abstract: A catheter system for creating an arteriovenous (AV) fistula includes a proximal base having a distal end surface. A distal tip is connected to the proximal base and is movable relative to the proximal base. The distal tip has a proximal end surface. The distal end surface and the proximal end surface are adapted to contact opposing sides of a tissue portion to create the fistula. A peripheral edge defines the distal end surface of the proximal base. A stop is formed in the peripheral edge and is configured to limit movement of the distal tip in a proximal direction.

Abstract: A device for creating intravascular access and guidewire placement includes a main body having a lumen and a piercing member disposed in the lumen. The piercing member moves distally out of the lumen and pierces tissue while moving. A needle guide is provided for guiding the piercing member, the needle guide having a distal end which comprises a first alignment member. A guidewire has a distal tip with a second alignment member disposed on the guidewire distal tip. The first alignment member may comprise a magnetic attachment, at least one magnetic implant, a proximity sensor, an ultrasonic sensor, or other suitable system for alignment of devices disposed on opposing sides of opaque tissue. Similarly, the second alignment member may comprise a magnetic attachment or implant, a proximity sensor, or an ultrasonic sensor.

Abstract: A catheter-based device tracks over a guidewire which has been placed from a first blood vessel into a second blood vessel. The distal tip of the catheter is advanced into the second vessel while a proximal member remains in the first vessel. Matching blunt tapered surfaces on each of the distal tip and the proximal member are clamped together, with adjacent walls of each vessel between them, after which a known, controlled pressure is applied between the two surfaces. Heat energy is then applied to the blunt surfaces for approximately 1-30 seconds to weld the walls of the two vessels together. After coaptation of the vessel walls, the heat is increased to then cut through the vessel walls to create a fistula of the desired size.

Abstract: A catheter system includes a proximal base having a distal diagonal end surface and a distal tip connected to the proximal base and movable relative to the proximal base, wherein the distal tip has a proximal diagonal end surface. The distal diagonal end surface and the proximal diagonal end surface contact opposing sides of a tissue portion to create the fistula. A peripheral edge defines the proximal distal end surface. A proximal point is disposed on the peripheral edge. The proximal point comprises a shortened angle and a fully radiused edge relative to a remaining portion of the peripheral edge and a relief recess is disposed on a distal end of the proximal base, both for the purpose of minimizing tissue snagging.

Abstract: Systems and methods for creating an arteriovenous (AV) fistula comprise an elongate member, a distal member connected to the elongate member and movable relative to the elongate member, and a heating member disposed on at least one of the movable distal member and the elongate member. The distal member comprises structure for capturing tissue to be cut to create the fistula, and the heating member is adapted to cut through the tissue to create the fistula. The elongate member comprises an elongate outer tube. A shaft connects the distal member to the elongate member, and is extendable and retractable to extend and retract the distal member relative to the elongate member.

Abstract: A method of percutaneously creating a fistula includes inserting percutaneously a medical instrument to a target location having a first blood vessel and a second blood vessel. A fastener is then deployed via the medical instrument to the target location. The fastener is in a first configuration before the deploying and a second configuration after the deploying. The fastener limits relative movement between the first blood vessel and the second blood vessel when in the second configuration. An anastomosis between the first blood vessel and the second blood vessel is percutaneously produced.

Abstract: A device and method for creating an arteriovenous (AV) fistula includes a proximal base having a distal diagonal end surface and a distal tip connected to the proximal base and movable relative to the proximal base. The distal tip has a proximal diagonal end surface. A heating assembly, including an energized heating element, is disposed one of the distal diagonal end surface and the proximal diagonal end surface. A passive heating assembly is disposed on the mating diagonal end surface. The distal diagonal end surface and the proximal diagonal end surface are adapted to contact opposing sides of a tissue portion to create a fistula. The angle of the proximal diagonal end surface matches the angle of the distal diagonal end surface, so that the two surfaces match one another during deployment.