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 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 method of operating a catheter assembly including monitoring a gap feedback signal indicative of a distance between a first tissue contact surface and a second tissue contact surface. Producing, via a user interface of the catheter assembly, a graphical depiction of the first tissue contact surface and the second tissue contact surface spaced apart from the first tissue contact surface by the distance. Producing, via the user interface of the catheter assembly, a gap distance warning when the gap feedback signal indicates that the distance is outside of a target gap range.

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 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 advancing a biologic graft over a guidewire into a blood vessel at a biologic graft attachment site, advancing a catheter over the guidewire, and creating an anastomosis between the biologic graft and the blood vessel by activating the catheter to apply energy to a vessel wall of the blood vessel and to a wall of the biologic graft.

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 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: 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: 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 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 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 method of creating an arteriovenous (AV) fistula between first and second vessels includes inserting a catheter comprising a proximal member and a distal member into the first vessel so that the distal member comes into contact with a selected anastomosis site. Creating an aperture between the first and second vessels advancing the distal member into the second vessel. Clamping the first and second vessels together using the proximal and distal members. Applying energy to a heating member on one of the proximal and distal members to further cut the first and second vessels and shape the aperture. The step of applying energy to the heating member further cauterizes and welds an edge of the aperture in order to create the desired fistula between the first and second vessels.

Abstract: Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways.

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.

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.