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 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 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 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: 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: 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 device for extending, elongating, or repairing a previously created arteriovenous fistula between a first blood vessel and an adjacent second blood vessel includes a main body having a primary lumen and an articulating jaw member disposed at the distal end of the main body. The jaw member is configured with two elements to allow rotation of one element about a pivot point to grasp tissue while being rotated. The jaw member is also configured to allow thermal energy delivery to one or both elements of the jaw member that allow tissue welding and cutting. A second lumen located within one element of the jaw member is configured to allow advancement over a guidewire into the second vessel while the other element of the jaw member remains within the first blood vessel at the position where the arteriovenous fistula, or aperture, exists between the first and second blood vessel.

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 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: A method of creating an AV fistula between adjacent first and second blood vessels, includes steps of cutting a hole through the adjacent walls of the first and second blood vessels and inserting a welding catheter into the first vessel, and through the hole into the second vessel, so that a distal end of the welding catheter is disposed within the second vessel. A portion of wall defining the welding catheter is then expanded radially outwardly, and the expanded wall portion is pulled proximally to engage the wall of the second blood vessel and to pull it toward the wall of the first blood vessel. Then, a portion of wall proximal to the first expanded wall portion and disposed in the first blood vessel is expanded radially outwardly, thereby capturing the walls of each of the second and first blood vessels between the two expanded wall portions. Cutting elements on the expanded wall portions are then energized to create a tissue welded elongate aperture between the first and second blood vessels.

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 device for allowing passage of a guidewire from a primary blood vessel to an adjacent secondary blood vessel includes a main body having a primary lumen and a secondary lumen, and a piercing member disposed in the secondary lumen, and configured to be moved distally out of the secondary lumen, and to pierce through tissue while being distally moved. A third lumen located within the piercing member is configured to allow placement of a guidewire from the primary blood vessel to the adjacent secondary blood vessel. In one embodiment, the secondary lumen is configured to allow articulation of the distal end of the piercing element. The piercing member has a sharp point on one end to facilitate cutting a small communicating aperture from the primary blood vessel to the secondary blood vessel.

Abstract: A method of creating an AV fistula between adjacent first and second blood vessels, includes steps of cutting a hole through the adjacent walls of the first and second blood vessels and inserting a welding catheter into the first vessel, and through the hole into the second vessel, so that a distal end of the welding catheter is disposed within the second vessel. A portion of wall defining the welding catheter is then expanded radially outwardly, and the expanded wall portion is pulled proximally to engage the wall of the second blood vessel and to pull it toward the wall of the first blood vessel. Then, a portion of wall proximal to the first expanded wall portion and disposed in the first blood vessel is expanded radially outwardly, thereby capturing the walls of each of the second and first blood vessels between the two expanded wall portions. Cutting elements on the expanded wall portions are then energized to create a tissue welded elongate aperture between the first and second blood vessels.

Abstract: A device for allowing passage of a guidewire from a primary blood vessel to an adjacent secondary blood vessel includes a main body having a primary lumen and a secondary lumen, and a piercing member disposed in the secondary lumen, and configured to be moved distally out of the secondary lumen, and to pierce through tissue while being distally moved. A third lumen located within the piercing member is configured to allow placement of a guidewire from the primary blood vessel to the adjacent secondary blood vessel. In one embodiment, the secondary lumen is configured to allow articulation of the distal end of the piercing element. The piercing member has a sharp point on one end to facilitate cutting a small communicating aperture from the primary blood vessel to the secondary blood vessel.

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 device for creating an arteriovenous (AV) fistula comprises 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 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: 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: An AV fistula between first and second blood vessels is created by forming a hole through adjacent walls of the vessels and inserting a welding catheter into the first vessel, and through the hole into the second vessel, so that a distal end of the catheter is disposed within the second vessel. A portion of wall defining the welding catheter is then expanded radially outwardly, and the expanded wall portion is pulled proximally to engage the wall of the second blood vessel and to pull it toward the wall of the first blood vessel. A portion of wall proximal to the first expanded wall portion and disposed in the first blood vessel is expanded radially outwardly, thereby capturing the walls of each of the second and first blood vessels between the two expanded wall portions. Cutting elements are energized to create a tissue welded elongate aperture between the blood vessels.