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: 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 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 intravascular access includes positioning the main body of a device within a primary vessel and manipulating a guidewire having a second alignment member to a location proximate to an inner wall of a secondary vessel. Engaging the alignment member of the distal end of the device and the second alignment member of the guidewire through the respective walls of the primary and secondary vessels, so that the device and guidewire are in close proximity and in alignment, thereby pushing the primary and secondary vessels together. Extending the piercing member distally from the main body, through the wall of the primary vessel, and through an adjacent wall of the secondary vessel, so that the end of the piercing member is disposed within the secondary vessel and thereby creating a communicating aperture on the opposing walls of the primary and secondary vessel.

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 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 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 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 method of creating a native vessel bypass percutaneously includes steps of selecting a target procedural site adjacent to a paired artery and vein, usually near an occlusion or blockage disposed in the artery and advancing a catheter through the vein with its distal tip extending through the vessel walls into the adjacent artery. An anastomosis is formed by applying heat to tissue forming the vessel walls which is captured between surfaces on a proximal base and the distal tip of the catheter. The venous valves are disabled to permit retrograde venous flow of arterial blood, in order to bypass the arterial occlusion.

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 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 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 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.