Avenu Medical, Inc.

Baja Research, LLC

Jeffrey E Hull

Mark Andrew Ritchart

David K Wrolstad

Brad M Kellerman

David Trottingwolf Aldridge

Gene B Reu

Seth Arnold Foerster

Justin K Mann

Gene Reu

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.

Systems and methods for percutaneously placing biologic grafts at a procedural site

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.

Intravascular arterial to venous anastomosis and tissue welding catheter

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.

Systems and methods for percutaneous access and formation of arteriovenous fistulas

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.

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.

Systems and methods for creating arteriovenous (AV) fistulas

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.

Percutaneous arterial to venous anastomosis clip application catheter system and methods

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

Systems and methods for percutaneous access, formation, and maintenance of arteriovenous fistulas

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.

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.

Intravascular arterial to venous anastomosis and tissue welding catheter and methods

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.

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Midlothian, VA, United States of America

Jeffrey E Hull