Abstract: A dual lumen introducer sheath provides access to at least one renal artery and at least one peripheral blood vessel of a patient. The introducer sheath includes a proximal hub comprising first and second ports, a first lumen, and a second lumen. The first lumen extends from the first port to a first distal aperture and has sufficient length such that when the first port is positioned outside the patient the first distal aperture is positionable in the abdominal aorta at or near origins of the patient's renal arteries. The second lumen extends from the second port to a second distal aperture, has a shorter length than the length of the first lumen, and is configured to allow passage of a catheter device through the second lumen and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient.

Abstract: Techniques for assessing a physiological profile of a patient include advancing a catheter shaft of a bifurcated renal catheter system into an aorta of the patient, deploying branches of the bifurcated renal catheter system into the renal arteries of the patient, detecting a renal arterial physiological parameter with a sensing mechanism, and assessing the physiological profile of the patient based on the physiological parameter. Related techniques include modifying or initiating pharmacological or surgical treatments for the patient based on the assessment.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blood vessel of a major blood vessel, generally comprising an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member.

Abstract: Systems and methods for the clinical treatment of individuals susceptible to or suffering from acute kidney injury are provided. Drugs, biologics, or other therapies or treatments are administered by fluid agent delivery directly to the kidneys via their arterial blood supply. Bifurcated renal artery infusion catheter devices and methods can treat kidney injury in patients with locally-delivered drugs, biologics, and other agents, so as to increase the ability of the kidneys to excrete nitrogenous waste products from the blood, and prevent or ameliorate azotemia.

Abstract: A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal injection assembly to the location within the abdominal aorta.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blond vessel of a major blood vessel comprises an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member.

Abstract: A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal injection assembly to the location within the abdominal aorta.

Abstract: Methods and apparatus are provided for treating congestive heart failure using a catheter having an inlet end configured for placement in the source of arterial blood such as the aorta, left ventricle or a femoral artery, and an outlet end having at least one conduit configured to be placed in the renal arteries. The catheter includes a lumen through which blood passes from the aorta or left ventricle directly to the renal artery, means for engaging the first conduit with renal artery. The means for engaging also may reduce backflow of blood into the abdominal aorta. The catheter preferably is configured to permit percutaneous, transluminal implantation. Methods of using and implanting the catheter are also provided.

Abstract: Methods and apparatus are provided for treating congestive heart by actively or passively enhancing perfusion to the renal arteries. A first embodiment comprises a specially configured balloon catheter and extracorporeal pump, wherein the pump operates in a “once-through” fashion or alternating volume displacement mode. In another embodiment the catheter includes a pair of balloons to isolate a region of the aorta, and a third balloon that directs flow into the renal arteries. In still further embodiments, a stent or cuff having a constricted region is deployed in or around the aorta, respectively, to create a backpressure upstream of the stent or cuff. Methods of enhancing renal perfusion also are provided.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blond vessel of a major blood vessel comprises an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member.

Abstract: Renal infusion systems include an infusion catheter having a bifurcated distal end with a first branch and second branch, the branches being biased to deploy laterally when unconstrained. Systems also include a delivery sheath having a lumen which receives the infusion catheter and constrains the first branch and second branch. A distal opening of the delivery sheath is formed asymmetrically to allow one of the first and second branches to open laterally while the other of the branches remains constrained. Methods of using renal infusion systems are also provided.

Abstract: Two renal delivery members have two distal ports that are adapted to be positioned within two renal arteries via their corresponding renal ostia at unique locations along an abdominal aortic wall. A proximal coupler assembly is outside the body and is coupled to deliver material to the two distal ports for bi-lateral renal therapy. One or both of the delivery members may be self-cannulating into the corresponding renal ostium, or may be controllably steered into the respective ostium. Non-occlusive anchors may be coupled with one or both of the delivery members at anchoring positions in the renal artery or abdominal aorta to secure the renal delivery member within the renal artery. Renal-active fluid agents are coupled to the bi-lateral delivery system. Another renal therapy system cannulates a renal vein from the vena cava and controls a retrograde delivery of agents to the respective kidney.

Abstract: An apparatus and method particularly useful in treatments and therapies directed at the kidneys such as the prevention of radiocontrast nephropathy (RCN) arising from diagnostic procedures using iodinated contrast materials. A series of treatment schemes are provided based upon local therapeutic agent delivery to the kidneys that can be used as a prophylactic treatment for patients undergoing interventional procedures that have been identified as being at an elevated risk for developing RCN as well as for low risk patients. The methods may include pre-exposure and post contrast exposure treatments alone or in combination with the local delivery of therapeutic agents to the kidneys. Among the agents identified for such treatments are normal saline and the vasodilators papaverine and fenoldopam mesylate and appropriate dosing is provided.

Abstract: A system for delivering a renal treatment and a peripheral treatment includes a renal catheter, a peripheral catheter, and an introducer sheath having first and second lumens. The first lumen is configured to receive the renal catheter and is sized to extend from a patient insertion site to a femoral or iliac artery location near or distal to a patient aortic branch. The second lumen is configured to receive the peripheral catheter and is sized to extend from the patient insertion site to an opposite femoral or iliac artery location near or distal to the patient aortic branch. A method of delivering a renal treatment and a peripheral treatment includes positioning an introducer sheath in an iliac artery, advancing a renal catheter and a peripheral catheter through the introducer sheath, where the renal catheter is separated from the peripheral catheter within the introducer sheath by a flap.

Abstract: A renal flow system and method direct fluid into renal arteries from a location within the aorta. A renal flow assembly has a tapered tube that is adjustable between a radially collapsed condition for delivery to the location through a delivery sheath and a radially expanded condition that divides aortic flow into exterior and interior paths. The tube's wall is made from a sheet of flexible material, such as PTFE or ePTFE. Two, nickel-titanium rings radially support the tube's ends and are connected by a longitudinal spine support. A fluid delivery assembly injects drug to flow along the exterior flow path and the tubular wall directs the agent into the renal artery ostium. The tube's taper has localized shape for circumferential agent mixing to infuse both kidneys' renals. The flow assembly allows an interventional device, e.g. delivery catheter, to advance across the location while directing blood into the renals and perfusing downstream circulation.

Abstract: Methods and apparatus are provided for treating congestive heart failure using a catheter having an inlet end configured for placement in the source of arterial blood such as the aorta, left ventricle or a femoral artery, and an outlet end having at least one conduit configured to be placed in the renal arteries. The catheter includes a lumen through which blood passes from the aorta or left ventricle directly to the renal artery, means for engaging the first conduit with renal artery. The means for engaging also may reduce backflow of blood into the abdominal aorta. The catheter preferably is configured to permit percutaneous, transluminal implantation. Methods of using and implanting the catheter are also provided.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blood vessel of a major blood vessel, generally comprising an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member. The radially expandable member is located down-stream of the shaft agent delivery port, and has an expanded configuration with an outer diameter larger than an outer diameter of the tubular member.

Abstract: An introducer system delivers therapy locally to a renal system in a patient. A proximal coupler assembly is coupled to an introducer sheath that delivers multiple devices simultaneously into a location within an abdominal aorta associated with first and second renal artery ostia. The coupler assembly has a network of branch lumens arranged to allow for smooth slideable engagement of multiple coupled devices without substantial interference therebetween. A first branch lumen typically introduces a percutaneous translumenal interventional device such as an angiography or guiding catheter into the introducer sheath and is substantially aligned with a longitudinal axis of the sheath. One or more other branch lumen are off-axis from the longitudinal axis by about 30 degrees or less and introduce components of a bilateral renal delivery assembly into the introducer sheath in conjunction with the other device. Novel insertion devices are provided to coordinate the coupling of the multiple devices.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blond vessel of a major blood vessel comprises an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member.

Abstract: A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bilaterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly (100) includes two injection members (104, 106), each having an injection port (112) that couples to a source of fluid agent externally of the patient. The injection ports may be positioned within an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries.