Abstract:
A local renal delivery system includes a flow isolation assembly and a local injection assembly. The flow isolation assembly in one mode is adapted to isolate only a partial flow region along the outer circumference along the aorta wall such that fluids inject there are maintained to flow substantially into the renal arteries. Various types of flow isolation assemblies and local injection assemblies are described.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS  
       [0001]     The present application is a continuation of PCT/US02/29743 (Attorney Docket No. 022352-001200PC) filed Sep. 22, 2003, which claims priority from U.S. provisional application Ser. Nos. 60/412,343 (Attorney Docket No. 022352-000700US), filed on Sep. 20, 2002; 60/412,476 (Attorney Docket No. 022352-000800US), filed on Sep. 20, 2002; and 60/486,349 (Attorney Docket No. 022352-001200US), filed on Jul. 10, 2003. The full disclosure of each of the foregoing applications is hereby incorporated reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention relates to the field of medical devices, and more particularly to a system and method for locally delivering fluids or agents within the body of a patient. Still more particularly, it relates to a system and method for locally delivering fluids or agents into branch blood vessels or body lumens from a main vessel or lumen, respectively, and in particular into renal arteries extending from an aorta in a patient.  
         [0004]     2. Description of Related Art  
         [0005]     Many different medical device systems and methods have been previously disclosed for locally delivering fluids or other agents into various body regions, including body lumens such as vessels, or other body spaces such as organs or heart chambers. Local “fluid” delivery systems may include drugs or other agents, or may even include locally delivering the body&#39;s own fluids, such as artificially enhanced blood transport (e.g. either entirely within the body such as directing or shunting blood from one place to another, or in extracorporeal modes such as via external blood pumps etc.). Local “agent” delivery systems are herein generally intended to relate to introduction of a foreign composition as an agent into the body, which may include drug or other useful or active agent, and may be in a fluid form or other form such as gels, solids, powders, gases, etc. It is to be understood that reference to only one of the terms fluid, drug, or agent with respect to local delivery descriptions may be made variously in this disclosure for illustrative purposes, but is not generally intended to be exclusive or omissive of the others; they are to be considered interchangeable where appropriate according to one of ordinary skill unless specifically described to be otherwise.  
         [0006]     In general, local agent delivery systems and methods are often used for the benefit of achieving relatively high, localized concentrations of agent where injected within the body in order to maximize the intended effects there and while minimizing unintended peripheral effects of the agent elsewhere in the body. Where a particular dose of a locally delivered agent may be efficacious for an intended local effect, the same dose systemically delivered would be substantially diluted throughout the body before reaching the same location. The agent&#39;s intended local effect is equally diluted and efficacy is compromised. Thus systemic agent delivery requires higher dosing to achieve the required localized dose for efficacy, often resulting in compromised safety due to for example systemic reactions or side effects of the agent as it is delivered and processed elsewhere throughout the body other than at the intended target.  
         [0007]     Various diagnostic systems and procedures have been developed using local delivery of dye (e.g. radiopaque “contrast” agent) or other diagnostic agents, wherein an external monitoring system is able to gather important physiological information based upon the diagnostic agent&#39;s movement or assimilation in the body at the location of delivery and/or at other locations affected by the delivery site. Angiography is one such practice using a hollow, tubular angiography catheter for locally injecting radiopaque dye into a blood chamber or vessel, such as for example coronary arteries in the case of coronary angiography, or in a ventricle in the case of cardiac ventriculography.  
         [0008]     Other systems and methods have been disclosed for locally delivering therapeutic agent into a particular body tissue within a patient via a body lumen. For example, angiographic catheters of the type just described above, and other similar tubular delivery catheters, have also been disclosed for use in locally injecting treatment agents through their delivery lumens into such body spaces within the body. More detailed examples of this type include local delivery of thrombolytic drugs such as TPA™, heparin, cumadin, or urokinase into areas of existing clot or thrombogenic implants or vascular injury. In addition, various balloon catheter systems have also been disclosed for local administration of therapeutic agents into target body lumens or spaces, and in particular associated with blood vessels. More specific previously disclosed of this type include balloons with porous or perforated walls that elute drug agents through the balloon wall and into surrounding tissue such as blood vessel walls. Yet further examples for localized delivery of therapeutic agents include various multiple balloon catheters that have spaced balloons that are inflated to engage a lumen or vessel wall in order to isolate the intermediate catheter region from in-flow or out-flow across the balloons. According to these examples, a fluid agent delivery system is often coupled to this intermediate region in order to fill the region with agent such as drug that provides an intended effect at the isolated region between the balloons.  
         [0009]     The diagnosis or treatment of many different types of medical conditions associated with various different systems, organs, and tissues, may also benefit from the ability to locally deliver fluids or agents in a controlled manner. In particular, various conditions related to the renal system would benefit a great deal from an ability to locally deliver of therapeutic, prophylactic, or diagnostic agents into the renal arteries.  
         [0010]     Acute renal failure (“ARF”) is an abrupt decrease in the kidney&#39;s ability to excrete waste from a patient&#39;s blood. This change in kidney function may be attributable to many causes. A traumatic event, such as hemorrhage, gastrointestinal fluid loss, or renal fluid loss without proper fluid replacement may cause the patient to go into ARF. Patients may also become vulnerable to ARF after receiving anesthesia, surgery, or a-adrenergic agonists because of related systemic or renal vasoconstriction. Additionally, systemic vasodilation caused by anaphylaxis, and anti-hypertensive drugs, sepsis or drug overdose may also cause ARF because the body&#39;s natural defense is to shut down, i.e., vasoconstrict, non-essential organs such as the kidneys. Reduced cardiac output caused by cardiogenic shock, congestive heart failure, pericardial tamponade or massive pulmonary embolism creates an excess of fluid in the body, which can exacerbate congestive heart failure. For example, a reduction in blood flow and blood pressure in the kidneys due to reduced cardiac output can in turn result in the retention of excess fluid in the patient&#39;s body, leading, for example, to pulmonary and systemic edema.  
         [0011]     Previously known methods of treating ARF, or of treating acute renal insufficiency associated with congestive heart failure (“CHF”), involve administering drugs. Examples of such drugs that have been used for this purpose include, without limitation: vasodilators, including for example papavarine, fenoldopam mesylate, calcium-channel blockers, atrial natriuretic peptide (ANP), acetylcholine, nifedipine, nitroglycerine, nitroprusside, adenosine, dopamine, and theophylline; antioxidants, such as for example acetylcysteine; and diuretics, such as for example mannitol, or furosemide. However, many of these drugs, when administered in systemic doses, have undesirable side effects. Additionally, many of these drugs would not be helpful in treating other causes of ARF. While a septic shock patient with profound systemic vasodilation often has concomitant severe renal vasoconstriction, administering vasodilators to dilate the renal artery to a patient suffering from systemic vasodilation would compound the vasodilation system wide. In addition, for patients with severe CHF (e.g., those awaiting heart transplant), mechanical methods, such as hemodialysis or left ventricular assist devices, may be implemented. Surgical device interventions, such as hemodialysis, however, generally have not been observed to be highly efficacious for long-term management of CHF. Such interventions would also not be appropriate for many patients with strong hearts suffering from ARF.  
         [0012]     The renal system in many patients may also suffer from a particular fragility, or otherwise general exposure, to potentially harmful effects of other medical device interventions. For example, the kidneys as one of the body&#39;s main blood filtering tools may suffer damage from exposed to high density radiopaque contrast dye, such as during coronary, cardiac, or neuro angiography procedures. One particularly harmful condition known as “radiocontrast nephropathy” or “RCN” is often observed during such procedures, wherein an acute impairment of renal function follows exposure to such radiographic contrast materials, typically resulting in a rise in serum creatinine levels of more than 25% above baseline, or an absolute rise of 0.5 mg/dl within 48 hours. Therefore, in addition to CHF, renal damage associated with RCN is also a frequently observed cause of ARF. In addition, the kidneys&#39; function is directly related to cardiac output and related blood pressure into the renal system. These physiological parameters, as in the case of CHF, may also be significantly compromised during a surgical intervention such as an angioplasty, coronary artery bypass, valve repair or replacement, or other cardiac interventional procedure. Therefore, the various drugs used to treat patients experiencing ARF associated with other conditions such as CHF have also been used to treat patients afflicted with ARF as a result of RCN. Such drugs would also provide substantial benefit for treating or preventing ARF associated with acutely compromised hemodynamics to the renal system, such as during surgical interventions.  
         [0013]     There would be great advantage therefore from an ability to locally deliver such drugs into the renal arteries, in particular when delivered contemporaneous with surgical interventions, and in particular contemporaneous with radiocontrast dye delivery. However, many such procedures are done with medical device systems, such as using guiding catheters or angiography catheters having outer dimensions typically ranging between about 4 French to about 12 French, and ranging generally between about 6 French to about 8 French in the case of guide catheter systems for delivering angioplasty or stent devices into the coronary or neurovascular arteries (e.g. carotid arteries). These devices also are most typically delivered to their respective locations for use (e.g. coronary ostia) via a percutaneous, translumenal access in the femoral arteries and retrograde delivery upstream along the aorta past the region of the renal artery ostia. A Seldinger access technique to the femoral artery involves relatively controlled dilation of a puncture hole to minimize the size of the intruding window through the artery wall, and is a preferred method where the profiles of such delivery systems are sufficiently small. Otherwise, for larger systems a “cut-down” technique is used involving a larger, surgically made access window through the artery wall.  
         [0014]     Accordingly, a local renal agent delivery system for contemporaneous use with other retrogradedly delivered medical device systems, such as of the types just described above, would preferably be adapted to allow for such interventional device systems, in particular of the types and dimensions just described, to pass upstream across the renal artery ostia (a) while the agent is being locally delivered into the renal arteries, and (b) while allowing blood to flow downstream across the renal artery ostia, and (c) in an overall cooperating system that allows for Seldinger femoral artery access. Each one of these features (a), (b), or (c), or any sub-combination thereof, would provide significant value to patient treatment; a local renal delivery system providing for the combination of all three features is so much the more valuable.  
         [0015]     Notwithstanding the clear needs for and benefits that would be gained from such local drug delivery into the renal system, the ability to do so presents unique challenges as follows.  
         [0016]     In one regard, the renal arteries extend from respective ostia along the abdominal aorta that are significantly spaced apart from each other circumferentially around the relatively very large aorta. Often, these renal artery ostia are also spaced from each other longitudinally along the aorta with relative superior and inferior locations. This presents a unique challenge to locally deliver drugs or other agents into the renal system on the whole, which requires both kidneys to be fed through these separate respective arteries via their uniquely positioned and substantially spaced apart ostia. This becomes particularly important where both kidneys may be equally at risk, or are equally compromised, during an invasive upstream procedure—or, of course, for any other indication where both kidneys require local drug delivery. Thus, an appropriate local renal delivery system for such indications would preferably be adapted to feed multiple renal arteries perfusing both kidneys.  
         [0017]     In another regard, mere local delivery of an agent into the natural, physiologic blood flow path of the aorta upstream of the kidneys may provide some beneficial, localized renal delivery versus other systemic delivery methods, but various undesirable results still arise. In particular, the high flow aorta immediately washes much of the delivered agent beyond the intended renal artery ostia. This reduces the amount of agent actually perfusing the renal arteries with reduced efficacy, and thus also produces unwanted loss of the agent into other organs and tissues in the systemic circulation (with highest concentrations directly flowing into downstream circulation).  
         [0018]     In still a further regard, various known types of tubular local delivery catheters, such as angiographic catheters, other “end-hole” catheters, or otherwise, may be positioned with their distal agent perfusion ports located within the renal arteries themselves for delivering agents there, such as via a percutaneous translumenal procedure via the femoral arteries (or from other access points such as brachial arteries, etc.). However, such a technique may also provide less than completely desirable results.  
         [0019]     For example, such seating of the delivery catheter distal tip within a renal artery may be difficult to achieve from within the large diameter/high flow aorta, and may produce harmful intimal injury within the artery. Also, where multiple kidneys must be infused with agent, multiple renal arteries must be cannulated, either sequentially with a single delivery device, or simultaneously with multiple devices. This can become unnecessarily complicated and time consuming and further compound the risk of unwanted injury from the required catheter manipulation. Moreover, multiple dye injections may be required in order to locate the renal ostia for such catheter positioning, increasing the risks associated with contrast agents on kidney function (e.g. RCN)—the very organ system to be protected by the agent delivery system in the first place. Still further, the renal arteries themselves, possibly including their ostia, may have pre-existing conditions that either prevent the ability to provide the required catheter seating, or that increase the risks associated with such mechanical intrusion. For example, the artery wall may be diseased or stenotic, such as due to atherosclerotic plaque, clot, dissection, or other injury or condition. Finally, among other additional considerations, previous disclosures have yet to describe an efficacious and safe system and method for positioning these types of local agent delivery devices at the renal arteries through a common introducer or guide sheath shared with additional medical devices used for upstream interventions, such as angiography or guide catheters. In particular, to do so concurrently with multiple delivery catheters for simultaneous infusion of multiple renal arteries would further require a guide sheath of such significant dimensions that the preferred Seldinger vascular access technique would likely not be available, instead requiring the less desirable “cut-down” technique.  
         [0020]     In addition to the various needs for locally delivering agents into branch arteries described above, much benefit may also be gained from simply locally enhancing blood perfusion into such branches, such as by increasing the blood pressure at their ostia. In particular, such enhancement would improve a number of medical conditions related to insufficient physiological perfusion into branch vessels, and in particular from an aorta and into its branch vessels such as the renal arteries.  
         [0021]     Certain prior disclosures have provided surgical device assemblies and methods intended to enhance blood delivery into branch arteries extending from an aorta. For example, intra-aortic balloon pumps (IABPs) have been disclosed for use in diverting blood flow into certain branch arteries. One such technique involves placing an IABP in the abdominal aorta so that the balloon is situated slightly below (proximal to) the branch arteries. The balloon is selectively inflated and deflated in a counterpulsation mode (by reference to the physiologic pressure cycle) so that increased pressure distal to the balloon directs a greater portion of blood flow into principally the branch arteries in the region of their ostia. However, the flow to lower extremities downstream from such balloon system can be severely occluded during portions of this counterpulsing cycle. Moreover, such previously disclosed systems generally lack the ability to deliver drug or agent to the branch arteries while allowing continuous and substantial downstream perfusion sufficient to prevent unwanted ischemia.  
         [0022]     It is further noted that, despite the renal risks described in relation to radiocontrast dye delivery, and in particular RCN, in certain circumstances local delivery of such dye or other diagnostic agents is indicated specifically for diagnosing the renal arteries themselves. For example, diagnosis and treatment of renal stenosis, such as due to atherosclerosis or dissection, may require dye injection into a subject renal artery. In such circumstances, enhancing the localization of the dye into the renal arteries may also be desirable. In one regard, without such localization larger volumes of dye may be required, and the dye lost into the downstream aortic flow may still be additive to impacting the kidney(s) as it circulates back there through the system. In another regard, an ability to locally deliver such dye into the renal artery from within the artery itself, such as by seating an angiography catheter there, may also be hindered by the same stenotic condition requiring the dye injection in the first place (as introduced above). Still further, patients may have stent-grafts that may prevent delivery catheter seating.  
         [0023]     Notwithstanding the interest and advances toward locally delivering agents for treatment or diagnosis of organs or tissues, the previously disclosed systems and methods summarized immediately above generally lack the ability to effectively deliver agents from within a main artery and locally into substantially only branch arteries extending therefrom while allowing the passage of substantial blood flow and/or other medical devices through the main artery past the branches. This is in particular the case with previously disclosed renal treatment and diagnostic devices and methods, which do not adequately provide for local delivery of agents into the renal system from a location within the aorta while allowing substantial blood flow continuously downstream past the renal ostia and/or while allowing distal medical device assemblies to be passed retrogradedly across the renal ostia for upstream use. Much benefit would be gained if agents, such as protective or therapeutic drugs or radiopaque contrast dye, could be delivered to one or both of the renal arteries in such a manner.  
         [0024]     Several more recently disclosed advances have included local flow assemblies using tubular members of varied diameters that divide flow within an aorta adjacent to renal artery ostia into outer and inner flow paths substantially perfusing the renal artery ostia and downstream circulation, respectively. Such disclosures further include delivering fluid agent primarily into the outer flow path for substantially localized delivery into the renal artery ostia. These disclosed systems and methods represent exciting new developments toward localized diagnosis and treatment of pre-existing conditions associated with branch vessels from main vessels in general, and with respect to renal arteries extending from abdominal aortas in particular.  
         [0025]     However, such previously disclosed designs would still benefit from further modifications and improvements in order to: maximize mixing of a fluid agent within the entire circumference of the exterior flow path surrounding the tubular flow divider and perfusing multiple renal artery ostia; use the systems and methods for prophylaxis and protection of the renal system from harm, in particular during upstream interventional procedures; maximize the range of useful sizing for specific devices to accommodate a wide range of anatomic dimensions between patients; and optimize the construction, design, and inter-cooperation between system components for efficient, atraumatic use.  
         [0026]     A need still exists for improved devices and methods for diverting blood flow principally into the renal arteries of a patient from a location within the patient&#39;s aorta adjacent the renal artery ostia along the aorta wall while at least a portion of aortic blood flow is allowed to perfuse downstream across the location of the renal artery ostia and into the patient&#39;s lower extremities.  
         [0027]     A need still exists for improved devices and methods for substantially isolating first and second portions of aortic blood flow at a location within the aorta of a patient adjacent the renal artery ostia along the aorta wall, and directing the first portion into the renal arteries from the location within the aorta while allowing the second portion to flow across the location and downstream of the renal artery ostia into the patient&#39;s lower extremities. There is a further benefit and need for providing passive blood flow along the isolated paths and without providing active in-situ mechanical flow support to either or both of the first or second portions of aortic blood flow. Moreover, there is a further need to direct the first portion of blood along the first flow path in a manner that increases the pressure at the renal artery ostia.  
         [0028]     A need still exists for improved devices and methods for delivering agents such as radiopaque dye or drugs into a renal artery from a location within the aorta of a patient adjacent the renal artery&#39;s ostium along the aorta wall, and without requiring translumenal positioning of an agent delivery device within the renal artery itself or its ostium.  
         [0029]     A need still exists for improved devices and methods for locally isolating delivery of fluids or agents such as radiopaque dye or drugs simultaneously into multiple renal arteries feeding both kidneys of a patient using a single delivery device and without requiring translumenal positioning of multiple agent delivery devices respectively within the multiple renal arteries themselves.  
         [0030]     A need still exists for improved devices and methods for locally isolating delivery of fluids or agents into the renal arteries of a patient from a location within the patient&#39;s aorta adjacent the renal artery ostia along the aorta wall, and while allowing other treatment or diagnostic devices and systems, such as angiographic or guiding catheter devices and related systems, to be delivered across the location.  
         [0031]     A need still exists for improved devices and methods for locally delivering fluids or agents into the renal arteries from a location within the aorta of a patient adjacent to the renal artery ostia along the aorta wall, and other than as a remedial measure to treat pre-existing renal conditions, and in particular for prophylaxis or diagnostic procedures related to the kidneys.  
         [0032]     A need still exists for improved devices and methods for locally isolating delivery of fluids or agents into the renal arteries of a patient in order to treat, protect, or diagnose the renal system adjunctive to performing other contemporaneous medical procedures such as angiograms other translumenal procedures upstream of the renal artery ostia.  
         [0033]     A need still exists for improved devices and methods for delivering both a flow diverter system and at least one adjunctive distal interventional device, such as an angiographic or guiding catheter, through a common delivery sheath.  
         [0034]     A need also still exists for improved devices and methods for delivering both a flow diverter system and at least one adjunctive distal interventional device, such as an angiographic or guiding catheter, through a single access site, such as a single femoral arterial puncture.  
         [0035]     A need also still exists for improved devices and methods for treating, and in particular preventing, ARF, and in particular relation to RCN or CHF, by locally delivering renal protective or ameliorative drugs into the renal arteries, such as contemporaneous with radiocontrast injections such as during angiography procedures.  
         [0036]     In addition to these particular needs for diverting blood flow into a patient&#39;s renal arteries via their ostia along the aorta, other similar needs also exist for diverting blood flow into other branch vessels or lumens extending from other main vessels or lumens, respectively, in a patient.  
       BRIEF SUMMARY OF THE INVENTION  
       [0037]     In general, various of the aspects of the invention described immediately below provide a local renal infusion system for treating a renal system in a patient from a location within the abdominal aorta associated with abdominal aortic blood flow into first and second renal arteries via respective first and second renal ostia having unique relative locations along the abdominal aorta wall. Moreover, such a system is generally provided with a local injection assembly and a flow isolation assembly.  
         [0038]     According to one such aspect, the system includes a local injection assembly is provided in combination with a flow isolation assembly with a tubular wall having a longitudinal axis between a first end and a second end. The flow isolation assembly is adapted to be delivered to the location in a first condition with the tubular wall in a first configuration with a first diameter transverse to the longitudinal axis, and such that the first end is located upstream of the renal ostia and the second end is located downstream of the first end. The flow isolation assembly at the location is adjustable from the first condition to a second condition with the tubular wall in a second configuration as follows. The tubular wall in the second configuration has a second diameter that is greater than the first diameter and that is substantially constant between the first and second ends. According to this arrangement, a first region of abdominal aortic flow within an exterior flow path between the wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow located within an interior flow path within the tubular wall, and the first and second regions of abdominal aortic blood flow are not substantially diverted by the tubular shaped wall. The local injection assembly is adapted to be fluidly coupled to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region between the abdominal aortic wall and the tubular wall in the second configuration at the location.  
         [0039]     Another such aspect provides a local injection assembly in combination with a flow isolation assembly with a tubular wall having a longitudinal axis extending between a first end and a second end and also with a support member that is substantially ring-shaped and that is coupled to the tubular wall at one of the first and second ends. The flow isolation assembly is adapted to be delivered to the location in a first condition with the tubular wall in a first configuration and with the support member in a radially collapsed condition with a collapsed diameter transverse to the longitudinal axis, and further such that the first end is located upstream of the renal ostia and the second end is located downstream of the first end. At this location, the flow isolation assembly at the location is adjustable from the first condition to a second condition with the tubular wall in a second configuration and the support member in a radially extended condition with an extended diameter that is greater than the collapsed diameter. The support member in the radially extended condition supports the tubular wall at least in part in the second configuration with a tubular shape that is radially expanded relative to the first configuration with respect to the longitudinal axis. Accordingly, the assembly is adapted such that a first region of abdominal aortic flow within an exterior flow path between the tubular wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow located within an interior flow path within the tubular wall. Of substantial benefit, the support member is constructed from a superelastic metallic wire with two opposite ends and a curved region between the two opposite ends that forms a substantially looped shape around a circumferential path. The wire has a memory shape with the two opposite ends at first and second memory positions relative to each other with respect to the circumferential path such that the curved region has a memory diameter that is less than the extended diameter. The wire in the flow isolation assembly is secured relative to the tubular member in a superelastically deformed condition with the two opposite ends at first and second displaced positions relative to each other such that the support member in the second configuration and with the extended diameter comprises a superelastically deformed condition for the wire. The local injection assembly is adapted to be fluidly coupled to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region with the flow isolation assembly in the second condition at the location.  
         [0040]     Another aspect includes a local injection assembly in combination with a flow isolation assembly with a tubular wall having a longitudinal axis between a first end and a second end as follows. A retraction member is also provided in the system with a proximal end portion and a distal end portion that is coupled to the flow isolation assembly. The flow isolation assembly is adapted to be delivered to the location in a first condition with the tubular wall in a first configuration with a first diameter transverse to the longitudinal axis, and such that the first end is located upstream of the renal ostia and the second end is located downstream of the first end. The flow isolation assembly at the location is adjustable from the first condition to a second condition with the tubular wall in a second configuration. The tubular wall in the second configuration comprises a second diameter that is greater than the first diameter such that a first region of abdominal aortic flow within an exterior flow path between the tubular wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow along an interior flow path within the tubular wall. Accordingly, the retraction member is adapted to adjust the tubular wall from the second configuration to a third configuration by proximal withdrawal of the proximal end portion of the retraction member externally of the patient. In this third configuration the tubular wall is partially retracted and has a third diameter that is less than the second diameter but greater than the first diameter. In addition, the local injection assembly is adapted to couple to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region with the flow isolation assembly in the second condition.  
         [0041]     Another aspect also includes a local injection assembly with a flow isolation assembly with a tubular wall, an inflatable member, and an expandable member. The tubular wall has a first end, a second end, an outer surface, and an inner surface that defines a longitudinal passageway that extends along a longitudinal axis between the first and second ends. The inflatable member is located within the longitudinal passageway of the tubular wall and is adjustable between a deflated condition with a deflated diameter and an inflated condition with an inflated diameter that is greater than the deflated diameter. The tubular wall is adjustable, by inflating the inflatable member from the deflated condition to the inflated condition, from a first configuration with the longitudinal passageway having a first inner diameter transverse to the longitudinal axis to a second configuration with the longitudinal passageway having a second inner diameter that is greater than the first inner diameter. The inflatable member in the inflated condition does not completely occlude the longitudinal passageway of the tubular wall in the second configuration such that at least one flow passageway extends along the longitudinal passageway between the first and second ends. In addition, the expandable member is located on the outer surface of the tubular member and is adjustable between a radially collapsed condition relative to the outer surface and a radially expanded condition that is expanded from the outer surface of the tubular member relative to the radially collapsed condition. Also, the flow isolation assembly is adapted to be delivered to the location in a first condition that is characterized by the inflatable member in the deflated condition, the tubular wall in the first configuration, and the expandable member in the radially collapsed condition, and such that the first end is located upstream of the renal ostia and the second end is located downstream of the first end. The flow isolation assembly at the location is adjustable from the first condition to a second condition that is characterized by the inflatable member in the inflated condition, the tubular wall in the second configuration, the expandable member in the radially expanded condition. In the second condition at the location, the flow isolation assembly is adapted to substantially isolate a first region of abdominal aortic blood flow externally around the tubular member from a second region of abdominal aortic blood flow internally within the tubular member along the at least one flow passageway. The local injection assembly is adapted to couple to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region when the flow isolation assembly is in the second condition at the location.  
         [0042]     Another aspect includes a delivery member with an elongate body with a proximal end portion and a distal end portion with a longitudinal axis and a circumference, and a bilateral local renal delivery assembly comprising a local injection assembly and a flow isolation assembly. The local injection assembly has a plurality of arms that are spaced circumferentially around the distal end portion. Each arm extends along the longitudinal axis between a proximal position and a distal position. The local injection assembly further includes a plurality of injection ports located along the plurality of arms, respectively, between the respective proximal and distal positions. The flow isolation assembly includes a wall assembly coupled to the plurality of arms. Accordingly, the bilateral local renal delivery assembly is adapted to be delivered with the distal end portion to the location in a first condition with the plurality of arms and wall assembly in a radially collapsed condition relative to the elongate body with the proximal end portion extending externally of the patient. The bilateral local renal delivery assembly is thus adjustable at the location from the first condition to a second condition wherein the plurality of arms and wall assembly are in a radially extended condition that is extended from the elongate body relative to the radially collapsed condition. In the second condition the arms and wall assembly form an expanded tubular wall that substantially isolates a first region of abdominal aortic blood flow along an exterior flow path between the tubular wall and the abdominal aortic wall from a second region of abdominal aortic blood flow along an interior flow path extending within the tubular wall between the proximal and distal positions, respectively. Also in the second condition at the location, the plurality of injection ports are fluidly coupled to the first region and are adapted to be fluidly coupled to a source of fluid agent located externally of the patient. The injection ports are adapted to inject a volume of fluid agent from the source and into the first region such that the injected volume flows substantially into the first and second renal arteries via the respective first and second renal ostia.  
         [0043]     Another aspect provides a local injection assembly in combination with a flow isolation assembly with a wall that has a first portion and a second portion with a vent. The local injection assembly is adapted to be delivered to the location and to be fluidly coupled to a source of fluid agent located externally of the patient. In a first condition for the flow isolation assembly the wall is in a first configuration and is adapted to be delivered to the location. At the location, the flow isolation assembly is adjustable from the first condition to the second condition. In the second condition at the location, the first portion of the wall is adapted to isolate a first region from a second region of abdominal aortic blood flow at the location. The local injection assembly is adapted to cooperate with the flow isolation assembly so as to inject a volume of fluid agent from the source and into the first region at the location with the flow isolation assembly in the second condition at the location. Furthermore, the vent is adapted to allow the first region to communicate with the second region along the second portion.  
         [0044]     Another aspect provides a local injection assembly in combination with a flow isolation assembly with a wall having a first end and a second end. The flow isolation assembly has a first condition with the wall in a first configuration and such that the flow isolation assembly is adapted to be delivered to the location with the first end located upstream of the renal ostia and with the second end located downstream of the first end. The flow isolation assembly at the location is adjustable from the first condition to a second condition wherein the wall is in a second configuration that is angled relative to a longitudinal axis of the abdominal aorta such that the first end is closer to a portion of the abdominal aorta wall than the second end and such that a first region of abdominal aortic blood flow between the wall and the portion is substantially isolated from a second region of abdominal aortic blood flow opposite the first region relative to the wall. The local injection assembly is adapted to couple to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region with the flow isolation assembly in the second condition at the location.  
         [0045]     Another aspect is a local injection assembly in combination with a flow isolation assembly that is adjustable between a first condition and a second condition. The flow isolation assembly in the first condition is adapted to be delivered to the location. The flow isolation assembly at the location is adjustable from the first condition to the second condition. The flow isolation assembly in the second condition at the location is adapted to isolate fluid communication between a first region and a second region of abdominal aortic blood flow. The local injection assembly is adapted to couple to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region with the flow isolation assembly in the second condition at the location. Further to this aspect, the first region does not include a portion of an outer region of the abdominal aortic blood flow along the abdominal aortic wall.  
         [0046]     Another aspect provides a local injection assembly with first and second injection ports in combination with a flow isolation assembly. The flow isolation assembly is adjustable between a first condition and a second condition as follows. In the first condition, the flow isolation assembly is adapted to be delivered to the location. The flow isolation assembly at the location is adjustable from the first condition to the second condition that is adapted to isolate fluid communication between a first region and a second region of abdominal aortic blood flow. The first and second injection ports are adapted to be delivered to first and second positions that are fluidly coupled with the first region when the flow isolation assembly is in the second condition at the location. The first and second injection ports at the first and second positions are adapted to be fluidly coupled to a source of fluid agent located externally of the patient and to simultaneously inject a volume of fluid agent from the source and into the first region such that the injected volume of fluid agent flows substantially into the first and second renal arteries, respectively, via the respective first and second renal ostia.  
         [0047]     Another aspect provides a delivery member with an elongate body having a proximal end portion and a distal end portion and also a delivery lumen extending along a longitudinal axis between a proximal port along the proximal end portion and a distal port along the distal end portion, and also provides a local injection assembly that is adjustable between a first configuration and a second configuration The delivery lumen has a proximal portion with a first inner diameter along the proximal end portion, and has a distal portion with a second diameter that is greater than the first diameter along the distal end portion. The local injection assembly in the first configuration is located within the distal portion of the delivery lumen; wherein the distal end portion is adapted to be positioned with the local injection assembly in the first configuration at the location while the proximal end portion extends externally from the patient. The local injection assembly at the location is adapted to be fluidly coupled to a source of fluid agent located externally of the patient. The local injection assembly is adjustable at the location from the first configuration to the second configuration that is extended distally from the distal portion of the delivery lumen through the distal port and into the abdominal aorta at the location. Moreover, the local injection assembly in the second configuration at the location is adapted to inject a volume of fluid agent from the source and substantially into the first and second renal arteries.  
         [0048]     Another aspect of the invention is a proximal coupler assembly for concurrent use with a bilateral local renal delivery device and percutaneous translumenal interventional device. This is of particular benefit where the bilateral local renal delivery device comprises an elongate body with a proximal end portion and a distal end portion and a local injection assembly located along the distal end portion. The system according to this aspect includes a housing with a distal end and a proximal end. The distal end includes a distal coupler that is adapted to be coupled to an introducer sheath that provides percutaneous translumenal access into a vasculature of a patient that leads to a location within an abdominal aorta associated with renal artery ostia. The proximal end comprises an adjustable hemostatic coupler that is adapted to simultaneously receive the bilateral local renal delivery device and the percutaneous translumenal device into the housing and is substantially aligned along a longitudinal axis with the distal end of the housing. Also included in this system are means for securing the proximal end portion of the bilateral local renal delivery device off-axis relative to the longitudinal axis so as to reduce interference between the percutaneous translumenal interventional device and the bilateral local renal delivery device when the percutaneous translumenal interventional device is manipulated within the hemostatic valve.  
         [0049]     Another aspect of the invention is a method for treating a renal system in a patient from a location within the abdominal aorta associated with abdominal aortic blood flow into each of first and second renal arteries via first and second renal ostia, respectively, at unique respective locations along the abdominal aorta wall.  
         [0050]     One such method includes positioning a local injection assembly at the location; fluidly coupling to the local injection assembly at the location to a source of fluid agent externally of the patient; and injecting a volume of fluid agent from the source and into the abdominal aorta at the location in a manner such that the injected fluid flows principally into the first and second renal arteries via the first and second renal ostia, respectively, and without substantially occluding or isolating a substantial portion of an outer region of aortic blood flow along a circumference of the abdominal aorta wall and across the location.  
         [0051]     Another method aspect includes delivering a flow isolation assembly with a tubular wall having a longitudinal axis between a first end and a second end to the location in a first condition with the tubular wall in a first configuration with a first diameter transverse to the longitudinal axis, and such that the first end is located upstream of the renal ostia and the second end is located downstream of the first end. Also included is adjusting the flow isolation assembly at the location from the first condition to a second condition with the tubular wall in a second configuration that comprises a second diameter that is greater than the first diameter and that is substantially constant between the first and second ends such that a first region of abdominal aortic flow within an exterior flow path between the wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow located within an interior flow path within the tubular shaped wall, and further such that the first and second regions of abdominal aortic blood flow are not substantially diverted by the tubular shaped wall. Further includes is fluidly coupling a local injection assembly to a source of fluid agent located externally of the patient. Also included is injecting a volume of fluid agent from the source and into the first region between the abdominal aortic wall and the tubular wall in the second configuration at the location.  
         [0052]     Another method aspect includes delivering a flow isolation assembly with a tubular wall to the location in a first condition with the tubular wall in a first configuration and with a support member in a radially collapsed condition with a collapsed diameter transverse to a longitudinal axis of the tubular wall, and such that a first end of the tubular wall is located upstream of the renal ostia and a second end of the tubular wall is located downstream of the first end. Another step of this aspect includes adjusting the flow isolation assembly at the location from the first condition to a second condition with the tubular wall in a second configuration and the support member in a radially extended condition with an extended diameter that is greater than the collapsed diameter. Still a further step includes: supporting the tubular wall in the second configuration with the support member in the radially extended condition such that the tubular wall has a tubular shape that is radially expanded relative to the first configuration with respect to the longitudinal axis, and such that a first region of abdominal aortic flow within an exterior flow path between the tubular wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow located within an interior flow path within the tubular wall. This method is of particular benefit wherein the support member includes a superelastic metallic wire with two opposite ends and a curved region between the two opposite ends that forms a substantially looped shape around a circumferential path, and the support member in the second configuration and with the extended diameter includes a superelastically deformed condition for the wire. Another step includes fluidly coupling the local injection assembly to a source of fluid agent located externally of the patient. A further step is: injecting a volume of fluid agent with the local injection assembly from the source and into the first region with the flow isolation assembly in the second condition at the location.  
         [0053]     Another aspect of the invention includes a method for treating a renal system in a patient from a location within the abdominal aorta associated with abdominal aortic blood flow into first and second renal arteries via respective first and second renal ostia having unique relative locations along the abdominal aorta wall. This further method includes: providing a local injection assembly and a flow isolation assembly with a tubular wall having a longitudinal axis between a first end and a second end. Also included is using a retraction member with a proximal end portion and a distal end portion that is coupled to the flow isolation assembly to control the flow isolation assembly. This method further includes delivering a flow isolation assembly to the location in a first condition with a tubular wall in a first configuration with a first diameter transverse to a longitudinal axis within the tubular wall, and such that a first end of the tubular wall is located upstream of the renal ostia and a second end of the tubular wall is located downstream of the first end. Also included is adjusting the flow isolation assembly at the location from the first condition to a second condition with the tubular wall in a second configuration that comprises a second diameter that is greater than the first diameter such that a first region of abdominal aortic flow within an exterior flow path between the tubular wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow along an interior flow path within the tubular shaped wall. A further step is adjusting the tubular wall from the second configuration to a third configuration by proximal withdrawal of a proximal end portion of a retraction member externally of the patient, wherein a distal end portion of the retraction member is coupled to the tubular wall, and such that in the third configuration the tubular wall is partially retracted and has a third diameter that is less than the second diameter but greater than the first diameter. Still further is coupling a local injection assembly to a source of fluid agent located externally of the patient, and injecting a volume of fluid agent with the local injection assembly from the source and into the first region with the flow isolation assembly in the second condition.  
         [0054]     Another method aspect includes as a step: delivering a flow isolation assembly to the location in a first condition that is characterized by an inflatable member within a longitudinal passageway of a tubular wall in a deflated condition with a deflated diameter, the tubular wall in a first configuration, and an expandable member on an outer surface of the tubular wall in a radially collapsed condition, and such that a first end of the tubular wall is located upstream of the renal ostia and a second end of the tubular wall is located downstream of the first end. Also included is the following step: adjusting the flow isolation assembly at the location from the first condition to a second condition by inflating the inflatable member to an inflated condition with an inflated diameter that is greater than the deflated diameter and that expands the tubular wall such that the longitudinal passageway has a second inner diameter that is greater than the first inner diameter, and also by expanding the expandable member to a radially expanded condition that is expanded from the outer surface of the tubular member relative to the radially collapsed condition, and further such that the inflatable member in the inflated condition does not completely occlude the longitudinal passageway of the tubular wall in the second configuration so as to provide at least one flow passageway extending along the longitudinal passageway between the first and second ends. Still a further step includes substantially isolating a first region of abdominal aortic blood flow externally around the tubular member from a second region of abdominal aortic blood flow internally within the tubular member along the at least one flow passageway with the flow isolation assembly in the second condition at the location. Another step is: coupling a local injection assembly to a source of fluid agent located externally of the patient; and injecting a volume of fluid agent with the local injection assembly from the source and into the first region when the flow isolation assembly is in the second condition at the location.  
         [0055]     Another method aspect includes providing a delivery member with an elongate body with a proximal end portion and a distal end portion with a longitudinal axis and a circumference; providing a bilateral local renal delivery assembly with a local injection assembly and a flow isolation assembly, wherein the local injection assembly comprises a plurality of arms that are spaced circumferentially around the distal end portion, wherein each arm extends along the longitudinal axis between a proximal position and a distal position, wherein the local injection assembly further comprises a plurality of injection ports located along the plurality of arms, respectively, between the respective proximal and distal positions, and wherein the flow isolation assembly comprises a wall assembly coupled to the plurality of arms; delivering the bilateral local renal delivery assembly with the distal end portion of the elongate body of the delivery member to the location in a first condition with a plurality of arms and wall assembly in a radially collapsed condition relative to the elongate body while a proximal end portion of the elongate body extends externally of the patient; adjusting the bilateral local renal delivery assembly at the location from the first condition to a second condition wherein the plurality of arms and wall assembly are in a radially extended condition that is extended from the elongate body relative to the radially collapsed condition; forming an expanded tubular wall with the arms and wall assembly in the second condition; substantially isolating a first region of abdominal aortic blood flow along an exterior flow path between the tubular wall and the abdominal aortic wall, and a second region of abdominal aortic blood flow along an interior flow path extending within the tubular wall between proximal and distal ports adjacent to and located between the proximal and distal positions, respectively, with the expanded tubular wall at the location. According to another step in the second condition at the location, fluidly coupling the plurality of injection ports to the first region and also to a source of fluid agent located externally of the patient. Further included is injecting a volume of the fluid agent with the injection ports from the source and into the first region such that the injected volume flows substantially into the first and second renal arteries via the respective first and second renal ostia.  
         [0056]     Another method aspect includes delivering a flow isolation assembly in a first condition with a wall in a first configuration to the location; fluidly coupling the local injection assembly at the location to a source of fluid agent located externally of the patient; adjusting the flow isolation assembly at the location from the first condition to a second condition wherein a first portion of the wall is adapted to isolate a first region from a second region of abdominal aortic blood flow at the location; injecting a volume of fluid agent with a local injection assembly from the source and into the first region at the location with the flow isolation assembly in the second condition at the location; and allowing the first region to communicate with the second region through a vent located along a second portion of the wall.  
         [0057]     Another method aspect includes delivering a flow isolation assembly in a first condition to the location with a wall in a first configuration and a first end of the wall located upstream of the renal ostia and a second end of the wall located downstream of the first end; adjusting the flow isolation assembly at the location from the first condition to a second condition with the wall in a second configuration that is angled relative to a longitudinal axis of the abdominal aorta such that the upstream end is closer to a portion of the abdominal aorta wall than the downstream end and such that a first region of abdominal aortic blood flow between the wall and the portion is substantially isolated from a second region of abdominal aortic blood flow opposite the first region relative to the wall; coupling a local injection assembly to a source of fluid agent located externally of the patient; and injecting a volume of fluid agent with the local injection assembly from the source and into the first region while the flow isolation assembly is in the second condition at the location.  
         [0058]     Another method aspect includes delivering a flow isolation assembly in a first condition to the location; adjusting the flow isolation assembly at the location from the first condition to a second condition wherein the flow isolation assembly is adapted to isolate fluid communication between a first region and a second region of abdominal aortic blood flow and wherein the first region does not include a portion of an outer region of the abdominal aortic blood flow along the abdominal aortic wall; coupling the local injection assembly to a source of fluid agent located externally of the patient; and injecting a volume of fluid agent from the source and into the first region while the flow isolation assembly is in the second condition at the location.  
         [0059]     Another method aspect includes delivering a flow isolation assembly in a first condition to the location; adjusting the flow isolation assembly at the location from the first condition to a second condition that is adapted to isolate fluid communication between a first region and a second region of abdominal aortic blood flow; delivering first and second injection ports of a local injection assembly to first and second positions that are fluidly coupled with the first region when the flow isolation assembly is in the second condition at the location; fluidly coupling the first and second injection ports at the first and second positions to a source of fluid agent located externally of the patient; and simultaneously injecting a volume of fluid agent from the source and into the first region such that the injected volume of fluid agent flows substantially into the first and second renal arteries, respectively, via the respective first and second renal ostia.  
         [0060]     Another method aspect includes providing a delivery member with an elongate body having a proximal end portion and a distal end portion and also a delivery lumen extending along a longitudinal axis between a proximal port along the proximal end portion and a distal port along the distal end portion; providing a local injection assembly that is adjustable between a first configuration and a second configuration. The delivery lumen has a proximal portion with a first inner diameter along the proximal end portion, and has a distal portion with a second diameter that is greater than the first diameter along the distal end portion. Another step is positioning a local injection assembly in the first configuration within the distal portion of the delivery lumen. Still another is delivering the distal end portion with the local injection assembly in the first configuration at the location while the proximal end portion extends externally from the patient. A further step includes fluidly coupling the local injection assembly at the location to a source of fluid agent located externally of the patient; adjusting the local injection assembly at the location from the first configuration to a second configuration that is extended distally from the distal portion of the delivery lumen through the distal port and into the abdominal aorta at the location; and injecting a volume of fluid agent from the source and substantially into the first and second renal arteries with the local injection assembly in the second configuration at the location.  
         [0061]     Further aspects of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0062]     The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only:  
         [0063]      FIG. 1  is a schematic illustration of the natural blood flow patterns of the aorta and renal arteries.  
         [0064]      FIG. 2  illustrates an aortic flow diverter with a single hoop and double walled skirt.  
         [0065]      FIG. 3  is a schematic illustration of the aortic flow diverter in  FIG. 2  inserted in the aorta above the renal arteries.  
         [0066]      FIG. 4  is an illustration of another aortic flow diverter with two hoops.  
         [0067]      FIG. 5  is a partial side section view of the aortic flow diverter in  FIG. 4  inserted in the aorta above the renal arteries.  
         [0068]      FIG. 6A  illustrates a side view of an aortic flow diverter with a skirt with a partial conical shape.  
         [0069]      FIG. 6B  illustrates a dorsal view of the aortic flow diverter shown in  FIG. 6A .  
         [0070]      FIG. 6C  illustrates the aortic flow diverter shown in  FIG. 6A  inserted in the aorta near the renal arteries.  
         [0071]      FIG. 7  illustrates an aortic flow diverter with the distal hoop larger than the proximal hoop and holes to direct aortic blood flow.  
         [0072]      FIG. 8  shows the aortic flow diverter of  FIG. 7  positioned in the aorta above the renal arteries.  
         [0073]      FIG. 9  illustrates a metal frame of a scalloped shape aortic flow diverter.  
         [0074]      FIG. 10  illustrates the fabric covering the frame shown in  FIG. 9 .  
         [0075]      FIG. 11  illustrates the scallop shaped flow diverter shown in  FIG. 10  in a bifurcated configuration and positioned in the aorta.  
         [0076]      FIG. 12  is a top cross section view of the scallop shape flow diverter shown in  FIG. 1  positioned in the aorta.  
         [0077]      FIG. 13  illustrates the catheter cross section of another mode of deploying a scallop shaped flow diverter as shown in  FIG. 11 .  
         [0078]      FIG. 14 . illustrates the retraction of the scallop shaped flow diverter as shown in  FIG. 11  into a sheath.  
         [0079]      FIG. 15  Illustrates a catheter with an enlarged distal tip adapted to deliver an aortic flow diverter.  
         [0080]      FIG. 16  illustrates schematically the positioning of the aortic flow diverter shown in  FIG. 15  in the aorta system.  
         [0081]      FIG. 17  illustrates schematically the aortic flow diverter shown in  FIG. 16  deployed near the renal arteries in an expanded state.  
         [0082]      FIG. 18  illustrates an aortic flow diverter with a pull wire in a partially collapsed state.  
         [0083]      FIG. 19  illustrates the aortic flow diverter shown in  FIG. 18  deployed into an expanded state by relaxing the pull wire.  
         [0084]      FIG. 20  illustrates a variation of the aortic flow diverter  FIG. 18  that adapts to a collapsed shape using a pulley assembly with a pull wire.  
         [0085]      FIG. 21  illustrates the aortic flow diverter in  FIG. 20  deployed into an expanded state by relaxing the pull wire.  
         [0086]      FIG. 22  illustrates positioning of the aortic flow diverter shown in  FIG. 21  with a proximal hub assembly and introducer sheath.  
         [0087]      FIG. 23  shows schematically an aortic flow diverter configured as a collar around a guide catheter.  
         [0088]      FIG. 24  shows another embodiment of the aortic flow diverter in  FIG. 23  where an expandable tubular member is placed on a fluid delivery lumen.  
         [0089]      FIG. 25  illustrates schematically a fluid agent delivery system where a guide catheter is a dual lumen extrusion.  
         [0090]      FIG. 26  illustrates schematically another fluid delivery system where the guide catheter has three lumens and an inflatable member.  
         [0091]      FIG. 27  illustrates schematically another fluid delivery catheter where an aortic flow diverter assembly is attached to the catheter at a position downstream of a fluid delivery port.  
         [0092]      FIG. 28 . is an illustration of an expandable aortic flow diverter.  
         [0093]      FIG. 29  illustrates the expandable aortic flow diverter shown in  FIG. 28  in a collapsed state.  
         [0094]      FIG. 30  is a schematic illustration of the expandable aortic flow diverter shown in  FIG. 28  positioned in an aorta.  
         [0095]      FIG. 31  illustrates an expandable aortic flow diverter adapting to a small aorta.  
         [0096]      FIG. 32  illustrates an expandable aortic flow diverter adapting to a large aorta.  
         [0097]      FIG. 33A  illustrates a hoop for an aortic flow diverter, formed of a superelastic alloy, in its expanded condition and in its relaxed, zero strain state.  
         [0098]      FIG. 33B  illustrates a hoop, formed of a superelastic alloy, for an aortic flow diverter in its relaxed, zero strain state, where it is configured smaller than its expanded condition but larger than its collapsed condition.  
         [0099]      FIG. 34A  illustrates a typical stress strain graph for compressing the hoop configuration shown in  FIG. 33A .  
         [0100]      FIG. 34B  illustrates a typical stress strain graph for compressing the hoop configuration shown in  FIG. 33B .  
         [0101]      FIG. 35  illustrates a tool for forming an aortic flow diverter hoop shown in  FIG. 33A .  
         [0102]      FIG. 36  illustrates a tool for forming an aortic flow diverter hoop shown in  FIG. 33B .  
         [0103]      FIG. 37  illustrates a first step in forming lumens for an aortic flow diverter starting with a tube of ePTFE material, extruded with multiple lumens.  
         [0104]      FIG. 38  is a cross section of the tube shown in  FIG. 37  illustrating the position of lumens and the position for making an axial cut line.  
         [0105]      FIG. 39  illustrates the sheet formed from the tube shown in  FIG. 37  after the axial cut.  
         [0106]      FIG. 40  illustrates a flow diverter clip assembly.  
         [0107]      FIG. 41  illustrates a variation of the flow diverter clip assembly shown in  FIG. 40 .  
         [0108]      FIG. 42  illustrates another beneficial embodiment of the flow diverter clip assembly shown in  FIG. 40 .  
         [0109]      FIG. 43  illustrates the left or right placement of a flow diverter clip assembly as shown in  FIG. 40  on a patient.  
         [0110]      FIG. 44  illustrates the position of a left flow diverter clip assembly shown in  FIG. 43  with an aortic flow diverter and a catheter inserted in the aorta.  
         [0111]      FIG. 45  is an aortic flow diverter where the elongated expandable member is formed from an elastomer-encased braided tube.  
         [0112]      FIG. 46  illustrates the aortic flow diverter shown in  FIG. 45  with the elongated expandable member changed to a shorter, larger diameter state.  
         [0113]      FIG. 47  illustrates the aortic flow diverter shown in  FIG. 45  located in the aorta with the expandable tubular member inflated and positioned downstream of the renal arteries.  
         [0114]      FIG. 48  is a transverse cross sectional view of the aortic flow diverter shown in  FIG. 47  taken along line  48 - 48 .  
         [0115]      FIG. 49  is a transverse cross sectional view of the aortic flow diverter shown in  FIG. 47  taken along line  49 - 49 .  
         [0116]      FIG. 50  is a transverse cross sectional view of the aortic flow diverter shown in  FIG. 47  taken along line  50 - 50 .  
         [0117]      FIG. 51  is an enlarged view, partially in phantom, of an aortic flow diverter having an expandable tubular sheath member over a collapsible frame and an inflatable member.  
         [0118]      FIG. 52  is an enlarged view, partially in phantom, of an aortic flow diverter having a radially expandable sheath member with a radially enlarged section.  
         [0119]      FIG. 53A  is a transverse cross sectional view of another embodiment having an expandable tubular member with a small profile wrapped configuration.  
         [0120]      FIG. 53B  is a transverse cross sectional view of the tubular member shown In  FIG. 53A , illustrating the tubular member in the expanded unwrapped configuration.  
         [0121]      FIG. 54A  is a transverse cross sectional view of another embodiment having an expandable tubular member with a small profile wound configuration.  
         [0122]      FIG. 54B  is a transverse cross sectional view of the tubular member shown in  FIG. 54A , illustrating the tubular member in the expanded unwound configuration.  
         [0123]      FIG. 55A  illustrates an expandable tubular member wound like a rolled awning.  
         [0124]      FIG. 55B  illustrates the tubular member of  FIG. 55A  in the expanded unwound configuration.  
         [0125]      FIG. 56  illustrates a transverse cross sectional view in which the tubular member comprises a plurality of inflatable balloons within an outer sheath in a non-inflated low profile configuration.  
         [0126]      FIG. 57  illustrates the tubular member shown in  FIG. 56  in an expanded state.  
         [0127]      FIG. 58  illustrates another embodiment of an aortic flow diverter in section view with an inner inflatable member formed in a helical shape.  
         [0128]      FIG. 59  illustrates an aortic flow diverter with the tubular member supported on a frame.  
         [0129]      FIG. 60  illustrates an embodiment of an aortic flow diverter with an inner inflatable member encased in a sheath and an outer inflatable member.  
         [0130]      FIG. 61  illustrates another variation of the aortic flow diverter shown in  FIG. 60  where four inner inflatable tubular members present a four lobed, clover shape, cross section.  
         [0131]      FIG. 62  illustrates a proximal coupler system for positioning aortic fluid delivery systems adjunctively with other medical devices.  
         [0132]      FIG. 63  illustrates a section view of the proximal coupler system as shown in  FIG. 62 .  
         [0133]      FIG. 64A  illustrates a proximal coupler system as shown in  FIG. 62  coupled to a local fluid delivery system.  
         [0134]      FIG. 64B  illustrates a proximal coupler system as shown in  FIG. 64A  with a fluid delivery system advanced into an introducer sheath.  
         [0135]      FIG. 65  illustrates a proximal coupler system as shown in  FIG. 54  through  56 B with an aortic flow diverter positioned near the renal arteries and a catheter deployed adjunctively in the aorta.  
         [0136]      FIG. 66  illustrates a proximal coupler assembly and fluid delivery assembly as shown in  FIG. 65  as components of a renal therapy system including an introducer sheath system and a vessel dilator. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0137]     The description herein provided relates to medical methods to divert blood flow from a major blood vessel into one or more branch vessels.  
         [0138]     For the purpose of providing a clear understanding, the term proximal should be understood to mean locations on a system or device relatively closer to the operator during use, and the term distal should be understood to mean locations relatively further away from the operator during use of a system or device.  
         [0139]     These present embodiments below therefore generally relate to treatment at the renal arteries, generally from the aorta. However, it is contemplated that these systems and methods may be suitably modified for use in other anatomical regions and for other medical conditions without departing from the broad scope of various of the aspects illustrated by the embodiments.  
         [0140]     As will be appreciated by reference to the detailed description below and in further respect to the Figures, the present invention is principally related to selective aortic flow diverter systems and methods, which are thus related to subject matter disclosed in the following prior filed, co-pending U.S. patent applications that are commonly owned with the present application: Ser. No. 09/229,390 to Keren et al., filed Jan. 11, 1999; Ser. No. 09/562,493 to Keren et al., filed May 1, 2000; and Ser. No. 09/724,691 to Kesten et al., filed Nov. 28, 2000. The disclosures of these prior patent applications are herein incorporated in their entirety by reference thereto.  
         [0141]     The invention is also related to certain subject matter disclosed in other Published International Patent Applications as follows: WO 00/41612 to Libra Medical Systems, published Jul. 20, 2000; and WO 01/83016 to Libra Medical Systems, published Nov. 8, 2001. The disclosures of these Published International Patent Applications are also herein incorporated in their entirety by reference thereto.  
         [0142]     In general, the disclosed material delivery systems will include a flow diverter assembly, a proximal coupler assembly and one or more elongated bodies, such as wires, tubes or catheters. These elongated bodies may contain one or more lumens and generally consist of a proximal region, a mid-distal region, and a distal tip region. The distal tip region will typically have means for diverting blood flow from a major vessel, such as an aorta, to a branch vessel, such as a renal artery. The distal tip region may also have a device for delivering a material such as a fluid agent. Radiopaque markers or other devices may be coupled to the specific regions of the elongated body to assist introduction and positioning.  
         [0143]     The flow diverter and/or the material delivery system is intended to be placed into position by a physician, typically either an interventionalist (cardiologist or radiologist) or an intensivist, a physician who specializes in the treatment of intensive-care patients. The physician will gain access to a femoral artery in the patient&#39;s groin, typically using a Seldinger technique of percutaneous vessel access or other conventional method.  
         [0144]     In addition, various of the embodiments are illustrated as catheter implementations, and are further illustrated during in-vivo use. Other techniques for positioning the required flow diverter assemblies described may be used where appropriate, such as transthoracic or surgical placement that either use or don&#39;t use percutaneous translumenal catheter techniques. In addition, reference to the illustrative catheter embodiments thus portray specific proximal-distal relationships between the inter-cooperating components of a flow diverter in relation to blood flow and their relative orientations on a delivery catheter platform. For example, some embodiments illustrate or are otherwise described by reference to retrograde femoral approach to renal delivery, such that the distal end of the catheter including the aortic flow diverter is located upstream form the proximal end of the catheter. Other embodiments may show an opposite relative positioning, such as via an antegrade access to the site of renal arteries, e.g. from a brachial or radial arterial access procedure. However, it is to be further understood that such embodiments, though shown or described in relation to one such mode, may be appropriately modified by one of ordinary skill for use in the other orientation approach without departing from the intended scope.  
         [0145]      FIG. 1  shows a schematic cross-section of the abdominal aorta  10  taken in the immediate vicinity of the renal arteries  12 .  FIG. 1  shows the natural flow patterns through the abdominal aorta  10  and the natural flow patterns from the abdominal aorta  10  into the renal arteries  12 . As shown, the flow down the abdominal aorta  10  maintains a laminar flow pattern. The flow stream along the wall of the abdominal aorta  10 , as indicated by flow lines  14  contains a natural laminar flow stream into the branching arteries, e.g., the renal arteries  12 . Moreover, the flow stream near the middle of the abdominal aorta  10 , as indicated by flow pattern  16  continues down the abdominal aorta  10  and does not feed into any of the side branches, e.g., the renal arteries  12 . As such, a drug solution infusion down the middle of the abdominal aorta flow stream can be ineffective in obtaining isolated drug flow into the renal arteries  12 .  
         [0146]     In general, the flow stream  16  is of a higher velocity than flow stream  14  along the wall of aorta  10 . It is to be understood that near the boundaries of flow stream  14  with flow stream  16 , there can be flow streams into the branching renal arteries  12  as well as down the abdominal aorta  10 .  
         [0147]     Further, the ostia of renal arteries  12  are positioned to receive substantial blood flow from the blood flow near the posterior wall of aorta  10  as well as the side walls. In other words, blood flow  14  is greater than blood flow  16  when along the posterior wall of aorta  10  relative to blood flow in the center of aorta  10  as shown in  FIG. 1 . Thus, drug infusion above renal arteries  12 , and along the posterior wall of aorta  10 , will be effective in reaching renal arteries  12 .  
         [0148]     Accordingly, in order to maximize the flow of a drug solution into the renal arteries using the natural flow patterns shown in  FIG. 1 , it is beneficial to provide a device, as described in detail below, that is adapted to selectively infuse a drug solution along the side wall or posterior wall of the abdominal aorta  10  instead of within the middle of the abdominal aorta  10  or along the anterior wall.  
         [0149]      FIG. 2  illustrates a beneficial embodiment of an aortic flow diverter  20  with a circular skirt  22  of sheet material, such as ePTFE, attached to catheter lumen  24  and supported by metal wire hoop  26 . Two infusion ports  28  are placed in the outside of skirt  22  approximately 90 degrees to about 180 degrees apart and are fluidly connected to catheter lumen  24  through fluid channels  30 . The single hoop  26  allows for sizing to an aorta  10  to maintain the infusion ports  28  along the inner wall of aorta  10 . The particular embodiment shown allows advancement of a interventional catheter (not shown) through the open center of device  20  and does not alter blood flow. The embodiment shown in  FIG. 2  reduces the presence of stagnant blood thereby minimizing the occurrence of blood clotting on aortic flow diverter  20 . It is to be appreciated that wire hoop  26  can be adjusted between a collapsed condition, such as radially constrained in a sheath, and an expanded condition as shown in  FIG. 1 . In one exemplary embodiment, Aortic flow diverter  20  is about 1.5 cm in total length.  
         [0150]      FIG. 3  is a schematic dorsal view of the aortic flow diverter  20  shown in  FIG. 2  placed upstream of renal arteries  12  in aorta  10 . Fluid agent  32  flows through catheter lumen  24 , through fluid channels  30  and out of infusion ports  28 . Fluid agent  32  is carried by outer blood flow  14  into renal arteries  12 . In one embodiment, catheter lumen  24  has an offset that is a slight S shape (not shown) and positions aortic flow diverter  20  off the aorta wall  10 .  
         [0151]      FIG. 4  shows another embodiment of an aortic flow diverter  34  comprising a distal metal wire hoop  36  and a proximal metal wire hoop  38  connected to catheter  24  to form parallel circular openings perpendicular to catheter  24 . In a beneficial embodiment, distal hoop  36  and proximal hoop  38  are about 2 centimeters apart. A partial skirt  40 , of material such as ePTFE, is attached and supported by distal hoop  36 , proximal hoop  38 , and extends along the spine or dorsal side of catheter lumen  24 . Approximately 50 percent to about 75 percent of partial skirt  40  is cut away in an area bounded by distal hoop  36 , proximal hoop  38  and the hoop circumferences opposite catheter lumen  24  so that partial skirt  40  assumes an hourglass shape between distal hoop  36  and proximal hoop  38  and symmetrical about catheter lumen  24 . Infusion ports  42  are fluidly connected to catheter lumen  24  through fluid channels  44  and placed midway between distal hoop  34  and proximal hoop  36  on the edges of partial skirt  38 . It is to be appreciated that distal hoop  36  and proximal hoop  38  can be adjusted between a collapsed condition, such as radially constrained in a sheath, and an expanded condition as shown. In one embodiment, catheter lumen  24  has an offset that is a slight S shape (not shown) and positions the aortic flow diverter off the aorta wall.  
         [0152]      FIG. 5  is a schematic illustration of the aortic flow diverter shown in  FIG. 4  inserted in aorta  10  above renal arteries  12 . Wire hoops  36  and  38  contact the inner wall of aorta  10  and flex at the joint with catheter lumen  24 . This presses the dorsal side of partial skirt  40  against the inner wall of aorta  10  and places infusion ports  42  near the dorsal aorta wall and above renal arteries  12 . This particular embodiment allows one device size to be used on many different sized aorta. The reduced material in the blood stream of partial skirt  40  beneficially reduces the occurrence of stagnant blood and blood clotting.  
         [0153]      FIG. 6A  through  FIG. 6C  illustrate another embodiment of an aortic flow diverter  50  where  FIG. 6A  is a side view and  FIG. 6B  is a dorsal view. Catheter lumen  52  has a distal end  54  and a mid proximal position  56 . A circular wire hoop  58 , made of a flexible memory shape material, is coupled in an approximately perpendicular orientation to catheter lumen  52  at mid proximal position  56 . A partial conical skirt  60  extends from the distal end  54  of catheter lumen  52  to proximal wire hoop  58 . Conical skirt  60 , made from a sheet material such as ePTFE, is cut away lengthwise and on the opposite side of catheter lumen  52 . Covering only one-half the conical shape reduces stagnant blood and the chance of blood clot formation. Infusion ports  62  are in fluid communication with catheter lumen  52  through fluid channels  64  in conical skirt  60 . In the embodiment shown here, catheter lumen  52  has an offset adaptation between mid proximal position  56  and distal end  54  to optimally position aortic flow diverter  50  in the aorta  10 .  
         [0154]      FIG. 6C  shows the aortic flow diverter  50  shown in  FIG. 6A  and  FIG. 6B  positioned near renal arteries  12  in aorta  10 . It is to be appreciated that circular wire hoop  58  can be adjusted between a collapsed condition, such as radially constrained in a sheath, and an expanded condition as shown.  
         [0155]      FIG. 7  is another embodiment of an aortic flow diverter  70 . Catheter  72 , shown in partial section view, has a distal end  74  and a mid proximal position  76 . A proximal wire hoop  78 , made of a flexible memory shape material, is coupled in an approximately perpendicular orientation to catheter lumen  72  at mid proximal position  76 . A distal wire hoop  80  is coupled at distal end  74  and is larger in diameter than proximal wire hoop  78 . Skirt  82 , made of a fabric or sheet material such as ePTFE, is attached to hoop  72 , hoop  74  and catheter lumen  24  forming a funnel. Holes  84  are placed symmetrically on opposite sides of catheter  72  and placed midway between distal hoop  80  and proximal hoop  78  in skirt  82 . Fluid agent is delivered from catheter  72  through infusion channels  86  and exits infusion channels  86  at or near holes in fabric  84  (shown in  FIG. 8 ). In one beneficial embodiment, radiopaque marker bands  88  are coupled to catheter  72  at distal end  74  and mid proximal position  76  to aid in positioning.  
         [0156]      FIG. 8  is aortic flow diverter  70  shown in  FIG. 7  deployed in aorta  10  above renal arteries  12 . Blood flow  14  flows alongside aortic flow diverter  70  and into the renal arteries. Blood flow  16  flows through the center of aortic flow diverter  70  and past renal arteries  12 . Some of blood flow  16  flows along the wall inside of aortic flow diverter  70  with some flowing out through holes  84 , delivering fluid agent  32  from infusion channel  86  to blood flow  14  and flowing down the wall of aorta  10  and into renal arteriesl  2 .  
         [0157]      FIG. 9  through  FIG. 12  illustrates a double scallop shaped flow diverter.  
         [0158]     In  FIG. 9 , a metal frame  100  is shaped in a scallop shape by making an arc loop and bending it 90 degrees. The ends of frame  100  are formed into a “V” shape. Agent delivery tube  102  with agent delivery port  103  is coupled to frame  100  at the wire ends.  
         [0159]      FIG. 10  illustrates a fabric covering  104  fastened over frame  100  to form a semi conical scallop assembly  106 . Agent delivery port  103 , at the distal end of agent delivery tube  102  is on the concave side of fabric  104 . Because fabric  104  is supported by frame  100 , it maintains a predictable shape during use.  
         [0160]     In  FIG. 11 , two scallop assemblies  106  as shown in  FIG. 10 , with concave surfaces facing outward, are connected by a center tube  108  in fluid communication with agent delivery tubes  102  and agent delivery ports  103  (not shown for clarity) to form a bifurcated scallop assembly  109 . The concave face of each scallop assembly  106  is sealed against the walls of aorta  10  at renal arteries  12 . In one beneficial mode, an outward spring force in agent delivery tubes  102  keeps the scallop assemblies  106  in place against the aorta wall. Because the spring force can have a wide range, one bifurcated scallop assembly  109  can be used on different sized aorta. In another mode, radio opaque markers (not shown) at strategic locations such as on the top loop of wire  100  and at the union of agent delivery tubes  102 , aid in positioning of the bifurcated scallop assembly  109 . In a further mode, each scallop assembly  106  is introduced independently on agent delivery tube  102  from a proximal coupler assembly (not shown). Blood flow  14  flowing near the wall of aorta  10  is diverted by the arc end of scallop assembly  106  to the concave face of scallop assembly  106  where it mixes with fluid agent  32  flowing from agent delivery tubes  102  and perfuses into the renal arteries  12 . Blood flow  16  near the center of aorta  10  flows past scallop assembly  106 .  
         [0161]      FIG. 12  is a cross section of  FIG. 11  showing the placement of scallop assemblies  106  against the wall of aorta  10  upstream of renal arteries  12  and the position of agent delivery port  103 .  
         [0162]      FIG. 13  illustrates a further beneficial mode of the scallop assemblies  106  shown in  FIG. 11  wherein a supporting member  110 , shown in cross section, is positioned inside sheath  112  and engages a section of agent delivery tubes  102  below the “V” of wires  100  for both scallop assemblies  106 . Supporting member  110  is connected to controls in a proximal coupler assembly (not shown) and aids in rotating scallop assemblies  106  during insertion and positioning from sheath  112 . Supporting member  110  is configured to be removed proximally from sheath  112  once scallop assemblies  106  (shown in  FIG. 12 ) are positioned at the renal arteries  12 .  
         [0163]      FIG. 14  illustrates the withdrawal of scallop assemblies  106  into sheath  112 . Sheath  112  forces the “V” legs of wire frame  100  together so that scallop assemblies  106  form a cone with the opening pointing upstream. This cone configuration helps capture thrombus that has formed during the medical procedure and is flowing in the aorta.  
         [0164]      FIG. 15  through  FIG. 17  illustrates another delivery system for an aortic flow diverter which does not require an introducer sheath that extends into the renal artery region of the aorta. In  FIG. 15 , the distal portion  116  of a delivery sheath  118  is enlarged to a diameter larger than the body of delivery sheath  118 . The enlarged distal portion  116  is made of a suitable flexible material such as Pebax. Aortic flow diverter  120  is configured to fit within enlarged distal portion  116  in a collapsed or partially collapsed state.  
         [0165]      FIG. 16  illustrates schematically the positioning of the aortic flow diverter  120  shown in  FIG. 15  above the renal arteries  12  in aorta  10 . Introducer sheath  122  with distal end  123  is of a length to just reach the aorto-iliac bifurcation  124  from a percutaneous entry point  125 . In one exemplary embodiment, the introducer sheath  122  is about 1 French larger in diameter than standard introducer sheaths. By way of comparison, sheath-within-a-sheath systems require a significant increase in introducer sheath diameter of about 3 French or more. Delivery sheath  118  is advanced through proximal coupler assembly  126  and through introducer sheath  122 . Enlarged distal portion  116  of delivery sheath  118 , with aortic flow diverter  120  in a partially collapsed state, is positioned just above renal arties  12  in aorta  10 .  
         [0166]      FIG. 17  illustrates the aortic flow diverter  120  in  FIG. 16  where the delivery sheath  118  has been retracted through proximal coupler assembly  126  and aortic flow diverter  120  is deployed from enlarged distal portion  116  of delivery sheath  118  and assumes an expanded state at renal arteries  12 . In one beneficial embodiment, delivery sheath  116  remains in the aorta system and is available to reposition aortic flow diverter  120  during medical procedures. Proximal coupler assembly  126  is not retracted to correspondingly retract the distal end  123  of introducer sheath  122 . By not retracting proximal coupler assembly  126 , a standard length catheter, such as 100 cm, (not shown) can be deployed through proximal coupler assembly  126  alongside delivery sheath  118  and through aortic flow diverter  120  to reach target areas (not shown) in the aorta  10  system.  
         [0167]      FIG. 18  and  FIG. 19  are a partial cut away section views of another embodiment of an aortic flow diverter delivery system that is deployed without retracting an introducer sheath. Proximal hub assemblies for introducing a catheter have been omitted for clarity.  FIG. 18  illustrates an aortic flow diverter  128  in a partially collapsed state supported on hypotube  129  which is used for structural support and fluid delivery. Delivery sheath  130  with distal end  131  and a proximal position  132  has hypotube lumen  133  and pull wire lumen  134  Proximal position  132  of delivery sheath  130  is coupled to a Y manifold assembly  135 . A pull wire  136  extends from the ends of lower hoop  137  of flow diverter  128  through pull wire lumen  134  and through Y manifold assembly  135  to pull wire activator  138 . Lower hoop  137  is in a hoop channel of the fabric of aortic flow diverter  128  and is not attached to hypotube  129 . When pull wire activator  138  is retracted, pull wire  136  retracts lower hoop  137  of aortic flow diverter  128  partially out of the hoop channel and causes aortic flow diverter  128  to take a partially collapsed state. In one embodiment, hypotube lumen  133  and lower hoop  137  are made from Nitinol™. Further, hypotube lumen  133  and pull wire lumen  134  at distal end  131  of delivery tube  130  are adapted to accommodate the ends of lower hoop  137  when pull wire  136  is retracted.  
         [0168]     In  FIG. 19 , pull wire activator  138  is relaxed and pull wire  136  advances in the pull wire lumen  134  of delivery lumen  130  allowing lower hoop  137  to expand in the hoop channel to a fully deployed state.  
         [0169]      FIG. 20  and  FIG. 21  are partial cut away section views of another embodiment of the aortic flow diverter delivery system shown in  FIG. 18  and  FIG. 19 . In  FIG. 20 , aortic flow diverter  128  includes a pulley assembly  139  on the distal end  140  of hypotube  129 . When pull wire  136  is retracted by pull wire activator  138 , pull wire  136  pulls lower hoop  137  distally and flow diverter  128  assumes a collapsed or partially collapsed state.  
         [0170]      FIG. 21  illustrates the aortic flow diverter  128  shown in  FIG. 19  deployed in an expanded state by relaxing pull wire  136  and allowing lower hoop  137  to deploy proximally and expand outward.  
         [0171]      FIG. 22  illustrates an embodiment of the aortic flow diverter  128  in  FIG. 21  with a proximal hub assembly  126  and introducer sheath  122  as shown in  FIG. 16  and  FIG. 17 . Proximal hub assembly  126  couples Y hub assembly  135  and introducer sheath  122 . Delivery tube  130  is advanced through Proximal hub assembly  126  through introducer sheath  122  until distal end  131  is in the region of renal arteries  12 . Pull wire  136  is retracted pulling lower hoop  137  up to partially collapse aortic flow diverter  128 . Delivery sheath  130  is advanced to position and deploy aortic flow diverter  128 . When pull wire  136  is relaxed, aortic flow diverter  128  expands and deploys. Delivery sheath  130  can be retracted during deployment without retracting introducer sheath  122 . A standard interventional catheter (not shown) may be advanced through proximal coupler assembly  126  and through introducer sheath  122  along side delivery sheath  130 .  
         [0172]      FIG. 23  shows schematically an aortic flow diverter  140  configured as a collar around guide catheter  142  and supported by fluid delivery lumen  144 . Aortic flow diverter  140  has a distal hoop  146  and a proximal hoop  148 . Infusion ports (not shown) are positioned on the inside of aortic flow diverter  140  and fluidly connected to fluid delivery lumen  144 . Distal hoop  146  of and proximal hoop  148  slide on guide catheter  142 . In this example, fluid agent  32  perfuses out distal hoop  146  and proximal hoop  148  of aorta flow diverter  140  and to the lower extremities including renal arteries  12 . It is to be understood that additional variations (not shown) of aortic flow diverters are contemplated. In one embodiment, aortic flow diverter  140  is configured with the distal hoop  146  adapted to slide closely to guide catheter  142  to preferentially perfuse fluid agent out the proximal hoop  148 . In another embodiment, aortic flow diverter  140  is configured with the proximal hoop  148  adapted to slide closely to guide catheter  142  to preferentially perfuse fluid agent out the distal hoop  146 . It is to be understood that aortic flow diverter  140  can be configured with both hoops  146 ,  148  loosely adapted to perfuse fluid agent from both hoops  146 ,  148 .  
         [0173]      FIG. 24  shows another embodiment of aortic flow diverter  140  in  FIG. 23  where an expandable tubular member  150  is coupled to fluid delivery lumen  144  and positioned proximal of aortic flow diverter  140 . In this embodiment, aortic flow diverter  140  is positioned upstream of renal arteries  12  and expandable tubular member  150  is positioned below renal arteries  12  in aorta  10  to divert blood flow preferentially toward the renal arteries  12 . Fluid agent  32  perfuses out the distal hoop  148  of aorta flow diverter  140  and preferentially into renal arteries  12 .  
         [0174]      FIG. 25  illustrates schematically a fluid agent delivery catheter where catheter  152  is a dual lumen extrusion with one large lumen  154  for interventional equipment and a small lumen  156  for fluid agent delivery. Catheter  152  has fluid agent port  158  that is fluidly connected to small lumen  156 . Catheter  152  is positioned in aorta  10  with fluid agent port  158  upstream of renal arteries  12  for delivery of fluid agent  32  to renal arteries  12 . in this configuration, approximately 15 percent of the fluid agent  32  infused from fluid agent port  158  reaches each renal artery  12  for a total of 30 percent. This embodiment has the advantage of eliminating a second fluid agent delivery device.  
         [0175]      FIG. 26  illustrates schematically a fluid delivery catheter similar to the one shown in  FIG. 25  where catheter  160  comprises three lumens; a large lumen  162  for interventional equipment, a first small lumen  164  for fluid agent delivery, and a second small lumen  166  for inflation. A radially inflatable member  168  is attached to catheter  160  proximal of fluid agent port  170 . First small lumen  164  is fluidly connected to fluid agent port  168 . Second small lumen  166  is fluidly connected to radially inflatable member  168 . Radially inflatable member  168  may be made from a compliant or semi-compliant material such as nylon, PEBAX, polyurethane or silicone. Lumen  160  is positioned into aorta  10  with fluid agent port  170  upstream of renal arteries  12  and radially inflatable member  168  downstream of renal arteries  12 . Radially inflatable member  168  is inflated to partially or completely block aortic blood flow and increase blood flow into the renal arteries  12 . Fluid agent is perfused from fluid agent port  170  into the aortic blood flow. This embodiment has the advantage of delivering more fluid agent  32  to the renal arteries  12  due to the flow diversion of radially inflatable member  168 .  
         [0176]      FIG. 27  illustrates flow diverter assembly  172  coupled to catheter  173  at a position proximal of fluid delivery port  174  in catheter  173 . A frame  175 , configured much like a basket or an umbrella, supports membrane  176 . The frame  175  is preferably made from a memory metal, e.g., NiTi, to allow for conformability to the aorta and pre-shaped capabilities. In this aspect of the present invention, the membrane  176  can be made from nylon, PEBAX, polyurethane, low density PTFE or any other similar material with low porosity to allow for blood diffusion through the membrane  176 . Moreover, the membrane  176  can be lazed or otherwise formed with plural holes  177  of varying diameter, e.g., from twenty-five micrometers to five-hundred micrometers (25 μm-500 μm) to allow blood flow through the material film. It can be appreciated that the flow diverter  172  can be expanded such that it engages the inner wall of the abdominal aorta  10 . Further, flow diverter  172  can be collapsed within an outer sheath  178  disposed around the drug infusion catheter  173 . Once the drug infusion catheter  173  is in place within the abdominal aorta  10 , the sheath  178  can be retracted causing the flow diverter  172  to be deployed in the region of the renal arteries  12 .  
         [0177]      FIG. 28 . and  FIG. 29  illustrate an expandable aortic flow diverter  200  placed near the distal end  202  of multi lumen catheter  204 . In one beneficial embodiment, catheter  204  is a specialized introducer sheath/infuser type of about 6 French to about 8 French in diameter. The distal ends  206  of three or more flexible, hollow struts  208 , made of suitable shape retaining material such as Nitinol™ hypotubing, are fluidly connected near the distal end  202  of catheter  204  It is understood that other arrangements for fluidly coupling struts  208  to multilumen catheter  204  may be used and that the struts  208  may be of flattened tubing.  FIG. 28  illustrates a beneficial embodiment with three struts  208  visible. The proximal ends  210  of struts  208  are connected to the distal end of a diverter sheath  212  proximal of aortic flow diverter  200 . Struts  208  assume a bow shape parallel to catheter  204  when deployed. An infusion port  214  is placed in the wall of each strut  208  distal of the bow apex  216  of struts  208  by a suitable process such as a laser cut hole, slit or other micro fenestration process. Membrane  218  is a stretchable fabric formed in a truncated cone or funnel shape and attached to struts  208  with the smaller opening  220  of membrane  216  attached near the distal end  206  of struts  208  forming an annular opening around catheter  204 . The larger opening  222  of membrane  216  is attached near the bow apex  214  of struts  208 . When diverter sheath  212  is advanced distally on catheter  204 , aortic flow diverter  200  is expanded outward.  
         [0178]      FIG. 29  illustrates the expandable aortic flow diverter  200  shown in  FIG. 28  in a collapsed state with diverter sheath  212  retracted proximally on catheter  204 , struts  208  straightened, and membrane  218  collapsed against catheter  204 .  
         [0179]      FIG. 30  is a schematic illustration of the expandable aortic flow diverter  200  shown in  FIG. 28  positioned in aorta  10  to infuse a fluid agent  32  into renal arteries  12 . Distal end  202  of catheter  204  is positioned above renal arteries  12 . Diverter sheath  212  is advanced distally on catheter  204  allowing the bow apex  216  of struts  208  to contact the inner wall of aorta  10 . Membrane  218  diverts outer aortic blood flow  14  into renal arteries  12 . Fluid agent  32  is infused from infusion ports  214  and into the renal arteries  12 . Having multiple infusion ports  214  eliminate the need to rotate aortic flow diverter  200  for correct positioning. Inner blood flow  16  flows through the annular space between membrane  218  and catheter  204  and down aorta  10  to the lower extremities. Guide catheter  224  is deployed upstream through catheter  204  for further intervention procedures.  
         [0180]      FIG. 31  is a stylized illustration of the expandable aortic flow diverter  200 , shown in  FIG. 28 , adapting to a small aorta  10 . It is understood that there are a number of different ways of positioning infusion ports  214  on the outside of membrane  218 , or supporting membrane  218 . Upper edge  220  of membrane  218  forms a relatively smaller annular space when the lower edge  222  of membrane  218  is sealed against the inner wall of aorta  10 .  
         [0181]      FIG. 32  shows the expandable aortic flow diverter  200  shown in  FIG. 28  adapting to a large aorta  10  where upper edge  220  of membrane  218  forms a relatively larger annular space when the lower edge  222  of membrane  218  is sealed against the inner wall of aorta  10 .  
         [0182]      FIG. 33A  through  FIG. 36  illustrate a beneficial adaptation for a wire hoop in an aortic flow diverter. Because aortic flow diverters are typically compressed in a sheath to advance in the aorta and position near the renal arteries, as discussed previously, the wire hoops of the aortic flow diverter may experience a permanent kink if the superelastic limit of the wire material is exceeded in the compressed state. The relative tendency to kink increases as the hoop diameter relative to the sheath size increases or the wire diameter increases.  
         [0183]      FIG. 33A  illustrates a typical wire hoop  230  formed for an aortic flow diverter with hoop element  231  having diameter D 1 . In this embodiment, legs  232  are formed at a 90 degree angle from the hoop element  231  and legs  232  are close together or touching when wire hoop  230  is in it free state. This is the at rest configuration of a typical wire hoop  230  when integrated into an aortic flow diverter.  
         [0184]      FIG. 33B  illustrates a wire hoop  234  formed with hoop element  235  having diameter D 2 . Legs  236  are formed at a 90 degree angle from the hoop element  235  and legs  236  are spaced apart by length L 1  when wire hoop  234  is in its free state. D 2  in  FIG. 33B  is smaller than D 1  in  FIG. 33A , but, in this example, wire hoop  234  increases to a diameter about equal to D 1  when legs  236  are brought close together or touch. When wire loop  234 , shown in  FIG. 33B , is used in a flow diverter and compressed in a sheath, it has a decreased tendency to kink than a comparable wire loop  230 , as shown in  FIG. 33A , made of similar diameter and material. This decreased tendency to kink is further explained below and in  FIG. 34A  and  FIG. 34 B . In an exemplary embodiment, a wire hoop  234  is made of Nitinol™ wire of about 0.014 inch diameter but wire diameters of 0.011 inches and about 0.013 inches are contemplated. The diameter of hoop element  235  in its free state is about 19.8 millimeters and the diameter in its expanded state when the legs  236  are brought together is about 22.9 millimeters. However, hoop diameters in the expanded state of about 20 millimeters to about 25 millimeters are contemplated. In this embodiment, the wire hoop  235  can be collapsed into an introducer sheath of about 8 French nominal diameter without permanent deformation.  
         [0185]      FIG. 34A  is illustrative of the stress strain relationship  238  for wire hoop  230  in  FIG. 33A  and  FIG. 34A  is illustrative of the stress strain relationship  240  for wire hoop  234  in  FIG. 33B . In  FIG. 34A , the rhombus area  239  of relationship  238  represents a region where a hoop of memory shape material, such as Nitinol™ wire, will return to its free state when the stress of compression is reduced, and in this embodiment, eventually to zero. In this non limiting example, wire hoop  230  will not kink in a range from zero to about region  239 . A linear compressive strain beyond region  239  or in this example, greater than about 8 percent, results in permanent deformation, or kinking of the wire hoop  230 .  
         [0186]      FIG. 34B  illustrates the stress strain relationship  240  for wire hoop  234  in  FIG. 33B . Wire hoop  240  is first expanded from a free state as shown in  FIG. 33B  to a form similar to hoop  230  in  FIG. 33A  and integrated into a flow diverter (not shown). This expanded state is expressed as a negative stress represented by negative strain region  241 . When wire hoop  234  is compressed, it first returns to a zero stress, zero strain state  242 , then continues into a compressive strain region  243 . The range of non deforming stress and strain, from region  241  to region  243 , in this example is about double the range of zero to region  239  shown in  FIG. 34A .  
         [0187]      FIG. 35  illustrates a tool for producing a wire hoop similar to wire hoop  230  in  FIG. 33A . Cylindrical forming mandrel  244 , of diameter D 1  as shown in  FIG. 33A , has axis pins  245  and  246  positioned on the cylindrical surface of mandrel  246  perpendicular to the longitudinal axis of mandrel  246  and relatively close together. A wire hoop  230  is formed by looping the wire around mandrel  244  to form hoop element  231  and pulling the ends of the wire between pins  245 ,  246  to form parallel legs  232  as shown in  FIG. 33A .  
         [0188]      FIG. 36  illustrates a tool for producing wire hoop  234  in  FIG. 33B . forming mandrel  247  has axis pins  248  and  249  positioned perpendicular to the longitudinal axis of mandrel  246  and apart at predetermined distance about L 1  relative to each other. A wire hoop  234  is formed by looping the wire around mandrel  247  and pulling the wire ends past the outside of pins  248 ,  249  relative to each other, and then perpendicular to form parallel legs  236  as shown in  FIG. 33B  In one beneficial embodiment, mandrel  246  is about 0.75 inches in diameter and pins  248  and  249  form an angle of about 43 degrees when projected through the centerline of mandrel  246 . In a further beneficial embodiment, wire hoop  234  is positioned tightly on mandrel  246  as described above and placed in a furnace at 535 degrees centigrade for 10 minutes.  
         [0189]      FIG. 37  through  FIG. 39  illustrate steps for creating a sheet material with integrated lumens or channels for further assembly into an aortic flow diverter that is beneficial for process and bulk considerations in relation to assembly from sheet material. For clarity and understanding, a typical method of manufacturing of a flow diverter is described first without illustration. In one mode, manufacturing starts with sheet or fabric ePTFE cut in a rhombus shaped template (not shown). Channels at the edge of the fabric are made by rolling the material over a mandrel and bonding with silicone or a suitable bonding agent. A third infusion channel about midway in the fabric requires bonding another piece of ePTFE to the main sheet with silicone or other suitable bonding agent. This process is relatively complex, time consuming and increases bulk in the resultant aortic flow diverter which is typically compressed into about an 8 French diameter sheath.  
         [0190]     In  FIG. 37 , a highly beneficial method is described where tube  250  is formed by ram extruding a slurry of PTFE powder and solvent. The resultant ePTFE properties are determined by extrusion parameters and post processing (not shown). Tube  250  is extruded forming multiple lumens, and in this non-limiting embodiment, three lumens  252 ,  254  and  256  respectively are formed.  FIG. 38  is a cross section of the tube  250  shown in  FIG. 37  showing the position of lumens  252 ,  254  and  256  and the position of axial cut line  258 .  
         [0191]      FIG. 39  illustrates tube  250  shown in  FIG. 38  flattened into a sheet after axial cut  258 , typically with a calendaring process. Lumen  252  and lumen  254  are positioned on the top and bottom edge respectively to mount on a wire hoop or other support to form an aortic flow diverter. Lumen  256  is positioned between lumen  252  and lumen  254  in the sheet to form a channel to connect to a support tube and infusion ports in an aortic flow diverter  
         [0192]      FIG. 40  illustrates an aortic flow diverter clip assembly  260  for insertion and positioning of aortic flow diverters adjunctive with catheters and other medical devices. It is to be understood that aortic flow diverter clip assembly  260  may be used for insertion and positioning of other devices adjunctive with a catheter. Details of manipulation handles, pivot pins and springs are omitted for clarity. Clip assembly  260  comprises a base  262 , configured to accommodate an infusion line clip  264  and a hemostasis valve clamp  266 . A typical introducer sheath  268  terminates at hemostasis valve assembly  270  which is held in position by hemostasis valve clamp  266 . Guide catheter  272  and infusion lumen  274  enter introducer sheath  268  through hemostasis valve assembly  270 . While guide catheter  272  enters hemostasis valve assembly  270  in an approximately straight position, infusion lumen  274  is guided in a gentle curve towards hemostasis valve assembly  270  and held in position by infusion line clip  264 . A side port tube  276 , for infusion of saline solution, or other fluid agent, into introduction sheath  268  is shown connected to hemostasis valve assembly  270  and positioned under hemostasis valve clamp  266 .  
         [0193]      FIG. 41  is another embodiment of the clip assembly  260  in  FIG. 40  with side port tube  276  connected to hemostasis valve assembly  270  and positioned opposite hemostasis valve clamp  266 .  
         [0194]      FIG. 42  illustrates another beneficial embodiment of the flow diverter clip assembly  260  shown in  FIG. 40  where bracket  278  is adapted to base  262  approximately medial of infusion line clip  264  and hemostasis valve  270  with channel  280  configured to hold infusion lumen  274  in a straightened position and adjacent guide lumen  272 . Infusion lumen  274  is guided in a gentle curve toward bracket  278  and held in position by infusion line clip  264 . This embodiment reduces potential for leakage at hemostasis valve  270  due to deflection of infusion lumen  274 .  
         [0195]      FIG. 43  illustrates the positioning of a left flow diverter clip assembly  282 , with the infusion tube exiting to the left, and a right flow diverter clip assembly  284 , with the infusion lumen exiting to the right. Actual selection and placement of a left or right diverter clip assembly  282 ,  284  depends on the intervention procedures on patient  286  and physician preference.  
         [0196]      FIG. 44  illustrates the position of a left flow diverter clip assembly  282  shown in  FIG. 43  coupled to introducer sheath  286  inserted in the common iliac artery with guide catheter  268  in the upper portion of aorta  10  and aortic flow diverter  288  positioned near renal arteries  12 . Left diverter clip assembly  282  anchors aortic flow diverter  288  in place during manipulation of guide catheter  268 .  
         [0197]      FIG. 45  through  FIG. 50  illustrate an aortic flow diverter  310  generally comprising an elongated shaft  312  having a proximal end, a distal end, and at least one lumen  314  extending therein, a tubular member  316  on a distal section of the elongated shaft  312  and a radially expandable member  318  on the tubular member  316 . Adapter  320  on the proximal end of the shaft provides access to lumen  314 .  FIG. 45  illustrates the tubular member  316  and the radially expandable member  318  in low profile, unexpanded configurations for entry into the patient&#39;s blood vessel.  
         [0198]     In  FIG. 45 , the radially expandable member  318  on flow diverter  310  is an inflatable balloon. The radially expandable member  318  has proximal and distal ends secured to an outer surface of the tubular member  316 , and an interior in fluid communication with an inflation lumen  328  (shown in  FIG. 48 ) in the shaft  312 . The radially expandable member  318  can be formed of a variety of suitable materials typically used in the construction of catheter occlusion balloons, and in another embodiment is highly compliant and is formed of a material such as latex, polyisoprene, polyurethane, a thermoplastic elastomer such as C-Flex. In another embodiment, the radially expandable member  318  may be noncompliant or semi-compliant. While discussed primarily in terms of a radially expandable member comprising a balloon, it should be understood that the radially expandable member may have a variety of suitable configurations.  
         [0199]     In  FIG. 45 , the tubular member  316  comprises braided filaments  321 , such as wire, ribbon, and the like, having a sheath  322 , and having a lumen or interior passageway  324  (shown in  FIG. 49 ) therein. A pull line  326  having a distal portion secured to the tubular member is configured to be retracted or pulled proximally to radially expand the tubular member  316 . Specifically, the braided filaments  321  can reorient from a longer, smaller diameter configuration and a shorter, larger diameter configuration cause the tubular member  316  to shorten, thereby radially expanding the tubular member  316 . When the pull line  326  is not under tension, the spring force of the elastomeric material of the sheath  322  will cause the tubular body  316 , defined by the braided filaments  321 , to elongate and reduce in diameter. The sheath  322  is preferably an elastomeric polymer on the braided filaments. The sheath  322  can be on an inner or outer surface of the braided filaments  321 , or the braided filaments  321  can be completely or partially embedded within the sheath  322 . In the embodiment in which the sheath  322  is on a surface of the braided filaments  321 , the sheath  322  is preferably secured to a surface of the filaments  321  as for example with adhesive or heat bonding. The braided filaments  321  can be formed of a variety of suitable materials such as metals or stiff polymers. A variety of suitable polymeric materials can be used to form the sheath  322 . While discussed below primarily in terms of a tubular member comprising a braided tube, it should be understood that the tubular member may have a variety of suitable configurations.  
         [0200]     The dimensions of catheter  310  are determined largely by the size of the blood vessel(s) through which the catheter must pass, and the size of the blood vessel in which the catheter is deployed. In a beneficial embodiment, the length of-the-tubular member  316  is about 50 to about 150 mm, preferably about 80 to about 120 mm. The tubular member  316  has an unexpanded outer diameter of the tubular member of about 1 mm to about 5 mm, preferably about 2 to about 4 mm, and a radially expanded outer diameter of about 40 mm to about 140 mm, preferably about 60 mm to about 120 mm. The radially expanded interior passageway  324  of the tubular member  316  is about 30 mm to about 130 mm, preferably about 50 mm to about 110 mm to provide sufficient perfusion. The interior passageway  324  of the tubular member  316  has a radially expanded inner diameter which is about 1000% to about 6000% larger than the unexpanded inner diameter of the passageway  324 . The radially expandable member  318  has a length of about 10 mm to about 50 mm, preferably about 20 mm to about 40 mm. The expanded outer diameter of the radially expandable member  318  is about 10 mm to about 35 mm, preferably about 15 mm to about 30 mm. In this embodiment, the shaft  312  has an outer diameter of about 1 mm to about 5 mm. The inflation lumen  328  (shown in  FIG. 48 ) has an inner diameter of about 0.02 mm to about 0.06 mm and the agent delivery lumen  332  (shown in  FIG. 48 ) has an inner diameter of about 0.01 mm to about 0.04 mm. The length of the shaft  312  is about 40 mm to about 100 cm, but in a further beneficial embodiment, about 60 to about 90 cm.  
         [0201]      FIG. 46  illustrates the tubular member  316  in the expanded configuration after retraction of the pull line  326 . As best illustrated in  FIG. 46 , showing the distal section of the shaft  312  within the inner lumen of the tubular member  316  in dotted phantom lines, the distal end of the shaft  312  is located proximal to the distal end of the expanded tubular member  316 . In the embodiment illustrated in  FIG. 46 , the radially expandable member  318  is in a non-expanded configuration. The section of the expanded tubular member  316  under the radially expandable member  318  is illustrated in dashed phantom lines.  
         [0202]      FIG. 47  illustrates schematically, the expanded tubular member  316  with the radially expandable member  318  in the expanded configuration. As best illustrated in  FIG. 48 ,  FIG. 49  and  FIG. 50  showing transverse cross sections of the elongated shaft  312  shown in  FIG. 47 , taken along lines  48 - 48 ,  49 - 49 , and  50 - 50 , respectively, the elongated shaft  312  has an inflation lumen  328  extending from the proximal end of the shaft  312  to an inflation port  330  (shown in  FIG. 49 ) located on the shaft distal section, in fluid communication with the interior of the radially expandable member  318 . Arm  336  on adapter  320  (shown in  FIG. 45 ) provides access to the inflation lumen  328 , and is in fluid communication with a source of inflation fluid (not shown). The elongated shaft  312  also has an agent delivery lumen  332  extending from the proximal end to an agent delivery port  334  in the distal end of the shaft  312 . Arm  336  on adapter  320  (shown in  FIG. 45 ) provides access to the agent delivery lumen  332 , and is in fluid communication with an agent source (not shown). The tubular member sheath  322  has an agent delivery opening  338  adjacent to the shaft agent delivery port  334 , for providing a pathway for agent delivery from the lumen  332  to exterior to the tubular member  316 . In the illustrated embodiment, the inflation lumen  328  and agent delivery lumen  332  are side-by-side in a multilumen shaft  312 , with inflation port  330  extending through a side wall of the shaft  312 , as shown in  FIG. 48 . However, a variety of suitable configurations may be used as are conventionally used in catheter shaft design including coaxial lumens in fluid communication with side ports or ports in the distal extremity of the shaft. The agent delivery port  334  is preferably in a side wall of the shaft  312  distal section in fluid communication with the agent delivery lumen  332 , however, alternatively, the agent delivery port  334  may be in the distal end of the shaft  312 .  
         [0203]     These embodiments are illustrated schematically and the relationship of the elements may be combined in various combinations and specific modes by one of ordinary skill in the art. For example,  FIG. 49  illustrates a more specific embodiment where multilumen shaft  312  is attached to the inner wall of tubular member  316 . Inflation lumen  328  is in fluid communication through inflation port  330  and agent delivery lumen  332  is in fluid communication with blood flow  14  through agent delivery port  334  and agent delivery opening  338 .  
         [0204]      FIG. 47  illustrates the catheter  310  in a descending aorta  10 , of a patient, having renal arteries  12 , opening therein. The catheter  310  is introduced and advanced within the patient&#39;s blood vessel  10  in the low profile, unexpanded configuration shown in  FIG. 45 . The agent delivery port  334  is positioned proximate to (up-stream or inline with) the one or more branch vessels  12 , and the distal end of the tubular member is preferably up-stream of the one or more branch vessels  12 . The tubular member  316  is expanded to its expanded configuration, and, preferably, thereafter the radially expandable member  318  is radially expanded by directing inflation fluid into the radially expandable member  318  interior. Specifically, in one mode, the elongated shaft  312  is introduced into the femoral artery, as for example by the Seldinger technique, preferably slidingly over a guide wire (not shown), and advanced into the descending aorta  10 . Although not illustrated, the elongated shaft  312  may be provided with a separate guide wire lumen, or the catheter may be advanced over a guide wire in agent delivery lumen  332  adapted to slidingly receive a guide wire. Alternatively, the catheter  310  may be advanced without the use of a guide wire. The agent delivery port  334  is positioned proximate to one or both renal arteries  12 , as illustrated in  FIG. 47 , and the tubular member  316  extends within the aorta  12  up-stream and down-stream of the renal arteries  12 . The tubular member  316  is radially expanded by retracting pull line  326 . The interior passageway  324  of the tubular member  316  separates blood flow through the blood vessel  10  into an outer blood flow stream  14  exterior to the tubular member  316 , and an inner blood flow stream  16  within the interior passageway  324  of the tubular member  316 .  
         [0205]     The radially expandable member  318  is expanded by directing inflation fluid into the inflation lumen  328 . In the embodiment illustrated in  FIG. 47 , the radially expandable member  318  is expanded to an outer diameter which does not completely occlude the patient&#39;s aorta  10 . However, in another mode, the balloon expands into contact with the wall of the aorta  10 , to an outer diameter which completely occludes the outer blood flow  14  in aorta  10  (not shown). Radially expandable member  318  may have a length and elongated configuration configured to provide mechanical stability for and coaxial centering of the operative distal section of the catheter in the aorta  10 . A stabilizing member (not shown) may be provided on an outer surface of the distal end of the tubular member  318 , such as for example unfoldable arms which anchor the distal end of the catheter in the aorta  10  during delivery of agent.  
         [0206]     A variety of suitable imaging modalities may be used to position the catheter in the desired location in the blood vessel, such as fluoroscopy, or ultrasound. For example, radiopaque markers (not shown) on the shaft  312  may be used in positioning the balloon  318  and agent delivery port  334  at the desired location in the blood vessel  10 .  
         [0207]     A therapeutic or diagnostic agent (hereafter “agent”) is delivered to the renal arteries  10  by introducing the agent into the agent delivery lumen  332  in shaft  312 , and out the agent delivery port  334 . An agent delivery opening  338  in the tubular member  316  adjacent to the agent delivery port  334  provides a pathway for agent delivery from lumen  332  to external to the tubular member  312 . The agent delivery port  334  is up-steam of the renal arteries  12  and proximal to the distal end of the tubular member  316 . Thus, the outer blood flow stream  14  has a relatively high concentration of agent and the inner blood flow stream  16  has a relatively low concentration or no agent. Additionally, the balloon  318  in the expanded configuration restricts the flow of blood to decrease the blood flow exterior to the proximal portion of the tubular member  316  down-stream of the renal arteries  12  in comparison to the blood flow stream exterior to the distal portion of the tubular member  316  up-stream of the renal arteries  12 . As a result, a relatively large amount of the agent delivered from the agent delivery port  334  is directed into the renal arteries  12 , in comparison to the amount of agent which flows down-stream of the renal arteries  12  in the aorta  10 . In one embodiment, the outer blood flow stream  14  is substantial.  
         [0208]     In one embodiment, the cross-sectional area of the inner lumen  324  of the tubular member  316  is about 4% to about 64% of the blood vessel  10  (i.e., aorta) cross-sectional area, or about 4 mm to about 16 mm for a blood vessel  10  having a 20 mm inner diameter. It should be noted that in some embodiments, the cross-sectional area of the wall of the tubular member  316  is not insignificant in relation to the cross-sectional area of the blood vessel  10 . In the embodiment illustrated in  FIG. 45  in which tubular member  316  comprises sheath  322  on a frame of filaments  321 , this cross-sectional area is negligible. In one beneficial embodiment, the cross-sectional area of the wall of the tubular member  316  may be about 2% to about 50%, more specifically about 5% to about 20%, of the cross-sectional area of a section of the blood vessel  10  located at the up-stream most end of the catheter  310 .  
         [0209]     Additionally, the aorta has multiple branch vessels in addition to the renal arteries which effect the total flow in the aorta at a given location therein. Thus, a percentage of the blood flow that enters the abdominal aorta, i.e., past the diaphragm, is delivered in the normal rest state of circulation to the celiac trunk, the superior and inferior mesenteric arteries, and the renal arteries. Nonetheless, the flow segmentation created by the presence of the deployed catheter  310  is such that the blood flow in the outer blood flow stream  14  of a patient at rest is about 10% to about 90% of the total blood flow immediately up-stream of the up-stream or distal most end of the tubular member  316 , i.e., of the total blood flow present in the section of the aorta  10  immediately adjacent to the renal arteries  12 . Similarly, the blood flow in the inner blood flow stream  16  of a patient at rest is about 10% to about 90% of the total blood flow immediately up-stream of the up-stream or distal most end of the tubular member  316 . The flow in the outer blood flow stream  14  is sufficient to provide adequate kidney function, although the flow required will vary depending upon factors such as the presence of drugs which increase flow or increase the ability of the tissue to withstand ischemic conditions.  
         [0210]     While the renal arteries  12  are illustrated directly across from one another in  FIG. 47 , and the method is discussed primarily in terms of delivery of agent to both renal arteries together, it should be understood that the catheter may be positioned and used- to deliver agent to the renal arteries individually, and specifically in anatomies having the renal arteries longitudinally displaced from one another. When treatment of the renal arteries  12  is no longer needed, the flow of agent is stopped. The tubular member  316  is contracted by urging the pull line  326 , distally, and the radially expandable member  318  is collapsed by removal of the inflation fluid, and the aortic flow diverter  310  is removed from the patient. A variety of suitable radially expandable tubular members  316  may be used in aortic flow diverter  310 .  
         [0211]      FIG. 51  illustrates another embodiment of an aortic flow diverter  340  in which the tubular member  341  comprises a self-expanding frame  342  having a sheath  343  thereon. As discussed above in relation to the embodiment of  FIG. 45 , catheter shaft  312  defines an inflation lumen  328  and an agent delivery lumen  332 , and radially expandable member comprises a balloon  344  on an outer surface of sheath  343 . For ease of illustration, the balloon  344  is shown as a transparent material. In the embodiment illustrated in  FIG. 51 , catheter shaft  312  comprises a multilumen proximal shaft  346  defining proximal sections of the inflation lumen  347  fluidly coupled to inflation port  348 , and a second distal tubular member  349  fluidly coupled to agent delivery port  350 . First tubular member  347  extends distally from the distal end of the proximal section of the inflation lumen  328  in the multilumen proximal shaft. Similarly, second tubular member  349  extends distally from the distal end of the proximal section of the agent delivery lumen  332  in the multilumen proximal shaft. First and second tubular members  347 , 349 , are typically formed of thin-walled polymeric material such as polyimide, with an inner diameter of about 0.002 inch to about 0.006 inch, and a wall thickness of about 0.0005 inch to about 0.002 inch. In other embodiments, catheter shaft  312  comprises an outer tubular member with first and second inner tubular members defining inflation lumen and agent delivery lumen, respectively, extending within the outer member and out the distal end thereof. The agent delivery lumen  349  extends to a location proximal to the distal end of the tubular member  316  and distal to the balloon  344 . One or more agent delivery ports  350  are provided in a distal section of the agent delivery lumens, as discussed above in relation to the embodiment of  FIG. 45 . In other embodiments, one or more additional agent delivery lumens may be provided.  
         [0212]     In the embodiment illustrated in  FIG. 51 , the frame  342  comprises longitudinally extending filaments or struts, such as wires, joined together at the proximal and distal ends thereof. In another embodiment, frame  342  is formed of high strength metal, such as stainless steel, nickel-titanium alloy, or titanium. However a variety of suitable materials can be used including rigid polymers. The filaments typically have a round transverse cross section, with a diameter of about 0.006 inch to about 0.016 inch, or a rectangular transverse cross section with a thickness of about 0.001 inch to about 0.006 inch and a width of about 0.006 inch to about 0.016 inch. Sheath  343  is similar to sheath  322  discussed in relation to the embodiment of  FIG. 45 , and is preferably a thin walled elastomeric tubular member. The tubular member  341  is illustrated in  FIG. 51  in the expanded configuration. The frame  342  is radially collapsible to a low profile configuration with the sheath  343  in a folded or pleated compact configuration for advancement within the patient&#39;s blood vessel. Once in place at a desired location within the blood vessel, a restraining member which applies a radially compressive force, which holds the frame in the collapsed smaller diameter configuration, is removed so that the frame expands. The frame may be held in the collapsed smaller diameter configuration by a variety of suitable restraining members such as a delivery catheter or removable outer sheath. For example, in one embodiment, the frame is deformed into the smaller diameter configuration within the lumen of a delivery catheter  352 , and then expanded in the blood vessel lumen by longitudinally displacing the frame out the distal end of the delivery catheter  352  to thereby remove the radially compressive force of the delivery catheter  352 . Although not illustrated, a pull line similar to pull line  326  discussed above in relation to the embodiment of  FIG. 45  may be provided to apply additional radially expanding force to the filaments to supplement their inherent spring force, and is preferably provided in the embodiments having a radially expandable member comprising an inflatable balloon where inflation of the balloon creates a radially compressive force on the tubular member. In the embodiment illustrated in  FIG. 51 , balloon  344  is inflated into contact with the aorta wall  10  to an outer diameter which completely occludes the outer blood flow stream downstream of the renal arteries  12 . Thus, the outer blood flow stream is directed into the branch vessels  12 . However, the balloon may be configured to inflate to an outer diameter which does not completely occlude the downstream outer blood flow stream, as discussed above in relation to the embodiment of  FIG. 47 .  
         [0213]      FIG. 52  illustrates another aortic flow diverter  360  sharing certain similarities with the aortic flow diverter  340  shown in  FIG. 51  except that the balloon member is replaced with a radially enlarged section  362  of the tubular member  364 . Thus, the frame  365 , with sheath  366  thereon, forming the tubular member  364  does not have a uniform outer diameter, but instead radially expands from a collapsed configuration to define a smaller diameter section  367  defining tubular member  364 , and a larger diameter section  368  defining a larger radial expandable member  362 .  
         [0214]      FIGS. 53A and 53B  illustrate transverse cross sectional views of another tubular member  370  comprises a sheet configured to unwind from a wound low profile to an unwound radially expanded configuration, shown in  FIG. 53B , to thereby radially expand the interior passageway of the tubular member  370 . in  FIG. 53A , the sheet  371  has a section wound back and forth into a plurality of folds  372 . A restraining member (not shown) such as an outer sheath or delivery catheter is removed so that the sheet  371  unfolds as illustrated in  FIG. 53B . The sheet section configured to be folded is preferably a thinner walled or otherwise more flexible than the section of the sheet which is not folded.  
         [0215]     In another embodiment of a tubular member  373 , illustrated in  FIG. 54A  and  FIG. 54B , the sheet  374  is wound around itself into a rolled-up configuration having a free edge  375  extending the length of the sheet  374 , which unrolls to the radially expanded configuration illustrated in  FIG. 54B .  
         [0216]      FIGS. 55A and 55B  illustrate another tubular member  376  that is wound like a rolled awning type mechanism on support member  377  around shaft  312 .  
         [0217]      FIG. 55B  illustrates tubular member  376  unwound from shaft  312 . A variety of suitable unfurling or uncoiling configurations may be used in a tubular member which is radially expandable in accordance with the invention  
         [0218]      FIG. 56  illustrates a transverse cross sectional view of another tubular member  378  comprising a plurality of inflatable balloons  380  within an outer sheath  382 . The balloons  380  can be inflated from a non-inflated low profile configuration to an inflated configuration shown in  FIG. 57 .  
         [0219]     In the inflated configuration, shown in  FIG. 57 , inner passageway  384  is defined between the inflated balloons  380  in part by the sheath  382 . Preferably, three or more balloons  380  are provided to in part define the inner passageway  380 . Balloons  380  are preferably formed of a noncompliant material such as PET, or a compliant material such as polyethylene having reinforcing members such as wire members. Although four cylindrical balloons  378  are illustrated in  FIG. 57 , it should be understood that a variety of suitable configurations may be used, including balloons having outer channels such as a spiraled balloon defining an outer spirally extending blood flow channel, similar in many respects to perfusion balloons for dilatation. An inflation lumen is provided in the catheter shaft  312  in fluid communication with balloons  378 .  
         [0220]      FIG. 58  illustrates another embodiment of an aortic flow diverter  390  in an expanded state comprising an inner inflatable member  392  formed in a helical shape by either a blow molding process or by using helical wire constraints and attached to catheter  312 . A cylindrical sheet member  394  encloses inner inflatable member  392 . Outer annular inflatable member  396  is formed on the outside of cylindrical sheet member  394  and when inflated, occlude outer blood flow  14  in aorta  10 . Inner blood flow  16  flows through helical passageway  398  formed by inner inflatable member  392 . An infusion port (not shown) can be used to deliver fluid agent to outer blood flow  14  distal of the occlusion site of outer annular inflatable member  396 .  
         [0221]      FIG. 59  Illustrates an aortic flow diverter  400  formed proximal of the distal section  402  of multilumen catheter  404 . Tubular member  406  is supported on frame  408  consisting of three or more flexible legs connecting catheter  404  with catheter distal section  402 . Flexible legs that comprise frame  408  may also be formed from longitudinal cuts into the flexible tubing forming catheter  404 . Inflatable member  410  attaches to the exterior of tubular member  406  and is in fluid communication with an inflation lumen  412 . Fluid agent lumen  414  in catheter  404  is connected to one or more flexible legs of frame  408  and fluidly connects to infusion port  416  through tubular member  406  and distal of inflatable member  410 . Pull wire  418  is attached to the distal section  402  of catheter  404  and pulls the distal section  402  towards catheter  404  when retracted. During insertion, pull wire  418  is relaxed, frame  408  is in an extended state and inflatable member is collapsed and folded or pleated around frame  408 . Aortic flow diverter  400  could also be encased in a delivery sheath (not shown) during insertion. When deployed, pull wire  418  is retracted causing frame  408  to expand against tubular member  406  and forming passageway  420 . Inflatable member  410  is inflated to occlude or partially occlude blood flow as shown previously in  FIG. 47 . Fluid agent may be infused into an outer blood flow through infusion port  416  as shown previously in  FIG. 47 .  
         [0222]      FIG. 60  illustrates another embodiment of an aortic flow diverter  430  with two inner inflatable tubular members  432 , made of PET or other suitable compliant material, each formed to present a triangular cross section with one apex of the triangle attached to multilumen catheter  434  when inflated, and encased in cylindrical sheet material  436 . Outer inflatable member  438 , made of urethane, polyisoprene or other suitable material, encases cylindrical sheet material  436 . Inner inflatable tubular members  432  are fluidly connected to an inflation lumen  440  in catheter  434  and fluidly connected to outer inflatable member  438 . When inserted, aortic flow diverter  430  is deflated and outer inflatable member  438  pleated or folded around cylindrical sheet material  436 . When place in an aorta or major blood vessel, inner inflatable tubular members  432  are inflated to form a blood flow passageway  442  with cylindrical sheet material  436 . Outer inflatable member  438  inflates to occlude or partially occlude a major blood vessel as shown previously in  FIG. 47 .  
         [0223]      FIG. 61  illustrates another variation of the aortic flow diverter  430  in  FIG. 60  where four inner inflatable tubular members  432  are formed to present a four lobed, clover shape, cross section within tubular member  436 . Inner inflatable tubular members  432  are in fluid communication with outer inflatable member  438  and an inflation lumen  440  in multilumen catheter  434 . Inner blood passageway  442  is formed between inner inflatable tubular members  432  and outer blood flow is occluded or partially occluded by outer inflatable member  438  as previously shown in  FIG. 47 .  
         [0224]      FIG. 62  through  FIG. 65  illustrates an embodiment of a proximal coupler system  850  used to deploy and position renal fluid delivery devices adjunctive with interventional catheters.  FIG. 62  and  FIG. 63  illustrate a proximal coupler system  850  in side view, and cut away section view. Y Hub body  852  is configured with an introducer sheath fitting  854  at the distal end  856  of hub body  852  and a main adapter fitting  858  at the proximal end  860  of Y hub body  852 . Main branch  862  has tubular main channel  864  aligned on axis  866 . Main channel  862  fluidly connects introducer sheath fitting  854  and main adapter fitting  858 . By way of example and not of limitation, one embodiment of main channel  864  is adapted to accommodate a 6 Fr guide catheter. Side port fitting  868  is positioned on main branch  862  and is fluidly connected to main channel  864 . Secondary branch  870  has tubular branch channel  872  that intersects main channel  864  at predetermined transition angle β. In one beneficial embodiment, transition angle β is approximately 20 degrees. Proximal end  874  of secondary branch  870  has secondary fitting  876 . In one beneficial embodiment, a channel restriction  878  is molded into introducer sheath fitting  854 . Y hub body  852  may be molded in one piece or assembled from a plurality of pieces.  
         [0225]      FIG. 64A  and  FIG. 64B  illustrate a proximal coupler system  850  with a hemostasis valve  880  attached at main port  858  and Touhy Borst valve  882  attached at branch port  876 . Fluid tube  884  is coupled to side port  868  and fluidly connects stop valve  886  and fluid port  888 . Introducer sheath  890  with proximal end  892  and distal end  894  is coupled to Y hub body  852  at Sheath fitting  854 . Proximal coupler system  850  is coupled to a local fluid delivery system  900 . A stiff tube  902 , has a distal end  904  (shown in  FIG. 64B ), a mid proximal section  906 , and a proximal end  908 . In one embodiment, stiff tube  902  is made of a Nickel-Titanium alloy. Stiff tube  902  is encased in delivery sheath  910  distal of mid proximal section  906 . By way of example and not of limitation, delivery sheath  910  may be about 6 Fr to about 8 Fr in diameter. A torque handle  912  is coupled to stiff tube  902  at a mid proximal position  906 . A material injection port  916  is positioned at the proximal end  908  of stiff tube  902 . Material injection port  916  is coupled to an adapter valve  920  for introducing materials such as fluids. Side port fitting  922  is coupled to tube  924  and further coupled to stopcock  926  and fluid fitting  928 . In an exemplary embodiment, adaptor  920  is a Luer valve. In another exemplary embodiment, side port fitting  922  is used for injecting a saline solution. Delivery sheath handle  930  is positioned and attached firmly at the proximal end  932  of delivery sheath  910 . Delivery sheath handle  930  has two delivery handle tabs  934 . In an exemplary embodiment, delivery sheath handle  930  is configured to break symmetrically in two parts when delivery handle tabs  934  are forced apart.  
         [0226]     In  FIG. 64B , Delivery sheath  910  is inserted through Touhy Borst adapter  882  through secondary branch channel  872  until distal end (not shown) of delivery sheath  910  is against channel restriction  878  (see  FIG. 63 ). At that point, force  940  is applied in a distal direction at torque handle  912  to push stiff tube  902  through delivery tube  910 . An aortic flow diverter (not shown) on distal end  904  of stiff tube  902  is adapted to advance distally into introduction sheath  890 . In  FIG. 64B , stiff tube  902  has been advanced into introduction sheath  890 . In one mode, delivery sheath handle  930  is split in two by pressing inwardly on delivery handle tabs  934 . Delivery sheath  910  is split by pulling delivery tabs  934  apart and retracted from Y hub assembly  852  through Touhy Borst adapter  882  to allow a medical intervention device (shown in  FIG. 64 ) to enter hemostasis valve  880  for further advancement through main channel  864  (see  FIG. 63 ) and adjacent to stiff tube  902 . In a further mode, delivery sheath  910  is completely retracted from Y hub assembly  852  before splitting and removing from stiff tube  902 .  
         [0227]      FIG. 65  is a stylized illustration of the proximal coupler system  850  of  FIG. 64B  with introducer sheath  890  is inserted in aorta system  10 . Delivery sheath  910  (not shown) has been retracted proximally and removed and one or more fluid agent infusion devices  936  have been advanced through introducer sheath  809  and positioned near renal arteries  12 . Intervention catheter  940  enters hemostasis valve  880  and is advanced through introducer sheath  890  and past aortic flow diverter  936  for further medical intervention while aortic flow diverter  936  remains in place at renal arteries  12 . It is to be understood that proximal coupler systems can be further modified with additional branch ports to advance and position more than two devices through a single introducer sheath.  
         [0228]      FIG. 66  illustrates a further embodiment of the proximal coupler assembly and fluid delivery assembly shown in  FIG. 65 . Renal therapy system  950  includes an introducer sheath system  952 , a vessel dilator  954  and a fluid delivery system  956  with an aortic infusion assembly  958 . Details of channels, saline systems and fittings as shown previously in  FIG. 62  through  FIG. 65  are omitted for clarity. Introducer sheath system  952  has Y hub body  960  as shown previously in  FIG. 62  and  FIG. 63  configured various inner structures as shown previously in  FIG. 63 . Y hub body  960  has hemostasis valve  962  on proximal end  966  and Touhy Borst valve  968  on secondary end  970 . Distal end  972  of Y hub body  960  is coupled to proximal end  974  of introducer sheath  976 . Introducer sheath  976  has distal tip  978  that has a truncated cone shape and radiopaque marker band  980 . In one embodiment, introducer sheath  976  is constructed with an inner liner of PTFE material, an inner coiled wire reinforcement and an outer polymer jacket. Introducer sheath  976  has predetermined length L measured from proximal end  974  to distal tip  978 .  
         [0229]     Vessel dilator  954 , with distal end  980  and proximal end  982  is a polymer, e.g. extrusion tubing with a center lumen for a guide wire (not shown). Distal end  980  is adapted with a taper cone shape. Proximal end  982  is coupled to a Luer fitting  984 .  
         [0230]     Fluid delivery system  956  has stiff tube  986 , torque handle  988 , and proximal hub  990  as previously described in  FIG. 64A  and  FIG. 64B  with aortic infusion assembly  958  coupled at distal end  992  with radiopaque marker bands  997  to aid positioning. The proximal hub  990  of fluid delivery system  956  has a Luer fitting  1002  for infusing a fluid agent, and is fluidly coupled with the stiff tube  986 .  
         [0231]     A single lumen, tear-away delivery sheath  1004  has a distal end  1006 , a proximal end  1008 , and slidingly encases stiff tube  986 . delivery sheath  1004  is positioned between the torque handle  988  and the bifurcated catheter  956 . The distal end  1006  has a shape and outer diameter adapted to mate with the channel restriction in the distal end of the main channel of the Y hub body as shown previously in  FIG. 63 . The proximal end  1008  of the delivery sheath  1004  is coupled to a handle assembly  1010  with two handles  1012  and a tear away cap  1014 .  
         [0232]     Dilator  954  is inserted through Touhy Borst valve  968  on secondary port  970  until distal end  980  protrudes from distal tip  978  of introducer sheath  976  to form a smooth outer conical shape. Distal tip  978  of introducer sheath  976  is positioned in the aorta system proximal of the renal arteries (not shown). Dilator  954  is removed and fluid delivery device  956  is prepared by sliding delivery sheath  1004  distally until aortic infusion assembly  958  is enclosed in delivery sheath  1004 . Distal end  1006  of delivery sheath  1004  is inserted in Touhy Borst valve  968  and advanced to the restriction in the main channel of the Y hub body shown in  FIG. 63 . Aortic infusion assembly  958  is advanced distally into introducer sheath  976 . Tear away delivery sheath  1004  is retracted and removed through Touhy Borst valve  968  as shown previously in  FIG. 56B . Aortic infusion assembly  958  is advanced distally out of the distal tip  978  of introducer sheath  976  and positioned to infuse fluid agent in the renal arteries as shown in  FIG. 65 .  
         [0233]     The various embodiments herein described for the present invention can be useful in treatments and therapies directed at the kidneys such as the prevention of radiocontrast nephropathy (RCN) from diagnostic treatments using iodinated contrast materials. As a prophylactic treatment method for patients undergoing interventional procedures that have been identified as being at elevated risk for developing RCN, a series of treatment schemes have been developed based upon local therapeutic agent delivery to the kidneys. Among the agents identified for such treatment are normal saline (NS) and the vasodilators papaverine (PAP) and fenoldopam mesylate (FM).  
         [0234]     The approved use for fenoldopam is for the in-hospital intravenous treatment of hypertension when rapid, but quickly reversible, blood pressure lowering is needed. Fenoldopam causes dose-dependent renal vasodilation at systemic doses as low as approximately 0.01 mcg/kg/min through approximately 0.5 mcg/kg/min IV and it increases blood flow both to the renal cortex and to the renal medulla. Due to this physiology, fenoldopam may be utilized for protection of the kidneys from ischemic insults such as high-risk surgical procedures and contrast nephropathy. Dosing from approximately 0.01 to approximately 3.2 mcg/kg/min is considered suitable for most applications of the present embodiments, or about 0.005 to about 1.6 mcg/kg/min per renal artery (or per kidney). As before, it is likely beneficial in many instances to pick a starting dose and titrate up or down as required to determine a patient&#39;s maximum tolerated systemic dose. Recent data, however, suggest that about 0.2 mcg/kg/min of fenoldopam has greater efficacy than about 0.1 mcg/kg/min in preventing contrast nephropathy and this dose is preferred.  
         [0235]     The dose level of normal saline delivered bilaterally to the renal arteries may be set empirically, or beneficially customized such that it is determined by titration. The catheter or infusion pump design may provide practical limitations to the amount of fluid that can be delivered; however, it would be desired to give as much as possible, and is contemplated that levels up to about 2 liters per hour (about 25 cc/kg/hr in an average about 180 lb patient) or about one liter or 12.5 cc/kg per hour per kidney may be beneficial.  
         [0236]     Local dosing of papaverine of up to about 4 mg/min through the bilateral catheter, or up to about 2 mg/min has been demonstrated safety in animal studies, and local renal doses to the catheter of about 2 mg/min and about 3 mg/min have been shown to increase renal blood flow rates in human subjects, or about 1 mg/min to about 1.5 mg/min per artery or kidney. It is thus believed that local bilateral renal delivery of papaverine will help to reduce the risk of RCN in patients with pre-existing risk factors such as high baseline serum creatinine, diabetes mellitus, or other demonstration of compromised kidney function.  
         [0237]     It is also contemplated according to further embodiments that a very low, systemic dose of papaverine may be given, either alone or in conjunction with other medical management such as for example saline loading, prior to the anticipated contrast insult. Such a dose may be on the order for example of between about 3 to about 14 mg/hr (based on bolus indications of approximately 10-40 mg about every 3 hours—papaverine is not generally dosed by weight). In an alternative embodiment, a dosing of 2-3 mg/min or 120-180 mg/hr. Again, in the context of local bilateral delivery, these are considered halved regarding the dose rates for each artery itself.  
         [0238]     Notwithstanding the particular benefit of this dosing range for each of the aforementioned compounds, it is also believed that higher doses delivered locally would be safe. Titration is a further mechanism believed to provide the ability to test for tolerance to higher doses. In addition, it is contemplated that the described therapeutic doses can be delivered alone or in conjunction with systemic treatments such as intravenous saline.  
         [0239]     It is to be understood that the invention can be practiced in other embodiments that may be highly beneficial and provide certain advantages. For example radiopaque markers are shown and described above for use with fluoroscopy to manipulate and position the introducer sheath and the aortic flow diverter. The required fluoroscopy equipment and auxiliary equipment is typically located in a specialized location limiting the in vivo use of the invention to that location. Other modalities for positioning aortic flow diverters are highly beneficial to overcome limitations of fluoroscopy. For example, non fluoroscopy guided technology is highly beneficial for use in operating rooms, intensive care units and emergency rooms. The use of non-fluoroscopy positioning allows aortic flow diverter systems and methods to be used to treat other diseases such as ATN and CHF.  
         [0240]     In one embodiment, the aortic flow diverter is modified to incorporate marker bands with metals that are visible with ultrasound technology. The ultrasonic sensors are placed outside the body surface to obtain a view. In one variation, a portable, noninvasive ultrasound instrument is placed on the surface of the body and moved around to locate the device and location of both renal ostia. This technology is used to view the aorta, both renal ostia and the aortic flow diverter.  
         [0241]     In another beneficial embodiment, ultrasound sensors are placed on the introducer sheath and the aortic flow diverter itself; specifically the distal end of the catheter. The aortic flow diverter with the ultrasonic sensors implemented allows the physician to move the sensors up and down the aorta to locate both renal ostia.  
         [0242]     A further embodiment incorporates Doppler ultrasonography with the aortic flow diverter. Doppler ultrasonography detects the direction, velocity, and turbulence of blood flow. Since the renal arteries are isolated along the aorta, the resulting velocity and turbulence is used to locate both renal ostium. A further advantage of Doppler ultrasongoraphy is it is non invasive and uses no x rays.  
         [0243]     A still further embodiment incorporates optical technology with the aortic flow diverter. An optical sensor is placed at the tip of the introducer sheath. The introducer sheath optical sensor allows visualization of the area around the tip of the introducer sheath to locate the renal ostia. In a further mode of this embodiment, a transparent balloon is positioned around the distal tip of the introducer sheath. The balloon is inflated to allow optical visual confirmation of renal ostium. The balloon allows for distance between the tip of the introducer sheath and optic sensor while separating aorta blood flow. That distance enhances the ability to visualize the image within the aorta. In a further mode, the balloon is adapted to allow profusion through the balloon wall while maintaining contact with the aorta wall. An advantage of allowing wall contact is the balloon can be inflated near the renal ostium to be visually seen with the optic sensor. In another mode, the optic sensor is placed at the distal tips of the aortic flow diverter. Once the aortic flow diverter is deployed within the aorta, the optic sensor allows visual confirmation of the walls of the aorta. The aortic flow diverter is tracked up and down the aorta until visual confirmation of the renal ostia is found. With the optic image provided by this mode, the physician can then track the aortic flow diverter to the renal arteries.  
         [0244]     Another embodiment uses sensors that measure pressure, velocity or flow rate to located renal ostium without the requirement of fluoroscopy equipment. The sensors are positioned at the distal tip of the aortic flow diverter. The sensors display real time data about the pressure, velocity or flow rate. With the real time data provided, the physician locates both renal ostium by observing the sensor data when the aortic flow diverter is around the approximate location of the renal ostia. In a further mode of this embodiment, the aortic flow diverter has multiple sensors positioned at a mid distal and a mid proximal position on the catheter to obtain mid proximal and mid distal sensor data. From this real time data, the physician can observe a significant flow rate differential above and below the renal arteries and locate the approximate location. With the renal arteries being the only significant sized vessels within the region, the sensors would detect significant changes in any of the sensor parameters.  
         [0245]     In a still further embodiment, chemical sensors are positioned on the aortic flow diverter to detect any change in blood chemistry that indicates to the physician the location of the renal ostia. Chemical sensors are positioned at multiple locations on the aortic flow diverter to detect chemical change from one sensor location to another.  
         [0246]     The invention has been discussed in terms of certain preferred embodiments. One of skill in the art will recognize that various modifications may be made without departing from the scope of the invention. Although discussed primarily in terms of controlling blood flow to a branch vessel such as a renal artery of a blood vessel, it should be understood that the catheter of the invention could be used to deliver agent to branch vessels other than renal arteries, or to deliver to sites other than branch vessels, as for example where the catheter is used to deliver an agent to the wall defining the body lumen in which the catheter is positioned, such as a bile duct, ureter, and the like. Moreover, while certain features may be shown or discussed in relation to a particular embodiment, such individual features may be used on the various other embodiments of the invention.  
         [0247]     Although the description above contains many details, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.”