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

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS  
       [0001]     This application is a continuation of PCT Patent Application No. PCT/US03/299995 (Attorney Docket No. 022352-001100PC), 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; 60/479,329 (Attorney Docket No. 022352-000900US), filed on Jun. 17, 2003; and 60/502,389 (Attorney Docket No. 022352-00110US), filed on Sep. 13, 2003. The full disclosure of each of the foregoing applications is hereby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention pertains generally to medical device systems and methods for intra aortic fluid delivery into regions of the body. More specifically, it is related to intra aortic renal fluid delivery systems and methods.  
         [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, an intra aortic 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 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; an intra aortic 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 intra aortic 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 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 renal drug delivery. Thus, an appropriate intra aortic delivery system for such indications would preferably be adapted to feed multiple renal arteries perfusing both kidneys.  
         [0017]     In another regard, mere 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 delivering agents into branch arteries described above, much benefit may also be gained from simply 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 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 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 delivering agents 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.  
         [0028]     A need still exists for improved devices and methods for locally 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 bilateral 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 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 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 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 an intra aortic drug delivery 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 an intra aortic drug delivery 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]     A need still exists for improved devices to deliver fluid agents bilaterally to both sides of the renal system from within the aorta system.  
         [0037]     A need still exists for improved devices to deliver fluid agents bilaterally to both sides of the renal system without requiring cannulation of the renal arteries themselves.  
         [0038]     A need also exists for improved devices to deliver fluid agents bilaterally to both sides of the renal system without substantially occluding, isolating, or diverting blood flow within the abdominal aorta.  
         [0039]     In addition to these particular needs for selective fluid delivery into a patient&#39;s renal arteries via their ostia along the aorta, other similar needs also exist for fluid delivery into other branch vessels or lumens extending from other main vessels or lumens, respectively, in a patient.  
       BRIEF SUMMARY OF THE INVENTION  
       [0040]     These present embodiments therefore generally relate to intra aortic renal drug delivery systems generally from a position proximal to the renal arteries themselves; 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. For example, intra aortic fluid delivery according to various of these embodiments benefits from particular dimensions, shapes, and constructions for the subject devices herein described. However, suitable modifications may be made to deliver fluids to other multi-lateral branch structures from main body spaces or lumens, such as for example in other locations within the vasculature (e.g. right and left coronary artery ostia, fallopian tubes stemming from a uterus, or gastrointestinal tract.  
         [0041]     One aspect of the invention is a local renal infusion system for treating a renal system in a patient from a location within the abdominal aorta associated with first and second flow paths within an outer region of abdominal aortic blood flow generally along the abdominal aorta wall and into first and second renal arteries, respectively, via their corresponding first and second renal ostia along an abdominal aorta wall in the patient. This system includes a local injection assembly with first and second injection ports. The local injection assembly is adapted to be positioned at the location with the first and second injection ports at first and second respective positions, respectively, corresponding with the first and second flow paths. The local injection assembly is also adapted to be fluidly coupled to a source of fluid agent externally of the patient when the local injection assembly is positioned at the location. Accordingly, the local injection assembly is adapted to inject a volume of fluid agent from the source, through the first and second injection ports at the first and second positions, respectively, and bi-laterally into the first and second renal arteries, also respectively. This assembly is in particular adapted to accomplish such localized bilateral renal delivery via the respective corresponding first and second renal ostia and without substantially altering abdominal aorta flow along the location.  
         [0042]     According to certain further modes of this aspect, the local injection assembly is adapted to inject the volume of fluid agent into the first and second flow paths such that the injected volume flows substantially only into the first and second renal arteries without substantially diverting, occluding, or isolating one region of aortic blood flow with respect to the first or second regions of aortic blood flow.  
         [0043]     Another further mode also includes a delivery member with a proximal end portion and a distal end portion with a longitudinal axis. The local injection assembly comprises first and second injection members with first and second injection ports, respectively, and is adapted to extend from the distal end portion of the delivery member and is adjustable between a first configuration and a second configuration as follows. The local injection assembly in the first configuration is adapted to be delivered by the delivery member to the location. The local injection assembly at the location is adjustable from the first configuration to the second configuration such that the first and second first injection members are radially extended from the longitudinal axis with the first and second injection ports located at the first and second positions, respectively, at the first and second flow paths.  
         [0044]     According to another mode, the local injection assembly includes an elongate body that is adapted to be positioned within the outer region. The first and second injection ports are spaced at different locations around the circumference of the elongate body such that the first and second injection ports are adapted to inject the volume of fluid agent in first and second different respective directions laterally from the elongate body and generally into the first and second flow paths, respectively.  
         [0045]     According to one embodiment of this mode, a positioner cooperates with the elongate body and is adapted to position the elongate body within the outer region at the location. In one variation of this embodiment, the positioner is coupled to the elongate body and is adjustable from a first configuration to a second configuration. The positioner in the first configuration is adapted to be delivered to the location with the elongate body. The positioner at the location is adapted to be adjusted from the first configuration to the second configuration that is biased to radially extend from the elongate body relative to the first configuration and against the abdominal aorta wall with sufficient force so as to deflect the orientation of the elongate body into the outer region. Further to this variation the positioner may also beneficially be a partial loop-shaped member that extends with first and second legs from the elongate body. In the first configuration at the location the partial loop-shaped member has a first orientation with respect to the elongate body and is adapted to be delivered to the location. In the second configuration at the location the partial loop-shaped member has a second orientation that is radially extended from the elongate body relative to the first orientation. In still further features according to this variation, the partial loop-shaped member is adjusted to the first configuration when subject to deformation force away from a memory shape, and is self-adjustable from the first configuration to the second configuration by material recovery of the partial loop-shaped member from the first configuration toward the memory shape. The first and second legs may be extendable from the elongate body through first and second extension ports, such that in the first configuration the first and second legs are withdrawn into the elongate body, and in the second configuration the first and second legs are extended from the elongate body through the first and second extension ports, respectively.  
         [0046]     In another embodiment, a control member is coupled to the partial loop-shaped member and also to the elongate body, and is adapted to adjust the looped-shape member between the first and second configurations by manipulating the position of the control member.  
         [0047]     In still a further embodiment, the positioner comprises a plurality of partial loop-shaped members such as described above.  
         [0048]     In another mode of this aspect of the invention, the local injection assembly further includes an elongate body with a longitudinal axis and that is adapted to be positioned at the location. The first and second injection members in the first configuration have first radial positions relative to the longitudinal axis, and in the second configuration have second radial positions. The second radial positions are radially extended from the longitudinal axis relative to the first radial position.  
         [0049]     In one embodiment of this mode, the first and second injection members are located on opposite respective sides of the elongate body around a circumference of the elongate body. In one variation of this embodiment, each of the first and second injection members extends between proximal and distal respective locations on each of the opposite respective sides of the elongate body, and in the second configuration the first and second injection members are biased outward from the elongate body between the respective proximal and distal respective locations.  
         [0050]     In another embodiment, the local injection assembly is in the form of a generally loop-shaped member, such that the first and second injection members comprise first and second regions along the loop-shaped member, and whereas the first and second injection ports are located on each of the first and second regions. The loop-shaped member in the first configuration has a first diameter between the first and second injection ports such that the loop-shaped member is adapted to be delivered to the location. The loop-shaped member in the second configuration has a second diameter between the first and second injection ports that is greater than the first diameter and is sufficient such that the first and second positions generally correspond with first and second flow paths within the outer region, respectively. According to one variation of this embodiment, the local injection assembly in the second configuration for the loop-shaped member includes a memory shape. The loop-shaped member is adjustable from the second configuration to the first configuration within a radially confining outer delivery sheath. The loop-shaped member is adjustable from the first configuration to the second configuration by removing it from radial confinement outside of the outer delivery sheath.  
         [0051]     In another mode, the local injection assembly comprises a plurality of n injection members, wherein n is an integer that is greater than two. Further to this mode, n injection ports are located on the n injection members, respectively. Each of the n injection members is adapted to be positioned at the location such that the n injection ports are located at n unique respective positions within the outer region. The local injection assembly is adapted to be oriented at the location such that n minus two of the plurality of injection members are oriented with the corresponding n minus two injection ports against the abdominal aorta wall, and such that the remaining two injection members of the plurality are oriented such that the two corresponding injection ports are at the first and second positions. Accordingly, the remaining two injection members are the first and second injection members, and the remaining two injection ports on the two remaining injection members are the first and second injection ports.  
         [0052]     In one embodiment of this mode, each of the plurality of injection ports at its respectively unique position within the outer region is adapted to be fluidly coupled simultaneously with the source of fluid agent externally of the body. The n minus two injection ports are adapted to be substantially prevented by the abdominal wall from injecting a substantial volume of fluid agent from the source and into the outer region. The remaining two injection ports are adapted to inject a substantial volume of fluid agent from the source and into the first and second renal ostia, respectively, such that local injection of fluid agent from the source is substantially isolated to the two injection ports.  
         [0053]     In another embodiment, in the first configuration at the location the n injection members are positioned at n generally unique radially collapsed positions around a circumference having a first diameter around a longitudinal axis of the abdominal aorta at the location. In the second configuration at the location the n injection members are positioned at n generally unique radially expanded positions around a circumference having a second diameter around the longitudinal axis that is greater than the first outer diameter and that is sufficient to position the respective n injection ports at the n respective positions, respectively.  
         [0054]     According to another mode, each of the first and second injection members includes an infusion passageway with an array of n injection regions, wherein n is an integer. Each array of n injection regions is adapted to be coupled to the source of fluid agent outside the body. The first and second injection members are adapted to be oriented at the location such that x of the n respective injection regions of each array are positioned within the outer region and in fluid communication with the respective renal ostium, and such that y of the respective injection regions of each array are against the abdominal aorta wall such that they are substantially prevented by the abdominal aorta wall from injecting a volume of fluid agent into the outer region. Accordingly, the first injection port includes at least one of the x injection regions along the first injection member. The second injection port includes at least one of the x injection regions along the second injection member. Further to this description, in general x is a positive number that is not greater than n, and n is equal to x plus y.  
         [0055]     In a further mode of the present aspect, first and second markers located along first and second injection members, respectively, at locations generally corresponding with the first and second injection ports. Each of the first and second markers is adapted to indicate to an operator externally of the patient the locations of the first and second injection ports to assist their delivery to the first and second positions, respectively. In particular beneficial embodiments, the first and second markers are radiopaque and provide guidance under fluoroscopy. In a further embodiment, the first and second injection members extend distally from the delivery member from a bifurcation location, and a proximal marker is located at the bifurcation location.  
         [0056]     In another mode, a the delivery member is provided that is an introducer sheath with a proximal end portion and a distal end portion that is adapted to be positioned at the location with the proximal end portion of the introducer sheath extending externally from the patient. The delivery member includes a delivery passageway extending between a proximal port assembly along the proximal end portion of the introducer sheath and a distal port assembly along the distal end portion of the introducer sheath. The injection assembly is adapted to be slideably engaged within the introducer sheath, and is adjustable between first and second longitudinal positions. The first and second injection members are located within the delivery passageway in the first longitudinal position and are extended distally through the distal port and from the distal end portion in the second longitudinal position. In a further embodiment of this mode, the distal end portion of the introducer sheath includes a distal tip and a delivery marker at a location corresponding with the distal tip such that the delivery marker is adapted to indicate the relative position of the distal tip within the abdominal aorta at the location. In one further embodiment, the distal port assembly has first and second ports through which the first and second delivery members are extended during adjustment to the second configuration.  
         [0057]     In another further embodiment, a catheter body is provided with a proximal end portion and a distal end portion that is adapted to be positioned at the location when the proximal end portion of the catheter body extends externally from the patient. The first and second injection members are coupled to and extend distally from the distal end portion of the catheter body. The proximal port assembly of the introducer sheath comprises a single proximal port, and the first and second injection members and distal end portion of the catheter body are adapted to be inserted into the delivery passageway through the single proximal port.  
         [0058]     According to another mode, the system further includes a proximal coupler assembly that is adapted to be fluidly coupled to a source of fluid agent externally of the patient, and also to the first and second injection ports at the first and second positions, respectively.  
         [0059]     In one embodiment, the proximal coupler assembly comprises first and second proximal couplers. The first proximal coupler is fluidly coupled to the first injection port, and the second proximal coupler is fluidly coupled to the second injection port. In one variation of this embodiment, a first elongate body extends between the first proximal coupler and the first injection member, and with a first fluid passageway coupled to the first proximal coupler and the first injection port; a second elongate body extends between the second proximal coupler and the second injection member, and with a second fluid passageway coupled to the second coupler and the second injection port. In another variation, the proximal coupler assembly includes a single common coupler that is fluidly coupled to each of the first and second injection ports via a common fluid passageway. According to one feature that may be employed per this variation, an elongate body extends between the single common coupler and the first and second injection members. The elongate body has at least one delivery passageway fluidly coupled to the single common coupler and also to the first and second injection ports.  
         [0060]     According to still a further mode of this aspect of the invention, the system further includes a source of fluid agent that is adapted to be coupled to the local injection assembly. The fluid agent may comprises one, or combinations of, the following: saline; a diuretic, such as Furosemide or Thiazide; a vasopressor, such as Dopamine; a vasodilator; another vasoactive agent; Papaverine; a Calcium-channel blocker; Nifedipine; Verapamil; fenoldapam mesylate; a dopamine DA1 agonist; or analogs or derivatives, or combinations or blends, thereof.  
         [0061]     Another mode includes a vascular access system with an elongate tubular body with at least one lumen extending between a proximal port assembly and a distal port that is adapted to be positioned within a vessel having translumenal access to the location. The system per this mode also includes a percutaneous translumenal interventional device that is adapted to be delivered to an intervention location across the location while the local injection assembly is at the location. The local injection assembly and percutaneous translumenal interventional device are adapted to be delivered percutaneously to the location and intervention location, respectively, through the vascular access device, and are also adapted to be simultaneously engaged within the vascular access device.  
         [0062]     In one embodiment, the percutaneous translumenal interventional device comprises an angiographic catheter. In another, the percutaneous translumenal interventional device is a guiding catheter. In another regard, the interventional device may be between about 4 French and about 8 French.  
         [0063]     In another embodiment, the proximal port assembly includes first and second proximal ports. The percutaneous translumenal interventional device is adapted to be inserted into the elongate body through the first proximal port. The first and second ports of the injection assembly are adapted to be inserted into the elongate body through the second proximal port.  
         [0064]     According to another mode, the local injection assembly includes a fluid reservoir and the first injection port is fluidly coupled to the fluid reservoir. The fluid reservoir is adjustable between a first condition, a second condition, and a third condition. In the first condition the fluid reservoir is adapted to be delivered to the location with the first injection port at the first position at the location. The fluid reservoir at the location is adapted to be fluidly coupled to a source of fluid agent located externally of the patient. The fluid reservoir at the location is adjustable from the first condition to the second condition such that the first volume from the source is delivered into the fluid reservoir. The local injection assembly at the location is further adjustable from the second condition to the third condition wherein the fluid reservoir discharges the first volume of fluid agent through the injection port at the position. The injected first volume of fluid agent is adapted to flow principally into the first flow path.  
         [0065]     Another aspect is a local infusion system for locally delivering a volume of fluid agent from a source located externally of a patient and into a location within a body space of a patient. This system includes a delivery member with a proximal end portion and a distal end portion with a longitudinal axis, and a local injection assembly comprising first and second injection members with first and second injection ports, respectively. The local injection assembly extends from the distal end portion of the delivery member and is adjustable between a first configuration and a second configuration as follows. The local injection assembly in the first configuration is adapted to be delivered by the delivery member to the location. The local injection assembly at the location is adjustable from the first configuration to the second configuration such that the first and second first injection members are radially extended from the longitudinal axis with the first and second injection ports located at first and second relatively unique positions, respectively, at the location. The first and second injection ports at the first and second respective positions are adapted to be fluidly coupled to a source of fluid agent externally of the patient and to inject a volume of fluid agent into the patient at the first and second positions, also respectively, at the location.  
         [0066]     Another aspect of the invention is a local infusion system with a local injection assembly comprising an injection member with an injection port and a fluid reservoir fluidly coupled to the injection port. The local injection assembly is adjustable between a first condition, a second condition, and a third condition as follows. In the first condition the local injection assembly is adapted to be delivered to a location within a body space of a patient with the injection port and fluid reservoir at a position within the location. The injection port at the position is adapted to be fluidly coupled to a source of fluid agent located externally of the patient. The local injection assembly at the location is adjustable from the first condition to the second condition such that a volume of fluid agent from the source is delivered via the injection port into the fluid reservoir. The local injection assembly at the location is further adjustable from the second condition to the third condition wherein the fluid reservoir discharges the volume of fluid agent into the location at the position.  
         [0067]     Another aspect of the invention is a local infusion system for delivering a volume of fluid agent from a source located externally of a patient and into a portion of an outer region within and generally along a wall of a body space at a location along the body space in the patient. The system includes a local injection assembly with an injection port, and a flow isolation assembly that cooperates with the local injection assembly as follows. The local injection assembly is adapted to be delivered to the location with the injection port at a position within the portion of the outer region. The injection port at the position 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 into the portion of the outer region of the body space. The flow isolation assembly is adjustable between a first condition and a second condition as follows. 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 a second condition that is adapted to isolate the injected volume of fluid agent to flow substantially within the portion of the outer region along the location. The portion is located along only a part of the circumference of the outer region that is less than all of the circumference.  
         [0068]     Another aspect of the invention is 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. This system includes in one regard a delivery catheter with an elongate body having a proximal end portion, a distal end portion with a distal tip that is adapted to be delivered across the location and to a delivery location that is upstream of the location while the proximal end portion is located externally of the patient, and a delivery lumen extending between a proximal port along the proximal end portion and a distal port along the distal end portion. A local injection assembly is also provided with an injection port. The local injection assembly is adapted to be delivered at least in part by the elongate body to the location such that the injection port is at a position within the location while the distal tip of the delivery catheter is at the delivery position. The injection port at the location 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 into abdominal aorta at the location such that the injected volume flows substantially into the first and second arteries via the first and second renal ostia, respectively.  
         [0069]     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 first and second renal arteries via respective first and second renal ostia having unique relative locations along the abdominal aorta wall. This method includes in one regard delivering a delivery catheter with an elongate body having a proximal end portion and a distal end portion with a distal tip across the location and to a delivery location that is upstream of the location while the proximal end portion is located externally of the patient. The method further includes delivering a local injection assembly that includes an injection port at least in part by the elongate body to the location such that the injection port is at a position within the location while the distal tip of the delivery catheter is at the delivery position. The injection port at the location is fluidly coupled to a source of fluid agent located externally of the patient. A volume of fluid agent from the source is injected through the injection port and into abdominal aorta at the location such that the injected volume flows substantially into the first and second arteries via the first and second renal ostia, respectively.  
         [0070]     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 first and second renal arteries via their respective first and second renal ostia, respectively, at unique respective locations along the abdominal aorta wall. This method includes: positioning a local injection assembly at the location with first and second injection ports at first and second unique respective positions at the location. Also includes is fluidly coupling the local injection assembly at the location to a source of fluid agent externally of the patient. A further step includes simultaneously injecting a volume of fluid agent from the source through the first and second injection ports at the first and second positions and principally into the first and second renal arteries, respectively.  
         [0071]     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. This method includes positioning a local injection assembly at the location, and fluidly coupling to the local injection assembly at the location to a source of fluid agent externally of the patient. Also included is 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.  
         [0072]     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. This method aspect includes positioning a delivery member within an abdominal aorta of a patient, and delivering with the delivery member a local injection assembly having first and second injection members with first and second injection ports, respectively, in a first configuration to the location. Also included is adjusting the local injection assembly between the first configuration and a second configuration at the location. Further to this method, in the second configuration the local injection assembly extends from the distal end portion of the delivery member with the first and second first injection members radially extended relative to each other across a portion of the abdominal aorta at the location and with the first and second injection ports located at first and second relatively unique positions, respectively, at the location. A further mode of this aspect is fluidly coupling the first and second injection ports at the first and second respective positions to a source of fluid agent externally of the patient, and injecting a volume of fluid agent into the first and second renal arteries via their respective first and second renal ostia from the first and second positions, respectively.  
         [0073]     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 a renal artery via a renal ostium located along the abdominal aorta wall. This method includes delivering a local injection assembly comprising an injection member with a fluid reservoir and an injection port in a first condition to the location with the injection port at a position at the location. Also included is fluidly coupling the fluid reservoir at the location to a source of fluid agent located externally of the patient. Further steps include adjusting the local injection assembly at the location from the first condition to a second condition such that a volume of fluid agent from the source is delivered into the fluid reservoir, and adjusting the local injection assembly at the location from the second condition to a third condition wherein the fluid reservoir discharges the volume of fluid agent through the injection port at the position. Accordingly, the injected volume of fluid agent is adapted to flow principally into the renal artery via the renal ostium.  
         [0074]     Another method 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 a renal artery via a renal ostium located along the abdominal aorta wall. This method includes delivering a local injection assembly with an injection port to the location with the injection port at a position within a portion of an outer region of the abdominal aortic blood flow generally along the abdominal aorta wall at the location. Further included is fluidly coupling the injection port at the position to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source into the portion of the outer region. Further steps are 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, and isolating the injected volume of fluid agent to flow substantially within the portion of the outer region along the location with the flow isolation assembly in the second condition. According to this method, the portion is located along only a part of the circumference of the outer region that is less than all of the circumference.  
         [0075]     Another aspect of the invention is a method for providing local therapy to a renal system in a patient from a location within the abdominal aorta associated with first and second flow paths within an outer region of abdominal aortic blood flow generally along the abdominal aorta wall and into first and second renal arteries, respectively, via their corresponding first and second renal ostia along an abdominal aorta wall in the patient. This method includes positioning a local injection assembly at the location with first and second injection ports at first and second respective positions, respectively, corresponding with the first and second flow paths. Also included is fluidly coupling the local injection assembly to a source of fluid agent externally of the patient when the local injection assembly is positioned at the location, and injecting a volume of fluid agent from the source, through the first and second injection ports at the first and second positions, respectively, and bi-laterally into the first and second renal arteries, also respectively, via the respective corresponding first and second renal ostia without substantially altering abdominal aorta flow along the location.  
         [0076]     Further modes of these various method aspects include beneficially enhancing renal function with the injected volume of fluid agent. This may include in particular injecting the volume of fluid agent into the location while performing an interventional procedure at an intervention location within a vasculature of the patient. In one embodiment, this further includes injecting the volume of fluid agent during a period when a volume of radiocontrast dye injection is within the patient&#39;s vasculature, and such that the fluid agent is adapted to substantially prevent RCN in response to the radiocontrast dye injection. According to a further beneficial variation, the method includes treating acute renal failure with the injected volume of fluid agent.  
         [0077]     Whereas each of these aspects, modes, embodiments, variations, and features is considered independently beneficial and are not to be required in combination with the others, nevertheless the various combinations and sub-combinations thereof as would be apparent to one of ordinary skill are further considered within the intended scope as further independently beneficial aspects of the invention.  
         [0078]     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  
       [0079]     The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only:  
         [0080]      FIG. 1  is an anterior perspective view of an abdominal aorta in the generally vicinity of the renal arteries.  
         [0081]      FIG. 2  is a cross-section view of an abdominal aorta taken in the vicinity of the renal arteries showing the general blood flow patterns through the abdominal aorta and the renal arteries.  
         [0082]      FIG. 3  is an anterior view of an embodiment of a bifurcated fluid infusion catheter disposed within an abdominal aorta in the vicinity of the renal arteries.  
         [0083]      FIG. 4  is a detailed view of one portion of the fluid infusion assembly shown in  FIG. 3  in a diastole configuration.  
         [0084]      FIG. 5  is a detailed view of the portion of the fluid infusion assembly shown in  FIG. 4 , except shows it in a systole configuration.  
         [0085]      FIG. 6  is a detailed view of another fluid infusion assembly in a diastole configuration.  
         [0086]      FIG. 7  is a detailed view of the fluid infusion assembly shown in  FIG. 6 , except shows it in a systole configuration.  
         [0087]      FIG. 8  is a perspective view of another form of bifurcated drug infusion catheter in an expanded configuration.  
         [0088]      FIG. 9  is a side plan view of the bifurcated drug infusion catheter shown in  FIG. 8 , except shows the catheter in a collapsed configuration.  
         [0089]      FIG. 10  is an anterior view of another bifurcated drug infusion catheter embodiment with an infusion ring shown in an expanded configuration.  
         [0090]      FIG. 11  is an anterior view of the bifurcated fluid infusion catheter embodiment shown in  FIG. 10 , shown in one mode of operation discharging medication.  
         [0091]      FIG. 12  is an anterior view of the bifurcated drug infusion catheter of  FIGS. 10 and 11 , and shows it disposed within an abdominal aorta adjacent to the renal arteries.  
         [0092]      FIG. 13  is a left side plan view of the bifurcated drug infusion catheter shown in  FIGS. 10-12 , and shows one mode of use disposed within an abdominal aorta adjacent to the renal arteries.  
         [0093]      FIG. 14  is an anterior view of the bifurcated drug infusion catheter shown in  FIGS. 10-12 , and shows another mode of use disposed within an abdominal aorta immediately above the renal arteries.  
         [0094]      FIG. 15  is a plan view of a fluid infusion catheter with positioning struts according to a further embodiment, and shows the struts in a collapsed configuration.  
         [0095]      FIG. 16  is an anterior view of the fluid infusion catheter shown in  FIG. 15 , shown with the struts disposed within an abdominal aorta adjacent to the renal arteries in an expanded configuration.  
         [0096]      FIG. 17  is a plan view of another fluid infusion catheter with struts shown in a collapsed configuration.  
         [0097]      FIG. 18  is an anterior view of the fluid infusion catheter shown in  FIG. 17 , and shows the positioning struts disposed within an abdominal aorta adjacent to the renal arteries in an expanded configuration.  
         [0098]      FIG. 19  is a plan view of another fluid infusion catheter with positioning struts shown in a collapsed configuration.  
         [0099]      FIG. 20  is an anterior view of the fluid infusion catheter of  FIG. 19 , and shows the struts disposed within an abdominal aorta adjacent to the renal arteries in an expanded configuration.  
         [0100]      FIG. 21  is an anterior view of another fluid infusion catheter with an anchor disposed within an abdominal aorta adjacent to the renal arteries in an expanded configuration.  
         [0101]      FIG. 22  is a detailed view of certain aspects of the fluid infusion catheter shown in  FIG. 21 .  
         [0102]      FIG. 23  is a detailed view of the fluid infusion catheter taken at circle  23  in  FIG. 21 .  
         [0103]      FIG. 24  is an anterior view of another fluid infusion catheter with a positioning loop disposed within an abdominal aorta immediately above the renal arteries in an extended configuration.  
         [0104]      FIG. 25  is a top plan view of the fluid infusion catheter shown in  FIG. 24 , and shows the positioning loop is disposed within an abdominal aorta immediately above the renal arteries in an extended configuration.  
         [0105]      FIG. 26  is a side plan view of the fluid infusion catheter shown in  FIGS. 24-25 , and shows the positioning loop disposed within an abdominal aorta immediately above the renal arteries in an extended configuration.  
         [0106]      FIG. 27  is a second side plan view of the fluid infusion catheter shown in  FIGS. 24-25 , and shows the positioning loop disposed within an abdominal aorta immediately above the renal arteries in an extended configuration.  
         [0107]      FIG. 28  is an anterior view of another fluid infusion catheter with an adjustable positioning loop in a retracted configuration.  
         [0108]      FIG. 29  is an anterior view of another fluid infusion catheter with a positioning loop in a partially extended configuration.  
         [0109]      FIG. 30  is a anterior view of another fluid infusion catheter with positioning loops in an extended configuration.  
         [0110]      FIG. 31  is a top plan view of the fluid infusion catheter shown in  FIG. 30 , and shows the positioning loops in an extended configuration.  
         [0111]      FIG. 32  is a perspective view of another embodiment according to the invention with a fluid infusion catheter cooperating with a flow diverter.  
         [0112]      FIG. 33  is an anterior view of the fluid infusion catheter shown in  FIG. 32 , and shows the flow diverter disposed within an abdominal aorta adjacent to the renal arteries.  
         [0113]      FIG. 34  is a perspective view of another drug infusion catheter with a flow diverter according to a further embodiment.  
         [0114]      FIG. 35  is an anterior view of the fluid infusion catheter shown in  FIG. 34 , and shows the flow diverter disposed within an abdominal aorta adjacent to the renal arteries.  
         [0115]      FIG. 36  is a perspective view of another fluid infusion catheter with a flow diverter according to still a further embodiment.  
         [0116]      FIG. 37  is a side plan view of another embodiment of the fluid infusion catheter with flow diverter shown in  FIG. 36 .  
         [0117]      FIG. 38  is an anterior view of the fluid infusion catheter shown in  FIGS. 36-37 , and shows the flow diverter disposed within an abdominal aorta adjacent to the renal arteries.  
         [0118]      FIG. 39  is an anterior view of a fluid infusion guide catheter disposed within an abdominal aorta adjacent to the renal arteries.  
         [0119]      FIG. 40  is an anterior view of another fluid infusion guide catheter disposed within an abdominal aorta adjacent to the renal arteries.  
         [0120]      FIG. 41  is an anterior view of another fluid infusion guide catheter disposed within an abdominal aorta adjacent to the renal arteries.  
         [0121]      FIG. 42  is a plan view of the fluid infusion guide catheter shown in  FIG. 41 , except showing in another collapsed mode of use.  
         [0122]      FIG. 43  is an anterior view of a guide catheter with a coaxial drug infuser disposed within an abdominal aorta adjacent to the renal arteries according to another embodiment.  
         [0123]      FIG. 44  is a top plan view of the system shown in  FIG. 43 .  
         [0124]      FIG. 45  is an anterior view of another guide catheter with a coaxial drug infuser disposed within an abdominal aorta adjacent to the renal arteries.  
         [0125]      FIG. 46  is a perspective view of another catheter assembly with a drug infusion introducer sheath disposed within an abdominal aorta adjacent to the renal arteries.  
         [0126]      FIG. 47  is a perspective view of another catheter assembly with an infusion balloon disposed within an abdominal aorta adjacent to the renal arteries.  
         [0127]      FIG. 48  is a rear perspective view of a self-shaping drug infusion catheter in a first configuration.  
         [0128]      FIG. 49  is an anterior view of a self-shaping drug infusion catheter in a second shaped configuration and disposed within an abdominal aorta adjacent to the renal arteries.  
         [0129]      FIG. 50  is a top plan view of a self-shaping drug infusion catheter in a shaped configuration and disposed within an abdominal aorta adjacent to the renal arteries.  
         [0130]      FIG. 51  is a side plan view of a self-shaping drug infusion catheter assembly.  
         [0131]      FIG. 52  is a side view of another embodiment of a catheter fluid delivery system with a multilumen sheath.  
         [0132]      FIG. 53  is a top section view of the catheter fluid delivery system in  FIG. 52 .  
         [0133]      FIG. 54  illustrates a proximal coupler system for positioning aortic fluid delivery systems adjunctively with other medical devices.  
         [0134]      FIG. 55  illustrates a section view of the proximal coupler system as shown in  FIG. 54 .  
         [0135]      FIG. 56A  illustrates a proximal coupler system as shown in  FIG. 54  coupled to a local fluid delivery system.  
         [0136]      FIG. 56B  illustrates a proximal coupler system as shown in  FIG. 56A  with a fluid delivery system advanced into an introducer sheath.  
         [0137]      FIG. 57  illustrates a proximal coupler system as shown in  FIG. 54  through  56 B with a fluid infusion device positioned near the renal arteries and a catheter deployed adjunctively in the aorta.  
         [0138]      FIG. 58  illustrates a renal therapy system with an introducer sheath system, a vessel dilator, a fluid delivery system and an aortic infusion assembly.  
         [0139]      FIG. 59  is a stylized illustration of a double Y assembly with two local fluid delivery systems and an intervention catheter in an aorta system. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0140]     Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus generally shown in  FIG. 3  through  FIG. 59 . It will be appreciated that the apparatus may vary as to configuration and as to details of the parts, and that the method may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein.  
         [0141]     The description herein provided relates to medical material delivery systems and methods in the context of their relationship in use within a patient&#39;s anatomy. Accordingly, 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. These present embodiments below therefore generally relate to local renal drug delivery 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.  
         [0142]     In general, the disclosed material delivery systems will include a fluid delivery assembly, a proximal coupler assembly and one or more elongated bodies, such as 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 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 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]     For additional understanding, further more detailed examples of other systems and methods for providing local renal drug delivery are variously disclosed in the following published references: WO 00/41612 to Keren et al.; and WO 01/083016 to Keren et al. The disclosures of these references are herein incorporated in their entirety by reference thereto. Moreover, various combinations with, or modifications according to, various aspects of the present embodiments as would be apparent to one of ordinary skill upon review of this disclosure together with these references are also considered within the scope of invention as described by the various independently beneficial embodiments described below.  
         [0145]     The invention is also related to 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.  
         [0146]     Referring initially to  FIG. 1 , an abdominal aorta is shown and is generally designated  10 . As shown, a right renal artery  12  and a left renal artery  14  extend from the abdominal aorta  10 . A superior mesenteric artery  16  extends from the abdominal aorta  10  above the renal arteries  12 ,  14 . Moreover, a celiac artery  18  extends from the abdominal aorta  10  above the superior mesenteric artery  16 .  FIG. 1  also shows that an inferior mesenteric artery  20  extends from the abdominal aorta  10  below the renal arteries  12 ,  14 . Further, as shown in  FIG. 1 , the abdominal aorta  10  branches into a right iliac artery  22  and a left iliac artery  24 . It is to be understood that each embodiments of the present invention described in detail below can be used to deliver a drug or other fluid solution locally into the renal arteries  12 ,  14 . Each of the below-described embodiments can be advanced through one of the iliac arteries  22 ,  24  and into the abdominal aorta  10  until the general vicinity of the renal arteries  12 ,  14  is reached.  
         [0147]      FIG. 2  shows a schematic cross-section of the abdominal aorta  10  taken in the immediate vicinity of the renal arteries  12 ,  14 .  FIG. 2  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 ,  14 . As shown, the flow down the abdominal aorta  10  maintains a laminar flow pattern. Moreover, the flow stream near the middle of the abdominal aorta  10 , as indicated by dashed box  30 , continues down the abdominal aorta  10 , as indicated by arrows  32 , and does not feed into any of the side branches, e.g., the renal arteries  12 ,  14 . 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 ,  14 .  
         [0148]     Conversely, the flow stream along an inner wall  34  of the abdominal aorta  10 , as indicated by dashed box  36  and dashed box  38 , contains a natural laminar flow stream into the branching arteries, e.g., the renal arteries  12 ,  14 , as indicated by arrows  40 ,  42 . In general, the flow stream  32  is of a higher velocity than flow stream  40  along wall  34  of aorta  10 . It is to be understood that near the boundaries of dashed box  36 , 38  with dashed box  30  the flow stream can contain flow streams into the branching arteries  12 ,  14 —as well as down the abdominal aorta  10 .  
         [0149]     Further, the ostia of renal arteries  12 ,  14  are positioned to receive substantial blood flow from the blood flow near the posterior wall  34  of aorta  10  as well as the side walls. In other words, blood flow  40  in dashed boxes  36 ,  38  together is greater than blood flow  32  in dashed box  30  when along the posterior wall of aorta  10  relative to blood flow in the center of aorta  10  as shown in  FIG. 2 . Thus, drug infusion above renal arteries  12 , 14  and along the posterior wall of aorta  10  will be effective in reaching renal arteries  12 , 14 .  
         [0150]     Accordingly, in order to maximize the flow of a drug solution into the renal arteries using the natural flow patterns shown in  FIG. 2 , 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.  
         [0151]     As described in much greater detail below, it is beneficial to infuse a drug solution above the renal arteries  12 ,  14  at two locations along the wall  34  of the abdominal aorta  10  spaced approximately one-hundred and eighty degrees (180) apart from each other.  
         [0152]     Referring now to  FIG. 3 , a first embodiment of a bifurcated drug infusion catheter is shown and is generally designated  50 . As shown, the bifurcated drug infusion catheter  50  includes a central catheter body  51  that splits into a first bifurcated portion  52  and a second bifurcated portion  54 . Each bifurcated portion  52 ,  54  includes a free end  56  in which an infusion port  58  is formed. Each free end  56  further includes a radio-opaque marker band  59 . Also, an infusion assembly  60  is attached to the free end  56  of each bifurcated portion  52 ,  54  around the infusion port  58 . Details concerning the construction of each infusion assembly  60  are described below.  
         [0153]     It can be appreciated that the bifurcated drug infusion catheter  50  shown in  FIG. 3 , places a bifurcated portion  52 ,  54  on the inner wall  34  of the abdominal aorta  10  generally immediately upstream from the level of the renal arteries  12 ,  14 . The infusion ports  58  are positioned inside an infusion assembly  60 , described below, that releases a drug solution during the systolic phase of blood flow in which the blood flow within the abdominal aorta  10  is more predictable and more closely tracks the wall  34  of the abdominal aorta  10  into the renal arteries  12 ,  14 , as indicated by arrows  62 .  
         [0154]     It can be further appreciated that the infusion of a drug solution from the bifurcated portions  52 ,  54  of the bifurcated drug infusion catheter  50 , when positioned adjacent to the inner wall  34  of the abdominal aorta  10 , results in a greater percentage of the drug solution entering the renal arteries  12 ,  14  than systemic injection. However, “mixing” into the center of the abdominal aorta  10  can still take place, e.g., during the diastolic phase of blood flow through the abdominal aorta  10 . Thus, releasing a drug solution from a properly positioned bifurcated drug infusion catheter  50  during the systolic phase, when a more uniform flow pattern is present, can result in a majority of the drug solution flowing into the renal arteries  12 ,  14 . Further, a “passive” infusion assembly, as described below, allows the bifurcated drug infusion catheter  50  to work in a beneficial manner with improved efficiency and reduced complexity. While it is technically feasible to pulse the injection of a drug with an electro mechanical device driven by an ECG signal it is beyond the scope of the desired level of complexity desired.  
         [0155]     Referring now to  FIG. 4  and  FIG. 5 , details concerning the construction of one embodiment of the infusion assembly  60  attached to each bifurcated portion  52 ,  54  of the bifurcated drug infusion catheter  50  are shown. As shown, the infusion assembly  60  includes a collapsible tube  64  having a proximal end  66  and a distal end  68 . Further, a one way check valve  70  is installed in the distal end  68  of the collapsible tube  64 .  
         [0156]      FIG. 4  shows the infusion assembly  60  in the diastole configuration in which the one way check valve  70  is closed. It can be appreciated that during diastole, as indicated by arrow  72 , a drug solution  74  trickling from the infusion port  58  can collect in the tube  64  where it is prevented from mixing into the middle of the abdominal aorta  10 . However, during systole, as indicated by arrow  76  in  FIG. 5 , the infusion assembly  60  moves to the systole configuration, wherein blood flow opens the one way check valve  70  and the drug solution  74  flows out of the infusion assembly  60 , along the wall  34  of the abdominal aorta  10 , and into the renal artery  14 .  
         [0157]      FIG. 6  and  FIG. 7  show another embodiment of an infusion assembly, designated  80 , that can be used in conjunction with the bifurcated drug infusion catheter  50  shown in  FIG. 3 . As shown in  FIG. 6  and  FIG. 7 , the infusion assembly  80  includes a collapsible sock  82  having a distal end  84  and a proximal end  86 .  
         [0158]     During diastole, as indicated by arrow  88  in  FIG. 6 , the infusion assembly  80  is the diastole configuration wherein the drug solution  74  from the infusion port  58  can collect in the collapsible sock  82 . Within the collapsible sock  82 , during diastole, the drug solution  74  is prevented from mixing into the middle of the abdominal aorta  10 . However, during systole, as indicated by arrow  90  in  FIG. 7 , the infusion assembly  80  moves to the systole configuration, wherein the blood flow causes the collapsible sock  82  to collapse and the drug solution  74  flows out of the infusion assembly  80 , along the wall  34  of the abdominal aorta  10 , and into the renal artery  14 .  
         [0159]     It can be appreciated that the bifurcated drug infusion catheter  50 , shown in  FIG. 3 , can be used with either of the above-described infusion assemblies  60 ,  80 . Further, during use, the bifurcated drug infusion catheter  50  can be introduced through a long 8 or 9 French (Fr) diameter introducer sheath positioned near the renal arteries  12 ,  14 . Thereafter, partially withdrawing the introducer sheath can expose the free ends  56  of the bifurcated portions  52 ,  54  of the bifurcated drug infusion catheter  50  until separation can be detected, e.g., at approximately one-half (½) of the diameter of the abdominal aorta  10 . Viewing in an A-P plane the bifurcated drug infusion catheter  50  can be rotated back and forth until the marker bands  59  are in the most lateral position, i.e., when the distance between the marker bands  59  appears to be the greatest. Then, the longitudinal position of the bifurcated drug infusion catheter  50  can be fine tuned. A user, e.g., a physician, can continue to withdraw the introducer sheath until the free ends  56  of the bifurcated drug infusion catheter  50  are in contact with the inner wall  34  of the aorta  10 . It can be appreciated that the bifurcated drug infusion catheter  50  can be held in place within the abdominal aorta  10  by a spring force separating the bifurcated portions  52 ,  54  of the bifurcated drug infusion catheter  50 . It can be further appreciated that each of the embodiments shown in  FIGS. 3-7  are relatively easy to position, present limited surface area, and minimize flow stagnation. Moreover, upstream interventions may be performed, e.g. PCA.  
         [0160]     Referring now to  FIG. 8  and  FIG. 9 , another embodiment of a bifurcated drug infusion catheter is shown and is designated  100 . As shown, the bifurcated drug infusion catheter  100  includes a central catheter tube  102 . In one beneficial embodiment, catheter tube  102  is multilumen. A first infusion tube  104  and a second infusion tube  106 , made of a flexible material such as nickel-titanium tubing, are coupled to and extend from the central catheter tube  102  at approximately one-hundred and eighty degrees (180°) from each other. Each infusion tube  104 ,  106  includes a proximal end  108  and a distal end  110 . In one beneficial embodiment, the distal ends  110  of each infusion tube  104 ,  106  are coupled to the central catheter tube  102  and the proximal ends  108  enter catheter tube  102  and continue proximally to a proximal coupler assembly (not shown). It is to be understood that during drug infusion, a drug solution can flow from the central catheter tube  102  and through each infusion tube  104 ,  106 , e.g., from the proximal end  108  to the distal end  110 , or from the distal end  110  to the proximal end  108 , but drug solution principally exits through ports  112 .  
         [0161]      FIG. 8  and  FIG. 9  show the infusion tubes  104 ,  106  in an expanded configuration and a retracted configuration respectively. In one embodiment, the infusion tubes  104 ,  106  are advanced distally from a proximal coupler assembly (not shown) causing each infusion tube  104 ,  106  to bow outward in the expanded configuration shown in  FIG. 8 . When infusion tubes  104 ,  106  are retracted proximally from a proximal coupler assembly (not shown), they straighten in the retracted configuration shown in  FIG. 9 .  
         [0162]      FIG. 8  and  FIG. 9  further show that each infusion tube  104 ,  106  is formed with an infusion port  112  from which a drug solution can flow during drug infusion. Moreover, each infusion tube  104 ,  106  includes a marker band  114  to assist in properly positioning the bifurcated catheter tube  100  within the abdominal aorta  10  ( FIG. 1 ).  
         [0163]      FIG. 8  shows the bifurcated drug infusion catheter  100  in the expanded configuration. When expanded, the infusion tubes  104 ,  106  can bow away from the central catheter tube  102  in order to provide drug infusion nearer to the inner wall  34  ( FIG. 1 ) of the abdominal aorta  10  ( FIG. 1 ) and maintain positioning within aorta  10 . When there is no longer a need for drug infusion, the infusion tubes  104 ,  106 , are retracted against the central catheter tube  102 . In the retracted configuration, shown in  FIG. 9 , the bifurcated drug infusion catheter  100  can be inserted into the abdominal aorta  10 , e.g., from the right iliac artery  22  or the left iliac artery  24 . Additionally, following drug infusion, the infusion tubes  104 ,  106  can retract and aid in removal of the bifurcated drug infusion catheter  100  from the abdominal aorta  10  ( FIG. 1 ).  
         [0164]     It is to be understood that one or more additional struts or tubes (not shown) may be added to catheter  100  to position or stabilize the infusion tubes  104 ,  106  near the renal arteries. It is further understood that the additional struts may be made of different materials than the infusion tubes  104 ,  106 .  
         [0165]      FIG. 10  through  FIG. 14  show various modes according to a further embodiment of a bifurcated fluid infusion catheter, generally configured as an infusion ring, and designated  120 .  FIGS. 10 through 14  show that the bifurcated drug infusion catheter  120  includes a central catheter tube  122  that defines a proximal end (not shown) and a distal end  124 . An infusion ring  126  is attached to the distal end  124  of the central catheter tube  122 . More specifically, the infusion ring  126  includes a first end  128  and a second end  130  that are attached to the distal end  124  of the central catheter tube  122 . During infusion, a drug solution can flow from the central catheter tube  122  into the infusion ring  126  via the first end  128  and second end  130  thereof.  
         [0166]     Still referring to  FIG. 10  through  FIG. 14 , the infusion ring  126  is preferably formed with a first infusion port  132  and a second infusion port  134 . In a beneficial embodiment, the infusion ports  132 ,  134  are located along the infusion ring  126  at approximately one-hundred and eighty degrees (180°) from each other.  FIG. 10  through  FIG. 14  further show that the infusion ring  126  includes plural radio-opaque marker bands  136 . As shown in  FIG. 11 , during infusion, a drug solution  138  can flow from the infusion ports  132 ,  134 , e.g., at or above the renal arteries  12 ,  14 .  
         [0167]     It can be appreciated that the infusion ring  126  can be made of a material having a radial strength sufficient enough to maintain the infusion ring  126  against the inner wall  34  of the abdominal aorta  10 , as shown in  FIG. 12 . However, the infusion ring  126  is sufficiently flexible to allow it to become slightly squashed, i.e., elliptical, during insertion. Further, it can be appreciated that the infusion ring  126  can be radio-opaque in order to aid in locating and positioning the infusion ring  126  within the abdominal aorta  10 . The marker bands  138  can aid in positioning the infusion ports  132 ,  134 .  
         [0168]     As shown in  FIG. 12  and  FIG. 13 , the location of the infusion ring  126  can be exactly at the renal arteries  12 ,  14 , i.e., with the infusion ports  132 ,  134  aligned with the renal arteries  12 ,  14 , in order to maximize drug infusion into the renal arteries  12 ,  14 .  
         [0169]     One benefit of the infuser ring configuration is it is easy to position, visualize, advance and retract in the aorta. Another benefit is it is low profile. This allows guide catheters and guide wires to pass and reduces thrombus formation due to flow disruption. The low profile low bulk of the infusion ring allows insertion using smaller diameter sheaths. In one beneficial embodiment, the infusion ring is made of a memory shape material such as Nitinol tubing, vertically oriented, and fed through an introducer sheath in a collapsed state to its position near the renal arteries. In another embodiment, the infusion ring is a flexible free form material and a pull wire is extended through the infusion ring to control expansion of the ring and does not require placement by an introducer sheath. This configuration also allows rotational positioning in a contracted state without the risk of vessel trauma. In a further embodiment, additional homodynamic aids (wings, spoilers, flow directors, etc.) can be coupled on the Nitinol loop in areas which cause limited flow disruption (i.e. simply against the aortas&#39; posterior wall).  
         [0170]      FIG. 13  shows a configuration where the bifurcated drug infusion catheter  120  is installed within the abdominal aorta  10  and the central catheter tube  122  rests against the back of the abdominal aorta  10  while the infusion ring  126  is at an angle with respect to the abdominal aorta  10 . This configuration is beneficial to allow guide catheters and guide wires to pass through the infusion ring  126 .  
         [0171]     On the other hand, as shown in  FIG. 14 , the infusion ring  126  can be placed above the renal arteries  12 ,  14  with the infusion ports  132 ,  134  slightly distanced from the renal arteries  12 ,  14 . Due to the flow pattern discussed above in conjunction with  FIG. 2 , no vessel or side branch can disturb the flow stream above the renal arteries  12 ,  14 . With drug infusion along the wall  34  of the abdominal aorta  10 , other branches extending from the abdominal aorta  10  cannot disturb the flow streams into the renal arteries  12 ,  14 .  
         [0172]     Referring now to  FIG. 15  and  FIG. 16 , a further embodiment is a drug infusion catheter with positioning struts for positioning the catheter within an abdominal aorta is shown and is generally designated  150 .  FIG. 15  and  FIG. 16  shows that the drug infusion catheter  150  includes an outer tube  152  that defines a proximal end (not shown) and a distal end  154 . A central support tube  156  extends from within the outer tube  152  beyond the distal end  154  thereof. A tip  158  is provided at the end of the central support tube  156 .  
         [0173]      FIG. 15  and  FIG. 16  show that the drug infusion catheter  150  includes a first collapsible strut  160  and a second collapsible strut  162  slidably disposed within the outer tube  152 . Each collapsible strut  162  includes a proximal end (not shown) and a distal end  164  and the distal end  164  of each collapsible strut  162  is attached to the tip  158 . As intended by the present embodiment, when each collapsible strut  160 ,  162  is extended out of the outer tube  152 , they bow outward relative to the central support tube  156 —since the distal end  164  of the strut  160 ,  162  is affixed to the tip  158 .  
         [0174]     As shown, each collapsible strut  160 ,  162  includes an infusion port  166 . Further, each collapsible strut  160 ,  162  includes a first marker band  168  above the infusion port  166  and a second marker band  170  below the infusion port  166 . Preferably, each marker band is radio-opaque to assist in positioning the drug infusion catheter  150  within the abdominal aorta  10 .  
         [0175]      FIG. 15  shows the drug infusion catheter  150  in the collapsed configuration, i.e., with the collapsible struts  160 ,  162  that form positioning struts in the collapsed configuration. In the collapsed configuration, the drug infusion catheter  150  can be inserted into to the right or left iliac artery  22 ,  24  ( FIG. 1 ) and fed into the abdominal artery  10  until it is in proper position near the renal arteries  12 ,  14 . Once in position near the renal arteries  12 ,  14 , the collapsible struts  160 ,  162  can be advanced forward relative to the outer tube  152  causing them to release from the central support tube  156 . The collapsible struts  160 ,  162  can be advanced forward until they establish the expanded configuration shown in  FIG. 16 . In the expanded configuration, the infusion ports  166  are positioned immediately adjacent to the renal arteries  12 ,  14  and can release a drug solution directly into the renal arteries  12 ,  14 . It can be appreciated that the drug infusion catheter  150  can be placed so that the drug solution is infused immediately above the renal arteries  12 ,  14  along the wall  34  of the abdominal aorta  10 . After a specified dwell time within the abdominal aorta  10 , the drug infusion catheter  150  can be returned to the collapsed configuration and withdrawn from the abdominal aorta  10 .  
         [0176]     Referring briefly to  FIG. 17  and  FIG. 18 , another embodiment of a drug infusion catheter with positioning struts is shown.  FIG. 17  and  FIG. 18  shows that the drug infusion catheter  150  can include a third collapsible strut  172  and a fourth collapsible strut  174 . Accordingly, when expanded as described above, the drug infusion catheter  150  with the four collapsible struts  160 ,  162 ,  172 ,  174  resembles a cage.  
         [0177]      FIG. 19  and  FIG. 20  show another embodiment of a drug infusion catheter with positioning struts for positioning the catheter within an abdominal aorta, generally designated  200 . As shown, the drug infusion catheter  200  includes an outer tube  202  having a proximal end (not shown) and a distal end  204 . A first collapsible strut  206 , a second collapsible strut  208 , a third collapsible strut  210 , and a fourth collapsible strut  212  are established by the outer tube  202  immediately adjacent to the distal end  204  of the outer tube  202 . Moreover, a central support hypotube  214  is slidably disposed within the outer tube  202 . A distal end (not shown) of the central support hypotube  214  is affixed within the distal end  204  of the outer tube  202 . Accordingly, as intended by the present embodiment, when the central support hypotube  214  is retracted proximally in the outer tube  202 , the struts  206 ,  208 ,  210 ,  212  expand and create a cage configuration that can secure the drug infusion catheter  200 , e.g., within the abdominal aorta  10  near the renal arteries  12 ,  14 .  
         [0178]      FIG. 19  and  FIG. 20  show that the first strut  206  and the second strut  208  are each formed with an infusion port  216 . Additionally, a first marker band  218  is disposed above the infusion ports  216  along each strut. And, a second marker band  220  is disposed below the infusion ports  216  along each strut. During use, a drug solution can be released from the infusion ports  216  formed in the first and second struts  206 ,  208 . It can be appreciated that the third and fourth struts  210 ,  212  can also establish infusion ports and can further include marker bands, as described above. It can also be appreciated that drug infusion catheter  200  may be practiced with only a first and a second struts  206 ,  208  to present a lower profile.  
         [0179]      FIG. 19  shows the drug infusion catheter  200  in the collapsed configuration. In the collapsed configuration, the drug infusion catheter  200  can be inserted into to the right or left iliac artery  22 ,  24  ( FIG. 1 ) and fed into the abdominal artery  10  until it is in proper position near the renal arteries  12 ,  14 . Once in position near the renal arteries  12 ,  14 , the central support hypotube  214  is retracted proximally in outer tube  202  causing the struts  206 ,  208 ,  210 ,  212  to release from the central support tube  202  and bow outward. The central support hypotube  214  can be retracted proximally, as described above, until the struts  206 ,  208 ,  210 ,  212  establish the expanded configuration shown in  FIG. 20 .  
         [0180]     In the expanded configuration, the infusion ports  216  are positioned immediately adjacent to the renal arteries  12 ,  14  and can release a drug solution directly into the renal arteries  12 ,  14 . It can be appreciated that the drug infusion catheter  200  can be placed so that the drug solution is infused immediately above the renal arteries  12 ,  14  along the wall  34  of the abdominal aorta  10 . After a specified dwell time within the abdominal aorta  10 , the drug infusion catheter  200  can be returned to the collapsed configuration and withdrawn from the abdominal aorta  10 .  
         [0181]     Referring to  FIG. 21 , another embodiment of a drug infusion catheter with an anchor for positioning the catheter within an abdominal aorta is shown and is generally designated  250 ,  FIG. 21  shows the drug infusion catheter  250  installed within an abdominal aorta  10  in the vicinity of the renal arteries  12 ,  14 . As shown in  FIG. 21 , the drug infusion catheter  250  includes a central catheter tube  252  having a proximal end (not shown) and a distal end  254 . A hollow stent  256  is attached to the distal end  254  of the central catheter tube  252  and a drug solution can flow from the central catheter tube  252  into the hollow stent  256 . In this aspect of the present embodiment, the hollow stent  256  is formed partially or entirely of hollow hypo tubing, though other variations of elastomeric tubing may be used.  
         [0182]     As shown in  FIG. 22  and  FIG. 23 , the stent  256  can be punctured or otherwise formed with plural infusion ports  258  along the outer surface of the stent  256 . The drug infusion catheter  250  can be positioned, and expanded, within the abdominal aorta  10 , as shown in  FIG. 21 , such that the stent  256  is anchored in the vicinity of the renal arteries  12 ,  14 . As such, a drug solution can be released from the hollow stent  256  via the infusion ports  258  directly into the renal arteries  12 ,  14 . By expanding the stent  256  against the inner wall  34  of the abdominal aorta  10  in the area of the renal arteries  12 ,  14  all the infusion ports can be blocked (since they are established on the outside surface of the stent  256 ) except those that are directly over the renal ostia. Thus, when a drug solution is infused, its flow into the renal arteries  12 ,  14  is maximized.  
         [0183]     It can be appreciated that the stent  256  can form an expandable open-mesh structure that can have an element, or a few elements, that cross the renal ostia without disrupting the blood flow to the renal arteries  12 ,  14 . It is to be understood that the ability to deploy and recapture the stent  256  can be accomplished using a number of methods apparent to those of ordinary skill in the art based on review of this disclosure, e.g., by suitably modifying the methods typically employed for deploying and recapturing temporary vena cava filters or retractable stents.  
         [0184]     Referring now to  FIG. 24  through  FIG. 28 , another embodiment of a drug infusion catheter with positioning loops for positioning the catheter within an abdominal aorta is shown and is generally designated  300 .  FIG. 24  through  FIG. 28  show that the drug infusion catheter  300  includes a central catheter tube  302  that defines a proximal end (not shown) and a distal end  304 . As shown, a generally vertically oriented positioning loop  306  extends from the distal end  304  of the central catheter tube  302 . Preferably, the positioning loop  306  is made from a memory metal, e.g., nickel-titanium (NiTi). It is to be understood that the positioning loop  306  can be held in a pre-determined position via shape setting or it can be in a free-form shape and held in a final diameter via the inner wall  34  of the abdominal aorta  10 . As specifically shown in  FIG. 26  and  FIG. 27 , the positioning loop  306  can sufficiently hold the drug infusion catheter  300  in place regardless of the diameter of the abdominal aorta  10  e.g. as shown in the smaller and larger diameter aortas of  FIG. 26  and  FIG. 27 , respectively.  
         [0185]     As shown in  FIG. 24  through  28 , the drug infusion catheter  300  can include a pull wire  308  that extends from a port  310  formed in the central catheter tube  302 . The pull wire  308  is attached to the positioning loop  306  and can be used to control the expansion and contraction of the positioning loop  306  without the need for an external sheath.  FIG. 28  specifically shows the positioning loop  306  in a fully retracted configuration that can be used when inserting or withdrawing the drug infusion catheter  300 .  
         [0186]      FIG. 24  through  28  further show that the central catheter tube  302  is formed with a first infusion port  312  and a second infusion port  314 . A drug solution can exit the central catheter tube  302  and flow into the renal arteries  12 ,  14  as indicated by arrow  316  and  318 .  
         [0187]     It can be appreciated that the drug infusion catheter  300  shown in  FIG. 24  through  28  can allow rotational position adjustment and vertical position adjustment without the risk of trauma to the abdominal aorta  10 . Further, the positioning loop  306  can be retracted numerous ways to allow atraumatic rotation. And, since there are not any protruding or traumatic edges to catch aortic tissue on, the drug infusion catheter  300  can be moved up and down without retracting the positioning loop  306 . In another beneficial embodiment, positioning loop  306  is free form without pull wire  310 . It can be appreciated that positioning loop  306  can be made of a shape-memory alloy, such as Nitinol™, and advanced through the distal end  304  of catheter  300  for positioning and retracted for insertion and removal.  
         [0188]     The present embodiment recognizes that experimental observations have shown that a drug solution can flow into the renal arteries  12 ,  14  naturally, provided the drug infusion is undertaken above the renal arteries  12 ,  14  and above or closely adjacent to the posterior aspect of the inner wall  34  of the abdominal aorta  10 . As shown in  FIG. 25  through  FIG. 28 , the positioning loop  306  can easily position the central catheter tube  302  against the posterior of the inner wall  34  of the abdominal aorta  10  and does not require a flow diverter, e.g., a balloon or membrane, to maximize drug infusion to the renal arteries  12 ,  14 . As such, the possibility of thrombus formation due to the disruption of blood flow is minimized.  
         [0189]     It can be appreciated that the drug infusion catheter  300  can easily allow various guide catheters and guide wires to pass therethrough and that passage can have minimal effect on the tactile feedback or other performance aspects of the adjunctive catheters that are typically used in a percutaneous coronary intervention (PCI).  
         [0190]      FIG. 29  shows another embodiment of a drug infusion catheter with a positioning loop for positioning the catheter within an abdominal aorta, generally designated  330 . As shown, the drug infusion catheter  330  includes a central catheter tube  332  having a proximal end (not shown) and a distal end  334 . As shown, a positioning loop  336  extends from the distal end  334  of the central catheter tube  332 . Further, the drug infusion catheter  330  can include a pull wire  338  that extends from a port  340  formed in the central catheter tube  332 . The pull wire  338  is attached to the positioning loop  306  and can be used to retract the positioning loop  336  during insertion or withdrawal of the drug infusion catheter  330 .  
         [0191]     As shown in  FIG. 29 , a flow director  342  is affixed to the distal end  334  of the central catheter tube  332 . The flow director  342  is formed with a bifurcated (e.g. a T-shaped) infusion passage  344  that directs the flow of a drug solution from an infusion port (not shown) formed in the distal end  334  of the central catheter tube  332  in two opposing directions—as indicated by arrow  346  and arrow  348 .  
         [0192]     Referring to  FIG. 30  and  FIG. 31 , another embodiment of a drug infusion catheter with positioning loops for positioning the catheter within an abdominal aorta is shown and is generally designated  360 . As shown, the drug infusion catheter  360  includes a central catheter tube  362  that defines a proximal end (not shown) and a distal end  364 . As shown, a first positioning wire  366  and a second positioning wire  368  extend from a port  370  formed in the central catheter tube  362 . Each positioning wire  366 ,  368  defines a proximal end (not shown) and a distal end  372 . The distal end  372  of each positioning wire  366 ,  368  is attached to the distal end  364  of the central catheter tube  362 . It is to be understood that the positioning wires  366 ,  368  extend through the entire length of the central catheter tube  370  and can be used to establish an adjustable positioning loop. It can be appreciated that the adjustable positioning loop can be adjusted by extending or retracting the positioning wires  366 ,  368  through the port  370  in the central catheter tube  363 .  
         [0193]     Referring now to  FIG. 32  and  FIG. 33 , one embodiment of a drug infusion catheter with a renal flow isolator is shown and is generally designated  400 . As shown, the drug infusion catheter  400  includes a central catheter tube  402  that defines a proximal end (not shown) and a distal end  404 . A ring  406  is attached to the distal end  404  of the central catheter tube  402 . Moreover, a generally cylindrical curtain  408  extends from the ring  406 . Preferably, in this aspect of the present invention, the curtain  408  is made from expanded polytetrafluoroethylene (ePTFE) or any material with similar characteristics well known in the art. In one beneficial embodiment, the overall length of renal flow isolator  400  is about 1.5 cm.  
         [0194]      FIG. 32  and  FIG. 33  further show an infusion tube  410  that extends bi-directionally from the central catheter tube  402 . A first infusion port  412  and a second infusion port  414  are established on the outside of curtain  408  by the infusion tube  410 . In the exemplary, non-limiting embodiment shown in  FIG. 32  and  FIG. 33 , the single ring  406  allows for sizing to the abdominal aorta  10  to maintain the infusion ports  412 ,  414  along the inner wall  34  of the abdominal aorta  10 . It can be appreciated that the configuration of the drug infusion catheter  400  shown in  FIG. 32  and  FIG. 33  reduces the amount of stagnant blood around the drug infusion catheter  400  and thereby, minimizes the blood clotting thereon. This configuration also puts the drug along the aortic wall. In one embodiment, central catheter tube  402  has an offset that is a slight S shape (not shown) and positions renal flow diverter  400  off the aorta wall.  
         [0195]      FIG. 34  and  FIG. 35  show a further embodiment of a drug infusion catheter with a flow isolator, generally designated  430 . As shown, the drug infusion catheter  430  includes a central catheter tube  432  with a mid distal position  433  and a distal end  434 . An upper ring  436  is attached to the distal end  434  of the central catheter tube  432 . Moreover, a lower ring  438  is attached to the catheter tube  432  at mid distal position  433  and at a distance slightly spaced from the upper ring  436 .  FIG. 34  and  FIG. 35  further show catheter tube  432  connecting the upper ring  436  to the lower ring  438 . In this aspect of the present invention, the catheter tube  432  between mid distal position  433  and distal end  434  is covered with a layer of fabric  440 , such as ePTFE, extending from upper ring  436  to lower ring  438 . It can be appreciated that the orientation of fabric  440  reduces the amount of stagnant blood collecting around the drug infusion catheter  430  and thereby, minimizes the blood clotting thereon. In one beneficial embodiment, the overall length of drug infusion catheter is about 2 cm.  
         [0196]     As shown in  FIG. 34  and  FIG. 35 , a first infusion port  442  and a second infusion port  444  are established in a mid section of fabric  440  of the drug infusion catheter  430 . It is to be understood that the upper ring  436  and the lower ring  438  ensure that the infusion ports  442 ,  444  are placed along side of the inner wall  34  of the abdominal aorta  10 . The preferred position of the drug infusion catheter  430  within the abdominal aorta  10  is such that the infusion ports  442 ,  444  are closest to the posterior of the abdominal aorta  10 . Moreover, the rings  436  and  438  do not significantly alter blood flow through the abdominal aorta  10  and since they are open, a guiding catheter (not shown), or any other working catheter, can be advanced through the drug infusion catheter  430 . In one embodiment, central catheter tube  432  has an offset that is a slight S shape (not shown) and positions drug infusion catheter  430  off the aorta wall.  
         [0197]     Referring to  FIG. 36  through  FIG. 38 , another embodiment of a drug infusion catheter is shown and is generally designated  460 . As shown, the drug infusion catheter  460  includes a central catheter tube  462  that defines a proximal end (not shown) and a mid distal position  464 . A ring  466  is attached near the mid distal position  464  of the catheter tube  462 .  
         [0198]      FIG. 36  through  FIG. 38  further show central catheter tube  462  with an offset near mid distal position  464  and a sail  470  attached to the distal end  468  that extends partially around the perimeter of the ring  466 . It can be appreciated that the sail  470  forms a semi-conical shape between the mast  468  and the ring  466 . In this aspect, the sail  470  is made from ePTFE, though other suitable materials may be used or applied. It can be appreciated that the semi-conical shape of the sail  470  and the material from which it is constructed reduces the amount of stagnate blood around the drug infusion catheter  460  and as such, the chance of blood clots forming around the drug infusion catheter  460  is minimized.  FIG. 36  and  FIG. 38  show a first infusion port  472  and a second infusion port  474  established along the catheter tube  462  between distal end  468  and ring  466 .  
         [0199]     As intended by the present embodiment, the ring  466  maintains the position of the drug infusion catheter  460  against the inner wall  34  of the abdominal aorta  10 . Also, the sail  470  is designed to divert blood flow, and thus, the flow of a drug solution trickling from the infusion ports  472 ,  474 , into the renal arteries  12 ,  14 . The preferred position of the drug infusion catheter  460  within the abdominal aorta  10  is such that the infusion ports  472 ,  474  are closest to the posterior of the abdominal aorta  10 .  
         [0200]      FIG. 39  shows one embodiment a drug infusion guide catheter, designated  500 , that can be placed within an abdominal aorta  10  in the general vicinity just above the renal arteries  12 ,  14 . As shown, the drug infusion guide catheter  500  includes an infusion port  502  formed in the outer wall of the drug infusion guide catheter  500 . It can be appreciated that a drug solution can be released from the drug infusion guide catheter  500  via the infusion port  502 . The renal blood flow (see  FIG. 2 ) to each renal artery  12 ,  14  is about 15 percent of total aortic blood flow for a total of about 30 percent. With no change in blood flow, about 30 percent of drug solution released from infusion port  502  will reach renal arteries  12 , 14 .  
         [0201]     It is to be understood that it is most advantageous to release the drug solution from the drug infusion guide catheter  500  during systole, as indicated by arrow  504  and arrow  506 . As shown in  FIG. 39 , during systole, the drug solution can flow in a generally downward direction from the infusion port  502 , as indicated by arrow  508  and arrow  510 , and into the right renal artery  12  and the left renal artery  14 , as indicated by arrow  512  and arrow  514 . It is to be further understood that the drug infusion guide catheter  500  is at least formed with two lumens therein, i.e., a first relatively larger lumen for the exchange of devices and a second relatively smaller lumen for drug infusion. Accordingly, as intended by the present embodiment, the requirement for a secondary device, in addition to the drug infusion guide catheter  500 , to infuse drugs and medication to the renal arteries  12 ,  14  during a PCI is obviated.  
         [0202]      FIG. 40  shows another embodiment of a drug infusion guide catheter, generally designated  520 . As shown, the drug infusion guide catheter  520  can be inserted into the abdominal aorta  10 , e.g., via the left or right iliac artery  22 ,  24  ( FIG. 1 ), until it is in the vicinity of the renal arteries  12 ,  14 .  FIG. 40  shows that the drug infusion guide catheter  520  includes an infusion port  522  that is formed in the outer wall of the drug infusion guide catheter  520 . It can be appreciated that a drug solution can be released from the drug infusion guide catheter  520  via the infusion port  522 . As shown in  FIG. 40 , the drug infusion guide catheter  520  further includes a balloon  524  that can be inflated to divert blood flow into the renal arteries  12 ,  14 .  
         [0203]     In this aspect of the present invention, the balloon  524  can be made from silicon, nylon, PEBAX, polyurethane, or any other similar compliant or semi-compliant material well known in the art. Moreover, the balloon  524  can be inflated such that it engages the inner wall  34  of the abdominal aorta  10  or it can be inflated such that it is smaller than the diameter of the inner wall  34  of the abdominal aorta  10  so that it will not entirely block the flow of blood through the abdominal aorta  10 . Basically, the size of the balloon  524  can be easily varied by varying the inflation pressure of the balloon  524  thereby affecting the blood flow past renal arteries  12 ,  14 .  
         [0204]     It is to be understood that the drug infusion guide catheter  520  shown in  FIG. 40  is preferably formed with three lumens therein. For example, the drug infusion guide catheter  520  can include a first relatively large lumen for the exchange of devices, a second relatively small lumen for drug infusion, and a third relatively small lumen for balloon inflation.  
         [0205]     As previously stated above, it is beneficial to release a drug solution in the abdominal aorta  10 , e.g., from the drug infusion guide catheter  520 , during systole, as indicated by arrow  526  and arrow  528 . During systole, the drug solution can flow in a generally downward direction from the infusion port  522 , as indicated by arrow  530  and arrow  532 , and into the right renal artery  12  and the left renal artery  14 , as indicated by arrow  534  and arrow  536 . It can be appreciated that the balloon  524  maximizes the flow of the drug solution into the renal arteries  12 ,  14 . Per this embodiment, a counter pulsation of the balloon relative to the systolic/diastolic cycle may be used to enhance performance.  
         [0206]     Referring now to  FIG. 41  and  FIG. 42 , another embodiment of a drug infusion guide catheter is shown and is generally designated  550 . As shown, the drug infusion guide catheter  550  can be advanced into the abdominal aorta  10 , e.g., via the left or right iliac artery  22 ,  24  ( FIG. 1 ), until it is in the vicinity of the renal arteries  12 ,  14 .  FIG. 41  shows that the drug infusion guide catheter  550  includes an infusion port  552  that is formed in the outer wall of the drug infusion guide catheter  550 . It can be appreciated that a drug solution can be released from the drug infusion guide catheter  550  via the infusion port  552 . As shown in  FIG. 41 , the drug infusion guide catheter  550  further includes a flow diverter  554  that can be expanded to divert blood flow into the renal arteries  12 ,  14 .  
         [0207]      FIG. 41  shows that the flow diverter  554  includes a membrane  556  that can be expanded by a frame  558 —much like a basket or an umbrella. In this aspect of the present invention, the membrane  556  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  556 . Moreover, the membrane  556  can be lazed or otherwise formed with plural holes  560  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. In another embodiment, membrane  556  can be a wire mesh or stent-like devices. Further, the frame  558  is preferably made from a memory metal, e.g., NiTi, to allow for conformability to the aorta and pre-shaped capabilities. It can be appreciated that the flow diverter  554  can be expanded such that it engages the inner wall  34  of the abdominal aorta  10 .  
         [0208]     Referring briefly to  FIG. 42 , it is shown that the flow diverter  554  can be collapsed within an outer sheath  562  disposed around the drug infusion guide catheter  550 . Once the drug infusion guide catheter  550  is in place within the abdominal aorta  10 , the sheath  562  can be withdrawn causing the flow diverter  554  to be deployed near the renal arteries  12 ,  14 .  
         [0209]     It is to be understood that the drug infusion guide catheter  550  shown in  FIG. 41  is preferably formed with at least two lumens therein. For example, the drug infusion guide catheter  550  can include a first relatively large lumen for the exchange of devices, and a second relatively small lumen for drug infusion.  
         [0210]     As previously stated above, it is most beneficial to release a drug solution in the abdominal aorta  10 , e.g., from the drug infusion guide catheter  550 , during systole, as indicated by arrow  564  and arrow  566  shown in  FIG. 41 . During systole, the drug solution can flow in a generally downward direction from the infusion port  552 , as indicated by arrow  568  and arrow  570 , and into the right renal artery  12  and the left renal artery  14 , as indicated by arrow  572  and arrow  574 . It can be appreciated that the flow diverter  554 , when deployed, maximizes the flow of the drug solution into the renal arteries  12 ,  14 .  
         [0211]     Referring to  FIG. 43  and  FIG. 44 , an embodiment of a guide catheter with a coaxial drug infuser is shown and is generally designated  600 .  FIG. 43  shows that the guide catheter with a coaxial drug infuser  600  includes a central catheter tube  602  around which a generally ring shaped, drug infuser  604  is slidably disposed. A drug infusion catheter  606  extends from the drug infuser  604  and can be used to supply a drug solution to the drug infuser  604 .  FIG. 44  shows that an annular space can be established between the drug infuser  604  and the central guide catheter  602 . An infusion port (not shown) can be established in drug infuser  604 , and is fluidly connected to drug infusion catheter  606 .  
         [0212]      FIG. 43  shows that a drug solution can exit the drug infuser  604  via the top of the drug infuser  604 , as indicated by arrow  610  and arrow  612 . The drug solution can also exit the drug infuser  604  at the bottom of the drug infuser  604 , as indicated by arrow  614  and arrow  616 . In one embodiment, the bottom of drug infuser  604  fits closely around central catheter tube  602  and drug solution flows preferably out the top as shown by arrow  610 ,  612 . In another embodiment, the top of drug infuser  604  fits closely around central catheter tube  602  and drug solution flows preferably out the bottom as shown by arrow  614 ,  616  During systole, indicated by arrow  618  and arrow  620 , the drug solution can flow into the right and left renal arteries  12 ,  14 , as indicated by arrow  622  and arrow  624 . When positioned below renal arteries  12 ,  14  (not shown) drug infuser  604  provides drug solution preferentially to the lower extremities. While a ring shape is shown, other embodiments, e.g. a partial ring, are contemplated for slideable coupling for independent positioning.  
         [0213]     Referring now to  FIG. 45 , another embodiment of a guide catheter with a coaxial drug infuser is shown. As shown, the guide catheter with a coaxial drug infuser is identical to the embodiment shown in  FIG. 43  and  FIG. 44 . However, the guide catheter with a coaxial drug infuser shown in  FIG. 45  further includes a balloon  626  fluidly connected to the drug infusion catheter  606 . The balloon  626  can be inflated to divert the flow of blood therearound and further increase the flow of the drug solution into the renal arteries  12 ,  14 .  
         [0214]      FIG. 46  shows a catheter assembly with a drug infusion introducer sheath, generally designated  640 . As shown, the catheter assembly  640  includes a central guide catheter  642  that is inserted through the right iliac artery  22  and advanced until it is within the abdominal aorta  10 .  FIG. 46  further shows a drug infusion introducer sheath  644  around the central guide catheter  642 . The drug infusion introducer sheath  644  defines a proximal end  646  and a distal end  648 . As shown, the proximal end  646  of the introducer sheath  644  is attached to a catheter introducer hub  650  that can be used to advance the introducer sheath  644  into aorta  10 . Preferably, the drug infusion introducer sheath  644  can be advanced until the distal end  648  of the introducer sheath  644  is at or above the renal arteries  12 ,  14 .  
         [0215]     Further, as shown in  FIG. 46 , an annular infusion port  652  is established between the central guide catheter  642  and the drug infusion introducer sheath  644 . A drug solution can flow in the space between the central guide catheter  642  and the drug infusion introducer sheath  644  and exit through the annular infusion port  652  at or above the renal arteries  12 ,  14 . The drug solution can then flow into the right renal artery  12 , as indicated by arrow  654  and arrow  656 . Moreover, the drug solution can flow into the left renal artery  14  as indicated by arrow  658  and arrow  660 . It can be appreciated that the drug solution can be supplied to the drug infusion introducer sheath  644  via a drug infusion tube  662  connected to the catheter introducer hub  650 . While an annular infusion port  652  is shown, other shapes for an infusion port may be contemplated.  
         [0216]     In a beneficial embodiment, a standard catheter introducer sheath, usually 8-23 cm in length (not shown), is replaced with a longer catheter introducer sheath  644  that can reach the renal arteries. A longer sheath, 40-60 cm in length, depending on patient height and vascular tortuousity, is used in lieu of the standard catheter introducer sheath, and its distal tip is placed at a level slightly above the renals, preferably at or below the level of the superior mesenteric artery (SMA). The drug desired to be infused selectively into the renal arteries is infused through the catheter introducer sheath while the coronary procedure is performed. This is a marked improvement over systemic infusion of a drug solution since the flow to the renal arteries  12 ,  14  is about 30 percent of total aortic blood flow.  
         [0217]     Referring to  FIG. 47 a  catheter assembly with an infusion or “weeping” balloon is shown and is generally designated  700 . As shown, the catheter assembly  700  includes a central catheter tube  702  that is inserted through the right iliac artery  22  and advanced until it is within the abdominal aorta  10 .  FIG. 47  shows a drug infusion balloon  704  mounted mid-shaft on the central catheter tube  702 . As shown, a catheter introducer hub  706  can be used to advance the central catheter tube  702  into the abdominal aorta  10 . Preferably, the central catheter tube  702  can be advanced until the drug infusion balloon  704  is in the vicinity of the renal arteries  12 ,  14 . In another beneficial embodiment, central catheter tube is advanced into the aorta system through an introducer sheath system (not shown). It is understood that central catheter tube  702  may have one or more lumens for drug solution delivery.  
         [0218]      FIG. 47  shows that the drug infusion balloon  704  is formed with plural infusion ports  708 . The infusion ports  708  are small enough to allow for pressure to be built up inside the drug infusion balloon  704 . Additionally, the infusion ports  708  allow for a slow infusion of the inflating fluid, e.g., a drug solution, into the vascular system in which the drug infusion balloon  704  is placed, e.g., within the abdominal aorta  10 .  
         [0219]     In a beneficial embodiment, the central catheter tube  702  is advanced into the abdominal aorta  10  until the drug infusion balloon  704  is in the peri-renal aorta. The drug infusion balloon  704  is then inflated such that the drug infusion balloon  704  partially covers the renal arteries  12 ,  14 . Some of the infusion ports  708  formed in the drug infusion balloon  704  can be pressed against the inner wall  34  of the abdominal aorta  10  and accordingly, be blocked thereby. Other infusion ports  706  in proximity to the renal arteries  12 ,  14  can be unblocked. A drug solution can be supplied to the drug infusion balloon  704  via the central catheter tube  702 . A drug infusion tube  710  is connected to the catheter introducer hub  706  and supplies the drug solution to the central catheter tube  702 . Since the drug solution can flow through the unblocked infusion ports  708 , as indicated by arrow  712  and arrow  714 , the delivery of the drug solution to the renal arteries  12 ,  14  is maximized.  
         [0220]     It is to be understood that the catheter system  700  described in detail above can further include an intake (not shown) above the drug infusion balloon  704 . Thus, blood can flow into the drug infusion balloon  704  and pre-mix with the drug solution within the drug infusion balloon  704  prior to delivery to the renal arteries. Additionally, it can be appreciated that the catheter system  700  described above can be an individual system or it can be incorporated with another interventional device, i.e., mounted on a guiding catheter.  
         [0221]     Referring now to  FIG. 48  through  FIG. 50 a  self-shaping drug infusion catheter is shown and is generally designated  720 . The self-shaping drug infusion catheter  720  includes a proximal end (not shown) and a distal end  722 .  FIG. 48  shows the self-shaping drug infusion catheter  720  installed over a guide wire  724 . In one embodiment, the self-shaping drug infusion catheter  720  is made from a memory metal, e.g., NiTi, and a standard polymer. It is to be understood that the memory metal can be braided or coiled around a polymer tube. In another mode, the memory metal can be present in the polymer tube via a mandrel or a spine which runs the length of the self-shaping drug infusion catheter  720 . The memory metal can be shape set to create the preferred free state shape of the self-shaping drug infusion catheter  720 , described below.  
         [0222]     Accordingly, as intended by the present embodiment, the self-shaping drug infusion catheter  720  can remain straight and highly flexible with the guide wire  724  installed therein. However, when the guide wire  724  is withdrawn, or otherwise retracted, from within the self-shaping drug infusion catheter  720 , the self-shaping drug infusion catheter  720  returns to its free state shape. It can be appreciated that the self-shaping drug infusion catheter  720  can also return to its free state shape via a thermal response—if necessary.  
         [0223]     In a beneficial embodiment, shown in  FIG. 49  and  FIG. 50 , the free state shape of the self-shaping drug infusion catheter  720  is a generally spiral shape. Moreover, the self-shaping drug infusion catheter  720  is preferably formed with plural infusion ports  726 . When the self-shaping drug infusion catheter  720  is in its free state shape, i.e., the spiral shape, the infusion ports  726  are located on the outside of the spiral. In another beneficial embodiment, the spiral shape can extend about 1 inch to about 2 inches in length.  
         [0224]      FIG. 49  and  FIG. 50  show the self-shaping drug infusion catheter  720  installed in an abdominal aorta  10 . It can be appreciated that the self-shaping drug infusion catheter  720  can be inserted in the left iliac artery  24  and advanced therethrough until the distal end  722  of the drug infusion catheter  720  is in the general vicinity of the renal arteries  12 ,  14 . As described above, when the guide wire  724  ( FIG. 48 ) is withdrawn, the self-shaping drug infusion catheter  720  returns to its free shape, i.e., the spiral shape, such that the outer periphery of the self-shaping drug infusion catheter  720  is placed and somewhat pressed against the inner wall  34  of the abdominal aorta  10 .  
         [0225]     In the juxta-renal position, shown in  FIG. 49  and  FIG. 50 , a majority of the infusion ports  726  established around the outer periphery are blocked by the inner wall  34  of the abdominal aorta  10 . Several of the infusion ports  726 , located at the renal ostia, are not blocked and can allow the flow of a drug solution into the right renal artery  12  and the left renal artery  14 , as indicated by arrow  728  and arrow  730 . By way of example and not of limitation, the infusion ring pressed against the aortic wall will not flow drugs under the very low infusion rates and pressures expected, i.e. approaching 1 ml per minute from an IV pole. However the infusion ring will flow drugs where they are free and not in contact with the aorta wall at the renal ostia.  FIG. 49  shows that a second working catheter  732  can be introduced through the middle of the self-shaping drug infusion catheter  720  when it is in the free state spiral shape.  
         [0226]      FIG. 51  shows a self-shaping drug infusion catheter assembly generally designated  750  in which the self-shaping drug infusion catheter  720  and the working catheter  732  can be incorporated. As shown in  FIG. 51 , the self-shaping drug infusion catheter assembly  750  includes a Y hub assembly  752  through which the self-shaping drug infusion catheter  720  and the working catheter  732  can be introduced, and introducer sheath  754 . It is to be understood that the overall length of the introducer sheath  754  shown in  FIG. 51  can be relatively shorter than typical introducers used for tubular member flow diverters. This is largely due to the fact that the self-shaping drug infusion catheter  732  can be used to access the area of the renal arteries  12 ,  14 , whereas other introducers may use an additional delivery sheath for this purpose. Further, the Y-hub assembly  752  shown in  FIG. 51  can allow two catheters, e.g., the self-shaping drug infusion catheter  720  and the working catheter  732 , to be placed, e.g., in the femoral artery through a single percutaneous cut-down. Also, the Y-hub assembly  752  provides adequate hemostasis and overall tactile feedback and control of the catheters used in conjunction therewith.  
         [0227]      FIG. 52  is a side view, and  FIG. 53 a  section view of another embodiment of a catheter system  760  with a multilumen sheath  762  having a distal end  764  and a proximal end  766 . In  FIG. 53 , sheath  762  has center lumen  768 , left lumen  770  and right lumen  772 . A guide catheter  774 , having a distal portion  776  and a proximal end  778  is inserted in center lumen  768 . In one exemplary mode, guide catheter  774  is about 6 French in diameter.  
         [0228]     In  FIG. 52 , proximal end  766  of sheath  762  is attached to a Y hub assembly  780 . The illustration of Y hub assembly  780  is stylized for clarity. Y hub assembly  780  has left branch port  782  right branch port  784  and main port  786 . Left fluid delivery tube  788  has proximal portion  790  and distal portion  792  with proximal portion  790  inserted in left branch port  782  and fluidly connected with distal portion  792  through left lumen  770 . Right fluid delivery tube  794  has proximal portion  796  and distal portion  798  with proximal portion  790  inserted in right branch port  784  and fluidly connected with distal portion  798  through right lumen  772 . Proximal end  778  of guide catheter  774  is inserted in main port  786  of Y hub assembly  780  and is connected to distal portion  776  through center lumen  768 . Distal end of sheath  762  has left port  800  in left lumen  770  and right port  802  in right lumen  772 . In one embodiment, left port  800  and right port  802  are 180 degrees apart. Distal portion  792  of left fluid delivery tube  788  has a memory shape to extend out of left port  800  when advanced in sheath  762  and has mid port  804  and end port  806 . Distal portion  798  of right delivery tube  794  has a memory shape to extend out of right port  802  when advanced in sheath  762  and mid port  808  and end port  810 .  
         [0229]     In  FIG. 52 , sheath  762  has been inserted in aorta  10 , shown in  FIG. 1 , and distal end  764  of sheath  762  is positioned upstream of renal arteries  12 , 14 . Left and right fluid delivery tubes  788 ,  794  are advanced through left port  782  and right port  784  so distal ends  792 ,  798  extend towards left and right walls of aorta  10  respectively. Fluid agent, denoted by arrows  812 , is released from mid ports  804 ,  808  and from end ports  806 ,  810  to preferentially flow into renal arteries  12 , 14 . Guide catheter  774  is advanced through main port  786  of Y hub assembly  780  with distal portion  776  extending beyond distal end  764  of sheath  762  for further medical procedures.  
         [0230]      FIG. 54  through  FIG. 57  illustrates an embodiment of a proximal coupler system  850  used to deploy and position renal fluid delivery devices adjunctive with interventional catheters.  FIG. 54  and  FIG. 55  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.  
         [0231]      FIG. 56A  and  FIG. 56B  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. 56B ), 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.  
         [0232]     In  FIG. 56B , 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. 55 ). At that point, force  940  is applied in a distal direction at torque handle  912  to push stiff tube  902  through delivery tube  910 . A fluid agent infusion device  936  on distal end  904  of stiff tube  902  is adapted to advance distally through introduction sheath  890 . In  FIG. 56B , stiff tube  602  has been advanced through introduction sheath  890  and past the distal end  894  of introduction sheath  890 . Optionally, delivery sheath handle  930  is split in two by pressing inwardly on delivery handle tabs  934 . Delivery sheath  910  may be 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. 57 ) to enter hemostasis valve  880  for further advancement through main channel  864  (see  FIG. 55 ) and adjacent to stiff tube  902 .  
         [0233]      FIG. 57  is an illustration of the proximal coupler system  850  of  FIG. 56B  with introducer sheath  890  is inserted in aorta system  10 . Delivery sheath  910  has been retracted proximally and one or more fluid agent infusion devices  936  have been advanced and positioned at renal arteries  12 , 14 . Intervention catheter  940  enters hemostasis valve  880  and is advanced through introducer sheath  890  and past fluid agent infusion device  936  for further medical intervention while fluid agent infusion device  936  remains in place at renal arteries  12 , 14 . 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.  
         [0234]      FIG. 58  illustrates a further embodiment of the proximal coupler assembly and fluid delivery assembly shown in  FIG. 57 . Renal therapy system  950  includes an introducer sheath system  952 , a vessel dilator  954  and a fluid delivery system  956  with a aortic infusion assembly  958 . Details of channels, saline systems and fittings as shown previously in  FIG. 54  through  FIG. 57  are omitted for clarity. Introducer sheath system  952  has Y hub body  960  as shown previously in  FIG. 54  and  FIG. 55  configured various inner structures as shown previously in  FIG. 55 . 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 .  
         [0235]     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 .  
         [0236]     Fluid delivery system  956  has stiff tube  986 , torque handle  988 , and proximal hub  990  as previously described in  FIG. 56A  and  FIG. 56B  with aortic infusion assembly  958  coupled at distal end  992 . 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 .  
         [0237]     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. 55 . 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 .  
         [0238]     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 near 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. 55 . 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. 57 .  
         [0239]      FIG. 59  is a stylized illustration of a double Y proximal coupler  1150  with two local fluid delivery systems  1152 ,  1154  and an intervention catheter  1156  in an aorta system  10 . Details of local fluid delivery systems  1152 ,  1154  are shown in  FIGS. 56A and 56B  and are omitted here for clarity. The double Y proximal coupler  1150  is constructed similar to a proximal coupler assembly as shown in  FIG. 54  and  FIG. 55  but with another branch port added. Secondary branch  1160  accommodates local fluid delivery system  1152  for drug infusion in right renal artery  12 . Tertiary branch  1164  accommodates local fluid delivery system  1154  for drug infusion in left renal artery  14 . intervention catheter  1156  enters double Y proximal coupler  1150  through hemostasis valve  1168 . Introduction sheath  1170  is sized to accommodate local fluid delivery systems  1152 ,  1154  and catheter  1156  simultaneously.  FIG. 59  illustrates secondary branch  1160  and tertiary branch  1164  on the same side of the double proximal coupler, however they may be positioned on opposite sides or in another beneficial configuration. By way of example and not of limitation, the cross section of local fluid delivery system  1152 ,  1154  may be oval shaped. By way of example and not of limitation, double Y proximal coupler  1150  may be adapted to advance a wide mix of medical devices such as guide wires, diagnostic catheters, flow diverters and infusion assemblies through introducer sheath  1170  and into a vascular system such as aorta system  10 .  
         [0240]     It is to be understood that each of the embodiments described in detail above provide a device that can be used for selective therapeutic drug infusion as sites remote to a primary treatment site. These devices can be applicable to interventional radiology procedures, including interventional diagnostic and therapeutic procedures involving the coronary arteries. Further, each of the devices described above, can be beneficial for delivering certain drugs, e.g., papaverine; Nifedipine; Verapamil; fenoldopam mesylate; Furosamide; Thiazide; and Dopamine; or analogs, derivatives, combinations, or blends thereof, to the renal arteries of a patient who is simultaneously undergoing a coronary intervention with the intent of increasing the kidney&#39;s ability to process of organically-bound iodine, i.e., radiographic contrast, as measured by serum creatinine and glomerular filtration rate (GFR).  
         [0241]     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).  
         [0242]     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.  
         [0243]     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.  
         [0244]     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.  
         [0245]     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.  
         [0246]     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 intraveneous saline.  
         [0247]     From the foregoing discussion, it will be appreciated that the various embodiments described herein generally provide for infusion of renal protective drugs into each of two renal arteries perfusing both kidneys in a patient. The devices and methods of these embodiments are useful in prophylaxis or treatment of kidney malfunction or conditions, such as for example ARF. Various drugs may be delivered via the systems and methods described, including for example: vasodilators; vasopressors; diuretics; Calcium-channel blockers; or dopamine DA1 agonists; or combinations or blends thereof. Further, more specific, examples of drugs that are contemplated in the overall systems and methods described include but are not limited to: Papaverine; Nifedipine; Verapamil; Fenoldapam; Furosamide; Thiazide; and Dopamine; or analogs, derivatives, combinations, or blends thereof.  
         [0248]     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 intra aortic catheters. The required fluoroscopy equipment and auxiliary equipment devices are typically located in a specialized location limiting the in vivo use of the invention to that location. Other modalities for positioning intra aortic catheters 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, where fluoroscopy may not be readily available or its use may cause undue radiation exposure to users and others due to a lack of specific radiation safeguards normally present in angiography suites and the like. The use of non-fluoroscopy positioning allows intra aortic catheter systems and methods to be used to treat other diseases such as ATN and CHF in clinical settings outside of the angiography suite or catheter lab.  
         [0249]     In one embodiment, the intra aortic catheter 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 intra aortic catheter.  
         [0250]     In another beneficial embodiment, ultrasound sensors are placed on the introducer sheath and the intra aortic catheter itself; specifically the tip of the aortic catheter or at a proximal section of the catheter. The intra aorta catheter with the ultrasonic sensors implemented allows the physician to move the sensors up and down the aorta to locate both renal ostia.  
         [0251]     A further embodiment incorporates Doppler ultrasonography with the intra aortic catheters. 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 ostia. A further advantage of Doppler ultrasonography is it is non invasive and uses no x rays.  
         [0252]     A still further embodiment incorporates optical technology with the intra aorta catheter. An optical sensor is placed at the tip of the introducer sheath. The introducer sheath&#39;s 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 intra aortic catheter. Once the intra aortic catheter is deployed within the aorta, the optic sensor allows visual confirmation of the walls of the aorta. The intra aortic catheter 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 positioning of the intra aortic catheter to the renal arteries.  
         [0253]     Another embodiment uses sensors that measure pressure, velocity, and/or flow rate to locate renal ostia without the requirement of fluoroscopy equipment. The sensors are positioned at the distal end of the intra aortic catheter. The sensors display real time data about the pressure, velocity, and/or flow rate. With the real-time data provided, the physician locates both renal ostia by observing the sensor data when the intra aortic catheter is around the approximate location of the renal ostia. In a further mode of this embodiment, the intra aortic catheter 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.  
         [0254]     In a still further embodiment, chemical sensors are positioned on the intra aortic catheter 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 intra aortic catheter to detect chemical change from one sensor location to another.  
         [0255]     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.”