JP2006527629A - Method and apparatus for supplying intra-aortic material to branch vessels - Google Patents

Abstract

The renal fluid system injects a volume of fluid agent at a location within the abdominal aorta so that it flows bilaterally from each individually spaced mouth along the abdominal aorta wall to each of the two renal arteries. The local infusion assembly (100) includes two infusion members (104, 106) each having an infusion port (112) that couples to a fluid agent source external to the patient. The infusion port is placed in the outer region of blood flow along the abdominal aortic wall that perfuses the two renal arteries. The assembly is particularly adapted to provide such a limited bilateral kidney supply via the corresponding first and second renal ostium, without substantially changing the abdominal aorta along the predetermined location. Be adapted.

Description

(Cross-reference of related applications)
This application claims priority from US Provisional Application No. 60 / 508,751, filed Oct. 2, 2003, which is hereby incorporated by reference in its entirety.

  This application claims priority from PCT International Application PCT / US2003 / 029995 filed on September 22, 2003, and is a continuation-in-part of this application, which is incorporated by reference in its entirety. Incorporated into this application.

  This application claims priority to US Provisional Application No. 60 / 502,389, filed September 13, 2003, which is hereby incorporated by reference in its entirety.

  This application claims priority from US Provisional Application No. 60 / 479,329, filed Jun. 17, 2003, which is hereby incorporated by reference in its entirety.

  This application claims priority from US Provisional Application No. 60 / 412,343, filed Sep. 20, 2002, which is hereby incorporated by reference in its entirety.

  This application claims priority from US Provisional Application No. 60 / 412,476, filed Sep. 20, 2002, which is hereby incorporated by reference in its entirety.

(Explanation on federal support research and development)
Not applicable.

(Incorporation of materials provided on compact discs)
Not applicable.

(Background of the Invention)
(1. Field of the Invention)
The present invention relates generally to medical device systems and methods for supplying fluid from within the aorta into a region of the human body. In particular, the present invention relates to an intra-aortic renal fluid delivery system and method.

(2. Explanation of related technology)
There are many different medical device systems and methods for locally delivering fluids or other drugs into various human body regions, eg, human lumens such as tubes or other human body spaces such as organs or heart chambers. Have been disclosed. Local “fluid” delivery systems contain pharmaceuticals or other agents or contain a local supply of body fluids, eg, artificially enhanced blood transport (eg, guide or shunt blood from one location to another) Etc., completely within the human body or via an external blood pump, etc.). A local “drug” delivery system is intended herein to relate to the introduction of foreign substances, such as drugs, into the body, which foreign substances may contain drugs or other useful or effective drugs. It may be in the form of a fluid or in other forms such as gel, solid, powder, gas. In this disclosure, for the purpose of illustration, various references are made to the term fluid, pharmaceutical or drug in connection with the description of local delivery, but generally are not intended to exclude or omit others. Should be considered and unless otherwise specified, should be construed interchangeable if deemed appropriate by one skilled in the art.

  In general, topical drug delivery systems and methods often achieve a relatively high localized concentration of drug injected into the body to maximize the intended effect in the body and yet elsewhere in the body. It is used to minimize the unintentional eradication effect of the drug. Certain doses of locally delivered drugs are effective for the intended local effect, but the same dose delivered systemically will reach the same location after being substantially diluted throughout the human body . The intended local effects of the drug are similarly dilute and the efficacy is sacrificed. Thus, systemic drug delivery requires a relatively large amount of administration to achieve the local dose required to achieve efficacy, and as a result, the drug is delivered and the human body other than the intended target When treated somewhere, safety is often sacrificed, for example, due to systemic reactions or side effects of the drug.

  Various diagnostic systems and procedures have been developed using a local supply of dye (eg, a radiopaque “contrast” or other diagnostic agent), in which an external monitoring system is used to supply the body. Important physiological information can be collected based on the migration or absorption of the diagnostic agent at the location and / or other locations affected by the delivery site. Angiography uses a hollow tubular angiographic catheter to inject radiopaque dye locally into a blood chamber or blood vessel, for example, a coronary artery for angiography, or a ventricle for ventricular imaging One such method.

  Other systems and methods have been disclosed for local delivery of human body lumens within a particular body tissue of a patient. For example, angiography catheters of the type described above, and other similar tubular delivery catheters, are further disclosed for locally injecting therapeutic agents into these human body spaces within the human body via the human body supply lumen. It has been. Detailed examples of this type include topical supply of embolic drugs such as TPA®, heparin, coumadin or urokinase. In addition, various balloon catheter systems have also been disclosed, particularly in connection with blood vessels, for local administration of diagnostic agents within a target body lumen or space. Details previously disclosed for this type include a balloon having a porous or perforated wall that allows the drug to elute through the balloon wall into surrounding tissue such as the vessel wall. Yet another example for the localized delivery of diagnostic agents is a spaced-apart balloon that is inflated to engage a lumen or vessel wall and from an inflow or outflow across the balloon to an intermediate catheter Various multi-balloon catheters with balloons that isolate the region are included. According to these embodiments, fluid supply systems are often coupled to intermediate regions to fill these regions with agents such as pharmaceuticals that provide the intended effect in the isolation region between the balloons.

  Many different types of diagnosis or treatment of medical conditions associated with a variety of different systems, organs and tissues also benefit from the ability to locally deliver fluids or drugs in a controlled manner. In particular, various conditions associated with the renal urinary tract benefit greatly from the ability to locally deliver therapeutic, prophylactic or diagnostic agents into the renal arteries.

  Acute renal failure (“ARF”) is a rapid decline in the kidney's ability to drain waste products from the patient's blood. These changes in kidney function are due to many factors. A patient becomes ARF when a traumatic event occurs, such as bleeding, loss of gastrointestinal fluids without proper fluid exchange, or loss of kidney fluid. Patients become sensitive to ARF even after receiving anesthesia, surgery, or alpha-adrenergic drugs because of related systemic or renal vasoconstriction. In addition, systemic vasodilation caused by hypersensitivity, antihypertensives, sepsis, or overdose medications also causes ARF. This is because the natural defense of the human body may block organs that are not essential for vasoconstriction, such as the kidneys. Reduced cardiac output caused by cardiogenic shock, congestive heart failure, pericardial tamponade or pulmonary thromboembolism can create excessive fluid in the body and exacerbate congestive heart failure. For example, a decrease in blood flow and blood pressure in the kidney due to a decrease in cardiac output results in the preservation of excess fluid in the patient's body, causing edema, for example, in the lungs and throughout the body.

  Previously known methods for the treatment of ARF or the treatment of acute human dysfunction associated with congestive heart failure (“CHF”) involve the administration of a medicament. Examples of such pharmaceuticals that have been used for this purpose include, for example, papavarin, fenoldopam mesylate, calcium antagonists, atrial natriuretic peptide (ANP), acetylcholine, nifedipine, nitroglycerin, nitroprusside, adenosine, dopamine and theophylline. And diuretics such as mannitol or furosemide, but are not limited to these. However, many of these pharmaceuticals have undesirable side effects when administered at systemic doses. In addition, many of these medications are not useful for treating other causes of ARF. Patients with septic shock who exhibit deep systemic vasodilation often have significant renal vasoconstriction, but if patients with systemic vasodilation are administered a vasodilator that dilates the renal artery, the system May worsen overall vasodilation. In addition, for patients with severe CHF (eg, waiting for a heart transplant), mechanical methods such as hemodialysis or left ventricular assist device are performed. However, surgical device interventions such as hemodialysis have generally not been found to be very effective for long-term management of CHF. Such interventions are also not appropriate for many intensive patients with ARF.

  Many patients' renal urinary tract suffers from more specific vulnerabilities or is otherwise exposed to the potentially harmful effects of other medical device interventions. For example, the kidneys are damaged by exposure to high-density radiopaque contrast dyes, such as during coronary, cardiac or neuroangiographic procedures, as one of the main blood filtration tools of the human body. Acute dysfunction of kidney function occurs upon exposure to such radiographic contrast agents, and as a result, serum creatinine levels generally exceed 25% of baseline within 48 hours, or 0.5 mg / dl An absolute increase of. Thus, in addition to CHF, renal damage associated with RCN is also a frequent cause of ARF. In addition, renal function is directly related to cardiac output to the renal urinary tract and associated blood pressure. These physiological parameters may also require significant compromise during surgical interventions such as angiogenesis, coronary artery bypass, valve repair or replacement, or other cardiac intervention procedures, such as in CHF. Accordingly, various pharmaceutical agents used to treat patients who develop ARF in connection with other conditions, such as CHF, have also been used to treat patients suffering from ARF resulting from RCN. Such pharmaceuticals would be significantly beneficial for treating or preventing ARF associated with hemodynamics that caused acute damage to the renal urinary system, such as during surgical intervention.

  Thus, significant benefits may be gained from the ability to deliver these medications locally to the renal arteries, particularly when delivered simultaneously with surgical intervention and especially with radiocontrast dye delivery. However, many such procedures are generally in the range of about 4 French to about 12 French for guide catheter systems for delivering angioplasty or stent devices into coronary or neurovascular arteries (eg, the carotid artery), and usually Is performed using a medical device system, such as using a guide catheter or angiographic catheter having a dimension outside the range of about 6 French to about 8 French. These devices are also most commonly used by percutaneous, transluminal access within the femoral artery, and by a retrograde supply upstream along the aorta through the renal artery ostium. (E.g., coronary ostia). The Seldinger approach to the femoral artery expands the puncture hole in a relatively controlled manner to minimize the size of the entry window through the artery wall, and the profile of these delivery systems is small enough Is the preferred method. Otherwise, for larger systems, use a “reduction” technique in conjunction with an access window that is relatively large and surgically formed through the artery wall.

  Thus, an intra-aortic renal drug delivery system used simultaneously with other retrograde delivery medical device systems, such as those described above, is particularly useful for such interventional device systems of the type and dimensions described above, wherein (a) the drug is in the renal artery And (b) the blood can flow downstream across the renal artery ostium, and (c) the overall cooperation that allows the Seldinger femoral artery approach In the case of the system, it is preferable to modify it so that it can pass upstream across the renal artery ostium. Each one of these features (a), (b) or (c), or sub-joints thereof, provides significant value for patient treatment and provides an intra-aortic renal delivery system that provides a combination of all three features Is much more valuable.

  Despite the clear need for such intra-aortic drug supply to the renal urinary tract and the benefits that would be obtained, the ability to perform presents unique problems as follows: Yes.

  In some respects, the renal arteries extend from individual mouths along the abdominal aorta that are clearly spaced from one another around a relatively large aorta. In many cases, these renal arterial ostiums are also located longitudinally away from each other in the aorta, including relatively upper and lower locations. This presents a unique problem in delivering pharmaceuticals or other drugs into the renal urinary system as a whole, and both kidneys have their own arteries through the individual arteries of the renal urinary system. Must be fed through a substantially located and substantially spaced mouth. This is another indication if both kidneys are equally dangerous or equally damaged, when performing an upstream invasive procedure, or, of course, if both kidneys require the supply of kidney medication. It becomes particularly important when there is. Thus, it would be preferable to retrofit an intra-aortic delivery system suitable for these symptoms to supply multiple renal arteries that perfuse both kidneys.

  In other respects, simply supplying the drug into the natural physiological blood flow pathway of the aorta upstream of the kidney provides a localized benefit that is somewhat beneficial to the kidney compared to other systemic delivery methods. Can do. In particular, a high flow aorta immediately flushes much of the drug delivered beyond the intended renal artery opening. As a result, the amount of drug that actually perfuses the renal arteries is diminished, resulting in an undesirable loss of the drug that enters the other organs and tissues and circulates systemically (at the highest concentration directly into the downstream circulation). Inflow).

  In yet other respects, various known types of tubular local delivery catheters, such as angiographic catheters, other “endhole” catheters, or other catheters, each having a distal drug perfusion port within the renal artery itself. The drug is delivered to the renal artery by, for example, percutaneous transluminal procedures through the femoral artery (or from other access points such as the brachial artery). However, these techniques are by no means providing completely desirable results.

  For example, the distal tip of the delivery catheter in the renal artery is difficult to seat in this way from within the large diameter / high flow aorta and may cause deleterious intimal damage within the artery. Also, if drugs must be infused into multiple kidneys, multiple renal arteries must be cannulated sequentially using a single delivery device or simultaneously using multiple devices. As a result, it becomes unnecessarily complicated and time consuming and further exacerbates the risk of undesirable damage from the operation of a given catheter. In addition, multiple dyes need to be injected to locate the mouth of the kidney and position the catheter, which is primarily related to contrast agents for kidney function, an organ system that should be protected by the drug delivery system Risk (eg RCN) increases. Moreover, the renal artery itself, possibly including the mouth of the renal artery, may have existing conditions that interfere with the ability to provide the necessary catheter seating or increase the risks associated with such mechanical invasion. For example, the arterial wall is diseased or stenotic, for example, due to atherosclerotic platelets, clots, autopsy, or other damage or conditions. Finally, in other additional issues, the prior disclosures are of this type through a common inductor or guiding sheath that is shared with additional medical devices used for upstream interventions such as angiography or guiding catheters. It does not describe an effective and safe system and method for placing a local drug delivery device in the renal artery. In particular, in order to do so simultaneously using multiple delivery catheters for simultaneous infusion into multiple renal arteries, such a large sized guide sheath is further required and the preferred Slinger vascular access technique is not available. Instead, it appears that less desirable “reduction” techniques will be required.

  In addition to the various needs for delivering drugs into the aforementioned bifurcated arteries, many benefits are also obtained from simply enhancing blood perfusion into these bifurcations, such as by increasing blood pressure at the bifurcations. In particular, such enhancement appears to ameliorate many pathologies associated with inadequate physiological perfusion from a branch vessel, particularly the aorta, into the branch vessel, such as the renal artery.

  Certain prior disclosures have provided surgical device assemblies and methods that are intended to enhance blood supply into the branch artery extending from the aorta. For example, an intra-aortic balloon pump (IABP) has been disclosed for use when diverting blood flow into a particular branch artery. One such technique involves placing the IABP in the abdominal aorta so that the balloon is located slightly below (adjacent) the branch artery. The balloon is selectively inflated and deflated in counterpulsation mode (by referring to the physiological blood pressure cycle), so that the increased pressure distal to the balloon results in a larger volume of blood flow mainly in the branch artery Orient to the mouth area. However, the flow from such a balloon system to a relatively low end downstream can be significantly occluded during this counterpulsation cycle. In addition, these previously disclosed systems generally provide the ability to provide a continuous or substantial downstream perfusion sufficient to deliver a drug or agent to a branch artery and at the same time prevent unwanted ischemia. Missing.

  Moreover, despite the kidney risks described in connection with radiocontrast dye supply in particular situations, particularly the RCN, the supply of such dyes or other diagnostic agents is particularly useful for diagnosing the renal artery itself. Instructed. For example, the diagnosis and treatment of renal stenosis, such as atherosclerosis or autopsy, requires the injection of dye into the target renal artery. In such situations, localization of the dye into the renal artery is also desirable. At some point, without such localization, more dye is needed, and the dye lost in the downstream aortic flow will continue to add to the kidney as it passes back through the system and back into the kidney. To affect. In another respect, the ability to deliver such dye locally from within the artery itself into the renal artery, for example by seating an angiographic catheter in the artery, is also hampered by the same stenosis and the dye is injected first. Need arises (as above). In addition, the patient may have a stent graft that may prevent seating of the delivery catheter.

  Despite interest and advancement in the treatment of organs or tissues or the supply of diagnostic agents, the systems and methods previously disclosed and briefly described above generally provide agents from the main artery, substantially from the main artery. Lack of ability to effectively deliver locally only into the extending branch artery and allow substantial blood flow and / or other medical devices to pass through the main artery past the bifurcation. Yes. This is particularly true with respect to previously disclosed renal therapy and diagnostic devices and methods, where drugs are delivered locally from a location within the aorta into the renal urinary system and substantial blood flow is present. There is no adequate provision to allow continuous flow past the renal ostium and / or to allow the distal medical device assembly to pass back across the renal ostium and be used upstream. It would be advantageous to be able to supply drugs such as protective or therapeutic drugs or radiopaque contrast agents in this way to one or both renal arteries.

  Some relatively recently disclosed advances include various that divide the flow in the aorta adjacent to the renal artery ostium into outer and inner flows that each circulate downstream downstream of the renal artery ostium. There has been a local flow assembly that uses tubular members of various diameters. Such disclosure further includes primarily supplying a fluid agent in the outer flow path for substantially localized delivery into the renal artery ostium. These disclosed systems and methods represent an exciting new development for the localized diagnosis and treatment of pre-existing conditions associated with bifurcated blood vessels, typically with respect to the renal arteries extending from the main blood vessels, particularly from the abdominal aorta.

  However, such previously disclosed structures have been further modified and improved to allow fluid agent mixing within the entire perimeter of the outer channel surrounding the tubular flow divider and perfusing multiple renal artery ostiums. Useful of certain devices to maximize and use the systems and methods, especially during upstream interventional procedures, to prevent and protect the renal urinary tract from adverse effects and to accommodate a wide range of anatomical dimensions between patients Further benefits may be obtained by maximizing the sizing range and optimizing the cooperation between structure, design and system placement components for efficient atraumatic applications.

  The drug is supplied mainly from the location in the patient's aorta adjacent to the renal artery opening along the aorta wall into the patient's renal artery, and at least a part of the aortic blood flow passes through the predetermined location in the renal artery mouth. There is a further need for improved devices and methods so that they can be perfused across and downstream.

  Substantially isolating the first and second portions of aortic blood flow at a location within the patient's aorta adjacent to the renal artery ostium along the aortic wall, and the second portion crosses the predetermined location There is a further need for improved devices and methods so that they can flow downstream of the renal artery ostium and into the relatively low end of the patient. Providing passive blood flow along the isolation path without providing active mechanical flow support in situ for one or both of the first or second part of the aortic blood flow There are further benefits and needs for.

  Radiopaque into the renal artery from a location in the patient's aorta along the aortic wall adjacent to the renal artery opening without the need to place a drug delivery device transluminally in the renal artery itself or in the renal artery mouth There is a further need for improved devices and methods for locally delivering agents such as pigments or disgusting.

  There is no need for tube placement of multiple drug delivery devices within each renal artery itself, and a single delivery device is used to deliver fluids or drugs such as radiopaque dyes or pharmaceuticals to multiple kidneys. There is a further need for improved devices and methods for delivering left and right simultaneously into an artery and feeding both kidneys of a patient.

  Supply fluid or drug into the patient's renal artery from a location within the patient's aorta adjacent to the renal artery orifice along the aortic wall and other therapeutic or diagnostic devices and systems, such as angiography or guide catheter devices There is a further need for improved devices and methods to allow and related systems to be delivered across predetermined locations.

  Fluid or drug into the renal artery from some location in the patient's aorta along the aortic wall adjacent to the renal artery ostium, especially as a preventive or therapeutic measure not related to the kidney There is a further need for improved devices and methods to supply for diagnostic procedures.

  Supply fluid or medication into the patient's renal artery to treat, protect or diagnose the renal urinary system, and other concurrent medical procedures such as angiograms, other transluminal upstream of the renal artery ostium There is a further need for improved devices and methods to perform the procedures.

  There is a further need for improved devices and methods to deliver both an intra-aortic drug delivery system and at least one additional distal interventional device, such as an angiography or a guiding catheter, through a common delivery sheath. .

  Improved to deliver an intra-aortic drug delivery system and at least one additional distal interventional device, such as an angiography or guide catheter, through a single access site, such as a single femoral artery puncture There is a further need for devices and methods.

  In order to treat, particularly prevent ARF, particularly in connection with RCN or CHF, so as to deliver a renal protection or improving medicament locally into the renal artery simultaneously with the injection of a radiocontrast agent, for example during an angiographic procedure, There is also a need for improved devices and methods.

  There is a further need for improved devices to supply fluid agents from both sides of the aortic system bilaterally to both sides of the renal urinary tract.

  There is a further need for an improved device to deliver a fluid agent bilaterally on both sides of the renal urinary system without cannulation of the renal artery itself.

  There is also a need for an improved device for delivering bilateral fluid agents bilaterally to the renal urinary tract without substantially occluding, isolating or diverting blood flow in the abdominal aorta.

  In addition to this specific need to selectively supply fluid into the patient's renal artery through the renal artery orifice along the aorta, other branch vessels that extend from other main vessels or lumens in the patient Or other similar needs exist for supplying fluid into the lumen.

(Simple Summary of Invention)
Thus, although these embodiments of the present invention generally relate to a renal drug delivery system from a location that is usually adjacent to the renal artery itself into the aorta, these systems and methods are described in the various embodiments shown by these embodiments. Appropriate modifications are also contemplated for use in other anatomical regions and other medical conditions without departing from the broad scope of the embodiments. For example, intra-aortic fluid delivery according to these various embodiments benefits from the particular dimensions, shapes, and structures of the subject devices disclosed herein. However, appropriate improvements can be made to other multifaceted bifurcation structures in the main body space, or elsewhere in the vasculature (eg, left and right coronary ostia, fallopian tubes originating from the uterus, or digestive tract) This is done to supply fluid from a lumen.

  One aspect of the present invention provides a first and second renal artery respectively from a location within the abdominal aorta associated with the first and second flow paths that are substantially in the outer region of the abdominal aortic blood flow along the abdominal aortic wall. A local renal infusion system for treating the renal urinary tract of the patient leading to the patient through corresponding first and second renal ostiums along the abdominal aortic wall in the patient. The system includes a local injection assembly that includes first and second injection ports. The local infusion assembly is adapted to be disposed where the first and second infusion ports are present in respective first and second locations corresponding to the first and second flow paths, respectively. The local infusion assembly is also adapted to be fluidly coupled to the fluid drug source from outside the patient when the local infusion assembly is in place. Thus, the local infusion assembly is bilaterally quantified from the source of a quantity of fluid agent through the first and second infusion ports in the first and second positions, respectively, and again into the first and second renal arteries, respectively. Adapted to inject. The assembly is particularly adapted to provide such a limited bilateral kidney supply via the corresponding first and second renal ostium, without substantially changing the abdominal aorta along the predetermined location. Be adapted.

  In certain other modes of this aspect, the local infusion assembly infuses an amount of fluid agent into the first and second flow paths, where the infused amount is substantially within the first and second renal arteries. And is adapted to substantially bypass, occlude or isolate a region of aortic blood flow relative to the first or second region of aortic blood flow.

  Yet another mode includes a delivery member that includes a longitudinal axis and has a proximal end position and a distal end position. The local infusion assembly comprises first and second infusion members having first and second infusion ports, respectively, and is adapted to extend from the distal end position of the supply member, wherein the first arrangement and the second are as follows. Adjustable between placement. The local injection assembly in the first arrangement is adapted to be delivered to a predetermined location by a supply member. The local injection assembly in place has a longitudinal direction in which the first and second first injection members have first and second injection ports located at first and second positions, respectively, in the first and second flow paths. The first arrangement can be adjusted to the second arrangement so as to extend radially from the shaft.

  In another mode, the local infusion assembly comprises an elongate body adapted to be placed in the outer region. The first and second injection ports are spaced apart at various locations around the elongated body such that the first and second injection ports are in first and second different directions laterally from the elongated body. Are generally adapted to inject a quantity of fluid agent into the first and second flow paths, respectively.

  In one embodiment of this mode, the positioner cooperates with the elongated body and is adapted to position the elongated body within the outer region of the predetermined location. In one variation of this embodiment, the positioner is coupled to the elongated body and is adjustable from the first configuration to the second configuration. The positioner in the first arrangement is adapted to be delivered in place with the elongated body. The positioner in place is adjusted from the first configuration to the second configuration, ie, extends radially from the elongated body relative to the first configuration and with sufficient force against the abdominal aorta wall. Biased and adapted to deflect the orientation of the elongated body into the outer region. In yet another embodiment, the positioner is adapted from a plurality of partial loop-shaped members as described above.

  In another mode of this aspect of the invention, the local infusion assembly further comprises an elongate body including a longitudinal axis and adapted to be seated in place. The first and second infusion members have a first radial position with respect to the longitudinal axis in the first arrangement and a second radial position in the second arrangement. The second radial position extends radially from the longitudinal axis relative to the first radial position.

  In one embodiment of this mode, the first and second infusion members are disposed about the elongated body opposite the respective sides of the elongated body. In one variation of this embodiment, each of the first and second injection members extends between respective proximal and distal locations on each of the opposing respective sides of the elongated body, and In the two configuration, the first and second infusion members are biased outward from the elongated body during respective proximal and distal orientations, respectively.

  In another embodiment, the local injection assembly is generally in the form of a loop member, wherein the first and second injection members comprise first and second regions along the loop member, whereas the first and second regions are A second injection port is located on each of the first and second regions. The loop member in the first arrangement has a first diameter between the first and second injection ports, and the loop member is adapted to be fed into place. The loop member in the second arrangement has a second diameter between the first and second injection ports, the second diameter is greater than the first diameter, and the first and second positions are within the outer region, respectively. Is sufficient to substantially correspond to the first and second flow paths. According to one variation of this embodiment, the local injection assembly in the second arrangement of loop members includes a memory shape. The loop member is adjustable from the second configuration to the first configuration within the outer supply sheath limited to the radial direction. The loop member can be adjusted from the first configuration to the second configuration by removing the loop member from a radial restriction outside the outer supply sheath.

  In yet another mode, the first and second markers are located along the first and second infusion members at locations generally corresponding to the first and second infusion ports. Each of the first and second markers indicates the location of the first and second infusion ports to the operator outside the patient, and supplies the first and second infusion ports to the first and second positions, respectively. Adapted to promote. In certain beneficial embodiments, the first and second markers are radiopaque and are induced under fluoroscopy. In still other embodiments, the first and second infusion members extend from the bifurcation point distally from the supply member and the proximal marker is located at the bifurcation point.

  In another mode, a delivery member is provided that is an introducer sheath having a proximal end position and a distal end position, the proximal end position of the introducer sheath extending outside the patient. The delivery member includes a delivery passage extending between a proximal port assembly along the proximal end location of the introducer sheath and a distal port at the distal end location of the introducer sheath. The injection assembly is adjustable between the first and second positions. The first and second infusion members collapse at a first longitudinal position and extend radially from a distal end position at a second longitudinal position. In yet another embodiment of this mode, the distal end location of the introducer sheath comprises a distal tip and a delivery marker at a location corresponding to the distal tip, the delivery marker at a predetermined location within the abdominal aorta. Adapted to indicate the relative position of the distal tip.

  In yet another embodiment, the catheter body has proximal and distal end positions adapted to be placed in place when the proximal end position of the catheter body extends outward from the patient. Provided. The first and second infusion members are coupled to the distal end location of the catheter body and extend radially from the distal end location. The proximal port assembly of the introducer sheath consists of a single proximal port and the distal end position of the catheter body is adapted to be inserted through the single proximal port and into the supply passage.

  According to another mode, the system is proximally adapted to fluidly couple to a fluid agent source external to the patient and further to first and second infusion ports in first and second positions, respectively. Further comprising a coupler assembly.

  In one embodiment, the proximal coupler assembly consists of 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, the first elongate body extends between the first proximal coupler and the first infusion member, and the first fluid passageway includes the first proximal coupler and the first infusion. A second elongated body extends between the second proximal coupler and the second injection member, and a second fluid passage is coupled to the second coupler and the second injection port. In another variation, the proximal coupler assembly comprises a single common coupler that is fluidly coupled to each of the first and second injection ports via a common fluid passage. According to one feature used according to this variant, the elongated body extends between a single common coupler and the first and second injection members. The elongate body has at least one supply passage fluidly coupled to a single common coupler and further to the first and second injection ports.

  According to a number of modes of this aspect of the invention, the system further comprises a fluid agent source adapted to be coupled to the local infusion assembly. Fluid agents include one or a combination of: saline; diuretics such as furosemide or thiazide; vasoconstrictors such as arteries; vasodilators; other vasoactive agents; papabaline; calcium antagonists; nifedipine; Verapamil; fenoldopam mesylate; arterial DA1 agonist; or analogs or derivatives thereof, or combinations or blends thereof.

  Another mode is such that at least one lumen extends between the proximal port assembly and the distal port so that the distal port is placed in a conduit that is transluminally accessed in place. A vascular access system having an elongated tubular body adapted to the. The system according to this mode also includes a percutaneous transluminal interventional device that is adapted to be delivered across the predetermined location to the interventional location when the local infusion assembly is in place. The local injection assembly and the percutaneous transluminal interventional device are adapted to be delivered percutaneously through the vascular access device to the predetermined location and the intervention location, respectively, and further engage simultaneously within the vascular access device. To be adapted.

  In one embodiment, the percutaneous transluminal interventional device comprises an angiographic catheter. In another embodiment, the percutaneous transluminal interventional device is a guide catheter. In other respects, the interventional device may be about 4 French to about 8 French.

  In another embodiment, the proximal port assembly comprises first and second proximal ports. The percutaneous transluminal interventional device is adapted to be inserted into the elongated body through the first proximal port. The first and second ports of the injection assembly are inserted into the elongated body through the second proximal port.

  Another aspect is a local infusion system for locally delivering an amount of fluid agent from a source located outside the patient into a location within the patient's body space. The system includes a delivery member that includes a longitudinal axis and has a proximal end position and a distal end position, and a local injection assembly that includes first and second injection members having first and second injection ports, respectively. . The local injection assembly extends from the distal end location of the delivery member and is adjustable between a first configuration and a second configuration as follows. The local injection assembly in the first arrangement is adapted to be delivered to a predetermined location by a supply member. The local injection assembly at a predetermined location has a first and second injection port with first and second injection ports located at first and second relatively unique locations, respectively, at the predetermined location. The first arrangement can be adjusted to the second arrangement so as to extend radially from the directional axis. The first and second infusion ports in the first and second positions are fluidly coupled to a fluid agent source external to the patient, respectively, again in the first and second positions in place. It is adapted to inject a quantity of fluid into the patient.

  Another aspect of the present invention relates to the patient's renal urinary system from a location in the abdominal aorta associated with abdominal aortic blood flow to the first and second renal arteries with a unique relative to the abdominal aorta wall. A local renal infusion system for treatment via a first and second renal ostium each having a target location. In some respects, the system includes a delivery catheter having an elongated body, the elongated body having a proximal end position, a proximal end position located outside the patient, and a delivery lumen at the proximal end position. Adapted to be fed across a predetermined location to a supply location upstream of the predetermined location when extending between the proximal port along the distal end and the distal port along the distal end position A distal end position including a distal tip formed. The local injection assembly is also provided with an injection port. The local infusion assembly is at least partially delivered by the elongated body in place and adapted to have the infusion port in place within the location when the distal tip of the delivery catheter is in the delivery position. Is done. The infusion port at a given location is fluidly coupled to a fluid agent source located outside the patient, injecting an amount of fluid agent from the source into the abdominal aorta at the given location, Adapted to substantially flow into the first and second arteries via the first and second renal ostium, respectively.

  Yet another aspect of the present invention is a catheter for locally supplying a fluid agent to a patient's renal artery and containing a medical intervention device, the catheter having a proximal end position and an intermediate distal end position. And a distal end location, further comprising a central lumen and at least one outer lumen. The local injection assembly has at least one tube, each tube being inserted into a corresponding outer lumen. Each tube has a proximal end location and a distal end location, and the distal end location of each tube is coupled to the distal end location of the catheter. The local injection assembly has at least one first injection port, and the injection port is disposed on the at least one tube between the distal end position of the tube and the intermediate distal position of the catheter. Each tube is adjustable between a first position and a second position, where each tube is at a location within the abdominal aorta associated with blood flow into a plurality of renal artery openings. Adapted to be delivered, and in the second position, each tube is fixed in place and adapted to be arranged to inject an infusion port from a fluid agent source into the bloodstream. The Also, in the second position, the central lumen forms a passageway from the proximal end position to the distal end position of the catheter and is adapted to receive a medical intervention device.

  In another mode of this aspect, the infusion assembly has at least one second tube and at least one second infusion port in the second tube.

  In yet another mode of this aspect, the infusion assembly has at least one third tube, and in yet another mode, the infusion assembly has at least one fourth tube.

  In yet another mode, the catheter has a longitudinal axis, the first and second tubes in the first configuration have a first radial position relative to the longitudinal axis, and the first and second tubes in the second configuration. The second tube has a second radial position extending radially from the longitudinal axis relative to the first radial position.

  In another mode, the first and second tubes are placed around the catheter on opposite sides of the catheter.

  In yet another mode, each of the first and second tubes extends between an intermediate distal position and a distal position on each of the opposite sides of the catheter, and in the second configuration. Oh, the first and second tubes are biased outwardly from the catheter and between the respective intermediate and distal positions of the catheter.

  In yet another mode, the first and second markers are located along the first and second tubes, respectively, at locations corresponding approximately to the first and second injection ports. Each of the first and second markers indicates the location of the first and second infusion ports to the operator outside the patient, and supplies the first and second infusion ports to the first and second positions, respectively. Adapted to promote.

  In one embodiment of the above mode, the first and second markers are radiopaque markers.

  In another mode of the present invention, the first position is the memory shape of each tube, and each tube provides a forward force in a distal direction relative to the proximal end position of each tube. It is adjusted from the first position to the second position. Furthermore, each tube is self-adjustable from the second position to the first position by the memory recovery force after removing the forward force.

  Another aspect of the present invention relates to the patient's renal urinary system from a location in the abdominal aorta associated with abdominal aortic blood flow to the first and second renal arteries with a unique relative to the abdominal aorta wall. A method for treating and performing medical intervention through the first and second renal ostium, each having a target location. The method includes, at a point, providing a mosquito delivery catheter having an elongated body and a central lumen, the central lumen being located at a proximal end location and the proximal end location outside the patient. Sometimes the distal tip has a distal end position that traverses the predetermined location to the delivery location upstream of the predetermined location. The method further includes providing a local infusion assembly comprising an infusion port that is at least partially delivered by the elongated body in place, the infusion port having the distal tip of the delivery catheter in the delivery position. At some point, the injection port is at a position within a given location. The infusion port at the predetermined location is fluidly coupled to a fluid agent source located outside the patient. A quantity of fluid from the source is infused into the abdominal aorta at a predetermined location through the infusion port, the infused quantities being substantially the first and second via the first and second renal ostium, respectively. 2 flows into the artery. Medical intervention takes place through the central lumen.

  Another aspect of the present invention relates to a patient's renal urinary system from a location in the abdominal aorta associated with abdominal aortic blood flow to the first and second renal arteries, and the first and second renal ostium, respectively. Through the respective abdominal aortic wall to treat at each unique location. The method includes positioning the first and second injection ports at first and second unique respective locations of the predetermined location and the local injection assembly at the predetermined location. It further includes fluidly coupling the local infusion assembly in place to a fluid agent source external to the patient. Yet another step involves simultaneously injecting an amount of fluid agent from the source through the first and second infusion ports at the first and second locations, primarily into the first and second renal arteries, respectively.

  Another aspect of the present invention relates to a patient's renal urinary system from a location in the abdominal aorta associated with abdominal aortic blood flow to each of the first and second renal arteries, respectively. Through the abdominal aorta wall and at each unique location. The method includes placing the local infusion assembly in place and fluidly coupling the local infusion assembly in place to a fluid agent source external to the patient. In addition, traversing a predetermined location along the perimeter of the abdominal aorta wall so that the infused fluid flows primarily into the first and second renal arteries through the first and second renal ostium, respectively. Injecting an amount of fluid agent from a source into the abdominal aorta at a predetermined location without substantially changing, occluding or isolating a substantial location in the outer region of the aortic blood flow.

  Another aspect of the present invention relates to a patient's renal urinary system from a location in the abdominal aorta associated with abdominal aortic blood flow to each of the first and second renal arteries, respectively. Through the abdominal aorta wall and treatment at each unique location and medical intervention. An aspect of this method is to place a delivery member having a central lumen in a patient's abdominal aorta and have first and second infusion members with first and second infusion ports, respectively, in the first configuration with the delivery member. Providing a local injection assembly in place. Further, the method includes adjusting the local injection assembly between the first and second configurations at a predetermined location. According to this method, in the second configuration, the local infusion assembly extends from the distal end location of the delivery member, and the first and second first infusion members cross the place where the abdominal aorta is in place. Extending radially with respect to each other, the first and second injection ports are disposed at first and second relatively unique locations, respectively, in a predetermined location. Yet another mode of this aspect is to fluidly couple the first and second infusion ports at the first and second positions, respectively, to a fluid agent source outside the patient, Injecting into the first and second renal arteries from the first and second locations, respectively, via the first and second renal ostia. Yet another mode is to perform medical intervention through the central lumen.

  Another aspect of the present invention provides a first and second respectively from a location within the abdominal aorta associated with the first and second flow paths that are substantially within the outer region of the abdominal aortic blood flow along the abdominal aortic wall. A method for providing local treatment to a patient's renal urinary system leading into the renal artery via corresponding first and second renal ostiums along the patient's abdominal aortic wall. The method includes placing a local infusion assembly, placing a central lumen in place, and first and second infusion ports corresponding to first and second flow paths, respectively. Place at each position. In addition, when the local infusion assembly is in place, the local infusion assembly is fluidly coupled to a fluid agent source outside the patient to substantially occlude, isolate or alter the abdominal aorta in place. Without an amount of fluid agent from the source, through the first and second infusion ports in the first and second positions, respectively, and through the respective first and second renal ostia, respectively. Injecting bilaterally into the first and second renal arteries is also included.

  Another aspect of the invention is to produce a local renal infusion system with coronary access means for treating a patient's renal urinary system from a location within the abdominal aorta. The method includes providing an elongated member having a central lumen and at least two outer lumens. The elongate member has an intermediate distal position, a distal end position, and a longitudinal axis. Each of the outer lumens has an outer wall within the elongated member. The predetermined length slit is an outer lumen parallel to the longitudinal axis of the elongate member and extending from the distal end position of the elongate member to an intermediate distal position of the elongate member. Formed on the outer wall of each cavity. A single tube corresponding to the number of outer lumens is provided, each single tube having a proximal end and a distal end. A single tube is inserted into the corresponding outer lumen within the elongated member. The distal end of each single tube is coupled to the distal end location of the elongated member. The injection port is provided in at least two single tubes. The injection port is disposed between the distal end of each single tube and the intermediate distal position of the elongated member. The injection port is fluidly coupled to the fluid agent source and the proximal end of each single tube.

  Yet another mode of these various method aspects includes beneficially enhancing renal function using an injected volume of fluid. This mode specifically includes injecting a predetermined amount of fluid into a predetermined location and performing an interventional procedure at an intervention location within the patient's vasculature. In one embodiment, this mode allows the fluid agent to substantially prevent RCN in response to radiocontrast dye injection when an amount of radiocontrast dye is injected into the patient's vasculature. Injecting a predetermined amount of fluid agent as appropriate. According to yet another advantageous variation, the method includes treating acute renal failure using an infused amount of fluid.

  Each of these aspects, modes, embodiments, variations and features are useful alone and need not be combined with others, but nevertheless various combinations of these that would be apparent to those skilled in the art And the sub-combinations are further considered to be other beneficial embodiments of the present invention within the intended scope.

  Still other aspects of the invention will become apparent in the following portions of the specification. In this specification, the detailed description is intended to fully disclose the preferred embodiments of the present invention without any limitation.

(Detailed description of the invention)
More specifically, with reference to the drawings, the present invention is generally embodied in the apparatus shown in FIGS. It will be appreciated that the apparatus may vary with respect to placement and with respect to part details, and the method may vary with respect to specific steps and sequences without departing from the basic concepts disclosed herein. I will.

  The description provided herein relates to a medical material supply system associated with each relationship when used on a patient's body. Thus, for the sake of clarity, the term proximal should be taken to mean a location on the system or device that is relatively close to the operator when in use, and the term distal is from the operator when using the system or device. It should be considered to mean a relatively distant place. Thus, although the following embodiments of the present invention are generally associated with local renal drug delivery from the aorta, these systems and methods may be used without departing from the broad scope of the various aspects presented by the embodiments. It is intended to be able to be modified appropriately for use in other human body areas and other medical conditions.

  In general, the disclosed material supply system comprises a fluid supply assembly, a proximal coupler assembly, and one or more elongated bodies, such as a tube or catheter. These elongate bodies have one or more lumens, generally consisting of a proximal region, an intermediate distal region, and a distal tip region. The distal tip region typically has a means for supplying a material such as a fluid agent. Radiopaque markers or other devices are coupled to specific areas of the elongated body to facilitate introduction and placement.

  The material delivery system is placed in place by a physician, usually an interventionist (cardiologist or radiologist) or an intensive care specialist who specializes in treating intensive care patients. The physician typically uses a percutaneous vascular approach or other conventional method to access the femoral artery in the patient's crotch.

  For further understanding, more detailed examples of other systems and methods for performing topical renal drug delivery are variously disclosed in the following published references: Keren et al., WO 00/41612; and Keren et al., WO 01/083016. The disclosures of these references are incorporated herein by reference in their entirety. Further, various combinations of embodiments of the present invention with various aspects, or variations thereof, will also be apparent to those skilled in the art upon reviewing this disclosure in conjunction with these references. Are considered to be within the scope of the present invention as described by the various beneficial embodiments described below.

  The present invention also relates to the subject matter disclosed in the following published international patent applications: WO 00/41612 published on July 20, 200; and Libra Medical Systems published on November 8, 2001. WO 01/83016. The disclosures of these published international patent applications are also incorporated herein by reference in their entirety.

  Referring initially to FIG. 1, the abdominal aorta is shown and generally indicated at 10. As shown, the right renal artery 12 and the left renal artery 14 extend from the abdominal aorta 10 above the renal arteries 12, 14. Further, the celiac artery 18 extends from the abdominal aorta 10 above the superior mesenteric artery 16. FIG. 1 also shows that the inferior mesenteric artery 20 extends from the abdominal aorta 10 below the renal arteries 12, 14. Furthermore, as shown in FIG. 1, the abdominal aorta 10 branches into the right iliac artery 22 and the left iliac artery 24. It should be understood that each embodiment of the present invention described in detail below can be used to deliver a pharmaceutical or other fluid solution locally into the renal arteries 12,14. Each of the embodiments described below can be advanced through one of the iliac arteries 22, 24 into the abdominal aorta 10 until it is approximately near the renal arteries 12, 14.

  FIG. 2 is a schematic cross-sectional view of the abdominal aorta cut close to the renal arteries 12 and 14. FIG. 2 shows a natural flow pattern through the abdominal aorta 10 and a natural flow pattern from the abdominal aorta 10 into the renal arteries 12, 14. As shown, the flow flowing down the abdominal aorta 10 maintains a laminar flow pattern. Further, the flow near the middle of the abdominal aorta 10 indicated by the dotted rectangle 30 continues to flow down the abdominal aorta 10 as indicated by the arrow 32 and enters any of the side branches, eg, the renal arteries 12 and 14. Not supplied. Therefore, infusion of a pharmaceutical solution that flows down the middle of the flow of the abdominal aorta may be ineffective in isolating the pharmaceutical that flows into the renal arteries 12 and 14.

  Conversely, the flow flow along the inner wall 34 of the abdominal aorta 10 indicated by the dotted rectangle 36 and the dotted rectangle 38 is within the bifurcated artery, eg, the renal arteries 12, 14, as indicated by arrows 40, 42. Including natural fluid flow to In general, the flow stream 32 is faster than the flow stream 40 along the wall 34 of the aorta 10. Near the boundary between the dotted rectangles 36, 38 and the dotted rectangle 30, the flow may include a flow flowing into the branch arteries 12, 14 and a flow flowing down the abdominal aorta 10.

  In addition, the mouths of the renal arteries 12 and 14 are arranged to receive substantial blood flow from the blood flow near the posterior and side walls of the aorta 10. That is, when the blood flows in the dotted rectangles 36 and 38 are both along the posterior wall of the aorta 10 relative to the blood flow in the center of the aorta 10 as shown in FIG. More than blood flow. Therefore, infusion of pharmaceuticals on the renal arteries 12 and 14 and along the posterior wall of the aorta 10 is effective in reaching the renal arteries 12 and 14.

  Accordingly, to maximize the flow of the pharmaceutical solution into the renal artery using the natural flow pattern shown in FIG. It would be beneficial to provide a device adapted to selectively infuse a pharmaceutical solution along the side wall or posterior wall of the abdominal aorta 10 rather than along the abdominal aorta 10.

  As will be described in more detail below, it is beneficial to infuse the pharmaceutical solution at two locations on the renal arteries 12, 14 along the wall 34 of the abdominal aorta 10 located approximately 180 ° apart from each other. .

  Referring now to FIGS. 3 and 4, one embodiment of a pharmaceutical infusion catheter is shown and indicated at 100. As shown, the pharmaceutical infusion catheter 100 includes a central catheter tube 102. In one beneficial embodiment, the catheter tube 102 is a multiple lumen. A first infusion tube 104 and a second infusion tube 106 made from a flexible material, such as a nickel titanium tube material, are coupled to and extend from the central catheter tube 102 at about 180 ° to each other. Each infusion tube 104, 106 includes a proximal end 108 and a distal end 110. In one beneficial embodiment, the distal end 110 of each infusion tube 104, 106 is coupled to the central catheter tube 102 and the proximal end 108 enters the catheter tube 102 to a proximal coupler assembly (not shown). Continue to approach. During the infusion of the medicinal product, the medicinal solution may flow from the central catheter tube 102 through each infusion tube 104, 106, for example from the proximal end 108 to the distal end 110 or from the distal end 110 to the proximal end 108. Although possible, the pharmaceutical solution mainly exits from port 112.

  3 and 4 show infusion tubes 104, 106 in an expanded configuration and a contracted configuration, respectively. In one embodiment, the infusion tubes 104, 106 are advanced distally from a proximal coupler assembly (not shown) so that each infusion tube 104, 106 is bent outward in the expanded configuration shown in FIG. To do. Infusion tubes 104, 106 are straightened in the contracted configuration shown in FIG. 4 when retracted proximally from a proximal coupler assembly (not shown). In another mode, infusion tubes 104, 106 are confined radially within a delivery sheath (not shown) when in a contracted configuration.

  3 and 4 further show that an infusion port 112 is formed in each infusion tube 104, 106, and the pharmaceutical solution can flow out of the infusion port 112 during the infusion of the pharmaceutical. In addition, each infusion tube 104, 106 includes a marker band 114 for properly positioning the catheter tube 100 within the abdominal aorta 10 (FIG. 1).

  FIG. 3 shows the pharmaceutical infusion catheter 100 in an expanded configuration. Since the infusion tubes 104 and 106 can be bent from the central catheter tube 102 during expansion, the infusion tubes 104 and 106 infuse the drug closer to the inner wall 34 (FIG. 1) of the abdominal aorta 10 (FIG. 1). The positioning at can be maintained. When no pharmaceutical infusion is needed, the infusion tubes 104, 106 are deflated relative to the central catheter tube 102. In the contracted arrangement shown in FIG. 4, the pharmaceutical infusion catheter 100 can be inserted into the abdominal aorta 10 from the right iliac artery 22 or the left iliac artery 24, for example. Further, after drug infusion, the infusion tubes 104, 106 can contract, facilitating removal of the bifurcated drug infusion catheter 100 from the abdominal aorta 10 (FIG. 1).

  Adding one or more additional struts or tubes (not shown) to the catheter 100 can place or stabilize the infusion tubes 104, 106 near the renal artery. The additional struts may be manufactured from a different material than the infusion tubes 104,106.

  In one beneficial embodiment, the pharmaceutical infusion catheter 100 is used in place of a standard catheter introducer sheath, the distal tip of which is slightly above the level of the kidney, preferably the superior mesenteric artery (SMA). Placed at the level or below. Drugs that are desired to be selectively infused into the renal artery are infused through the drug infusion catheter 100 during the coronary procedure. This is a significant improvement over the systemic infusion of pharmaceutical solutions since the flow to the renal arteries 12, 14 is about 30% of the total aortic blood flow.

  Referring now to FIGS. 5 and 6, yet another embodiment is a pharmaceutical infusion catheter having a positioning post for positioning the catheter within the abdominal aorta, shown and generally indicated at 150. 5 and 6, pharmaceutical infusion catheter 150 includes an outer tube 152 that defines a proximal end (not shown) and a distal end 154. Center support tube 156 extends from the interior of outer tube 152 beyond its distal end 154. The tip 158 is provided at the end of the center support tube 156.

  5 and 6 show that the pharmaceutical infusion catheter 150 comprises a first collapsible column 160 and a second collapsible column 162, each column being in the form of a tube and slidably disposed within the outer tube 152. Is done. Each collapsible post 162 includes a proximal end (not shown) and a distal end 164, and the distal end 164 of each collapsible post 162 is attached to a tip 158. As contemplated by embodiments of the present invention, each collapsible strut 160, 162 has a central support since the distal end 164 of the strut is attached to the tip 158 when extending outwardly from the outer tube 152. Bends outward with respect to the tube 156.

  As shown, each collapsible post 160, 162 includes an infusion port 166. In addition, each collapsible post 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 radiopaque to facilitate positioning the pharmaceutical infusion catheter 150 within the abdominal aorta 10.

  FIG. 5 shows a pharmaceutical infusion catheter 150 in a collapsible arrangement, ie, the collapsible struts 160, 162 forming the positioning struts are in the collapsible arrangement. In the collapsed configuration, the pharmaceutical infusion catheter 150 is inserted into the right or left iliac artery 22, 24 (FIG. 1) and delivered into the abdominal aorta 10 until it is in the proper position near the renal arteries 12, 14. . In a position near the renal arteries 12, 14, the collapsible struts 160, 162 can be advanced forward relative to the outer tube and these struts are released from the central support tube 156. The collapsible struts 160, 162 can be advanced forward to establish the expanded arrangement shown in FIG. In the expanded configuration, the infusion port 166 is positioned directly adjacent to the renal arteries 12, 14 and can release the pharmaceutical solution directly into the renal arteries 12, 14. It can be appreciated that the pharmaceutical infusion catheter 150 can be placed to infuse the pharmaceutical solution directly onto the renal arteries 12, 14 along the wall 34 of the abdominal aorta 10. After a specified residence time in the abdominal aorta 10, the pharmaceutical infusion catheter 150 returns to the collapsed configuration and is withdrawn from the abdominal aorta 10.

  Referring briefly to FIGS. 7 and 8, another embodiment of a pharmaceutical infusion catheter having a positioning post is shown. FIGS. 7 and 8 illustrate that the pharmaceutical infusion catheter 150 can include a third collapsible post 172 and / or a fourth collapsible post 174. Thus, when expanded as described above, the pharmaceutical infusion catheter 150 with collapsible struts 160, 162, 172, 174 resembles a cage. It should be understood that the collapsible struts 172, 174 can be made from different materials or cannot be arranged for fluid infusion.

  FIGS. 9 and 10 show another embodiment of a pharmaceutical infusion catheter having a positioning post for positioning the catheter within the abdominal aorta, the catheter generally designated 200. As shown, the pharmaceutical infusion catheter 200 includes an outer tube 202 having a proximal end (not shown) and a distal end 204. The first collapsible column 206, the second collapsible column 208, the third collapsible column 210 and the fourth collapsible column 212 are provided by the outer tube 202 immediately adjacent to the distal end 204 of the outer tube 202. Established. Further, the center support hypotube 214 is slidably disposed within the outer tube 202. The distal end (not shown) of the center support hypotube 214 is mounted within the distal end 204 of the outer tube 202. Thus, as contemplated by this embodiment, when the central support hypotube 214 is retracted proximally into the outer tube 202, the struts 206, 208, 210, 212 extend outwardly and the pharmaceutical infusion catheter 200 can be, for example, abdominal. A cage arrangement is formed that can be secured near the renal arteries 12, 14 of the aorta 10.

  9 and 10 show that infusion ports 216 are formed in the first strut and second strut 208, respectively. Accordingly, the first marker band 218 is disposed over the infusion port along each strut. In addition, the second marker band 220 is disposed below the infusion port 216 along each column. In use, the pharmaceutical solution can be released from the infusion ports formed in the first and second struts 206,208. 210, 212 also establish infusion ports in the third and / or fourth struts and can be further provided with marker bands as described above. The pharmaceutical infusion catheter 200 is implemented with only the first and second struts 206, 208 and exhibits a relatively low profile. In yet another embodiment, the pharmaceutical infusion catheter is implemented using the first and second struts 206, 208 and the third strut 210.

  FIG. 9 shows the pharmaceutical infusion catheter 200 in a collapsed configuration. In the collapsed configuration, the pharmaceutical infusion catheter 200 is inserted into the right or left iliac artery 22, 24 (FIG. 1) and delivered into the abdominal aorta 10 until it is in the proper position near the renal arteries 12, 14. Is possible. After being placed in place near the renal arteries 12, 14, the central support hypotube 214 is retracted proximally into the outer tube 202 and the struts 206, 208, 210, 212 are released from the central support tube 202. Bend outward. The central support hypotube 214 can contract proximally as described above until the struts 206, 208, 210, 212 establish the expanded configuration shown in FIG.

  In the expanded configuration, the infusion port 216 is positioned directly adjacent to the renal arteries 12, 14 and can release the pharmaceutical solution directly into the renal arteries 12, 14. It can be appreciated that the pharmaceutical infusion catheter 200 can be placed so that the pharmaceutical solution is infused directly onto the renal arteries 12, 14 along the wall 34 of the abdominal aorta 10. After a specified residence time in the abdominal aorta 10, the pharmaceutical infusion catheter 200 can return to the collapsed configuration and be withdrawn from the abdominal aorta 10.

  Referring to FIGS. 11 and 12, another embodiment of a pharmaceutical infusion catheter having a positioning loop for positioning the catheter within the abdominal aorta is shown, generally indicated at 300. As shown, the pharmaceutical infusion catheter 300 includes a central catheter tube 302 that defines a proximal end (not shown) and a distal end 304. As shown, the first positioning wire 306 and the second positioning wire 308 extend from a port 310 formed in the central catheter tube 302. Each positioning wire 306, 308 defines a proximal end (not shown) and a distal end 312. The distal end 312 of each positioning wire 306, 308 is attached to the distal end 304 of the central catheter tube 302. Positioning wires 306, 308 extend through the entire length of the central catheter tube 310 and can be used to establish an adjustable positioning loop. In one embodiment, the positioning wires 306, 308 are in a separate lumen (not shown) in the central catheter tube 302 of the pharmaceutical product. It can be appreciated that the adjustable positioning loop can be adjusted by extending or retracting the positioning wires 306, 308 through the port 310 in the central catheter tube 302.

  FIGS. 11-12 further illustrate that a first infusion port 314 and a second infusion port 316 are formed in the central catheter tube 302. The pharmaceutical solution can exit the central catheter tube 302 and flow into the renal arteries 12, 14 as indicated by arrows 318 and 320. In yet other embodiments, the infusion ports 314, 316 are fluidly connected to a separate lumen (not shown) in the central catheter tube 302.

  It can be evaluated that the pharmaceutical infusion catheter 300 shown in FIGS. 11 to 12 enables the rotational position adjustment and the vertical position adjustment without risk of trauma to the abdominal aorta. Further, the positioning loops 306, 308 can be contracted to allow atraumatic rotation. Positioning loops 306, 308 are manufactured from a shape memory alloy, such as Nitinol®, and can be advanced through the central catheter tube 302 of the catheter 300 for positioning a pharmaceutical infusion, retracted, inserted and removed. The point can be evaluated.

  This embodiment provides that the pharmaceutical solution is placed in the renal arteries 12, 14, provided that the infusion of the pharmaceutical is performed on the renal arteries 12, 14 and on or near the posterior side of the inner wall 34 of the abdominal aorta 10. We recognize that experimental observations show that it can flow naturally. The positioning loops 306, 308 can be easily placed against the posterior portion of the inner wall 34 of the abdominal aorta 10 and do not require a shunt, such as a balloon or membrane, to maximize drug infusion to the renal arteries 12,14. It is. Therefore, the possibility of formation of a thrombus due to disruption of blood flow is minimal.

  The pharmaceutical infusion catheter 300 allows various guide catheters and guide wires to pass easily in parallel with the catheter tube 302 and between the positioning loops 306, 308, and the passageway is tactile feedback, or usually percutaneous. It can be appreciated that additional catheters used for coronary intervention (PCI) can minimize the impact on other performance aspects.

  FIGS. 13-16 illustrate another embodiment of a fluid infusion catheter assembly, generally designated 400. FIG. Although designated as a fluid infusion catheter, another embodiment is as a catheter positioning system where the catheter is placed in place in the blood vessel and does not require fluid infusion to accommodate the medical interventional device. used.

  FIG. 13 shows that the multi-lumen catheter 402 has a distal tip 404, a distal position 406, an intermediate distal position 408, and a proximal end (not shown). Fluid infusion catheter assembly 400 is shown in a collapsed state for insertion into the aorta and positioning near the renal artery (FIGS. 1 and 2).

  14 is a cross-sectional view of the catheter 402 taken along line 14-14 of FIG. 13, showing the central coronary artery traversing the lumen 410 and the catheter 402 having four positioning lumens 412. FIG. It should be understood that the number of positioning tube lumens may differ from other contemplated embodiments. Catheter 402 is manufactured from a polymer or other suitable material. The slit 414 is formed in the outer wall of the lumen 412 of each positioning tube in the catheter 402 as shown in FIGS. The slit is formed using a razor or another suitable cutting tool. As shown in FIG. 13, the slit 414 extends from the distal location 406 to the intermediate distal location 408. In the position embodiment, the slit 414 is a single cut. In another embodiment, the slit 414 is at least two cuts. Each of the positioning tubes 418 and 420 is inserted into the positioning tube lumen 412 from the proximal end (not shown) of the catheter 402, and the distal end (not shown) of the lumen 412 is at the distal location 406, respectively. Is coupled to catheter 402 within lumen 412 of the positioning tube. The positioning tubes 418, 420 are made from a rigid polymer, metal or other support material. The positioning tube 420 is shown with the injection port 422 positioned at the center of the distal position and at the intermediate distal position 408 of the catheter 402. The positioning tube 420 is fluidly connected to a fluid agent source at the proximal end, typically using the proximal coupler assembly described in FIGS. 17A-17B. In still other embodiments, the positioning tube 420 is disposed within the adjacent positioning lumen 412. The positioning tube 418 has an infusion port in yet another embodiment. It should be further understood that the positioning tube 418 may be a solid elongated member.

  In FIG. 15, the positioning tubes 418, 420 are deployed by advancing their proximal ends (not shown) distally to form a “basket” distal position 406 and intermediate distal position 408 of the catheter 402. And expand outward. Positioning tubes 418, 420 place the infusion port 422 in or on the renal artery (not shown) to locally infuse fluid agent along the outer bloodstream into the renal artery (FIG. 2). . The coronary catheter 422 is advanced distally through the coronary artery access lumen 410 and past the distal tip of the catheter 402 for further medical intervention. It should be understood that other medical catheters and devices are deployed through the coronary artery access lumen 410.

  FIG. 16 is a cross-sectional view of the catheter 402 of FIG.

  17A and 17B show a proximal coupler system 500 used to deploy and deploy a renal fluid supply device that is added to an interventional catheter. The Y hub body 510 has a main branch tube 512 having a catheter fitting 514 at the distal end 516 of the hub body 510 and a main adapter fitting 518 at the proximal end 520 of the Y hub body 510. The main branch fluidly connects the catheter fitting 514 and the main port 518. By way of example and not limitation, one embodiment of the main branch tube 512 is adapted to accommodate a 6Fr guide catheter. A side port fitting 522 is disposed on the main branch tube 512 and is fluidly connected to the main branch tube 512 to provide the main branch tube 512 fluid in use. Secondary branch 530 intersects main channel 512 at a predetermined transition angle β. In one useful embodiment, the transition angle β is about 20 °. The secondary branch tube has a secondary port 532 at the proximal end 534 of the secondary branch tube 530. The Y hub body 510 is shaped integrally and assembled from a plurality of parts.

  The hemostatic valve 536 is attached to the main port 518 and the Touhy Borst valve 538 is attached to the port 532 of the secondary branch. The interventional catheter 540 is introduced into the Y hub 510 through the hemostasis valve 536. A multi-lumen fluid infusion catheter 542 similar to the catheter shown in FIG. 15 has a proximal end 544 and a distal end 546 and is coupled to the Y hub body 510 with the proximal end 544 positioned on the catheter fitting 514. Is done. The fluid infusion catheter 542 includes a plurality of positioning tubes 550 and an infusion tube 552 within the fluid infusion catheter 542. Infusion tube 552 has an injection port 554 as previously described with respect to FIGS. Y hub body 510 is coupled to local fluid supply system 560. Rigid tube 562 passes through secondary branch port 532 and Touhy Borst valve 538, is physically and fluidly connected to infusion tube 552, and is physically connected to positioning tube 550. In one embodiment, positioning tube 550 and infusion tube 552 are fluidly and physically coupled to rigid tube 562 within secondary branch tube 530. In another embodiment, the rigid tube 562 is made from a nickel titanium alloy. A handle 566 is attached to the proximal end 564 of the rigid tube 562. The fluid injection coupling is fluidly connected to the proximal end 564 of the rigid tube 562. A fluid injection system 570 is coupled to the fluid injection port 568 to introduce a material such as a fluid. Details of fluid injection system 570 are omitted herein for clarity. In one aspect of the invention, Y hub 510, fluid supply system 560, and fluid infusion catheter 542 are provided as a kit.

  In FIG. 17B, the fluid infusion catheter distal end 546 of the fluid infusion catheter 542 is placed upstream of the renal artery by an introducer sheath, dilator, guidewire or other known vascular positioning method. Local fluid supply system 560 is pushed into secondary port 532 of Y hub 510 as indicated by arrow 580. The rigid tube 562 is advanced through the fluid infusion catheter 542, causing the positioning tube 550 and the infusion tube 552 to bend outward and secure against the aortic wall (see FIGS. 1 and 2). This step is repeated if the fluid infusion catheter 542 needs to be further aligned with respect to the renal artery. The fluid injection system 570 injects fluid into the fluid supply system 560, which flows out of the injection port 554 in the infusion tube 552 (as described above with respect to FIG. 15). Arrow 584 indicates that the interventional catheter 540 is advanced through the main branch tube 512 of the Y hub assembly 510 and the central lumen of the fluid infusion catheter 542 and out of the distal end 546 of the fluid infusion catheter 542. Indicates that

  In one embodiment, the distal end 546 of the fluid infusion catheter 542 is frustoconical (not shown) .In certain modes of this embodiment, the fluid infusion catheter 542 is adapted to receive a dilator. In another embodiment, one or more radiopaque marker bands (not shown) are attached to the distal end 546 of the fluid infusion catheter 542. In yet other embodiments, one or A plurality of radiopaque marker bands (not shown) are attached to positioning tube 550 and / or infusion tube 552. In yet other embodiments, infusion tube 552 and / or positioning tube 550 are distal to catheter 542. Used to position end 546 and no fluid infusion is performed.

  In another embodiment, fluid infusion catheter 542 is introduced into the vasculature through an introducer sheath (not shown). By way of example, and not limitation, the proximal coupler system 500 can be used to route a wide range of medical devices such as guide wires, diagnostic catheters, shunts and infusion assemblies through the fluid infusion catheter 542 and the vasculature such as the aortic system 10. Adapted to advance in. A plurality of Y proximal couplers (not shown) having two or more branch ports can be used to control a plurality of positioning and infusion tubes or to advance a plurality of medical devices.

  It should be understood that each of the embodiments described in detail above provides a device that can be used for selective therapeutic drug infusion at a site remote from the main treatment site. These devices can be applied to interventional radiation procedures, including interventional diagnostic and treatment procedures associated with coronary arteries. In addition, each of the above devices organically binds a specific pharmaceutical, such as papavarine; nifedipine; verapamil; phenoldpam mesylate; flossamide; thiazide; and dopamine; The ability of the kidney to treat iodine, ie, supplying the renal arteries of patients undergoing coronary intervention at the same time with the intention of increasing radiographic contrast as measured by serum creatinine and glomerular filtration rate (GFR) May be beneficial.

  Various embodiments described herein with respect to the present invention include treatments and therapies aimed at the kidney, such as the prevention of radiocontrast nephropathy (RCN) by diagnostic procedures using iodine-treated contrast agents, etc. May be useful. A series of treatment plans have been developed based on local diagnostic agents for the kidney as a preventive treatment for patients undergoing interventional procedures that have been recognized as being at high risk for developing RCN. Agents that have been identified for such treatment include saline (NS) and vasodilators, papavaline (PAP) and fenoldopam mesylate (FM).

  Approved use of fenoldopam is for in-hospital drip treatment of hypertension when rapid but rapidly recoverable blood pressure is needed. Fenoldopam produces dose-dependent renal vasodilation at systemic doses as low as about 0.01 mcg / kg / min to about 0.5 mcg / kg / min and increases blood flow to both the renal cortex and renal medulla . Because of these physiology, fenoldopam is used to protect the kidney from ischemic damage, such as high-risk surgical procedures, and contrast nephropathy. Administration of about 0.01 to about 3.2 mcg / kg / min is suitable for most applications of embodiments of the invention, or about 0.05 to about 1.6 mcg / per renal artery (ie per kidney). kg / min is considered suitable. As noted above, in many cases it may be beneficial to select a starting dose and increase or decrease enemy quantification to determine the patient's maximum tolerated systemic dose. However, recent data suggests that about 0.2 mcg / kg / min fenoldopam is more effective than about 0.1 mcg / kg / min in preventing contrast nephropathy. This dosage is preferred.

  The normal saline dose level supplied bilaterally to the renal arteries is set experimentally or advantageously customized to be determined by titration. The structure of the catheter or infusion pump places a practical limit on the amount of fluid that can be delivered. However, it may be desirable to provide as much fluid as possible, at levels below about 2 liters per hour (on average about 25 cc / kg / hour for a patient of about 180 lb), or about 1 liter per kidney or 12.5 cc / kg / hour is considered beneficial.

  Local administration of about 4 mg / min or less, or about 2 mg / min or less of papaverine through a bilateral catheter has been demonstrated to be safe in animal studies, and local kidney doses of about 2 mg / min and about 3 mg / min to the catheter Has been demonstrated to increase renal blood flow velocity in human subjects, ie from about 1 mg / min to about 1.5 mg / min per artery or kidney. Thus, local bilateral kidney supply of papavalin reduces the risk of RCN in patients due to high standards of serum creatinine, existing risk factors such as diabetes, or other evidence of impaired renal function It seems to be useful.

  According to yet another embodiment, a very small systemic dose of papavaline may be administered alone or in conjunction with other medical management, such as filling with saline, before the anticipated contrast agent injury occurs. Administration is also conceivable. Such dosages are, for example, on the order of about 3 to about 14 mg / hour (based on a bolus indication of about 10 to 40 mg every 3 hours—papavarin is generally not administered by weight). In an alternative position embodiment, the dosage is 2-3 mg / min or 120-180 mg / min. Again, in connection with local bilateral supply, this dose is thought to be halved with respect to the dose rate of each artery itself.

  Despite the specific benefits of each such dosage range for each of the above compounds, it is considered safe to provide relatively large doses locally. Titration is yet another mechanism that is believed to provide the ability to test tolerances for relatively large doses. It is further contemplated that the above therapeutic dosages can be provided alone or in connection with systemic treatments such as saline by infusion.

  From the above discussion, it will be appreciated that the various embodiments described herein generally provide for the infusion of a nephroprotective agent to each of the renal arteries that perfuses both kidneys of a patient. The devices and methods of these embodiments are useful for the prevention or treatment of conditions such as renal dysfunction or ARF. Various pharmaceuticals are supplied via the systems and methods described above, such as vasodilators; vasoconstrictors; diuretics; calcium antagonists; or dopamine DA1 agonists; or combinations or blends thereof. Can be mentioned. In addition, examples of more specific pharmaceutical agents contemplated for the overall system and method described above include papavarin; nifedipine; verapamil; fenoldapam; flossamide; and dopamine; Is mentioned.

  The present invention may be implemented in other highly beneficial embodiments and provide certain benefits. For example, radiopaque markers are used with fluoroscopy and are illustrated and described as described above for manipulating and deploying introducer sheaths and intra-aortic catheters. The necessary fluoroscopic equipment and auxiliary equipment devices are usually placed at designated locations that limit the use of the present invention in vivo to a given location. Other ways to position the intra-aortic catheter are very beneficial in overcoming the fluoroscopic limitations. For example, non-fluoroscopy guidance technology is used because fluoroscopy is not readily available, or because of the use of fluoroscopy, there is a lack of certain radiation safety devices that are usually present in angiography rooms, etc. Very useful for use in operating rooms, intensive care units and emergency rooms where excessive radiation exposure to the person and others may occur. Through the use of non-fluoroscopic positioning, intra-aortic catheter systems and methods can be used to treat other diseases, such as ATN and CHF, in a clinical environment outside the angiography room or catheter laboratory.

  In one embodiment, the intra-aortic catheter is modified to incorporate a metal that is visible with ultrasound technology into the marker band. The ultrasonic sensor is arranged outside the main body surface to obtain a field of view. In one variation, a portable non-invasive ultrasound instrument is placed on the surface of the body and moves around to confirm the location of the device and both renal ostia. This technique is used to observe the aorta, both renal orifices and intra-aortic catheters.

  In another beneficial embodiment, the ultrasonic sensor is placed on the introducer sheath and the intra-aortic catheter itself, particularly on the tip of the aortic catheter, or on the proximal portion of the catheter. With an intra-aortic catheter equipped with an ultrasonic sensor, a physician can move the sensor up and down the aorta to confirm the position of both renal ostia.

  Yet another embodiment incorporates Doppler ultrasonography in the intra-aortic catheter. 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 are used to confirm the location of both renal ostia. Yet another benefit of Doppler ultrasonography is that it is non-invasive and does not use x-rays.

  Yet another embodiment incorporates optical technology into the intra-aortic catheter. The optical sensor is disposed at the distal end of the introduction sheath. The introducer sheath optical sensor allows visualization of the area around the tip of the introducer sheath to confirm the location of the renal ostium. In yet another mode of this embodiment, a transparent balloon is placed around the distal tip of the introducer sheath. When the balloon is inflated, it makes it possible to visually and visually confirm the renal ostia. The balloon takes into account the distance between the tip of the introducer sheath and the optical sensor when separating the aortic blood flow. This distance enhances the ability to visualize images within the aorta. In yet another mode, the balloon is adapted to allow a large amount to pass through the balloon wall while maintaining contact with the aortic wall. The benefit of allowing contact with the wall is that the balloon is inflated near the renal ostium and can be visually seen with a light sensor. In another mode, the optical sensor is placed at the distal tip of the intra-aortic catheter. When the intra-aortic catheter is deployed within the aorta, the optical sensor allows visual confirmation of the aortic wall. The intra-aortic catheter is tracked up and down the aorta until visual confirmation of the renal ostia is obtained. The physician can track the position of the intra-aortic catheter relative to the renal artery using the light image provided in this mode.

  Another embodiment uses a sensor that measures pressure, velocity and / or flow to confirm the location of the renal ostium, and no fluoroscopic instrument is required. The sensor is placed at the distal end of the intra-aortic catheter. The sensor displays real-time data regarding pressure, speed and / or flow rate. When real-time data is provided, the physician confirms the location of both renal ostium by observing sensor data when the intra-aortic catheter is near the approximate location of the renal ostium. In yet another mode of this embodiment, the intra-aortic catheter has a plurality of sensors placed at intermediate distal and intermediate proximal positions on the catheter to obtain intermediate proximal and intermediate distal sensor data. From this real-time data, the doctor can observe a significant flow difference between the upper and lower sides of the renal artery to confirm the approximate location. If the renal artery is the only significant sized vessel in the region, the sensor will detect any significant change in sensor parameters.

  In yet another embodiment, a chemical sensor is placed on the intra-aortic catheter to detect any change in blood chemistry and to indicate the location of the renal ostium to the physician. Chemical sensors are placed at multiple locations on the intra-aortic catheter and detect chemical changes at each sensor location.

  While the above description includes many details, these details should not be construed as limiting the scope of the invention, but merely illustrate some of the presently preferred embodiments of the invention. Should be interpreted. Accordingly, the scope of the present invention fully encompasses other embodiments apparent to those skilled in the art, so that the scope of the present invention is not limited by anything other than the appended claims, and is singular with respect to certain elements. When referred to, it will be appreciated that it is not intended to be “one and only” unless explicitly stated otherwise, but is intended to mean “one or more”. All elements structurally, chemically and functionally equivalent to the elements of the preferred embodiments described above known to those skilled in the art are expressly incorporated herein by reference, and are Intended to be included. Further, a device or method need not address all of these problems, as every problem that the invention seeks to solve is within the scope of the claims of the present invention. Further, the elements, arrangement parts or method steps of the present disclosure are intended to be made available to the public regardless of whether the elements, arrangement parts or method steps are explicitly recited in the claims. Yes. Any element of a claim in this specification should be construed in accordance with the provisions of 35 USC 112, unless the element is explicitly cited using the phrase "means for" Should do.

The invention will be more fully understood by reference to the following drawings, which are merely illustrative.
FIG. 1 is a front perspective view of the abdominal aorta approximately near the renal artery. FIG. 2 is a cross-sectional view of the abdominal aorta cut in the vicinity of the renal artery and shows a general blood flow pattern through the abdominal aorta and the renal artery. FIG. 3 is a perspective view of the fluid infusion catheter in an expanded configuration. FIG. 4 is a side view of the fluid infusion catheter shown in FIG. 3, showing the fluid infusion catheter in a collapsed configuration. FIG. 5 is a plan view of a fluid infusion catheter having positioning struts according to yet another aspect, showing the struts in a collapsed configuration. FIG. 6 is a front view of the fluid infusion catheter shown in FIG. 5, showing the strut placed in the abdominal aorta adjacent to the renal artery in the expanded configuration. FIG. 7 is a plan view of another fluid infusion catheter, with the struts shown in a collapsed configuration. FIG. 8 is a front view of the fluid infusion catheter shown in FIG. 7, showing the positioning struts placed in the abdominal aorta adjacent to the renal artery in the expanded configuration. FIG. 9 is a plan view of another fluid infusion catheter, with the positioning struts shown in a collapsed configuration. FIG. 10 is a front view of the fluid infusion catheter of FIG. 9, showing struts placed in the abdominal aorta adjacent to the renal artery in an expanded configuration. FIG. 11 is a front view of another fluid infusion catheter with the positioning loop in an extended configuration. FIG. 12 is a cross-sectional view of the fluid infusion catheter taken along line 12-12 of FIG. 11, showing the positioning loop in an extended configuration. FIG. 13 is a fluid infusion catheter assembly with four positioning tubes in a collapsed state. 14 is a cross-sectional view of the fluid infusion catheter assembly of FIG. 13 taken along line 14-14. 15 is the fluid infusion catheter assembly shown in FIG. 13 in an expanded state. 16 is a cross-sectional view of the fluid infusion catheter assembly shown in FIG. 15 taken along line 16-16. FIG. 17A shows a proximal coupler system coupled to one embodiment of a fluid infusion catheter similar to the fluid infusion catheter shown in FIG. FIG. 17B shows the proximal coupler system shown in FIG. 17A with the fluid infusion catheter in an expanded state and the medical interventional device advanced into the catheter.

Claims (43)

A catheter for locally supplying a fluid agent to a patient's renal artery and containing a medical intervention device,
A catheter having a proximal end position, an intermediate distal position and a distal end position;
The catheter further comprising a central lumen and at least one outer lumen;
A local injection assembly having at least one tube, each tube being inserted into a corresponding outer lumen;
Each tube having a proximal end position and a distal end position,
A tube, wherein the distal end position of each tube is coupled to the distal end position of the catheter;
At least one first injection port disposed on at least one tube between the distal end position of the tube and the intermediate distal position of the catheter;
A fluid source fluidly coupled to a proximal end location of at least one tube comprising an injection port;
Each tube adjustable between a first position and a second position,
In the first position, each tube is adapted to be delivered to a location within the abdominal aorta associated with blood flow flowing into the plurality of renal artery ostiums,
In the second position, each tube is adapted to be fixed in place, the infusion port is adapted to supply fluid agent into the blood stream from a fluid source, and in the second position, in the center. The lumen comprises a tube adapted to provide a passageway from a proximal end position to a distal end position of the catheter to receive a medical intervention device. The catheter of claim 1, further comprising at least one second tube and at least one second infusion port disposed within the second tube. The catheter of claim 3, further comprising at least three tubes. The catheter of claim 3, further comprising at least four tubes. The catheter has a longitudinal axis;
The first and second tubes in the first arrangement have a first radial position relative to the longitudinal axis;
The catheter according to claim 2, wherein the first and second tubes in the second configuration have a second radial position extending radially from the longitudinal axis relative to the first radial position. The catheter of claim 5, wherein the first and second tubes are located on opposite sides of each of the catheters around the catheter. Each of the first and second tubes extends between an intermediate distal position and a distal position on a respective opposite side of the catheter;
The catheter of claim 6, wherein in the second configuration, the first and second tubes are biased outwardly from the catheter between a respective intermediate distal position and distal position of the catheter. Further comprising first and second markers located along the first and second tubes, respectively, at locations substantially corresponding to the first and second injection ports;
Each of the first and second markers directs the operator outside the patient to the location of the first and second injection ports and delivers the first and second injection ports to the first and second positions, respectively. The catheter of claim 2, wherein the catheter is adapted to facilitate. The catheter of claim 8, wherein the first and second markers comprise radiopaque markers. The first position is the memory shape of each tube;
Each tube is adjusted from a first position to a second position by applying an advancing force distally to the proximal end position of each tube,
The catheter of claim 1, wherein each tube is self-adjustable from a second position to a first position by memory recovery force after removal of the advance force. The patient's renal urinary tract from a location in the abdominal aorta associated with the first and second flow paths in the outer region of the abdominal aortic blood flow substantially along the abdominal aortic wall and into the first and second renal arteries, respectively. A local renal infusion system for treating the system via corresponding first and second renal ostiums along the patient's abdominal aortic wall,
An elongate member having a proximal end position, an intermediate distal position, a distal end position and a longitudinal axis;
The elongate member further comprising a central lumen, a first outer lumen and at least one second outer lumen;
Each outer lumen having an outer wall in the elongated member;
A slit of a predetermined length in the outer wall of each outer lumen, formed parallel to the longitudinal axis of the elongate member and intermediate distal of the elongate member from the distal end position of the elongate member A slit extending to a position;
A local injection assembly having a first single tube and at least one second single tube, each single tube being inserted into a corresponding outer lumen;
Each single tube having a proximal end and a distal end,
A single tube, wherein the distal end of each single tube is coupled to the distal end location of the elongated member;
The first single tube positioned between the distal end of the first single tube and the intermediate distal position of the elongated member;
Said second single tube having a second injection port disposed between a distal end of the second single tube and an intermediate distal position of the elongated member;
The single tube adjustable between a first arrangement and a second arrangement;
In the first arrangement, the single tube that collapses radially relative to the longitudinal axis of the elongated member,
In the second arrangement, the single tube extends through the slit in the outer wall radially from the longitudinal axis of the elongated member as the proximal end of the single tube is advanced distally;
In the second arrangement, the first injection port and the second injection port are in a first position and a second position, respectively,
The local injection assembly is adapted to be placed in place with first and second injection ports in first and second positions corresponding to the first and second flow paths, respectively;
The local infusion assembly is adapted to be fluidly coupled to a fluid agent source external to the patient when the local infusion assembly is in place;
A local infusion assembly delivers an amount of fluid agent from a fluid agent source, through first and second injection ports in first and second locations, respectively, and also bilaterally into the first and second renal arteries, respectively. A local kidney with a single tube that is infused through each corresponding first and second renal ostium and adapted to substantially not alter abdominal aortic flow along the predetermined location Infusion system. A local infusion assembly is adapted to inject a predetermined amount of fluid agent into the first and second flow paths so that the infused amount flows substantially only into the first and second renal arteries, 12. The system of claim 11, wherein there is no need to substantially divert one area to another area of aortic blood flow. A local infusion assembly is adapted to infuse a predetermined amount of fluid agent into the first and second flow paths, the infused amount flowing substantially only into the first and second renal arteries, and the abdominal aorta The system of claim 11, wherein the system does not substantially occlude blood flow. A local infusion assembly is adapted to inject a predetermined amount of fluid agent into the first and second flow paths, the infused amount flowing substantially only into the first and second renal arteries, The system of claim 11, wherein the second flow path is not isolated from an adjacent flow path at a predetermined location. A central lumen of the elongate member forms a passage extending from a proximal end position of the elongate member to a distal end position of the elongate member;
The system of claim 11, wherein the passage is adapted to accommodate a catheter selected from the group consisting essentially of a coronary guide catheter and an angiographic catheter. The system of claim 11, further comprising a third outer lumen and a third single tube. The system of claim 11, further comprising at least one fourth outer lumen and at least one fourth single tube. A proximal coupler assembly adapted to be coupled to a proximal end position of the elongated member;
The proximal coupler assembly further adapted to fluidly couple to a fluid agent source external to the patient;
The system of claim 11, further comprising the proximal coupler assembly further adapted to fluidly couple to the first and second injection ports in first and second positions, respectively. The system of claim 11, further comprising a fluid agent source adapted to couple to the local infusion assembly. The system of claim 19, wherein the fluid agent comprises a renal protective agent. The system of claim 19, wherein the fluid agent comprises a diuretic. 24. The system of claim 21, wherein the diuretic comprises furosemide, or an analog or derivative thereof. 24. The system of claim 21, wherein the diuretic comprises thiazide, or an analog or derivative thereof. The system of claim 19, wherein the fluid agent comprises a vasoconstrictor. 25. The system of claim 24, wherein the vasoconstrictor comprises dopamine or an analog or derivative thereof. The system of claim 19, wherein the fluid agent comprises a vasoconstrictor. The system of claim 19, wherein the fluid agent comprises a vasoactive agent. 20. The system of claim 19, wherein the fluid agent comprises papavaline, or an analog or derivative thereof. The system of claim 19, wherein the fluid agent comprises a calcium antagonist. 20. The system of claim 19, wherein the fluid agent comprises nifedipine, or an analog or derivative thereof. 20. The system of claim 19, wherein the fluid agent comprises verapamil, or an analog or derivative thereof. 20. The system of claim 19, wherein the fluid agent comprises fenoldapam mesylate, or an analog or derivative thereof. 21. The system of claim 19, wherein the fluid agent comprises a dopamine DA ₁ agonist. A patient's renal urinary system from one location in the abdominal aorta associated with abdominal aortic blood flow to the first and second renal arteries along the abdominal aortic wall via the first and second renal ostium, respectively A method for treating and carrying out medical interventions in each unique place,
Positioning the local injection assembly with the central lumen in place and the first and second injection ports in first and second unique positions in place;
Fluidly coupling a local infusion assembly in place to a fluid supply source external to the patient;
Injecting a quantity of fluid agent from the source simultaneously through the first and second infusion ports in the first and second locations, respectively, primarily into the first and second renal arteries, respectively;
Advancing the medical interventional device through the central lumen. The patient's renal urinary system from a location in the abdominal aorta associated with the abdominal aorta blood flow to each of the first and second renal arteries is first and 2. A method for treating via the renal ostium,
Inserting the local infusion assembly into the abdominal aorta in a collapsed configuration;
Positioning the local injection assembly in place;
Expanding the local injection assembly to an expanded configuration;
Fluidly coupling a local infusion assembly in place to a fluid agent source external to the patient;
Injecting an amount of fluid agent from a source into the abdominal aorta at a predetermined location, wherein the infused fluid is primarily into the first and second renal arteries via the first and second renal ostium, respectively. Injecting substantially substantially without altering, occluding or isolating a substantial portion of the outer region of the aortic blood flow across a predetermined location along the circumference of the abdominal aortic wall so as to flow in . A patient's renal urinary system from one location in the abdominal aorta associated with abdominal aortic blood flow to the first and second renal arteries along the abdominal aortic wall via the first and second renal ostium, respectively A method for treating and carrying out medical interventions in each unique place,
Positioning a delivery member having a central lumen in the patient's abdominal aorta;
Supplying a first and second injection member, together with a supply member, having first and second injection ports in a first arrangement, respectively, to a predetermined location;
Adjusting the local injection assembly between a first configuration and a second configuration at a predetermined location, comprising:
In the second configuration, the local infusion assembly extends from the distal end location of the delivery member, and the first and second infusion members are radially with respect to each other across a location of the abdominal aorta at a predetermined location. Extending, wherein the first and second injection ports are located in first and second unique positions, respectively, in a predetermined position;
Fluidly coupling the first and second infusion ports at a first and second position to a fluid supply source external to the patient;
Injecting an amount of fluid into the first and second renal arteries from the first and second locations via the respective first and second renal ostia;
Advancing the medical intervention device through the central lumen. The patient's renal urine from a location in the abdominal aorta associated with the first and second flow paths in the outer region of the abdominal aortic blood flow substantially along the abdominal aortic wall, and into the first and second renal arteries, respectively A method of providing local treatment to the tract system via corresponding first and second renal ostiums along the patient's abdominal aorta wall for medical intervention,
Positioning a local injection assembly having a central lumen at a location where the first and second injection ports are in respective first and second locations corresponding to the first and second flow paths, respectively;
Fluidly coupling the local infusion assembly to a fluid supply source external to the patient when the local infusion assembly is in place;
A corresponding amount of fluid agent from the source, through the first and second infusion ports in the first and second positions, respectively, and also into the first and second renal arteries, respectively, respectively. Injecting bilaterally through and not substantially changing the abdominal aorta along the predetermined location;
Advancing the medical interventional device through the central lumen. 38. The method of claim 34, 35, 36 or 37, further comprising enhancing renal function with an infused amount of fluid agent. Injecting a predetermined amount of fluid agent at a time when an injection of an amount of radiocontrast agent dye is performed in the patient's vasculature;
40. The method of claim 38, further comprising the step of the fluid agent being adapted to substantially prevent RCN in response to injection of the radiocontrast agent dye. 40. The method of claim 38, further comprising treating acute renal failure with an infused amount of fluid agent. Providing an elongated member having a central lumen, a first outer lumen, and at least one second outer lumen, comprising:
The elongate member further has an intermediate distal position, a distal end position, and a longitudinal axis;
Each of the outer lumens having an outer wall within the elongated member;
Forming a slit of a predetermined length in the outer wall of the outer lumen, wherein the slit is formed parallel to the longitudinal axis of the elongated member and from the distal end position of the elongated member Extending to an intermediate distal position of
Providing a first single tube and at least one second single tube, each single tube having a proximal end and a distal end;
Inserting a single tube into the corresponding outer lumen of the elongated member;
Coupling the distal end of each single tube to the distal end location of the elongated member;
Placing a first injection port on the first single tube;
Placing a second injection port on the second single tube;
39. The method of claim 38, further comprising positioning the first injection port and the second injection port between the distal ends of the first and second single tubes, respectively, and the intermediate distal position of the elongated member. the method of. 42. The method of claim 41, further comprising providing a third outer lumen and a third single tube. 43. The method of claim 42, further comprising providing at least one fourth outer lumen and at least one fourth single tube.

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