WO2019232488A1

WO2019232488A1 - Venous infusion catheter and methods for its use

Info

Publication number: WO2019232488A1
Application number: PCT/US2019/035071
Authority: WO
Inventors: Robert D. Schultz; Bridget C. VAUGHAN; Justin M. OLSHAVSKY; Melissa E. R. JONES; Aurko J. SHAW; Tatiana M. JANSEN
Original assignee: Voyage Biomedical Inc.
Priority date: 2018-06-01
Filing date: 2019-05-31
Publication date: 2019-12-05
Also published as: EP3801730A4; EP3801730A1; CA3101775A1

Abstract

A venous infusion catheter includes an elongated and hollow body defining an internal cavity and extending longitudinally between a proximal open end and a distal end, the elongated and hollow body being provided with a lateral port, the proximal open end being fluidly connectable to a source of fluid to be delivered; and an external balloon secured to an external face of the elongated and hollow body, the lateral port being located between the external balloon and the proximal end of the elongated and hollow body, the external balloon being modifiable between an inflated configuration and a deflated configuration, and the external balloon being fluidly connectable to a source of inflation fluid for inflating the external balloon.

Description

VENOUS INFUSION CATHETER AND METHODS FOR ITS USE

CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 62/679,242, filed June 1, 2018, which application is incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention. The present invention relates generally to medical catheters, and more particularly to central venous catheters.

[0003] Cardiopulmonary arrest, typically resulting from stopping of the heart but sometimes resulting from failure of a patient’s respiratory function, is a medical emergency where loss of blood flow to the brain can cause irreversible brain damage within as little as two minutes.

While cardiopulmonary resuscitation (CPR) may be used to restore cardiopulmonary function and revive the patient, brain death and permanent neurologic dysfunction can still occur.

Ischemic and hemorrhagic stroke and stopped-heart cardiac surgery can also affect blood flow to the brain and place the patient’s brain function at risk.

[0004] A number of interventions have been proposed to improve patient survival and reduce the risk of brain injury during cardiac surgery following cardiopulmonary arrest, ischemic and hemorrhagic stroke and other conditions that affect blood flow to the brain. Some methods rely on irrigating the patient’s brain following an arrest of the heart or lungs. While theoretically effective if administered immediately, such methods usually require time and require skilled personnel to administer. So techniques, such as retrograde cerebral perfusion and extracorporeal membrane oxygenation (a form of miniaturized heart lung bypass), are very effective when used during aortic and other cardiac surgeries while the heart is stopped, are not practical for use in emergency situations where the personnel and time needed for set up are usually not available. Even when the patient is hospitalized in the case of cardiac arrest, the ability to intervene with available protocols can be limited. In the case of cardiac surgery, though protective hypothermic techniques are employed readily, they achieve systemic bodily temperature reduction which is associated with adverse consequences.

[0005] Therefore, a need exists for methods and apparatus for the emergency treatment of patients experiencing various forms of cardiopulmonary arrest. In particular, it would be desirable to provide catheters and methods of their use which enable point of care personnel in a hospital or elsewhere to protect the patient’s brain immediately or very shortly after the patient enters cardiopulmonary arrest. In intensive care and rescue situations as well as cardiac and other surgeries, the apparatus would preferably be in place prior to onset of the emergency condition and be readily deployable by physicians or other point of care personnel. It would be further desirable if such apparatus and methods were also suitable for treating patients suffering from other conditions and treatments that compromise blood flow to the brain, including ischemic and hemorrhagic stroke, cardiac surgery, and the like. At least some of these objectives will be met by the inventions described below.

[0006] 2. Listing of the Background Art. Relevant patents and published patent applications include US4701166; US4973319 ; US5360403; US5827237; US6059757; US6059760;

US6276661; US6340356; US6520933; US6743208; US6,896,663; US7182746; US8313461; US9987449; US2017/0333685; EP1397175B1; and EP1740248B1.

SUMMARY OF THE INVENTION

[0007] According to a first broad aspect, the present invention provides a venous infusion catheter comprising an elongated catheter body having one or more lumens, such as perfusion lumens, drug delivery lumens, inflation lumens, and the like, extending longitudinally between a proximal end and a distal end. The elongated catheter body has at least one lateral port open to a perfusion lumen, with a proximal end of the perfusion lumen fluidly connectable to a source of fluid to be delivered, typically including a proximal hub with an inlet port. An expandable occlusion element, typically an inflatable balloon, is secured to an external surface of the elongated catheter body, and the at least one lateral port is located between the expandable occlusion element and the proximal end or hub. The expandable occlusion element can assume an expanded configuration and a contracted configuration, typically comprising a balloon structure fluidly connectable to a source of inflation fluid. The perfusion lumens of the present invention will be available for perfusion of all types of media, including hypothermic and other preservative media, drugs, medicaments, and the like.

[0008] In some embodiments, a distal end of the perfusion lumen may be closed so that the perfusion lumen has only the one or more lateral outlet ports disposed proximally of the expandable occlusion element. In such instances, all fluids will be delivered through the one or more lateral outlet ports, and the expandable occlusion element may be used to direct the flow in an antegrade or retrograde direction, as described in more detail below.

[0009] In other embodiments, a distal end of the perfusion lumen is open on a distal side of the expandable occlusion element, and/or other lateral ports will be formed on a distal side of the expandable occlusion element, so that fluids may be released in an antegrade direction regardless of whether the external expandable occlusion element is expanded or contracted. In such instances, the venous infusion catheter typically further comprises a flow diverter, such as an internal balloon, valve, sliding occluder, or other occluding structure, disposed in the perfusion lumen at a longitudinal position located between the at least one lateral port proximal of the external expandable occlusion element and the open distal end and/or lateral ports distal to the external expandable occlusion element. The flow diverter will block or redirect inlet flow from the proximal inlet port so that such inlet flow is not released from any ports or openings distal to the external expandable occlusion element.

[0010] In a first specific aspect of the present invention, a method for treating a patient comprises introducing a catheter into the patient’s venous vasculature to position a first outlet port on the catheter at a location where blood flows into the patient’s right atrium and a second outlet port on the catheter at a location where venous blood drains from the cerebral vasculature. One or more medicaments, drugs, or the like, may be delivered in an antegrade direction to the right atrium of the patient’s heart through the first outlet port of the catheter at selected times. At other selected times, a preservative medium, such as a hypothermic fluid, may be delivered in a retrograde direction to the patient’s cerebral vasculature through the second outlet port of the catheter. In this way, the catheter may be used in a manner analogous to a central venous catheter for delivering drugs and other medicaments to the patient’s heart, for example in a hospital setting such as an intensive care unit. Should an in-hospital cardiac arrest (IHCA) or other emergency occur, such as a stroke, the catheter may then be used for the delivery of a cooling or other preservative medium to the patient’s cerebral vasculature, as described in more detail hereinbelow.

[0011] In particular instances, the preservative medium may be delivered to the patient when the patient’s heart has stopped beating, e.g. when the patient has gone into cardiac arrest or when the patient’s heart has been stopped intentionally during cardiac surgery. In other instances, however, the preservative medium may be delivered to the patient while the patient’s heart continues beating, during emergencies such as ischemic stroke, hemorrhagic stroke, a failed cardiac intervention, or the like.

[0012] In other specific instances, the methods may further comprise selectively occluding the patient’s vasculature at a location on a heart side of the second outlet port in order to inhibit antegrade flow of the preservative medium from the second outlet port. In these instances, the first outlet port may be in the patient’s superior vena cava and the second outlet port may be in the patient’s internal jugular vein. Typically, selectively occluding the vasculature may comprise expanding and occlusion element on an exterior of the catheter within the patient’s internal jugular vein at said location.

[0013] In still further particular instances, the one or more medicaments and the preservative medium may be delivered through a common perfusion lumen of the catheter. Typically, the common perfusion lumen remains open while one or more medicaments are delivered in an antegrade direction to the right atrium through the lumen to the first outlet port. The common perfusion lumen may then be occluded to divert a flow of the preservative medium from the common lumen through the second outlet port to the cerebral vasculature. The expanded occlusion element will prevent the preservative medium being released from the second outlet port from flowing in an antegrade direction.

[0014] Occluding the common perfusion lumen may be achieved in a variety of ways. For example, an elastomeric occlusion member may be inflated within the common lumen to occlude the common lumen between the first and second outlet ports. Alternatively, an occluder slide, such as a cylindrical member, may be axially translated to selectively open the first outlet port while the second outlet port remains closed or, conversely, open the second outlet port while the first outlet port remains closed. For example, the occluder slide may comprise a cylindrical tubular body that slidably nests within the common lumen so that the medicaments may flow through an internal passage of the cylindrical tubular body to the first outlet port while the second outlet port remains closed.

[0015] In still other instances, the flow of the preservative medium through the second lumen and the catheter may be controlled by a valve. In particular instances, the valve may comprise ports on a cerebral side of an occlusion balloon on the catheter, where the occlusion balloon is inflated with the preservative medium to occlude the patient’s vasculature at a location on the heart side of the second outlet port, and wherein the preservative medium opens and flows through the ports on the cerebral side of the balloon.

[0016] In still further instances of the methods herein, the second port which delivers the preservative medium may be sealed to prevent flow therethrough until it is desired to deliver the protective medium to the patient. For example, the second port may be sealed with the external occlusion balloon when deflated. In this way, by inflating the occlusion balloon, the second port will be opened and the patient’s venous vasculature will be closed to inhibit or prevent antegrade flow of the preservative medium. In another example, the second port may be sealed with a frangible material that will break open in response to pressure from the delivered fluid being delivered. In this way, only upon fluid administration of a threshold pressure would this seal be broken, allowing for fluid communication with this second port.

[0017] In a second specific aspect of the present invention, a venous infusion catheter comprises an elongated catheter body having a proximal end, a distal end, and a fluid distribution network extending at least partially from the proximal end to the distal end. The fluid

distribution network has a medicament outlet port at or near the distal end of the elongated catheter body and a preservative medium outlet port spaced proximally of the medicament port. An expandable occlusion element is disposed on an exterior of the elongated catheter body at a location between the preservative medium port and medicament port. A hub is located on the proximal end of the elongated catheter body, and the hub includes a medicament port for attachment to the medicament inlet source and a preservative medium inlet port for attachment to a preservative medium source. In other embodiments where the catheter has only a single common perfusion lumen, the hub will have one port attached to that single lumen. Other ports may be provided in the hub for balloon inflation and other purposes as needed. The attachment port(s) are fluidly connected to the fluid distribution network, and the fluid distribution network is configured to selectively deliver a medicament from the medicament inlet port to medicament outlet port and a preservative medium from the preservative medium inlet port to preservative medium outlet port.

[0018] In particular instances, the fluid distribution network of the venous infusion catheter may include at least one common or other perfusion lumen and a flow diverter located in the lumen between the medicament outlet port and the preservative medium outlet port. In some instances, the flow diverter and the expandable occlusion element may be separately operable.

In other instances, the flow diverter and the expandable occlusion element will be coupled so that the occlusion element is expanded or otherwise actuated simultaneously with closing the flow diverter. Conveniently, the flow diverter and the expandable occlusion element may both be inflatable, and the fluid distribution network may be configured to deliver inflation medium to both the flow diverter and the occlusion element simultaneously.

[0019] In other instances, the flow diverter may comprise a tubular valve member configured to axially translate within the at least one perfusion lumen between a first position that covers a preservative medium outlet port while leaving the medicament outlet port open and a second position that covers medicament outlet port while leaving the preservative outlet port open. Typically, the tubular valve member will be translated by an elongated actuator element, such as a push-pull rod, having a distal end secured to the tubular valve member and a proximal end passing out of the hub to allow a user to manually reposition the tubular valve member.

[0020] While the tubular valve member is illustrated as a tubular cylindrical occluder slide, it will be appreciated that non-cylindrical shapes could be employed, such as those having ovoid cross-sections, irregular cross-sections, and the like. The outer cross-sectional shape of the occluder will typically conform to the inner cross-sectional shape of the common perfusion lumen, or at least that portion in which the occluder will slide, in order to limit flow around the occluder. Additionally or alternatively, the occluder could have a cross-sectional shape different than that of the of the common perfusion lumen so long as sliding seals were disposed between the occluder and the luminal wall to inhibit leakage. [0021] In still further instances, the venous infusion catheter may further comprise a seal removably positioned over the preservative medium outlet port. For example, the seal may comprise a segment of the expandable occlusion element, such as an inflatable balloon. By then expanding the expandable occlusion element the occlusion element will lift and unblock the preservative medium outlet port.

[0022] In still further instances, the expandable occlusion element may comprise an inflatable balloon, and the preservative medium outlet port may comprise a plurality of apertures formed on a proximal side of the inflatable balloon. In such instances, the fluid distribution network will be configured to inflate the balloon with a preservative medium that will be released through the plurality of apertures after inflation.

[0023] In still further instances, the elongate catheter body of the present invention may have at least a first drug delivery lumen extending from a first drug delivery inlet port in the hub to a first drug delivery outlet port at or near a distal end of the elongated catheter body. In such instances, the first drug delivery lumen will be fluidly isolated from the at least one perfusion lumen. Such embodiments have no need for a flow diverter. Optionally, such embodiments may further include at least a second drug delivery lumen extending from a second drug delivery inlet port in the hub to a second drug delivery outlet port in a distal end of the elongated catheter body. The second drug delivery lumen is fluidly isolated from the at least one perfusion lumen as well as optionally from the first drug delivery lumen. Still further, such venous infusion catheters may include at least a third drug delivery lumen extending from a third drug delivery inlet port in the hub to a third drug delivery outlet port in a distal end of the elongated catheter body. The third drug delivery lumen will also be fluidly isolated from the at least one perfusion lumen and from both the first and second drug delivery lumens.

[0024] While in most embodiments, medicaments will be delivered at different times from the medicament port(s) and proximal preservative media port and medicaments will be delivered from the distal medicament port(s) in other embodiments, in other embodiments these administrations can occur simultaneously, in a pulsed manner and/or in any order, and further medicaments may be delivered from proximal perfusion ports and/or preservative media may be delivered from the distal medicament port(s).

[0025] Regardless of which outlet port in the common perfusion/drug lumen is being used at any particular time, when medicament is being delivered, it must be released from the distal- most“open” outlet port, i.e that port which is closest to the patient’s right atrium, while fluid is being delivered. That is, any outlet port(s) in the common perfusion/drug lumen which is/are closer to the right atrium than the“open” port, must be closed and not in use. In this way, medicaments administered through the open outlet port closest to the right atrium will only occur when outlet port(s) proximal to the expandable occluder is/are closed. Other distal outlet ports on medicament delivery lumens (not on the common perfusion/drug lumen), however, may be used to deliver medicaments even when other ports are being used, for example during cardiac arrest when cold saline may be perfused through proximal port while epinephrine is delivered through distal port of another lumen.

[0026] In still other embodiments, the expandable occluder need only be distal to the perfusion port and not necessarily be proximal to the distal medicament port.

[0027] In yet further embodiments, the expandable occluder may be recessed in order to accommodate a delivery sheath, or the expandable occluder could be positioned on the delivery sheath or other separate exterior structure.

INCORPORATION BY REFERENCE

[0028] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative

embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

Further features and advantages of the present invention will become apparent from the following detailed description, taken in combination with the appended drawings, in which:

[0030] Figure l is a side view of a first embodiment of a venous perfusion catheter constructed in accordance with the principles of the present invention;

[0031] Figure 2 is a cross-sectional view of the venous infusion catheter of Figure 1;

[0032] Figure 3 is a front view of the venous infusion catheter of Figure 1;

[0033] Figure 4 is a side of a venous infusion catheter comprising balloons in an inflated configuration, in accordance with an embodiment;

[0034] Figure 5 is a cross-sectional view of the venous infusion catheter of Figure 4;

[0035] Figure 6 is a front view of the venous infusion catheter of Figure 4;

[0036] Figure 7 illustrates a venous infusion catheter installed in an internal jugular vein, in accordance with an embodiment; [0037] Figure 8 illustrates a venous infusion catheter comprising a conduit for delivering an inflation fluid to balloons, the balloons being in a deflated state, in accordance with an embodiment;

[0038] Figure 9 illustrates the venous infusion catheter of Figure 8 with the balloons in an inflated state;

[0039] Figure 10 illustrates a catheter comprising only an external balloon and configured for concurrently delivering two fluids in opposite directions, the external balloon being in a deflated state, in accordance with an embodiment; and

[0040] Figure 11 illustrates the catheter of Figure 10 with the external balloon in an inflated state.

[0041] Figure 12 is a side view of a second embodiment of a venous perfusion catheter constructed in accordance with the principles of the present invention;

[0042] Figure 12A illustrates an alternative hub and connector assembly for the catheter of Figure 12;

[0043] Figures 13 A through 13D are cross-sectional views taken along lines 13A-13A through 13D-13D of Figure 12;

[0044] Figures 14A through 14C illustrate external occlusion elements having alternative configurations;

[0045] Figure 15 illustrates the venous perfusion catheter of Figure 12 placed in a patient’s venous vasculature in accordance with the methods of the present invention;

[0046] Figure 16 is a block diagram illustrating the components of a system of the present invention;

[0047] Figures 17A and 17B illustrate a third embodiment of a venous perfusion catheter constructed in accordance with the principles of the present invention;

[0048] Figures 18A through 18D are cross-sectional views taken along lines 18A-18A through 18D-18D of Figure 17A;

[0049] Figures 19A and 19B are cross-sectional views taken along lines 19A-19A and 19B- 19B of Figure 17B;

[0050] Figures 20A and 20B illustrate a fourth embodiment of a venous perfusion catheter constructed in accordance with the principles of this present invention; and

[0051] Figures 21 A and 21B illustrate a fifth embodiment of a venous perfusion catheter constructed in accordance with the principles of this present invention.

[0052] It will be noted that throughout the appended drawings, like features are identified by like reference numerals. DETAILED DESCRIPTION OF THE INVENTION

[0053] Figures 1 to 3 illustrate a venous infusion catheter device 10 which comprises an elongated and hollow catheter body 12 which extends between a proximal end or hub 14 and a distal end 16. The venous infusion catheter 10 is further provided with at least one external inflatable balloon 18 secured to the external face of the elongated catheter body 12 and at least one internal inflatable balloon structure 20 secured to the internal face of the elongated catheter body 12. The elongated catheter body 12 is provided with an input port 22 located at the proximal hub 14, an output port 24 located at the distal end 16 and a lateral port 26 located on the wall of the elongated catheter body 12.

[0054] The external and internal balloons 18 and 20 are each secured at a respective position along the length of the elongated catheter body 12 and the lateral port is positioned at a given position along the length of the elongated catheter body 12 so that the lateral port 26 be located between the external balloon 18 and the proximal hub 14 of the elongated catheter body 12 and between the internal balloon 20 and the proximal hub 14 of the elongated catheter body 12 and between the internal balloon 20.

[0055] The proximal hub of the elongated catheter body 12 is fluidly connectable to a source of fluid, such as a liquid or other preservative medium, and the elongated catheter body 12 is adapted for propagating the fluid received from its proximal hub 14 along its length, typically through an axial or central lumen 13, and deliver the fluid via the output port 24 and the lateral port 26. At least a section of the elongated catheter body adjacent to the distal end 16 and comprising the lateral port 26 is insertable into a conduit such as a vein of a subject.

[0056] The external balloon 18 is inflatable so that it may change between a deflated state or configuration and an inflated state or configuration. Similarly, the internal balloon 20 is inflatable so that it may change between a deflated state or configuration and an inflated state or configuration. It should be understood that the external and internal balloons 18 and 20 illustrated in Figures 1 to 3 are each in the deflated state or configuration. As described below, the size and shape of the external and internal balloons 18 and 20 are chosen so that the external balloon 18 occludes the space between the elongated catheter body 12 and the venous lumen in which the venous infusion catheter 10 is inserted, and the internal balloon 20 occludes the lumen 13 of the elongated catheter body 12, when in the inflated configuration, and so that the external balloon 18 allows fluid to flow in the space between the elongated catheter body 12 and the conduit and the internal balloon 20 allows fluid to flow within the elongated catheter body, when in the deflated configuration.

[0057] When the external and internal balloons 18 and 20 are in the deflated configuration, fluid injected into the elongated catheter body 12 via the input port 22 flows into the elongated catheter body 12 while some of the fluid exits the elongated catheter body 12 via the lateral port 26 while the remaining fluid exits the elongated catheter body 12 via the output port 24.

[0058] Figures 4 to 6 illustrate the venous infusion catheter 10 when the balloons 18 and 20 are in the inflated configuration. The external balloon 18 is inflated around the circumference of the external face of the elongated catheter body 12. The diameter of the external balloon 18, when inflated, is chosen so as to abut the internal wall of the conduit into which the venous infusion catheter 10 is inserted. As a result, no fluid may flow outside of the elongated catheter body from the proximal hub 14 thereof towards the distal end 16 thereof. As illustrated in Figures 5 and 6, the internal balloon 18, when inflated, form occludes the internal cavity of the elongated catheter body 12 so that no fluid may flow within the lumen 13 of elongated catheter body 12 from the proximal hub 14 thereof towards the distal end 16 thereof.

[0059] As a result, when the external and internal balloons 18 and 20 are inflated, any fluid injected into the elongated catheter body 12 via input port 22 is blocked by the inflated internal balloon 20 and therefore cannot flow down to the distal output port 24, also referred to as a medicament or infusion outlet port. As a result the fluid exits the elongated catheter body 12 via the lateral port 26. After exiting the elongated catheter body 12, the fluid cannot propagate outside of the elongated catheter body 12 towards the distal end 16 of the elongated catheter body 12 because of the inflated external balloon 20. As a result, the fluid flows outside of the elongated catheter body from the lateral port 26 towards the proximal hub 14 of the elongated catheter body 12.

[0060] It should be understood that the external and internal balloons 18 and 20 are each fluidly connectable to a source of fluid (not shown) for inflating the balloons 18 and 20. For example, the source of fluid may be adapted to deliver a pressurized fluid such as air or water, typically saline, into the balloons 18 and 20 so as to inflate the balloons 18 and 20. In one embodiment, the source of fluid is further configured to aspirate fluid from the balloons 18 and 20 so as to deflate the balloons 18 and 20. In one embodiment, a source of inflation medium, such as a saline-filled syringe (not shown), may couple to a inflation luer or other connector 23 to deliver the inflation medium simultaneously to the external and internal balloons 18 and 20 through a common inflation port 19 formed in a wall of the elongated catheter body 12.

Typically, an axial inflation lumen (not illustrated) will also be formed in the wall of elongated catheter body 12 to pass the inflation medium from the connector 23 to the common inflation port 19.

[0061] While in the illustrated embodiment, the hollow body 12 has a tubular shape, it should be understood that the body 12 may be provided with any other adequate cross-sectional shape such as an oval cross-sectional shape. [0062] While in the illustrated embodiment, the internal balloon 20 and the external balloon 18 are positioned substantially at the same longitudinal position along the length of the elongated catheter body 12, it should be understood that the balloons 18 and 20 may be positioned at different longitudinal positions as long as the external and internal balloons 18 and 20 are positioned between the distal end 16 of the elongated catheter body 12 and the lateral port 26.

[0063] In one embodiment, the elongated catheter body 12 is made of a flexible material. For example, including but not limited to, radiopaque polyurethane, silicone, polyethylene, polyvinylchloride, polytetrafluoroethylene, nylon, or a material with favorable interactions with whole blood and its components such as red blood cell, platelets, and inflammatory mediators.

[0064] While in the above description the external balloon 18 has a cylindrical shape when in the deflated and inflated configurations, it should be understood that the balloon 18 may have on ovoid, irregular, or tulip-shaped, or other configuration in order to optimize retrograde flow path of fluid administered proximal to the expandable occluder so long as it can be inflated to conform to seal against an inner wall of the vein when inflated therein. Often the external balloon 18 may be formed wholly or partly from an elastomeric or other compliant material to promote conformance to and sealing against the inner vessel wall.

[0065] While the internal balloon structure 20 is illustrated as a pair of opposed, D-shaped kissing balloons so that meet and occlude the internal lumen 13 of the elongated catheter body 12 when inflated, as shown in Fig. 6, it will be appreciated that the balloon could have any one of a variety of specific configurations which would provide full luminal occlusion when inflated.

[0066] The venous infusion catheter 10 may comprise more than one external balloon 18 and/or more than one internal balloon structure 20. The number, position and shape of the external balloon(s) 18 are chosen so that no fluid may flow in the space surrounding the elongated catheter body 12 between the proximal and distal ends 14 and 16 of the elongated catheter body 12 when the external balloons) 18 are inflated. Similarly, the number, position and shape of the internal balloons structures 20 are chosen so that no fluid may flow through the lumen 13 the elongated catheter body 12, and in particular will be prevented from flowing from the inlet port 22 to the outlet port 24 at the distal end of the elongated catheter body 12.

[0067] While the above description refers to a single source of inflation fluid for inflating both the external and internal balloons 18 and 20, it should be understood that the external balloon 18 may be connected to a first source of inflation fluid and the internal balloon 20 may be connected to a second and different source of inflation fluid.

[0068] In an alternative embodiment (not illustrated), the elongated catheter body 12 comprises no output port 24. In this case, the distal outlet port 24 of the elongated catheter body 12 is a closed end so that fluid flowing from the input port 22 into the elongated catheter body 12 may exit the elongated catheter body 12 only via the lateral port 26. In this case, the venous infusion catheter 10 may comprise no internal balloon 20 and only comprise at least one external balloon 18.

[0069] While the above description refers to a single lateral port 26, it should be understood that the elongated catheter body 12 may be provided with more than one lateral port having any adequate shape and size distributed along as the lateral wall of the elongated catheter body 12. Similarly, the elongated catheter body 12 may be provided with more than one output port of which the position, shape and size may vary as long as the output ports are located at the distal end 16 of the elongated catheter body 12 or between the distal end 16 and the internal balloon 20

[0070] In other embodiments, the venous infusion catheter such as the catheter 10 may be used as a central venous catheter both to provide access to the right atrium for the delivery of medicaments and to provide retrograde cerebral perfusion during an emergency, such as cardiopulmonary arrest, a stroke, during cardiac surgery when the heart has been intentionally stopped, or the like. In such cases, as illustrated in Figure 7, the venous infusion catheter 10 is percutaneously introduced into the patient’s internal jugular vein 30 and into the brachiocephalic vein 25, also known as an innominate vein, so that the distal outlet port 24 is above the right atrium 27 of the patient’s heart 32. The lateral port 26 remains in the internal jugular vein 30 while the external balloon 18 is positioned at the junction between the internal jugular vein 30 and into the brachiocephalic vein 25. Normally, both the external and internal balloons 18 and 20 will remain deflated, and the venous perfusion catheter 10 can be used as a central venous catheter in the usual manner with medicaments and other substances delivered into the right atrium 27 through the inlet port 22. In the event that the patient suffers a cardiopulmonary or other emergency, however, the external and internal balloons 18 and 20 will be inflated to redirect the flow path through the catheter so that a preservative medium may be infused through the inlet port 22 to exit through lateral port 26 and flow in a retrograde direction through the internal jugular vein 30 into the cerebral vasculature to protect the brain tissue from damage in cardiac arrest, as described below.

[0071] When used as a central venous catheter, the balloons 18 and 20 remain in their deflated configurations, and the proximal hub 14 of the venous infusion catheter 10 is fluidly connected to a source of fluid to direct a first fluid, such as a preservative, towards the heart of the subject. Examples of preservative fluids include crystalloid solution, blood, oxygenated blood, oxygen carrying fluids, colloids, or the patient's own blood. Examples of medicaments that may be delivered include fluids, blood products, and nutritional media. [0072] The distal section of the venous infusion catheter 10 is inserted into the internal jugular vein 30 of the subject so that the port 26 of the elongated catheter body 10 be located inside the internal jugular vein 30, and once in place, the venous infusion catheter 10 is secured onto the subject. Once the catheter has been installed in the internal jugular vein 30 of the subject, the source of fluid may be activated to deliver the first fluid. The first fluid reaches the input port 22 and propagates into the elongated catheter body 12. The first fluid then exits the elongated catheter body 12 via the lateral port 26 and the output port 24 before propagating into the heart 32.

[0073] If an emergency is detected, e.g. the heart and/or lungs go into arrest, the venous infusion catheter 10 which is already in place in the subject may be used for perfusing the brain of the subject. To do so, the external and internal balloons 18 and 20 are inflated using the source(s) of inflation fluid. When inflated, the internal balloon 20 substantially hermetically obstructs the passageway within the elongated catheter body 12 so that no fluid within the lumen 13 of elongated catheter body 12 from the input port 22 may propagate up to the distal end 16 of the elongated catheter body 12 and exit the elongated catheter body 12 via the output port 24.

The fluid coming from the input port 22 will redirected (diverted) to exit the elongated catheter body 12 via the lateral port 26 only.

[0074] When inflated, the external balloon 18 extends in the space between the external face of the elongated catheter body 12 and the internal wall of the internal jugular vein 30 and abuts against the internal wall of the jugular vein 30 so as to substantially hermetically obstruct the passageway between the external face of the elongated catheter body 12 and the internal wall of the internal jugular vein 30. The fluid exiting the elongated catheter body 12 via the lateral port 26 cannot therefore propagate towards the heart 32 because of the inflated external balloon 18 and may then propagate in an opposite direction towards the brain.

[0075] In one embodiment, a second fluid different from the first fluid may be delivered once the external and internal balloons 18 and 20 have been inflated. In this case, the proximal hub 14 of the venous infusion catheter 10 is fluidly connected to a source of second fluid.

[0076] In another embodiment, the same fluid, i.e. the first fluid, may be delivered to the brain after the inflation of the external and internal balloons 18 and 20.

[0077] In one embodiment, the second fluid to be delivered to the brain after the inflation of the external and internal balloons 18 and 20 comprises a crystalloid fluid. Such a crystalloid fluid can cool and protect a brain and is usually available in an intensive care unit (ICU). In case of emergency, a non-sub specialized person, such as a nurse, may then inflate the external and internal balloons 18 and 20, connect the catheter to a source of crystalloid fluid to the proximal brain of the subject.

[0078] In another embodiment, the second fluid may be an oxygen carrying fluid such as blood.

[0079] It should be understood that any adequate means may be used for fluidly connecting the external and/or internal inflatable balloons 18 and 20 to at least one source of inflation fluid. For example, a first conduit or pipe may have a first end connect to a first source of inflation fluid and a second end fluidly connected to the external balloon 18. The first conduit is then located outside of the elongated catheter body 12. A second conduit or pipe inserted into the elongated catheter body 12 has a first end connected to a second source of inflation fluid and a second end fluidly connected to the internal balloon 20.

[0080] Figures 8 and 9 illustrate another configuration for fluidly connecting the external and internal balloons 18 and 20 to a source of inflation fluid. In this embodiment, a single conduit 40 is used for fluidly connecting the source of inflation fluid to both the external and internal balloons 18 and 20. In this embodiment, the wall of the elongated catheter body 12 is provided with an internal cavity 42 which extends along a section from a proximal position adjacent to the proximal hub 14 to a distal position that faces the external and internal balloons 18 and 20. The conduit 40 is inserted into the cavity 42 via a proximal aperture present in the elongated catheter body 12. The distal end of the conduit 40 is fluidly connected to the external and internal balloons so as to deliver thereto the inflation fluid.

[0081] Figures 10 and 11 illustrate an embodiment of a catheter configured for delivering two fluids concurrently. For example, this catheter may be used for delivering a first fluid towards the heart of a subject and a second fluid towards the brain of the subject. This catheter comprises no internal balloon but comprises a conduit 50 having a distal end connected to the lateral port 26 from the inside of the elongated catheter body 12 and a proximal hub connectable to a source fluid. As a result, when a fluid is injected into the elongated catheter body 12 via its proximal port, the fluid exits the elongated catheter body 12 via the distal port. When a fluid is injected into the conduit 50, the fluid exits the catheter via the lateral port 26.

[0082] In one embodiment, the catheter may be used for concurrently providing a first fluid to the heart of a subject and irrigating the brain of the subject. The catheter is inserted in the internal jugular vein as described above. The elongated catheter body 12 may be used for delivering a first fluid towards the heart of the subject by injecting the first fluid via the proximal port of the elongated catheter body 12. In case of emergency, the external balloon 18 is inflated and a second fluid is injected via the conduit 50. The second fluid exits the catheter via the lateral port 26. Since the inflated external balloon 18 prevents the second fluid from propagating 14 towards the heart of the subject, the second fluid flows in the reverse direction towards the brain of the subject. It should be understood that the first fluid can still be delivered to the heart while the second fluid is delivered to the brain of the subject.

[0083] A further exemplary catheter device 20, illustrated in FIGS. 12 and 13A-13D, comprises an elongated catheter body 102 having a distal end 104 and proximal end 106. As shown in particular in FIGS. 13A-13D, the elongated catheter body 102 includes a perfusion lumen 108, an inflation lumen 110, a first drug lumen 112, and second drug lumen 114. Each lumen has a corresponding connector attached via a proximal hub 118. More specifically, the inflation lumen 110 is typically connected to an inflation connector 120, the perfusion lumenl08 is connected to a perfusion connector 122, the first drug lumen 112 is connected to a first drug connector 126, and the second drug lumen 114 is connected to a second drug connector 128.

Each of the connectors will include a luer or other conventional terminal element to be removably attached to an appropriate material source, such as a perfusate, drugs, a protective medium, or an inflation source, such as a syringe.

[0084] Each of the internal lumens within the catheter body 102 terminates in a port on the catheter body. In particular, the perfusion lumenl08 terminates in a lateral perfusion port 134. The inflation lumen 110 terminates in an inflation port 132, and the first and second drug lumens 112 and 114 terminate in a first drug port 138 and a second drug port 140, respectively. In this way, it will be appreciated that fluids, drugs, inflation media, and the like, may be delivered from each of the connectors to their respective outlet ports in the elongated catheter body 102 by connection to the appropriate fluid or inflation source.

[0085] The catheter 100 also includes an expandable occlusion element 144, typically an inflatable balloon, positioned on the exterior surface of the catheter body 102 between the perfusion port 134 and the drug delivery ports 138 and 140. As will be described hereinafter, having the expandable occlusion element 144 between these ports allows flow from each port to be selectively directed in an antegrade or retrograde flow direction in a vein when the occlusion element 144 is expanded.

[0086] Referring now to FIG. 12 A, in some embodiments the inflation connector 120 and the perfusion connector 122 may be fused or otherwise joined together to facilitate connection management during use. In particular, by having the perfusion connection and the inflation connector together, the user may easily identify both connectors when there is a need to inflate the external occlusion element 144 and deliver a protective medium through the perfusion connector 122.

[0087] As illustrated in FIG. 12, the expandable occlusion element 144 is an inflatable balloon having a deflated configuration shown in full line. The balloon may be inflated to a generally cylindrical shape, as shown in broken line. As shown in FIGS. 14A-14C, the expandable occlusion elements may have a variety of shapes, such as spherical balloons 150 (FIG. 14A), inflatable elements having a circumscribing ridge as shown at 152 in FIG. 14B, and tulip-shaped 154 as shown in FIG. 14C. Such tulip-shaped occlusion elements 154 will typically have a concave surface oriented in an upstream direction so that blood flow will cause the conical structure to expand and further seal against the venous wall.

[0088] Placement and use of the catheter 100 is illustrated in FIG. 15, where both the patient’s venous and arterial vasculatures are shown. Venous blood flows caudally from the right internal jugular vein 300 through the right brachiocephalic vein 301 into the superior vena cava 302, and into the right atrium 303 of the heart 310. Venous blood is also returned to the right atrium of the heart 303 via the left 308 and right 301 brachiocephalic veins, collecting from the right 304 and left 305 external jugular veins and the left 306 and right 307 subclavian veins. Arterial flow is directed from the aorta 500 through the brachiocephalic artery 503, left common carotid artery 506, and left subclavian artery 507. From the brachiocephalic artery 503, arterial blood flows to both the right subclavian artery 508, and cranially, through the right common carotid 509, splitting into the right internal common carotid 510 and right external common carotid 511. Arterial blood additionally flows from the left common carotid artery 506 to the left external carotid artery 512 and left internal carotid artery 513.

[0089] As further shown in FIG. 15, the catheter 100 is located, as typical of central venous catheters, with the distal end 104 sitting in the superior vena cava 302 at the entrance to the right atrium 303. The device hub 118 is sutured to the skin 801 for secure placement, with each of the four connectors 120, 122, 126, and 128 located externally for access by medical team. The elongated catheter body 102 is introduced through a lumen of the right internal jugular vein 300, with the expandable occlusion element 144 in an unexpanded configuration. The expandable occlusion element 144 will typically be positioned above the junction with the right subclavian vein 307 and be left in the unexpanded configuration until a need arises for the delivery of a protective perfusion medium to the patient’s brain, e.g. during an in-hospital cardiac arrest (IHCA). While in this configuration, the catheter 100 may be used for delivering drugs or other substances to heart though either drug lumen 112 and 114 and drug port 138 and 140 in the same manner as a conventional central venous catheter.

[0090] When IHCA or other need arises for the delivering of a protective perfusion medium to the patient’s brain, the expandable occlusion element 144 is expanded to provide full occlusion of the right internal jugular vein 304. Partial or full occlusion of the right subclavian vein 307 may also occur. As illustrated in this embodiment, the expandable occlusion element 144 is an inflatable balloon, and expansion is caused by delivering saline or other inflation medium though the inflation connector 120 and inflation lumen 110, typically using a syringe. While specific reference has been made to intervention into the right internal jugular vein, it will be appreciated that other portions of the vasculature could also be accessed.

[0091] By occluding the right internal jugular vein 301 and optionally right subclavian vein 307, antegrade venous flow through the right internal jugular vein 301 is arrested and retrograde flow of the protective medium (such as a cooled crystalloid fluid) to the cerebral venous vasculature may occur.

[0092] Drug delivery to the heart may continue as appropriate to occur through the second drug lumen 114 and port 140 or through the first drug lumen 112 and port 138. Countercurrent heat exchange may then occur between the right internal jugular vein 300 and the right carotid arteries 509, 510, 511 as this potentially cooled fluid is administered through the perfusion lumen 108 and port 134. Arterial flow through vessels, none of which are occluded, will continue despite IHCA or other use indication, including intentional cardiac arrest during cardiac surgery, and the patient will experience blood flow during the chest compressions associated with CPR. This arterial blood flow will further accommodate temperature exchange through this countercurrent heat exchange, supplementary to the temperature modulation achieved by direct exposure in the venous system to potentially cooled fluids.

[0093] Referring now to FIG. 16, systems of the present invention typically comprise patient- interface components 1000, extracorporeal components 1200, and fluid transfer components 1100 between the patient-interface components and the extracorporeal components. The patient- interface components 1000 typically include a venous perfusion catheter 1010 and an associated temperature sensor 1020. The extracorporeal components 1200 include a crystalloid or other fluid 1210 to be housed within a specialized temperature-modulating receptacle 1220, and a readout feature 1230 of the temperature sensor. The fluid transfer components 1100 typically include temperature-modulating tubing, and the fluid 1210 to be administered will flow through the temperature-modulating tubing to the venous perfusion catheter 1010 where it will be released into the patient’s vasculature and directed cranially. Temperature fluctuation data will be communicated from the patient-interfacing system 1000 to the extracorporeal system 1200.

[0094] Referring now to FIGS. 17A-17B, 18A-18D and 19A-19B, an alternative distribution system for a venous perfusion catheter in accordance with the principles of the present invention will be described. The flow of distribution system 1300 may be incorporated into a venous perfusion catheter of the type previously disclosed. The flow distribution system 1300 utilizes a double-acting balloon configuration to simultaneously occlude venous flow and divert flow through the perfusion lumen from the distal or downstream side of the expanded balloon to the proximal or upstream side of the balloon. [0095] An elongated catheter body 1302 includes a perfusion lumen 1304, an inflation lumen 1306, a first drug lumen 1308, and a second drug lumen 1310. The drug lumens 1308 and 1310 are visible only in the lateral cross-sectional views of FIGS 18A-18D and 19A-19B and are not visible in the axial cross-sectional views of FIGS 17A-17B.

[0096] The perfusion lumen 1304 terminates in a distal port (not illustrated) for delivery of drugs, substances, or the like to the heart when the perfusion lumen is open (not occluded by the double-acting balloon as described below or other mechanical occlusion means). The perfusion lumen 1304 also has a second or cerebral perfusion port 1314 for delivery of perfusion medium, typically a protective perfusion medium, to the cerebral venous vasculature when the double- acting balloon is inflated.

[0097] As shown in FIGS. 17A and 18A-18D, an expandable occlusion element 1320 in the form of an inflatable balloon is in a deflated configuration. When deflated, a proximal segment of the balloon 1320 covers the proximal perfusion port 1314 as well as the occlusion port 1315.

[0098] As shown in FIGS. 17B and 19B, however, when the expandable occlusion balloon 1320 is inflated by delivery of an inflation medium through inflation lumen 1306, the balloon inflates and peels away to uncover the proximal perfusion port 1314. In addition, an occlusion protrusion 1322 of the balloon expands radially inwardly through the occlusion port 1315 in the sidewall of the elongated catheter body 1302. Thus, flow of the perfusion medium through the perfusion lumen 1304 is blocked by the expanded occlusion element 1320 and diverted through the uncovered perfusion port 1314 so that it can flow in a retrograde manner into the patient’s cerebral venous vasculature, as described previously.

[0099] Referring now to FIGS. 20 A and 20B, a venous perfusion catheter 1400 having a tubular flow diverter is illustrated. The venous perfusion catheter 1400 includes an elongated catheter body 1402 having a perfusion lumen 1404 and an inflation lumen 1406. The catheter will typically also include one or more additional drug delivery lumens, but such lumens are not visible in the axial cross-sectional views of FIGS. 20A and 20B.

[00100] The perfusion lumen 1404 includes a proximal or cerebral perfusion port 1414 and a distal or cardiac perfusion port 1418. The inflation lumen 1406 includes an inflation port 1416 positioned to inflate a balloon-like expandable occlusion element 1420 in a manner similar to prior embodiments.

[00101] As shown in FIG. 20A, a tubular flow diverter 1424 is in a proximally retracted position so that it covers the proximal or cerebral perfusion port 1414. That is, when the tubular flow diverter 1424 is proximally retracted, flow through the perfusion lumen 1404 cannot pass outwardly through the proximal or cerebral perfusion port 1414. Instead, flow through the perfusion lumen 1404 will pass through an interior passage of the tubular flow diverter 1424 so that it may pass out of the distal or cardiac perfusion port 1418.

[00102] In order to divert the perfusion flow to the proximal or cerebral perfusion port 1414, the tubular flow diverter 1424 is distally advanced to cover the distal or cardiac infusion port 1418, as shown in FIG. 20B. The proximal or cerebral perfusion port 1414 is simultaneously uncovered so that flow may then pass radially outwardly through the proximal port. In order to assure that the flow from the proximal port 1414 flows in a retrograde manner, the balloon-like expandable occlusion element 1420 is inflated by delivering an inflation medium through the inflation lumen 1406 and outwardly through the inflation port 1416 to occlude the vein as previously described.

[00103] Referring now to FIGS. 21A and 21B, a perfusion balloon catheter 1500 is illustrated. The perfusion balloon catheter 1500 includes an elongated catheter body 1502 having a combination perfusion/inflation lumen 1504 and at least one additional drug or other fluid delivery lumen 1506. When used as a central access catheter, an expandable occlusion element in the form of the perfusion balloon 1520 remains uninflated, as shown in FIG. 21 A. Drugs or other substances may be delivered through the drug delivery lumen 1506 and outwardly through a drug infusion port 1508, as shown in FIG. 21 A. Drugs may also be released through a second drug infusion port 1510, as shown in FIG. 21B.

[00104] When it is desired to deliver a perfusion medium, such as a cerebral protection medium, in a retrograde direction from the perfusion balloon catheter 1500, the protective or other perfusion medium is delivered through the combined perfusion/inflation lumen 1504 so that it inflates the balloon occlusion element 1520, as shown in FIG. 21B. A plurality of drug release apertures 1524 formed on a proximal or cerebral side of the inflated balloon open to release the inflating perfusion medium from the balloon in a retrograde direction, typically toward the patient’s brain. If desired, drugs may be delivered through any of the available drug delivery lumens in the catheter.

[00105] The embodiments of the invention described above are intended to be exemplary only. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims. While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

WHAT IS CLAIMED IS:

1. A method for treating a patient, said method comprising: introducing a catheter into the patient’s venous vasculature so that a first outlet port on the catheter is at a location where blood flows into the patient’s right atrium and a second outlet port on the catheter is at a location where venous blood drains from the cerebral vasculature; delivering one or more medicaments in an antegrade direction to the right atrium through the first outlet port of the catheter at selected times; and delivering a preservative medium in a retrograde direction to the patient’s cerebral vasculature through the second outlet port of the catheter at other selected times.

2. A method for treating a patient as in claim 1, wherein the preservative medium is delivered when the patient’s heart has stopped beating.

3. A method for treating a patient as in claim 1, wherein the preservative medium is delivered while the patient’s heart continues beating.

4. A method for treating a patient as in claim 1, further comprising selectively occluding the patient’s vascular at a location on a heart side of the second outlet port to inhibit antegrade flow of the preservative medium from the second outlet port.

5. A method for treating a patient as in claim 4, wherein the first outlet port is in the patient’s superior vena cava and the second outlet port is in the patient’s internal jugular vein.

6. A method for treating a patient as in claim 4, wherein selectively occluding the patient’s vasculature at the location on the heart side of the second outlet port comprises expanding an occlusion element on an exterior of the catheter within the patient’s internal jugular vein at said location.

7. A method for treating a patient as in claim 1, wherein the one or more

medicaments and the preservative medium are delivered through a common lumen in the catheter.

8. A method for treating a patient as in claim 7, wherein the common lumen remains open while one or more medicaments are delivered in an antegrade direction to the right atrium through the lumen to the first outlet port.

9. A method for treating a patient as in claim 8, further comprising occluding the common lumen to divert a flow of the preservative medium from the common lumen through the second outlet port to the cerebral vasculature.

10. A method for treating a patient as in claim 9, wherein occluding the common lumen comprises inflating an elastomeric occlusion member.

11. A method for treating a patient as in claim 9, further comprising occluding the first outlet port and opening the second outlet port to divert a flow of the preservative medium from the lumen through the second outlet port to the cerebral vasculature.

12. A method for treating a patient as in claim 9, wherein occluding the first outlet port and opening the second outlet port comprises axially translating an occluder slide within the common lumen.

13. A method for treating a patient as in claim 12, wherein the occluder slide comprises a cylindrical tubular body that slidably nests within the common lumen.

14. A method for treating a patient as in claim 1, wherein the one or more

medicaments are delivered through a first lumen in the catheter and the preservative medium is delivered through a second lumen in the catheter.

15. A method for treating a patient as in claim 14, wherein delivering the preservative medium through the second lumen in the catheter is controlled by a valve.

16. A method for treating a patient as in claim 15, wherein the valve comprises ports on a cerebral side of an occlusion balloon on the catheter, wherein the occlusion balloon is inflated with the preservative medium to occlude the patient’s vascular at a location on a heart side of the second outlet port and wherein the preservative medium opens and flows through the ports on the cerebral side of the balloon.

17. A method for treating a patient as in claim 1, further comprising sealing the second port until the preservative medium is delivered therethrough.

18. A method for treating a patient as in claim 17, wherein sealing the second port comprises covering the second port with a deflated balloon, further comprising inflating the balloon to unseal the second port.

19. A method for treating a patient as in claim 18, wherein inflating the balloon occludes the patient’s vasculature at the location on the heart side of the second outlet port to inhibit antegrade flow of the preservative medium from the unsealed second outlet port.

20. A method for treating a patient as in claim 1, wherein the medicament is selected from a group consisting of medications, fluids, blood products, and nutritional media.

21. A method for treating a patient as in claim 1, wherein the preservative medium is selected from a group consisting of crystalloid fluids, oxygenated fluids, blood products, and colloid fluids.

22. A venous infusion catheter comprising: an elongated catheter body having a proximal end, a distal end, and a fluid distribution network extending at least partially from the proximal end to the distal end and having a medicament outlet port at or near the distal end of the catheter body and a preservative medium outlet port spaced proximally of the medicament port; an expandable occlusion element disposed on an exterior of the elongated catheter body at a location between the preservative medium port and the medicament port; and a hub on the proximal end the elongated catheter body, said hub including at least one inlet port for attachment to a medicament inlet source and/or a preservative medium source, wherein said inlet port is fluidly connected to the fluid distribution network; wherein the fluid distribution network is configured to selectively deliver a medicament and/or a preservative medium from the inlet port to the medicament outlet port or to the preservative medium outlet port.

23. A venous infusion catheter as in claim 22, wherein the fluid distribution network includes at least one perfusion lumen and a flow diverter located between the medicament outlet port and the preservative medium outlet port.

24. A venous infusion catheter as in claim 23, wherein the flow diverter and the expandable occlusion element are separately operable.

25. A venous infusion catheter as in claim 23, wherein the flow diverter and the expandable occlusion element are coupled to simultaneously expand the occlusion element and operate the flow diverter to close the perfusion lumen between the medicament outlet port and the preservative medium outlet port.

26. A venous infusion catheter as in claim 25, the flow diverter and the expandable occlusion element are both inflatable and the fluid distribution network is configured to deliver inflation medium to both simultaneously.

27. A venous infusion catheter as in claim 23, wherein the flow diverter comprises an occluder slide configured to axially translate within the at least one perfusion lumen between a first position that covers the a preservative medium outlet port while leaving the medicament outlet port open and a second position that covers the medicament outlet port while leaving the preservative medium outlet port open.

28. A venous infusion catheter as in claim 27, further comprising an elongated actuator member having a distal end secured to the occluder slide and a proximal end passing out of the hub to allow a user to manually reposition the occluder slide.

29. A venous infusion catheter as in claim 22, further comprising a seal removably positioned over the preservative medium outlet port.

30. A venous infusion catheter as in claim 29, wherein the seal comprises a segment of the expandable occlusion element.

31. A venous infusion catheter as in claim 30, wherein the expandable occlusion element comprises an inflatable balloon configured to cover and seal the preservative medium outlet port prior to inflation.

32. A venous infusion catheter as in claim 22, wherein the expandable occlusion element comprises an inflatable balloon and the preservative medium outlet port comprises a plurality of apertures formed on a proximal side of the inflatable balloon, wherein the fluid distribution network is configured to inflate the balloon with a preservative medium that will be released through the plurality of apertures after inflation.

33. A venous infusion catheter as in claim 23, wherein the elongated catheter body has at least a first drug delivery lumen extending from a first drug delivery inlet port in the hub to a first drug delivery outlet port in a distal end of said elongated catheter body, wherein the first drug delivery lumen is fluidly isolated from the at least one perfusion lumen.

34. A venous infusion catheter as in claim 33, wherein the elongated catheter body has at least a second drug delivery lumen extending from a second drug delivery inlet port in the hub to a second drug delivery outlet port in a distal end of said elongated catheter body, wherein the second drug delivery lumen is fluidly isolated from the at least one perfusion lumen and from the first drug delivery lumen.

35. A venous infusion catheter as in claim 24, wherein the elongated catheter body has at least a third drug delivery lumen extending from a third drug delivery inlet port in the hub to a third drug delivery outlet port in a distal end of said elongated catheter body, wherein the third drug delivery lumen is fluidly isolated from the at least one perfusion lumen and from the first and second drug delivery lumens.

36. A venous infusion catheter as in claim 22, wherein the fluid distribution network includes a medicament inlet port and a preservative medium inlet port and is configured to selectively deliver a medicament from the medicament inlet port to the medicament outlet port and a preservative medium from the preservative medium inlet port to the preservative medium outlet port.

37. A venous infusion catheter as in claim 22, wherein the fluid distribution network includes a single inlet port connected to a common infusion port which opens to both the medicament outlet port and the preservative medium outlet port, further comprising a flow diverter configured to selectively block flow between the medicament outlet port while allowing flow to exit through the preservative medium outlet port.

38. A venous infusion catheter as in claim 37, further comprising means for selectively covering the preservative medium outlet port while leaving the medicament outlet port open.

39. A venous infusion catheter as in claim 38, wherein said means for selectively covering the preservative medium outlet port while leaving the medicament outlet port open further covers the medicament outlet port while leaving the preservative outlet port open.