WO1997048436A2

WO1997048436A2 - Externally valved catheter for controlled antegrade and retrograde fluid flow

Info

Publication number: WO1997048436A2
Application number: PCT/US1997/010581
Authority: WO
Inventors: John A. Macoviak; Michael Ross
Original assignee: Cardeon Corporation
Priority date: 1996-06-17
Filing date: 1997-06-17
Publication date: 1997-12-24
Also published as: AU3401197A; EP0914064A2; AU737754B2; JP2001503286A; CA2258641A1; WO1997048436A3

Abstract

A catheter device regulates fluid flow within a circulatory vessel. Included is an elongated catheter body configured to access one of a circulatory vessel or a heart chamber. The catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end. Optionally, a second and a third lumen are also included in the catheter body. The second and third lumens each have an open proximal end. An antegrade valve is coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body. The antegrade flow is greater than the retrograde flow. A retrograde valve may be included which provides a controllable retrograde and antegrade flow along the exterior of the catheter body. When a retrograde valve is used, the retrograde flow is greater than the antegrade flow.

Description

EXTERNALLY VALVED CATHETER FOR CONTROLLED ANTEGRADE AND RETROGRADE FLIJTD FLOW

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates generally to a catheter to regulate fluid flow through and around the catheter, and more particularly to a catheter which includes at least one antegrade valve coupled to an exterior of the catheter and configured to provide a controlled antegrade flow and a controlled retrograde flow past an exterior of the catheter within the circulatory vessel and/or a catheter which includes at least a retrograde valve coupled to the exterior of the catheter configured to provide a controlled antegrade flow and a controlled retrograde flow.

Description of Related Art Various cardiovascular, neurosurgical, pulmonary and other interventional procedures, including repair or replacement of aortic, mitral and other heart valves, repair of septal defects, pulmonary thrombectomy, coronary artery bypass grafting, angioplasty, atherectomy, treatment of aneurysms, electrophysiological mapping and ablation, and neurovascular procedures, are performed with the patient connected to cardiopulmonary bypass (CPB) equipment to maintain circulation of oxygenated blood throughout the patient's circulatory system. In some of these procedures, such as heart valve replacement and coronary artery bypass grafting, cardiac function is arrested, and peripheral circulation of oxygenated blood is maintained completely by a CPB system. In other procedures, such as angioplasty and atherectomy, the heart remains beating, and CPB is used to assist the heart in maintaining circulation of oxygenated blood during the procedure.

To establish cardiopulmonary bypass according to conventional techniques, a venous cannula is introduced into a major vein such as the inferior vena cava, or into the heart itself, to withdraw deoxygenated blood from the patient and deliver the deoxygenated blood to a CPB system for oxygenation. An arterial cannula is introduced into a major artery such as the aorta, an iliac artery, or a femoral artery, for delivering oxygenated blood from the CPB system to the patient's arterial system.

For endovascular procedures such as angioplasty and atherectomy in which cardiac function need not be arrested, interventional devices are introduced into an artery such as a femoral artery, and the devices are transluminally positioned at the treatment site where the procedure is performed. For example, in angioplasty or atherectomy, a catheter is introduced into a femoral artery and advanced through the aorta into a coronary artery to treat an occluded region therein. If CPB is utilized during such procedures, the arterial and venous CPB cannulae are usually introduced into a femoral artery and femoral vein, respectively, by means of a surgical cut-down or over guide wires percutaneously placed in the groin area on one side of a patient's body. Interventional devices may then be introduced into a femoral artery or vein in the groin area on the other side of the patient's body.

In those procedures where cardiac function is arrested, on the other hand, the heart and coronary arteries must be isolated from the remainder of the patient's arterial system. Using conventional techniques, the sternum is cut longitudinally (a median stemotomy), providing access between opposing halves of the anterior portion of the rib cage to the heart and other thoracic vessels and organs. Alternatively, a lateral thoracotomy is formed, wherein an incision, typically 10 cm to 20 cm in length, is made between two ribs. A portion of one or more ribs may be permanently removed to optimize access. Through this large opening in the chest, a mechanical cross-clamp may be placed externally on the ascending aorta downstream of the ostia of the coronary arteries, but upstream of the brachiocephalic artery, so as to allow oxygenated blood from the CPB system to reach the arms, neck, head, and remainder of the body. A catheter is then introduced through the stemotomy or thoracotomy and inserted into the ascending aorta between the cross-clamp and the aortic valve. Cardioplegic fluid is infused through the catheter into the aortic root and coronary arteries to perfuse the myocardium. An additional catheter may be introduced into the coronary sinus for retrograde perfusion of the myocardium with cardioplegic fluid. In addition, the myocardium is usually cooled by irrigation with cold saline solution and/or application of ice or cold packs to the myocardial tissue. Cardiac contractions will then cease.

While such open-chest techniques can produce significant benefits for some patients, such techniques entail many days to weeks of hospitalization and months of recuperation time, in addition to the pain and trauma suffered by the patient. Moreover, application of an external cross-clamp to a calcified or atheromatous aorta may cause the release of emboli into the brachiocephalic, carotid or subclavian arteries with serious consequences such as strokes. In response to these problems, new techniques have been developed to facilitate the performance of cardiac procedures such as heart valve repair, coronary artery bypass through a small incision and replacement using endovascular instruments, eliminating the need for a thoracotomy as well as the need for an external aortic cross-clamp. Such procedures are described in co-pending application Serial No. 07/991,188 and application Serial No.

07/730,559, which are assigned to the assignee of the present invention and are incorporated herein by reference. Similarly, in commonly-assigned U.S. patent application Serial No. 08/023,778, the complete disclosure of which is incorporated herein by reference, methods and devices are described for performing coronary artery bypass grafting and other procedures through small incisions or cannulae positioned through the chest wall, obviating the need for a thoracotomy. This new generation of minimally-invasive cardiac procedures provides significant advantages over conventional open surgical techniques, including reduced mortality and morbidity, decreased patient suffering, reduced hospitalization and recovery time, and lowered medical costs relative to open-chest procedures.

This new generation of minimally-invasive cardiac procedures and devices use balloons to isolate vessels and different sections of the heart. These balloons require large fluid inflation lumens in the catheter, thereby dimensioning respective effective inner diameters or requiring larger catheters. When the balloon is large the wall tensions of the balloon are increased and there is a significant chance of balloon rupture. Balloons may disrupt interior lesions of vessels. Additionally, balloons serve as total roadblocks to the passage of fluids, including but not limited to blood. It would be desirable to provide a catheter configured to access a vein, artery, a great artery or a heart chamber, which uses valves instead of balloons and minimize the problems associated with balloons. To regulate flow around the catheter it would be further desirable to provide a catheter with exterior antegrade valves that provide antegrade flow past the antegrade valve and a controllable retrograde flow past the antegrade valve. It would be even further desirable to provide exterior retrograde valves that provide retrograde flow past the retrograde valve and a controllable antegrade flow past the retrograde valve.

SUMMARY OF THE INVENTION Accordingly, an object of the invention is to provide a catheter device configured for access to a patient's vein, artery, heart chamber or a great vessel of the heart.

Another object of the invention is to provide a catheter device configured for access to a patient's vein, artery, heart chamber or a great vessel which includes at least one antegrade valve positioned at an exterior of the catheter body.

A further object of the invention is to provide a catheter device configured for access to a patient's vein, artery, heart chamber or a great vessel which includes at least one retrograde valve positioned at an exterior of the catheter body.

Yet another object of the invention is to provide a catheter device configured for access to a patient's vein, artery, heart chamber or a great vessel which includes at least one antegrade valve and one retrograde valve, both positioned at an exterior of a catheter body. Still another object of the invention is to provide an antegrade or retrograde valve which is a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body.

Another object of the invention is to provide an antegrade or retrograde valve which is a peripheral flow valve configured to provide the antegrade flow around an exterior of the leaflets and traverse between the leaflets and a circulatory vessel wall.

Yet a further object of the invention is to provide a catheter system with an antegrade valve positioned between the coronary ostia and the brachiocephalic artery, a first retrograde valve positioned in the aorta downstream from the antegrade valve, and a second retrograde valve positioned downstream from the first retrograde valve.

Another object of the invention is to provide a catheter system with an antegrade valve positioned between the coronary ostia and the brachiocephalic artery, a first retrograde valve positioned downstream from the first retrograde valve, a second retrograde valve positioned downstream from the first retrograde valve, and a third retrograde valve positioned downstream from the second retrograde valve.

Yet another object of the invention is to provide a catheter system with a first antegrade valve positioned downstream from a pulmonic valve within a pulmonary artery, and a second antegrade valve positioned upstream from the pulmonic valve within one of a right heart chamber or one of a vessel of a venous blood system.

Still another object of the invention is to provide a catheter system with a first antegrade valve positioned downstream from a pulmonic valve within a pulmonary artery, a second antegrade valve positioned upstream from the pulmonic valve within one of a right heart chamber or one of a vessel of a venous blood system, and a first retrograde valve positioned upstream from the pulmonic valve within one of a right heart chamber, a pulmonary vessel or a vessel in a venous blood system.

These and other objects are attained in a catheter device that regulates fluid flow within a circulatory vessel. Included is an elongated catheter body configured to access one of a circulatory vessel or a heart chamber. The catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end. Optionally, second and third lumens may be included in the catheter body. The second and third lumens each have an open proximal end. An antegrade valve is coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body. The antegrade flow is greater than the retrograde flow.

In another embodiment, a retrograde valve is coupled to an exterior of the catheter body. The retrograde valve is configured to provide a controllable retrograde flow and a controllable antegrade flow past the exterior of the catheter body. The antegrade and retrograde valves can be, (i) a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body or (ii) a peripheral flow valve configured to provide the antegrade flow around an exterior of the leaflets and traverse the leaflets and a circulatory vessel wall. In other embodiments, the catheter body can include one or more antegrade and retrograde valves, as well as one or inflatable balloons.

The antegrade and retrograde valves can be, (i) a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body or (ii) a peripheral flow valve configured to provide the antegrade flow around an exterior of the leaflets and traverse the leaflets and a circulatory vessel wall.

In other embodiments, the catheter body can include one or more antegrade and retrograde valves, as well as one or more inflatable balloons.

The antegrade and retrograde valves can be configured to be coupled in a moveable relationship to the exterior of the catheter. The antegrade and retrograde valves can be made of one or more leaflets. In resting positions, the antegrade and retrograde valves are in contacting or adjacent positions with an interior surface of a vessel or heart chamber. Each antegrade or retrograde valve is retractable to provide blood flow in both the antegrade and retrograde directions. One or more advancement and retraction members are coupled to the antegrade and retrograde valves. The advancement and retraction members can be positioned in open ended tracks formed in the catheter body.

The antegrade and retrograde valves are autoregulating in response to differing fluid pressures in the blood stream on either side of the valve so that excessive pressure on the vessel wall is avoided. Additionally, damage to the interiors of vessels and heart chambers is decreased and the chance of a disruption of lesions in the vessels is reduced. Further, the antegrade and retrograde valves are suitable for a variety of different applications, including but not limited to perfusion, drainage, unidirectional direct flow, controllable unidirectional direct flow, regulate the amount of flow and the like. Further, unlike balloons which are more subject to bursting, the antegrade and retrograde valves are more robust and durable.

A plurality of different lumens can be positioned in the catheter body. A second lumen can include a closed distal end but have one or more blood flow directional ports formed in a sidewall of the lumen. Two or more lumens can extend through the catheter body with open proximal and distal ends. A third lumen may also be included.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 (a) is a perspective view of a central flow valve with the valve open. Figure 1 (b) is a perspective view of the central flow valve with the valve closed. Figure 1 (c) is a cross-sectional view of a central flow valve with the valve open. Figure 1 (d) is a cross-sectional view of a central flow valve with the valve closed. Figure 2 (a) is a perspective view of a peripheral flow valve with the valve open. Figure 2 (b) is a perspective view of the peripheral flow valve with the valve closed. Figure 2 (c) is a cross-sectional view of a peripheral flow valve with the valve open. Figure 2 (d) is a cross-sectional view of a peripheral flow valve with the valve closed. Figure 3 is a cross-sectional view of a dual lumen catheter. Figure 4 is a cross- sectional view of a single lumen catheter with two valves configured for attachment to an exterior surface of the single lumen catheter, where the valves can be antegrade, retrograde, or a combination.

Figure 5 is a cross- sectional view of a dual lumen catheter with an antegrade or retrograde valve, first and second channels and a track formed in an exterior surface of the dual lumen catheter.

Figure 6 is a cross-sectional view of a dual lumen catheter with an antegrade valve.

Figure 7 is a cross-sectional view of a dual lumen catheter with a retrograde valve.

Figure 8 is a cross-sectional view of a dual lumen catheter with one antegrade valve and two retrograde valves.

Figure 9 is a cross-sectional view of a single lumen catheter with an antegrade valve.

Figure 10 is a cross-sectional view of a single lumen catheter with a retrograde valve.

Figure 11 is a cross-sectional view of a single lumen catheter with an antegrade valve and a retrograde valve and a balloon. Figure 12 is a cross- sectional view of a dual lumen catheter with an antegrade valve and a balloon positioned at a distal portion of the dual lumen catheter.

Figure 13 is a cross- sectional view of a dual lumen catheter with an antegrade valve and two retrograde valves that are positioned at a non-distal portion of the dual lumen catheter.

Figure 14 is a cross- sectional view of a dual lumen catheter with an antegrade valve and three retrograde valves.

Figure 15 is a cross-sectional view of a linear section of a dual lumen catheter with an antegrade valve.

Figure 16 is a cross-sectional view of a linear section of a dual lumen catheter with an antegrade valve and a retrograde valve. Figure 17 is a cross-sectional view of a linear section of a dual lumen catheter with an antegrade valve and two retrograde valves.

Figure 18 is a cross-sectional view of a linear section of a single lumen catheter with an antegrade valve.

Figure 19 is a cross-sectional view of a linear section of a single lumen catheter with an antegrade valve and a retrograde valve.

Figure 20 is a cross-sectional view of a linear section of a single lumen catheter with an antegrade valve and two retrograde valves.

Figure 21 is a cross- sectional view of a dual lumen catheter with an antegrade valve and two retrograde valves positioned in the aorta. Figure 22 is a cross-sectional view of a dual lumen catheter with two antegrade valves positioned in the right heart.

Figure 23 is a cross-sectional view of a dual lumen catheter and a limb catheter. Figure 24 is a cross-sectional view of the dual lumen catheter taken along the lines 24 - 24 of Figure 23, illustrating the directional side ports.

Figure 25 is a cross-sectional view of a dual lumen catheter in a circulatory vessel illustrating antegrade and retrograde blood flow, blood flow through a second lumen of the dual lumen catheter and perfusion of an associated open vessel.

Figure 26 is a cross-sectional view of the triple lumen catheter in a circulatory vessel.

Figure 26 (a) is a cross-sectional view of the triple lumen catheter of Figure 26 taken along the lines 26 (a) - 26 (a).

Figures 26 (b) through 26 (d) illustrate different cross-sectional views of double and triple lumen catheters.

Figure 27 is a cross-sectional view of a single lumen catheter with a track formed in a surface of the catheter body and a side port formed in the catheter body.

Figure 28 is a cross-sectional view of a single lumen catheter with a track formed in a surface of the catheter body, multiple side ports formed in the catheter body, and multiple channels formed in the catheter body.

Figure 29 is a cross-sectional view of a dual lumen catheter.

Figure 30 is a cross-sectional view of a dual lumen catheter with a track and a port each formed in a side wall of a different lumen.

Figure 31 is a cross-sectional view of a triple lumen catheter with multiple tracks, side ports and channels formed in the catheter body.

Figure 32 is a cross-sectional view of a dual lumen catheter with a dual diaphragm device coupled to a proximal end of the dual lumen catheter.

Figure 33 is a cross-sectional view of a dual lumen catheter with a dual diaphragm device coupled to a proximal end of the dual lumen catheter, and a distal end with a plurality of rings, struts and ports

Figure 34 is a cross-sectional view of a dual lumen catheter illustrating a dual diaphragm device, including its distal end.

DETAILED DESCRIPTION

The present invention is a catheter device that regulates fluid flow within a circulatory vessel by controlling flows through and around a catheter. Included is an elongated catheter body configured to access one of a circulatory vessel or a heart chamber. The catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end. An antegrade valve is coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body. The antegrade flow is greater than the retrograde flow. In other embodiments, second and third lumens are included. The proximal ends of the second and third lumens are open. The distal ends of the second and third lumens can be open or closed with or without side ports. Distal portions of the second and third lumens can include side ports, which may provide directional fluid flow. One or more antegrade and retrograde valves can be included with a catheter body. Further, one or more balloons may also be included, along with their associated elongated catheter inflation lumens.

Each antegrade or retrograde valve can be a central blood flow valve or a peripheral flow valve and made of one, two, three or more leaflets. The leaflets can include one or more fenestrations. The fenestrations may be longitudinal slits which provide for one-way flow. Antegrade and retrograde valves are either central flow or peripheral flow valves.

For purposes of the present application, "downstream" means in the direction of normal blood flow through a blood vessel, i.e., further from the heart in the arterial system, and closer to the heart in the venous system. "Upstream" means in the direction opposite the downstream direction. With respect to devices, "proximal" means in the direction toward the end of the device that is closest to and held or manipulated by the user, while "distal" means in the direction away from the user, opposite the proximal direction. "Antegrade flow" means fluid or blood flow in the direction of normal circulation. "Retrograde flow" means fluid or blood flow in the opposite direction to normal blood circulation.

"Controllable antegrade flow" and "controllable retrograde flow" mean that the flow around an exterior of the catheter body flows primarily in one direction or the other, and the level of flow is determined based upon the construction of the antegrade or retrograde valve. With an antegrade valve, there is more flow in the antegrade direction than in the retrograde direction. With a retrograde valve, there is more flow in the retrograde direction than in the antegrade direction. The difference in flow is dependent on the construction of the valve and may be as little as a few percent to a much greater percentage.

Figures 1 (a), 1 (b), 1 (c) and 1 (d) illustrate a central flow valve 10 which is useful as either an antegrade valve or as a retrograde valve. The central flow valve 10 is shown in a deployed position within a circulatory vessel 12. The central flow valve 10 is coupled to the exterior 16 of a cannula or catheter 14. The central flow valve 10 may be coupled to the exterior 16 of the catheter 14 in a fixed position or it may be slidable over the exterior 16 of the catheter 14. Catheter 14 has a diameter suitable for introduction through a femoral or iliac artery, usually less than about 9 mm. The length of catheter 14 is preferably greater than about 80 cm, usually about 90-100 cm, with its proximal end disposed outside of the body, preferably from the femoral or iliac artery in the groin area. Alternatively, catheter 14 may be configured for introduction through the carotid artery, through the brachial artery, or through a penetration in the aorta itself, wherein catheter 14 may have a length in the range of 20 to 60 cm.

Catheter 14 may be constructed of any of a variety of materials, including biocompatible polymers such as polyurethane, polyvinyl chloride, polyether block amide, or polyethylene. The catheter material will preferably be blended with a radiopaque material and/or radiopaque markers may be placed at one or more points along the catheter 14 to provide an indication of the catheter position during fluoroscopic placement of the catheter 14. In one embodiment, catheter 14 is made of urethane with a shore durometer in the range of 50D-80D. Catheter 14 may have a bending modulus in the range of 70 to 100 kpsi, preferably about 80-90 kpsi. A bending modulus in this range provides sufficient stiffness to optimize pushability from a femoral or iliac artery to the ascending aorta, while providing sufficient flexibility to navigate the tortuous iliac artery and the aortic arch.

Central flow valve 10 is constructed with one, two, three, four or more leaflets 21. The leaflets 21 are connected at an attachment point 20 along the outer rim of a retractable or collapsible skeleton structure 17 which supports the central flow valve 10 in the deployed position. The leaflets 21 may be formed of a flexible material such as a woven or knitted fabric, a polymeric film or a biological membrane. Alternatively, leaflets 21 may be formed of a rigid or semirigid polymeric or metallic material which is hingedly attached to the supporting skeleton structure 17. Leaflets 22 preferably have smooth, nonthrombogenic and nonhemolytic surfaces. The collapsible skeleton structure 17 has a plurality of struts 19 which form an interskeleton attaching the skeleton structure 17 to the exterior 16 of the catheter 14. The skeleton structure 17 and the struts 19 may be made of a metal or a polymeric material which may be rigid, malleable or resilient and may be hingedly or flexibly attached to the catheter 14 so that the central flow valve 10 can be introduced into the circulatory vessel in a collapsed configuration and deployed to an open configuration within the vessel, as shown. A deployment means, such as one or more metallic or polymeric advancement and retraction members 18 attached to the leaflets 21, skeleton structure 17 or struts 19, is used to deploy the central flow valve 10 after insertion and to collapse it prior to withdrawal from the patient. Alternatively, the skeleton structure 17 and the struts 19 of the interskeleton may be a hollow, inflatable structure made of polymer film, which is deployed by inflating it with a pressurized fluid. In another alternative construction, the skeleton structure 17, the struts 19 and/or the advancement and retraction members 18 may be formed of a shape memory material which may be deployed by a temperature change or by application of an electrical current. The central flow valve 10 is shown in an open position in Figures 1 (a) and 1 (c), and in a closed position in Figures 1 (b) and 1 (d). When blood flow is in the forward direction, as shown by the arrows in Figure 1 (c), the blood flow displaces leaflets 21 away from catheter 14, creating large blood flow apertures 23 between the leaflets 21 and the catheter 14. This allows for relatively unimpeded flow of blood in the forward direction. When blood flow is in the reverse direction, as shown by the arrows in Figure 1 (d), the blood flow displaces leaflets 21 toward the catheter 14, closing off the blood flow apertures. The material of the leaflets 21 is generally impermeable to fluid flow and the leaflets 21 are configured to overlap and be closely positioned relative to each other in order to eliminate fluid flow gaps. However, a predetermined degree of porosity or a number of slits, gaps or fenestrations may be made in or between the leaflets 21 to allow a controlled amount of reverse flow through the central flow valve 10. The central flow valve 10 may be used as an antegrade valve or as a retrograde valve by mounting it on the catheter 14 with the nominally forward blood flow direction pointing in the antegrade or retrograde direction, respectively.

Figures 2 (a), 2 (b), 2 (c) and 2 (d) illustrate a peripheral flow valve 24 which is also useful as either an antegrade valve or as a retrograde valve. The peripheral flow valve 24 is coupled to the exterior 16 of a cannula or catheter 14 for introduction into a circulatory vessel 12, as described above. The peripheral flow valve 24 may be coupled to the exterior 16 of the catheter 14 in a fixed position or it may be slidable over the exterior 16 of the catheter 14.

Peripheral flow valve 24 is constructed with one, two, three, four or more 24 leaflets 22 which are attached to the exterior 16 of the catheter 14. The leaflets 22 may be formed of a flexible material such as a woven or knitted fabric, a polymeric film or a biological membrane. Alternatively, leaflets 22 may be formed of a rigid or semirigid polymeric or metallic material which is hingedly attached to the exterior 16 of the catheter 14. Leaflets 22 preferably have smooth, nonthrombogenic and nonhemolytic surfaces. The leaflets 22 may be made with rounded or curved outer edges (best seen in Figures 6 et seq.) which present a smooth atraumatic surface to minimize disruption of calcifications or other lesions formed on an interior surface of the circulatory vessel wall 12. Optionally, the peripheral flow valve 24 may include a retractable or collapsible skeleton structure formed by a plurality of struts 27 which may help to deploy the peripheral flow valve 24, as shown in Figures 2 (c) and 2 (d). The struts 27 of the skeleton structure may be made of a metal or a polymeric material which may be rigid, malleable or resilient and may be hingedly or flexibly attached to the catheter 14 so that the peripheral flow valve 24 can be introduced into the circulatory vessel in a collapsed configuration and deployed to an open configuration within the vessel. A deployment means, such as one or more metallic or polymeric advancement and retraction members 18 is attached to the leaflets 22, or to the optional struts 27, and may be used to deploy the peripheral flow valve 24 after insertion and to collapse it prior to withdrawal from the patient. Alternatively, the struts 27 of the interskeleton may be a hollow, inflatable structure made of polymer film, which is deployed by inflating it with a pressurized fluid. In another alternative construction, the struts 27 and/or the advancement and retraction members 18 may be formed of a shape memory material which may be deployed by a temperature change or by application of an electrical current

The peripheral flow valve 24 is shown in an open position in Figures 2 (a) and 2 (c), and in a closed position in Figures 2 (b) and 2 (d). When blood flow is in the forward direction, as shown by the arrows in Figure 2 (c), the blood flow displaces leaflets 22 toward the catheter 14, creating a large blood flow aperture 25 around the leaflets 22 and the catheter

14. This allows for relatively unimpeded flow of blood in the forward direction. When blood flow is in the reverse direction, as shown by the arrows in Figure 2 (d), the blood flow displaces leaflets 22 away from the catheter 14 and against the wall of the circulatory vessel 12 to close off the blood flow apertures. Tension on the advancement and retraction members 18 may also be used to retract or partially retract the leaflets 22 to allow controlled forward and reverse flow around the peripheral flow valve 24. The material of the leaflets 22 is generally impermeable to fluid flow and the leaflets 22 are configured to overlap and be closely positioned relative to each other in order to eliminate fluid flow gaps. However, a predetermined degree of porosity or a number of slits, gaps or fenestrations may be made in or between the leaflets 22 to allow a controlled amount of reverse flow through the peripheral flow valve 24. The peripheral flow valve 24 may be used as an antegrade valve or as a retrograde valve by mounting it on the catheter 14 with the nominally forward blood flow direction in the antegrade or retrograde direction, respectively.

Catheter 14 can include one or more lumens. Figure 3 illustrates a cross-section view of an antegrade or retrograde double lumen cannula 26 including a first lumen 28, and a second lumen 30. Preferably, first lumen 28 is larger than second lumen 30. Each lumen is configured to be a fluid flow, e.g., blood flow, lumen, or adapted to receive a variety of different implements, including but not limited to working tools, scopes, irrigation and aspiration lumens, cardioplegia introduction lumens and the like. The cannula 26 may be configured with one or more tracks for various functions. By way of example, a first track 32, configured for fluid flow of a balloon inflation and deflation medium, is positioned in an interior of first lumen 28, and a second track 34, configured for receiving advancement and retraction member 18 or for introduction of working tools, is positioned at an exterior surface of catheter 14. Alternatively or additionally, a channel 35 can be positioned within an interior wall defining catheter 14. When a channel 35 is located within an interior wall defining catheter 14, there is a saving of valuable space. The same is true when a channel is positioned at an exterior of catheter 14. In both instances, the available volume for first and second lumens 28 and 30 is maximized.

Figure 4 depicts cannula 14 with only first lumen 32, and includes a first antegrade or retrograde valve 36 and a second antegrade or retrograde valve 38, each positioned in a fixed or slidable relationship to the exterior of cannula 14. Valves 36 and 38 have free-edges shown in their resting positions, and the associated advancement and retraction members 18 are relaxed.

In Figure 5, catheter 14 includes first lumen 28, second lumen 30, antegrade or retrograde valve 38, first track 32, second track 34 and a third track 40 that includes an open section. Third track 40 can be used to receive advancement and retraction member 18, a scope, an irrigation or aspiration lumen, working tools, and the like. The open section of the third track can be used for slidably mounting the antegrade or retrograde valve 38 to the exterior of the catheter. In one embodiment, a diaphragm device within valve leaflets 22 or equivalent structure is coupled to third track 40 to allow devices to pass through valve leaflets 22. At a proximal end of third track 40 the diaphragm device provides for the passage of an instrument but eliminates blood or other fluid leakage.

Referring now to Figure 6, double lumen cannula 14 includes an antegrade valve 42 positioned at a distal portion of double lumen cannula 14. Directional side ports 44 are formed in double lumen cannula 14 and in second lumen 30. Directional side ports 44 are downstream from the distal end of first lumen 28 and downstream from antegrade valve 42. In one preferred embodiment, shown in Figure 24, directional side ports 44 are configured to provide a downstream directional fluid or blood flow, as illustrated by the arrows. A side port 46 is formed in first lumen 28 or second lumen 30 and permits flow of a fluid to and from the respective lumen 28 or 30. A slidable member 48 is configured to advanced and retracted along the exterior of catheter 14 (single or double lumen). Slidable member 48 may be coupled to an advancement and retraction member 18 or other actuation means in order to open or close side port 46 and permit fluid or blood flow to come out of first or second lumens 28 or 30. Fluid flow in the circulatory vessel is upstream or downstream depending on die position of slidable member 48.

Figure 7 shows a double lumen catheter 14 with a single retrograde valve 50 that is positioned downstream from directional side ports 44. In Figure 8 double lumen catheter 14 includes one antegrade valve 42 and two retrograde valves 50 that are in fixed or moveable relationships to the exterior of double lumen catheter 14. Figure 9 illustrates a single lumen catheter 14 with a single antegrade valve 42 positioned upstream from directional side ports 44. The distal end of first lumen 28 may be opened or closed depending on the particular application.

Figure 10 also illustrates a single lumen catheter 14 with a single retrograde valve 50 positioned downstream from directional side ports 44. Figure 11 illustrates a single lumen catheter 14 with one antegrade valve 42, one retrograde valve 50, and one inflatable balloon 52. Valve 50 and balloon 52 are each positioned downstream from antegrade valve 42. Balloon 52 may be constructed of various materials, e.g. latex, silicone, polyurethane, vinyl or alloys thereof, and in various geometries. In one embodiment, balloon 52 has a collapsed profile small enough for introduction into the femoral or iliac artery, e.g., 4-9 mm outside diameter and an expanded (inflated) profile large enough to completely occlude the ascending aorta, e.g. 20-40 mm outside diameter. The ratio of expanded profile diameter to collapsed profile diameter will thus be between 2 and 10, and preferably between 5 and 10. Balloon 52 is further configured to maximize contact of the working surface of the balloon with the aortic wall to resist displacement and to minimize leakage around the balloon, preferably having a working surface with an axial length in the range of about 3 to about 7 cm when balloon 52 is expanded. Textural features such as ribs, ridges or bumps may also be provided on the balloon working surface for increased frictional effects to further resist displacement. Figure 12 illustrates a double lumen catheter 14 with an antegrade valve 42 positioned at a distal end of double lumen catheter 14, and a balloon 52. Antegrade valve 42 is positioned upstream of the aortic valve of the heart, and balloon 52 is positioned downstream of the aortic valve of the heart. Antegrade valve 42 is positioned at a distal end of double lumen catheter 14 or at an exterior surface of an extension member (not shown) which extends from the distal end of double lumen catheter 14. Double lumen catheter 14 may have a ring and strut construction which increases rigidity, minimizes kinking or coiling of double lumen catheter 14, or of a single lumen, triple lumen, and the like catheter 14.

Figure 13 illustrates a double lumen catheter 14 with an antegrade valve 42 and two retrograde valves 50.

Figure 14 illustrates a double lumen catheter 14 with an antegrade valve 42 and three retrograde valves 50.

Figures 15 through 17 illustrate a double lumen straight catheter 14, or a straight portion of catheter 14 with an antegrade valve 42 (Figure 15), an antegrade valve 42 and a retrograde valve 50 (Figure 16), a single antegrade valve 42 and two retrograde valves 50 (Figure 17).

Figures 18 through 20 correspond to Figures 15 through 17 except that a single lumen catheter 14 is illustrated.

Figure 21 illustrates a double lumen catheter 14 deployed in the aorta A with a distal end terminating just above the aortic valve AV. A single antegrade valve 42, which is preferably a peripheral flow valve, is positioned downstream from the aortic valve AV. A first retrograde valve 50 is positioned downstream from the left carotid artery C, and a second retrograde valve 50' positioned downstream from the left subclavian artery S.

Figure 22 illustrates a double lumen catheter 14 with first and second antegrade valves 42 deployed in the right heart. Double lumen catheter 14 enters the jugular vein and traverses down the superior vena cava SVC. Directional side ports 44 are configured to decompress the right atrium RA and the right ventricle RV. A distal tip of double lumen catheter 14 extends beyond die pulmonic valve. An antegrade valve 42 is positioned beyond the pulmonic valve PV. Figure 23 illustrates a double lumen cadieter 14 with an antegrade valve 42, two retrograde valves 50 and a limb catheter 54. Limb cadieter 54 perfuses or drains a blood vessel that is accessed peripherally. A balloon 52, or alternatively an antegrade valve, is positioned at limb catheter 54.

Figure 24 is a cross-section taken along line 24-24 in Figure 23 illustrating fluid flow from a directional side port 44 in a cross-sectional view.

In Figure 25 a double lumen cadieter 14 is positioned in a circulatory (blood) vessel. Double lumen catheter 14 includes an antegrade valve 42, a retrograde valve 50, and side directional ports 44 positioned between valves 42 and 50. Antegrade blood flow through a distal end of double lumen catheter 14 perfuses blood back into second lumen 30 which is then ejected through the directional side ports 44 between the valves 42 and 50. In this manner blood is directed into the circulatory vessel in the vicinity of directional side ports 44. When a branch vessel is positioned in the vicinity of directional side ports 44, the branch vessel is perfused.

Figure 26 illustrates a triple lumen catheter 14 positioned in a circulatory (blood) vessel and is similar to Figure 25. Triple lumen catheter 14 includes first lumen 28, second lumen 30 and diird lumen 56. An antegrade valve 42 and a retrograde valve 50 are included.

Figure 26 (a) illustrates a cross section of triple lumen catheter 14 at its distal end, taken along line 26(a)-26(a) in Figure 26. Second lumen 30 and diird lumen 56 can have open or closed distal ends. Second lumen 30 and third lumen 56 can each have a closed distal end and a port formed in a distal portion of a side wall of each respective lumen 30 and 56. Figures 26 (b) tiirough 26 (d) illustrate various embodiments of die distal ends of dual and triple lumen catheters 14 with open ends or closed ends and side holes 46 on the first lumen 28, second lumen 30 and optional third lumen 56.

Figure 27 illustrates a single lumen cadieter 14 with an open diird track 40 and an enclosed channel 58 formed in a body structure of single lumen cadieter 14. A single port 46 is formed in the body structure of single lumen catheter 14 and provides fluid communication between first lumen 28 and an exterior of single lumen catheter 14. Figure 28 illustrates a single lumen catheter 14 with a plurality of side ports 46 and enclosed channels 58 formed in die body structure of single lumen catheter 14.

Figure 29 illustrates a double lumen cadieter 14 where first lumen 28 and second lumen 30 occupy about 80% and 20%, respectively, of the effective working interior volume of double lumen catheter 14. Figure 30 illustrates a double lumen catheter 14 with a first lumen 28, a second lumen 30, an open third track 40, an enclosed channel 58 and a port 46.

Figure 31 illustrates one preferred embodiment of a triple lumen catheter 14 where first lumen 28, second 30 and third lumen 56 occupy about 80%, 10% and 10%, respectively, of the effective working interior volume of triple lumen catheter 14. In an alternate preferred embodiment, first lumen 28, second 30 and third lumen 56 occupy about 20%, 70% and 10%, respectively, of the effective working interior volume of triple lumen catheter 14.

Figure 32 illustrates a longitudinal cross-section view of a double lumen cadieter 14 with an antegrade valve 42 and a retrograde valve 50. Directional side ports 44 are formed in a body structure of second lumen 30. One or more slidable members 48 are positioned on die exterior surface of double lumen catheter 14 to open and close directional side ports 44. A limb perfusion/drainage catheter 54 is coupled to first lumen 28. A blood pump/oxygenator port 60 extends from double lumen catheter 14 at a selected angle, e.g. 45 degrees, and is coupled to first lumen 28. Blood pump/oxygenator port 60 is coupled to a blood pump/oxygenator 62 which is also coupled to second lumen 30. The blood pump/oxygenator 62 is connected to a second, venous cadieter (not shown) for receiving venous blood from the patient, oxygenating the blood and pumping it into the patient's arterial system dirough die double lumen cadieter 14. A third track 40 provides for passing an advancement and retraction member 18, to direct opening and closing of leaflets 22, and pass valves or, surgical instruments, scopes, irrigation and aspiration cannulas and die like.

A dual diaphragm device 64 is coupled to a proximal end of first lumen 28. Dual diaphragm device 64 can also be coupled to multiple lumen catheters. Dual diaphragm device 64 includes a first fluid irrigation port 66, a second fluid irrigation port 68, a first diaphragm 70, second diaphragm 72 and instrument or device introduction chamber 73. Dual diaphragm device 64 provides an air lock to first lumen 28. This permits die introduction of different instruments and devices into first lumen 28. A balloon 52 is positioned around an exterior of double lumen catheter 14 and is coupled to an inflation and deflation port 74 configured to introduce and remove an inflation solution into and out of balloon 52.

Figure 33 is similar to Figure 32 except a plurality of rings 76 and struts 78 are formed in the distal portion of dual lumen catheter 14, providing a reinforced structure tiiat is less subject to kinking and coiling. A plurality of side ports 46 may also be formed in die body of dual lumen catheter 14, in first lumen 28 and/or second lumen 30. The flexibility of the distal portion of the catheter 14 makes it especially useful for placing the catheter 14 across a septum of die heart from a first heart chamber to a second heart chamber, dirough a natural or artificially created septal defect.

Dual diaphragm device 64 is illustrated in Figure 34. First fluid irrigation port 66 is a flush fluid inlet port, while second fluid irrigation port 68 is a flush fluid outlet port, providing fluid circulation. A guide wire 82 having a blade member 80 can be introduced through instrument introduction chamber 73 and out the distal end of dual diaphragm device 64 to pierce a circulatory vessel, a heart chamber wall and access a mural wall of the heart.

Alternatively, the dual diaphragm device 64 can be made with a distal end that is geometrically configured to pierce a circulatory vessel, a heart chamber wall and access a mural wall of the heart.

The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that die scope of die invention be defined by the following claims and tiieir equivalents.

What is claimed is:

Claims

1. A catheter device to regulate fluid flow widiin a circulatory vessel, comprising: an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, the elongated catheter body including a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of die distal end of die first lumen; and an antegrade valve coupled to an exterior of the cadieter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body, wherein the antegrade flow is greater tiian the retrograde flow.

2. The catheter device of claim 1, wherein die cadieter body includes a second lumen including an open proximal end and a distal end.

3. The catheter device of claim 1 , wherein die cadieter body includes a second lumen including an open proximal end and a distal end and a diird lumen including an open proximal end and a distal end.

4. The cadieter device of claim 1 , wherein die antegrade valve includes one or more leaflets.

5. The catheter device of claim 4, wherein the antegrade valve is a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body.

6. The catheter device of claim 4, wherein the antegrade valve is a peripheral flow valve configured to provide the antegrade flow around an exterior of die leaflets and traverse between die leaflets and a circulatory vessel wall.

7. The catheter device of claim 4, wherein the antegrade valve includes one or more retraction and advancement members coupled to die antegrade valve.

8. The catheter device of claim 4, wherein die antegrade valve includes a retraction connection point at a leaflet.

9. The catheter device of claim 4, further comprising: one or more unidirectional or bidirectional fluid flow fenestrations formed in die leaflets and configured to regulate the antegrade flow or the retrograde flow.

10. The catheter device of claim 2, wherein the second lumen includes a port formed at a distal portion of die distal end of the second lumen.

11. The catheter device of claim 2, where the second lumen includes a second lumen port formed in the catheter body at a distal portion of die distal end of die second lumen.

12. The catheter device of claim 3, wherein die diird lumen includes a port formed at a distal portion of the distal end of the third lumen.

13. The catheter device of claim 3, where the third lumen includes a second lumen port formed in the cadieter body at a distal portion of die distal end of die diird lumen.

14. The catheter device of claim 1 , wherein die antegrade valve is mounted at a fixed position on the exterior of die catheter body.

15. The cadieter device of claim 1 , wherein die antegrade valve is movably mounted on die exterior of the cadieter body.

16. The catheter device of claim 1, wherein the antegrade valve includes one leaflet

17. The catheter device of claim 1 , wherein die antegrade valve includes two leaflets.

18. The catheter device of claim 1 , wherein die antegrade valve includes a supporting skeleton structure.

19. The catheter device of claim 18, wherein the skeleton structure has a collapsed position and a deployed position.

20. The catheter device of claim 19, wherein die skeleton structure is made of a malleable material.

21. The cadieter device of claim 18, wherein the skeleton structure includes a rim configured to be positioned adjacent to an interior of a circulatory vessel or heart chamber.

22. The cadieter device of claim 1 , wherein the antegrade valve is retractable to provide an antegrade and a retrograde fluid flow past the antegrade valve.

23. The cadieter device of claim 22, further comprising: a retraction member coupled to die antegrade valve to retract die antegrade valve in a direction towards the cadieter body.

24. The catheter device of claim 23, wherein die retraction member is coupled to an exterior surface of die catheter body.

25. The cadieter device of claim 23, wherein die retraction member is positioned in an interior of die cadieter body.

26. The cadieter device of claim 23, wherein the retraction member is positioned in the first lumen of the cadieter body.

27. The catheter device of claim 1 , wherein the antegrade valve is configured to regulate fluid flow past the antegrade valve resulting from differential pressures on a first and a second side of the antegrade valve.

28. The cadieter device of claim 27, further comprising: one or more side ports formed in the catheter body and configured to provide a directional fluid flow.

29. The catheter device of claim 1, wherein die antegrade valve is configured to minimize disruption of lesions formed on an interior surface of a vessel or a heart chamber.

30. The cadieter device of claim 29, wherein the antegrade valve has a rounded outer edge.

31. The cadieter device of claim 1 , further comprising: means for coupling the proximal end of die first lumen to a blood pump.

32. The cadieter device of claim 2, further comprising: means for coupling die proximal end of die first lumen and the proximal end of die second lumen to a blood pump.

33. The cadieter device of claim 32, wherein die blood pump is connected to a second catheter positioned within a patient's circulatory system, wherein the blood pump is configured to deliver a fluid to or from the second catheter.

34. The cadieter device of claim 32, wherein die distal end of die first lumen and the distal end of the second lumen are configured to provide a fluid flow to and from the blood pump.

35. The cadieter device of claim 1 , further comprising: a track formed and extending along at least a portion of die exterior of die catheter body.

36. The cadieter device of claim 35, wherein the track is at least partially enclosed.

37. The catheter device of claim 35, wherein the track is configured to receive die antegrade valve, wherein the antegrade valve is configured to move along the track.

38. The catheter device of claim 35, wherein die track is configured to receive one of an imaging device, an elongated surgical instrument and an advancement or retraction member coupled to die antegrade valve.

39. The cadieter device claim 4, wherein die valve leaflets are configured for movement in a direction towards or away from die exterior of the cadieter body when the cadieter is positioned within one of a circulatory vessel or a heart chamber.

40. The cadieter device of claim 1 , further comprising a side port formed in the cadieter body, wherein die side port provides a direction flow of a fluid.

41. The catheter device of claim 40, further comprising a slidable member positioned adjacent to die side port and configured to open or close the side port and regulate fluid flow dirough the side port.

42. The catheter device of claim 1, further comprising a marking coupled to die cadieter body to provide an indication of a catheter body position.

43. The catheter device of claim 42, wherein die marking comprises a radiopaque marking.

44. The cadieter device of claim 1 , further comprising: a dual diaphragm chamber device coupled to the first lumen proximal end including a first diaphragm, a second diaphragm and an entry port coupled to die first lumen, an inflow port and an outflow port, wherein die diaphragm chamber is coupled to an irrigation system and to the first lumen.

45. The catheter device of claim 44, wherein die diaphragm chamber is configured to provide an air lock to the first lumen while instruments are introduced into die first lumen.

46. The cadieter device of claim 1 , wherein the catheter body is configured for placement widiin an aorta of a patient

47. The cadieter device of claim 1 , wherein the catheter body is configured for placement across a septum from a first heart chamber to a second heart chamber.

48. The cadieter device of claim 1, wherein the cadieter body is advanceable into a circulatory system by one of a percutaneous puncture or a surgical open access.

49. The catheter device of claim 1, further comprising: a inflatable balloon coupled to die exterior of the catheter body; and an inflation lumen coupled to the balloon.

50. A catheter device to regulate fluid flow widiin a circulatory vessel, comprising: an elongated cadieter body configured to access one of a circulatory vessel or a heart chamber, wherein the cadieter body includes a proximal end, a distal end, a first lumen including an open proximal end and a distal end with a port formed at a distal portion of die distal end; and a retrograde valve coupled to an exterior of die cadieter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter, wherein the retrograde flow is greater than the antegrade flow.

51. The cadieter device of claim 50, wherein die cadieter body includes a second lumen including an open proximal end and a distal end.

52. The cadieter device of claim 50, wherein the catheter body includes a second lumen including an open proximal end and a distal end and a third lumen including an open proximal end and a distal end.

53. The cadieter device of claim 50, wherein the retrograde valve includes one or more leaflets.

54. The catheter device of claim 50, wherein the retrograde valve is a central flow valve configured to provide a fluid flow dirough a center portion of die central flow valve and fluid flow traverses between the central flow valve and the catheter body.

55. The catheter device of claim 50, wherein die retrograde valve is a peripheral flow valve configured to provide the retrograde flow around an exterior of die leaflets and traverse between the leaflets and a circulatory vessel wall.

56. The cadieter device of claim 50, wherein die retrograde valve includes one or more retraction and advancement members coupled to an retrograde valve.

57. The catheter device of claim 50, wherein die retrograde valve includes a retraction connection point at a leaflet.

58. The catheter device of claim 50, further comprising: one or more unidirectional or bidirectional fluid flow fenestrations formed in die leaflets and configured to regulate the antegrade flow or the retrograde flow.

59. A catheter device to regulate fluid flow within a circulatory vessel, comprising: an elongated cadieter body configured to access one of a circulatory vessel or a heart chamber, wherein the cadieter body includes a proximal end, a distal end, a first lumen including an open proximal end and a distal end with a port formed at a distal portion of die distal end; an antegrade valve coupled to an exterior of the cadieter body and configured to provide a controllable antegrade flow and a controllable flow along die exterior of the catheter body, wherein the antegrade flow is greater than die retrograde flow; and a retrograde valve coupled to an exterior of die catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter, wherein die retrograde flow is greater tiian die antegrade flow.

60. The catheter device of claim 59, wherein die cadieter body includes a second lumen including an open proximal end and a distal end.

61. The cadieter device of claim 59, wherein die cadieter body includes a second lumen including an open proximal end and a distal end and a third lumen including an open proximal end and a distal end.

62. The catheter device of claim 59, wherein die antegrade and retrograde valves each include one or more leaflets.

63. The cadieter device of claim 62, wherein the antegrade and retrograde valves are each a central flow valve configured to provide a fluid flow dirough a center portion of the central flow valve and fluid flow traverses between die central flow valve and the catheter body.

64. The catheter device of claim 62, wherein the antegrade valve is a peripheral flow valve configured to provide die antegrade flow around an exterior of die leaflets and traverse between the leaflets and a circulatory vessel wall.

65. The catheter device of claim 62, wherein die antegrade valve includes one or more retraction and advancement members coupled to die antegrade valve.

66. The cadieter device of claim 62, wherein die antegrade valve includes a retraction connection point at a leaflet.

67. The cadieter device of claim 62, further comprising: one or more unidirectional or bidirectional fluid flow fenestrations formed in die leaflets and configured to regulate the antegrade flow or die retrograde flow.