US20020161321A1 - Method of occluding a patient's ascending aorta and delivering cardioplegic fluid - Google Patents

Abstract

An extracorporeal support system including an extracorporeal support apparatus and an arterial circulation support catheter. The arterial circulation support catheter includes a blood lumen with a proximal end coupled to extracorporeal support apparatus and a distal end inserted into the blood circulation. A vent lumen has a distal end that crosses the aortic valve into the left ventricle and provides direct venting of the left ventricle through the vent lumen. An arterial circulation support catheter occluding member is positioned either in an interior or at an exterior of the arterial circulation support catheter. A venous circulation support catheter is provided and includes a blood lumen with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation. A venous circulation support catheter occluding member is included and positioned in an interior or at an exterior of the venous circulation support catheter. The venous circulation support catheter occluding member occludes the superior vena cava and the inferior vena cava.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a continuation-in-part of U.S. patent application Ser. No. 08/250,721 entitled “A CATHETER SYSTEM AND METHOD FOR PROVIDING CARDIOPULMONARY BYPASS PUMP SUPPORT DURING SURGERY” by Sweezer et al., filed May 27, 1994 incorporated herein by reference.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• This invention relates generally to an extracorporeal circulation support system coupled to the blood circulation, and more particularly to an extracorporeal circulation support apparatus which directly vents the left ventricle.[0003]
• 2. Background of the Invention[0004]
• Each year extracorporeal circulation support permits over 500,000 patients worldwide with disabling heart disease to undergo therapeutic cardiac operations. The goals of extracorporeal circulation support for heart surgery are, (i) to provide life-support functions, (ii) a motionless decompressed heart, (iii) a dry bloodless field of view for the surgeon, and (iv) adequate myocardial protection.[0005]
• One method of extracorporeal support includes a basic heart-lung life-support system. Oxygen-poor blood is diverted from the venous circulation of the patient and transported to the heart-lung machine where reoxygenation occurs. carbon dioxide is discarded and heat regulation, warming or cooling, is accomplished. This processed blood is then perfused into the patient's arterial circulation for distribution throughout the entire body to nourish and maintain viability of the vital organs. Although current venous diversion and arterial perfusion methods can be combined with other measures to effectively isolate the heart for cardiac surgery, they are associated with disadvantages and limitations which contribute significantly to patient morbidity, mortality, and health care costs. Another method may involve using a left ventricle assist system to channel blood from the left ventricle into aortic circulation.[0006]
• In order to perform coronary artery bypass, valve operations and other complex delicate surgical procedures on the heart, it is desirable to establish a resting, non-beating, non-distended state. This condition, along with a dry bloodless field, is ideal for safe manipulation and suturing of cardiac structures. It also contributes to decreased metabolic cardiac energy demands while promoting preservation of cellular functions. This non-beating state is accomplished by delivery of various methods including but not limited to delivery of a cardioplegia solution to the coronary circulation[0007]
• There are several methods of controlling distension, decompression or venting, and improved visibility of the heart during heart surgery. These include but are not limited to, (i) insertion of a catheter via the left atrium or a pulmonary vein that is directed across the mitral valve so that its openings at the top are positioned within the left ventricular chamber for venting of blood, (ii) inserting a catheter directly into the apex of the left ventricular muscle with its openings at the tip positioned within the left ventricular chamber for venting of blood, (iii) placement of a catheter in the isolated segment of the ascending aorta for antegrade cardioplegia delivery that can be alternatively switched to a suction so to accomplish aortic root venting (decompression) but not Left ventricular decompression (venting), and (iv) inserting a catheter across the aortic valve into the left ventricle to remove blood from the left ventricle and return it back into the arterial circulation. These methods have several disadvantages including but not limited to requiring major sternotomy or thoracotomy.[0008]
• Major invasive chest incisions are often associated with a higher incidence of morbidity including, but not limited to, intraoperative and post-operative bleeding, resulting in the likelihood of increased blood transfusion requirements, returns to surgery for re-exploration to control hemorrhage, longer healing and recovery times, pulmonary complications (such as lung collapse and pneumonia), catastrophic wound infection (mediastinitis), extensive scarring and adhesions. mechanical wound instability and disruption (dehiscence), chronic incisional pain, peripheral nerve and musculoskeletal dysfunction syndromes.[0009]
• Developing a system with features that avoids surgical maneuvers, instrumentation and devices known to be associated with increased morbidity and mortality, while maintaining the conditions necessary to perform various cardiac interventions, is desirable. Such improvements have the likelihood of resulting in a favorable impact on patient care. quality of life, and health care costs.[0010]
• Although peripherally inserted catheters of the prior art avoid direct cardiac trauma and can be placed without a major invasive chest incision (sternotomy or thoracotomy), they do not establish the condition of total extracorporeal circulation support.[0011]
• It is thus desirable to develop an extracorporeal circulation support system coupled to the blood circulation which directly removes blood from the left ventricle. It is further desirable to provide a method for directly venting the left ventricle.[0012]
SUMMARY OF THE INVENTION
• Accordingly, an object of the present invention is to provide an extracorporeal circulation support system that occludes the aorta and directly vents the left ventricle.[0013]
• Another object of the present invention is to provide an extracorporeal circulation support system with a vent lumen that directly vents the left ventricle.[0014]
• A further object of the present invention is to provide an extracorporeal circulation support system coupled to the blood circulation and directly vents the left ventricle.[0015]
• Still another object of the present invention is to provide a method for directly venting the left ventricle.[0016]
• These and other objects of the invention are provided in an extracorporeal support system coupled to the blood circulation. An extracorporeal support apparatus and an arterial circulation support catheter are provided. The arterial circulation support catheter includes a blood lumen with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation. A vent lumen has a distal end that crosses the aortic valve into the left ventricle and provides direct venting of the left ventricle through the vent lumen. An arterial circulation support catheter occluding member is positioned in an interior or an exterior of the arterial circulation support catheter. A venous circulation support catheter includes a blood lumen with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation. A venous circulation support catheter occluding member is included and positioned in an interior or at an exterior of the venous circulation support catheter. The venous circulation support catheter occluding member occludes the superior vena cava and the inferior vena cava.[0017]
• In another embodiment, a method for venting the left ventricle of the heart is disclosed. An extracorporeal circulation support system is provided and includes an extracorporeal support apparatus, a venous circulation support catheter, an arterial circulation support catheter and a vent lumen. The arterial circulation support catheter and venous circulation support catheter are introduced into the blood circulation. A vent lumen distal end is positioned in the left ventricle, and the left ventricle is directly vented through the vent lumen.[0018]
• An arterial circulation support catheter occluding member lumen can be coupled to the arterial circulation support catheter occluding member and positioned in the arterial circulation support catheter. The arterial circulation support occluding member can be slideably positioned in the blood lumen or in the arterial circulatory support occluding member lumen. The arterial circulation support catheter occluding member can be one or more clamps or balloons.[0019]
• A venous circulation support catheter occluding member lumen can be coupled to the venous circulation support catheter occluding member and positioned in the venous circulation support catheter. The venous circulation support catheter occluding member can be slideably positioned in the venous circulation support catheter blood lumen or in the venous circulation support catheter occluding member lumen.[0020]
• The arterial circulation support catheter may include an infusion lumen with a distal end that introduces an infusion medium into the aortic root. The infusion lumen may be positioned in the interior of the arterial circulation support catheter, at the exterior of the arterial circulation support catheter, in the blood lumen adjacent to the blood lumen or in the arterial circulation support catheter adjacent to the blood lumen.[0021]
• The venous circulation support catheter may also include an infusion lumen that introduces an infusion medium into the venous circulation. The infusion lumen can be positioned in the interior of the venous circulation support catheter, at the exterior of the venous circulation support catheter, in the blood lumen or in the venous circulation support catheter adjacent to the blood lumen. Inclusion of the infusion lumen permits the introduction of an incision medium into the venous circulation and may also vent mediums from the venous circulation and/or the right heart either simultaneously or at alternate times.[0022]
• An intervention al lumen, for the introduction of a diagnostic or therapeutic device into the blood circulation, may be positioned in an interior or exterior of the arterial circulation support catheter or in the blood lumen.[0023]
BRIEF DESCRIPTION OF THE FIGURES
• FIG. 1 is a schematic drawing illustrating the extracorporeal circulation support system of the present invention used for venting the left ventricle.[0024]
• FIG. 2 is a schematic drawing of an arterial circulation support catheter inserted into the subclavian artery.[0025]
• FIG. 3 is a schematic drawing illustrating positioning of the arterial and venous circulation support catheters of the present invention to achieve extracorporeal circulation support.[0026]
• FIGS.[0027]4(a) through4(d) are cross-sectional views of different arterial circulation support catheters of the present invention.
• FIGS.[0028]5(a) through5(c) are cross-sectional views of different venous circulation support catheters of the present invention.
• FIG. 6 is a cross-sectional view of an arterial circulation support catheter.[0029]
• FIG. 7 is a cross-sectional view of a distal end of a venous circulation support catheter.[0030]
• FIG. 8 is a phantom and part cross-sectional view of an embodiment of, an arterial circulation support catheter of the present invention.[0031]
• FIG. 9 is a schematic view illustrating an arterial circulation support catheter of the present invention inserted directly in the descending aorta.[0032]
• FIG. 10 is a schematic view illustrating an arterial circulation support catheter inserted through the femoral artery and a venous circulation support catheter occluding the superior and inferior vena cava.[0033]
DETAILED DESCRIPTION
• For purposes of this specification, venting is a method for decompressing or unloading a specific compartment of the circulation system. Typically, venting is the decompression of blood from a heart chamber. The left side of the heart is where oxygenated blood is introduced into the arterial system. The right side of the heart is where deoyxgenated blood is introduced into the pulmonary system. The patient may be a human, an animal or a simulator.[0034]
• Extracorporeal support system of the present invention can be used for a variety of procedures, both in the field of cardiology, as well as elsewhere in a patient. Cardiology applications (with a beating or non-beating heart) include but are not limited to, (i) CABG, (ii) congenital defects of the heart, (iii) valve repair and replacement, (iv) valvoplasty, (v) coronary bypass, (vi) heart venting, (vii) heart isolation and (viii) other procedures that are facilitated with heart venting without blood flowing into the heart chambers. The extracorporeal support system of the present invention is used with primary and reoperative surgical procedures as well as a life support system.[0035]
• An extracorporeal support system, denoted as[0036]10, is inserted in the blood circulation. Anextracorporeal support apparatus12 provides for the delivery of re-oxygenated blood to the blood circulation and in one embodiment includes anoutlet port14 for the delivery of re-oxygenated blood to the arterial circulation, and aninlet port16 for receiving blood from the venous circulation.Extracorporeal support apparatus12 can be a heart-lung apparatus, left ventricular assist device, roller pump, centrifugal device and the like. An arterialcirculation support catheter18 and a venouscirculation support catheter20 are provided. In one embodiment, arterialcirculation support catheter18 comprises a firstflexible cannula18′ and a secondflexible cannula18″. Aproximal end22 of arterialcirculation support catheter18 can be coupled tooutlet port14, and adistal end24 is introduced into the blood circulation including but not limited to the arterial circulation.distal end24 extends proximally to at least an occluding member coupled to arterialcirculatory support catheter18. Aproximal end26 of venouscirculation support catheter20 may be coupled toinlet port16, and adistal end28 is introduced into the blood circulation, including but not limited to the venous circulation.
• [0037]Extracorporeal support apparatus12 provides oxygenation and heating or cooling for blood and in one embodiment includes abubble oxygenator30, which incorporates a heat exchanger and an arterial reservoir, an arterial filter andline pressure monitor32, and apump34 from which oxygenated blood is returned to arterial circulation as shown by arrow C. A method to stop or start the heart may include a fibrillation and defibrillation apparatus coupled to the heart.
• First[0038]flexible cannula18′may be selectively placed in communication with apump33. This pump may also provide for the delivery of acardioactive agent37 to the aortic root through one ormore orifices35 contained indistal end24, or for venting blood from the aortic root Vented blood need not be returned toextracorporeal support apparatus12. In one method the path of returned blood is shown by arrow D through a cardiotomy reservoir return line tobubble oxygenator30 and a heat exchanger. The vented blood is thereafter oxygenated and then delivered to apump34 where it is returned into arterial circulation as shown by arrow C. In another method the path of blood extracted from the left ventricle is reintroduced into the arterial system distal to an arterial circulation support catheter occluding member.
• In one embodiment, arterial[0039]circulation support catheter18 may be minimally invasively inserted directly into the aorta This technique may require inserting a thorascope through an intercostal incision. The descending thoracic aorta and distal arch are identified. The thorascope is further utilized to obtain an actual image of the cardiac anatomic structure.
• Specifically and without limiting the scope of the present invention, the technique described in the preceding paragraph is used to assist the surgeon in fashioning a pair of circular tourniquet purse string sutures at the sight selected for insertion of the catheter into the descending thoracic aorta. After the purse string sutures are fashioned, a side-biting vascular clamp is then applied to occlude and isolate the insertion site from the rest of the aorta. This maneuver prevents bleeding when the catheter is advanced through a hole made in the center of the purse strings. After the catheter is advanced through the hole, the tourniquets are drawn taunt to snugly seal the aortic tissue around the catheter entry site. The side-biting vascular clamp is then removed.[0040]
• In another method to create the arteriotomy, a device is used which can facilitate the introduction and closure of the arteriotomy.[0041]
• Arterial[0042]circulation support catheter20 allowsdistal end24 to transverse the aortic valve wheredistal end24 has one or more openings for venting the left ventricle. Extracorporeal circulation support can be achieved with venouscirculation support catheter20 remotely inserted into the veins. Preferably, the insertion is in the femoral vein. Venouscirculation support catheter20 is then advanced and positioned at the atrio-caval junction by ultrasound or fluoroscopic techniques. To achieve delivery of blood into arterial circulation, one or more arterial catheters may be inserted peripherally into arterial vessels and then advanced and positioned in the aorta, or directly inserted into the aorta by utilizing purse string sutures and the like.
• As illustrated in FIG. 2, arterial[0043]circulation support catheter18 is inserted insubclavian artery36. Arterialcirculation support catheter18 and venouscirculatory support catheter20 may be manipulated with a joy stick, steerable and non-steerable guide wires, and the like. In one embodiment arterialcirculation support catheter18 is steered by ajoy stick38 into aortic arch40 such that afirst opening42 of arterialcirculation support catheter18 is positioned adjacent to the descending orthoracic aorta44. This permits the flow of oxygenated blood fromextracorporeal support apparatus12 into the arterial circulation. Firstflexible cannula18′ is slideably extendable from secondflexible cannula18″ and has one ormore occluding members46, which can be clamps, balloons, and the like, positioned in an interior or exterior of arterialcirculation support catheter18 adjacent todistal end24. For purposes of this specification, and without limitation, occludingmember46 shall hereafter be referred to asballoon46. In one embodiment,distal end24 is spaced a sufficient fixed distance fromballoon46 to transverseaortic valve48. In another embodimentdistal end24 is positioned directly adjacent to balloon46. Because of the slidable relationship of first and secondflexible cannulas18′ and18″ the distance betweenballoon46 and a second balloon (if included) can be varied. This slidable relationship permits arterialcirculation support catheter18 to be used with a greater spectrum of patients.
• In a further embodiment,[0044]distal end24 is extendable distally relative to balloon46 to permitdistal end24 to be advanced acrossaortic valve48 and intoleft ventricle50.Balloon46 may be positioned-in the ascending aorta by utilizing ultrasound or fluoroscopic imagery. One or more apertures can be formed indistal end24 to introduce a variety of different cardioactive agents.
• Referring now to FIG. 3, venous[0045]circulation support catheter20 is inserted peripherally into the femoral vein and advanced with the use of a joy stick, guide wire and the like. In one embodiment, to assist the surgeon in locatingdistal end24, and also to positionballoon46 in the aortic arch, a sensor is fixed adjacent todistal end24. The sensor can be made of an ultrasonic reflective material, coated with a piezoelectric or other material, or may be a radiopaque marker for fluoroscopically imagingdistal end24. One or more sensors are fixed to secondflexible cannula18″ adjacent to proximal and distal ends ofballoon46 respectively.
• Venous[0046]circulation support catheter20 is then positioned by ultrasound, Doppler, electromagnetic mark, fluoroscopy, and the like such thatdistal end28 extends intosuperior vena cava54.Superior vena cava54 is occluded by a first occludingmember56 which is located adjacent todistal end28 and placed cephalad to atrio-caval junction58. An optional second occludingmember60 is coupled to venouscirculation support catheter20 and spaced proximally from first occludingmember56 either in a fixed or adjustable relationship. First and second occludingmembers56 and60 can be balloons, clamps, deployment devices including but not limited to umbrellas and the like, positioned both at the interior and exterior of venouscirculation support catheter20, and the like.
• For purposes of this specification, and without limitation, occluding[0047]members46,56 and60 will hereafter be called a balloon. Suitable balloon materials include but are not limited to, silicon rubber, polyuretane, latex nylon, polyamide, polyethylene and the like. First and secondflexible cannulas18′ and18″ may be made of silicon rubber, polyvinyl chloride, polyurethane, ethylene, nylon and the like. Inflation ofballoons56 and60, as well asballoon46 may be achieved through the injection of a saline solution or other biocompatible fluid by a syringe through lumens contained within therespective catheters18 and20. Instead of a fluid, a gas including but not limited to CO₂may be used.
• [0048]Second balloon60 is positioned proximately of atrio-caval junction58 to occludeinferior vena cava62. First andsecond balloons56 and60 straddle atrio-cava junction58 and when inflated isolate the heart from blood flow into the right atrium of the heart. Arrows A illustrate the blood flow fromsuperior vena cava54 through one or morevenous orifices64 which are located indistal end28 of venouscirculation support catheter20.Venous orifice64 communicates with the axially extendingblood lumen66 and provide a flow path toextracorporeal support apparatus12.
• Extracorporeal circulation support during heart surgery requires the insertion of venous[0049]circulation support catheter20 through a peripheral vein access site and thereafter positioning distal venous return ports ofcatheter20 in superior andinferior vena cava54 and62 at atrio-caval junction58. Venouscirculatory support catheter20 contains one ormore balloons56 and/or59 that allow the choice of either partial or total heart isolation. Total heart isolation occurs ifballoon56, and/or the combination ofballoons56 and60, completely occluded both inferior andsuperior vena cava62 and54, thereby preventing blood flow into the right atrium.
• An insertion site for venous[0050]circulation support catheter20 may be the femoral vein, iliac vein, subclavian vein, axillary vein, or internal jugular vein. Insertion of venouscirculation support catheter20 through a peripheral vein access site avoids, (i) the necessity for a major chest incision to expose the heart and (ii) eliminates the surgical trauma that would occur to the right atrium,superior vena cava54, andinferior vena cava62. This procedure eliminates costly surgical instruments, tourniquets and reduces the operative time associated with conventional approaches to extracorporeal circulation support.
• To provide blood in arterial circulation, arterial[0051]circulation support catheter18 is inserted peripherally into arterial vessels to permit firstflexible cannula18′ to be advanced through the vessel into the ascending aorta. In one embodiment, arterialcirculation support catheter18 carriesballoon46 proximately ofdistal end24 for occluding the aorta afterballoon46 is positioned in the ascending aorta cephalad of the junction of the coronary arteries in the aortic root. Arterialcirculation support catheter18 is then connected toextracorporeal support apparatus12 which is then activated to permit oxygenated blood to be delivered to arterial circulation Cardioactive agents may be infused into the aortic root to arrest the heart. Additionally, contrast agents may also be introduced to visualize coronary structures.Balloons56 and60 of venouscirculation support catheter20 are expanded sufficiently to preclude blood flow from inferior andsuperior vena cava62 and54 into the right atrium. Total extracorporeal circulation support is achieved. If the vena cava is not totally occluded by complete inflation of one or both ofballoons56 and60 the result is partial isolation of the heart.
• In one embodiment, a pair of venous sensors are carried by venous[0052]circulation support catheter20 and located at the distal and proximal ends offirst balloon56. These sensors may be made of a material that is reflective of ultrasound or coated with a piezoelectric or other material. The piezoelectric material may generate an electric signal for transmission to a catheter system interface. The transmission is then presented on a monitor to assist the surgeon in visualizing the distal and proximal ends offirst balloon56 during its passage through the femoral vein and ultimate positioning in atrio-caval junction58. Alternatively, the sensors may be radiopaque markers for use in fluoroscopically imaging the location ofballoon56. Other methods of imaging known in the art may also be used.
• [0053]Inferior vena cava62 is occluded by the inflation ofsecond balloon60. Blood flowing toward the right atrium afterballoon60 is inflated is precluded from flowingpast balloon60 and enters venouscirculation support catheter20 throughvenous return ports68. The blood is then transported directly toextracorporeal support apparatus12.
• Arterial[0054]circulation support catheter18 may include one or more different lumens which may provide for the introduction and expulsion of blood to and from the arterial circulation.
• As illustrated in FIGS.[0055]4(a) to4(d) , a variety of lumens can be included and positioned in an interior or at an exterior of arterial circulation support catheter. These lumens can include, (i) avent lumen72, (ii) ablood lumen74, (iii) aninfusion lumen76, and anintervention lumen78.Vent lumen72 is used to directly vent blood fromleft ventricle50, introduce fluids or other devices. An inflation lumen coupled toballoon46 may also be includes
• [0056]Vent lumen72 has a distal end that crosses the aortic valve intoleft ventricle50.Vent lumen72 may also be utilized as an infusion lumen and/or introduce devices. Arterialcirculation support catheter18 can be a blood lumen, or alternatively include aseparate blood lumen74 which can be positioned adjacent to ventlumen72,infusion lumen76 orintervention lumen78.
• [0057]Infusion lumen76 andintervention lumen78 can be positioned inblood lumen74.Infusion lumen76 can introduce a variety of different infusion mediums into the arterial circulation. Suitable infusion mediums include but are not limited to, a cardio-active agent, one or more contrast agents, an iontropic agent, and the like.Infusion lumen76 may introduce the infusion medium into the aortic root and also be used to vent from the aortic root either simultaneously or at alternate times.Intervention lumen78 introduces a variety of different diagnostic or therapeutic devices into the arterial circulation.
• Referring now to FIGS.[0058]5(a) through5(c), venouscirculation support catheter20 can include ablood lumen80, aninfusion lumen82, anintervention lumen84 and avent lumen86. The functions ofblood lumen80,infusion lumen82,intervention lumen84 andvent lumen86 are substantially the same as their equivalent lumens associated with arterialcirculation support catheter18. Each of the lumens can be positioned in an interior or at an exterior ofvenous lumen20. Venouscirculation support catheter20 can be a blood lumen. Alternatively, aseparate blood lumen80 can be positioned in an interior of venouscirculation support catheter20.Infusion lumen82 introduces an infusion medium into the venous circulation, and can be positioned adjacent to or inblood lumen80.Intervention lumen84 may also be positioned adjacent to or inblood lumen80. Additionally, an inflation lumen can be coupled toballoon56 and/or60.
• By reference now to FIG. 6, it can be seen that first[0059]flexible cannula18′ may have four steeringlumens92 which extend in part axially throughflexible cannula18′ to permitsteering wires94 to pass through firstflexible cannula18′ in slidable relationship where the distal ends of thesteering wires94 are connected to the distal end of the firstflexible cannula18′. Through the manipulation ofjoy stick38 appropriate linkagepermits steering wires94 to be placed in tension relative to each other This permitsdistal end24 of arterialcirculation support catheter18 to articulate.
• A clearance exists between first[0060]flexible cannula18′ and secondflexible cannula18″ to permitflexible cannula18′ to be advanced through secondflexible cannula18″. Movement in either direction can induce the slidable advancement offirst cannula18′ withinsecond cannula18″. This arrangement permits the surgeon to positionfirst opening42 of secondflexible cannula18″ inaortic arch40 and thereafer to slidefirst cannula18′ relative tosecond cannula18″ andposition occluding member46 in the aortic root. In one embodiment a first sensor is carried by firstflexible cannula18′ proximally ofballoon46 and a second sensor is positioned at the distal end ofballoon46 where the sensors may be made of material that efficiently reflects ultrasonic waves.
• Ultrasound waves are detectable by a device such as a transesophageal echo device[0061]96 (FIG. 2) for a clear presentation of the extremities ofballoon46. This provides a more precise positioning ofballoon46 in aortic arch40 cephalid of the junction of the coronary arteries. Fluoroscopic imaging, Doppler, electromagnetic positioning, and other methods may also be used to positioned the catheters.
• Other embodiments of arterial[0062]circulation support catheter18 may utilize a reflective material to promote fluoroscopic imaging ofballoon46 extremities to achieve proper positioning in the aortic root. Suitable reflective materials include barium sulfate, bismuth subcarbonate and the like. First and secondflexible cannulas18′ and18″ may also be in part, (i) impregnated with materials for positioning and visualization, including but not limited to radiopaque materials such as barium sulfate, bismuth subcarbonate or iodine containing molecules, (ii) impregnated with tungsten, (iii) include materials to enhance performance characteristics including but not limited to fillers such as plasticizer or other pigmentation or anti-oxidants, or (iv) coated with blood physiology agents, and other agents and materials to promote visualization of arterialcirculation support catheter18 andballoon46 within the arterial vessel and aortic wall.
• Another embodiment of[0063]venous catheter20 is shown in FIG. 7 which permits the spacing between first andsecond balloons56 and60 to be adjustable. Only a single balloon need be used This enhances venous circulation support catheter's20 universality of use.
• In this embodiment, venous[0064]circulation support catheter20 is comprised of a firstflexible cannula20′ which is in part slideably contained for slidable axial movement relative to a secondflexible cannula20″. Because of the slideable relationship of the first and secondflexible cannulas20′ and20″ the distance betfirst balloon56 andsecond balloon60 can be varied. This slidable relationship permits venouscirculation support catheter20 to be used with a greater spectrum of patients.
• Venous[0065]circulation support catheter20 has one ormore orifices64 located indistal end28 which redirect blood flowing throughsuperior vena cava54 toward the right atrium where The blood is transported through venouscirculation support catheter20 toextracorporeal support apparatus12. Blood flowing throughinferior vena cava62 is prevented from reaching the right atrium by the inflation ofsecond balloon60. Blood flows through secondvenous return ports70 into venouscirculation support catheter20 where the blood is transported toextracorporeal support apparatus12.Distal end28 of venouscirculation support catheter20 may have an associated distal sensor. The distal sensor may be coated with a piezoelectric material, made of a suitable ultrasound reflective material, or be a radiopaque marker for fluoroscopically imaging the location ofdistal end28 of venouscirculation support catheter20. Additionally, one or more steering wires may be included to provide articulation and promote passage of venouscirculation support catheter20 through the venous circulation. Venouscirculation support catheter20 may include one or more different cavities or lumens which provide for the introduction and expulsion of blood to and from the venous circulation.
• An embodiment illuming total isolation of the heart is shown in FIG. 10, described later on in this specification. Although not shown in the figures, isolation of the heart may be achieved by utilizing two venous[0066]circulation support catheters20 of substantially identical construction. These catheters each have aninflatable balloon60 at their distal ends28. One of thecatheters20 is inserted through a peripheral vein the jugular vein for example,distal end28 is advanced intosuperior vena cava54 and positioned to occludesuperior vena cava54 at atrio-caval junction58. Orifices located proximally ofballoon60 permit blood flowing toward the right atrium to be diverted into a lumen within venouscirculation support catheter20 for transport toextracorporeal support apparatus12. Similarly, second venouscirculation support catheter20 is inserted through the femoral vein and advanced and positioned ininferior vena cava62 at atrio-caval junction58.Balloon60 is then inflated and blood flow redirected through one or more orifices located proximally ofballoon60 toextracorporeal support apparatus12.
• Arterial[0067]circulation support catheter18 of FIG. 8 provides an extendeddistal end24 which may pass acrossaortic valve48 and intoleft ventricle50 to provide direct venting. Acardioactive agent37 can be delivered into the aortic root, as in the above-described embodiments of arterialcirculation support catheter18, or the same flow path may be used for aspiration of the aortic root. Extendeddistal end24 of arterialcirculation support catheter18 is positioned inaortic arch40 afterballoon46 where firstflexible cannula18′ is extendable from secondflexible cannula18″. One or more flow lumens are included in firstflexible cannula18′ to provide for blood venting fromleft ventricle50 toextracorporeal support apparatus12.
• A specific embodiment for venting using arterial circulation[0068]support catheter circuit98 is illustrated in FIG. 9. These elements provide for injection ofcardioactive agent37, venting of the aortic root,balloon46 inflation and deflation, arterial circulation of blood from the bypass pump, and leftventricle50 decompression. Arterialcirculation support catheter18 may also be inserted into ascending aortic arch40 after a sternotomy has been performed and the heart exposed.
• [0069]Distal end24 is positioned inleft ventricle50 where blood may be suctioned through one or more arterial venting orifices106. Arterialcirculation support catheter18 allows blood inleft ventricle50 to be vented. Simultaneously, blood present in the aortic root may also be vented through one ormore venting orifices102.Cardioactive agent37 may thereafer be infused through ventingorifice102 through avent lumen72, and the solution will flow into the coronary arteries and stop the heart.
• FIG. 10 illustrates an embodiment where total isolation of the heart is achieved. Arterial[0070]circulation support catheter18 is advanced through the femoral artery and positioned such thatballoon46 may be inflated to occlude the aorta cephalad of the aortic root. Oxygenated blood is then delivered throughblood lumen74, or alternatively throughvent lumen72, into arterial circulation.Vent lumen72,blood lumen74 orinfusion lumen76 deliverscardioactive agent37 to arrest the heart, provide venting the aortic root and provide extension ofdistal end24 intoleft ventricle50 across the aortic valve. This permits decompression ofleft ventricle50 before the right atrium is isolated by inflation ofballoon56 and/orballoons56 and60.
• Another method for providing extracorporeal circulation support during heart surgery includes using two arterial[0071]circulation support catheters18. Both are advanced intoaortic arch40. Venouscirculation support catheter20 is then positioned to preclude blood flow into the right atrium. Passage of blood from the aortic root into the systemic arterial circulation is occluded.Cardioactive agent37 is then infused into the aortic root to arrest the heart and the aortic root is then vented. The right atrium and the heart are isolated. Total heart isolation is achieved.
• 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 the scope of the invention be defined by the following claims and their equivalents.[0072]

Claims (47)

What is claimed is:

1. An extracorporeal support system coupled to a blood circulation, comprising:

an extracorporeal support apparatus;

an arterial circulation support catheter with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation, the arterial circulation support catheter including a blood lumen and a vent lumen with a distal end that crosses the aortic valve into the left ventricle for direct venting of the left ventricle through the vent lumen;

an arterial circulation support catheter occluding member positioned in an interior or at an exterior of the arterial circulation support catheter;

a venous circulation support catheter with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation, the venous circulation support catheter including a blood lumen; and

a venous circulation support catheter occluding member to occlude the superior vena cava and the inferior vena cava, the venous circulation support catheter occluding member being positioned in an interior or at an exterior of the venous circulation support catheter.

2. The system ofclaim 1, wherein the extracorporeal support apparatus includes an outlet port for the delivered of re-oxygenated blood to the blood circulation, and an inlet port for receiving blood from the blood circulation.

3. The system ofclaim 2, wherein the arterial circulation support catheter proximal end is coupled to the outlet port, and the venous circulation support catheter proximal end is coupled to the inlet port.

2. The system ofclaim 1, further comprising:

an arterial circulatory support occluding member lumen coupled to the arterial circulatory support occluding member and positioned in the arterial circulation support catheter.

3. The system ofclaim 1 and2, wherein the arterial circulatory support occluding member is slideably positioned in the blood lumen or the arterial circulation support occluding member lumen.

4. The system ofclaim 1, wherein the arterial circulation support catheter occluding member is a clamp.

5. The system ofclaim 1, further comprising:

a venous circulation support catheter occluding member lumen coupled to the venous circulation support catheter occluding member and positioned in the venous circulation support catheter.

6. The system of claims1 and5, wherein the venous circulation support catheter occluding member is slideably positioned in the venous circulation support catheter blood lumen or the venous circulation support catheter occluding member lumen.

7. The system ofclaim 1, wherein the vent lumen provides infusion capability into the left ventricle.

8. The system ofclaim 1, wherein the arterial circulation support catheter occluding member is a balloon.

9. The system ofclaim 1, wherein the arterial circulation support catheter includes two occluding members.

10. The system ofclaim 1, wherein the arterial circulation support catheter further comprises:

an infusion lumen including a distal end that introduces an infusion medium into the aortic root, wherein the infusion lumen is positioned in the interior or at the exterior of the arterial circulation support catheter.

11. The system ofclaim 10, wherein the infusion lumen is positioned in the blood lumen.

12. The system ofclaim 10, wherein the infusion lumen is positioned in the arterial circulation support catheter adjacent to the blood lumen.

13. The system ofclaim 10, wherein the infusion lumen introduces an infusion medium into the aortic root and vents mediums from the aortic root simultaneously or at alternative times.

14. The system ofclaim 1, wherein the arterial circulation support catheter further comprises:

an international lumen including a distal end that introduces a diagnostic or therapeutic device into the blood circulation, wherein the interventional lumen is positioned in the interior or at the exterior of the arterial circulation support catheter.

15. The system ofclaim 14, wherein the interventional lumen is positioned in the blood lumen.

16. The system ofclaim 14, wherein the infusion lumen is positioned in the arterial circulation support catheter adjacent to the blood lumen.

17. The system ofclaim 1, wherein the extracorporeal support apparatus includes a device to re-oxygenate blood.

18. The system ofclaim 17, wherein the extracorporeal support apparatus further includes a temperature control device to cool the heart and assist in stopping the heart from beating, and subsequently heat the heart to assist in initiating the heart to beat.

19. The system ofclaim 18, wherein the flirter comprising:

a fibrillation and defibrillation apparatus coupled to the heart.

20. The system ofclaim 1, wherein the arterial circulatory support catheter occluding member is positioned in the ascending aorta.

21. The system ofclaim 10, wherein the infusion medium is a cardio-active agent.

22. The system ofclaim 10, wherein the infusion medium is one or more contrast agents.

23. The system ofclaim 10, wherein the infusion medium is an iontropic agent.

24. The system ofclaim 1, wherein the venous circulation support catheter occluding member includes two occluding members.

25. The system ofclaim 24, wherein the two occluding members are balloons.

26. The system ofclaim 24, wherein the occluding members are adjustably positioned relative to each other.

27. The system ofclaim 1, wherein the venous circulation support catheter further composes:

an infusion lumen including a distal end that introduces an infusion medium into the venous circulation, wherein the infusion lumen is positioned in the interior or at the exterior of the venous circulation support catheter.

28. The system ofclaim 27, wherein the infusion lumen is positioned in the blood lumen.

29. The system ofclaim 27, wherein the infusion lumen is positioned in the venous circulation support catheter adjacent to the blood lumen.

30. The system ofclaim 27, wherein the infusion lumen introduces an infusion medium into the blood circulation and vents mediums from the blood circulation simultaneously or at alternatively.

31. The system ofclaim 1, wherein the venous circulation support catheter further comprises:

an interventional lumen including a distal end that introduces a diagnostic or therapeutic device into the blood circulation, wherein the interventional lumen is positioned in the interior or at the exterior of the venous circulation support catheter.

32. The system ofclaim 25, wherein the interventional lumen is positioned in the blood lumen.

33. The system ofclaim 25, wherein the interventional lumen is positioned in the venous circulation support catheter adjacent to the blood lumen.

34. The system ofclaim 30, wherein the infusion medium is a cardio-active agent.

35. The system ofclaim 30, wherein the infusion medium is one or more contrast agents.

36. The system ofclaim 30, wherein the infusion medium is an iontropic agent.

37. The system ofclaim 31, wherein the interventional lumen introduces a therapeutic device.

38. The system ofclaim 31, wherein the interventional lumen permits balloon valvuloplasty.

39. An extracorporeal support system coupled to a blood circulation, comprising:

an extracorporeal support apparatus;

an arterial circulation support catheter including a blood lumen with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation;

an arterial circulation support catheter occluding member positioned in an interior or at an exterior of the arterial circulation support catheter;

a vent lumen with a distal end positioned in the left ventricle and provide direct venting of the left ventricle, wherein the vent lumen is positioned in the interior or the exterior of the arterial circulatory support lumen.

a venous circulation support catheter including a blood lumen with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation; and

a venous circulation support catheter occluding member to occlude the superior vena cava and the inferior vena cava, the venous circulation support catheter occluding member being positioned in an interior or at an exterior of the venous circulation support catheter.

40. The system ofclaim 39, wherein the distal end of the vent lumen crosses the aortic valve.

41. The system ofclaim 39, wherein the vent lumen is positioned in the arterial circulation support catheter blood lumen.

42. A method for venting a left ventricle of a heart, comprising:

providing an extracorporeal circulation support system including an extracorporeal support apparatus, a venous circulation support catheter, an arterial circulation support catheter and a vent lumen;

introducing the arterial circulation support catheter into a blood circulation;

introducing the venous circulation support catheter into the blood circulation;

positioning a vent lumen distal end into a left ventricle of the heart; and

venting the left ventricle rough the vent lumen.

43. The method ofclaim 42, wherein a proximal end of the arterial circulation support catheter is coupled to an outlet port of the extracorporeal support device.

44. The method ofclaim 43, wherein a proximal end of the venous circulation support catheter is coupled to an inlet port of the extracorporeal support device.

45. The method ofclaim 42, wherein the left ventricle is directly vented through the vent lumen.

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