Abstract: The present invention relates to a catheter or cannula system that facilitates cardiopulmonary bypass surgeries and enables prolonged circulatory support of the heart. More specifically, the present invention provides an aortic catheter system including a porous aortic root balloon capable of occluding the aorta, delivering cardioplegia and providing tactile feedback and helping to maintain the competency of regurgitant aortic valves.

Abstract: The present invention provides methods, systems and devices for performing cardipulmonary bypass (CPB), cardioplegic arrest, suction of fluid from the aorta to remove embolic or other fluid from the general circulation and the selective segmentation of the arterial system to perform differential perfusion eliminating hypoperfusion. An aortic catheter having an arch lumen which extends at least in part along the length of the catheter shaft has a proximal opening coupled to a CPB machine and a distal arch opening. A corporeal lumen extends at least in part along the length of the catheter shaft and has a proximal opening coupled to a CPB machine and a distal corporeal opening. A suction lumen extends at least in part along the length of the catheter shaft and has a proximal suction opening coupled to a suction source and a distal suction opening residing in the aortic lumen of a patient.

Abstract: A system for establishing differential perfusion without the use of an occlusion balloon or other flow separator devices. The flows through two lumens are controlled such that the blood flow issuing from one lumen terminating in the aortic arch supplies the entire demand of the cerebral subcirculation while the blood flow issuing from a second lumen terminating in the descending aorta supplies the entire demand of the corporeal subcirculation. When the two flows are properly balanced, an inversion layer forms therebetween and no intermixing of the two flows takes place.

Abstract: An aortic shunt apparatus and methods for cerebral embolic protection are described for isolating the aortic arch vessels from the aortic lumen, for selectively perfusing the arch vessels with a fluid and for redirecting blood flow within the aortic lumen and any potential embolic materials carried in the blood through a shunt past the isolated arch vessels. The perfusion shunt apparatus may be mounted on a catheter or cannula for percutaneous introduction or for direct insertion into the aorta. The perfusion shunt apparatus has application for protecting a patient from embolic stroke and hypoperfusion during cardiopulmonary bypass or cardiac surgery and also for selectively perfusing the cerebrovascular circulation with oxygenated blood or with neuroprotective fluids in the presence of risk factors, such as head trauma or cardiac insufficiency. The perfusion shunt apparatus will also find application for selective perfusion of other organ systems within the body.

Abstract: A method and device for perfusing an organ system is provided. The device may be further described as a catheter or cannula with an expandable flow control member positioned of the distal portion of the catheter shaft. The flow control member has a porous portion, and at least one impermeable portion, which prevent fluid from flowing out the ends of the flow control member. The flow control member is further characterized as having an interior chamber that is in fluid communication with a perfusion lumen that extends along the length of the catheter shaft and is in fluid communication with an external perfusion pump. The perfusion lumen is configured for providing flow to the interior of the flow control member, to create radial expansion thereof and to provide adequate flow to the arch vessels through said porous portion to sustain the metabolic demands of the brain.

Abstract: Described is a closed chest intravascular catheter system for a simultaneous biventricular approach to (1) intravascular cardiopulmonary surgery; (2) acute or prolonged mechanical circulatory support. The catheter system includes a left heart catheter and a right heart catheter with flow control members that segment the circulatory system into subcirculations of cardiopulmonary support. The left heart catheter has an elongated shaft with a first flow control member positioned at the entry site into a peripheral artery, a second flow control member positioned in the proximal descending aorta, a third flow control member positioned in the ascending aorta, and a fourth flow control member positioned within the left ventricle.

Abstract: A system and methods are described for performing catheter based procedures on high risk patients that mitigate the risk to the patient and extend the acceptable time window for response when emergencies or complications arise. The system is useful for stopped heart catheter procedures or as a safety backup in beating heart catheter procedures and is compatible with concurrent or sequential surgical interventions. The system combines a therapeutic or diagnostic catheter subsystem with a selective aortic perfusion and cardiopulmonary bypass subsystem. The catheter subsystem may include catheters for angioplasty, stent delivery, atherectomy, valvuloplasty or other diagnostic or therapeutic procedures.

Abstract: The present invention discloses a multi-access cannula for use in a variety of surgical procedures, particularly for use in the course of performing conventional open-chest and peripheral access cardiopulmonary bypass (CPB). The multi-access cannula is capable of being inserted through a single puncture site with a percutaneous tip. At the appropriate depth of insertion, a closure seal may be engaged at the point of entry to secure the positioning of the cannula and prevent leakage of blood from the incision. Once the cannula is at the appropriate position the cannula provides a multiplicity of procedural options for the surgeon. For example, when approaching through the ascending aorta, the multi-access cannula enables the simultaneous passage of various fluids and multiple catheters or instruments in opposing directions within the lumen of the aortic arch through a single insertion site.

Abstract: The present invention relates to catheters for selectively cooling or warming tissue within a patient's vasculature. The present invention utilizes novel heat exchanging devices, which reside inside the catheter body for selectively altering the temperature of fluid that flows through the catheter shaft. In addition, the present invention utilizes novel pumping devices, which reside within a patient's vasculature for withdrawing oxygenated blood into the catheter body where heat exchange occurs across a heat transfer interface for selective cooling or warming of the blood occurs. The present invention can be used in a multiplicity of medical disciplines where it is advantageous to selectively alter the temperature of tissue, including beating heart applications, as well as stopped heart medical interventions.

Abstract: The present invention provides an aortic catheter having an upstream occlusion member positioned in the ascending aorta between the coronary arteries and the brachiocephalic artery and a downstream anchoring member positioned in the descending aorta, downstream of the aortic arch. The upstream occlusion member is in the form of a narrow, disk-shaped inflatable balloon. The downstream anchoring member may be a larger inflatable balloon or other anchoring structure that provides sufficient friction to prevent migration of the balloon catheter in the upstream or downstream direction. In addition, an arch perfusion lumen, a corporeal perfusion lumen and a cardioplegia lumen are provided for performing selective perfusion and cardioplegic arrest.

Abstract: A method and device for perfusing an organ system is provided. The device may be further described as a catheter or cannula with an expandable flow control member positioned of the distal portion of the catheter shaft. The flow control member has a porous portion, and at least one impermeable portion, which prevent fluid from flowing out the ends of the flow control member. The flow control member is further characterized as having an interior chamber that is in fluid communication with a perfusion lumen that extends along the length of the catheter shaft and is in fluid communication with an external perfusion pump. The perfusion lumen is configured for providing flow to the interior of the flow control member, to create radial expansion thereof and to provide adequate flow to the arch vessels through said porous portion to sustain the metabolic demands of the brain.

Abstract: A circulatory support system and method for circulatory support are described for performing cardiopulmonary bypass using differential perfusion and/or isolated segmental perfusion of the circulatory system. The circulatory support system includes one or more venous cannulae for draining blood from the venous side of the patient's circulatory system, one or more arterial cannulae for perfusing the arterial side of the patient's circulatory system, and one or more blood circulation pumps connected between the venous cannulae and the arterial cannulae. The arterial cannulae and the venous cannulae of the circulatory support system may take one of several possible configurations. The circulatory support system is configured to segment a patient's circulatory system into one or more isolated circulatory loops.

Abstract: The invention is a catheter with a fluid flow divider positioned near the distal end of the catheter for dividing a first lumen into two channels at a point where a second lumen branches from the first lumen, and for selectively perfusing the branch lumen. The invention is particularly suited for use in the aortic arch. The fluid flow divider may comprise one or more inflatable chambers or one or more deployable shrouds comprising a plurality of arms with a webbing extending between adjacent arms. The inflatable chambers may be relatively noncompliant or they may be compliant, exhibiting elastic behavior after initial inflation, to closely fit the aortic lumen size and curvature. The catheter may further include one or more additional or auxiliary flow control members located upstream or downstream from the fluid flop divider to further segment the patient's circulatory system for selective perfusion to different organ systems within the body or to assist in anchoring the catheter in a desired position.

Abstract: A perfusion filter catheter is used to capture potential emboli within the aorta during heart surgery and cardiopulmonary bypass. An expandable embolic filter assembly having fine filter mesh for capturing macroemboli and microemboli is mounted on a catheter shaft having a perfusion lumen with perfusion ports located upstream of the filter. The embolic filter assembly can be actively or passively deployed within the ascending aortic. An optional outer tube covers the embolic filter assembly to prevent premature deployment. Radiopaque markers, sonoreflective markers and/or an aortic transillumination system are provided to monitor the position of the catheter and the deployment state of the embolic filter assembly. The embolic filter assembly is configured to maximize the effective filter surface area when deployed.

Abstract: The present invention relates to a catheter or cannula system that facilitates cardiopulmonary bypass surgeries and enables prolonged circulatory support of the heart. More specifically, the present invention provides an aortic catheter system including a porous aortic root balloon capable of occluding the aorta, delivering cardioplegia and providing tactile feedback and helping to maintain the competency of regurgitant aortic valves.

Abstract: A perfusion shunt apparatus and methods are described for isolating and selectively perfusing a segment of a patient's cardiovascular system and for directly circulatory flow around the isolated segment. An aortic perfusion shunt apparatus is configured for deployment within a patient's aortic arch and methods are described for isolating the aortic arch vessels from the aortic lumen, for selectively perfusing the arch vessels with a fluid and for directly blood flow within the aortic lumen through a shunt past the isolated arch vessels. The perfusion shunt apparatus may be mounted on a catheter or cannula for percutaneous introduction or for direct insertion into a circulatory vessel, such as the aorta.

Abstract: The present invention includes an apparatus and methods for differentially perfusing a patient undergoing cardiopulmonary bypass. A cardiopulmonary bypass machine is configured to provide hypothermic oxygenated blood and normothermic oxygenated blood to an aortic balloon catheter. The catheter has arch perfusion ports and corporeal perfusion ports and is introduced into a patient's aorta and navigated transluminally until the occlusion balloon is located in the descending aorta. The occlusion balloon is inflated and hypothermic oxygenated blood is perfused to the arch vessels while normothermic oxygenated blood is perfused to the corporeal circulation. This procedure offers the benefit of cerebral protection from embolic events during cardiopulmonary bypass surgery.

Abstract: A perfusion shunt apparatus and methods are described for isolating and selectively perfusing a segment of a patient's cardiovascular system and for directing circulatory flow around the isolated segment. An aortic perfusion shunt apparatus is configured for deployment within a patient's aortic arch and methods are described for isolating the aortic arch vessels from the aortic lumen, for selectively perfusing the arch vessels with a fluid and for directing blood flow within the aortic lumen through a shunt past the isolated arch vessels. The perfusion shunt apparatus may be mounted on a catheter or cannula for percutaneous introduction or for direct insertion into a circulatory vessel, such as the aorta.

Abstract: The present invention provides an aortic catheter having an upstream occlusion member positioned in the ascending aorta between the coronary arteries and the brachiocephalic artery and a downstream anchoring member positioned in the descending aorta, downstream of the aortic arch. The upstream occlusion member may be an inflatable balloon or a selectively deployable external catheter valve. The downstream anchoring member may be a larger inflatable balloon or other anchoring structure that provides sufficient friction to prevent migration of the balloon catheter in the upstream or downstream direction. In addition, an arch perfusion lumen, a corporeal perfusion lumen and a cardioplegia lumen are provided for performing selective perfusion and cardioplegic arrest.

Abstract: Described is a closed chest intravascular catheter system for a simultaneous biventricular approach to (1) intravascular cardiopulmonary surgery; (2) acute or prolonged mechanical circulatory support. The catheter system includes a left heart catheter and a right heart catheter with flow control members which segment the circulatory system into subcirculations of cardiopulmonary support. The left heart catheter has an elongated shaft with a first flow control member positioned at the entry site into a peripheral artery, a second flow control member positioned in the proximal descending aorta, a third flow control member positioned in the ascending aorta, and a fourth flow control member positioned within the left ventricle.