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 flow 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 aortic 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. The embolic filter assembly includes an aortic occlusion device, which may be a toroidal balloon, an expandable balloon or a selectively deployable external catheter flow control valve. The combined device allows percutaneous transluminal administration of cardiopulmonary bypass and cardioplegic arrest with protection from undesirable embolic events.

Abstract: An apparatus and method are described for therapeutic hypothermia of the heart by selective hypothermic perfusion of the myocardium through the patient's coronary arteries. The apparatus and method provide rapid cooling of the affected myocardium to achieve optimal myocardial salvage in a patient experiencing acute myocardial infarction. The therapeutic hypothermia system includes one or more selective coronary perfusion catheters and a fluid source for delivering a hypothermically-cooled physiologically-acceptable fluid, such as saline solution, oxygenated venous blood, autologously-oxygenated arterial blood and/or an oxygenated blood substitute. The system may also include one or more guidewires, subselective catheters and/or interventional catheters introduced through a lumen in the selective coronary perfusion catheter.

Abstract: The present invention is related to cerebral embolic protection assemblies (CEPA) to be used during a medical procedure to help redirect or catch emboli before it is pumped into the cerebral circulation. A variety of CEPA's are disclosed including a perfusion filter catheters and fluid flow dividers for capturing and redirecting potential emboli within the aorta during heart surgery and cardiopulmonary bypass. The catheter devices may further include one or more additional or auxiliary flow control members. Furthermore, oxygenated blood is perfused through a perfusion lumen in the catheter. The present invention describes devices that are capable of capturing and/or redirected emboli away from the cerebral circulation. The devices are configured for percutaneous, intercostal, lateral or central insertion with attendant administration of cardiopulmonary bypass and cardioplegic arrest with protection from undesirable embolic events.

Abstract: The present invention is related to cerebral embolic protection assemblies (CEPA) to be used during a medical procedure to help redirect or catch emboli before it is pumped into the cerebral circulation. A variety of CEPA's are disclosed including a perfusion filter catheters and fluid flow dividers for capturing and redirecting potential emboli within the aorta during heart surgery and cardiopulnonary bypass. The catheter devices may further include one or more additional or auxiliary flow control members. Furthermore, oxygenated blood is perfused through a perfusion lumen in the catheter. The present invention describes devices that are capable of capturing and/or redirected emboli away from the cerebral circulation. The devices are configured for percutaneous, intercostal, lateral or central insertion with attendant administration of cardiopulmonary bypass and cardioplegic arrest with protection from undesirable embolic events.

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 methods for secure distribution of documents over electronic networks. The method may be implemented over public private and/or semi-private electronic networks, including computer networks, intranets, the Internet or combinations thereof. The method includes novel clueing and encryption mechanisms for secure transmission of documents and other electronic data. The method may further include steps for recording the transmitted document in a tangible medium and secure delivery of the document to an intended recipient.

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: 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 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: Apparatus and methods for defibrillating a heart in fibrillation are provided using apparatus that forms a plurality of transmural channels in a wall of the heart. The apparatus includes a single-use handpiece having a mechanical cutting head and means for stabilizing the cutting head in contact with the tissue. The handpiece is coupled by a disposable cable to a controller that houses a vacuum pump and mechanisms for driving the cutting head. The cutting head is adapted to cooperate with the vacuum pump to evacuate tissue severed during the channel forming process.

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.

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: 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. 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.