Abstract: A blood flow pump device includes a centrifugal pump having a single ball-and-cup hybrid magnetic/blood immersed bearing-supported shrouded impeller driven by a magnetically coupled motor drive. The device further includes a housing, an impeller, and a shroud, thus forming a pump chamber. The impeller is a shrouded impeller having extended blades from a hub of the impeller and the shroud. The system and method employ a blood flow pump device having a housing with a blood inlet and a blood outlet, the housing defining a fluid pathway between the inlet and the outlet, and the housing containing an impeller comprising a base, a base lid, two blades, and a shroud, with the housing positioned on a motor. A controller communicates with the motor and controls rotational speed of the impeller in response to the blood flow through the blood outlet.

Abstract: The present invention discloses a self-sealing cannula and methods of its use. The self-sealing cannula can be minimally invasively placed into the heart for drawing and/or returning blood with a self-sealing function at the interface of the blood access site. The disclosed cannula can be implemented as a single lumen cannula or a double lumen cannula, which can be used with ventricular assist devices for heart support or pump-oxygenators for ECMO and respiratory support. Through a self-sealing mechanism fixed on the ventricular wall or atrial wall, a cannula body is attached to the self-sealing fixture and blood is drawn into the lumen via an external pump and returned to the circulation system through a separate cannula. In the case of the double lumen cannula embodiment, the blood will be drawn into the drainage lumen of the double lumen cannula and returned through an infusion lumen at the desired location.

Abstract: An oxygen supply unit for use with a blood oxygenator comprises an oxygen concentrator and a carbon dioxide scrubber. In an on-line operational mode, oxygen-rich gas from the oxygen concentrator is predominantly supplied to the blood oxygenator with a reduced flow of recycled gas from the concentrator. In an off-line operational mode where the oxygen supply unit is being powered by battery only, a larger flow of recycled gas from the blood oxygenator is passed through the carbon dioxide scrubber and combined with a lesser amount of oxygen-rich gas from the oxygen concentrator. The oxygen supply unit may be used in combination with a blood pump and oxygenator to provide ambulatory blood oxygenation to patients with compromised lung function.

Abstract: A modular cannula for drainage and return of fluids from and to a body, such as the body of a patient, is adjustable to enable an operator to achieve desired flow characteristics during such fluid drainage and return procedures. The modular, dual-lumen cannula system has an outer drainage cannula and an inner return cannula that is moveable with respect to the outer drainage cannula. By enabling movement of the inner return cannula with respect to the outer drainage cannula, a distance between return outlet ports at the distal end of the return cannula and drainage ports at the distal end of the drainage cannula may be manually adjusted. Such adjustable distance allows for optimal positioning of both the drainage and return ports that are particularly adapted to an individual patient’s physiology, in turn enabling optimal fluid flow characteristics to be achieved regardless of that patient physiology.

Abstract: A device and method is provided herein for esophageal impingement of a patient's aorta. The device may be inserted into a patient's esophagus and positioned at the location where the esophagus passes over the patient's aorta. In this position, an actuation device is used to apply pressure to the patient's aorta through their esophagus to impinge or occlude the aorta to stop or significantly reduce hemorrhaging. A manually operable actuator handle enables a physician to manipulate a head assembly of the device through three distinct degrees of freedom of movement so as to control placement and direction of force against the patient's esophagus and, in turn, their aorta.

Abstract: An oxygen supply unit for use with a blood oxygenator comprises an oxygen concentrator and a carbon dioxide scrubber. In an on-line operational mode, oxygen-rich gas from the oxygen concentrator is predominantly supplied to the blood oxygenator with a reduced flow of recycled gas from the concentrator. In an off-line operational mode where the oxygen supply unit is being powered by battery only, a larger flow of recycled gas from the blood oxygenator is passed through the carbon dioxide scrubber and combined with a lesser amount of oxygen-rich gas from the oxygen concentrator. The oxygen supply unit may be used in combination with a blood pump and oxygenator to provide ambulatory blood oxygenation to patients with compromised lung function.

Abstract: A device and method is provided herein for esophageal impingement of a patient's aorta. The device may be inserted into a patient's esophagus and positioned at the location where the esophagus passes over the patient's aorta. In this position, an actuation device is used to apply pressure to the patient's aorta through their esophagus to impinge or occlude the aorta to stop or significantly reduce hemorrhaging. A manually operable actuator handle enables a physician to manipulate a head assembly of the device through three distinct degrees of freedom of movement so as to control placement and direction of force against the patient's esophagus and, in turn, their aorta.

Abstract: The device of the present invention includes a dual chamber gas exchanger that is configured for increased flexibility and scalability for many clinical applications. The dual chamber oxygenator can be configured and used in various applications, such as in a heart-lung machine for cardiopulmonary support during cardiothoracic surgery, in an extracorporeal membrane oxygenation (ECMO) circuitry, as a respiratory assist device for patients with lung failure, and the like. The dual chamber gas exchanger features two sweep gas flow paths and two gas exchange membrane bundles enclosed in a housing structure with various blood flow distribution and gas distribution mechanisms. The gas exchanger includes an outer housing, an intermediate housing, two gas exchange fiber bundles, a blood inlet, a blood outlet, two gas inlets, two gas outlets, two gas distribution chambers and an optional heat exchanger.

Abstract: The device of the present invention includes a dual chamber gas exchanger that is configured for increased flexibility and scalability for many clinical applications. The dual chamber oxygenator can be configured and used in various applications, such as in a heart-lung machine for cardiopulmonary support during cardiothoracic surgery, in an extracorporeal membrane oxygenation (ECMO) circuitry, as a respiratory assist device for patients with lung failure, and the like. The dual chamber gas exchanger features two sweep gas flow paths and two gas exchange membrane bundles enclosed in a housing structure with various blood flow distribution and gas distribution mechanisms. The gas exchanger includes an outer housing, an intermediate housing, two gas exchange fiber bundles, a blood inlet, a blood outlet, two gas inlets, two gas outlets, two gas distribution chambers and an optional heat exchanger.

Abstract: Devices and methods are provided for trans-esophageal aortic flow control. The device comprises a controller, an esophageal tube extending from the controller, an anchor device at a distal end of the esophageal tube and configured to anchor the distal end of the device inside a patient's stomach, and an actuator positioned proximally to the anchoring device by a sufficient distance so that the actuator will be proximal to the intersection of the patient's esophagus with their diaphragm when the anchoring device is positioned inside of the patient's stomach. In this position, the anchoring device is aligned with the location at which the patient's esophagus and aorta cross that is above (or proximal to) the intersection with the patient's diaphragm, with the patient's aorta then positioned between the spine and the esophagus.

Abstract: A blood oxygenator is disclosed comprising a housing, a blood inlet, a blood outlet, a spiral volute, a gas inlet, an oxygenator fiber bundle, and a gas outlet. The housing encloses the fiber bundle and provides the structure for the blood flow path and connectors. The fiber bundle comprises gas-exchange membranes which transfer oxygen to the blood and remove carbon dioxide when the blood flows across the membranes. The spiral volute guides the blood to flow through the fiber bundle. A gas flow chamber receives sweep gas containing oxygen and distributes the sweep gas into the fiber membranes, which gas is then exchanged with the blood being oxygenated.

Abstract: A demand-adapting and auto-regulatory ECMO system and method is disclosed that may be configured to provide complete cardiopulmonary replacement. The system and method employ a blood gas exchanger having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, an oxygen sensor positioned to detect oxyhemoglobin saturation at the blood inlet, and a carbon dioxide sensor positioned to detect exhaust gas CO2 concentration at the gas outlet. A controller communicates with the oxygen sensor and the carbon dioxide sensor and controls blood flow and gas flow through the blood gas exchanger in response to a sensed oxygen level by the oxygen sensor and a sensed carbon dioxide level by the carbon dioxide sensor, in turn maintaining the sensed oxygen level and the sensed carbon dioxide level within a pre-designated range of values to maintain a patients metabolic requirements.

Abstract: A blood oxygenator is disclosed comprising a housing, a blood inlet, a blood outlet, a spiral volute, a gas inlet, an oxygenator fiber bundle, and a gas outlet. The housing encloses the fiber bundle and provides the structure for the blood flow path and connectors. The fiber bundle comprises gas-exchange membranes which transfer oxygen to the blood and remove carbon dioxide when the blood flows across the membranes. The spiral volute guides the blood to flow through the fiber bundle. A gas flow chamber receives sweep gas containing oxygen and distributes the sweep gas into the fiber membranes, which gas is then exchanged with the blood being oxygenated.

Abstract: Disclosed is a self-expanding cannula, systems using such cannulae, and methods of their use. The cannulae may comprise single lumen cannula (“SLC”) configurations and double lumen cannula (“DLC”) configurations, and include at least a first cannula and a self-expanding wire frame attached to the first cannula. Self-expanding wire frame is automatically expandable from a compressed state (providing a reduced cannula diameter as it is moved through a patient's body to the site at which it is to be deployed) to an expanded state (which increases the diameter of the cannula to the diameter intended for its normal use). The expanded wire frame provides radial support to prevent a drainage canal (whether a patient's blood vessel or a portion of the system inserted into the patient's blood vessel) from collapsing as fluid is drained from the patient.

Abstract: Disclosed is a self-expanding cannula, systems using such cannulae, and methods of their use. The cannulae may comprise single lumen cannula (SLC) configurations and double lumen cannula (DLC) configurations, and include at least a first cannula and a self-expanding wire frame attached to the first cannula. Self-expanding wire frame is automatically expandable from a compressed state (providing a reduced cannula diameter as it is moved through a patients body to the site at which it is to be deployed) to an expanded state (which increases the diameter of the cannula to the diameter intended for its normal use). The expanded wire frame provides radial support to prevent a drainage canal (whether a patients blood vessel or a portion of the system inserted into the patients blood vessel) from collapsing as fluid is drained from the patient.

Abstract: A device and method is provided herein for esophageal impingement of a patients aorta. The device may be inserted into a patients esophagus and positioned at the location where the esophagus passes over the patients aorta. In this position, an actuation device is used to apply pressure to the patients aorta through their esophagus to impinge or occlude the aorta to stop or significantly reduce hemorrhaging. A manually operable actuator handle enables a physician to manipulate a head assembly of the device through three distinct degrees of freedom of movement so as to control placement and direction of force against the patients esophagus and, in turn, their aorta.

Abstract: The present invention discloses a self-sealing cannula and methods of its use. The self-sealing cannula can be minimally invasively placed into the heart for drawing and/or returning blood with a self-sealing function at the interface of the blood access site. The disclosed cannula can be implemented as a single lumen cannula or a double lumen cannula, which can be used with ventricular assist devices for heart support or pump-oxygenators for ECMO and respiratory support. Through a self-sealing mechanism fixed on the ventricular wall or atrial wall, a cannula body is attached to the self-sealing fixture and blood is drawn into the lumen via an external pump and returned to the circulation system through a separate cannula. In the case of the double lumen cannula embodiment, the blood will be drawn into the drainage lumen of the double lumen cannula and returned through an infusion lumen at the desired location.

Abstract: The device of the present invention includes a dual chamber gas exchanger that is configured for increased flexibility and scalability for many clinical applications. The dual chamber oxygenator can be configured and used in various applications, such as in a heart-lung machine for cardiopulmonary support during cardiothoracic surgery, in an extracorporeal membrane oxygenation (ECMO) circuitry, as a respiratory assist device for patients with lung failure, and the like. The dual chamber gas exchanger features two sweep gas flow paths and two gas exchange membrane bundles enclosed in a housing structure with various blood flow distribution and gas distribution mechanisms. The gas exchanger includes an outer housing, an intermediate housing, two gas exchange fiber bundles, a blood inlet, a blood outlet, two gas inlets, two gas outlets, two gas distribution chambers and an optional heat exchanger.

Abstract: The present invention discloses a self-sealing cannula that through a self-sealing mechanism fixed on the ventricular wall or atrial wall, the cannula body is attached to the self-sealing fixture and blood is drawn into the lumen via an external pump and returned to the circulation system through a separate cannula; in the case of the double lumen cannula embodiment, the blood will be drawn into the drainage lumen of the double lumen cannula and returned through an infusion lumen at the desired location.

Abstract: An oxygen supply unit for use with a blood oxygenator comprises an oxygen concentrator and a carbon dioxide scrubber. In an on-line operational mode, oxygen-rich gas from the oxygen concentrator is predominantly supplied to the blood oxygenator with a reduced flow of recycled gas from the concentrator. In an off-line operational mode where the oxygen supply unit is being powered by battery only, a larger flow of recycled gas from the blood oxygenator is passed through the carbon dioxide scrubber and combined with a lesser amount of oxygen-rich gas from the oxygen concentrator. The oxygen supply unit may be used in combination with a blood pump and oxygenator to provide ambulatory blood oxygenation to patients with compromised lung function.