Abstract: A multiple power-source housing adapted to prevent simultaneous removal of more than a single power source, such as a battery, at a time. In an example embodiment, the power-source housing is used to house batteries for an intra-aortic balloon pump, which use battery power during transport. The power-source housing holds a first and second power source. When the first power source is removed, a mechanism, such as a knob, prevents simultaneous removal of the second power source or removal of the second power source until the first power source is replaced. Similarly, when the second power source is removed the mechanism prevents simultaneous removal of the first power source or removal of the first power source until the second power source is replaced.

Abstract: In a method for intermittently occluding the coronary sinus, in which the coronary sinus is occluded using an occlusion device, the fluid pressure in the occluded coronary sinus is continuously measured and stored, the fluid pressure curve is determined as a function of time, and the occlusion of the coronary sinus is triggered and/or released as a function of at least one characteristic value derived from the measured pressure values. The pressure increase and/or pressure decrease per time unit each occurring at a heart beat are used as characteristic values.

Abstract: An apparatus and method for use in assisting a human heart are disclosed. The apparatus comprises an aortic compression means which may be fully implanatable, a fluid reservoir and a pump means adapted to pump a fluid from the reservoir to the aortic compression means so as to actuate the aortic compression means at least partly in counterpulsation with the patient's heart. In addition, the device is adapted to be wholly positioned within the right chest cavity of the patient. The aortic compression means of the device may be curved along its length so as to substantially replicate the curve of the ascending aorta.

Abstract: At least one aspect of the invention is directed to a pump system for pumping blood though a body passageway. The pump system includes a distal section having at least one inlet to receive blood, a pumping section in fluid communication with the distal section to receive blood from the distal section, and a pump constructed and arranged to be positioned within the pumping section to draw blood into the pumping section in a first phase of operation and to pump blood out of the at least one outlet valve in a second phase of operation. The pump system may be configured such that the at least one inlet is in fluid communication with the pumping section in both the first phase of operation and the second phase of operation. At least one other aspect of the invention is directed to a pump system for pumping blood from one of the right atrium and the right ventricle to the pulmonary artery.

Abstract: A medical device may include a gas delivery apparatus, a patient interface, a connection system, and an electrical circuit. The gas delivery apparatus may be configured to deliver gas to a patient. The patient interface may be configured to interface with the patient to deliver gas communicated by the gas delivery apparatus to the patient. The connection system may be configured to communicate gas from the gas delivery apparatus to the patient interface. The electrical circuit may be configured to communicate electrical signals between the patient interface and the gas delivery apparatus, and may including one or more first electrical conductors at least partially integral with the patient interface and one or more second electrical conductors at least partially integral with the connection system.

Abstract: Devices and methods are disclosed for implanting, positioning, removing, replacing and operating intra-aortic balloon pumps.

Abstract: Devices and methods are disclosed for implanting, positioning, removing, replacing and operating intra-aortic balloon pumps.

Abstract: A blood pump (26) includes a stator assembly including a fluid inlet (24) and a fluid outlet (26). A rotor assembly (120) includes an impeller (40) rotatable about an axis (44) to move fluid from the inlet (24) to the outlet (26). A motor (50) imparts rotation of the impeller (40) about the axis (44). The motor (50) includes a motor stator (52) fixed to the stator assembly (122), a motor rotor (54) fixed to the rotor assembly (120), and a radial motor gap (34) between the stator (52) and the rotor (54). The pump (20) is configured to direct a mixed blood flow from the fluid inlet (24) to the fluid outlet (26) and a wash flow through the motor gap (34).

Abstract: Devices and methods are disclosed for implanting, positioning, removing, replacing and operating intra-aortic balloon pumps.

Abstract: Devices and methods are disclosed for implanting, positioning, removing, replacing and operating intra-aortic balloon pumps.

Abstract: Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Abstract: A supplemental blood flow system for assisting with blood circulation in a patient. The system includes a supplemental blood flow device implantable in the patient and a controller for directing electrical power to the supplemental blood flow device and controlling the flow rate of blood through the device. The controller includes first and second power inlets and a power outlet. The power outlet is adapted to be coupled to an electrical line leading to the supplemental blood flow device. A portable programming module may be coupled to at least one of the first and second power inlets and operable to allow pump operating parameters stored in the controller to be changed according to the needs of the patient.

Abstract: Some embodiments of a system or method for treating heart tissue can include a catheter device that provides a user with the ability to perform a number of heart treatment tasks (before, during, and after a cardiac surgery or a percutaneous coronary intervention). In particular embodiments, the catheter device can be used to (i) precondition heart muscle tissue before the heart is isolated from the circulatory system, (ii) deliver cardioplegia into the coronary sinus during the cardiac surgery when the heart is isolated from the circulatory system, and (iii) control the blood flow through the heart after the heart is reconnected with the circulatory system. In some embodiments, the catheter device can perform some or all of: (i) intermittently occluding the coronary sinus, (ii) delivering a treatment fluid into the coronary sinus, and (iii) monitoring a flow rate of blood passing from the coronary sinus to the right atrium.

Abstract: A dynamic device for reducing functional mitral regurgitation is described. The device is disposed externally to the heart and effectively acts as a splint for reducing further dilation of the heart in patients diagnosed with cardiomyopathy, and for reducing tethering of the papillary muscle on the mitral valve. The device does not require cardiopulmonary bypass for its installation since it is attached to the outside of the left ventricle, thereby reducing surgical risk, and is not exposed to the patient's blood once installed, thereby reducing the risk of thromboembolic disease.

Abstract: At least one aspect of the invention is directed to a pump system for pumping blood though a body passageway. The pump system includes a distal section having at least one inlet to receive blood, a pumping section in fluid communication with the distal section to receive blood from the distal section, and a pump constructed and arranged to be positioned within the pumping section to draw blood into the pumping section in a first phase of operation and to pump blood out of the at least one outlet valve in a second phase of operation. The pump system may be configured such that the at least one inlet is in fluid communication with the pumping section in both the first phase of operation and the second phase of operation. At least one other aspect of the invention is directed to a pump system for pumping blood from one of the right atrium and the right ventricle to the pulmonary artery.

Abstract: Counterpulsation methods and systems for assisting the heart of a patient involve, for example, coordinating the operation of a pulsatile pump to suction blood from an artery through a first conduit while the heart is in systole and expel the blood into the first conduit and the artery while the heart is in diastole.

Abstract: A multilayered impedance pump is formed by an inner tube and an outer tube which have different mechanical characteristics. The outer tube is relatively stiff, and can be used for a structural material. The inner tube is excitable, and a gel is placed between the inner and outer tube. The actuator actuates the gel to cause pressure waves along the inner tube.

Abstract: A drive unit to control the peak pressure of air for the inflation of a left ventricular assist system is disclosed. The control of the peak pressure can address the problem of the “kick” experienced by patients when the peak inflation pressure reaches approximately 200 mm Hg. The peak pressure of the air released for the inflation cycle of the system is reduced either by the reduction of the inner diameter of the interconnect line running from the compression tank to the valve manifold or the use of a multi-valve manifold with independently controlled valves and an electronic controller to selectively open and close the valves of the manifold. Either technique, whether used alone or in combination, reduces the peak pressure of the air released for the inflation cycle to below the levels associated with the “kick,” while still meeting the operating specifications to properly inflate and deflate the system's blood pump.

Abstract: An actuator (10) for a heart assist device. The actuator (10) includes an inflatable balloon (12) and a shroud or wrap (14). The inflatable balloon (12) has a first body portion (22), a second body portion (26) and a flexure region joining (24) the first (22) and second (26) body portions. The shroud or wrap (14) is positioned adjacent the first body portion (24) and has a peripheral extent at least equal to the peripheral extent of the balloon flexure region (24). The balloon (12) and the shroud or wrap (14) are shaped such that the shroud or wrap (14) restrains a part of the balloon first body portion (22) at or near the flexure region (24) against displacement towards the shroud or wrap (outward displacement) past a predetermined limit but allows unrestrained displacement away from the shroud or wrap (inward displacement).

Abstract: An apparatus and method for use in assisting a human heart are disclosed. The apparatus comprises an aortic compression means which may be fully implanatable, a fluid reservoir and a pump means adapted to pump a fluid from the reservoir to the aortic compression means so as to actuate the aortic compression means at least partly in counterpulsation with the patient's heart. In addition, the device is adapted to be wholly positioned within the right chest cavity of the patient. The aortic compression means of the device may be curved along its length so as to substantially replicate the curve of the ascending aorta.

Abstract: The present invention provides methods and apparatus for selecting a deflation timing mode for an intra-aortic balloon (IAB) based on comparison of the time required to deflate the IAB and the time between the ECG R wave and systolic upstroke.

Abstract: A fluid pressure generating means (10) for a heart assist device having blood pumping means. The pressure generating means (10) includes a housing (11), defining an interior volume (18), and having a substantially rigid first housing portion (12), a substantially rigid second housing portion (14), a flexible third housing portion (16) extending between the first (12) and second (14) housing portions and an inlet/outlet port (15) adapted for fluid communication with the blood pumping means. The pressure generating means (10) also includes a fluid filling the housing and a motor (20) disposed within the housing (11) and connected between the first (12) and second (14) housing portions. Actuation of the motor (20) moves the first (12) and second (14) housing portions relative to one another to generate fluid pressure changes at the inlet/outlet port (15). A related heart assist device and method for the treatment of congestive heart failure, myocardial ischemia and like conditions are also disclosed.

Abstract: Disclosed herein are embodiments of long-term ambulatory intra-aortic balloon pump systems for providing left ventricular cardiac assistance to a patient. The systems can comprise an external drive system for supplying a compressed fluid, the drive system operating in accordance with a control program stored in memory, an intra-luminal balloon pump having an elongate inflatable chamber positionable to be lying completely within a descending aorta of the patient, and a percutaneous access device. The percutaneous access device can be a biocompatible implantable portal comprising a communicative passage through an interior bore and an exterior having a neck region adapted to promote autologous cell growth thereon in an implantable region, the neck region having a plurality of channels extending about the neck region.

Abstract: Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Abstract: An actuator (10) for a heart assist device. The actuator (10) includes an inflatable balloon (12) and a shroud or wrap (14). The inflatable balloon (12) has a first body portion (22), a second body portion (26) and a flexure region joining (24) the first (22) and second (26) body portions. The shroud or wrap (14) is positioned adjacent the first body portion (24) and has a peripheral extent at least equal to the peripheral extent of the balloon flexure region (24). The balloon (12) and the shroud or wrap (14) are shaped such that the shroud or wrap (14) restrains a part of the balloon first body portion (22) at or near the flexure region (24) against displacement towards the shroud or wrap (outward displacement) past a predetermined limit but allows unrestrained displacement away from the shroud or wrap (inward displacement).

Abstract: A method for mechanically assisting the pumping action of the heart. A catheter is provided comprising an elongate member having a proximal end, a distal region, an expandable member attached in the distal region, and an inflatable member in the distal region and attached distal the expandable member. The catheter is advanced into the aorta. The expandable member is expanded to at least partially obstruct the aorta. The inflatable member is inflated during diastole. The inflatable member is then deflated during the ejection phase of the left ventricle while expansion of the expandable member is maintained. The pumping action of the heart is thereby mechanically assisted. Cerebral perfusion augmentation may also be achieved by use of combined coarctation-counterpulsation devices and methods. Devices for practicing methods with increased volume-displacement efficiency are also described.

Abstract: At least one aspect of the invention is directed to a pump system for pumping blood though a body passageway. The pump system includes a distal section having at least one inlet to receive blood, a pumping section in fluid communication with the distal section to receive blood from the distal section, and a pump constructed and arranged to be positioned within the pumping section to draw blood into the pumping section in a first phase of operation and to pump blood out of the at least one outlet valve in a second phase of operation. The pump system may be configured such that the at least one inlet is in fluid communication with the pumping section in both the first phase of operation and the second phase of operation. At least one other aspect of the invention is directed to a pump system for pumping blood from one of the right atrium and the right ventricle to the pulmonary artery.

Abstract: Devices and methods are disclosed for implanting, positioning, removing and replacing devices that penetrate an artery.

Abstract: A percutaneous gas-line (10) for a medical device (14). The gas-line including a first gas-line part (10a) and a second gas-line part (10b). The first gas-line part (10a) is adapted to be wholly implanted in a patient and has a first end (10a?) adapted for sealing connection to the medical device (14) and a second end (10a?) with a connection fitting (20). The second gas-line part (10b) is adapted to be part-implanted and part-external and has a first (external) end (10b?) adapted for sealing connection to an external driver (12) and a second (implanted) end (10b?) adapted for removable sealing connection with the connection fitting (20) on the second end (10a?) of the first gas-line part (10a).

Abstract: The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.

Abstract: The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.

Abstract: The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.

Abstract: The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.

Abstract: A method of controlling the operation of a pulsatile heart assist device (14) in a patient (10). The method consisting of utilizing sounds produced by the heart (12) to control the operation of the heart assist device (14).

Abstract: A medical device including a Rouleaux degausser that directs a degaussing magnetic field to a patient's blood flow. The degaussing magnetic field reduces magnetically-induced Rouleaux and/or Red Blood Cell aggregation. The device also has a power source for supplying power to the Rouleaux degausser.

Abstract: The present invention provides an anatomically-compatible and physiologically-compatible in vivo device for improving diastolic function of either the left or right ventricle of the heart, comprising at least one air-impermeable sheet that is capable of being operatively connected to the external ventricular surface of the heart using one or more connecting elements, such that said at least one air-impermeable sheet is capable of creating a sub-atmospheric pressure within said closed empty space as a consequence of changes in the volume of said space during the course of the cardiac cycle, thereby exerting an outward and normally directed force on the external ventricular surface of the heart.

Abstract: The present invention is directed to an electromechanical pumping system for simulating the beating of heart in a cardiac surgery training environment. A computer-controllable linear actuator is used to control the electromechanical pumping system. In a preferred embodiment, the electromechanical pumping system is linked to a porcine heart. The heart is made to beat by inserting intra-ventricular balloons placed inside the heart and connected to the pumping system. When controlled by the electromechanical pumping system, the porcine heart is able to display normal and abnormal beating rhythms, as well as ventricular fibrillation. In addition, an electronic pressure sensor incorporated into the pumping system can be used to trigger a ventricular fibrillation mode when the porcine heart attached to the pumping system is handled by a trainee surgeon.

Abstract: Apparatus is described including a sensor that senses a phase of cyclic motion of a portion of a subject's body. During a first phase of a first cycle of the cyclic motion, a tool modulator does not to facilitate movement of a tool with respect to the portion. Subsequent to the first phase, in response to the sensor sensing that the first cycle is at a second phase thereof, the modulator facilitates movement of the tool. In a cycle subsequent to the first cycle, the modulator facilitates movement of the tool, during the entire subsequent cycle. During the first phase of the first cycle, an accumulation-facilitator facilitates an accumulation of energy in the accumulation-facilitator. An accumulation-inhibitor inhibits accumulation of energy in the accumulation-facilitator during the subsequent cycle, by actively inhibiting movement of at least a portion of the accumulation-facilitator. Other embodiments are also described.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: In a method for intermittently occluding the coronary sinus, in which the coronary sinus is occluded using an occlusion device, the fluid pressure in the occluded coronary sinus is continuously measured and stored, the fluid pressure curve is determined as a function of time, and the occlusion of the coronary sinus is triggered and/or released as a function of at least one characteristic value derived from the measured pressure values. The pressure increase and/or pressure decrease per time unit each occurring at a heart beat are used as characteristic values.

Abstract: A cardiac assist device (100) comprises a stent 103, 403) which is implantable into a blood vessel of a patient. The stent (103, 403) encloses an inner volume (119, 419). At least one inflatable element (104, 409-413) is attached to the stent (103). The at least one inflatable element (104, 409-413) is provided in the inner volume (119, 419) of the stent (103, 403), wherein the ai least one inflatable element (104, 409-413) annularly encloses a central opening (118, 418) being parallel to a longitudinal axis of said stent (103, 403). The cardiac assist device (100) further comprises a fluid supply adapted for periodically inflating and deflating the at least one inflatable element (104, 409-413), wherein said fluid supply comprises at least one fluid supply line (105, 405) connectable to the at least one inflatable element (104, 409-413) and implantable into a blood vessel of the patient.

Abstract: Counterpulsation methods and systems for assisting the heart of a patient involve, for example, coordinating the operation of a pulsatile pump to suction blood from an artery through a first conduit while the heart is in systole and expel the blood into the first conduit and the artery while the heart is in diastole.

Abstract: A cannulation system (10) for perfusing a patient's circulatory system, includes an inflow cannula (14) having a first end adapted to be connected to said circulatory system and a second end adapted to be connected to a blood pump (19), an outflow cannula (23) having a first end adapted to be connected to the blood pump (19) and a second end adapted to be connected to said circulatory system at a location downstream of the first end of the inflow cannula. The flow of blood from the pump (19) is in series with the normal blood flow of the circulatory system of the patient and creates a localized region of hypertension.

Abstract: An apparatus for extracorporeal oxygenation of a patient's blood during cardiopulmonary bypass surgery. The apparatus comprises a bubble sensor, arranged at or connected to a venous line, for detecting bubbles in the venous blood received from the patient. When air bubbles are detected, a second pump is activated to draw air from an air chamber provided in an air filter connected to the venous line and arranged downstream of the bubble sensor. A first pump draws the blood from the air filter and supplies the blood to an oxygenator and to the patient via an arterial line.

Abstract: A fluid pressure generating means (10) for a heart assist device having blood pumping means. The pressure generating means (10) includes a housing (11), defining an interior volume (18), and having a substantially rigid first housing portion (12), a substantially rigid second housing portion (14), a flexible third housing portion (16) extending between the first (12) and second (14) housing portions and an inlet/outlet port (15) adapted for fluid communication with the blood pumping means. The pressure generating means (10) also includes a fluid filling the housing and a motor (20) disposed within the housing (11) and connected between the first (12) and second (14) housing portions. Actuation of the motor (20) moves the first (12) and second (14) housing portions relative to one another to generate fluid pressure changes at the inlet/outlet port (15). A related heart assist device and method for the treatment of congestive heart failure, myocardial ischemia and like conditions are also disclosed.

Abstract: Disclosed is an intracardiac blood pump with a flexible screen between which discharge ports are located. The pump parts are connected to the flexible screen which catches the axially discharged flow and deflects the same in an axial direction. The delivery rate of the pump is increased by preventing impact losses and swirls at the discharge ports.

Abstract: An apparatus for treatment of a failing heart by reducing the wall tension therein. In one embodiment, the apparatus includes a tension member for drawing at least two walls of a heart chamber toward each other. Methods for placing the apparatus on the heart are also provided.

Abstract: Systems and methods for reducing distention in designated portions of a heart muscle while assisting cardiac valve alignment and coaptation. Anchoring devices are secured to the heart muscle and a bio-compatible cardiac assist device placed over portions of the heart muscle is separately secured to the anchoring devices. The cardiac assist device may be a material that wraps portions of the heart muscle, or may be straps that wrap portions of the heart muscle. Tightening and securing the cardiac assist device in place helps to reduce distention in chambers of the heart muscle and aids alignment and coaptation of cardiac valves.

Abstract: A cardiocirculatory aiding device is disclosed generally comprising a housing with a cavity, an inlet, an outlet, and first and second sides with apertures therein, first and second shells mounted to the sides of the housing, and first and second membranes disposed between the housing and the shells such that the membranes cover the apertures in the sides of the housing, thereby creating a central blood chamber and two outer gas chambers. A pump supplies gas through a duct into the gas chambers to cause the membranes to flex into the blood chamber to pump the blood in that chamber through the outlet. In some embodiments, the pump is external and the duct passes through an incision in the body. In some embodiments, the membranes are elastomer membranes.

Abstract: A ventricular assist device includes a pump such as an axial flow pump, an outflow cannula connected to the outlet of the pump, and an anchor element. The anchor element is physically connected to the pump, as by an elongate element. The pump is implanted within the left ventricle with the outflow cannula projecting through the aortic valve but desirably terminating short of the aortic arch. The anchor element is fixed to the wall of the heart near the apex of the heart so that the anchor element holds the pump and outflow cannula in position.