Devices, systems and methods for controlling or preventing left and/or right ventricular overload with and without concurrent extracorporeal life support.

An access device for a heart chamber, a removable hemostatic valve unit, and a system and a method of creating a transapical passage on a beating heart are disclosed. In examples, the access device (1) includes an apical base plate (100) and a sealing unit (3) configured to provide a separation of a wet zone from a heart chamber and a dry zone with a gaseous environment outside of said heart chamber inside a patient body at the same time.

Apparatus and methods for cleaning a single-port fluidic device, such as a single-port, diaphragm-based cardiac pump, with a continuous stream of fresh cleaning fluid, while simultaneously draining soiled fluid, via a single input-output port of the fluidic device. A first coupler releasably mates with the input-output port. The first coupler includes an injector nozzle and a return port. The injector nozzle is oriented to direct a stream of pressurized cleaning fluid toward an interior chamber of the single-port fluidic device. The return port simultaneously removes soiled cleaning fluid from the interior chamber. A circulation pump delivers the pressurized cleaning fluid from a tank to the injector nozzle, and returns soiled cleaning fluid from the return port to the tank, via a cleaning fluid circulation circuit. Optionally, the diaphragm may be alternately driven between two positions, to agitate the cleaning fluid within the interior chamber, thereby enhancing cleaning efficiency.

A controller for an implantable medical device including a housing sized and configured to be received within a patient, the housing having a thermally conductive shell defining an exterior surface. At least a portion of the exterior surface of the thermally conductive shell defines at least one from the group consisting of a plurality of corrugations and a plurality of protuberances.

A heat exchange system for controlling the temperature of the blood of a patient. The heat exchange system comprises a disposable component having a blood inlet to receive blood from the patient and a blood outlet to return blood to the patient, and a permanent component. The permanent component includes a first housing having an inlet and an outlet to exchange thermal fluid with an external device and a second housing having an inlet and an outlet to exchange thermal fluid with the external device. The disposable component is inserted between the first housing and the second housing, such that in a closed position of the permanent component, a first surface of the disposable component is pressed into contact with a surface of the first housing and a second surface of the disposable component is pressed into contact with a surface of the second housing.

A heat exchange system for controlling the temperature of the blood of a patient. The heat exchange system comprises a disposable component having a blood inlet to receive blood from the patient and a blood outlet to return blood to the patient, and a permanent component. The permanent component includes a first housing having an inlet and an outlet to exchange thermal fluid with an external device and a second housing having an inlet and an outlet to exchange thermal fluid with the external device. The disposable component is inserted between the first housing and the second housing, such that in a closed position of the permanent component, a first surface of the disposable component is pressed into contact with a surface of the first housing and a second surface of the disposable component is pressed into contact with a surface of the second housing.

Systems and methods for evaluating blood behavior when flowing through an implantable medical device are provided. A flow loop includes the implantable medical device, and a blood reservoir configured to contain a volume of blood and to supply blood from the volume of blood to the implantable medical device. The flow loop further includes a plurality of tubing sections coupled in flow communication between the implantable medical device and the blood reservoir, the plurality of tubing sections including a least a first tubing section having a first diameter and a second tubing section having a second diameter, wherein the second diameter is smaller than the first diameter, and a flow diverter coupled in flow communication between the plurality of tubing sections and the blood reservoir, the flow diverter comprising an outlet that is configured to be positioned below a surface of the volume of blood.

HeartWare medical device bag cover kit comprises: (a) a three dimensional, generally rectangular-shape cover with a closing flap; a cover means a thing which lies around something, especially in order to protect or conceal it; right and left side opening/slit for driveline accessibility; (b) at least 3 magnetic fasteners; (c) a detachable cover for the carrying strap, which will be adjustable in length, therefore coincided with the existing medical grade strap, that is provided for the device; (d) a separate shoulder pad will also be included with a thicker padding and coordinating fabric(s).

All covering will be sold as a kit for the Lvad/Rvad device bag, including the adjustable strap cover that will give patients the freedom to determine the cosmetic appearance, without altering the function and safety of the device, as provided by the manufacturer.

A blood pump system including an optical sensor configured to detect an optical signal during pumping operation of the blood pump, and an optical fiber configured to transmit the optical signal from the optical fiber sensor to an evaluation device communicatively coupled to the optical fiber sensor. The evaluation device is configured to receive as inputs the transmitted optical signal and a signal indicative of the motor current and determine a mechanical failure event associated with the blood pump based on the motor current and the optical signal.

A system and method of increasing the pumping efficiency of an individual's heart, wherein an actual pumping efficiency is compared to an optimal pumping efficiency to determine a force assist profile. A cardiac assist device is created that will apply the force assist profile to the heart. The cardiac assist device is surgically inserted in vivo to physically affect the heart. The cardiac assist device has an outer shell and at least one inflatable membrane that passes over the ventricles of the heart, wherein the inflatable membrane is inflated and deflated in accordance with a pressure profile provided by a pneumatic pump. The outer shell embodies outer shell strain characteristics. Each inflatable membrane embodies membrane strain characteristics. The force assist profile is a function of the outer shell strain characteristics, the membrane strain characteristics, and the pressure profile.