Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: A pulsatile fluid pump apparatus includes an integral pump assembly employing a flexible diaphragm in a diaphragm assembly; a pulsatile fluid pump system including a control housing, for removably receiving the integral pump assembly, the control housing and the integral pump assembly being configured for operation, in a first mode, so that the pulsatile fluid pump system reciprocally actuates the diaphragm assembly to cause pumping automatically; and a manual driver assembly, wherein the integral pump assembly is configured, in a second mode, in the absence of actuation of the diaphragm assembly by the pulsatile fluid pump system, to removably receive the manual driver assembly to support manual actuation and operation of the diaphragm assembly.

Abstract: A pulsatile fluid pump system includes a pump-valving assembly including a chamber and a diaphragm assembly coupled to the chamber and including a flexible diaphragm. The diaphragm assembly and the pump-valving assembly are configured as an integral pump assembly. The system further includes a linear motor having a magnet and a coil, the magnet moving in relation to the coil, the coil having an electrical input. The system also includes a control housing rigidly coupled to the linear motor and a controller system having an electrical output coupled to the electrical input of the coil, the controller system defining an electrical waveform at the electrical output to cause desired operation of the diaphragm. The integral pump assembly is configured to be removably coupled to the control housing, and the diaphragm assembly of the integral pump assembly is configured to be removably coupled to the linear motor.

Abstract: A pulsatile fluid pump system for driving a fluid pump assembly includes a reciprocating linear motor having a magnet and a coil, the magnet moving in relation to the coil, the coil having an electrical input. The pulsatile fluid pump system further includes a controller system having an electrical output coupled to the electrical input of the coil, and the controller system is configured to execute a waveform program defining an electrical waveform at the electrical output. The waveform program is configured to control operation of the linear motor by modification of a feature, selected from the group consisting of amplitude, frequency, shape, and combinations thereof, of the electrical waveform at the electrical output. The waveform program is further configured to accept a set of user-specifiable parameters defining the performance of the linear motor and to modify the electrical waveform in response to such parameters.