Abstract: A system and method for evaluating, altering and/or creating an opening around the heart to receive a construct. Using a minimally invasive techniques, a first guide is advanced into an area adjacent to the heart. The first guide is used to probe the area and determine if an opening can be safely formed in that area. The guide is then used to direct a larger guide catheter into the targeted area. The larger guide catheter is used to direct a more robust guide into the targeted area. The robust guide is then used to direct a delivery guide catheter into the targeted area. The delivery guide catheter can be used to stall. a device deployment guide. Either the delivery guide catheter or the device deployment guide can be used to advance the construct into the targeted area.

Abstract: A system and method for determining the proper dynamic strain profile of an elastomeric construct. The strain characteristics of a deficient heart are determined and compared to the normal strain characteristics of a healthy heart. A construct having elastomeric elements is provided that can expand along multiple axes. In an unloaded condition remote from the deficient heart, the elastomeric elements are pressurized to determine the pressure differential being experienced. Furthermore, optimal strain characteristics are calculated along a first axis and a second axis as a function of the pressure differential. The first optimal strain characteristic and the second optimal strain characteristic are used to estimate the dynamic strain characteristics that will be applied to the heart. Using an automated drive, the dynamic strain characteristics are compared to the optimal strain characteristics required by the heart to determine if the construct is proper.

Abstract: A system and method for determining the proper dynamic strain profile of an elastomeric construct. The strain characteristics of a deficient heart are determined and compared to the normal strain characteristics of a healthy heart. A construct having elastomeric elements is provided that can expand along multiple axes. In an unloaded condition remote from the deficient heart, the elastomeric elements are pressurized to determine the pressure differential being experienced. Furthermore, optimal strain characteristics are calculated along a first axis and a second axis as a function of the pressure differential. The first optimal strain characteristic and the second optimal strain characteristic are used to estimate the dynamic strain characteristics that will be applied to the heart. The dynamic strain characteristics are compared to the optimal strain characteristics required by the heart to determine if the construct is proper using an automated drive.

Abstract: A system and method for evaluating, altering and/or creating an opening around the heart to receive a construct. Using a minimally invasive techniques, a first guide is advanced into an area adjacent to the heart. The first guide is used to probe the area and determine if an opening can be safely formed in that area. The guide is then used to direct a larger guide catheter into the targeted area. The larger guide catheter is used to direct a more robust guide into the targeted area. The robust guide is then used to direct a delivery guide catheter into the targeted area. The delivery guide catheter can be used to stall. a device deployment guide. Either the delivery guide catheter or the device deployment guide can be used to advance the construct into the targeted area.

Abstract: A system and method for evaluating, altering and/or creating an opening around the heart to receive a construct. Using a minimally invasive techniques, a first guide is advanced into an area adjacent to the heart. The first guide is used to probe the area and determine if an opening can be safely formed in that area. The guide is then used to direct a larger guide catheter into the targeted area. The larger guide catheter is used to direct a more robust guide into the targeted area. The robust guide is then used to direct a delivery guide catheter into the targeted area. The delivery guide catheter can be used to stall a device deployment guide. Either the delivery guide catheter or the device deployment guide can be used to advance the construct into the targeted area.

Abstract: A system and method for assisting a heart in pumping blood, wherein the heart has external force requirements that need to be externally applied to the heart using a cardiac assist device that is powered by a drive fluid. The cardiac assist device is powered by a drive fluid having a pressure/flow profile that is customized to the needs of the heart. The pressure/flow profile is generated by a displacement pump. If the pressure/flow profile requires pressures that cannot be made by the displacement pump, then the pressure/flow profile can be altered by venting pressure and/or adding pressurized fluid into the system. In this manner, a precise pressure/flow profile can be produced that meets the exact needs of a heart being acted upon by a cardiac assist device.

Abstract: A fluid controlled system for a cardiac assist device and its method of operation. The cardiac assist device has a cup assembly with a receptacle area. The cup assembly has at least one inflatable membrane that expands into the receptacle area. A single pressure tube connects the cup assembly to a fluid pump. A valve assembly is incorporated into the cardiac assist device. The valve assembly includes at least one valve that controls fluid flow between the inflatable membranes and the pressure tube and/or fluid flow between the receptacle area and the pressure tube. The valve assembly controls fluid flow to advance the cup assembly onto the heart, to maintain the cup assembly in an operable position, to operate the cup assembly, and to remove the cup assembly.

Abstract: A system and method for the installation and operation of a cardiac assist device. Flexible guides are advanced into a prepared space using minimally invasive techniques. A heart pump construct is advanced into position in the pericardial area along the flexible guides. Once in position, the heart pump construct is activated while still engaged with the flexible guides. The flexible guides provide structural integrity to the heart pump construct needed in order for the heart pump construct to function properly. The forces supplied to the heart by the heart pump construct are affected by the presence of the flexible guides. The structure of the flexible guides, the position of the flexible guides and the structure of the heart pump construct are customized to supply the forces needed by a particular heart in order to assist the heart in pumping more efficiently.

Abstract: A system and method for determining the proper dynamic strain profile of an elastomeric construct. The strain characteristics of a deficient heart are determined and compared to the normal strain characteristics of a healthy heart. A construct having elastomeric elements is provided that can expand along multiple axes. In an unloaded condition remote from the deficient heart, the elastomeric elements are pressurized to determine the pressure differential being experienced. Furthermore, optimal strain characteristics are calculated along a first axis and a second axis as a function of the pressure differential. The first optimal strain characteristic and the second optimal strain characteristic are used to estimate the dynamic strain characteristics that will be applied to the heart. The dynamic strain characteristics are compared to the optimal strain characteristics required by the heart to determine if the construct is proper using an automated drive.

Abstract: 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.

Abstract: A system and method for positioning a modular heart pump about the ventricles of the heart. The modular heart pump has at least one active panel and an apical base. Each active panel includes an inflatable membrane. The apical base helps retain the active panels on position about the heart. The components are assembled in vivo to create a pump assembly that encircles all or part of the heart. During installation, the active panels are advanced along the outside of the ventricles. Suction is provided on the leading edge of the active panels to remove any fluids and/or loose tissue that may prevent the active panel from advancing to an operable position.

Abstract: A control system for a cardiac support device and the method of supporting the functionality and synchronized contraction of a heart. An optimal strain profile is calculated for a healthy heart. The cardiac support device is attached to the heart and a true ventricular strain profile is measured. The cardiac support device applies external forces to the heart, therein altering said ventricular strain profile of said heart to be closer to the optimal strain profile. The cardiac support device is dynamically controlled to synchronize with the beating rhythm of the heart. The external forces have an applied strain profile. The applied strain profile has a peak strain, a time to peak strain, and a cycle time. These variables can be adjusted either individually or in combinations to fine tune the cardiac support device and cause the altered strain profile of the heart to be closer to the optimal strain profile.

Abstract: Disclosed are techniques to generate ideal or near ideal profiles for regulation of the volume of fluid flow in a drive system of a pump for an externally mechanically supported heart, pressure in or near the pump, or measured strain/strain rates of the supported heart, based on an estimate/measurement of the heart's size. A part of the techniques for regulation may focus on achieving mechanical synchrony with the intrinsic cyclic pump function of a partially functional heart. The techniques do not fundamentally rely on hemodynamic measurements to function. However, when hemodynamic measures are available, those measures can be fed to control algorithms to increase the efficacy of regulation to restore the heart's pump function.

Abstract: Disclosed are techniques to generate ideal or near ideal profiles for regulation of the volume of fluid flow in a drive system of a pump for an externally mechanically supported heart, pressure in or near the pump, or measured strain/strain rates of the supported heart, based on an estimate/measurement of the heart's size. A part of the techniques for regulation may focus on achieving mechanical synchrony with the intrinsic cyclic pump function of a partially functional heart. The techniques do not fundamentally rely on hemodynamic measurements to function. However, when hemodynamic measures are available, those measures can be fed to control algorithms to increase the efficacy of regulation to restore the heart's pump function.

Abstract: Disclosed is a device for assisting the function of a heart that is collapsible to facilitate minimally invasive procedures. The cup-shaped device may be inserted into the chest cavity and deployed on the heart via a specially configured tube. The device comprises a cup-shaped shell expanded by a support cage disposed within the shell, and an elastic cup-shaped liner, together forming an inflatable cavity between the outer surface of the liner and the inner surface of the shell. Alternate application of positive and negative pressures to the cavity provides controlled, active, systolic and diastolic support to the heart.

Abstract: A process for assisting the function of a heart disposed within a body, and comprising an outer wall, comprising the steps of measuring at least one parameter that is indicative of the function of the heart, applying a compressive force to a portion of the outer wall of the heart, and applying an expansive force to the portion of the outer wall of the heart. The process is preferably performed with an apparatus comprising a cup-shaped shell having an exterior wall, an interior wall, an apex, and an upper edge; a liner having an outer surface and an inner surface, an upper edge joined to said interior wall of the cup-shaped shell, and a lower edge joined of the interior wall of the cup-shaped shell, thereby forming a cavity between the outer surface thereof and the interior wall of the shell; and a drive fluid cyclically interposed within the cavity, the drive fluid applying a uniform force on a portion of the outer wall of the heart.

Abstract: A process for assisting the function of a heart disposed within a body, and comprising an outer wall, comprising the steps of measuring at least one parameter that is indicative of the function of the heart, applying a compressive force to a portion of the outer wall of the heart, and applying an expansive force to the portion of the outer wall of the heart. The process is preferably performed with an apparatus comprising a cup-shaped shell having an exterior wall, an interior wall, an apex, and an upper edge; a liner having an outer surface and an inner surface, an upper edge joined to said interior wall of the cup-shaped shell, and a lower edge joined of the interior wall of the cup-shaped shell, thereby forming a cavity between the outer surface thereof and the interior wall of the shell; and a drive fluid cyclically interposed within the cavity, the drive fluid applying a uniform force on a portion of the outer wall of the heart.