Biphasic and dynamic adjustable support devices and methods with assist and recoil capabilities for treatment of cardiac pathologies
Inventors
Altman, William C. • Biswas, Saurabh • Criscione, John C. • Harrison, Lewis D. • Moreno, Michael R. • Robbins, Dennis I.
Assignees
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Publication Number
US-9259520-B2
Publication Date
2016-02-16
Expiration Date
Abstract
The present invention provides a biphasic and dynamic direct cardiac contact device adapted to be implanted in a patient suffering from congestive heart failure and related cardiac pathologies, said cardiac device having means for providing ventricular assist, ventricular support and diastolic recoil, or for providing ventricular support and diastolic recoil only.
Core Innovation
The invention relates to an implantable, minimally invasive, extra-cardiac biphasic and dynamic direct cardiac contact device for congestive heart failure. The device provides direct cardiac contact ventricular support and diastolic recoil, and separately modulates an end systolic configuration and an end diastolic configuration of the heart. An adjustable passive support component is positioned to continually apply support to the heart via contact with an epicardial surface, constraining ventricle filling when cardiac volume exceeds a target end diastolic volume (TEDV).
An elastic memory component is positioned in contact with the adjustable passive support component and creates negative pressure to promote ventricle filling when cardiac volume is lower than the target TEDV. The device operates in a biphasic mode about a phase transition point that is adjustable about the target TEDV, establishing a filling enhancement phase and a filling impediment phase. The intrinsic pneumatic attachment and elastic memory generate negative pressure to promote filling and to impede filling when cardiac volume is above the target TEDV.
Optionally, end-systolic bladders and contoured inflatable compartments are integrated to maintain physiological strain and curvature, and to reduce dyskinesis and hypokinesis. The disclosed configuration also includes a layered anti-pericardial-adhesion barrier with fluid-filled bladders between biocompatible films adhered to the epicardium and to the chest wall, intended to reduce postoperative pericardial adhesion. The disclosure further describes post-implant adjustability of the TEDV to match changing cardiac response.
Claims Coverage
The independent claims cover two principal aspects: a method of using a biphasic direct cardiac contact ventricular support and diastolic recoil device with an adjustable phase transition about a target TEDV, and a direct cardiac contact diastolic recoil device for improving diastolic recoil while reducing postoperative pericardial adhesion using layered films separated by fluid-filled bladders. Across the independent claims, the key inventive elements are an adjustable passive support component, an elastic memory component that creates negative pressure tied to a target TEDV, a biphasic operating mode about an adjustable phase transition point, and a film-and-bladder anti-adhesion structure.
Biphasic direct cardiac contact ventricular support and diastolic recoil about adjustable phase transition
Providing a biphasic direct cardiac contact device that can separately modulate an end systolic configuration and an end diastolic configuration of a heart, determining the target end diastolic volume for the heart, determining a phase transitioning point from the target end diastolic volume, and operating the biphasic direct cardiac contact device in a biphasic mode about the phase transition point, wherein the phase transition point is an adjustable phase transition point adjustable about the target end diastolic volume for the heart.
Adjustable passive support constrains filling above target TEDV
Providing an adjustable passive support component in contact with an epicardial surface of the heart to continually apply support to the heart, wherein the adjustable passive support component constrains ventricle filling when the cardiac volume exceeds a target end diastolic volume.
Elastic memory creates negative pressure below target TEDV
Providing an elastic memory component in contact with the adjustable passive support component wherein the elastic memory component creates a negative pressure that promotes ventricle filling when a cardiac volume is lower than a target end diastolic volume.
Elastic memory negative pressure with target TEDV diastolic recoil device
A direct cardiac contact diastolic recoil device comprising an elastic memory component in contact with a first biocompatible film for adhesion to the epicardial surface of the heart, wherein the elastic memory component creates a negative pressure on the heart to promote ventricle filling when a cardiac volume is lower than a target end diastolic volume.
Layered anti-adhesion films separated by fluid-filled bladders
A direct cardiac contact diastolic recoil device comprising a second biocompatible film for adhesion to the chest cavity and one or more fluid filled bladders that separate the first biocompatible film and the second biocompatible film to prevent adhesion between the epicardial surface of the heart and the chest wall, wherein the device improves diastolic recoil of a heart and reduces postoperative pericardial adhesion.
Collectively, the independent claims require a direct cardiac contact device that uses an adjustable passive support component and an elastic memory component with negative pressure governed by a target TEDV, operating in a biphasic mode about an adjustable phase transition point. A separate independent claim specifies a layered biocompatible film configuration separated by fluid-filled bladders to prevent epicardial-to-chest-wall adhesion while promoting diastolic recoil and ventricle filling.
Stated Advantages
Minimized blood contact to reduce thrombosis and infection.
No suturing.
Failsafe deflation/deactivation.
Promotes ventricle filling when cardiac volume is below the target end diastolic volume and impedes filling when cardiac volume is above the target end diastolic volume.
Continually applies support to promote reverse remodeling.
Improves diastolic recoil while reducing postoperative pericardial adhesion.
Compatibility with combination therapies, including stem cell therapies.
Documented Applications
Treatment of congestive heart failure using an implantable, minimally invasive, extra-cardiac biphasic and dynamic direct cardiac contact ventricular support and diastolic recoil device.
Postoperative reduction of pericardial adhesion using a layered anti-pericardial-adhesion barrier with fluid-filled bladders separating biocompatible films.
Use in combination therapies, including stem cell therapies.
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