Abstract: A method for implanting a cardiac support device (CSD) on a patient's heart. An amount of contrast agent sufficient to cause structures on the heart to be visible upon fluoroscopic or other imaging is introduced into the pericardial space surrounding the heart. The heart and contrast agent are imaged to provide a visual indication of the location of the structures of the heart. The CSD is placed on the heart using the visual indications provided by the imaging.

Abstract: A cardiac constraint jacket is formed of flexible material defining a volume between an open upper end and a lower end. The jacket is dimensioned for an apex of a patient's heart to be inserted into the volume through the open upper end and for the jacket to be slipped over the heart. A delivery device is used to place the jacket on the heart. The delivery device includes a plurality of attachment locations. Each of the attachment locations is releasably secured to separate positions surrounding a periphery of the open upper end of the jacket. The delivery device also includes a control arrangement which is selectively movable between an open position and a closed position. The control arrangement is connected to the attachment locations such that the attachment locations are in a compact array urging the open upper end of the jacket into a collapsed configuration when the control member is in the closed position.

Abstract: A cardiac constraint jacket is formed of flexible material defining a volume between an open upper end and a lower end. The jacket is dimensioned for an apex of a patient's heart to be inserted into the volume through the open upper end and for the jacket to be slipped over the heart. A delivery device is used to place the jacket on the heart. The delivery device includes a plurality of attachment locations. Each of the attachment locations is releasably secured to separate positions surrounding a periphery of the open upper end of the jacket. The delivery device also includes a control arrangement which is selectively movable between an open position and a closed position. The control arrangement is connected to the attachment locations such that the attachment locations are in a compact array urging the open upper end of the jacket into a collapsed configuration when the control member is in the closed position.

Abstract: Methods and apparatus are disclosed for treating congestive heart failure. The method includes relieving wall stress on a diseased heart by an amount to decrease a rate of myocardial cell loss. Further, the method includes pharmacologically encouraging a myocardial cell gain. Cell gain may be encouraged by cell replication, cell recruitment or inhibition of cell death. Further embodiments of the method include a passive cardiac constraint selected to reduce wall stress on the heart. An apparatus of the present invention includes a passive cardiac constraint and a pharmacological agent to encourage cell gain.

Abstract: A cardiac support device that can be efficiently implanted on a patient's heart. The cardiac support device includes a jacket for constraining cardiac expansion and one or more lubricious elements releasably secured with respect to an inside surface of the jacket.

Abstract: The present disclosure is directed to a cardiac reinforcement device (CRD) and method for the treatment of cardiomyopathy. The CRD provides for reinforcement of the walls of the heart by constraining cardiac expansion, beyond a predetermined limit, during diastolic expansion of the heart. A CRD of the invention can be applied to the epicardium of the heart to locally constrain expansion of the cardiac wall or to circumferentially constrain the cardiac wall during cardiac expansion.

Abstract: A cardiac constraint device comprising a jacket of biological compatible material and an adjustment member. The jacket is adapted to be secured to the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole. The adjustment mechanism is configured to alter the internal volume defined by the jacket after the jacket is secured to the heart. The invention also provides a method for treating cardiac disease.

Abstract: An apparatus for placing a cardiac support device (CSD) on a heart. The apparatus includes a body, a deployment mechanism on the body for supporting the CSD in an open position for placement on the heart, and a release mechanism coupled to the deployment mechanism for releasably mounting the CSD to the deployment mechanism. The release mechanism includes a release element for releasably engaging the CSD, and a release actuator coupled to the release element for actuating the release element to release the CSD.

Abstract: A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device including a jacket adapted to be secured to the heart, and a non-adherent material in association with the jacket. The jacket is fabricated from a flexible material defining a volume between an upper and a lower end, the jacket being adapted to be adjusted on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain expansion of the heart beyond the maximum adjusted volume during diastole and permit substantially unimpeded contraction of the heart during systole. As a result of the flexible material, the jacket allows unimpeded diastolic filling of the heart.

Abstract: A method for efficiently implanting a cardiac support device on a patient's heart. The method includes causing lubricious material to be located between the cardiac support device and the heart while the cardiac support device is being implanted on the heart. The lubricious material is removed from between the cardiac support device and the heart after the cardiac support device is implanted.

Abstract: A delivery device for efficiently delivering a cardiac support device of the type having a jacket. The device includes a body, a deployment mechanism and an actuating mechanism. The deployment mechanism is for releasable connection to a cardiac support device and movable within the jacket between retracted and extended states to drive the jacket between collapsed and open configurations. At least portions of the deployment mechanism within the jacket have a lubricious surface to substantially reduce friction between the jacket and a heart onto which the jacket is being positioned. The actuating mechanism moves the deployment mechanism between the retracted and extended states.

Abstract: A method for tightening a cardiac support device includes forming offsets in excess material in the cardiac support device and inserting a fastener through the offsets. A device for tightening a cardiac support device includes first and second clamp members moveable into and out of mateable engagement. Each of the first and second clamp members includes offset-forming structure.

Abstract: Tools for managing the pericardium during intra-pericardial procedures such as the delivery of cardiac support devices. One embodiment of the tool includes a tubular body of low friction material having a diameter, a fixed lip on an exterior end and an extendable lip on an interior end. The extendable lip moves with respect to the body between a retracted state and an expanded state. The tool is inserted through an incision in the pericardium and deployed by moving the lip to the expanded state. When deployed a barrier portion of the body engages the edges of the incision and the extendable lip lines the inside of the pericardium around the incision.

Abstract: A method for managing the pericardium during intra-pericardial procedures such as the delivery of cardiac support devices. One embodiment of the method includes making an incision through the pericardium to provide access to the pericardial space, and inserting a plurality of strips of lubricious material into and through the incision. The strips of material are spaced around the edges of the incision to form a tubular barrier against the pericardium. End portions of the strips of material in the pericardial space are expanded away from the body to form a lip that lines the inside of the pericardium around the incision.

Abstract: The present disclosure is directed to a cardiac reinforcement device (CRD) and method for the treatment of cardiomyopathy. The CRD provides for reinforcement of the walls of the heart by constraining cardiac expansion, beyond a predetermined limit, during diastolic expansion of the heart. A CRD of the invention can be applied to the epicardium of the heart to locally constrain expansion of the cardiac wall or to circumferentially constrain the cardiac wall during cardiac expansion.

Abstract: A cardiac support device and placement tool assembly. The cardiac support device has a flexible jacket with an open base end. The placement tool includes a cannula having an open end, a collapsible support on the end of the cannula releasably connected to the cardiac support device at a plurality of locations around the base end, and an acutuator. The collapsible support is movable between a collapsed state in a retracted position at which the collapsible support and cardiac support device are within the end of the cannula, and an open state in an extended position at which the collapsible support and cardiac support device are outside of the cannula with the collapsible support holding the base end of the cardiac support device in an open position for placement onto a patient's heart. The actuator moves the collapsible support between the collapsed and open states.

Abstract: A method for applying a cardiac support device to a heart of a mammal includes surgically accessing a heart, providing a cardiac support device including a jacket, and positioning the jacket around at least a portion of the heart by applying a pulling force to the jacket. The step of positioning the jacket can include using a tool from a position superior to the heart to pull the jacket onto the heart. One device for placing a cardiac support jacket onto the heart includes first and second tubular walls. The second tubular wall is oriented within the first tubular wall and against an internal surface of the first tubular wall. The second tubular wall includes a plurality of grooves and has an open interior volume to hold the cardiac support jacket. Another device for placing a cardiac support jacket onto the heart includes a tubular wall having a plurality of lumens extending between opposite ends of the tubular wall.

Abstract: A cardiac support device including a jacket and elastic self-fitting structures between base and apex ends of the jacket. The fitting structures can include undulating metal and polymer elements and a silicone panel between the base and apex ends of the jacket.

Abstract: A cardiac support device including a jacket and elastic securing structure for self-securing the jacket to a heart. The securing structures can include undulating metal and polymer elements, a silicone band and elastomeric filaments.

Abstract: A cardiac support device including a jacket and elastic attachment structure for self-securing the jacket to a heart. The attachment structures can include undulating metal and polymer elements, a silicone band and elastomeric filaments on a base end of the jacket.