Abstract: An apparatus for delivering a medical device onto a heart includes a housing within which is releasably disposed the medical device. The housing in one embodiment comprises inner and outer deflectors between which is delivered the medical device. Both deflectors are self-expanding. A deflector compression sheath is slidable longitudinally over the housing to a delivery position at which it moves the deflectors to a collapsed configuration. The compression sheath is retracted to a deployment position to permit the deflectors to deploy by self-expanding to their larger diameters. The outer deflector has an expanded diameter sufficient to engage the inner surface of the pericardium to hold it away from the delivery site while the second deflector guides the medical device into position over the heart while protecting the heart. In another embodiment, the housing includes only an outer deflector.

Abstract: A cardiac harness for treating or preventing congestive heart failure is configured to be placed about at least a portion of a patient's heart so as to apply a mild compressive force on the heart. In one embodiment, the cardiac harness comprises a plurality of spaced apart conductive panels arranged so that there is no electrical continuity circumferentially around the harness. In an additional embodiment, a cardiac harness is provided that is insulated so as not to conduct electricity circumferentially about the harness.

Abstract: A cardiac harness for treating or preventing congestive heart failure is configured to be placed about at least a portion of a patient's heart so as to apply a mild compressive force on the heart. In one embodiment, the cardiac harness is configured so that the variation of load as a function of expansion through a selected range of expansion is represented generally in the form y=ax+b, and the value of “a” does not increase as the percent expansion increases.

Abstract: An apparatus and method of preparing a cardiac harness for use in controllably delivering a medicament such as an mTOR inhibitor or aldosterone blockade from the surface of the cardiac harness to the epicardium of a patient's heart for the site-specific treatment of cardiac and non-cardiac maladies. The delivery of the medicament from the cardiac harness is achieved by: coating the medicament on the surface of the cardiac harness; coating the cardiac harness with a polymer material or dielectric material and impregnating the coating with the medicament; or by loading the medicament into an implant attached to the cardiac harness.

Abstract: A system for creating a passage through the pericardium of a patient to permit access of a cardiac harness delivery device, including a tubular introducer sleeve and a tubular dilator sleeve insertable into the introducer sleeve. The introducer sleeve has a slot and a distal portion biased in a reduced opening. The distal end being positioned within an incision through the pericardium. Insertion of the dilator sleeve into the introducer sleeve causes it to push outwardly against the reduced opening, thereby expanding the reduced opening of the introducer sleeve sufficiently to permit a cardiac harness delivery device to access the epicardium. The introducer sleeve is releasably locked to the dilator sleeve by operation of a slot on the introducer sleeve and a protrusion on the dilator sleeve, which slides within the slot.

Abstract: An apparatus for delivering a medical device onto a heart includes a housing within which is releasably disposed the medical device. The housing in one embodiment comprises inner and outer deflectors between which is delivered the medical device. Both deflectors are self-expanding. A deflector compression sheath is slidable longitudinally over the housing to a delivery position at which it moves the deflectors to a collapsed configuration. The compression sheath is retracted to a deployment position to permit the deflectors to deploy by self-expanding to their larger diameters. The outer deflector has an expanded diameter sufficient to engage the inner surface of the pericardium to hold it away from the delivery site while the second deflector guides the medical device into position over the heart while protecting the heart. In another embodiment, the housing includes only an outer deflector.

Abstract: A cardiac harness assembly for treating congestive heart failure and for use in defibrillation and/or pacing/sensing is provided. The cardiac harness includes a number of longitudinal ribs spaced apart by connectors, the longitudinal ribs extending from the base to the apex of the heart. The longitudinal ribs have a high degree of longitudinal flexibility so that when the cardiac harness is mounted on the heart, the longitudinal ribs flex along the longitudinal axis of the ribs as the heart expands and contracts circumferentially. The cardiac harness provides a uniform and continuous compressive force on the heart throughout the cardiac cycle.

Abstract: A system for treating the heart including a cardiac harness configured to conform generally to at least a portion of a patient's heart. The system also includes an electrode associated with the cardiac harness and positioned on or proximate to the epicardial surface of the heart. In order to ensure that the electrode will operate with a pulse generator, the system has an impedance between approximately 10 ohms and approximately 120 ohms.

Abstract: The apparatus includes and elongate body having a proximal portion and a distal portion. The body includes a cavity sized to contain a cardiac harness in a compacted configuration and also includes a plurality of elongate push rods movable with respect to the body. The cardiac harness is releasably connected to each of the push rods such that advancement of the push rods in a distal direction moves the harness from a compacted configuration, within the cavity, to an expanded configuration, outside the cavity. The apparatus also includes a releasing member for releasing the connections between the push rods and the harness upon actuation of the releasing member by a user.

Abstract: A high fatigue life superelastic nickel-titanium (nitinol) wire, ribbon, sheet, tubing, or the like is disclosed. The nitinol has a 54.5 to 57.0 weight percent nickel with a balance of titanium composition and has less than 30 percent cold work as a final step after a full anneal and before shape setting heat treatment. Through a rotational beam fatigue test, fatigue life improvement of 37 percent has been observed.

Abstract: A cardiac harness for treating or preventing congestive heart failure is configured to be placed about at least a portion of a patient's heart so as to apply a mild compressive force on the heart. In one embodiment, the cardiac harness comprises a plurality of spaced apart conductive panels arranged so that there is no electrical continuity circumferentially around the harness. In an additional embodiment, a cardiac harness is provided that is insulated so as not to conduct electricity circumferentially about the harness.

Abstract: A delivery device configured for delivering a cardiac harness onto the heart is disclosed. The device includes a plurality of push rods, a housing, and a control mechanism. The device also includes a method of pulling a cardiac harness onto a heart. The method includes inserting the delivery device through a minimally invasive incision sized to receive the housing. The housing is advanced through the incision so that the housing is adjacent the heart and advanced distally out of the housing by advancing the control assembly distally over a shaft. The housing mounts the cardiac harness on the heart and releases the harness from the push rods.

Abstract: An apparatus for delivering a cardiac harness onto a heart includes an elongate body and a plurality of elongate push rods longitudinally movable with respect to the elongate body. The elongate body has a tubular housing that is sized to contain the cardiac harness which is removably attached to the push rods. The cardiac harness is releasably attached to the push rods such that advancement of the push rods in a distal direction moves the cardiac hearness from a compacted configuration in the housing to an expanded configuration outside the housing. A deflector is attached to the elongate body and is configured to flare radially outwardly. As the push rods advance out of the housing, the push rods slide over the deflector to more easily and safely advance over the enlarged heart and position the cardiac harness over the heart.

Abstract: A delivery system for providing and deploying a cardiac harness over a heart. The delivery system includes an introducer tube having a plurality of distal fingers biased into a compressed delivery diameter. A dilator tube is slidably mounted within the introducer tube for dilating the fingers into an expanded diameter for deploying a suction cup into secure attachment with the heart. The suction cup is used to manipulate the heart as the cardiac harness is also deployed from the dilator tube over the suction cup, and over the heart. The suction cup is shaped to securely attach to the apex of the heart in one embodiment.

Abstract: A cardiac harness for treating or preventing congestive heart failure is configured to be placed about at least a portion of a patient's heart so as to apply a mild compressive force on the heart. In one embodiment, the cardiac harness comprises a plurality of spaced apart conductive panels arranged so that there is no electrical continuity circumferentially around the harness. In an additional embodiment, a cardiac harness is provided that is insulated so as not to conduct electricity circumferentially about the harness.

Abstract: A high fatigue life superelastic nickel-titanium (nitinol) wire, ribbon, sheet, tubing, or the like is disclosed. The nitinol has a 54.5 to 57.0 weight percent nickel with a balance of titanium composition and has less than 30 percent cold work as a final step after a full anneal and before shape setting heat treatment. Through a rotational beam fatigue test, fatigue life improvement of 37 percent has been observed.

Abstract: A high fatigue life superelastic nickel-titanium (nitinol) wire, ribbon, sheet, tubing, or the like is disclosed. The nitinol has a 54.5 to 57.0 weight percent nickel with a balance of titanium composition and has less than 30 percent cold work as a final step after a full anneal and before shape setting heat treatment. Through a rotational beam fatigue test, fatigue life improvement of 37 percent has been observed.

Abstract: A method and apparatus for treating heart failure is configured to be placed about at least a portion of a patient's heart to apply a mild compressive force on the heart over a range of elastic deformation of the apparatus. The apparatus can be shifted to second range of deformation. In some embodiments, the apparatus is shifted to the second range of deformation by application of a stimulus or alteration of environmental conditions beyond a threshold level.

Abstract: A cardiac harness is configured to fit about a portion of a patient's heart so as to exert a compressive force on the heart during at least a portion of the cardiac cycle. The harness can be constructed of a plurality of individual modules assembled ex vivo or in vivo. The modules can have different physical characteristics, such as having different compliance, and may or may not include spring hinges. Portions of a cardiac harness can be connected to each other using a coupling mechanism such as, for example, a zip coupler.

Abstract: A cardiac harness is configured to fit about a portion of a patient's heart so as to exert a compressive force on the heart during at least a portion of the cardiac cycle. The harness can be constructed of a plurality of individual modules assembled ex vivo or in vivo. The modules can have different physical characteristics, such as having different compliance, and may or may not include spring hinges. Portions of a cardiac harness can be connected to each other using a coupling mechanism such as, for example, a zip coupler.