Abstract: A cardiac pacemaker, other CRT device or neurostimulator has one or more fine wire leads. Formed of a glass, silica, sapphire or crystalline quartz fiber with a metal buffer cladding, a unipolar lead can have an outer diameter as small as about 300 microns or even smaller. The buffered fibers are extremely durable, can be bent through small radii and will not fatigue even from millions of iterations of flexing. Bipolar leads can include several conductors side by side within a glass/silica fiber, or can be concentric metal coatings in a structure including several fiber layers. An outer protective sheath of a flexible polymer material can be included.

Abstract: Method and apparatus are disclosed for treating congestive heart failure by administering a fibrosis-inducing agent to an epicardial surface of the heart in an amount selected to induce the formation of fibrosis on the epicardial surface. The fibrosis-inducing agent may be a drug, metal, abrasive or an electrical stimulation on the epicardial surface.

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 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: 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: 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 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 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 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: 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 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.

Abstract: A device for delivery of a cardiac support device for treating cardiac disease of a heart includes a multistage deployment mechanism and an actuating mechanism for controlling the positions of the deployment mechanism. The deployment mechanism is operable to change between a retracted state and an extended state, and includes a plurality of independent stages, including, in one embodiment, a first stage including a guide structure for location adjacent a portion of the patient's heart when in the extended state. A second stage is movably coupled to the first stage, and is guided by the guide structure between the retracted and extended states. The second stage further releasably engages and supports the cardiac support device and positions the cardiac support device at the desired implantation location, guided by the guide structure of the stage. In some embodiments, the deployment mechanism may include additional stages.

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 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: 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: 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 delivery source for the delivery of one or more therapeutic agents to the surface of the heart. 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 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: 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.