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. The jacket includes a receiving member along its upper end for engagement to a delivery apparatus, the apparatus used in positioning the jacket on the heart. The delivery apparatus includes a handle and a band. The band is generally hoop shaped having a first end and a second end attached to the handle, the first end fixedly attached to the handle and the second end releasably attached to the handle. Alternatively, the first end can be attached to a releasable end cap of the handle. In use, the second end of the band is released from the handle and inserted into the jacket receiving member. The jacket is threaded onto the band and the band end re-attached to the handle.

Abstract: A pouch to at least partly enclose a heart (1), the wall of the pouch (2) being elastic. The purpose of the pouch is to enclose at least part of a heart (1) and to oppose excessive dilation of the heart (1) that might be due to infectious disease of the heart muscle, for instance a viral infection or an autoimmune process. In many cases the use of such a pouch (2) may circumvent the need for a heart transplant.

Abstract: A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.

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: 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: 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: 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: 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 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 jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.

Abstract: A tension indicator and a method for treating cardiac disease using the tension indicator is provided. The tension indicator is configured for placement between a cardiac support device and the epicardial surface to determine the pressure exerted by the device on the epicardial surface.

Abstract: An adjustment clamp suitable for adjusting the tension of a material such as a cardiac support device. The adjustment clamp comprises a pair of interconnected, intersecting arms capable of rotating around a common axis. The arms each comprise a handle, a jaw and a shaft between the handle and jaw. The clamp also includes a latch operably mounted to the handle, wherein the latches of the two arms are capable of engaging each other to secure the clamp at a desired position. In one embodiment, the jaw comprises a flat contact surface. In another embodiment, at least one jaw of one arm comprises a roller assembly. Preferably, the clamp also includes a turning mechanism operably mounted to at least one roller assembly. Methods for using the adjustment claim to increase tension in a material are also described. In a preferred embodiment, the clamp is used to adjust the tension of a cardiac support device.

Abstract: A pattern for a three dimensional cardiac support device that includes a proximal edge having a concave shape; and a seam edge that includes: first and second sides, wherein said first and second sides are substantially symmetrical along a vertical axis, first and second upward inflection regions, first and second downward inflection regions; and an intersection point. A three dimensional cardiac support device that includes: a pattern, wherein said pattern is substantially symmetrical along a vertical axis, and wherein said pattern includes a proximal edge having a concave shape, and a seam edge that includes: first and second sides, first and second downward inflection regions, first and second downward inflection regions, and an intersection point; and a seam wherein the seam is formed by folding the pattern across the vertical axis and joining the seam edge to itself.

Abstract: A tension indicator and a method for treating cardiac disease using the tension indicator is provided. The tension indicator is configured for placement between a cardiac support device and the epicardial surface to determine the pressure exerted by the device on the epicardial surface.

Abstract: An apparatus for treating congestive heart disease and related cardiac complications such as valvular disorders that includes a support device placed on the heart. Support devices such as jackets of flexible material of knit construction defining a volume between an open upper end and a lower end are included in the invention. Such support devices can be dimensioned and sized based in part on the desired function of the device. The support device includes at least one indicator marker along the longitudinal axis of the device for indicating and/or monitoring the level of tension of the device or for selecting a predetermined level of tension of the support device.

Abstract: A pouch to at least partly enclose a heart (1), the wall of the pouch (2) being elastic. The purpose of the pouch is to enclose at least part of a heart (1) and to oppose excessive dilation of the heart (1) that might be due to infectious disease of the heart muscle, for instance a viral infection or an autoimmune process. In many cases the use of such a pouch (2) may circumvent the need for a heart transplant.

Abstract: A method and device are disclosed for treating congestive heart disease. The material of the device is secured to the heart proximate the septal wall. The material covering the ventricles may or may not have the same tension and or compliance. The device can be constructed as a unitary “jacket” that is slipped over the apex of the heart. Alternately, the device implanted as one, two or more separate components. In one embodiment, the material covers both the left and right ventricles. In another embodiment, the material covers only one ventricle. The device may include at least one adjustment mechanism configured to adjust the tension of the material.

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: This invention relates to implantable heart sack that can be equipped with pacemaker leads and/or defibrillation leads for the treatment of cardiomyopathy, hypertrophic cardiomyopathy, tachycardia, bradycardia, ventricular fibrillation, atrial fibrillation etc. The heart sack was prepared from biocompatible, biostable, implantable polyetherurethane, polycarbonateurethane, silicone, polysiloxaneurethane, polyfluoroethylene, or hydrogenated poly(styrene-butadiene) copolymer. The heart sack is equipped with attached sutures to make it easier to attach onto the heart. The heart sack can be made semipermeable or perforated to have numerous holes. The heart sack can be reinforced with fiber or filament. Ordinary pacemaker leads can be attached to the inner side of the heart sack.

Abstract: A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.