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Pericardium reinforcing devices and methods for using themRelated Patent Categories: Surgery, Internal Organ Support Or SlingPericardium reinforcing devices and methods for using them description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070073100, Pericardium reinforcing devices and methods for using them. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 09/963,848 (Attorney Docket No. 020979-002400US), filed Sep. 25, 2001, the full disclosure of which is incorporated herein by reference. BACKGROUND OF THE INVENTION Field of the Invention [0002] This invention relates to surgical devices and to methods of using them. In particular, the device is one for reinforcing the pericardial sac surrounding the heart to assist in the treatment of congestive heart failure. The device, generically, is an enclosure having an interior and an exterior. The interior surface is made in such a way that it tends not to or does not form adhesions with or accept ingrowth with the myocardial tissue of the epicardium. The exterior surface of the device, in contrast, is adapted to adhere to or to ingrow with or otherwise to attach sufficiently to the pericardium so that it reinforces that membrane or structure. The nature of the device is that it tends not to allow the pericardium to expand further with time. The device, after complete deployment, desirably envelopes some measure of pericardial fluid in its interior separating it from the epicardial surface. This device helps to prevent further declination of the condition of the heart during the course of congestive heart failure. The device is preferably introduced into the pericardial space and onto the inner surface of the pericardium using transcutaneous or minimally invasive techniques. [0003] Congestive Heart Failure ("CHF"), or simply "Heart Failure" is a progressive path found in many forms of heart disease. In general, it is a condition in which the heart is unable to pump blood at a rate sufficient for the proper supply of nutrients to metabolizing tissues. There are many specific disease states leading to CHF, but each typically results in the dilatation of the ventricles. Various etiologies for CHF are viral and ischemic and, of course, idiopathic. Myocardial injury and chronic volume overload generally are thought to cause this course of ventricular dilatation. The typical adaptation process undertaken by the stressed heart muscle is not achieved during CHF and, instead of gaining a stronger heart muscle, the heart instead gets larger as it attempts to adapt to its increased volume load. [0004] Chronic pressure overload causes another response mechanism to develop. Specifically, hypertrophy of the heart muscle, entailing an increase both in the size of individual muscle cells and in overall muscle mass, begins to occur. Although this response helps the heart to overcome higher pressure, it has limitations and is associated with various structural and biochemical changes that have deleterious long term effects. [0005] Additionally, system-wide vascular constriction occurs during the course of CHF. The constriction causes blood flow to be redistributed so that certain regions and systems have a reduced blood supply, e.g., skeletal muscle, kidneys, and skin. These regions do not produce significant amounts of vasodilating metabolites. In contrast, the brain and heart have high metabolic rates and produce a greater amount of vasodilators. Consequently, the latter organs receives a higher proportion of the restricted blood supply. [0006] Therapy for CHF is staged. Correction of a reversible causative factors is the first line of offense. Treatment of bradyarrhythmias, perhaps by use of an artificial pacemaker or by provision of an appropriate drug such as digitalis, can help alleviate CHF. CHF that continues after correction of such reversible causes is often treated with a regime of salt restriction, vasodilators, diuretics, and the like. Bed rest to increase venous return to the heart and move fluid from the periphery is often helpful. As noted above, digitalis has been an important drug for increasing cardiac output in persons with specific types of CHF. It has been used for over 200 years. Other drugs used for treatment of CHF include beta-adrenergic agonists such as norepinephrine, epinephrine, and isoproterenol. Each stimulate cardiac beta-adrenergic receptors. Dopamine and dobutamine are also used. Various diuretics and vasodilators for variously dilating both veins and arteries are used, each for slightly different reasons based on the detected manifestation of the CHF in the heart. Few interventional or surgical pathways for alleviation of CHF are currently widely practiced. Indeed, the only permanent treatment for CHF is a heart transplant. [0007] One surgical procedure known as cardiomyoplasty is used for early stage CHF. In that procedure, a muscle taken from the shoulder (the latissimus dorsi) is wrapped around the heart. The added muscle is paced synchronously with the ventricular systole. This procedure is highly invasive requiring a stemotomy to access the heart. Some have suggested that the benefits of the procedure are due more to remodeling from the mere placement of the shoulder muscle around the heart rather than from a muscular assistance. [0008] There are a variety of devices that may be applied to the heart for treatment of CHF. Patents owned by Abiomed (U.S. Pat. Nos. 6,224,540; 5,800,528; 5,643,172) generally show a girdle-like device situated to provide structure to a failing heart. U.S. Patents owned by Acorn Cardiovascular, Inc. (U.S. Pat. Nos. 6,241,654; 6,230,714; 6,193,648; 6,174,279; 6,169,922; 6,165,122; 6,165,121; 6,155,972; 6,126,590; 6,123,662; 6,085,754; 6,077,218; 5,702,343) show various devices, also for treatment of CHF, which typically include a mesh sock-like device placed around the myocardial wall. U.S. Patents to Myocor, Inc. (U.S. Pat. Nos. 6,264,602; 6,261,222; 6,260,552; 6,183,411; 6,165,120; 6,165,119; 6,162,168; 6,077,214; 6,059,715; 6,050,936; 6,045,497; 5;961,440) show devices for treatment CHF generally using components that pierce the ventricular wall. [0009] None of the documents mentioned above appears to suggest the devices and methods provided for herein. BRIEF SUMMARY OF THE INVENTION [0010] This invention is a device and a method for reinforcing the pericardium. Generically, it is made of at least one compliant member having an interior surface for placement adjacent to or spaced away from the epicardium and an exterior surface for attachment to the interior of a pericardium. The compliant member may be conformable in shape to at least a portion of the epicardium. [0011] The interior surface is adapted to inhibit adhesions or attachment to the epicardium, e.g., via use of a material that does not substantially permit ingrowth with or that resists ingrowth with the epicardium. Suitable choices for materials that functionally provide such results include various lubricious material, perhaps polymeric, e.g., fluorocarbon polymers especially those selected from the group consisting of polytetrafluoroethylene, ethylene-chlorofluoroethylene, fluorinated ethylene propylene, polychlorotrifluoroethylene, polyvinylfluoride, and polyvinylidenefluoride and certain expanded polytetrafluoroethylenes (ePTFE). Other suitable lubricious polymers include those selected from the group consisting of LLDPE, LDPE, HDPE, polypropylene, and polyamides their mixtures and co-polymers. [0012] The exterior surface functionally adheres to or reacts with or ingrows with the pericardium in such a way that the resulting pericardium-implant combination is substantially reinforced compared to the previously existing pericardium. The outer layer, for instance, may comprise a material for ingrowth into or with or for attachment to or adherence with the pericardium. The exterior surface may comprise a material that itself promotes ingrowth, e.g., polyethylene terephthalate, polyglycolic acid, polylactic acid, reconstituted collagen, poly-p-dioxanone, poly(glycolide-lactide) copolymer, poly(glycolide-trimethylene carbonate) copolymer, poly(glycolide-.epsilon.-caprolactone) copolymer, glycolide-trimethylene carbonate triblock copolymer, their block and random copolymers, mixtures, and alloys. Physical mixtures of the biodegradable polymers with other substantially non-biodegradable materials, (such as polyolefins or polyfluorocarbons) is desired to preserve to integrity of the flexible or compliant member. Particularly desirable are mixtures of biodegradable and non-bio-degradable polymeric fibers, perhaps by coweaving or other suitable manner of making an integrated fabric. [0013] The outer surface may further comprise a material promoting endothelialization, such as an effective hyalonurate salt or one or more angiogenic materials such as are listed below. Physically, the outer surface may be an independent layer or an integrated layer, a woven or non-woven polymeric material. The attachment to the outer layer may be simply mechanical, and produced by, e.g., suturing or adhesively attaching it to the pericardium. The exterior surface may be textured to assist with ingrowth into the pericardium. [0014] As noted above, the compliant member may comprise a separate inner member and an outer member, e.g., where at least one of the inner members and the outer members comprises a woven or non-woven fabric. They may be laminated together or with an intermediate between. In some instances, at least one, of the inner members and the outer members is substantially non-porous, non-porous, or non-continuous. [0015] It is desirable that the inventive device include an adjuster adapted for changing the compliant member size after attachment of that compliant member to the interior of the pericardium. The adjuster, for instance, may be a rotatable roller, a drawstring, a band, or the like. One preferable band variation is made up of an upper end and an apical end and has a length extending from the upper end to the apical end and where the length of the band is less than about 1/3 length of a heart to which it is applied. The band may have a length substantially matching the width of the A-V groove on that heart. [0016] The shape of the compliant member may be that of a sack having a closed end, particularly one having a closed end and sized to be positioned only along and less than about 1/3 length of the heart when positioned from the apical end. The compliant member may be a substantially elongated member having a distal end and a proximal end and configured to be helical upon introduction into the region of the pericardium, perhaps having a lumen (in some instances expandable) extending from the proximal end at least partially to the distal end. The lumen may have at least one orifice open to the exterior surface when the device is helically configured in the region of the pericardium, perhaps to pass glue or adhesive to the pericardium side of the device. In some variations, the source of glue or adhesive also forms a component of the inventive device. [0017] One very desirable form of the compliant member is an enclosure generally conforming in shape to at least a portion of an epicardium where the enclosure has at least one rib separated by and spaced apart by webbing. The rib may be at least one band having an upper end and an apical end and a length extending from the upper end to the apical end and having at least two open, generally opposing openings. Desirably, the wound band has a length less than about 1/3 length of a heart to which it is applied. [0018] Preferably, the various ribs have a flexibility different than that of the webbing. The at least one rib may have the form of a generally helical member, perhaps ribbon-like in form. A "ribbon" is considered to have a width-thickness ratio greater than about two, perhaps greater than about seven. The helical member may be inflatable over at least a portion of the enclosure, perhaps incrementally inflatable along its length. [0019] The compliant member may be made up of an enclosure generally conforming in shape to at least a portion of a pericardium and having multiple ribs extending from the upper end to the apical end. Desirably each rib may be ribbon-like. Alternatively, the ribs may each have a round cross section or may have a cross section with a width-thickness ratio of two or less. The multiple ribs may be zigzag in shape and where there are multiple zigzag ribs having substantially adjacent points, at least some of the adjacent points may be connected. At least some of the multiple ribs may be joined at the apical end. [0020] The webbing may be of a variety of forms, e.g., a woven fabric, a woven open weave fabric, one or more ribbons extending between at least some of the multiple ribs, one or more fibers extending between at least some of the multiple ribs, an elastic material, a substantially inelastic material, or the like. Continue reading about Pericardium reinforcing devices and methods for using them... 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