Pericardium reinforcing devices and methods for using them

Abstract

A surgical device for reinforcing the pericardial sac surrounding the heart to assist in the treatment of congestive heart failure includes an enclosure having an interior and an exterior. The interior surface limits adhesions or accepts ingrowth with the myocardial tissue of the epicardium. The exterior surface is adapted to adhere to or otherwise attach to the pericardium to provide reinforcement.

1 . A method for treating a heart condition in a patient, said method comprising:
 introducing a compliant and substantially non-elastic member into the pericardium of the patient's heart;   surrounding a substantial portion of the patient's heart with the non-elastic member such that an interior surface of the non-elastic member surrounds an epicardium of the patient and an exterior surface of the non-elastic member directly contacts and conforms to the pericardium; and   coupling the non-elastic member with the pericardium such that a substantial portion of the exterior surface between an apical end and an upper end of the non-elastic member is in contact with the pericardium so as to constrain expansion of the pericardium.   
     
     
         2 . The method of  claim 1 , wherein the non-elastic member is coupled with the pericardium such that the apical end of the non-elastic member is contained entirely within the pericardium. 
     
     
         3 . The method of  claim 1 , wherein the non-elastic member is coupled with the pericardium such that the interior surface of the non-elastic member is separated from the epicardium so that the non-elastic member surrounds a pericardial space filled with pericardial fluid between the interior surface and the epicardium such that fluid pressure of the pericardial fluid in the pericardial space exerts a force on the epicardium without substantial contact between the non-elastic member and epicardium. 
     
     
         4 . The method of  claim 1 , wherein the treated heart condition comprises congestive heart failure. 
     
     
         5 . The method of  claim 1 , wherein introducing the non-elastic member into the pericardium comprises introducing the non-elastic member below the xiphoid process of the patient through a pericardial wall into a pericardial space. 
     
     
         6 . The method of  claim 5 , wherein introducing the non-elastic member into the pericardium further comprises puncturing skin beneath the xiphoid process with a needle, passing the needle and a guidewire through the pericardium to the pericardial space, removing the needle from the pericardial space, and advancing a catheter over the guidewire and into the pericardial space. 
     
     
         7 . The method of  claim 1 , wherein coupling the non-elastic member with the pericardium comprises promoting ingrowth of the pericardium with the exterior surface of the non-elastic member. 
     
     
         8 . The method of  claim 7 , wherein promoting ingrowth of the pericardium with the exterior surface of the non-elastic member comprises promoting angiogenesis adjacent the pericardium. 
     
     
         9 . The method of  claim 7 , wherein promoting ingrowth of the pericardium with the exterior surface of the non-elastic member comprises using a material that promotes ingrowth with the pericardium on the outer surface of the non-elastic member. 
     
     
         10 . The method of  claim 9 , wherein the material that promotes ingrowth with the pericardium comprises expanded polytetrafluoroethylene (ePTFE) that is adapted to promote ingrowth. 
     
     
         11 . The method of  claim 10 , wherein the ePTFE is adapted to promote ingrowth by having an inter-nodal distance of greater than about 60 microns. 
     
     
         12 . The method of  claim 10 , wherein the non-elastic member comprises an ePTFE sheet having an inter-nodal gradient between a first side and a second side. 
     
     
         13 . The method of  claim 12 , wherein the first side has an inter-nodal distance of less than about 40 microns, and the second side has an inter-nodal distance of greater than about 60 microns. 
     
     
         14 . The method of  claim 1 , wherein coupling the non-elastic member with the pericardium comprises mechanically fastening the exterior surface of the non-elastic member to the pericardium. 
     
     
         15 . The method of  claim 14 , wherein mechanically fastening the exterior surface of the non-elastic member to the pericardium comprises suturing the exterior surface to the pericardium. 
     
     
         16 . The method of  claim 14 , wherein mechanically fastening the exterior surface of the non-elastic member to the pericardium comprises stapling the exterior surface to the pericardium. 
     
     
         17 . The method of  claim 1 , wherein coupling the non-elastic member with the pericardium comprises adhesively adhering the exterior surface of the non-elastic member to the pericardium. 
     
     
         18 . The method of  claim 1 , further comprising inhibiting adhesion or attachment of the interior surface of the non-elastic member to the epicardium. 
     
     
         19 . The method of  claim 18 , wherein inhibiting adhesion or attachment of the interior surface of the non-elastic member to the epicardium comprises using a material that does not substantially permit ingrowth with or that resists ingrowth with the epicardium for the inner surface of the non-elastic member. 
     
     
         20 . The method of  claim 19 , wherein the material that does not substantially permit ingrowth with or that resists ingrowth with the epicardium comprises a lubricous material. 
     
     
         21 . The method of  claim 20 , wherein the lubricous material comprises a lubricous polymeric material. 
     
     
         22 . The method of  claim 21 , wherein the lubricous polymeric material comprises a fluorocarbon polymer. 
     
     
         23 . The method of  claim 22 , wherein the fluorocarbon polymer is selected from the group consisting of polytetrafluoroethylene, ethylene-chlorofluoroethylene, fluorinated ethylene propylene, polychlorotrifluoroethylene, polyvinylchloride, and polyvinylidenefluoride. 
     
     
         24 . The method of  claim 22 , wherein the lubricous polymeric material comprises expanded polytetrafluoroethylene (ePTFE) that is adapted to inhibit ingrowth. 
     
     
         25 . The method of  claim 24 , wherein the ePTFE is adapted to inhibit ingrowth by having an inter-nodal distance of less than about 40 microns. 
     
     
         26 . The method of  claim 21 , wherein the lubricous polymeric material is selected from the group consisting of LLDPE, LDPE, HDPE, polypropylene, polyamides, their mixtures, and their co-polymers. 
     
     
         27 . The method of  claim 1 , further comprising changing the size of the non-elastic member after the non-elastic member has been coupled with the pericardium. 
     
     
         28 . The method of  claim 27 , wherein changing the size of the non-elastic member comprises providing an adjuster for the non-elastic member. 
     
     
         29 . The method of  claim 28 , wherein the adjuster comprises a rotatable roller, a drawstring, or a band. 
     
     
         30 . The method of  claim 1 , wherein surrounding a substantial portion of the patient's heart with the non-elastic member comprises surrounding no more than ⅓ of the patient's heart measured from the apex of the patient's heart. 
     
     
         31 . A method for treating a heart condition in a patient, said method comprising:
 coupling a device to a pericardium of the patient's heart to reinforce the pericardium such that expansion of the pericardium is inhibited while maintaining a pericardial space between the pericardium and an epicardium of the patient's heart, the pericardial space containing a fluid which exerts pressure on the epicardium without the device contacting the epicardium.   
     
     
         32 . The method of  claim 31 , wherein the treated heart condition comprises congestive heart failure. 
     
     
         33 . The method of  claim 31 , wherein the device is non-elastic. 
     
     
         34 . The method of  claim 31 , further comprising changing the size of the device after the device has been coupled to the pericardium. 
     
     
         35 . The method of  claim 34 , wherein changing the size of the device comprises providing an adjuster for the device. 
     
     
         36 . The method of  claim 35 , wherein the adjuster comprises a rotatable roller, a drawstring, or a band. 
     
     
         37 . The method of  claim 31 , wherein the device is coupled to the pericardium such that the device surrounds a substantial portion of the patient's heart. 
     
     
         38 . The method of  claim 37 , wherein the device is coupled to the pericardium such that the device surrounds no more than ⅓ of the patient's heart measured from the apex of the patient's heart. 
     
     
         39 . The method of  claim 31 , wherein the device is coupled to the pericardium such that a substantial portion of a surface of the device between an apical end and an upper end of the device is in contact with the pericardium so as to inhibit the expansion of the pericardium. 
     
     
         40 . The method of  claim 31 , wherein coupling the device to the pericardium comprises promoting ingrowth of the pericardium with a surface of the device in contact with the pericardium. 
     
     
         41 . The method of  claim 40 , wherein promoting ingrowth of the pericardium comprises promoting angiogenesis adjacent the pericardium. 
     
     
         42 . The method of  claim 40 , wherein promoting ingrowth of the pericardium comprises using a material that promotes ingrowth with the pericardium for the surface of the device in contact with the pericardium. 
     
     
         43 . The method of  claim 42 , wherein the material that promotes ingrowth with the pericardium comprises expanded polytetrafluoroethylene (ePTFE) that is adapted to promote ingrowth. 
     
     
         44 . The method of  claim 43 , wherein the EPTFE that is adapted to promote ingrowth by having an inter-nodal distance of greater than about 60 microns. 
     
     
         45 . The method of  claim 43 , wherein the device comprises an ePTFE sheet having an inter-nodal gradient between a first side and a second side. 
     
     
         46 . The method of  claim 45 , wherein the first side has an inter-nodal distance of less than about 40 microns, and the second side has an inter-nodal distance of greater than about 60 microns. 
     
     
         47 . The method of  claim 31 , wherein coupling the device to the pericardium comprises mechanically fastening a surface of the device to the pericardium. 
     
     
         48 . The method of  claim 47 , wherein mechanically fastening the surface of the device to the pericardium comprises suturing the surface to the pericardium. 
     
     
         49 . The method of  claim 47 , therein mechanically fastening the surface of the device to the pericardium comprises stapling the surface to the pericardium. 
     
     
         50 . The method of  claim 31 , wherein coupling the device to the pericardium comprises adhesively adhering the exterior surface of the non-elastic member to the pericardium.