Closure devices, related delivery methods and tools, and related methods of use

Abstract

A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor.

1 - 102 . (canceled)  
   
   
       103 . A device for sealing a passageway in a human heart, the device comprising: 
 a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms made of a first material, wherein the first anchor does not include a structure spanning between the plurality of arms;    a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms and a cover spanning between the plurality of arms; and    an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member being made of a second material different from the first material.    
   
   
       104 . The device of  claim 103 , wherein the passageway is a patent foramen ovale.  
   
   
       105 . The device of  claim 103 , wherein the elongate member is flexible.  
   
   
       106 . The device of  claim 103 , wherein the plurality of arms of the first anchor extend from a central hub of the first anchor.  
   
   
       107 . The device of  claim 103 , wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.  
   
   
       108 . The device of  claim 103 , wherein the plurality of arms of the second anchor extend from a central hub of the second anchor.  
   
   
       109 . The device of  claim 103 , wherein the plurality of arms of the second anchor can assume a collapsed state and a deployed state.  
   
   
       110 . The device of  claim 103 , wherein the first anchor pivots relative to the elongate member.  
   
   
       111 . The device of  claim 103 , wherein the second anchor pivots relative to the elongate member.  
   
   
       112 . The device of  claim 103 , wherein the device is a closure device for sealing a patent foramen ovale in a heart, the first anchor is configured to engage a left atrial opening of the passageway, and the second anchor is configured to engage a right atrial opening of the passageway.  
   
   
       113 . The device of  claim 103 , wherein the elongate member has a first end fixedly connected to the first anchor.  
   
   
       114 . The device of  claim 103 , wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.  
   
   
       115 . The device of  claim 103 , wherein the second anchor is movable with respect to the elongate member.  
   
   
       116 . The device of  claim 115 , wherein the elongate member includes a fixing portion configured to receive a fixing element for fixing a position of the second anchor relative to the elongate member, and wherein the fixing element may be positioned at any point along a length of the fixing portion of the elongate member.  
   
   
       117 . The device of  claim 103 , wherein the elongate member is configured to permanently connect the first and second anchors when implanted in the body.  
   
   
       118 . The device of  claim 103 , wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.  
   
   
       119 . The device of  claim 103 , wherein the device includes a fixing element positioned on and movable relative to the elongate member to fix the location of the second anchor with respect to the elongate member.  
   
   
       120 . The device of  claim 119 , wherein the elongate member includes a fixing portion configured to receive the fixing element, and wherein the fixing element may be positioned at any point along a length of the fixing portion of the elongate member.  
   
   
       121 . The device of  claim 119 , wherein the fixing element is a locking element movable in only one direction along the elongate member.  
   
   
       122 . The device of  claim 119 , wherein the fixing element is a releasable fixation element.  
   
   
       123 . The device of  claim 122 , wherein the releasable fixation element forms a central portion of the second anchor.  
   
   
       124 . The device of  claim 103 , wherein the cover spanning between the plurality of arms of the second anchor is formed from a single sheet of material.  
   
   
       125 . The device of  claim 103 , wherein the cover spanning between the plurality of arms of the second anchor is made from one of a woven polyester, a knit polyester, and ePTFE.  
   
   
       126 . The device of  claim 103 , wherein the cover spanning between the plurality of arms of the second anchor comprises a porous material having a porosity sufficient to encourage ingrowth of tissue.  
   
   
       127 . The device of  claim 103 , wherein the cover spanning between the plurality of arms of the second anchor includes a non-thrombogenic coating.  
   
   
       128 . The device of  claim 127 , wherein the non-thrombogenic coating is heparin.  
   
   
       129 . The device of  claim 103 , wherein the cover is attached to the plurality of arms of the second anchor by sutures.  
   
   
       130 . The device of  claim 103 , wherein the second material is a polymeric material.  
   
   
       131 . The device of  claim 130 , characterized in that the second material is one of ultra-high molecular weight polyethylene, liquid crystal polymer, and polyester.  
   
   
       132 . The device of  claim 131 , wherein the second material is an ultra-high molecular weight polyethylene and wherein the second material is one of SPECTRA and DYNEEMA.  
   
   
       133 . The device of  claim 131 , wherein the second material is the liquid crystal polymer VECTRAN.  
   
   
       134 . The device of  claim 103 , wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.  
   
   
       135 . The device of  claim 103 , wherein the plurality of arms of the second anchor are made of the first material.  
   
   
       136 . The device of  claim 103 , wherein the first material is metallic.  
   
   
       137 . The device of  claim 136 , wherein the first material is a metallic wire.  
   
   
       138 . The device of  claim 136 , wherein the first material is one of stainless steel, nickel-titanium, ELGILOY, or MP 35 N.  
   
   
       139 . The device of  claim 103 , wherein the elongate member is a braided structure.  
   
   
       140 . The device of  claim 103 , wherein the elongate member is a multifilar structure.  
   
   
       141 . A device for sealing a passageway in a human heart, the device comprising: 
 a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms, wherein the first anchor does not include a structure spanning between the plurality of arms;    a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms and a cover spanning between the plurality of arms; and    an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member having sufficient flexibility to conform to a shape of the passageway.    
   
   
       142 . The device of  claim 141 , wherein the passageway is a patent foramen ovale.  
   
   
       143 . The device of  claim 141 , wherein the elongate member is flexible.  
   
   
       144 . The device of  claim 141 , wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.  
   
   
       145 . The device of  claim 141 , wherein the plurality of arms of the second anchor can assume a collapsed state and a deployed state.  
   
   
       146 . The device of  claim 141 , wherein the first anchor pivots relative to the elongate member.  
   
   
       147 . The device of  claim 141 , wherein the second anchor pivots relative to the elongate member.  
   
   
       148 . The device of  claim 141 , wherein the device is a closure device for sealing a patent foramen ovale in a heart, the first anchor is configured to engage a left atrial opening of the passageway, and the second anchor is configured to engage a right atrial opening of the passageway.  
   
   
       149 . The device of  claim 141 , wherein the second anchor is movable with respect to the elongate member.  
   
   
       150 . The device of  claim 149 , wherein the elongate member includes a fixing portion configured to receive a fixing element for fixing a position of the second anchor relative to the elongate member, and wherein the fixing element may be positioned at any point along a length of the fixing portion of the elongate member.  
   
   
       151 . The device of  claim 141 , wherein the device includes a fixing element positioned on and movable relative to the elongate member to fix the location of the second anchor with respect to the elongate member.  
   
   
       152 . The device of  claim 151 , wherein the elongate member includes a fixing portion configured to receive the fixing element, and wherein the fixing element may be positioned at any point along a length of the fixing portion of the elongate member.  
   
   
       153 . The device of  claim 151 , wherein the fixing element is a locking element movable in only one direction along the elongate member.  
   
   
       154 . The device of  claim 141 , wherein the cover spanning between the plurality of arms of the second anchor is formed from a single sheet of material.  
   
   
       155 . The device of  claim 141 , wherein the cover spanning between the plurality of arms of the second anchor is made from one of a woven polyester, a knit polyester, and ePTFE.  
   
   
       156 . The device of  claim 141 , wherein the cover spanning between the plurality of arms of the second anchor comprises a porous material having a porosity sufficient to encourage ingrowth of tissue.  
   
   
       157 . The device of  claim 141 , wherein the cover spanning between the plurality of arms of the second anchor includes a non-thrombogenic coating.  
   
   
       158 . The device of  claim 157 , wherein the non-thrombogenic coating is heparin.  
   
   
       159 . The device of  claim 141 , wherein the cover is attached to the plurality of arms of the second anchor by sutures.  
   
   
       160 . The device of  claim 141 , wherein the elongate member is a braided structure.  
   
   
       161 . The device of  claim 141 , wherein the elongate member is a multifilar structure.  
   
   
       162 . An improved occlusion device, comprising: 
 a center post;    first and second fixation devices connected to the center post, the first and second fixation devices comprising at least five arms;    first and second sheets attached to the first and second fixation devices respectively.    
   
   
       163 . The occlusion device of  claim 162 , wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.  
   
   
       164 . The occlusion device of  claim 163 , wherein the arms of the first fixation device do not have equal lengths.  
   
   
       165 . The occlusion device of  claim 164 , wherein the arms of the second fixation device do not have equal lengths.  
   
   
       166 . The occlusion device of  claim 162 , wherein each arm is spaced at an equal angle from the adjacent arm.  
   
   
       167 . The occlusion device of  claim 162 , wherein the number of sides of the first and second sheets is equal to the number of arms of the fixation devices.  
   
   
       168 . The occlusion device of  claim 162 , wherein the first and second fixation devices comprise six arms.  
   
   
       169 . The occlusion device of  claim 168 , wherein the six arms are formed by three wires extending through holes in the center post.  
   
   
       170 . An occlusion device with improved seating ability, the occlusion device comprising: 
 a center post;    first and second fixation devices emanating from the center post, wherein the first and second fixation devices comprise at least six arms; and    first and second sails attached to the first and second fixation devices, respectively.    
   
   
       171 . The occlusion device of  claim 170 , wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.  
   
   
       172 . The occlusion device of  claim 170 , wherein the arms do not have equal lengths.  
   
   
       173 . The occlusion device of  claim 170 , further comprising holes in the center post through which the first fixation device extends.  
   
   
       174 . The occlusion device of  claim 170 , wherein the first and second fixation devices comprise eight arms.  
   
   
       175 . The occlusion device of  claim 170 , wherein the first and second fixation devices comprise ten arms.  
   
   
       176 . The occlusion device of  claim 170 , wherein the number of sides of the first and second sails is equal to the number of arms of the fixation devices.  
   
   
       177 . An occlusion device for occluding a septal defect, the occlusion device comprising: 
 a first fixation device configured to be placed on a first side of a septal defect, the first fixation device comprising at least five arms; and    a second fixation device configured to be positioned on a second side of a defect, the second fixation device comprising at least five arms.    
   
   
       178 . The occlusion device of  claim 177 , wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.  
   
   
       179 . The occlusion device of  claim 178 , wherein the arms of the first fixation device do not have equal lengths.  
   
   
       180 . The occlusion device of  claim 179 , wherein the arms of the second fixation device do not have equal lengths.  
   
   
       181 . The occlusion device of  claim 177 , wherein each arm is spaced at an equal angle from the adjacent arm.  
   
   
       182 . The occlusion device of  claim 177 , further comprising first and second sails attached to the first and second fixation devices.  
   
   
       183 . The occlusion device of  claim 177 , wherein the first and second fixation devices comprise six arms.  
   
   
       184 . The occlusion device of  claim 177 , further comprising a center post to which the first and second fixation devices are attached.  
   
   
       185 . The occlusion device of  claim 177 , wherein the arms of the first and second fixation devices are formed to have a stiffness that ensures proper occlusion of the defect and provides the desired tension, yet does not decrease fatigue life of the fixation devices.  
   
   
       186 . An occlusion device for occluding a septal defect, the occlusion device comprising: 
 a first fixation device configured to be placed on a first side of a septal defect, the first fixation device comprising a plurality of arms which do not have equal lengths; and    a second fixation device configured to be positioned on a second side of a septal defect, the second fixation device comprising a plurality of arms which do not have equal lengths.    
   
   
       187 . The occlusion device of  claim 186 , wherein the length of the arms of the first fixation device is not equal to the length of the arms of the second fixation device.  
   
   
       188 . The occlusion device of  claim 186 , wherein the plurality of arms comprises five arms.  
   
   
       189 . The occlusion device of  claim 186 , wherein the plurality of arms comprises six arms.