Septal occluder and associated methods

Abstract

Devices are provided for closing septal defects such as PFOs. The devices generally include a proximal anchor member, a distal anchor member, and a flexible center joint connecting the two anchor members.

1 . A septal defect closure device, comprising: a proximal anchor member having a generally cylindrical shape for deployment proximate a first end of a septal defect; a distal anchor member having a generally cylindrical shape for deployment proximate a second end of said septal defect; and a suture connecting said proximal and distal anchor members. 
     
     
         2 . The device of  claim 1  wherein said suture is slidingly mounted on said proximal anchor member. 
     
     
         3 . The device of  claim 2  wherein said suture includes a biasing spring at one end thereof to bias the proximal and distal anchor members toward each other when the device is deployed. 
     
     
         4 . The device of  claim 1  wherein the suture comprises a shape memory wire. 
     
     
         5 . The device of  claim 1  wherein said suture comprises a resilient elastomeric material. 
     
     
         6 . The device of  claim 1  wherein a side of each anchor member for contacting a tissue surface is generally flattened to increase surface contact. 
     
     
         7 . The device of  claim 1  wherein said proximal and distal anchor members each comprise a cylindrical structure formed by rolling a layer of material. 
     
     
         8 . The device of  claim 1  wherein said proximal and distal anchor members are inflatable. 
     
     
         9 . The device of  claim 1  wherein said device is collapsible for passage through a catheter or sheath. 
     
     
         10 . The device of  claim 9  wherein said device can be collapsed with the proximal and distal anchor members being in a generally aligned, end to end arrangement for passage through a catheter or sheath. 
     
     
         11 . The device of  claim 1  wherein said proximal and distal anchor members are collapsible for deployment or removal. 
     
     
         12 . The device of  claim 11  wherein the proximal and distal anchor members are generally foldable. 
     
     
         13 . The device of  claim 12  wherein each anchor member includes two elements separated by an elastic hinge. 
     
     
         14 . The device of  claim 1  further comprising a removal string attached to the device to facilitate removal of the device from the septal defect. 
     
     
         15 . The device of  claim 14  wherein said removal string is slidingly mounted in said proximal anchor member and attached to said distal anchor member. 
     
     
         16 . The device of  claim 14  wherein said removal string is mounted to slide through said proximal anchor member. 
     
     
         17 . The device of  claim 14  further comprising a delivery string to facilitate deployment of the device at the septal defect. 
     
     
         18 . The device of  claim 1  further comprising a wire connecting said proximal and distal anchor members to provide clamping force to close the defect. 
     
     
         19 . The device of  claim 18  wherein said wire has a serpentine configuration. 
     
     
         20 . A method of retrieving a deployed septal closure device having a proximal anchor member positioned proximate a first end of a septal defect, a distal anchor member for positioned proximate a second end of said septal defect, and a flexible connection member connecting said proximal and distal anchor members, said method comprising: moving a sheath toward the proximal anchor member; applying tension to the proximal anchor member to first withdraw the proximal anchor member into the sheath and then to withdraw the distal anchor member into the sheath; wherein the proximal and distal anchor members are generally in an end to end, aligned arrangement in said sheath. 
     
     
         21 . The method of  claim 20  further comprising moving the sheath toward the distal anchor member prior to withdrawing the distal anchor member into the sheath. 
     
     
         22 . The method of  claim 20  wherein applying tension to the proximal anchor member comprises pulling a string attached to the proximal member. 
     
     
         23 . The method of  claim 22  wherein said string is slidingly mounted in said proximal anchor member and is attached to said distal anchor member. 
     
     
         24 . A septal defect closure device, comprising: a proximal anchor member having a frame structure for deployment proximate a first end of a septal defect; a distal anchor member having a frame structure for deployment proximate a second end of said septal defect; and a flexible joint connecting said proximal and distal anchor members. 
     
     
         25 . The device of  claim 24  wherein said flexible joint comprises a layer of thrombogenic or inflammatory material. 
     
     
         26 . The device of  claim 24  wherein said flexible joint comprises a plurality of fibers connecting said anchor members. 
     
     
         27 . The device of  claim 24  wherein said flexible joint is porous or textured. 
     
     
         28 . The device of  claim 24  wherein said flexible joint comprises a resilient elastomeric material. 
     
     
         29 . The device of  claim 24  wherein said flexible joint comprises two layers of flexible material joined to each other generally at centers thereof. 
     
     
         30 . The device of  claim 24  wherein said anchor members each have a frame structure having a polygonal or circular structure. 
     
     
         31 . The device of  claim 24  wherein said anchor members each have a frame structure having a generally “+” shaped structure. 
     
     
         32 . The device of  claim 24  wherein said anchor members each have a frame structure having a generally “G” shaped structure. 
     
     
         33 . The device of  claim 24  wherein said anchor members each have a collapsible frame structure to facilitate deployment of said device in a delivery catheter. 
     
     
         34 . The device of  claim 24  wherein each frame structure includes metal or polymer components. 
     
     
         35 . A septal defect closure device, comprising: a proximal anchor member for deployment proximate a first end of a septal defect; a distal anchor member for deployment proximate a second end of said septal defect; and a connecting member connecting said proximal and distal anchor members, wherein the distal and proximal anchors each comprise a layer that is rolled to form a cylinder during device deployment, and generally flat after deployment.