Systems and methods for treating septal defects

Abstract

A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, a stabilization device configured to stabilize the body member and a positioning device configured to position the delivery device in a desired location.

1 . An implantable apparatus for treating a septal defect, comprising: 
 a body comprising a first end portion, a second end portion and a central portion located therebetween, the first end portion being configured to engage a first septal surface, the second end portion being configured to engage a second septal surface and the central portion being configured to fit within an opening in a septal wall, at least one of said portions being coiled.    
     
     
         2 . The apparatus of  claim 1 , wherein the first end portion is coiled.  
     
     
         3 . The apparatus of  claim 2 , wherein the first end portion comprises a plurality of coiled segments.  
     
     
         4 . The apparatus of  claim 3 , wherein the plurality of coiled segments are coiled about a common axis.  
     
     
         5 . The apparatus of  claim 3 , wherein the plurality of coiled segments have varying diameters.  
     
     
         6 . The apparatus of  claim 3 , wherein the first end portion overlaps the central portion.  
     
     
         7 . The apparatus of  claim 3 , wherein the body has a first end located on the first end portion and a second end located in the second end portion, the coiled segment located closest to the first end having a relatively larger width than an adjacent coiled segment.  
     
     
         8 . The apparatus of  claim 3 , wherein the body has a first end located on the first end portion and a second end located in the second end portion, the coiled segment located closest to the first end having a relatively smaller width than an adjacent coiled segment.  
     
     
         9 . The apparatus of  claim 1 , wherein the first end portion comprises a coiled segment having a constant rate of curvature.  
     
     
         10 . The apparatus of  claim 1 , wherein the first end portion comprises a coiled segment having a variable rate of curvature.  
     
     
         11 . The apparatus of  claim 1 , wherein the first end portion comprises a coiled segment having a straight portion.  
     
     
         12 . The apparatus of  claim 1 , wherein the first end portion is configured to apply a force at least partially towards the central portion.  
     
     
         13 . The apparatus of  claim 1 , wherein the central portion is coiled.  
     
     
         14 . The apparatus of  claim 13 , wherein the central portion comprises a plurality of coiled segments.  
     
     
         15 . The apparatus of  claim 14 , wherein the plurality of coiled segments are coiled about a common axis.  
     
     
         16 . The apparatus of  claim 14 , wherein the plurality of coiled segments have varying widths.  
     
     
         17 . The apparatus of  claim 14 , wherein the plurality of coiled segments have constant widths.  
     
     
         18 . The apparatus of  claim 13 , wherein the central portion comprises blocking material coupled with the body.  
     
     
         19 . The apparatus of  claim 1 , wherein the central portion is configured to apply a compressive force between the first and second end portions.  
     
     
         20 . The apparatus of  claim 1 , wherein the central portion comprises at least one coiled section comprising at least one coiled segment and at least one generally straight section.  
     
     
         21 . The apparatus of  claim 20 , wherein the coiled section is located relatively closer to either the first or second end portions.  
     
     
         22 . The apparatus of  claim 1 , wherein the body is composed of an elastic material.  
     
     
         23 . The apparatus of  claim 22 , wherein the body is composed of NITINOL.  
     
     
         24 . The apparatus of  claim 1 , wherein the body is deformable from a first configuration to a second configuration.  
     
     
         25 . The apparatus of  claim 24 , wherein the first configuration is configured for housing within a delivery device.  
     
     
         26 . The apparatus of  claim 24 , wherein the second configuration is configured for treating a septal defect.  
     
     
         27 . The apparatus of  claim 1 , wherein the first end portion and the second end portion are configured to engage a surface of a septal wall.  
     
     
         28 . The apparatus of  claim 1 , wherein the body comprises a first end tip and a second end tip.  
     
     
         29 . The apparatus of  claim 28 , wherein the first and second end tips are configured to be atraumatic.  
     
     
         30 . The apparatus of  claim 1 , wherein the body comprises at least one end tip having an aperture.  
     
     
         31 . The apparatus of  claim 1 , wherein the end tip aperture is configured to receive a tether.  
     
     
         32 . The apparatus of  claim 1 , wherein the body is at least partially coiled and wire-like.  
     
     
         33 . The apparatus of  claim 1 , wherein the body is at least partially coiled and ribbon-like.  
     
     
         34 . The apparatus of  claim 1 , wherein the body comprises a textured surface region.  
     
     
         35 . The apparatus of  claim 1 , wherein the body comprises a plurality of apertures.  
     
     
         36 . The apparatus of  claim 1 , wherein the body is at least partially coated with a coating.  
     
     
         37 . The apparatus of  claim 1 , wherein the coating is abrasive.  
     
     
         38 . The apparatus of  claim 1 , wherein the coating comprises a therapeutic agent.  
     
     
         39 . The apparatus of  claim 1 , wherein the body has a varying thickness.  
     
     
         40 . The apparatus of  claim 1 , wherein the body comprises an elastomeric portion.  
     
     
         41 . The apparatus of  claim 1 , wherein the first end portion, second end portion and central portion are coiled.  
     
     
         42 . The apparatus of  claim 41 , wherein the central portion is configured to apply a compressive force between the first and second end portions.  
     
     
         43 . The apparatus of  claim 42 , wherein the central portion has a width that is smaller than a width of the first end portion and a width of the second end portion.  
     
     
         44 . The apparatus of  claim 43 , wherein the width of one of the first and second end portions is greater than the width of the other of the first and second end portions.  
     
     
         45 . The apparatus of  claim 1 , wherein the second end portion is coiled.  
     
     
         46 . The apparatus of  claim 45 , wherein the second end portion comprises a plurality of coiled segments.  
     
     
         47 . The apparatus of  claim 45 , wherein the plurality of coiled segments are coiled about a common axis.  
     
     
         48 . The apparatus of  claim 46 , wherein the plurality of coiled segments have varying widths.  
     
     
         49 . The apparatus of  claim 46 , wherein the second end portion overlaps the central portion.  
     
     
         50 . The apparatus of  claim 46 , wherein the body has a first end located on the first end portion and a second end located in the second end portion, the coiled segment located closest to the second end having a relatively larger width than an adjacent coiled segment.  
     
     
         51 . The apparatus of  claim 46 , wherein the body has a first end located on the first end portion and a second end located in the second end portion, the coiled segment located closest to the second end having a relatively smaller width than an adjacent coiled segment.  
     
     
         52 . The apparatus of  claim 1 , wherein the second end portion comprises a coiled segment having a constant rate of curvature.  
     
     
         53 . The apparatus of  claim 1 , wherein the second end portion comprises a coiled segment having a variable rate of curvature.  
     
     
         54 . The apparatus of  claim 1 , wherein the second end portion comprises a coiled segment having a straight portion.  
     
     
         55 . The apparatus of  claim 1 , wherein the second end portion is configured to apply a force at least partially towards the central portion.  
     
     
         56 . A treatment system, comprising: 
 a first flexible elongate member; and    a second flexible elongate member having a distal end adjustably coupled with the first elongate member, wherein the orientation of the distal end is adjustable from a first orientation to a second orientation upon movement of the second elongate member with respect to the first elongate member.    
     
     
         57 . The treatment system of  claim 56 , wherein the distal end is rotatably coupled with the first elongate member.  
     
     
         58 . The treatment system of  claim 56 , wherein the distal end is flexibly coupled with the first elongate member.  
     
     
         59 . The treatment system of  claim 55 , wherein the second elongate member is configured to deliver at least one implantable treatment device.  
     
     
         60 . The treatment system of  claim 56 , wherein the second elongate member has an inner lumen with an open distal end configured to slidably receive a needle member.  
     
     
         61 . The treatment system of  claim 60 , wherein the needle member has an inner lumen with an open, substantially sharp, distal end.  
     
     
         62 . The treatment system of  claim 61 , wherein the inner lumen of the needle member is configured to slidably receive an inner elongate member having a distal end configured to contact an implantable treatment device.  
     
     
         63 . The treatment system of  claim 62 , wherein the inner member is configured to push the implantable treatment device in a distal direction.  
     
     
         64 . The treatment system of  claim 63 , wherein the inner lumen of the needle member is configured to house the implantable treatment device.  
     
     
         65 . The treatment system of  claim 62 , wherein the inner member is configured to pull the implantable treatment device in a proximal direction.  
     
     
         66 . The treatment system of  claim 65 , wherein the needle member is configured to store the implantable treatment device in a location at least partially external to the inner lumen of the needle member.  
     
     
         67 . The treatment system of  claim 62 , wherein the distal end of the inner member has a contoured surface configured to contact the implantable treatment device.  
     
     
         68 . The treatment system of  claim 62 , wherein a portion of the inner member proximal to the distal end of the inner member has a smaller width than a width of the distal end of the inner member.  
     
     
         69 . The treatment system of  claim 60 , wherein the needle member comprises at least one aperture configured to provide flexibility.  
     
     
         70 . The treatment system of  claim 60 , wherein the needle member comprises a pressure sensor.  
     
     
         71 . The treatment system of  claim 56 , wherein the first elongate member has a first longitudinal axis and the second elongate member has a second longitudinal axis at the distal end of the second elongate member, the first and second longitudinal axes being substantially parallel when the distal end of the second elongate member is in the first orientation and transverse when the distal end of the second elongate member is in the second orientation.  
     
     
         72 . The treatment system of  claim 56 , wherein the second elongate member is configured for movement with the vasculature of a patient when the distal end of the second elongate member is in the first orientation and for delivery of an implantable treatment device to a septal wall of the patient when the distal end of the second elongate member is in the second orientation.  
     
     
         73 . The treatment system of  claim 72 , wherein the distal end of the second elongate member is substantially normal to a surface of the septal wall in the second orientation.  
     
     
         74 . The treatment system of  claim 56 , wherein the distal end of the second elongate member is adjustable from the first orientation to the second orientation upon advancement of the second elongate member in a distal direction with respect to the first elongate member.  
     
     
         75 . The treatment system of  claim 74 , wherein a portion of the second elongate member is configured to extend outwards from the first elongate member when the distal end of the second elongate member is in the second orientation.  
     
     
         76 . The treatment system of  claim 75 , wherein the first elongate member has an inner lumen with an open distal end configured to slidably receive the second elongate member, the portion of the second elongate member configured to extend outwards being located outside of the inner lumen of the first elongate member.  
     
     
         77 . The treatment system of  claim 56 , wherein the second elongate member comprises a braided sheath.  
     
     
         78 . The treatment system of  claim 77 , wherein the braided sheath is a polymeric braided sheath.  
     
     
         79 . The treatment system of  claim 77 , wherein the braided sheath is a metallic braided sheath.  
     
     
         80 . The treatment system of  claim 56 , wherein the second elongate member comprises a coating.  
     
     
         81 . The treatment system of  claim 56 , wherein the first elongate member comprises a coating.  
     
     
         82 . The treatment system of  claim 56 , further comprising a tissue engagement device.  
     
     
         83 . The treatment system of  claim 82 , wherein the tissue engagement device comprises an arm member coupled between the first elongate member and the distal end of the second elongate member.  
     
     
         84 . The treatment system of  claim 83 , wherein the tissue engagement device further comprises: 
 a first hinge configured to rotatably couple the arm member with the first elongate member; and    a second hinge configured to rotatably couple the arm member with the distal end of the second elongate member.    
     
     
         85 . The treatment system of  claim 83 , wherein the arm member is configured to pivot to engage tissue.  
     
     
         86 . The treatment system of  claim 85 , wherein the arm member is configured to grasp tissue when the distal end of the second elongate member is in the second orientation.  
     
     
         87 . The treatment system of  claim 86 , wherein the arm member is configured to clamp tissue between the arm member and one of the first elongate member or a third elongate member in a substantially fixed position with respect to the arm member.  
     
     
         88 . The treatment system of  claim 85 , wherein the arm member has a surface configured to grasp a limbus of a septal wall of a patient.  
     
     
         89 . The treatment system of  claim 82 , wherein the arm member is elastomeric.  
     
     
         90 . The treatment system of  claim 82 , wherein the arm member is superelastic.  
     
     
         91 . The treatment system of  claim 82 , wherein the arm member is configured to steer the distal end of the second elongate member.  
     
     
         92 . The treatment system of  claim 91 , wherein the arm member comprises two wires movable with respect to each other and controllable by a user to steer the distal end of the second elongate member.  
     
     
         93 . The treatment system of  claim 82 , wherein the arm member is biased to a position adjacent to a longitudinal axis of the first elongate member.  
     
     
         94 . The treatment system of  claim 82 , wherein the arm member is configured to position the distal end of the second elongate member in a desired location on a septal wall of a patient.  
     
     
         95 . The treatment system of  claim 94 , wherein the arm member has an adjustable length.  
     
     
         96 . The treatment system of  claim 56 , further comprising a third elongate member configured to stabilize the position of at least one of the first elongate member and the second elongate member.  
     
     
         97 . A treatment system, comprising: 
 an elongate tubular member having a distal end and an inner lumen configured to slidably receive an elongate inner member, the elongate tubular member and elongate inner member configured for insertion with the vasculature of a patient;    wherein the elongate inner member is configured to deploy a grasping element upon movement of the elongate inner member with respect to the elongate tubular member, the grasping element being configured to grasp septal tissue.    
     
     
         98 . The treatment system of  claim 97 , wherein the elongate inner member is configured to deploy a grasping element upon movement of the elongate inner member with respect to the elongate tubular member in a proximal direction.  
     
     
         99 . The treatment system of  claim 98 , wherein the elongate tubular member has an aperture through which the grasping element can be deployed, the aperture being located proximal to the distal end.  
     
     
         100 . The treatment system of  claim 99 , wherein the inner lumen is a first inner lumen, the elongate tubular member having a second inner lumen with the aperture being a first end of the second lumen, the second end being an open end providing communication with the first inner lumen.  
     
     
         101 . The treatment system of  claim 100 , wherein the second inner lumen is configured to facilitate deployment of the grasping element.  
     
     
         102 . The treatment system of  claim 101 , wherein the second inner lumen has contoured walls.  
     
     
         103 . The treatment system of  claim 97 , wherein the grasping element is deployable from a first configuration within the inner lumen to a second configuration extending outwards from the tubular member to a third configuration extending alongside the tubular member.  
     
     
         104 . The treatment system of  claim 103 , wherein the grasping element is configured to grasp a septum primum of the patient.  
     
     
         105 . The treatment system of  claim 103 , wherein the grasping element is deformable between the three configurations.  
     
     
         106 . The treatment system of  claim 105 , wherein the grasping element is shaped to facilitate deployment in the three configurations.  
     
     
         107 . The treatment system of  claim 103 , wherein the grasping element comprises two members configured to overlap in the third configuration.  
     
     
         108 . The treatment system of  claim 103 , wherein the grasping element is deployable from an open distal end of the tubular member by advancing the inner member in a distal direction with respect to the tubular member.  
     
     
         109 . The treatment system of  claim 97 , wherein the grasping element is flap-like.  
     
     
         110 . The treatment system of  claim 97 , wherein the grasping element is wire-like.  
     
     
         111 . The treatment system of  claim 97 , further comprising a magnet configured to provide a magnetic force to the grasping element.  
     
     
         112 . The treatment system of  claim 97 , wherein the grasping element is deployable from an open distal end of the tubular member by advancing the inner member in a distal direction with respect to the tubular member.  
     
     
         113 . The treatment system of  claim 97 , wherein the grasping element is a deflectable portion of the tubular member, deployable by applying a force to an inner side of the grasping element with the inner member.  
     
     
         114 . The treatment system of  claim 97 , wherein the grasping element is a deflectable portion of a distal end of the inner member, the distal end having an inner lumen configured to receive an abutment on the tubular member, the abutment usable to apply a force to an inner side of the grasping element.  
     
     
         115 . The treatment system of  claim 97 , wherein the tubular member further comprises at least one positioning member configured to position the tubular member within a patent foramen ovale tunnel.  
     
     
         116 . The treatment system of  claim 97 , further comprising an elongate delivery device configured to deliver an implantable treatment apparatus to a septal wall, the grasping element configured to grasp tissue to stabilize the position of the delivery device.  
     
     
         117 . The treatment system of  claim 116 , further comprising an elongate body member configured to receive the delivery device and the elongate tubular member.  
     
     
         118 . A treatment system, comprising: 
 a flexible positioning member having a distal end; and    an elongate support member having an inner lumen configured to slidably receive the flexible positioning member, the inner lumen having a distal end configured to abut the distal end of the flexible positioning member and an open portion located proximal to the distal end of the lumen, wherein the flexible positioning member is configured to extend from the open portion upon advancement of the flexible positioning member distally against the distal end of the inner lumen.    
     
     
         119 . The treatment system of  claim 118 , wherein the elongate support member is insertable within a patent foramen ovale tunnel and the positioning member is configured to contact a sidewall of the tunnel and position the support member in a desired position within the tunnel.  
     
     
         120 . The treatment system of  claim 118 , wherein the flexible positioning member is a first flexible positioning member, the inner lumen is a first inner lumen, and the open portion is a first open portion, and the system further comprises a second flexible positioning member, the support member having a second inner lumen configured to slidably receive the second flexible positioning member, the second inner lumen having a distal end configured to abut a distal end of the second flexible positioning member and a second open portion located proximal to the distal end of the second inner lumen, wherein the second flexible positioning member is configured to extend from the second open portion upon advancement of the second flexible positioning member distally against the distal end of the second inner lumen.  
     
     
         121 . The treatment system of  claim 120 , wherein the first and second flexible positioning members are configured to extend in opposite directions.  
     
     
         122 . The treatment system of  claim 121 , wherein the first and second flexible positioning members are configured to center the support member within the tunnel.  
     
     
         123 . The treatment system of  claim 118 , wherein the support member is configured to deflect a substantially sharp member.  
     
     
         124 . The treatment system of  claim 118 , wherein the flexible positioning member is a wire band.  
     
     
         125 . The treatment system of  claim 118 , wherein a portion of the flexible positioning member located proximal to the distal end of the positioning member is configured to extend away from the support member upon advancement of the flexible positioning member.  
     
     
         126 . The treatment system of  claim 118 , wherein the flexible positioning member has an arcuate shape when extended.  
     
     
         127 . The treatment system of  claim 118 , wherein the flexible position member has a polygonal shape when extended.  
     
     
         128 . The treatment system of  claim 118 , wherein the flexible positioning member is configured to extend with a first and a second outcropping extending relatively further than the rest of the flexible positioning member.  
     
     
         129 . The treatment system of  claim 128 , wherein the first and the second outcropping are in spaced relation such that a sidewall of a patent foramen ovale is positionable between them.  
     
     
         130 . The treatment system of  claim 118 , further comprising a plurality of flexible positioning members adjustable by a user independently of each other.  
     
     
         131 . A treatment system, comprising: 
 a first flexible positioning member having a distal end and deformable between a first housed configuration and a second configuration;    a second flexible positioning member having a distal end and deformable between a first housed configuration and a second configuration; and    an elongate support member having an inner lumen with an open distal end configured to slidably receive the first and second flexible positioning members, wherein the first and second flexible positioning members are configured to deform from the first configuration to the second configuration upon advancement of the flexible positioning members distally from the open distal end.    
     
     
         132 . The treatment system of  claim 131 , wherein the elongate support member is insertable within a patent foramen ovale tunnel and the positioning members are configured to contact a sidewall of the tunnel and position the support member in a desired position within the tunnel.  
     
     
         133 . The treatment system of  claim 132 , wherein the first and second flexible positioning members are configured to extend in opposite directions.  
     
     
         134 . The treatment system of  claim 133 , wherein the first and second flexible positioning members are configured to center the support member within the tunnel.  
     
     
         135 . The treatment system of  claim 131 , wherein the flexible positioning member is a wire band.  
     
     
         136 . The treatment system of  claim 131 , wherein the flexible positioning member has an arcuate shape when extended.  
     
     
         137 . The treatment system of  claim 131 , wherein the flexible position member has a polygonal shape when extended.  
     
     
         138 . The treatment system of  claim 131 , wherein the flexible positioning member is configured to extend with a first and a second outcropping extending relatively further than the rest of the flexible positioning member.  
     
     
         139 . The treatment system of  claim 138 , wherein the first and the second outcropping are in spaced relation such that a sidewall of a patent foramen ovale is positionable between them.  
     
     
         140 . The treatment system of  claim 131 , wherein a proximal end of the first flexible positioning member is coupled with a proximal end of the second flexible positioning member on a common shaft.  
     
     
         141 . The treatment system of  claim 131 , wherein a grasping element is coupled to the distal end of each flexible positioning member, the grasping element being configured to grasp tissue.  
     
     
         142 . A method of treating a septal defect in a septal wall, comprising: 
 abutting a limbus of a septum secundum with an abutment of a medical device;    creating a hole in a septal wall with the limbus as a point of reference; and    using the hole to facilitate delivery of a treatment device configured to treat a septal defect.    
     
     
         143 . The method of  claim 142 , wherein the treatment device is an implantable device configured to at least partially close an opening between the septum secundum and a septum primum.  
     
     
         144 . The method of  claim 143 , further comprising delivering the device through the hole.  
     
     
         145 . The method of  claim 142 , wherein the medical device comprises an elongate body member and an elongate delivery device comprising a tissue engagement device.  
     
     
         146 . The method of  claim 145 , further comprising moving the delivery device with respect to the body member to position an open distal end of the delivery device in proximity with the septal wall.  
     
     
         147 . The method of  claim 146 , further comprising creating the hole with a needle member advanceable from the open distal end of the delivery device.  
     
     
         148 . The method of  claim 145 , further comprising clamping the limbus with the tissue engagement device.  
     
     
         149 . The method of  claim 142 , further comprising engaging the limbus.  
     
     
         150 . The method of  claim 149 , further comprising engaging the limbus with a textured surface of a tissue engagement device located on the medical device.  
     
     
         151 . The method of  claim 142 , wherein the hole is located in the septum secundum.  
     
     
         152 . The method of  claim 151 , wherein the hole is a first hole, the method further comprising creating a second hole in the septum primum.  
     
     
         153 . The method of  claim 142 , wherein the hole is located in the septum primum.  
     
     
         154 . The method of  claim 142 , wherein the hole is located in a fossa ovalis of a septal wall.  
     
     
         155 . The method of  claim 142 , wherein the hole is located in the septal wall in a location adjacent a patent foramen ovale tunnel.  
     
     
         156 . The method of  claim 142 , wherein the hole is created at a predetermined distance from the limbus.  
     
     
         157 . The method of  claim 156 , wherein the hole is centered with respect to a first and second sidewall of a patent foramen ovale tunnel.  
     
     
         158 . A treatment system for treating a septal defect, comprising: 
 an implantable treatment device;    a flexible elongate delivery device having a first longitudinal axis and configured to deliver the implantable treatment device; and    an elongate body member having a second longitudinal axis and configured for insertion within the vasculature of a patient, the body member configured to slidably receive the delivery device, wherein the delivery device has is configured to deliver the implantable treatment device along the first longitudinal axis when different than the second longitudinal axis.    
     
     
         159 . The treatment system of  claim 158 , wherein the implantable treatment device is coiled.  
     
     
         160 . The treatment system of  claim 158 , further comprising a stabilization device insertable within an opening in a septal wall and configured to stabilize the delivery device.  
     
     
         161 . The treatment system of  claim 160 , wherein the body member has an inner lumen configured to slidably receive the delivery device and stabilization device.  
     
     
         162 . The treatment system of  claim 160 , wherein a positioning device is integrated with the stabilization device.  
     
     
         163 . The treatment system of  claim 162 , wherein the positioning device is a flexible positioning member configured to extend outwards from the stabilization device.  
     
     
         164 . The treatment system of  claim 162 , wherein the body member has a first inner lumen configured to slidably receive the delivery device and a second inner lumen configured to slidable receive the stabilization device.  
     
     
         165 . The treatment system of  claim 162 , wherein the stabilization device is configured to fixably couple with the delivery device such that rotation of the delivery device about the stabilization device is prevented.  
     
     
         166 . The treatment system of  claim 160 , wherein the stabilization device is configured to fixably couple with the delivery device such that rotation of the delivery device about the stabilization device is prevented.  
     
     
         167 . The treatment system of  claim 158 , wherein the delivery device further comprises a grasping device coupled between the delivery device and the body member.  
     
     
         168 . The treatment system of  claim 158 , further comprising a positioning device insertable within a patent foramen ovale tunnel.  
     
     
         169 . The treatment system of  claim 168 , wherein the positioning device is integrated with the body member.  
     
     
         170 . The treatment system of  claim 169 , wherein the positioning device is a flexible positioning member.  
     
     
         171 . The treatment system of  claim 170 , wherein the body member has an inner lumen configured to slidably receive the flexible positioning member, the inner lumen having a distal end configured to abut the distal end of the flexible positioning member and an open portion located proximal to the distal end of the lumen, wherein the flexible positioning member is configured to extend from the open portion upon advancement of the flexible positioning member distally against the distal end of the inner lumen.  
     
     
         172 . The treatment system of  claim 169 , wherein the positioning device comprises a first and a second flexible positioning member and the body member is insertable within a patent foramen ovale tunnel, the first and second flexible positioning members being configured to position the body member within the tunnel.  
     
     
         173 . The treatment system of  claim 172 , wherein the first and second flexible positioning members are configured to center the body member within the tunnel.  
     
     
         174 . The treatment system of  claim 169 , wherein the body member has a first inner lumen configured to slidably receive the delivery device.  
     
     
         175 . The treatment system of  claim 174 , further comprising a stabilization device insertable within an opening in a septal wall and configured to stabilize the delivery device, wherein the body member has a second inner lumen configured to slidably receive the stabilization device.  
     
     
         176 . The treatment system of  claim 175 , further comprising a guidewire, wherein the second inner lumen is configured to slidably receive the guidewire.  
     
     
         177 . The treatment system of  claim 174 , wherein the body member has a second inner lumen configured to slidably receive a guidewire.  
     
     
         178 . The treatment system of  claim 169 , wherein the body member has a distal end with an atraumatic tip located thereon and the body member has an inner lumen configured to slidably receive the delivery device.  
     
     
         179 . A method of treating a septal defect, comprising: 
 placing a delivery device in proximity with a septal wall having a septal defect;    stabilizing the delivery device with an elongate device placed at least partially within the septal defect;    positioning a distal end of the delivery device in a desired orientation with respect to the septal wall, wherein a first longitudinal axis of the delivery device at the distal end is transverse to a second longitudinal axis of the elongate device.    
     
     
         180 . The method of  claim 179 , further comprising; 
 creating a hole in the septal wall; and    delivering an implantable treatment device with the delivery device in the hole, wherein the implantable treatment device is configured to treat the septal defect.    
     
     
         181 . The method of  claim 179 , wherein the delivery device is slidably housed at least partially within an inner lumen of an elongate body member.  
     
     
         182 . The method of  claim 181 , wherein placing the delivery device in proximity comprises advancing the body member over a guidewire positioned within the patient's vasculature.  
     
     
         183 . The method of  claim 181 , wherein the body member comprises an atraumatic distal tip and wherein placing the delivery device in proximity comprises advancing the body member within the patient's vasculature.  
     
     
         184 . The method of  claim 181 , wherein the distal end of the delivery device is rotatably coupled with the body member and wherein positioning the distal end of the delivery device comprises advancing the delivery device in a distal direction with respect to the body member until the distal end is in a desired orientation with the septal wall.  
     
     
         185 . The method of  claim 184 , wherein the first longitudinal axis is substantially parallel to a normal axis to the septal surface when in the desired orientation.  
     
     
         186 . The method of  claim 184 , wherein positioning the distal end of the delivery device comprises abutting a limbus with the delivery device.  
     
     
         187 . The method of  claim 186 , further comprising clamping the limbus.  
     
     
         188 . The method of  claim 180 , wherein creating a hole comprises advancing a needle member through the septal wall.  
     
     
         189 . The method of  claim 188 , further comprising confirming that the needle member is through the septal wall.  
     
     
         190 . The method of  claim 189 , further comprising confirming that the needle member is through the septal wall with a pressure sensor.  
     
     
         191 . The method of  claim 189 , further comprising infusing dye to confirm that the needle member is through the septal wall.  
     
     
         192 . The method of  claim 188 , wherein deploying the implantable treatment device comprises pushing the treatment device out of an inner lumen of the needle member.  
     
     
         192 . The method of  claim 192 , wherein deploying the implantable treatment device further comprises rotating the implant to the desired orientation.  
     
     
         194 . The method of claim  193 , wherein stabilizing the delivery device further comprises grasping tissue.  
     
     
         195 . The method of  claim 179 , wherein positioning the delivery device comprises centering the delivery device.  
     
     
         196 . The method of  claim 179 , wherein the septal defect is a patent foramen ovale tunnel and centering the delivery device comprises extending at least one flexible positioning member within the tunnel.