Patent Publication Number: US-2012041480-A1

Title: Systems and Methods for Treating Septal Defects

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 12/260,932, filed Oct. 29, 2008, which is a divisional of U.S. patent application Ser. No. 11/175,814, filed Jul. 5, 2005, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 10/847,747, filed on May 7, 2004, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 10/734,670, filed Dec. 11, 2003, which is a divisional of Ser. No. 09/948,453, filed Sep. 7, 2001, now U.S. Pat. No. 6,702,835, which is a continuation-in-part of Ser. No. 09/948,502, filed Sep. 6, 2001, now U.S. Pat. No. 6,776,784, all of which are fully incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to systems and methods for closing internal tissue defects, and more particularly to systems and methods for closing a patent foramen ovale or other septal defect. 
     BACKGROUND OF THE INVENTION 
     By nature of their location, the treatment of internal tissue defects is inherently difficult. Access to a defect through invasive surgery introduces a high level of risk that can result in serious complications for the patient. Access to the defect remotely with a catheter or equivalent device is less risky, but treatment of the defect itself is made more difficult given the limited physical abilities of the catheter. The difficulty in accessing and treating tissue defects is compounded when the defect is found in or near a vital organ. For instance, a patent foramen ovale (“PFO”) is a serious septal defect that can occur between the left and right atria of the heart and a patent ductus arteriosus (“PDA”) is an abnormal shunt between the aorta and pulmonary artery. 
     During development of a fetus in utero, oxygen is transferred from maternal blood to fetal blood through complex interactions between the developing fetal vasculature and the mother&#39;s placenta. During this process, blood is oxygenated within the fetal lungs. In fact, most of the fetus&#39; circulation is shunted away from the lungs through specialized vessels and foramens that are open during fetal life, but typically closed shortly after birth. Occasionally, however, these foramen fail to close and create hemodynamic problems, which, in extreme cases, can ultimately prove fatal. During fetal life, an opening called the foramen ovale allows blood to pass directly from the right atrium to the left atrium (bypassing the lungs). Thus, blood that is oxygenated via gas exchange with the placenta may travel through the vena cava into the right atrium, through the foramen ovale into the left atrium, and from there into the left ventricle for delivery to the fetal systemic circulation. After birth, with pulmonary circulation established, the increased left atrial blood flow and pressure causes the functional closure of the foramen ovale and, as the heart continues to develop, this closure allows the foramen ovale to grow completely sealed. 
     In some cases, however, the foramen ovale fails to close entirely. This condition, known as a PFO, can allow blood to continue to shunt between the left and right atria of the heart throughout the adult life of the individual. PFO&#39;s can pose serious health risks for the individual, including strokes and migraines. The presence of PFO&#39;s have been implicated as a possible contributing factor in the pathogenesis of migraine. Two current hypothesis that link PFO&#39;s with migraine include the transit of vasoactive substances or thrombus/emboli from the venous circulation directly into the left atrium without passing through the lungs where they would normally be deactivated or filtered respectively. Other diseases that have been associated with PFO&#39;s (and which could benefit from PFO closure) include but are not limited to depression and affective disorders, personality and anxiety disorders, pain stroke, TIA, dementia, epilepsy, and sleep disorders. 
     Still other septal defects can occur between the various chambers of the heart, such as atrial-septal defects (ASD&#39;s), ventricular-septal defects (VSD&#39;s), and the like. To treat these defects as well as PFO&#39;s, open heart surgery can be performed to ligate and close the defect. Alternatively, catheter-based procedures have been developed that require introducing umbrella or disc-like devices into the heart. These devices include opposing expandable structures connected by a hub or waist. Generally, in an attempt to close the defect, the device is inserted through the natural opening of the defect and the expandable structures are deployed on either side of the septum to secure the tissue surrounding the defect between the umbrella or disc-like structure. 
     These devices suffer from numerous shortcomings. For instance, these devices typically involve frame structures that often support membranes, either of which may fail during the life of the patient, thereby introducing the risk that the defect may reopen or that portions of the device could be released within the patient&#39;s heart. These devices can fail to form a perfect seal of the septal defect, allowing blood to continue to shunt through the defect. Also, the size and expansive nature of these devices makes safe withdrawal from the patient difficult in instances where withdrawal becomes necessary. The presence of these devices within the heart typically requires the patient to use anti-coagulant drugs for prolonged periods of time, thereby introducing additional health risks to the patient. Furthermore, these devices can come into contact with other portions of the heart tissue and cause undesirable side effects such as an arrhythmia, local tissue damage, and perforation. 
     Accordingly, improved systems and methods for closing internal tissue defects within the heart are needed. 
     SUMMARY 
     Improved systems and methods for closing internal tissue defects, such as septal defects and the like, are provided herein by the way of exemplary embodiments. These embodiments are examples only and are not intended to limit the invention. 
     In one exemplary embodiment, an implantable apparatus for treating a septal defect is provided having a body with a first end portion, a second end portion and a central portion located therebetween. Preferably, the first end portion is configured to engage a first septal surface, the second end portion is configured to engage a second septal surface and the central portion is configured to fit within an opening in a septal wall. 
     In another exemplary embodiment, a treatment system is provided having a first elongate member and a second elongate delivery member having a distal end rotatably coupled with the first elongate member, wherein the orientation of the distal end is adjustable from a first orientation to a second orientation upon advancement of the elongate member in a distal direction. 
     In another exemplary embodiment, a treatment system is provided having an elongate tubular member having an inner lumen configured to slidably receive and interact with an inner elongate member. Preferably, the inner elongate member is configured to deploy a grasping device through an aperture in the elongate tubular member upon movement of the elongate inner member with respect to the elongate tubular member. 
     In yet another exemplary embodiment, a treatment system is provided having 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. Preferably, the inner lumen has 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. The flexible positioning member is also preferably configured to extend from the open portion upon advancement of the flexible positioning member distally against the distal end of the inner lumen. 
     In another exemplary embodiment, a method of treating a septal defect is provided, the method including abutting a limbus of a septum secundum with an abutment of a medical device, creating a hole in the septum secundum with the limbus as a point of reference, and using the hole to facilitate delivery of a device configured to treat a septal defect. 
     In another exemplary embodiment, a treatment system is provided having an implantable treatment device, a flexible elongate delivery device configured to deliver the implantable treatment device, a stabilization device insertable within an opening in a septum, or tunnel between two septa, and configured to stabilize an elongate body member, and the elongate body member configured for insertion within the vasculature of a patient, the body member configured to slidably receive the delivery device and stabilization device. 
     Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims. It is also intended that the invention is not limited to require the details of the example embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The details of the invention, both as to its structure and operation, may be gleaned in part by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. 
         FIG. 1  is a block diagram depicting an exemplary embodiment of a treatment system. 
         FIG. 2A  is an exterior/interior view of the right atrium depicting an example human heart. 
         FIGS. 2B-2C  are enlarged views of an example arterial septal wall. 
         FIG. 2D  is a cross-sectional view taken along line  2 D- 2 D of  FIGS. 2B-2C  depicting another example septal wall. 
         FIG. 3  is a block diagram depicting an exemplary embodiment of an implantable treatment device. 
         FIG. 4A  is a perspective view depicting another exemplary embodiment of an implantable treatment device. 
         FIG. 4B  is a perspective view depicting an exemplary embodiment of several coiled segments of an implantable treatment device. 
         FIG. 4C  depicts a side view of the embodiment of the implantable treatment device taken along direction  330  of  FIG. 4A . 
         FIG. 4D  is a schematic view depicting another exemplary embodiment of the implantable treatment device as viewed from direction  329  of  FIG. 4C . 
         FIG. 4E  is cross-sectional view depicting the exemplary embodiment of the implantable treatment device depicted in  FIG. 4A  implanted within an example heart. 
         FIGS. 4F-G  are cross-sectional views of additional exemplary embodiments of the treatment system with a delivery device. 
         FIGS. 5A-E  are perspective views depicting additional exemplary embodiments of the central portion the implantable treatment device. 
         FIGS. 6A-I  are perspective views depicting additional exemplary embodiments of either the first and/or the second end portions of the implantable treatment device. 
         FIG. 7A-C ,  8  and  9 A-C are perspective views depicting additional exemplary embodiments of the implantable treatment device. 
         FIG. 10A  is a flow diagram depicting one exemplary method of manufacturing another exemplary embodiment of the implantable treatment device. 
         FIG. 10B  is a perspective view of an exemplary embodiment of a body shaping device. 
         FIGS. 11A-B  is a perspective view depicting another exemplary embodiment of an implantable treatment device. 
         FIG. 12  depicts another exemplary embodiment of the treatment system within a heart. 
         FIG. 13  is a block diagram depicting an exemplary embodiment of a delivery device. 
         FIG. 14A  is a perspective view depicting another exemplary embodiment of the treatment system. 
         FIG. 14B  is a cross-sectional view depicting another exemplary embodiment of the delivery device. 
         FIGS. 14C-F  are perspective views depicting a portion of the septal wall and an additional exemplary embodiment of the treatment system. 
         FIGS. 15A-D  are perspective views depicting additional exemplary embodiments of the delivery device. 
         FIGS. 16A-B  are cross-sectional views depicting additional exemplary embodiments of the treatment system. 
         FIG. 16C  is a perspective view depicting the embodiment described with respect to  FIGS. 16A-B  during delivery. 
         FIG. 17  is a cross-sectional view depicting an exemplary embodiment of the delivery device taken along line  17 - 17  of  FIG. 14A . 
         FIG. 18A  is a cross-sectional view of an exemplary embodiment of a needle member. 
         FIGS. 18B-C  are cross-sectional views depicting additional exemplary embodiments of a delivery device. 
         FIGS. 19A-B  are cross-sectional views depicting exemplary embodiments of a delivery device and an implantable treatment device. 
         FIGS. 20A-B  are schematic views depicting additional exemplary embodiments of a delivery device and an implantable treatment device. 
         FIG. 21  is a cross-sectional view depicting another exemplary embodiment of a delivery device taken along lines  21 - 21  of  FIG. 14A . 
         FIG. 22  is a block diagram depicting an exemplary embodiment of a stabilization device. 
         FIGS. 23A-C  are cross-sectional views depicting additional exemplary embodiments of a stabilization device. 
         FIGS. 24A-B  are perspective views depicting additional exemplary embodiments of a stabilization device. 
         FIGS. 25A-D  are cross-sectional views depicting additional exemplary embodiments of a stabilization device. 
         FIGS. 26A-C  are cross-sectional views depicting additional exemplary embodiments of a stabilization device. 
         FIG. 27A  is a perspective view depicting an additional exemplary embodiment of a stabilization device. 
         FIG. 27B  is a cross-sectional view depicting another exemplary embodiment of a stabilization device. 
         FIGS. 28A-C  are cross-sectional views depicting additional exemplary embodiments of a centering device. 
         FIG. 28D  is a schematic view depicting another exemplary embodiment of a centering device within a septal wall. 
         FIGS. 29A-C ,  30  and  31  are schematic views depicting additional exemplary embodiments of a centering device. 
         FIGS. 32A-B  are cross-sectional views depicting additional exemplary embodiments of a centering device. 
         FIG. 32C  is a cross-sectional view depicting another exemplary embodiment of a centering device with an exemplary embodiment of a stabilization device. 
         FIG. 32D  is a schematic view depicting another exemplary embodiment of a centering device with an exemplary embodiment of a stabilization device. 
         FIG. 33A  is a longitudinal cross-sectional view of an exemplary embodiment of a treatment system. 
         FIG. 33B  is a radial cross-sectional view of another exemplary embodiment of a treatment system taken along line  33 B- 33 B of  FIG. 33A . 
         FIG. 34A  is a longitudinal cross-sectional view of an exemplary embodiment of a treatment system. 
         FIG. 34B  is a radial cross-sectional view of another exemplary embodiment of a treatment system taken along line  34 B- 34 B of  FIG. 34A . 
         FIG. 34C  is a longitudinal cross-sectional view of another exemplary embodiment of a treatment system taken along line  34 C- 34 C of  FIG. 34A . 
         FIG. 35A  is a longitudinal cross-sectional view of an exemplary embodiment of a treatment system. 
         FIG. 35B  is a radial cross-sectional view of another exemplary embodiment of a treatment system taken along line  35 B- 35 B of  FIG. 35A . 
         FIG. 36A  is a longitudinal cross-sectional view of an exemplary embodiment of a treatment system. 
         FIG. 36B  is a radial cross-sectional view of another exemplary embodiment of a treatment system taken along line  36 B- 36 B of  FIG. 36A . 
         FIG. 37A  is a longitudinal cross-sectional view of an exemplary embodiment of a treatment system. 
         FIG. 37B  is a radial cross-sectional view of another exemplary embodiment of a treatment system taken along line  37 B- 37 B of  FIG. 37A . 
         FIGS. 38A-E  are cross-sectional views of a septal wall depicting exemplary embodiments of the implantable treatment device. 
         FIGS. 39A-B  are flow diagrams depicting an example of a method of treating a septal defect. 
         FIG. 40  is a flow diagram depicting another exemplary method of treating a septal defect. 
     
    
    
     DETAILED DESCRIPTION 
     Described herein are improved devices and methods for treating septal defects. For ease of discussion, the devices and methods will be described with reference to treatment of a PFO. However, it should be understood that the devices and methods can be used in treatment of any type of septal defect including ASD&#39;s, VSD&#39;s and the like, as well as PDA&#39;s or other structural cardiac or vascular defects. 
       FIG. 1  is a block diagram depicting a distal portion of an exemplary embodiment of a septal defect treatment system  100  configured to treat, and, preferably close, a PFO. In this embodiment, treatment system  100  includes an elongate body member  101  configured for insertion into the vasculature of a patient (human or animal) having a septal defect. Body member  101  has a longitudinal axis  107  and can include one or more lumens  102 , each of which can be configured for achieving multiple functions. Preferably, treatment system  100  includes an implantable device  103  (referred to herein as an “implant”) configured to at least partially close a septal defect. Treatment system  100  can include a flexible elongate delivery device  104  configured to house and deliver implant  103 . To minimize the width of body member  101 , implant  103  can be deformable from the configuration desired after implantation to a configuration having a smaller cross-section for storage and housing within delivery device  104  prior to implantation. 
     Treatment system  100  can also optionally include a stabilization device  105  for stabilization of body member  101  during delivery of implant  103  and a centering device  106  for facilitating the centering or the otherwise desired positioning of implant  103  for delivery. Although shown here as four separate components, any combination of body member  101 , delivery device  104 , stabilization device  105  and centering device  106  can be integrated together to reduce the number of components to three, two or one total components in treatment system  100 . 
     To better understand the many alternative embodiments of treatment system  100 , the anatomical structure of an example human heart having a PFO will be described in brief.  FIG. 2A  is an exterior/interior view depicting an example human heart  200  with a portion of the inferior vena cava  202  and the superior vena cava  203  connected thereto. Outer tissue surface  204  of heart  200  is shown along with the interior of right atrium  205  via cutaway portion  201 . Depicted within right atrium  205  is septal wall  207 , which is placed between right atrium  205  and the left atrium located on the opposite side (not shown). Also depicted is fossa ovalis  208 , which is a region of septal wall  207  where the tissue is relatively thinner than the surrounding tissue. PFO region  209  is located near the upper portion beyond the fossa ovalis  208 . 
       FIG. 2B  is an enlarged view of septal wall  207  depicting PFO region  209  in more detail as viewed from right atrium  205 . PFO region  209  includes septum secundum  210 , which is a first flap-like portion of septal wall  207 . The edge of this flap above fossa ovalis  208  is referred to as the limbus  211 .  FIG. 2C  is also an enlarged perspective view of septal wall  207 , instead depicting septal wall  207  as viewed from left atrium  212 . Here, PFO region  209  is seen to include septum primum  214 , which is a second flap-like portion of septal wall  207 . Septum primum  214  and septum secundum  210  partially overlap each other and define a tunnel-like opening  215  between sidewalls  219  (indicated as dashed lines in  FIGS. 2B-C ) that can allow blood to shunt between right atrium  205  and left atrium  212  and is commonly referred to as a PFO. 
       FIG. 2D  is a cross-sectional view depicting an example PFO region  209  taken along line  2 D- 2 D of  FIGS. 2B-C . Here, it can be seen that septum secundum  210  is thicker than septum primum  214 . Typically, the blood pressure within left atrium  212  is higher than that within right atrium  205  and tunnel  215  remains sealed. However, under some circumstances a valsava condition can occur where the blood pressure within right atrium  205  becomes higher than the blood pressure within left atrium  212  and blood shunts from right atrium  205  to left atrium  212 . Because most typical shunts occur in this manner and for purposes of facilitating the discussion herein, region  217  in  FIG. 2D  will be referred to as PFO entrance  217 , and region  218  will be referred to as PFO exit  218 . 
     Many different variations of PFO&#39;s can occur. For instance, thickness  220  of septum primum  214 , thickness  221  of septum secundum  210 , overlap distance  222  and the flexibility and distensibility of both septum primum  214  and septum secundum  210  can all vary. In  FIGS. 2B-C , PFO entrance  217  and PFO exit  218  are depicted as being relatively the same size with the width of tunnel  215 , or the distance between sidewalls  219 , remaining relatively constant. However, in some cases PFO entrance  217  can be larger than PFO exit  218 , resulting in an tunnel  215  that converges as blood passes through. Conversely, PFO entrance  217  can be smaller than PFO exit  218 , resulting in an opening that diverges as blood passes through. Furthermore, multiple PFO entrances  217  and multiple PFO exits  218  can be present, with one or more individual openings  215  therebetween. Also, in  FIGS. 2B-D , both septum primum  214  and septum secundum  210  are depicted as relatively planar tissue flaps, but in some cases one or both of septum primum  214  and septum secundum  210  can have folded, non-planar, highly irregular shapes. 
     As will be described in more detail below, treatment of a PFO preferably includes inserting treatment system  100  into the vasculature of a patient and advancing body member  101  through the vasculature to inferior vena cava  202 , from which access to right atrium  205  can be obtained. Once properly positioned within right atrium  205 , delivery device  104  can be used to deliver implant  103  to PFO region  209 , preferably by inserting implant  103  through septum secundum  210  and primum  214  such that implant  103  lies transverse to tunnel  215  and can at least partially close tunnel  215 . 
       FIG. 3  is a block diagram depicting one exemplary embodiment of implant  103 . Implant  103  can be configured in an almost limitless number of different ways, as this block diagram shows. Here, implant  103  includes a first end portion  301 , a second end portion  302  and a central portion  303  preferably coupled therebetween. First and second end portions  301 - 302  are each preferably configured to engage opposing surfaces of septal wall  207 . First end portion  301  can be configured to engage the surface of septal wall  207  on the right atrium (RA) side, while second end portion can be configured to engage the surface of septal wall  207  on the left atrium (LA) side. Although end portions  301 - 302  can be placed anywhere within heart  200  as desired, in order to facilitate the description of implant  103  herein, first end portion  301  will be referred to as RA portion  301  and second end portion will be referred to as LA portion  302 . 
     Central portion  303  is preferably configured to fit within a manmade or surgically created opening in either septum primum  214 , septum secundum  210  or both. Central portion  303  is also preferably configured to apply a force adequate to bring end portions  301 - 302  towards one another when implanted, to be implantable into septal walls  207  of varying thickness and to fit within elongate body member  101 , the diameter of which is preferably minimized for ease of insertion within the patient&#39;s vasculature. 
     Implant  103  can be configured in any manner desired to fit the needs of the application. Implant  103  can have any size and shape and can include additional portions not shown in  FIG. 3  to achieve a different set of functions. Implant  103  can also be fabricated in any desired manner and from any materials suitable for implantation within the patient including, but not limited to, elastic materials, superelastic materials, shape-memory materials, composite materials, polymeric materials and biodegradable materials. 
       FIG. 4A  is a perspective view depicting another exemplary embodiment of implant  103  shown in an “at rest” configuration. In this embodiment, implant  103  is configured in a coil-shaped manner with a wire-like body  304  composed of an elastic material. Wire-like body  304  can have any wire-like cross-sectional shape including, but not limited to circular, elliptical, oval, rounded, arcuate, polygonal and any combination thereof. Each portion  301 - 303  can be composed of one or more coiled segments  306 , with a coiled segment  306  being defined herein as a segment that is curved in any manner about one or more axes. A coiled segment  306  can be curved less than 360 degrees about the one or more axes.  FIG. 4B  is a perspective view depicting an exemplary embodiment of several coiled segments  306 , which could be used in any of portions  301 - 303 . In this embodiment, each coiled segment  306  is coiled with a constant rate of curvature about the same axis  309 . Coiled segments  306  have approximately the same width  310  and are stacked and separated by a distance  311 , which will be referred to herein as stacking distance  311 . 
     Referring back to  FIG. 4A , implant  103  has an overall width  336 . Central portion  303  includes a plurality of coiled segments  306  having substantially the same width  310 . Each end portion  301 - 302  includes a plurality of coiled segments having varied widths  310 . In this case, the width  310  of the outermost coiled segment  306  is the greatest and the widths  310  of each successive coiled segment  306  decreases as one approaches the innermost coiled segment  306 . Each end portion  301 - 302  is coupled with central portion  303  via optional generally straight sections  305 . Generally straight sections  305  can prevent blood from shunting between the right and left atria through open interior region  327  of coiled central portion  303 , by allowing the adjacent tissue to encroach upon and surround straight section  305 . Plugs of bioabsorbable or hydrophilic material may also be provided to minimize such shunting. Generally straight sections  305  can also prevent tissue from getting caught, or hung up, between central portion  303  and RA/LA portions  301 / 302 . Each generally straight sections  305  is not required to be straight and, in fact, can have any non-coiled shape. Central portion  303  can be placed approximately equidistant from end portions  301 - 302 , as depicted here, or central portion  303  can be placed closer to one of end portions  301 - 302  than the other. Generally straight sections  305  are optional and can be included on only one side of central portion  303  or omitted altogether, in which case the coiled segments  306  of central portion  303  extend directly up to a coiled segment  306  of each end portion  301 - 302 . 
     The end tips  307  of body  304  are preferably atraumatic so as to minimize injury to cardiac tissue. In this embodiment, end tips  307  are rounded and have a larger diameter than body  304 . End tips  307  can also be configured as floppy tips that are curled or coiled and can be flexible or non-flexible. Also, it should be noted that any part of implant  103  can be modified for imaging purposes. For instance, in this embodiment end tips  307  are radio-opaque to increase visibility of implant  103  during imaging. 
       FIG. 4C  depicts a side view of the embodiment of implant  303  taken along direction  330  of  FIG. 4A . For ease of illustration,  FIG. 4C  depicts only the outermost coiled segment  306  of RA portion  301 , transition section  331  and the generally straight section  305  located between RA portion  301  and central portion  303 . Transition section  331  is an optional section of implant  103  that can be straight, curved or any other shape.  FIG. 4D  depicts RA portion  301 , transition section  331  and the generally straight section  305  located between RA portion  301  and central portion  303  as viewed from direction  329  of  FIG. 4C . Here, it can be seen that transition section  331  connects to generally straight section  305  at 90 degree angle  332 . Angle  332  can be varied as desired, but values of angle  332  approaching 0 degrees or 180 degrees are less preferable due to the increased risk of RA portion  301  (or LA portion  302 ) being drawn into manmade opening  315 , which is described in more detail below. 
       FIG. 4E  is cross-sectional view depicting the exemplary embodiment of implant  103  depicted in  FIG. 4A  implanted within heart  200  using one exemplary method of implantation. Here, an opening  315  has been surgically created in septum primum  214  and septum secundum  210  and implant  103  has been positioned such that central portion  303  resides within the opening  315 . RA portion  301  and LA portion  302  are positioned on opposite sides of septal wall  207  to engage surface  320  of septum secundum  210  and surface  321  of septum primum  214 , respectively. Central portion  303  preferably exerts a contractile force  312  to bring portions  301 - 302  towards one another, which in turn preferably draws septum primum  214  and septum secundum  210  together to at least partially close PFO tunnel  215 . As mentioned above, the widths  310  of coiled segments  306  of RA and LA portions  301 - 302  get progressively larger from the innermost to the outermost segment  306 . If the rate of change of width  310  is large enough to allow coiled segments  306  to pass through each other, then portions  301  and  302  can exert additional closure forces  313  and  314 , respectively, which oppose each other and assist central portion  303  in closing PFO tunnel  215 . 
     LA portion  302  and RA portion  301  can each be sized in any manner desired. Preferably, LA portion  302  is configured to have relatively larger coiled segment widths  310 , include relatively more coiled segments  306  and exert a closure force over a relatively larger area  314  than RA portion  301 . This can be for one of at least two reasons. As will be described in more detail below, preferably, LA portion  302  is deployed in PFO region  209  first and, once in contact with septal wall  207 , LA portion  302  is used to help deploy, or pull, portions  303  and  301  from delivery device  104 . Also, septum primum  214  is typically thinner than septum secundum  210  and more likely to tear or deform to the extent that LA portion  302  can be pulled though septum primum  214 . 
     Preferably, implant  103  is configured to adjust to septal walls  207  having varying degrees of thickness. Accordingly, central portion  303  preferably has a compressibility sufficient to apply a closure force  312  to thinner septal walls  207  while at the same time having an expandability sufficient to accommodate thicker septal walls  207  without becoming permanently deformed. In one exemplary embodiment, which is for purposes of illustration only and should not be used to limit the scope of the invention in any way, central portion  303  is expandable from 3 to 8 millimeters (mm) without becoming excessively permanently deformed. 
     As mentioned above, implant  103  can be deformable between a configuration suited for housing within delivery device  104  and the implanted configuration depicted in  FIG. 4E .  FIG. 4F  is a cross-sectional view of an exemplary embodiment of treatment system  100  depicting delivery device  104  having an inner lumen  402  with implant  103  housed therein. Implant  103  is preferably housed within lumen  402  until body member  101  is advanced within the patient into the desired position within heart  200  for implantation, at which time implant  103  is delivered to PFO region  209  through open distal end  403 . Here, implant  103  is deformed from the at rest, i.e., unbiased, configuration depicted in  FIG. 4A  into a generally straight configuration where coiled portions  301 - 303  are mostly unwound into a relatively straight state. This housed configuration significantly reduces the overall width  336  of implant  103  and allows the size of delivery device  104  and, in turn, body member  101  to be minimized. 
       FIG. 4G  is a cross-sectional view of another exemplary embodiment of treatment system  100  depicting delivery device  104  with implant  103  in the housed configuration. Here, central portion  303  of implant  103  remains coiled in a state similar to the resting state of  FIG. 4A , while RA/LA portions  301 / 302  are partially unwound into a relatively straight state from the coiled rest state. Preferably, coiled segments  306  of central portion  303  generally have smaller widths  310  than most of the coiled segments  306  of RA/LA portions  301 / 302 . Coiled segments  306  having a smaller width, i.e., more tightly wound coils, can be permanently deformed more easily when unwound and, therefore, by maintaining central portion  303  in the coiled state, the risk of permanent deformation to central portion  303  is reduced. Implant  103  can be deformed in any manner when housed within delivery device  104 . For coil-like embodiments of implant  103 , this can include deforming any or all of coiled segments  306 , to any degree, in any portion  301 - 303 . 
     To facilitate the deformation of implant  103  between the housed configuration and the implanted configuration depicted in  FIG. 4E , implant  103  is preferably composed of an elastic material. Preferably, body  304  is composed of a titanium-nickel alloy such as NITINOL, although any elastic material can be used, including polymers, rubber-like materials, stainless steel, other metal alloys and the like. As one of skill in the art will recognize, the amount of closure force  312 - 314 , the degree of allowable deformation and the like will depend, in part, on the type of material used to form body  304 . 
       FIGS. 5A-E  are perspective views depicting additional exemplary embodiments of central portion  303  of implant  103 . Each of these embodiments can be used with any RA portion  301  and LA portion  302 . In  FIG. 5A , central portion  303  includes a plurality of coiled segments  306  where the stacking distance  311  between each segment  306  is relatively greater than the embodiment of central portion  303  depicted in  FIG. 5B . Generally, a smaller stacking distance  311  will provide a greater closure force  312 , if all other implant parameters remain the same. Any stacking distance  311  can be used in central portion  303  as desired, including configurations where there is no gap between each coiled segment  306 , i.e., each coiled segment  306  lies flush with any adjacent coiled segment  306 . Use of a larger stacking distance  311  that provides for gaps between adjacent coiled segments  306  allows the adjacent septal tissue to grow into the open interior region  327  of the coiled central portion  303 , which can provide positional stability to the device, reduce immune reactions to the device and reduce any risk of blood shunting through open region  327 . 
     In  FIG. 5C , central portion  303  includes a combination of coiled sections  324  and generally straight sections  305 . It should be noted that central portion  303  can include any number of one or more coiled sections  324  in any combination with any number of one or more generally straight sections  305 . As can be seen here, each coiled section  324  can be configured differently from any other coiled section  324 , i.e., each coiled portion can include a different number of coiled segments  306 , with different stacking distances  311  and different widths  310 , etc. 
       FIG. 5D  depicts another exemplary embodiment where blocking material  326  has been coupled with coil body  304 . Blocking material  326  preferably reduces any risk of blood shunting through the interior of coiled segments  306 , either by blocking blood flow directly or by facilitating the formation of blood clots within open interior region  327 . In one exemplary embodiment, blocking material  326  can include multiple DACRON fibers adhesively or mechanically coupled to the outer surface of body  304 . In another exemplary embodiment, a polymer or metal plug is placed in open interior region  327  to prevent blood flow. As one of skill in the art will readily recognize, any type of plug, device, material or coating can be used and attached to body  304  in any manner, the numerous combinations of which will not be listed here. 
     Central portion  303  is not required to include a coiled section  324  and can, in fact, be only a generally straight section  305 . Furthermore, central portion  304  is not required to be formed from a wire-like body  304  and can be configured in any manner desired as depicted in the block diagram of  FIG. 3 . For instance, central portion  303  can be formed from an elastomeric or rubber-like stretchable member, as depicted in  FIG. 5E . 
     Referring in more detail to RA portion  301  and LA portion  302 ,  FIGS. 6A-I  are perspective views depicting multiple embodiments exemplary of either RA portion  301  or LA portion  302 . Any of the RA/LA portions  301 / 302  depicted here can be used with any embodiment of central portion  303  described with respect to  FIGS. 5A-E . For instance, an exemplary embodiment of implant  103  can have RA portion  301  configured in a manner similar to that described with respect to  FIG. 6A , central portion  303  configured in a manner similar to that described with respect to  FIG. 5A , and RA portion  301  configured in a manner similar to that described with respect to  FIG. 6B . 
     In  FIG. 4A , RA/LA portions  301 / 302  include multiple stacked coiled segments  306  having gradually decreasing widths  310  from the outermost to the innermost segment  306 . In  FIG. 6A , RA/LA portions  301 / 302  include multiple coiled segments  306  having gradually increasing widths  310  from the outermost to the innermost segment  306 . The embodiment of portions  301 - 302  described with respect to  FIG. 4A  can be less susceptible to entering opening  315 , due to the presence of a relatively larger coiled segment  306  coupled with transition region  305 . 
     In both  FIGS. 4A and 6A , coiled segments  306  of RA/LA portions  301 / 302  are stacked in an inwards manner, i.e., the outermost segment  306  is coupled with central portion  303  or generally straight section  305 , if present (as shown here) and RA/LA portion  301 / 302  overlaps central portion  303 . In  FIGS. 6B-C , RA/LA portions  301 / 302  include multiple coiled segments  306  stacked in an outwards manner, i.e., the innermost segment  306  is coupled with central portion  303  or generally straight section  305 , if present (as shown here). Generally, stacking segments  306  in an inwards manner will provide greater closure forces than stacking in an outwards manner. In  FIG. 6B , RA/LA portions  301 / 302  include multiple coiled segments  306  having gradually increasing widths  310  from the outermost to the innermost segment  306 , while in  FIG. 6C , RA/LA portions  301 / 302  include multiple coiled segments  306  having gradually decreasing widths  310  from the outermost to the innermost segment  306 . 
     In  FIG. 6D , RA/LA portions  301 / 302  are tightly stacked with a constant width  310  such that no gap exists between adjacent coiled segments  306 . This embodiment of RA/LA portions  301 / 302  exhibits a high resistance to the potential for being pulled into opening  315 . 
     RA/LA portions  301 / 302  are not required to be implemented in a stacked configuration. For instance, in  FIGS. 6E-F , RA/LA portions  301 / 302  each include multiple coiled segments  306  having varying widths  310  arranged in a generally co-planar fashion, i.e., for all segments  306  the stacking distance  311  is close to or equal to zero. In  FIG. 6E , the smallest coiled segment  306  is coupled with generally straight section  305 , while in  FIG. 6F , the largest coiled segment  306  is coupled with generally straight section  305 . To lessen the risk of RA/LA portions  301 / 302  being pulled into opening  315  in the embodiment depicted in  FIG. 6F , transition section  329  is preferably positioned on the outside of coiled segments  306  such that, when implanted, coiled segments  306  are located between transition section  329  and septal wall  327 . 
     In the embodiments discussed above, the radius of curvature of the coiled segments  306 , present in either RA/LA portions  301 / 302  or central portion  303 , is generally constant or varies at a constant rate, resulting in a circular, spiral or helical appearance when viewed from the side (e.g., direction  330  of  FIG. 4A ). It should be understood that the radius of curvature can vary at any rate, abruptly or gradual, allowing coiled segments  306  to take any shape or form desired, whether in RA/LA portions  301 / 302  or central portion  303 . For instance,  FIGS. 6G-H  are schematic views depicting additional exemplary embodiments of RA/LA portions  301 / 302  as viewed from the side.  FIG. 6G  depicts RA/LA portion  301 / 302  having an elliptical D shape. Here, RA/LA portion  301 / 302  has an elliptical portion  334  and a generally straight portion  335 , which can be placed adjacent to fossa ovalis  208  to lessen the extent to which RA/LA portion  301 / 302  overlaps fossa ovalis  208  and minimize the risk of piercing or rupturing fossa ovalis  208 .  FIG. 6G  depicts another exemplary embodiment of RA/LA portion  301 / 302  having a generally pentagonal shape. 
     RA/LA portions  301 / 302  are not required to include coiled segments  306  and are not required to be formed from a wire-like body  304 . As mentioned above, RA/LA portions  301 / 302  can be configured in any manner desired as depicted in the block diagram of  FIG. 3 . For instance, RA/LA portions  301 / 302  can be formed from an elastomeric or rubber-like membrane  336  in an umbrella-like fashion, or a sheet-like fashion as depicted in the exemplary embodiment of  FIG. 61 . 
       FIG. 7A-C  are perspective views depicting additional exemplary embodiments of implant  103  having a ribbon-like body  304 . Ribbon-like bodies  304  can have a generally polygonal cross-section and can be differentiated from the wire-like bodies  304  depicted in  FIGS. 4A-5E , which can have generally circular, rounded etc. cross-sections as described above.  FIG. 7A  is an embodiment of implant  103  having a ribbon-like body  304  configured similar to that of the embodiment depicted in  FIG. 4A . Generally, any of the embodiments described with respect to wire-like bodies  304  can also be implemented with ribbon-like bodies  304 . Ribbon-like bodies  304  can have any ribbon-like cross-sectional shape desired.  FIGS. 7B-C  are cross-sectional views depicting ribbon-like body  304  having generally polygonal shapes.  FIG. 7B  is a cross-sectional view depicting ribbon-like body  304  having a generally tapered trapezoidal shape.  FIG. 7C  is a cross-sectional view depicting ribbon-like body  304  having a generally rectangular shape with rounded corners. 
     In addition to other parameters, the thickness of implant body  304  can vary as desired. For instance,  FIG. 8  is a perspective view depicting another exemplary embodiment of implant  103  having a wire-like body  304  with varying thicknesses. Here, it can be seen that generally straight section  305  is relatively thicker than the coiled segments  306  of central portion  303 , while interface  333  between generally straight sections  305  and transition sections  329  is relatively thicker still. Relatively thicker regions of body  304 , whether formed from a wire, ribbon or other structure, generally have greater strength and less flexibility than relatively thinner regions of body  304 . Thus, relatively thicker regions can be used to add strength while relatively thinner regions can be used where added flexibility is desired. 
     Like the thickness, the surface of body  304  can also be varied as desired. The surface can be modified directly or through etching, grinding, additional coatings or add-ons, which are applied to the underlying body  304 . The surface can be modified for any purpose including, but not limited to increasing surface friction with tissue, increasing the ability to engage tissue, allowing tissue in-growth, promoting healing, promoting scarring, promoting thrombogencity, preventing blood passage or shunting around or through implant  103 , minimizing thrombus formation, promoting anti-coagulation (e.g., with drugs such as heparin and the like), modifying imaging characteristics (e.g., radio-opacity and the like) and decreasing body surface friction (e.g., with a hydrophilic coating and the like). 
       FIGS. 9A-C  are perspective views depicting just several additional exemplary embodiments of implant  103  having a modified surface region  340 . The surface of implant  103  can be modified in any location and in any manner desired, including, but not limited to, etching, grinding, coating, drilling, and cutting. For instance,  FIGS. 9A-C  depict the innermost coiled segment  306  of exemplary embodiments of RA/LA portion  301 / 302 . In  FIG. 9A , wire-like body  304  has been etched or otherwise treated such that modified surface region  340  is a textured surface including multiple recesses  341  for increasing surface friction and allowing coiled segment  306  to more easily grasp septal wall  207 . It should be noted that any surface texture pattern can be used. In  FIG. 9B , a coating has been applied to ribbon-like body  304  to create an abrasive surface region  340 , also to increase surface friction. In  FIG. 9C , apertures  342  in ribbon-like body  304  are present to facilitate tissue in-growth on and around modified surface region  340 . The use of closely spaced apertures  342  can reduce a body&#39;s immune reaction to the presence of implant  103 . Also, in this embodiment the orientation of ribbon-like body  340  has been rotated 90 degrees so that the widest surface is adjacent to the septal tissue. 
     As stated above, implant  103  can be configured in any manner desired in accordance with the needs of the application. The following is a non-exhaustive list of just some exemplary factors one of skill in the art may consider in designing, configuring, manufacturing and/or otherwise implementing implant  103 . 
     LA portion  302  can configured to use compressive force  312  from center portion  303  to hold septum primum  214  against septum secundum  210  and at least partially close or seal PFO tunnel  215 . LA portion  302  can also be configured to maintain a stable position as central portion  303  and RA portion  301  are deployed without being pulled through septum primum  210 . LA portion  302  can be configured to lie flush against septum primum  214  when deployed and not to distort the native geometry of tunnel  215  to create residual shunts. LA portion  302  can be sized to provide adequate coverage over PFO tunnel  215 . (In one exemplary embodiment, which is included as an example only and should not be used to limit the invention, LA portion  302  has a maximum width  310  of  1 . 2  centimeters to accommodate most large PFO tunnels  215 .) LA portion  302 , in combination with central portion  303  and RA portion  301 , can be configured to exert enough closure force  314  to seal PFO tunnel  215  and prevent shunting during normal and valsava atrial blood pressures. LA portion  302  can also be configured: to be deployable with minimal and consistent push force (e.g., push force on pusher member  406 , which will be descried in more detail below); so that the shape before and after deployment is predictable; to be devoid of characteristics that cause chronic or excessive tissue irritation, inflammation, etc.; and/or for visibility during imaging procedures. 
     Central portion  303  can be configured to maintain LA portion  302  and RA portion  301  in a state of contact with septal wall  207  with enough closure force  312  to at least partially close and seal PFO tunnel  215 . Central portion  303  can also be configured: with an adequate spring constant (K) to prevent tunnel  215  from opening during normal and valsava atrial blood pressures; to not distort the native geometry of tunnel  215  and create residual shunts; to be deployable with minimal and consistent push force (e.g., push force on pusher member  406 , which will be descried in more detail below); for visibility during imaging procedures; to expand or stretch to accommodate variable septal wall thicknesses without permanent deformation; with adequate strength to withstand any motion it may experience in vivo; to allow LA portion  302  or RA portion  301  to tilt, for instance, if the area of delivery is wedge shaped; so that central portion  303  does not pinch or sever any tissue that could embolize, for instance, with a spring constant low enough to prevent severing tissue; to exert adequate closure force  212  to close any residual shunts that exist; and/or with maximized width  310  and minimized strains to optimize fatigue performance. 
     RA portion  301  can be configured to hold septum secundum  210  against septum primum  214  and at least partially close or seal PFO tunnel  215 . RA portion  301  can also be configured: to lie flush against septum secundum  210  when deployed and not to distort the native geometry of tunnel  215  to create residual shunts; to be deployable with minimal and consistent push force (e.g., push force on pusher member  406 , which will be described in more detail below); so that the shape before and after deployment is predictable; to be devoid of characteristics that cause chronic or excessive tissue irritation, inflammation, etc.; for visibility during imaging procedures; and/or to resist being pulled through septal wall  207 . 
     Also provided herein are methods of manufacturing implant  103 .  FIG. 10A  is a flow diagram depicting one exemplary method  350  of manufacturing an exemplary embodiment of a coil-like implant  103  having body  304 , which can be wire, ribbon or the like, composed of NITINOL. First, at  351 , a section of NITINOL, from which body  304  can be formed, is pre-processed. Pre-processing  351  can include adding a modified surface region  340  having a desired texture, adjusting body thickness, adjusting the cross-sectional shape of body  304  and the like. 
     With a ribbon-like implant  103 , pre-processing can include etching of the NITINOL section. Methods of etching NITINOL materials are readily understood to one of skill in the art. For instance, a sheet of NITINOL is first etched or grinded or otherwise altered to vary the cross-sectional shape, thickness, surface texture and the like of one or more sections present on the sheet. Etching of the NITINOL sheet can allow for the implementation of numerous different cross-sectional shapes, thicknesses, surface textures and combinations thereof. Afterwards, each section of NITINOL can be cut from the sheet and trimmed as desired. 
     At  352 , the NITINOL section is fixed to body shaping device  380  in preparation for a heat treatment. Heat treatment of NITINOL can instill the desired at rest configuration to body  304  and is well known to those of skill in the art. Accordingly, body shaping device  380  is preferably shaped such that when the NITINOL section is coiled around body shaping device  380 , it is in the final desired at rest configuration. One exemplary embodiment of body shaping device  380  is depicted in  FIG. 10B . Here, body shaping device  380  is shaped for the exemplary embodiment of implant  103  depicted in  FIG. 4A . Body shaping device  380  includes a central body shaping portion  383  corresponding to the shape of central portion  303 , and two end body shaping portions  381  and  382  corresponding to the shape of RA portion  301  and LA portion  302 , respectively. End body shaping portions  381  and  382  are preferably configured to telescope over central body shaping portion  383  to allow for the inwards manner of coiling of RA/LA portions  301 / 302  over central portion  303 . Central portion  303  includes recesses  384  into which the NITINOL section can be placed to form generally straight sections  305 . End body shaping portions  381  and  382  also preferably include recess  385  that can allow for each transition section  331 . 
     Once wrapped around and fixed to body shaping device  380 , at  353 , the NITINOL section is then preferably heat treated to instill the desired shape. Heat treating can occur at any time and temperature sufficient to instill the desired at rest shape and level of elasticity in implant  103 . In one embodiment, which is included as an example only and should in no way be used to limit the invention, heat treating can occur at a temperature range of 500-550 degrees Celsius for approximately five minutes. 
     At  354 , the NITINOL section is preferably cooled, e.g., by rapid quenching in room temperature water, then at  355 , the NITINOL section is preferably removed from body shaping device  380  and end tips  307  are trimmed, if necessary, to the desired length to form body  304 . Finally, at  356 , any post-processing is performed, such as the addition of radio-opaque markers, the shaping of end tips  307  and the addition of any desired coatings or blocking material  326 . 
       FIGS. 11A-B  depict additional exemplary embodiments of implant  103 . Specifically,  FIG. 11A  is a perspective view depicting an exemplary embodiment of implant  103  formed from a NITINOL tube. In this embodiment, central portion  303  includes multiple coiled segments  306  coupled with RA/LA portions  301 / 302 . RA/LA portions  301 / 302  include tubular sections  390  having multiple outward extending members  391 , which in this embodiment are in the shape of flaps  391 . Flaps  391  are preferably configured to engage septal wall  207  and at least partially close PFO tunnel  215 . Flaps  391  can be deflected inwards from the configuration depicted here to lower the overall width  336  of implant  103  and allow the size of delivery device  104  to be minimized. 
     This embodiment of implant  103  can be formed by cutting a NITINOL tube with, for instance, a laser or electrical discharge machining (EDM) and the like.  FIG. 11B  depicts an exemplary embodiment of a NITINOL tube  393 , with dashed lines  394  indicating the desired cut-lines. After being cut, flaps  391  can be extended outwards and heat treated to instill the desired outward extending shape. Also, coiled segments  306  can be wound to a different width  310  with a different stacking distance  311  as desired using body shaping device  380  in a manner similar to that described with respect to  FIGS. 10A-B . This embodiment of implant  103  can also be pre-processed and post-processed in a manner similar to that described with respect to  FIG. 10A  above. 
     Turning now to the devices and methods for delivering implant  103 ,  FIG. 12  depicts another exemplary embodiment of treatment system  100  within heart  200 . Implant  103  is preferably delivered from right atrium  205 , although delivery from left atrium  212  is also possible. Right atrium  205  is preferably accessed via inferior vena cava  202 . In this embodiment, implant  103  is delivered from within delivery device  104 . To facilitate delivery in this manner, longitudinal axis  108  of delivery device  104  is preferably substantially parallel, i.e., at least close to parallel but not necessarily parallel, to the normal  109  of the surface of septal wall  207  into which implant  103  is to be delivered. However, as shown in  FIG. 12 , longitudinal axis  108  of delivery device  104  is close to perpendicular to this normal  109  (shown here extending into the page). To accommodate for this, treatment system  100  is preferably configured for off-axis delivery, which allows the orientation of delivery device  104  to be changed so that the longitudinal axis  108  of delivery device  104  is transverse to the longitudinal axis  107  (not shown) of body member  101 . 
       FIG. 13  is a block diagram depicting one exemplary embodiment of delivery device  104  configured for off-axis delivery. Here, delivery device  104  includes an off-axis (OA) delivery member  401 . Delivery device  104  is preferably configured to grasp or engage cardiac tissue to support and/or facilitate orientation of delivery member  401 . Accordingly, an optional tissue engagement device  404  is included within delivery device  104 . Delivery device  104  can also include a needle member  405  for puncturing septal wall  207  and a pusher member  406  for pushing implant  103  from within delivery device  104 . 
       FIG. 14A  is a perspective view depicting another exemplary embodiment of treatment system  100 , including body member  101 , delivery device  104  and stabilization device  105 . Here, OA delivery member  401  is an elongate flexible tubular member having open distal end  410  Inner lumen  102  of body member  101  is preferably configured to slidably receive OA delivery member  401 , such that OA delivery member  401  can be advanced both proximally and distally. Distal end  410  of OA delivery member  401  is coupled with an elongate support structure  411  of body member  101  via optional grasping device  404 . In this embodiment, grasping device  404  includes an arm member  409  coupled with support structure  411  and OA delivery member  401  with hinges  407  and  408 , respectively. A biasing element  413  can also be optionally included, to apply a bias force to maintain arm member  409  in the position shown here. Stabilization device  105  is also an elongate member preferably placed in a location to oppose arm member  401 . 
       FIG. 14B  is a cross-sectional view depicting another exemplary embodiment of OA delivery member  401  with embodiments of needle member  405 , pusher member  406  and implant  103  located within lumen  414 . Needle member  405  has an open distal end  415  and an inner lumen  414  in which pusher member  406  and implant  103  are slidably received and housed. In this embodiment, implant  103  is deformed to the housed configuration where RA/LA portions  301 / 302  are relatively straightened but central portion  303  remains in the coiled at rest configuration. As will be discussed in more detail below, delivery of implant  103  is accomplished by first orienting delivery device  104  in the desired orientation transverse to longitudinal axis  107  such that distal end  410  is in proximity with septal wall  207 , then advancing needle member  405  through septal wall  207  to create opening  315 . After needle member  405  has advanced through septal wall  207  into left atrium  212 , pusher member  406  is advanced distally to push LA portion  302  of implant  103  from within lumen  414 . Once outside lumen  414 , LA portion  302  returns to the coiled at rest configuration. Needle member  405  can then be retracted proximally such that LA portion  302  engages septal wall  207  and remains in left atrium  212 . As needle member  405  is retracted through septal wall  207 , central portion  303  deploys within opening  315 . Once needle member  405  is retracted back into lumen  402 , OA delivery member  401  can be retracted from septal wall  207  thereby allowing RA portion  301  to deploy and engage septal wall  207  in a coiled configuration. 
       FIGS. 14C-F  are perspective views depicting a portion of septal wall  207  and an additional exemplary embodiment of treatment system  100  during use of delivery device  104  prior to insertion of needle member  405 . Here, the preferred location for insertion of needle member  405  is indicated by location  419 .  FIG. 14C  depicts treatment system  100  with delivery device  104  in the on-axis position, where the longitudinal axes  107 - 108  are generally or substantially parallel. Stabilization device  105 , the use and structure of which will be described in more detail below, is shown positioned within PFO tunnel  215 . In  FIG. 14D , OA delivery member  401  has been retreated proximally with respect to body member  101  and in opposition to bias member  413 , causing distal end  410  to rotate, or pivot, away from stabilization device  105  by way of arm member  409  and hinges  407 - 408 . In  FIG. 14E , treatment system  100  is advanced distally in direction  416  until the underside surface  417  of arm member  409  abuts limbus  211 , at which point OA delivery member  401  can be advanced distally with respect to body member  101  to force arm member  409  back towards stabilization device  105  to clamp, or grasp limbus  211  between arm member  409  and stabilization device  105 , which is preferably in a substantially fixed position with respect to arm member  409 . By grasping limbus  211  in this manner, treatment system is effectively anchored to septal wall  207 . 
     In  FIG. 14F , OA delivery member  401  is further advanced distally with respect to body member  101 , which causes OA delivery member to deflect, or arc outwards, in order to rotate distal end  410  about hinge  408  into the desired orientation with respect to septal wall  207 . Distal end  410  is now preferably in contact with septal wall  207  at the desired needle insertion location  419 . As shown here, OA delivery member  401  is in an outwardly arced state. The degree to which OA delivery member  401  arcs outwards can be adjusted by altering the length of OA delivery member  401  present outside of body member  101 . Because needle member  405 , pusher member  406  and implant  103  all preferably move within OA delivery member  401 , the radiva of curvature of the arc is preferably kept large enough to allow movement within OA delivery member  401 . A very large rate of curvature can result in sharp angles or kinking in OA delivery member  401  that can make movement difficult. 
     As shown in  FIG. 14F , longitudinal axis  108 , as measured at distal end  410 , is now transverse to longitudinal axis  107 . Preferably, the delivery angle  417 , which is the angle between longitudinal axis  107  and longitudinal axis  108  as measured at distal end  410 , is approximately 90 degrees. Once distal end  410  is in the desired orientation, needle member  405  can be advanced into septal wall  207 . 
     The needle insertion location  419  can be placed in any desired location, but should be chosen based in part on the configuration and size of implant  103  and the degree of overlap between septum primum  214  and septum secundum  210 . For instance, in one exemplary embodiment, which is included for illustration only and in no way should be used to limit the invention, needle insertion location  419  is placed between 3 and 7 mm from limbus  211 . The position of needle insertion location  419  can be determined by the length of arm member  409 , which in turn can position distal end  410  using limbus  211  as a point of reference. To allow for added flexibility, the length of arm member  409  can be configured to be adjustable during the implantation procedure. Thus, arm member  409  is preferably configured for at least two functions: (1) to stop travel of body member  101  at limbus  211  by abutting limbus  211  and (2) to position distal end  410  in the desired needle insertion location  419 . 
       FIGS. 15A-D  are perspective views depicting additional exemplary embodiments of grasping device  404  in a pulled back position. In  FIG. 15A , arm member  409  is configured to engage limbus  211  with a contoured undersurface  417  that accommodates the shape of limbus  211  in order to facilitate grasping or engagement. Undersurface  417  can also be textured as desired to increase surface friction, or made lubricious to assist in friction-free centering, and, as shown here, undersurface can include abutments  420  configured to fixably grasp limbus  211 . Also, it should be noted that any type of hinges  407 - 408  can be used including, but not limited to, the swivel type hinges depicted here. 
       FIGS. 15B-C  depict exemplary embodiments of grasping device  404  where hinges  407  and  408  are integrated into arm member  409 . In  FIG. 15B , arm member  409  includes two elastic wires  420  and  421  each configured to flex at hinge positions  407  and  408 , e.g., by reducing the thickness of the material at the hinge positions. Arm member  409  is preferably biased towards a downwards position, which can allow elimination of any additional biasing element  413 . In  FIG. 15C , arm member  409  is configured to be both flexible and stretchable and can be composed of an elastomeric or rubber-like material or thin or slotted metal. This flexibility and stretchability facilitates the conformance of arm member  409  to limbus  211 . Here, arm member  409  includes tubular portions  422  and  423  for coupling arm member  409  with OA delivery member  401  and support structure  411 , respectively. 
       FIG. 15D  is a perspective view depicting yet another exemplary embodiment of grasping device  404 . Here, arm member  409  again includes two flexible wires  420  and  421  that can be coupled with OA delivery member  401 . Like the embodiment described with respect to  FIG. 15B , hinges  407  and  408  can be integrated into wires  420  and  421 , which can be biased towards a downwards position. As shown in  FIG. 15D , wires  420  and  421  are preferably routed through aperture  499  into a lumen  102  within body member  101  and to the proximal end of body member  101 , where they can be independently adjusted to control, or steer, OA delivery member  401 . For instance, distal movement of both wires  420  and  421  moves distal end  410  of OA delivery member  401  distally and proximal movement of both wires  420  and  421  moves distal end  410  of OA delivery member  401  proximally. Distal advancement of wire  420  with respect to wire  421 , alone or in combination with proximal movement of wire  421  with respect to wire  420 , moves distal end  410  in lateral direction  497 , while reverse movement moves distal end  410  in lateral direction  498 . 
       FIGS. 16A-B  are cross-sectional views depicting additional exemplary embodiments of treatment system  100  with delivery device  104 .  FIG. 16A  depicts a longitudinal cross-sectional view of treatment system  100  and  FIG. 16B  depicts a radial cross-sectional view of treatment system  100  taken along line  16 B- 16 B of  FIG. 16A . Here, delivery device  104  includes a steerable OA delivery member  401 , which is configured to be freely steerable to position distal end  410  in the desired orientation at needle insertion location  419 . Accordingly, distal end  410  is preferably left unconnected with any grasping device  404  (not shown). Preferably, steerability is provided through the use of one or more pull wires  424  coupled with distal end cap  475 . In this embodiment, four pull wires  470 - 473  are equally spaced apart from each other within lumen  402 . This configuration allows for manipulation of distal end  410  to any three-dimensional (X, Y, Z) orientation. For instance, pulling wire  470  back proximally with respect to wires  471 - 473 , or pulling wire  472  back proximally with respect to wires  470 - 471  and  473  allows movement of distal end  410  in the X-Z plane. Pulling wire  471  back proximally with respect to wires  470  and  472 - 473 , or pulling wire  473  back proximally with respect to wires  470 - 472  allows movement of distal end  410  in the Y-Z plane. 
       FIG. 16C  is a perspective view depicting the embodiment described with respect to  FIGS. 16A-B  during delivery. Here, distal end  410  has been oriented in its needle insertion location  419  and longitudinal axis  108  lies within both the X-Z and Y-Z planes. The degree of steerability can be altered as desired for each individual application. For instance, the inclusion of additional pull back wires can provide for more finely controllable steerability, while the deletion of any of pull wires  470 - 473  can eliminate freedom of steerability, but can simplify the overall design of device  104 . The design and use of steerable devices is also discussed in parent U.S. patent application 10/847,747, filed on May 7, 2004. 
     As mentioned above, OA delivery member  401  is preferably configured to allow slidable movement of needle member  405 , pusher member  406  and implant  103  within inner lumen  402 . Preferably, OA delivery member  401  is configured so as to maintain a sufficient degree of structural integrity and kink resistance, while at the same time providing adequate torque or twist control. In one exemplary embodiment, OA delivery member  401  is composed of a flexible braided metal reinforced polymeric tube configured to provide the desired amount of kink resistance and torque control. In another exemplary embodiment, OA delivery member  401  is composed of a metal tube having apertures located therein to provide added flexibility. For instance, OA delivery member  401  can be a NITINOL slotted tube, with the size and spacing of each slot configured for optimal flexibility, kink resistance and torque control. The apertures are preferably placed in a location corresponding to the portion of OA delivery member  401  that extends or arcs out, while the portion of OA delivery member  401  proximal to this can be left solid without apertures to maintain resilience in OA delivery member  401  and provide resistance to push back from needle member  405  as it penetrates septal wall  207 . 
     Furthermore, OA delivery member  401  can be coated to provide low friction surfaces to facilitate advancement of OA delivery member  401  within body member  101  and the patient&#39;s body, as well as to facilitate movement of needle member  405  within lumen  402 . For instance,  FIG. 17  is a cross-sectional view depicting an exemplary embodiment of OA delivery member  401  taken along line  17 - 17  of  FIG. 14A . Here, OA delivery member  401  includes an inner coating  427  and an outer coating  428 . Coatings  427  and  428  can be any material used to lower surface friction, including, but not limited to polymers such as polytetrafluoroethylene, fluorinated ethylene/propylene copolymers, silicones, hydrogels, hydrophilic coatings or polyurethane (PU) and the like. Preferably, a high density PU material is used that is thin enough to provide the desired degree of flexibility while at the same time providing a low friction surface. 
     Like OA delivery member  401 , needle member  405  and pusher member  406  are also preferably flexible elongate members.  FIG. 18A  is a cross-sectional view of an exemplary embodiment of needle member  405 . Distal end  415  of needle member  405  is preferably substantially sharp enough to penetrate the desired portion of septal wall  207 . In this embodiment, distal end  415  is tapered similar to a conventional needle. Also, needle member  405  is preferably flexible enough to move within OA delivery member  401  when deflected for off-axis delivery. 
     For instance, needle member  405  can include one or more openings, or apertures  436 , to increase flexibility. Here, needle member  405  includes multiple apertures  436  in various arrangements. Needle member  405  can be fabricated from any desired material including, but not limited to, NITINOL and stainless steel, and apertures  436  can be formed in any manner including, but not limited to, molding, milling, grinding, laser cutting, EDM, chemical etching, punching and drilling The design and use of flexible needles is also discussed in parent U.S. patent application 10/847,747, filed on May 7, 2004. 
     A first region  437  of needle member  405  includes apertures  436  located at various intervals around the circumference of needle member  405 . A second region  438 , located distal to the first region  437 , includes apertures  436  on the lower portion of needle member  405 .  FIG. 18B  is a cross-sectional view depicting an exemplary embodiment of needle member  405  in a deflected state within an exemplary embodiment of OA delivery member  401 . Because apertures  436  in region  437  are located around the circumference of needle member  405 , region  437  is relatively more flexible than region  438 . In region  438 , placement of apertures  436  on the lower surface, reduces the possibility that implant  103  will catch or snag an aperture  436  during advancement of needle member  405  from OA delivery member  401 . In addition, distal tip  439  of needle member  405  is also preferably aligned on the lower portion of needle member  405  to reduce the possibility that distal tip  439  will impact, catch, snag, or damage OA delivery member  401 . 
     Treatment system  100  preferably includes one or more sensors to facilitate determination of when needle member  405  has entered left atrium  212 . For instance, in one exemplary embodiment, needle member  405  includes a sensor at or near distal end  415 . The sensor can be any type of applicable sensor, such as a pressure sensor, thermal sensor, imaging device, acoustic device and the like. In one exemplary embodiment, a pressure sensor is included that is configured to sense the blood pressure change between right atrium  205  and left atrium  212 . The pressure sensor can be any type of pressure sensor including, but not limited to, an electrical sensor and a fluid feedback sensor such as a lumen within needle member  405  having an open distal end in fluid communication with the exterior environment. In an alternative exemplary embodiment, distal end  415  of needle member  405  is configured to be visible by an external imaging device, which can then be used to track the position of distal end  415  with respect to septal wall  207 . 
       FIG. 18C  is a cross-sectional view of another exemplary embodiment of delivery device  104 . Here, distal end  440  of pusher member  406  is configured to push against central portion  303  of implant  103  as opposed to end tip  336  of RA portion  301 . This reduces the likelihood that RA portion  301  will coil when pushed within lumen  414 , which could result in bunching of implant  103  within lumen  414  making delivery more difficult. Because distal end  440  of pusher member  406  is located distal to RA portion  301 , pusher member  405  includes a relatively thinner portion  441  that can provide additional room for RA portion  301  within lumen  414  as well as provide added flexibility to pusher member  406 . Relatively thinner portion  441  is relatively thinner than distal end  440 , which is preferably thick enough to adequately engage central portion  303 . Distal end  440  can include a recess  442  to provide enough room for RA portion  301 . Distal end surface  443  can be configured in any manner desired to facilitate proper contact and engagement of implant  103 . 
     For instance,  FIGS. 19A-B  are cross-sectional views depicting exemplary embodiments of pusher member  406  and implant  103 . In  FIG. 19A , distal end surface  443  is contoured with a rounded recessed portion  444  into which a coiled central portion  303  can rest and an elevated portion  445  configured to fit within open interior region  327 . As one of skill in the art will readily recognize, the contours of distal end surface  443  are dependent on the type and housed configuration of implant  103 , as well as the desired point of contact on implant  103 . In  FIG. 19B , distal end surface  443  is contoured with a narrow recessed portion  446  into which end tip  336  of RA portion  301  can rest. 
     Pusher member  406  can also be configured to releasably couple with implant  103 . For instance, in one exemplary embodiment, pusher member  406  is tethered to implant  103  with a tether in order to allow implant  103  to be drawn back into needle member  405  if needed, such as in a case of improper deployment. If implant  103  is properly deployed, the tether can be released from pusher member  406 . In another exemplary embodiment, pusher member  406  can be configured to both push and pull implant  103  while within needle member  405 , as depicted in  FIGS. 20A-B . 
       FIGS. 20A-B  are schematic views depicting additional exemplary embodiments of needle member  405 , pusher member  406  and implant  103 . In  FIG. 20A , implant  103  is placed over outer surface  450  of needle member  405  and end tips  336  of RA portion  301  and LA portion  302  can be routed through apertures  451  and  452 , respectively, and housed within lumen  414 . To deliver implant  103 , after needle member  405  has traversed septal wall  207  into left atrium  212 , pusher member  406  is used to pull implant  103  back proximally to expose end tip  336  of LA portion  302  as depicted in  FIG. 20B . To grasp end tip  336 , pusher member  405  can include any type of grasping device desired. Here, pusher member  406  includes a clamp-type device  453 . Once removed from aperture  452 , LA portion  302  can enter the coiled state. As needle member  405  is withdrawn back through septal wall  207 , LA portion  302  engages septal wall  207  and cause implant  103  to slide off needle member  405 . Pusher member  406  can also be used to push end tip  336  of RA portion  301  to facilitate deployment. 
     Delivery device  104  can be configured to maintain the proper orientation of OA delivery member  401 , needle member  405 , pusher member  406  and implant  103  during delivery.  FIG. 21  is a cross-sectional view depicting another exemplary embodiment of delivery device  104  taken along lines  21 - 21  of  FIG. 14A  where delivery device  104  is configured to use a lock and key technique to maintain proper orientation. Here, the lock and keys are implemented with a combination of abutments and corresponding recesses. For instance, outer surface  450  of needle member  405  includes a recess  456  configured to receive an abutment  455  located on inner surface  457  of OA delivery member  401 . Recess  456  can extend longitudinally along needle member  405  for any desired distance to ensure proper orientation even when needle member  405  is advanced and retreated within OA delivery member  401 . Similarly, outer surface  458  of pusher member  406  includes a recess  459  configured to receive an abutment  460  located on inner surface  461  of needle member  405 . Like recess  456 , recess  459  can extend longitudinally along pusher member  406  for any desired distance to ensure proper orientation when pusher member  405  is advanced and retracted. As discussed above with respect to  FIGS. 18A-B , pusher member  406  can include recess  442  to accommodate for the presence of RA portion  301 . This recess  442  can also maintain implant  103  in the proper orientation with respect to pusher member  406 . 
     The distances that OA delivery member  401 , needle member  405  and pusher member  406  are moved proximally and distally with respect to body member  101 , can be relatively small. Manual movement of these components, while possible, can be difficult. Treatment system  100  can include one or more automated systems or devices at the proximal end of body member  101  to facilitate movement of these components and lessen the risk that each component is inadvertently advanced too far or not enough. The automated systems or devices can also be configured to apply the desired amount of force to move each component and sense if too much force is being used, which could be indicative of an error in the delivery process. 
     To further facilitate movement of OA delivery member  401 , needle member  405  and pusher member  406 , each can be optionally pre-shaped. For instance, in one exemplary embodiment, one or more of OA delivery member  401 , needle member  405  and pusher member  406  can include a curved section that corresponds to the desired deflected arc shape of OA delivery member  401  depicted in  FIG. 14F . 
     As described with respect to  FIG. 1 , treatment system  100  can optionally include stabilization device  105 .  FIG. 22  is a block diagram depicting an exemplary embodiment of stabilization device  105  within treatment system  100 . Here, stabilization device  105  is preferably configured to stabilize treatment system  100  during delivery of implant  103 . Stabilization device  105  can have any configuration desired in accordance with the needs of the application. For instance, stabilization device  105  can be configured as a body routed through PFO tunnel  215  or any portion of the patient&#39;s vasculature, such as superior vena cava  203 . Stabilization device  105  preferably includes an elongate stabilization member  501  and can optionally include grasping device  502 , which is preferably configured to grasp nearby tissue in order to facilitate stabilization. 
       FIGS. 23A-C  are cross-sectional views depicting additional exemplary embodiments of stabilization device  105  being used to in an exemplary method of stabilizing treatment system  100 . Here, stabilization member  105  is configured as an elongate member including an outer tubular sheath  501  having an inner lumen  504  configured to slidably receive inner elongate pull member  505 . Outer tubular sheath  501  and inner pull member  505  are preferably semi-rigid, having enough rigidity to stabilize treatment system  100  while at the same time having enough flexibility to allow movement and manipulation within the patient&#39;s vasculature and heart  200 . In these embodiments, stabilization device  105  is preferably configured to be routed from right atrium  205  through PFO tunnel  215  into left atrium  212 , where grasping device  502  can be used to cover a portion of septum primum  214  and anchor stabilization device  105  thereto. 
     The nature of the tissue forming septum primum  214  can be irregular, for instance including overlapping folds, variations in tissue thickness and variations in distensibility, each of which can cause septum primum  214  to move, or tent, when needle member  405  is advanced through. The inclusion of grasping device  502  can also provide the additional advantage of holding septum primum  214  in place and reducing the risk of tenting. 
     Grasping device  502  preferably includes a flexible grasping element  506  coupled with inner pull member  505 . Here, grasping element  506  is configured as a rectangular element. Outer sheath  501  preferably includes lumen  507  having open distal end  508 , from which grasping element  506  can be deployed. Lumen  507  can be configured with contoured sidewalls to facilitate deployment of grasping element  506 . To deploy grasping element  506 , inner member  505  can be pulled in a proximal direction with respect to outer sheath  501 , causing grasping element  506  to advance through lumen  507  and out of distal end  508 . Grasping element  506  can optionally include an atraumatic end  512 , which in this embodiment is a radio-opaque element, which may be gold or platinum. In this embodiment, grasping element  506  is configured as a deformable, pre-shaped element having three main configurations. 
       FIG. 23A  depicts grasping element  506  in a first configuration housed within lumen  507 . This configuration is preferably used while treatment system  100  is moved through the patient&#39;s vasculature and as well as when stabilization device  105  traverses PFO tunnel  215 , as depicted here.  FIG. 23B  depicts grasping element  506  in a second configuration partially deployed from within lumen  507 . Once stabilization device  105  is advanced through PFO tunnel  215  and out of PFO exit  218 , grasping element  506  is preferably deployed to this configuration by pulling inner member  505  proximally with respect to outer sheath  501 . In this configuration, grasping element  506  can be used to catch the edge of septum primum  214  as stabilization device  105  is pulled slightly back in proximal direction  509 .  FIG. 23C  depicts grasping element  506  in a third, fully deployed configuration, after inner member  505  has been pulled back further. Grasping element  506  can optionally include a recess configured to engage an abutment on outer sheath  501  in this configuration, which is preferably used to more fully grasp or engage septum primum  214  to anchor stabilization device  105  thereto. 
     Once the delivery procedure is complete, inner member  505  can be advanced distally with respect to outer sheath  501  to draw grasping element  506  back within lumen  507 . Any component of treatment system  100  adequately coupled with stabilization device  105  is thereby also anchored to septum primum  214 . One of skill in the art will readily recognize that this and similar embodiments of stabilization device  105  can be used to engage any tissue flap or edge desired, not solely septum primum  214 . 
     Grasping device  502  can be configured in any manner desired in accordance with the needs of the application.  FIGS. 24A-B  are perspective views depicting additional exemplary embodiments of stabilization device  105  with grasping device  502 . In  FIG. 24A , grasping device  502  includes multiple grasping elements  506  for grasping over a wider area. In  FIG. 24B , grasping device  502  includes a wire-like grasping element  506 . Here, grasping element  506  is looped into lumen  507  (not shown) via apertures  510  and  511 , which communicate with lumen  507 . 
       FIGS. 25A-D  are cross-sectional views depicting additional exemplary embodiments of stabilization device  105 . Here, grasping element  506  has a flap-like shape with tapered inner surface  516  and is located on distal end member  517  of outer sheath  501  Inner member  505  includes an abutment  514  on distal end portion  515  and is configured to push against and apply a force to grasping element  506 .  FIG. 25A  depicts grasping element  506  in the first, housed configuration. To deploy grasping element  506  to the second configuration for catching septum primum  214 , inner member  505  is advanced distally with respect to outer sheath  501  as depicted in  FIG. 25B . Because of tapered inner surface  516 , the more inner member  505  is advanced distally, the more outwards deflection of element  506  will occur. To more fully grasp septum primum  214 , inner member  505  is retreated proximally by the desired amount, as depicted in  FIG. 25C . Manufacture of this embodiment can be made relatively simple. For instance, distal end member  517  and grasping element  506  can be formed by laser or EDM cutting a NITINOL tube. In  FIG. 25D , distal end member  517  is located on distal end of inner member  505  and abutment  514  is located on sheath  501 . 
       FIGS. 26A-C  are cross-sectional views of additional exemplary embodiments of stabilization device  105 . Here, outer sheath  501  preferably includes an open distal end  518 , from which grasping device  502  can be deployed. Grasping element  506  is preferably located on distal end portion  515  of inner member  505  and can be formed of a deformable elastic material such as stainless steel, NITINOL, shape memory polymers and the like. Grasping element  506  is preferably configured to be slidable within inner lumen  504  and is preferably pre-shaped, such as by heat-treating NITINOL, so that grasping element  506  can assume a desired shape when advanced from inner lumen  504 . In  FIG. 26A , grasping element  506  is depicted in the first, housed configuration within inner lumen  504 . In  FIG. 26B , inner member  505  has been advanced distally to deploy grasping element  506  in the second configuration for catching septum primum  214 . In  FIG. 26C , inner member  505  has been advanced further distally to place grasping element  506  in the third configuration for grasping septum primum  214 . Embodiments of stabilization device  105  where grasping device  502  can be deployed by pushing device  503  out from within inner lumen  504 , such as that described with respect to  FIGS. 26A-C , will be referred to herein as “push out” embodiments. 
       FIG. 27A  is a perspective view depicting an additional exemplary embodiment of stabilization device  105  having a “push-out” grasping device  502 . Here, grasping device  502  is shown in the fully deployed third configuration having two grasping elements  506 . It should be noted that grasping device  502  can include any number of grasping elements  506 . Here, each grasping element  506  overlaps so as to provide additional grasping force.  FIG. 27B  is a cross-sectional view depicting another exemplary embodiment where grasping element  506  is configured to attract to a magnetic force  522  provided by magnet  523  coupled with inner member  505 . Once deployed, the magnetic force is preferably great enough to penetrate outer sheath  501  and septum primum  214  and attract elements  506  to provide additional grasping force. Of course, magnet  523  can be placed in any desired location, for instance, on outer sheath  501  or on grasping element  506 , in which case inner member  505  could be configured to attract to the magnetic force. 
     It should be noted that, in order to provide additional surface friction, additional abutments can be included on grasping element  506  and/or the surface of grasping element  506  can be etched or coated or otherwise textured. 
     As discussed with respect to  FIG. 1 , treatment system  100  can include centering device  106  to facilitate proper placement of implant  103 . Centering device  106  can be configured to align delivery device  104  in the desired location with respect to the center of PFO tunnel  215 . Although the term “centering” is used, it should be understood that device  106  can be configured to align delivery device  106  in any location, not necessarily the center of PFO tunnel  215 . 
       FIGS. 28A-C  are cross-sectional views depicting additional exemplary embodiments of centering device  106 . In this embodiment, centering device  106  includes an elongate centering support member  601  having two elongate flexible positioning members  602 , referred to herein as centering arms  602 , located on opposite sides of and extending along the length of support member  601 . Support member  601  can include two lumens  603 , each configured to slidably receive a centering arm  602 . Each lumen  603  preferably has an open distal end  606  which opens to an open or recessed portion  605  of support member  601 . Each centering arm  602  preferably extends through this recessed portion  605  and into seat  604  preferably configured to receive distal end  607  of each centering arm  602 . Seat  604  is preferably located in recessed portion  605  in a position opposite to lumen  603 . 
       FIG. 28A  depicts centering arms  602  at rest within recessed portion  605  along the sides of support member  601 .  FIG. 28B  is a cross-sectional view of centering device  106  taken along line  28 B- 28 B of  FIG. 28A . As depicted here, centering arms  602  are preferably configured as rectangular wire bands, although any configuration can be used as desired. Advancement of centering arms  602  in a distal direction causes distal end  607  to contact seat  604  and forces centering arms  602  to extend outwards from recessed portion  605  as depicted in  FIG. 28C . Configuration of centering arms  602  as bands helps ensure that arms  602  extend directly away from support member  601  in direction  611 . 
     When centering device  106  is placed within PFO tunnel  215 , centering arms  602  can be extended until coming into contact with sidewalls  219 , as depicted in  FIG. 28D , which is a perspective view of centering device  106  within PFO tunnel  215 . Here, sidewalls  219  and PFO exit  218  are shown as dashed lines to indicate their presence underneath septum secundum  210 . When centering arms  602  are each advanced the same amount until contact with both sidewalls  219  is made, the extension distance  608  of each arm  602  will likewise be the same amount and support member  601  will be forced into a centered position within PFO tunnel  215 . 
     In this manner, centering device  106  can be centered within PFO tunnel  215  and can be used as a reference point for delivering implant  103 . Preferably, centering device  106  is coupled with delivery device  104 , so that centering of centering device  106  will also cause centering of delivery device  104 . Preferably, once implant  103  is delivered, centering arms  602  are returned to their original positions and centering device can be retreated through PFO tunnel  215 . Surface  610  of recessed portion  605  is preferably curved, or tapered, to reduce the risk that support member  601  will catch or become hung up on any tissue in or around PFO tunnel  215 . 
     Here, the extended portions of centering arms  602  are shown as being located entirely within PFO tunnel  215 . One of skill in the art will readily recognize that variation of length  609  of recessed portion  605  will cause the extended portion of centering arms  602  to vary accordingly. 
     Support member  601  and centering arm  602  can each be composed of any desired material in accordance with the needs of the application. Preferably, support member  601  is composed of a flexible polymer, such as polyimides, polyamides, polyproylene and the like. Preferably, centering arms  602  are composed of a flexible polymer or metal, such as NITINOL, stainless steel and the like. 
     In the embodiment described with respect to  FIGS. 28A-D , centering arms  602  have a curved or arcuate shape when extended from support member  601 . As the  FIGS. 29A-C  will show, centering arms  602  can be configured to have any desired shape when extended.  FIGS. 29A-B  are schematic views depicting additional exemplary embodiments of centering device  106  with centering arms  602  extended in a three-sided and two-sided shapes, respectively. Preferably, portions  612  of centering arms  602  are made thinner than the surrounding portions, so that centering arms  602  have a tendency to flex first in portions  612 , allowing these polygonal shapes to be achieved. 
     Also, arms  602  can be pre-shaped to be biased to assume a desired shape when allowed to advance from recessed portion  605 . For instance, in one exemplary embodiment, arms  602  are composed of NITINOL and are heat-treated for pre-shaping. One of skill in the art will readily recognize, in light of this disclosure, that variation of the thickness of arms  602  and pre-shaping can allow an almost limitless number of shapes to be achieved, having curved portions, straight portions and any combination thereof which can be symmetric or asymmetric. 
     As mentioned above, in some cases, sidewalls  219  of PFO tunnel  215  are not equidistant along the length of PFO tunnel  215 , causing PFO tunnel  215  to diverge or converge from PFO entrance  217  to PFO exit  218 . Divergence or convergence of PFO tunnel  215  can cause centering device  106  to slip out from PFO tunnel  215  when arms  602  are extended.  FIG. 29C  is a schematic view depicting another exemplary embodiment of centering device  106  where each centering arm  602  is configured to extend with two outcroppings  614 . These outcroppings  614  can be placed outside PFO tunnel  215  to prevent centering device  602  from slipping out of PFO tunnel  215 . Outcroppings  614  can be formed by making that portion of centering arm  602  relatively thicker than the surrounding portions, making outcropping  614  less likely to flex. A desired radius of curvature in centering arms  602  can be implemented by pre-shaping, or by gradually varying the thickness of centering arms  602 , where a relatively thinner portion will correspond to a relatively larger rate of curvature. 
     It should be noted that centering device  106  can include any number of one or more arms  602  for centering/positioning purposes.  FIG. 30  is a schematic view depicting another exemplary embodiment of centering device  106  having one centering arm  602  extended within PFO tunnel  215 . In this embodiment, PFO tunnel  215  is curved to one side and centering arm  602  is positioned on the opposite side. Centering arm  602  can then be extended a predetermined distance to position centering device  106  in the desired location. 
     In some embodiments, it can be desirable to keep centering device  106  within PFO tunnel  215  while needle member  405  is advanced through septal wall  207 . To reduce the risk that needle member  405  will damage centering device  106  during this procedure, support member  601  can be configured to be impact resistant.  FIG. 31  is a schematic view depicting an exemplary embodiment of centering device  106  where support member  601  is a rigid cylindrical member  649  having a smooth, or polished, surface  615  between lumen  603  and seat  604  (as shown in  FIG. 28A ), which are formed in rigid extrusions  650  which are preferable metal and located on member  649 . Here, if sharpened distal end  415  of needle member  405  comes into contact with support member  601 , it is more likely to be deflected from support member  601 . 
       FIGS. 32A-B  are cross-sectional views depicting additional exemplary embodiments of centering device  106  where support member  601  includes an open distal end  616  from which one or more pre-shaped centering arms  602  can be extended. Centering arms  602  are preferably pre-shaped to the extended position allowing elimination of seat  604  and recessed portion  605 . Centering arms  602  are preferably deformable from a first configuration to allow housing within inner lumen  617  of support member  601  as depicted in  FIG. 32A . In  FIG. 32B , centering arms  602  are shown deployed from inner lumen  617  in their extended second configuration. Although in  FIGS. 32A-B , centering arms  602  are shown as separate elements, the proximal end of the pre-shaped portion of each arm  602  can be coupled together on a common elongate shaft. 
     It should be noted that the functionality of the various embodiments described herein can be combined and integrated together to reduce the number of components in treatment system  100 , simplify the design of treatment system  100  and so forth. For instance,  FIG. 32C  depicts an exemplary embodiment of treatment system  100  where the embodiments described with respect to FIGS.  27 A and  32 A-B have been integrated together to form device  110 . Here, centering arms  602 , similar to that depicted in  FIGS. 32A-B  each include grasping element  506  of stabilization device  105 , similar to that depicted in  FIG. 27A , located distal to the centering portion  618 . Here, centering device  106  is used for centering and stabilization, allowing the elimination of a separate stabilization device  105  from system  100 . 
     For stabilization and centering, support member  601  is preferably advanced through PFO exit  218 . Once in left atrium  212 , centering arms  602  can be advanced distally to deploy grasping elements  506  from the first, housed configuration, to the second and third configurations for catching and grasping septum primum  214 . Once septum primum  214  is grasped, support member  601  can be retreated proximally with respect to centering arms  602  in order to deploy centering portions  618  of each arm  602 . The centering portions  618  can then expand outwards and center device  106 , while at the same time maintaining a grasp of septum primum  214 . 
       FIG. 32D  is a schematic view depicting another exemplary embodiment of treatment system  100  where centering device  106  and stabilization device  105  have been integrated together. Here, stabilization member  501  includes two lumens  603  and seats  604  (not shown), and recessed portions  605  for use with centering arms  602 . After stabilization with device  105 , centering arms  602  can be extended in directions  611  to center or otherwise place combined device  110  in the desired position. 
     As discussed with respect to  FIG. 1 , delivery device  104 , stabilization device  105  and centering device  106  are each preferably used in conjunction with body member  101 . Body member  101  can be configured in any manner desired in accordance with the needs of the application.  FIGS. 33A-B  are cross-sectional views depicting another exemplary embodiment of treatment system  100  where body member  101  includes two lumens  630  and  631 .  FIG. 33A  is a longitudinal cross-sectional view and  FIG. 33B  is a radial cross-sectional view taken along line  33 B- 33 B of  FIG. 33A . Preferably, lumen  630  is configured to slidably receive delivery device  104 , while lumen  631  is configured to slidably receive either stabilization device  105  or an optional guidewire to facilitate routing body member  101  through the patient&#39;s vasculature. The guidewire can be placed in lumen  631  until body member  101  is in the desired position within the patient, at which time the guidewire can be removed and stabilization device  105  can be inserted. Also, centering device  106  is preferably integrated with stabilization device  105 , such as in the embodiment described with respect to  FIG. 32D , in order to provide treatment system with both stabilization and centering capability. In order to prevent rotation of elongate body member  101  around stabilization device  105  during delivery, stabilization device is preferably fixably coupled with either body member  101  or delivery device  104 . 
       FIGS. 34A-C  are cross-sectional views depicting another exemplary embodiment of treatment system  100  where body member  101  includes four lumens  630 - 633  as well as centering arms  602 . Here,  FIG. 34A  is a first longitudinal cross-sectional view,  FIG. 34B  is a radial cross-sectional view taken along line  34 B- 34 B of  FIG. 34A  and  FIG. 34C  is a second longitudinal cross-sectional view taken along line  34 C- 34 C of  FIG. 34A . Preferably, lumen  630  is configured to slidably receive delivery device  104 , while lumen  631  is configured for any purpose, including reception of stabilization device  105 , a guidewire, dye infusion and the like.  FIG. 34B  depicts centering arms  602  within lumens  632 - 633  and  FIG. 34C  depicts centering arms  602  located within lumens  632 - 633 , recessed portions  605  and seats  604 . Here, recessed portions  605  and seats  604  are located distal to grasping device  404  on elongate support section  411 . The distal portion of support section  411  can be placed within PFO tunnel  215  where centering arms  602  can be deflected for centering prior to deployment of implant  103  in left atrium. 
       FIGS. 35A-B  are cross-sectional views depicting another exemplary embodiment of treatment system  100  where body member  101  includes three lumens  630 ,  632  and  633  as well as centering arms  602 . Here,  FIG. 35A  is a longitudinal cross-sectional view and  FIG. 35B  is a radial cross-sectional view taken along line  35 B- 35 B of  FIG. 35A . In this embodiment, distal end  410  of body member  101  includes an atraumatic tip  640 , which in this embodiment is a floppy tip. Here, with the aid of atraumatic tip  640 , body member  101  is configured to be advanceable within the patient&#39;s vasculature without the aid of a guidewire. Accordingly, no additional lumen  631  is included for use with a guidewire. Also in this embodiment, stabilization device  105  has been optionally omitted, allowing body member  101  to achieve a relatively smaller radial cross-section size. In another exemplary embodiment, atraumatic tip  640  is omitted and body member  101  is configured to be slidably advanced through a tubular guide catheter placed within the patient&#39;s vasculature. 
       FIGS. 36A-B  are cross-sectional views depicting another exemplary embodiment of treatment system  100  where body member  101  includes four lumens  630 - 633  as well as centering arms  602 . Here,  FIG. 36A  is a longitudinal cross-sectional view and  FIG. 36B  is a radial cross-sectional view taken along line  36 B- 36 B of  FIG. 36A . This embodiment is similar to the embodiment described with respect to  FIGS. 34A-C  except here, lumen  631  is configured for use with guidewire  641  only, which can be relatively thinner than stabilization device  105 , allowing the radial cross-section size of lumen  631  and body member  101  to be reduced. 
       FIGS. 37A-B  are cross-sectional views depicting another exemplary embodiment of treatment system  100  where body member  101  includes four lumens  630 - 633  as well as centering arms  602 . Here,  FIG. 37A  is a longitudinal cross-sectional view and  FIG. 37B  is a radial cross-sectional view taken along line  37 B- 37 B of  FIG. 37A . This embodiment is similar to the embodiment described with respect to  FIGS. 35A-C  except here, lumen  631  is configured to facilitate exchange of stabilization device  105  and guidewire  641 . Proximal portion  642  of lumen  631  includes a divider  643  to separate lumen  631  into a first portion  644  for stabilization device  105  and a second portion  645  for guidewire  641 . Distal portion  646  of lumen  631  is preferably tapered to minimize the radial cross-section size of lumen  631 . Exchange between stabilization device  105  and guidewire  641  is facilitated because both can reside within proximal portion  642  at the same time, with the desired one of stabilization device  105  or guidewire  641  being advanced distally through open distal end  647  for use. 
     It should be noted that in each of the embodiments described with respect to  FIGS. 33A-37B , functionality can be added or removed as desired, while still remaining within the scope of treatment system  100 . For instance, treatment system  100  can be further configured for dye infusion, pressure sensing, imaging, drug delivery, ablation, the use of occlusive devices such as balloons and stents, coronary sinus application of pacing or defibrillation leads, the use of a stylet and the like. These and other additional types of functionality can be added in any manner, including, but not limited to the addition of one or more lumens  102 , or the use of the existing lumens  102 , integration directly into body member  101 , or the addition of one or more extra body members  101 . 
     In addition, treatment system  100  can include multiple delivery devices  104  for delivery of multiple implants  103 , multiple stabilization devices  105  for stabilization on multiple tissue surfaces, multiple centering devices  106  and multiple body members  101  as desired. If treatment system  100  is used to access septal wall  207  via inferior vena cava  202 , the maximum radial cross-section size of body member  101  is preferably 13 french or less, although it should be noted that any size body member  101  can be used in accordance with the needs of the application. Body member  101  can be constructed from any material as desired, but is preferably constructed from a flexible polymer such as polyethylene, polypropylene, nylon and the like. 
     Furthermore, it should be noted that any component or component portion within treatment system  100  can be configured to facilitate any type of imaging, including, but not limited to, internal and external ultrasound imaging, optical imaging, magnetic resonance imaging (MRI), and flouroscopy. For instance, OA delivery member  401  can be entirely radio-opaque, or can include portions that are radio-opaque, such as on distal tip  430  of  FIG. 14A . 
     Also described herein are methods  700  and  800  of treating PFO tunnel  215 , preferably by at least partially closing PFO tunnel  215 . Methods  700  and  800  are preferably used with treatment system  100 , but can be used with any medical system as desired. For ease of discussion, method  700  will be described with respect to treatment system  100  and method  800  will be described without reference to a particular treatment system, although it should be understood that methods  700  and  800  can be used with or without treatment system  100 . Generally, the steps of methods  700  will vary, in part, on the actual configuration of implant  103 , the number of implants  103  to be delivered, the location in which each implant  103  is to be delivered, the use of guidewire  641  or a guide catheter and the optional use of stabilization device  105  and/or centering device  106 . 
     In  FIG. 4E , implant  103  is delivered through both septum primum  214  and septum secundum  210 . It should be noted, however, that implant  103  can be delivered in any location desired.  FIGS. 38A-C  are cross-sectional views of septal wall  207  depicting exemplary embodiments of implant  103  in just several of the many alternate locations that can be used. In  FIG. 38A , implant  103  has been delivered through the upper portion of septum secundum  210  adjacent to PFO exit  218 . In  FIG. 38B , implant  103  has been delivered through the lower portion of septum primum  214 , adjacent to PFO entrance  217  and near (or in) fossa ovalis  208 . In  FIG. 38C , implant  103  has been delivered through septal wall  207  adjacent to sidewall  219 , septum primum  214  and septum secundum  210 . 
     Also, as many implants  103  can be used in any arrangement as desired.  FIGS. 38D-E  are views of septal wall  207  depicting exemplary embodiments of multiple implants  103  in just several of the many alternate arrangements that can be used. In  FIG. 38D , three implants  103  have been delivered through both septum primum  214  and septum secundum  210 . In  FIG. 38E , six implants  103  have been delivered through septal wall  207  adjacent to both sidewalls  219 , septum primum  214  and septum secundum  210 . 
     Although there are many different implementations and variations of method  700 , for ease of discussion, method  700  will be described herein as using one implant  103 , delivered through both septum primum  214  and septum secundum  210 , using an exemplary embodiment of treatment system  100  similar to that described above with respect to  FIGS. 33A-B , where body member  101  is configured for use with stabilization device  105  having centering device  106  integrated thereon. 
       FIGS. 39A-B  are flow diagrams depicting an example of method  700 . First, at  701 , body member  101  is placed in proximity with PFO region  209 . As mentioned above, implant  103  can be delivered from left atrium  212  or right atrium  205 . Preferably, implant  103  is placed into proximity with PFO region  209  by advancing body member  101  from the femoral vein to right atrium  205  in a conventional manner. For instance, in one example, a needle is inserted into the femoral vein and a guidewire is advanced through the needle into the femoral vein. The needle can then be removed and an access sheath can be routed over the guidewire, which can also then be removed. A J-tip guidewire, such as a 0.035″/0.038″ guidewire, can be routed through the patient&#39;s vasculature into inferior vena cava  202  and right atrium  205 . From there, the guidewire can be routed through PFO tunnel  215  and into left atrium  212 . Next, an exchange sheath or multi-purpose guide can then be advanced over the J-tip guidewire into left atrium  212 , at which point the J-tip guidewire can be removed. A relatively stiffer guidewire  641  can then be advanced through the exchange sheath or multi-purpose guide and into left atrium  212  and optionally the pulmonary vein, which can act as an anchor for the guidewire. Body member  101  can then be advanced over the guidewire  641  into proximity with PFO region  209 , preferably through PFO tunnel  215  and into left atrium  212 . In addition, a catheter or guidewire having a sizing device, such as a balloon, can be placed within PFO tunnel  215  to measure the size of PFO tunnel  215 , for use in choosing a placement location, implant size, etc. 
     At  702 , guidewire  641 , if present, can be removed. At  704 , stabilization device  105  is preferably advanced through lumen  631  and into left atrium  212 . At  706 , body member  101  can be retreated proximally into right atrium  205 . Preferably, stabilization device  105  includes a stabilization member  501  and grasping device  502  with grasping element  506 . At  708 , grasping element  506  can be deployed from the first housed configuration to the second configuration for catching tissue, which, in this example, is preferably septum primum  214 . 
     Next, at  710 , stabilization member  501  is preferably moved distally until grasping element  506  catches septum primum  214 . Then, at  712 , OA delivery member  401  can be retracted proximally with respect to body member  101  to raise arm member  409 . At  714 , body member  101  and OA delivery member  401  are advanced distally until arm member  409  abuts limbus  211 . At  716 , centering device  106  can be used to center delivery device  101 , preferably by deflecting centering arms  602 . Once centered, if not already done so, at  717  stabilization device  105  can be fixably coupled to delivery device  104  (e.g., with a rotating hemostasis valve or Tuohy-Borst valve and the like). Next, at  718 , grasping element  506  can be further deployed to the third configuration to grasp septum primum  214  and lock stabilization device  105  to septum primum  214 . Alternatively, either  716 ,  717 ,  718  or any combination thereof can be implemented prior to  712 . Also,  716 - 718  can be implemented in any order desired with respect to each other. 
     Once stabilized, centered and locked in place, OA delivery member  401  is preferably advanced distally with respect to body member  101  to rotate distal end  410  into the desired orientation with surface  320  of septum secundum  210 . At  722 , needle member  405  can be advanced through septum secundum  210  and septum primum  214  and into left atrium  212 . Then, at  724 , pusher member  406  can be advanced distally to at least partially deploy LA portion  302  of implant  103  from distal end  415  of needle member  405 . In embodiments where centering arms  602  are in their deflected state for centering, it is possible for needle member  405  to pass between centering arms  602  and stabilization member  501  when inserted, based on needle insertion location  419 . To avoid capture of implant  103  between centering arms  602  and stabilization member  501 , centering arms  602  can be retracted proximally back into elongate body  101  thereby removing them from seats  604  and preventing implant  103  from being trapped between centering arms  602  and stabilization member  501 . Next, at  726 , grasping element  506  can be moved to the second configuration to free stabilization device  105  from septum primum  214 . Alternatively,  726  can be performed before  724  if desired. 
     Then, at  728 , LA portion  302  can be fully deployed if not already. At  730 , grasping element  506  can be removed to the first configuration, housed within stabilization member  501 . Next, at  732 , centering device  106  can be undeployed if not already, preferably by collapsing centering arms  602 , after which stabilization device  105  can be retreated proximally from PFO entrance  217  at  734 . At  736 , needle member  405  can be withdrawn into OA delivery member  401  to deploy central portion  303  of implant  103  and at least a portion of RA portion  301 . Here, at  738 , an optional closure test can be performed to confirm at least partial closure, and preferably substantially complete closure, of PFO tunnel  215 . Any desired closure test can be performed including, but not limited to, the introduction of gaseous bubbles simultaneously with imaging using contrast enhanced trans-cranial doppler (CE-TCD), intracardiac echocardiography (ICE) and the like. The test may be performed by pulling back OA delivery member  401  as far as it will more to deploy RA coil  301  and then test while device is at PFO entrance. 
     If the desired degree of closure is confirmed, then any tether connection to implant  103  can be released at  740 . At  742 , OA delivery member  401  can be retracted proximally with respect to body member  101  to complete deployment of RA portion  301 , release limbus  211  and place OA delivery member  401  in the original position. Finally, at  744 , body member  101  can be retracted distally and withdrawn from the patient. 
       FIG. 40  depicts another exemplary method  800  of treating a septal defect. At  802 , limbus  211  is abutted with an abutment of a medical device. Preferably, limbus  211  is engaged with the medical device and optionally grasped such that the medical device is anchored to limbus  211 . Then, at  804 , a hole in septal wall  207 , preferably in septum secundum  210 , is created using limbus  211  as a point of reference. For instance, the hole can be created at a fixed or adjustable distance from limbus  211 . At  806 , the hole is used to facilitate delivery of a device configured to treat a septal defect. In one example, the device is deployed through the hole such that it causes at least partial closure of the septal defect. In this example of method  800 , limbus  211  is abutted and used as a reference. In another example of method  800 , the edge of septum primum  214  is abutted and used as a reference. In other examples of method  800 , one or both sidewalls  219  and/or fossa ovalis  208  are abutted and used as points of reference. 
     It should be noted that any feature, function, method or component of any embodiment described with respect to  FIGS. 1-40  can be used in combination with any other embodiment, whether or not described herein. As one of skill in the art will readily recognize, treatment system  100  and the methods for treating a septal defect can be configured or altered in an almost limitless number of ways, the many combinations and variations of which cannot be practically described herein. 
     The devices and methods herein may be used in any part of the body, in order to treat a variety of disease states. Of particular interest are applications within hollow organs including but not limited to the heart and blood vessels (arterial and venous), lungs and air passageways, digestive organs (esophagus, stomach, intestines, biliary tree, etc.). The devices and methods will also find use within the genitourinary tract in such areas as the bladder, urethra, ureters, and other areas. 
     Furthermore, the off-axis delivery systems may be used to pierce tissue and delivery medication, fillers, toxins, and the like in order to offer benefit to a patient. For instance, the device could be used to deliver bulking agent such as collagen, pyrolytic carbon beads, and/or various polymers to the urethra to treat urinary incontinence and other urologic conditions or to the lower esophagus/upper stomach to treat gastroesophageal reflux disease. Alternatively, the devices could be used to deliver drug or other agent to a preferred location or preferred depth within an organ. For example, various medications could be administered into the superficial or deeper areas of the esophagus to treat Barrett&#39;s esophagus, or into the heart to promote angiogenesis or myogenesis. Alternatively, the off-axis system can be useful in taking biopsies, both within the lumen and deep to the lumen. For example, the system could be used to take bronchoscopic biopsy specimens of lymph nodes that are located outside of the bronchial tree or flexible endoscopic biopsy specimens that are located outside the gastrointestinal tract. The above list is not meant to limit the scope of the invention. 
     In some embodiments, the off-axis delivery system is used with an anchoring means in order to anchor the device to a location within the body prior to rotation of the off-axis system. This anchoring means may involve the use of a tissue grasper or forceps. It should be noted that any device or set of devices can be advanced within the lumen of the off-axis delivery system, including but not limited to needles, biopsy forceps, aspiration catheters, drug infusion devices, brushes, stents, balloon catheters, drainage catheters, and the like. 
     While the invention is susceptible to various modifications and alternative forms, a specific example thereof has been shown in the drawings and is herein described in detail. It should be understood, however, that the invention is not to be limited to the particular form disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure.