Abstract:
The present invention provides a defect patch device and method that patches a defect in the heart or other cardiovascular tissue. One aspect provides a PFO closure device and method that patches a PFO in the right atrium without the device extending through the PFO into the left atrium. The patch device includes a patch and a heart tissue engaging member for attaching the device over the defect. A deployment device and method includes a device positioner to advance the device out of a catheter and to position the device over the defect to attach the device to the tissue around the defect. The positioner may include a device expander or opener that opens the device for deployment.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates to a device and method for closing or patching a hole or defect in a cardiovascular organ, especially a defect in a heart such as a defect in the septum.  
       BACKGROUND OF THE INVENTION  
       [0002]     A variety of defects can occur in the wall of a heart or major vessels that may be treated by repair, closure or patching. Such defects may include, for example, holes or other defects in the atrial septum or ventricular septum. (ASD or VSD), ventricular aneurysms, patent foramen ovales, aortic dissections, ventricular free wall rupture and various vascular ruptures or holes.  
         [0003]     A more frequently occurring of such defects is a patent foramen ovale (“PFO”). A PFO is an opening between the atria of the heart that results from an incomplete closure of the atrial septum shortly after birth. A thin tissue flap on the left atrial side of the septum, which represents an embryological remnant of the septum primum, forms the valve of the fossa ovalis. After birth, normally the left atrial pressure exceeds the right atrial pressure and forces the valve against the limbus, thus typically achieving physiological closure. The PFO defect occurs when the closure is not complete. The PFO works like a flap valve, with overlapping flaps that open up when a patient creates more pressure inside their chest, which can occur, e.g., when people cough, sneeze, or strain at stool. If the pressure is enough to open the defect, blood can flow between the atria. In particular, if blood flows from the right atrium to left atrium and if there are clots or other debris present in the blood at the site of the defect or crossing it, embolisms, clots, or obstructions can form, e.g., lodging in the brain causing a stroke, or in the heart causing a heart attack.  
         [0004]     Currently there are devices for closing a PFO that comprise a double umbrella that with a connector extending through the PFO. The opposing umbrellas sandwich the PFO from within opposing atria whereby the tissue grows around the device to close the defect in the atrial septum. A potential problem with this device is that it leaves hardware in the left atrium, which could cause thrombosis, embolism or perforation of critical structures if for example, the device breaks off in the left atrium. Furthermore, anything passing through the PFO may keep the PFO open and may widen it with respect to its native geometry.  
         [0005]     Accordingly, it would be desirable to provide a device for treating, closing, repairing or patching cardiac and vascular defects.  
         [0006]     It would also be desirable to provide a PFO closure patch device that can be deployed in a single chamber of the heart without extending through the PFO into the opposite atrium. It would also be desirable to provide a PFO closure device that reduces the possibility of clotting or device breakage in the left atrium.  
       SUMMARY OF THE INVENTION  
       [0007]     The present invention provides a device for patching cardiac and vascular defects. One aspect according to the present invention provides a PFO closure device that patches the PFO in the right atrium without the device extending through the PFO and further leaving hardware in the left atrium.  
         [0008]     An embodiment of the invention comprises a patch formed of a material such as a woven Dacron, ePTFE, or metal that can be placed over a tissue defect area. Where the device is for patching a PFO it is configured to be delivered in the right atrium and placed over the PFO. The device further comprises at least one engaging or attachment element for attaching the patch to the wall of the right atrium over the defect.  
         [0009]     In one variation of the embodiment, the device includes a spring support member supporting the patch and biasing the device toward a tissue or wall engaging position whereby the attachment element engages the wall of the heart. The spring support member may be formed of a shape memory alloy such as Nitinol.  
         [0010]     In one embodiment, the device is in the form of an umbrella-like structure with spoke like spring members coupled to the patch material. In one variation of the embodiment, the device includes barbs that engage the wall of the right atrium. During deployment, the spokes may be hyper-extended to open the device and place it over the tissue defect area, then released whereby the spring of the spokes biases the umbrella in a wall engaging position with the barbs piercing the atrial wall to hold the patch in position over the tissue defect.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  is a schematic front view of a heart with a PFO.  
         [0012]      FIG. 2A  is a schematic front view of a portion of heart with a PFO and a device according to the invention placed over the PFO.  
         [0013]      FIG. 2B  is a schematic side view, partial breakaway of a heart showing the implant from within the right atrium and device of  FIG. 2A .  
         [0014]      FIG. 2C  is a cutaway detailed view of the distal side of the device of  FIG. 2A .  
         [0015]      FIG. 3A  is perspective view of a PFO closure device according to the invention.  
         [0016]      FIG. 3B  is a side view of the patch of  FIG. 3A   
         [0017]      FIG. 4  is a schematic side view of a PFO device in an embodiment of a delivery catheter according to the invention.  
         [0018]      FIG. 5  is a schematic side view of the PFO device and the delivery catheter of  FIG. 4  with the device advanced out of the catheter in its relaxed position.  
         [0019]      6  is a schematic side view of the PFO device and the delivery catheter of  FIG. 4  with the device advanced out of the catheter in a hyper-extended position for placement over a PFO.  
         [0020]      7  is a perspective view of the PFO device and catheter of  FIGS. 4-6 .  
         [0021]      8  is a perspective view of an alternative embodiment of a PFO device and delivery catheter according to the invention.  
         [0022]      9  is a perspective view of an alternative embodiment of a PFO device and delivery catheter according to the invention.  
         [0023]      10  is a side view of an embodiment of a PFO device according to the invention with the device in a relaxed position.  
         [0024]      11  is a side view of the PFO device of  FIG. 10  with the device in a hyper-extended position.  
         [0025]      12  is a schematic side cross section of a variation of the delivery system of  FIGS. 4-7 .  
         [0026]      13  illustrates a side view of a variation of the delivery system of  FIGS. 4-7 .  
         [0027]      14 A is a side view of another embodiment of a PFO closure device according to the invention in a pre-deployment configuration.  
         [0028]      14 B is a side view of the device of  FIG. 14A  in an expanded configuration.  
         [0029]      14 C is a side view of the device of  FIG. 14B  after it is released and recoils towards its pre-deployment configuration.  
         [0030]      15  is a side view of the PFO closure device of  FIG. 14A  as it is being placed over a PFO.  
         [0031]      16  is a side view of the PFO closure device of  FIG. 14A  in place over a PFO.  
         [0032]      FIG. 17  is a top view of the deployed PFO closure device as illustrated in  FIG. 16 .  
         [0033]      FIG. 18A  is a side cross section of an alternative PFO closure device and delivery system.  
         [0034]      FIG. 18B  is front view of the delivery system as illustrated in  FIG. 18A .  
         [0035]      FIG. 19A  is a side view of a PFO closure device in accordance with the invention loaded into a catheter.  
         [0036]      FIG. 19B  is a side view of the device of  FIG. 19A  partially deployed out of the catheter.  
         [0037]      FIG. 19C  is a side view of the device of  FIG. 19A  fully deployed out of the catheter. 
     
    
     DETAILED DESCRIPTION  
       [0038]     Referring to  FIG. 1 , there is illustrated a heart  100  with a tissue defect, in this illustration, a patent foramen ovale  109 . The heart  100  has a right atrium  101 , right ventricle  103 , left atrium  102  and left ventricle  104 . The septum  106  between the right atrium  101  and the left atrium  102  comprises a septum primum  107  and a septum secundum  108 . The patent foramen ovale  109  is an opening in the septum  106  that has not properly closed. Where a patent foramen ovale  109  is present, the septum primum  107  typically overlaps the septum secundum  108  and the higher pressure in the left atrium  102  typically closes the flaps of the septum primum  107  and the septum secundum  108  so that blood does not leak between the atria  101 ,  102 . However, when there is a pressure change in the chest, the flaps may separate permitting blood to flow through the patent foramen ovale and between the atria  101 ,  102 .  
         [0039]     A PFO closure device  30  according to the invention is illustrated in  FIGS. 2A-2C  and  3 A- 3 B.  FIGS. 2A-2B  illustrate the device  30  in place over the patent foramen ovale  109  in the right atrium  101  and attached to the septum  106 . The device  30  is in the form of an umbrella-like structure or circular shaped patch  31  comprising a woven or mesh material such as, e.g., Dacron, ePTFE or metal. The patch  31  may have other shapes depending on the geometry of the anatomy of the PFO  109 . For example, the patch  31  may be elliptical, arc shaped, split-shaped or otherwise customized based on a patient&#39;s anatomy. An expansion element  32  coupled to the patch  31 , e.g., by stitching, may be used to spread, open or expand the patch from a compact configuration wherein the patch  31  may be delivered through a catheter, to an expanded or open configuration wherein the patch  31  may cover a portion of a wall of a heart chamber like an atrium wall. The patch covers a hole or other defect, including for example, a PFO  109 .  
         [0040]     As illustrated in  FIGS. 2A and 3A , the expansion element  32  comprises a plurality of spokes  33  extending from a hub portion  34 . The hub portion  34  includes an opening  41  therethrough for receiving a guidewire over which a delivery catheter and the patch device  30  are guided to the tissue defect site. As illustrated in  FIG. 2A , the distal side  40  of the patch device  30  has a plurality of petals  42  formed of the patch material that overlay each other to close the opening  41 . When a guidewire is inserted through the opening  41  the petals  42  permit the guidewire to extend through the opening while when the guidewire is removed, the petals  42  close over the opening  41 .  
         [0041]     In addition, the device  30  comprises an attachment element  35  configured to engage the septum  106  from within the right atrium  101 . The attachment element  35  as illustrated in  FIGS. 3A and 3B  is in the form of barbs  36  formed on or coupled (e.g. by welding) to the end of the spokes  33  and a surgical adhesive  31   c  may be applied to the outer rim  31   b  of the patch  31 . (In one example, eyelets cut at the ends of the arms are fitted with spikes and fixed, to create barbs.) The surgical adhesive  31   c  is coated with a cap coat  31   d  of a dissolvable material such as a biocompatible bioresorbable material, for example, a glucose based absorbable material or polyglycolic acid or polylactic acid. The cap coat  31   d  is preferably selected and applied to dissolve at a predetermined rate so that the adhesive  31   c  is active after the device has been delivered via catheter to the surgical site and expanded. The surgical adhesive comprises a biocompatible adhesive that may be used in the circulatory system such as, for example, fibrin glue, BioGlue™, or FloSeal™.  
         [0042]     The device  30  is shown deployed over the PFO  109  in  FIGS. 2A and 2B . The patch  31  is opened by the expansion element  32  and the barbs  36  engage the septum primum  107  and the septum secundum  108  at points of engagement  36   a . The cap coat  31   d  is exposed to body fluids in the circulatory system as it is being delivered and deployed whereby the cap coat dissolves at a predetermined rate and the glue becomes active to seal the patch  31  against the wall of the septum  106 .  
         [0043]     In variations of the invention either one or both of an adhesive and tissue engaging elements (such as barbs) may be used.  
         [0044]     The device according to the invention further may have some surface modifications such as a textured or porous surface (open or closed pore) to promote tissue ingrowth; a coating or infusion of a material or substance that promotes a tissue response such as tissue ingrowth on or over the device to thereby further close any opening or patch any defect or that promotes tissue adhesion that improves the device&#39;s gripping of the heart or other structure. The tissue adjacent the device may also be treated, e.g., by ablating or otherwise causing tissue adhesions or scarring around the edges of the device to improve device fixation. For example a coating or surface treatment may be provided on the device&#39;s outer surface  31   a  to promote tissue growth closing around the PFO  109 . Also the rim  31   b  of the device may be configured to promote tissue ingrowth or adherence to the device.  
         [0045]     Furthermore, the device or any portion thereof in this or other examples herein may be constructed of a resorbable material so that it is absorbed or dissolved after a predetermined time in which the PFO has had an opportunity to close, or in which tissue has formed over the device or the opening. Such materials are generally known in the art and include materials such as, for example, silk keratin, collagen, gelatin, fibrinogen, elastin, actin, dextrin, chitin, and cellulose, as well as resorbable forms of polyolefin elastomers, silicones, block copolymers, filled polymers, and hydrogels. The materials may be selected for their specific resorption properties such as resorption rate.  
         [0046]     Additional features of the device and its delivery are illustrated in  FIGS. 4-7 .  
         [0047]      FIGS. 4-7  illustrate a method and device for delivering a PFO closure device  30  in accordance with an embodiment of the invention. Referring to  FIG. 4 , the device  30  is in a compressed configuration within a catheter  80 . A delivery device  81  comprises an inner member push tube  82  extending through the catheter  80  to a push rod engaging element  37  on the device  30 . The inner member push tube  82  includes a lumen therethrough for receiving a guidewire  84 . A middle sheath  83  is slidably positioned over the inner member push tube  82  and expanders  85  comprising miniature hypotubes are coupled to the middle sheath  83 . The middle sheath  83  is actuable to extend and retract the expanders  85  coupled to the middle sheath  83 .  
         [0048]     In use, a guidewire  84  is inserted through a patient&#39;s vasculature, through the vena cava into the right atrium  101  of the heart  100 . The guidewire  84  is then passed through the patent foramen ovale  109 . The catheter  80  containing the delivery device  81  and PFO closure device  30  is then passed over the guidewire  84  into the right atrium  101 , locating the catheter and the device  30  adjacent the PFO  109 . The delivery device  81  push tube  82  engages the push element  37  of the PFO closure device  30  while expanders  85  of the delivery device  81  are removably coupled to the device  30 .  
         [0049]     As shown in  FIG. 5 , the inner push tube  82  is advanced, engaging the push element  37  of the device  30  which pushes the PFO closure device  30  out of the distal end  80   a  of the catheter  80 . The spokes  33  of the expansion element  32  are constructed of a spring material, e.g., of a shape memory alloy such as Nitinol. The spokes  33  tend to expand to an open position such as that illustrated in  FIG. 5 , opening the patch  31 .  
         [0050]     The expanders  85  illustrated in  FIGS. 4-7  comprise a plurality of miniature flexible hypotubes  86  opening adjacent the barbs  36  on the device  30 . Each of the hypotubes  86  have sutures  87  extending through the catheter  80  into the hypotube  86  and then out of the distal end  86   a  of the hypotube  86  and looping around a corresponding barb  36 . The sutures  87  may be actuated through the catheter  80  by pulling on the sutures  87  to draw the patch  31  back, i.e., further open it into a hyper-extended position ( FIG. 6 ). The sutures  87  and hypotubes  86  may also be used to stabilize the patch device  30  while the push tube  82  is extended to further open or hyper-extend the device  30  during deployment. The combination of positioning the hypotubes  86  against the device, pulling the sutures  87  and pushing the device  30  with the push tube  82  pulls the barbs  33  back into a position where they are generally perpendicular to the wall of the septum  106  as shown in  FIG. 6 . The device  30  may then be advanced into position over the PFO  109  with the barbs  33  piercing or engaging the septal wall (i.e., both the septum primum  107  and the septum secundum  108 ). When the sutures  87  are released and removed and/or the push tube  82  is released from the device  30 , the device  30  will tend to move back to its relaxed position as illustrated in  FIGS. 5 and 7 . The barbs  33  then hook into the wall of the septum  106  as illustrated in  FIG. 2A .  
         [0051]      FIG. 8  illustrates an alternative deployment device  181 . The deployment device  181  is shown in  FIG. 8  extending out of the distal end  180   a  of the catheter  180 . The deployment device  181  comprises flexible bars  186  coupled to a middle sheath  183 , and each having a hook  184  located on the distal end of a bar  186 . Each hook  184  is hooked around a barb  36  of the PFO closure device  30 . The bars  183  are retracted to stabilize and extend the device  30  as it is deployed while a push rod  182 , slidable within the middle sheath  183 , stabilizes and hyper extends the device  30 . After deployment the middle sheath  183  is twisted, releasing the hooks  184  from the device  30  so that the catheter  180  and deployment device  181  may be removed.  
         [0052]      FIG. 9  illustrates an alternative deployment device  281 . The deployment device  281  is shown in  FIG. 9  extending out of the distal end  280   a  of the catheter  280 . The deployment device  281  comprises flexible bars  286  coupled to a middle sheath  283 , each having an eyelet  284  on its distal end  281   a  for threading one of a plurality of sutures  285 . Each of the plurality of sutures  285  is further looped around or coupled to a barb  36  of the PFO closure device  30 . The sutures  285  then extend proximally through the catheter  280  so they may be pulled to retract the spokes  34  and barbs  36  of the PFO closure device and/or to stabilize the device  30  while the push rod  282  slidable within the middle sheath  283  hyper-extends and/or stabilizes the device  30  as it is deployed. After deployment the sutures  285  are cut from the proximal end so that one cut end of each of the sutures can be pulled to release the sutures from the device  30  so that the catheter  280  and deployment device  281  may be removed. The sutures  285  may each comprise a suture loop that may be cut and the pulled out of the catheter  280  from its proximal end.  
         [0053]     Referring to  FIGS. 10 and 11 , the PFO closure device  30  is illustrated having slightly different initial relaxed configuration ( FIG. 10 ) and a slightly different hyper-extended configuration ( FIG. 11 ) than illustrated in  FIG. 1-7 . These configurations may be set in the material of the extension member  32  of the device  30  and/or the patch  31 . As illustrated in  FIG. 10 , the relaxed position is flat so that when the device  30  is deployed, it tends towards a flat position against a septum  106 . Likewise, when the device  30  is hyper-extended as illustrated in  FIG. 11 , it is convex with respect to its interface with the septal wall so that the barbs  36  may be positioned to be placed in the septal wall and then may return to the position illustrated in  FIG. 10  after deployment so that the barbs  36  grab the tissue of the septum  106 .  
         [0054]      FIG. 12  illustrates the delivery device  81 ′ similar to delivery device  81  of  FIGS. 4-7 , with an alternative push rod  82 ′ and the PFO closure device  30  with an alternative push rod engaging element  37 ′. The push rod  82 ′ has a threaded (or alternatively keyed) end  89 ′ that screws (or otherwise connects) into threaded (or keyed) opening  39 ′ of the push rod engaging element  37 ′. The PFO closure device  30  is deployed as described with reference to  FIGS. 4-7  except that the push rod engaging element  37 ′ and the push rod  82 ′ are engaged by threading the two together. The expanders  85 ′ comprising flexible hypotubes  86 ′ coupled to middle sheath  83 ′ contain sutures similar to hypotubes  86  described above with reference to  FIGS. 4-7 , hold the device  30  in place deployed over the PFO while the push rod  82 ′ is unscrewed from the push rod engaging element  37 ′. The expanders  85  are then retracted as described herein with reference to  FIGS. 4-7 . The device  30  may be retrieved after deployment by coupling the end  89 ′ to the push rod engaging element  37 ′ and retracting the device  30  into the catheter  80 .  
         [0055]      FIG. 13  illustrates a variation of the delivery system of  FIGS. 4-7 . The PFO closure device  30  is illustrated being deployed through the catheter  80  over the PFO  109 . According to this variation, instead of a guidewire guiding the catheter  80  and device  30  towards the PFO  109 , a balloon catheter  84 ′ is place through the PFO  109 . A balloon  88 ′ at the tip of the balloon catheter  84 ′ is inflated to expand on the opposite side of the PFO  109  (the left atrium  102 ). The push rod  82  ( FIGS. 4-7 ) pushes the device  30  into place while the balloon catheter  84 ′ and balloon  88 ′ stabilized and direct the delivery device  81  ( FIGS. 4-7 ) as it deploys the device  30 . The balloon  88 ′ and the device  30  are aligned with respect to the same guidewire, accordingly, the balloon  88 ′ may also act to center the device  30  over the PFO. The device delivery system is thus self-centering. The balloon  88 ′ is deflated when the PFO device  30  is in place, and the balloon catheter  84 ′ is retracted into the catheter  80 . Other know centering devices may be used as well.  
         [0056]      FIGS. 14A-14C  illustrate another embodiment of a PFO closure device  330  according to the invention. The device  330  comprises a tubular portion  331  constructed of a material such as Dacron or ePTFE and annular support members  332  coupled to the tubular portion (e.g., by stitching). The annular members  332  may be spring members formed of a material such as Nitinol preset to a first configuration as illustrated in  FIG. 14A . A plurality of barbs  335  is located on the distal end  336  of the device  330  to engage the tissue of the septum  106 . The top of the device  333  is covered with a resilient elastic material such as biodegradable and biostable elastomers, polyolefin elastomers, silicones (homo and co-polmers), block co-polymers (e.g., polyurethane, and polyurethane blends with PTFE); filled polymers (e.g., with hydroxyapatite fillers), hydrogels, collagen, elastin, polyesters acrylics, shape memory polymer. These materials may also be surface modified, either chemically or physically, to render them non-thrombogenic. The top of the device  333  has a slit  334  through the material for passing a balloon catheter or other device that may be used to expand or open the device  330  to an open configuration such as illustrated in  FIG. 14B . The slit  334  will close when the catheter or expansion device is removed as illustrated in  FIG. 14C . The PFO closure device  330  may be expanded to an open position whereby the sharp elbow portion  337  of the barb  335  is forced into the tissue of the septum  106 . Thus, the device  330  is deployed over the PFO  109  (see  FIG. 17 ). The natural recoil of the device  330  back to its preset configuration (see  FIG. 14C ) draws the ends  338  of barbs  335  into engagement with the tissue of the septum  106  and holds the septum primum  107  and the septum secundum  108  together. A substance promoting tissue growth may be coated over the device to encourage tissue growth over the device  330  and between the septum primum  107  and the septum secundum  108  after a period of time. Tissue growth may also occur at the wall of the left atrium  102  of the heart  100  as the device  330  holds the septum primum  107  and septum secundum  108  in place for a sufficient duration to permit such growth.  
         [0057]     As shown in  FIG. 15 , the device  330  is being deployed. A guidewire  340  has been placed through the vasculature, into the right atrium  101 , through the PFO  109  and into the left atrium  102 . The device  330  is preloaded on a balloon catheter  350 . The balloon catheter tip  351  is placed through the slit  334  and the annular members  332  are loaded over the balloon catheter tip  351  in a compressed position in a similar manner to how an expandable stent is loaded on a balloon catheter. The balloon catheter  350  is guided over the guidewire  340  to a position within the right atrium  101 , the balloon tip  351  of the catheter  350  and the barbs  335  of the device  330  positioned adjacent the PFO  109 . The balloon catheter tip  351  is expanded, expanding the device  330  from its first position as illustrated in  FIG. 14A , to a second expanded position as illustrated in  FIG. 14B . The elbows  336  of the barbs  335  pierce the wall of the septum primum  107  and the septum secundum  108  upon expansion of the balloon catheter tip  351 . Upon deflation of the balloon catheter tip  351 , the recoil of the device  330  tends to draw the barbs  335  in towards the device  330  so that the ends  337  of the barbs  335  engage the tissue of the septum  106  ( FIGS. 16 and 17 ).  
         [0058]      FIGS. 18A and 18B  illustrate the PFO closure device  30  and a delivery device  441  according to the invention. The delivery device  441  is positioned within a catheter  440  that has accessed the deployment site through the vasculature. The delivery device  441  includes a stent push member  443  that engages and pushes the device  30  during deployment. The stent push member  443  is configured like a stent with a series of attached diamond shaped structures or annular support members that provide columnar strength while being collapsible to a smaller diameter when retracted. The push stent member  443  may be constructed of a shape memory alloy that is preset to a predetermined diameter. When the push stent member  443  is advanced out of the catheter  440  that is holding it in a compressed position, it expands to its preset shape. The stent member may also include sutures tied around the stent and extend to the proximal end of the catheter whereby the sutures may be pulled to draw the stent member into a smaller diameter shape when it is retracted. The push member  443  is attached, e.g., by heat welding, to a middle sheath  442 , which is positioned over the proximal end of the push stent  443 . An inner sheath  444  is positioned within the push member  443 . The inner sheath  444  includes an engaging tip  450  that engages the push rod engaging element  37  of the device  30  to additionally push and maneuver the device  30 . A pull device  449  is positioned in the sheath  444  and is configured to pull or stabilized the patch device  30  against the push stent device as it is being deployed. The pull device  449  includes a first wire  445  attached to the patch device  30  and ball  446  attached to the wire  445 . The pull device  449  further includes a second wire  447  extending out of the proximal end of the catheter, and a ball  448  attached to the wire  446 . The balls  446 ,  448  are positioned in an engaging position with each other, with each ball positioned on the opposite side of the other ball from the direction to which their respective wires  445 ,  447  lead. Thus in a pulling relationship, the balls  446 ,  448  engage one another. The sheath  444  is placed over the balls  445 ,  447  and wires  446  and extends out of the proximal end of the catheter where it may be pushed to engage the device  30  or retracted to release the balls  446 ,  448  from engaging one another.  
         [0059]     In use, the PFO closure device  30  is loaded in the catheter  440  with the device  30  and the push stent  443  compressed to a low profile. The pull device  449  is coupled to the patch  30  with balls  445 ,  447  of the pull device  449  creating an engaged relationship between the PFO closure device  30  and the pull device  449  that allows the pull device  449  to exert a pull force on the PFO closure device  30 . The sheath  442  and inner member  444  are advanced out of the catheter  440 , the inner member  444  pushing the push rod engaging element  37  of the device  30 . The push stent  443 , which is attached to the middle sheath  442 , is thereby advanced out of the catheter  440 . As the push stent  443  is advanced out of the catheter  440 , it expands to a preset shape having an outer diameter to match the outer diameter of the device  30 . Thus, the push stent  443  and the inner sheath  444  push and maneuver the device  30  while the pull device  449  stabilizes it. The inner member  444  may be used to push and hyper-extend the patch  31  so that the barbs  36  are generally perpendicular to the tissue as the patch is deployed. The patch  31  is positioned over a PFO or other defect and is pushed into the tissue so that the barbs  36  engage the tissue and the adhesive further attaches the device to the tissue. The sheath  444  is then retracted into the catheter  440  while the wire  447  is released. The sheath  444  that held the balls  446 ,  448  in an engaged position is thereby removed permitting disengagement of the ball  448  and wire  447  from ball  446  and wire  445 , releasing the device. The ball  448  and wire  447  are also retracted into the catheter  440  as well as the push member retracted by the middle sheath  442  to which it is attached.  
         [0060]      FIGS. 19A-19C  illustrate a patch device  530  and delivery system  580  in accordance with the invention. The patch device  530  includes a patch material similar to the patch material  31  described above with reference to  FIGS. 4-7 . A plurality of spokes  543  formed of Nitinol or a spring material are attached to the patch material, also in a similar manner as the spokes and patch material described with reference to  FIGS. 4-7 . A plurality of barbs  536  are formed at the distal ends of the spokes  543 . The spokes  543  join at the proximal end of the patch device  530  to form a bulb shaped proximal portion  544  when the spokes  543  are in their preset shape. When in this position, the barbs  536  tend to point inward so that they will engage tissue when the patch device  530  is deployed in tissue. The bulb shaped proximal portion  544  may be deflected to draw the spoke  543  outward as illustrated in  FIG. 19B . In this position the barbs  536  are generally pointing in the direction of the catheter  581  of the delivery system  580  and thus generally perpendicular to a wall of tissue into which the device  530  is directed by the catheter  581 .  
         [0061]     The device  530  is initially positioned within the catheter  581  in a compressed configuration wherein the bulb shaped proximal portion  544  is deflected while the spokes  543  are contained within the catheter  581  in a closed position. A guidewire  584  is positioned through the catheter  581 , through the patch device  530 , and into a PFO (not shown) to guide the patch device  530  into position. A push rod  582  is positioned within the catheter  581 , proximally of the patch device  530 . As illustrated in  FIG. 19B , the push rod  582  is advanced predetermined distance to a first stage where the spokes  543  extend out of the catheter  581  and the catheter distal end  585  contains and depresses the bulb shaped proximal end  544  of the device  530 . With the barbs  536  extending straight out, the device  530  is directed into the tissue with the catheter  581 . As illustrated in  FIG. 19C , the push rod  582  is then advanced so that the device is deployed out of the catheter  581 . When released from the catheter  581 , the bulb shaped proximal end  544  returns to is preset bulb shaped configuration whereby the barbs  536  turn inward to engage the tissue.  
         [0062]     While the invention has been described with reference to particular embodiments, it will be understood to one skilled in the art that variations and modifications may be made in form and detail without departing from the spirit and scope of the invention. For example, the device may be used to patch a variety of defects or holes in various locations within the circulatory system including the heart and vasculature. Means for attaching the patch to the wall of the heart may include other similar means such as glues, bonds, and mechanical means such as, for example, staples, clips, or sutures.