Abstract:
The present invention relates in general to anchoring systems for occluder devices, and more specifically, to an anchoring system and method for implanting an occluder device within a left atrial appendage (“LAA”) of the heart. The anchoring system is configured so that an anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of an LAA wall. The purpose of the present invention is to provide an occluder device anchor that has a low risk of embolization and/or causing injury to neighboring valve structures. An additional purpose of the present invention is to provide an anchoring system and method for implanting an occluder device within the LAA that allows for the occluder device to be retrievable after initial placement, reusable, and repositionable for an optimal final placement within the LAA.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a Continuation-in-Part of U.S. patent application Ser. No. 14/819,724 filed Aug. 6, 2015 and PCT/US2016/044005 filed Jul. 26, 2016, herein incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates in general to an anchoring system and method of attaching and retrieving an occluder device in the left atrial appendage of the heart. The purpose of the invention is to provide an anchoring system and method of attaching and retrieving an occluder device that ensures optimal placement within the left atrial appendage of the heart. A further purpose of the present invention is to provide an anchor for an occluder device that has a low risk of embolization. 
       BACKGROUND OF THE INVENTION 
       [0003]    Approximately 7 million Americans have what is known as non-valvular atrial fibrillation involving complications with the left atrial appendage of the heart (hereinafter, “LAA”). The LAA is a small, windsock shaped sac in the muscle wall of the left atrium. 
         [0004]    Though uncertain as to what function the LAA performs, if anything, what is certain is that in patients with non-valvular atrial fibrillation, 90% of the thrombus formation occurs in the body of the LAA. In normal conditions, electrical impulses that control a heartbeat travel in an orderly fashion throughout the heart. These electrical impulses cause the heart to contract wherein blood in the left atrium and LAA is driven into the left ventricle with each heartbeat. However, in patients with atrial fibrillation the electrical impulses are fast and chaotic, wherein many impulses begin at the same time and spread throughout the atria. For instance, a healthy atria contracts 60-80 times per minute, while a fibrillating atria quivers at 300-400 times per minute. Problems arise when the electrical impulses do not allow the atria enough time to fully contract and efficiently displace blood into the left ventricle from the left atrium and LAA. Consequently, blood pools and collects in the LAA due to inefficient contraction of the atria and the LAA&#39;s sac-like physiological structure, causing blood clots. Strokes may ultimately occur in patients when the blood clots are pumped out of the heart and embolize to the brain. Notably, individuals with atrial fibrillation are five to seven times more likely to have a stroke than the general population. 
         [0005]    Treatment of atrial fibrillation typically involves oral anticoagulant therapy. Patient&#39;s taking blood thinners have noted a reduction in the risk of stroke by 65% as compared to patients without medication. The oral anticoagulant warfarin (COUMADIN®) has been traditionally utilized to minimize thrombus formation in patients with atrial fibrillation. Due to the requirement of frequent blood draws to monitor a patient&#39;s anticoagulation status, frequent interactions of the medication with either dietary changes or with other medications, and the high risk of encountering serious bleeding events, Coumadin has recently fallen into disfavor in the medical community. Newer medications including dabigatran (PRADAXA®) and rivaroxaban (XARELTO®) are also being utilized. The advantage of these newer medications are that they have less interaction with dietary changes and do not require blood draws to monitor a patient&#39;s anticoagulation status. However, these medications continue to encounter serious gastrointestinal bleeding events, are not reversible, and are extremely expensive. 
         [0006]    Patients who cannot tolerate anticoagulants, or are not eligible for anticoagulant treatment due to pregnancy or other medical reasons, may elect to undertake various procedures to seal off or remove the LAA. One particular procedure, known as LAA occlusion, involves implanting a device into the heart that closes the LAA. Currently, there are several different occluder devices on the market or in current testing, including the WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and the AMULET™. In each of these devices, the major technical difficulty encountered is to get the device to reliably fix itself within the LAA without embolizing or migrating out of the LAA into the systemic circulation. The reason for this is multifactorial, although primarily being related to the LAA coming in many different sizes and configurations. Some sizes and configurations of the LAA are more amenable to device closure, whereas in others, device closure can be extremely difficult—if not impossible—to safely place an occluder device within the LAA. 
         [0007]    The heart is comprised of three layers: (1) an inner endocardium layer; (2) a middle myocardium layer; and (3) an outer epicardium layer. The endocardium is a fragile, thin layer of tissue that lines the heart&#39;s chambers and valves. The myocardium is the thickest layer of the heart and is comprised of muscle tissue. The epicardium is a thin layer of visceral tissue. Between the heart and mediastinal space is the pericardium. The pericardium is a visceral layer of endothelium. The pericardial space lies in between the heart&#39;s epicardial surface and the pericardium. The pericardial space is filled with clear fluid that minimizes friction between the heart and other structures within the chest wall. 
         [0008]    Current LAA occluder devices such as the WATCHMAN® and AMPLATZER™ have barbs on the outer edge of the device that latch on circumferentially to the endocardium layer of the LAA. Using barbs to fix the occluder device onto the endocardium layer of the LAA has significant disadvantages. For example, successfully “latching” an occluder device onto the endocardial layer of the LAA may be extremely difficult and time consuming for the interventional cardiologist. Problems are compounded if initial placement of the occluder device within the LAA is less than ideal, as the occluder device cannot be fully retrieved back within the delivery system without permanently damaging the retention barbs and/or the endocardium layer. Moreover, if the occluder device embolizes out of the LAA, irreparable damage to neighboring structures such as the mitral and/or aortic valves of the heart may occur in part, due to the presence of the barbs on the occluder device. Retrieval of an embolized occluder device is further complicated by the presence of the retention barbs. 
         [0009]    Therefore, what is needed is an anchoring system and method for implanting an occluder device in the LAA that would allow for complete retraction and removal of the occluder device without permanently damaging the device. What is also needed is an anchoring system and method for implanting an occluder device in the LAA that provides a low risk of embolization and/or causing injury to neighboring valve structures. What is further needed is an anchoring system and method for implanting an occluder device that allows the occluder device to be positioned in multiple locations within the LAA, being able to be used in all types of LAA anatomy, and still result in optimal final placement of the occluder device within the LAA. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    Therefore, it is a principal object, feature, and/or advantage of the present invention to overcome the aforementioned deficiencies in the art and provide an anchoring system and method for implanting and retrieving an occluder device in the LAA. 
         [0011]    A further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting and retrieving an occluder device in the LAA that may be used with a diverse range of LAA occluder devices. 
         [0012]    Another object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting and recapturing an occluder device in the LAA that minimizes the risk of the occluder device embolizing or migrating following release of the occluder device into the LAA. 
         [0013]    Yet another object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that allows an interventional cardiologist to anchor the occluder device in multiple locations within the LAA. 
         [0014]    A still further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that allows the occluder device to be retrieved and adjusted within the LAA to achieve an optimal final position. 
         [0015]    Another object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that causes minimal or no bleeding into the pericardial space upon anchoring. 
         [0016]    A further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that is easy to implant and retrieve by an interventional cardiologist. 
         [0017]    A still further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that allows the occluder device to be retrieved and adjusted by a interventional cardiologist within the LAA without damaging the occluder device. 
         [0018]    These and/or other objects, features, and/or advantages of the present invention will be apparent to those skilled in the art. The present invention is not to be limited to or by these objects, features, and advantages. No single aspect need provide each and every object, feature, or advantage. 
         [0019]    According to one aspect of the present invention, an anchoring system for implanting and retrieving an occluder device into a LAA comprises an outer sheath, a delivery catheter, an occluder device, and an anchor. The delivery catheter may be advanced through the outer sheath into the LAA, wherein the delivery catheter penetrates a wall of the LAA and enters the pericardial space creating a small hole. The anchor may comprise a first half and a second half connected by a shaft. The anchor may further comprise a contracted first position and a deployed second position. The occluder device, anchor catheter, and anchor may be advanced through the delivery catheter, wherein the anchor is in the contracted first position. The anchor catheter is further advanced to penetrate the LAA wall via the small hole and extend into the pericardial space. Specifically, the anchor catheter delivers the anchor, wherein the first half of the anchor remains inside the LAA and the shaft portion and the second half of the anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall. Once inside the pericardial space, the second half of the anchor self-expands to the deployed second position within the pericardial space to implant the anchor in the LAA wall. The first half of the anchor remaining within the LAA also self-expands to the deployed second position, pinning the occluder device against the wall of the LAA. Alternatively, the anchor may be integral with the occluder device. The outer sheath releases the occluder device into the LAA, wherein it is held in position by the anchor. By mooring the occluder device through all three layers of the LAA wall via the anchor, the risk of embolization is reduced. Another aspect of the present invention includes a method of implanting and retrieving an occluder device into a LAA using the anchoring system described above. 
         [0020]    Different aspects may meet different objects of the invention. Other objectives and advantages of this invention will be more apparent in the following detailed description taken in conjunction with the figures. The present invention is not to be limited by or to these objects, aspects, or figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIGS. 1-9  represent examples of the anchoring system, anchor, and method of the present invention. 
           [0022]      FIG. 1  is a view of an outer sheath of one aspect of an anchoring system of the present invention and method for implanting and retrieving an occluder device within a LAA. 
           [0023]      FIG. 2  is a view of an outer sheath, a delivery catheter, and an optional inner dilator of the anchoring system and method of  FIG. 1 , wherein the inner dilator and delivery catheter penetrate the LAA wall. 
           [0024]      FIG. 3A  is a view the anchoring system and method of  FIG. 2 , wherein an occluder device and an anchor are advanced through the outer sheath and anchor catheter, respectively. 
           [0025]      FIG. 3B  is a view the anchoring system and method of  FIG. 3A , wherein the occluder device and anchor are integral. 
           [0026]      FIG. 4A  is a frontal-side view of the anchor of the anchoring system and method of  FIG. 2 , wherein the anchor is in a deployed second position comprising a sheave shape with a first half, a second half, and a shaft connecting the two halves. 
           [0027]      FIG. 4B  is a frontal side-view of the anchor of the anchoring system and method of  FIG. 2 , wherein the anchor is in a deployed second position comprising a double-coiled shape with a first half, a second half, and a shaft connecting the two halves. 
           [0028]      FIG. 4C  is a side-view of the anchor of  FIGS. 4A and 4B , wherein the anchor is in a contracted first position. 
           [0029]      FIG. 4D  is a frontal side-view of the anchor of the anchoring system and method of  FIG. 2 , wherein the occluder device and the anchor are integral. 
           [0030]      FIG. 5A  is a view of the anchoring system and method of  FIG. 2 , wherein the second half of the anchor is deployed in the pericardial space. 
           [0031]      FIG. 5B  is a view the anchoring system and method of  FIG. 5A , wherein the occluder device and anchor are integral. 
           [0032]      FIG. 6A  is a view of the anchoring system and method of  FIG. 2 , wherein the first half of the anchor is partially deployed in the occluder device. 
           [0033]      FIG. 6B  is a view the anchoring system and method of  FIG. 6A , wherein the occluder device and anchor are integral. 
           [0034]      FIG. 7A  is a view of the anchoring system and method of  FIG. 2 , wherein the occluder device is released from the outer sheath and the second half of the anchor fully deployed to pin the occluder device against the LAA wall. 
           [0035]      FIG. 7B  is a view the anchoring system and method of  FIG. 7A , wherein the occluder device and anchor are integral. 
           [0036]      FIG. 8  is a view of the anchoring system and method of  FIG. 2  if problems arise after deployment of the occluder device, wherein the occluder device is retracted inside the outer sheath and the first half of the anchor is retracted inside the anchor catheter. 
           [0037]      FIG. 9  is a view of the anchoring system and method of  FIG. 2  if problems arise after deployment of the occluder device, wherein the anchor is left implanted in the LAA wall. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0038]      FIG. 1  illustrates one aspect of the present invention, an anchoring system  50  for implanting and retrieving an occluder device within a LAA. The anchoring system  50  may comprise an outer sheath  56 . A balloon-occlusion catheter may also be utilized by the present invention. However, it is intended that other catheters standard in the industry may also be utilized. The outer sheath  56  may be inserted into LAA  64  via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude the LAA  64  from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath  56  within the LAA  64  and allow for better imaging of the LAA  64  by an interventional cardiologist. 
         [0039]    Illustrated in  FIG. 2 , the anchoring system  50  of the present invention further comprises a delivery catheter  58  and an optional inner dilator  86 , wherein the inner dilator  86  includes a pointed distal end  88 . The delivery catheter  58  and inner dilator  86  may be configured to encompass a delivery wire  60  and/or a buddy wire  62 , wherein the delivery wire  60  and buddy wire  62  may traverse through an inner lumen of the delivery catheter  58  and inner dilator  86 . The delivery wire  60  and/or buddy wire  62  may be of types standardly used in the industry, wherein a diameter of the delivery wire  60  may range between approximately 0.025-0.052 inches and a diameter of the buddy wire  62  may range between approximately 0.008-0.025 inches. The delivery catheter  58  and the inner dilator  86  may be advanced through the outer sheath  56  to the LAA wall  66 . Using the pointed distal end  88  of the inner dilator  86 , the inner dilator  86  and the delivery catheter  58  may be further advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer to penetrate the LAA wall  66  and create a small hole  70 . Thus, the pointed distal end  88  of the inner dilator  86 , along with a distal end of the delivery catheter  58  and the delivery wire  60  and buddy wire  62 , may extend into the pericardial space  68 . When utilized, the inner dilator  86  may be subsequently removed from the delivery catheter  58 , wherein the distal end of the delivery catheter  58  remains extending into the pericardial space  68 . Alternatively, when the inner dilator  86  is not being utilized the delivery catheter  58  may be advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer to penetrate the of the LAA wall  66  and create small hole  70 . 
         [0040]    Illustrated in  FIG. 3A , the anchoring system  50  of the present invention further comprises an occluder device  80  and an occluder cable  84 . It is contemplated that the anchoring system  50  of the present invention may be used with a diverse range of LAA occluder devices  80  such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples of occluder devices  80  that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, the occluder device  80  may have a distal end with a hole approximately 1-5 mm in diameter. 
         [0041]    As shown in  FIG. 3A , the occluder cable  84  may be a hollow coaxial cable standardly used in the industry. The occluder cable  84  may be attached to the occluder device  80 , wherein the occluder cable  84  may be used for deploying and retrieving the occluder device  80  within the LAA  64 . The occluder device  80  and the occluder cable  84  may reside inside the delivery catheter  58 . The delivery catheter  58  may also comprise an anchor  72  and an anchor cable  82 . The anchor cable  82  may be attached to the anchor  72 , wherein the anchor cable  82  may be used for deploying the anchor  72  within the LAA wall  66 . The anchor cable  82  may be a hollow coaxial cable standardly used in the industry. The anchor cable  82  and anchor  72  may encompass the delivery wire  60  and/or buddy wire  62 , wherein the delivery wire  60  and/or buddy wire  62  may traverse through an inner lumen of the anchor  72  and an inner lumen of the anchor cable  82 . The delivery wire  60  may be used to navigate the anchoring system  50  through the LAA  64 . The buddy wire  62  may remain inside the pericardial space  68  and is a safety feature in case of emergencies. The buddy wire  62  allows an interventional cardiologist to advance another catheter through the LAA wall  66  and place a plug within the small hole  70  if a malfunction is observed with the anchor  72  or the occluder device  80 . Alternatively, the delivery wire  70  and buddy wire  72  may be retrieved and the anchor  72  and anchor cable  82  advanced through the delivery catheter  58  into the pericardial space  68  without using the delivery wire  60 . As shown in  FIG. 3B , the anchor  72  may be integral with the occluder device  80 . In this aspect, the anchor cable  82  may be used for deploying the anchor  72  within the LAA wall  66  and for deploying and retrieving the occluder device  80  within the LAA  64 , wherein the occluder cable  84  is not utilized. 
         [0042]    Illustrated in  FIGS. 4A and 4B , the anchor  72  may comprise a first half  74 , a second half  76 , and a shaft  78  connecting the first half  74  to the second half  76 . In particular, the anchor  72  may be shaped like a sheave ( FIG. 4A ) or a double-coil ( FIG. 4B ), although it is contemplated that other anchor shapes may also be utilized in the present invention. The particular coils of the double-coil anchor  72  may both unwind in opposite directions as depicted in  FIG. 4B . When unwinding in opposite directions (e.g., clockwise and counter-clockwise) there will be counter-forces acting on the coils to prevent the anchor  72  from unraveling while deployed within the LAA wall  66 . Alternatively, the particular coils of the double-coil anchor  72  may both unwind in the same direction (not shown). The anchor  72  may be comprised of wire and/or wire mesh having a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape, and may be comprised of single or multiple wires. The anchor  72  may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The anchor  72  may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor  72  may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. The anchor  72  may have a lumen wherein the delivery wire  60  traverses therein, alternatively, the anchor  72  may not have a lumen. The anchor  72  may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. 
         [0043]    Illustrated in  FIGS. 4A, 4B and 4C , the anchor  72  may have a contracted first position ( FIG. 4C ) and a deployed second position ( FIGS. 4A, 4B ). In the contracted first position ( FIG. 4C ), the first half  74 , second half  76 , and shaft  78  of the anchor  72  have a diameter of approximately 0.5-5 mm and a length of approximately 2-55 mm. In the deployed second position ( FIG. 4A, 4B ), the first half  74  and second half  76  of the anchor  72  may expand outwards a distance of approximately 5-25 mm in diameter, wherein the shaft  78  remains approximately 0.5-5 mm in diameter. The anchor  72  may self-expand from the contracted first position ( FIG. 4C ) to the deployed second position ( FIG. 4A, 4B ). Alternatively as illustrated in  FIG. 4D , the anchor  72  may be integral with the occluder device  80 . As shown in  FIG. 4D , the first half  74  of the anchor is connected to and formed integrally with the occluder device  80 . However, it is contemplated by the present invention that either half  74 ,  76  of the anchor may be formed integrally with the occluder device  80  as needed. 
         [0044]    Illustrated in  FIG. 5A , the anchor  72  in the contracted first position ( FIG. 4C ) may be advanced through the delivery catheter  58  using the anchor cable  82  and the delivery wire  60 , wherein the anchor  72  extends into the pericardial space  68 . The delivery catheter  58  may then be retracted, allowing the second half  76  of the anchor  72  to self-expand from the contracted first position to the deployed second position within the pericardial space  68 . While the second half  76  of the anchor  72  is in the deployed second position, the occluder device  80  including the shaft  78  and the first half  74  of the anchor  72  remain temporarily inside the delivery catheter  58 . Alternatively as shown in  FIG. 5B , the anchor  72  and occluder device  80  may be integral, wherein the integral anchor  72  in the contracted first position ( FIG. 4C ) may be advanced through the delivery catheter  58  using the anchor cable  82  and the delivery wire  60 , wherein the anchor  72  extends into the pericardial space  68  using the system  50  of the present invention described above. 
         [0045]    Illustrated in  FIG. 6A , the delivery catheter  58  may be further retracted, allowing the first half  74  of the anchor  72  to self-expand from the contracted first position to a partially deployed second position within the occluder device  80 , wherein the occluder device  80  remains inside the outer sheath  56 . The shaft  78  resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall  66 . The second half  76  of the anchor  72  remains in the deployed second position within the pericardial space  68 , wherein the first half  74  of the anchor  72  is in the partially deployed second position within the occluder device  80 . Alternatively as shown in  FIG. 6B , the anchor  72  and occluder device  80  may be integral, wherein the integral anchor  72  and occluder device  80  may be advanced together through the delivery catheter  58 , wherein the anchor  72  is implanted in the LAA wall  66  using the system  50  of the present invention described above. 
         [0046]    Illustrated in  FIG. 7A , the outer sheath  56  may be retracted to allow the occluder device  80  to expand inside the LAA  64 . Moreover, retracting the outer sheath  56  allows the first half  74  of the anchor  72  to fully expand into the deployed second position within the occluder device  80 . Thus, the shaft  78  of the anchor  72  may extend through the hole in the distal end of the occluder device  80 , wherein the distal end of the occluder device  80  pinches down on the shaft  78 . Furthermore, the first half of the anchor  74  in the deployed second position may pin the occluder device  80  against the LAA wall  66 , wherein the anchor  72  effectively moors the occluder device  80  inside the LAA  64 . At this time the expanded anchor  72  in the deployed second position covers a large surface area and therefore retains the occluder device  80  in an implanted position within the LAA  64 . Alternatively as shown in  FIG. 7B , the anchor  72  and occluder device  80  may be integral. By anchoring the occluder device  80  via the anchor  72  through all three layers of the LAA wall  66 —instead of merely latching onto the thin endocardium layer—the anchoring system  50  of the present invention lowers the risk of embolization. Here, the anchor cable  82  remains attached to the anchor  72  and the occluder device  80  in case problems arise after deployment of the occluder device  80 . If no problems arise and it is determined that the occluder device  80  is in an optimal location of the LAA  64 , the anchor cable  82  may be detached from the occluder device  80  and the anchor  72  and removed from the LAA  64 . The buddy wire  62  and delivery wire  60  may also be withdrawn from the LAA  64 , leaving the occluder device  80  anchored securely in the LAA  64  by the anchoring system  50  of the present invention. 
         [0047]      FIG. 8  illustrates the anchoring system  50  of the present invention if problems arise after deployment of the occluder device  80 . For instance, it may be determined that the occluder device  80  is not placed in an optimal location of the LAA  64  after deployment to achieve maximum occlusion. In this situation—prior to release of the occluder cable  84  from the occluder device  80  and the anchor cable  82  from the anchor  72 —the outer sheath  56  may be advanced over the occluder device  80  to the LAA wall  66 , wherein the occluder device  80  is retracted inside the outer sheath  56  using the occluder cable  82 . The delivery catheter  58  may then be advanced to the LAA wall  66 , wherein the occluder device  80  and the first half  74  of the anchor  72  is retracted inside the delivery catheter  58  using the anchor cable  82 . Thus, using the anchor cable  82 , the first half  74  of the anchor  72  retracts from the deployed second position to the contracted first position to fit inside the delivery catheter  58  along with the occluder device  80 . The occluder device  80  may then be removed from the LAA  64 , or the occluder device  80  may be re-deployed in a more optimal location of the LAA  64 . If the occluder device  80  is removed from the LAA  64 , the first half  74  of the anchor  72  may be allowed to expand from the contracted first position to the deployed second position within the LAA  64 . Thus, the deployed anchor  72  remains inside the LAA  64  and allows for occlusion of the small hole  70  that was created by the pericardial catheter  54  through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall  66 . Alternatively, if the anchor  72  and the occluder device  80  are integral both may be removed simultaneously from the LAA  64  using the anchor cable  82  via the delivery catheter  58 . 
         [0048]    Illustrated in  FIG. 9 , if optimal placement of the occluder device  80  was not achieved the anchor  72  may be released from the anchor cable  82  and deployed alone within the LAA wall  66  to plug the small hole  70  and prevent fluids from entering the pericardial space  68 . The delivery wire  60  and buddy wire  62  may be subsequently removed from the LAA  64 . This allows for a new anchor  72  to be placed within the LAA wall  66  using the anchoring system  50  cited above for achieving optimal placement of the occluder device  80  within the LAA  64 . On the other hand, if the anchor  72  is initially placed in an optimal location within the LAA wall  66  but there are problems with the occluder device  80 , a second occluder device may be advanced with the delivery catheter  58  and deployed within the LAA  64  using the anchoring system  50  cited above. Thus, the anchoring system  50  of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device  80  into the LAA  64  using anchor  72 , safely retrieve or re-deploy the occluder device  80  if initial placement was improper or if complications arise, with an option to re-implant a new occluder device and new anchor in an optimal location of the LAA  24 . After optimal placement of the occluder device  80  within the LAA  64  is achieved, the delivery wire  60  and buddy wire  62  may be removed from the LAA  64 . 
         [0049]    In another aspect of the present invention, an anchor  72  is provided depicted in  FIGS. 4A, 4B, 4C and 4D  for anchoring an occluder device  80  within a LAA  64  using the anchoring system  50  as explained above. 
         [0050]    In yet another aspect of the present invention, a method of implanting and retrieving an occluder device within a LAA is illustrated in  FIGS. 1-9 . The method of the present invention comprises providing anchoring system  50  as explained above. The method of the present invention further comprises inserting the outer sheath  56  into the LAA  64  via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure as depicted in  FIG. 1 . If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude the LAA  64  from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath  56  within the LAA  64  and allow for better imaging of the LAA  64  by an interventional cardiologist. 
         [0051]    Illustrated in  FIG. 2 , the method of the present invention further comprises providing a delivery catheter  58  and an optional inner dilator  86 , wherein the inner dilator  86  includes a pointed distal end  88 . The delivery catheter  58  and inner dilator  86  may be configured to encompass a delivery wire  60  and/or a buddy wire  62 , wherein the delivery wire  60  and buddy wire  62  may traverse through an inner lumen of the delivery catheter  58  and inner dilator  86 . The delivery wire  60  and/or buddy wire  62  may be of types standardly used in the industry, wherein a diameter of the delivery wire  60  may range between approximately 0.025-0.052 inches and a diameter of the buddy wire  62  may range between approximately 0.008-0.025 inches. The delivery catheter  58  and the inner dilator  86  may be advanced through the outer sheath  56  to the LAA wall  66 . Using the pointed distal end  88  of the inner dilator  86 , the inner dilator  86  and the delivery catheter  58  may be further advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer to penetrate the LAA wall  66  and create a small hole  70 . Thus, the pointed distal end  88  of the inner dilator  86 , along with a distal end of the delivery catheter  58 , extends into the pericardial space  68 . When utilized, the inner dilator  86  may be subsequently removed from the delivery catheter  58 , wherein the distal end of the delivery catheter  58  remains extending into the pericardial space  68 . Alternatively, when the inner dilator  86  is not being utilized the delivery catheter  58  may be advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer to penetrate the of the LAA wall  66  and create small hole  70 . 
         [0052]    Illustrated in  FIG. 3A , the method of the present invention further comprises providing an occluder device  80  and an occluder cable  84 . It is contemplated that the method of the present invention may be used with a diverse range of LAA occluder devices  80  such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples of occluder devices  80  that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, the occluder device  80  may have a distal end with a hole approximately 1-5 mm in diameter. 
         [0053]    As shown in  FIG. 3A , the occluder cable  84  may be a hollow coaxial cable standardly used in the industry. The occluder cable  84  may be attached to the occluder device  80 , wherein the occluder cable  84  may be used for deploying and retrieving the occluder device  80  within the LAA  64 . The occluder device  80  and the occluder cable  84  may reside inside the delivery catheter  58 . As further shown in  FIGS. 3 and 3A , the method of the present invention further comprises providing an anchor  72  and an anchor cable  82 , wherein the anchor  72  and anchor cable  82  are inserted in the delivery catheter  58 . The anchor cable  82  may be attached to the anchor  72 , wherein the anchor cable  82  may be used for deploying the anchor  72  within the LAA wall  66 . The anchor cable  82  may be a hollow coaxial cable standardly used in the industry. The anchor cable  82  and anchor  72  may encompass the delivery wire  60  and/or buddy wire  62 , wherein the delivery wire  60  and/or buddy wire  62  may traverse through an inner lumen of the anchor  72  and an inner lumen of the anchor cable  82 . The delivery wire  60  may be used to navigate the anchoring system  50  through the LAA  64 . Alternatively, the anchor  72  and anchor cable  82  may be advanced through the delivery catheter  58  into the pericardial space  68  without using the delivery wire  60 . The buddy wire  62  may remain inside the pericardial space  68  and is a safety feature in case of emergencies. The buddy wire  62  allows an interventional cardiologist to advance another catheter through the LAA wall  66  and place a plug within the small hole  70  if a malfunction is observed with the anchor  72  or the occluder device  80 . Alternatively as shown in  FIG. 3B , the anchor  72  may be integral with the occluder device  80 . In this aspect, the anchor cable  82  may be used for deploying the anchor  72  within the LAA wall  66  and for deploying and retrieving the occluder device  80  within the LAA  64 , wherein the occluder cable  84  is not utilized. 
         [0054]    Illustrated in  FIGS. 4A and 4B , the anchor  72  may comprise a first half  74 , a second half  76 , and a shaft  78  connecting the first half  74  to the second half  76 . In particular, the anchor  72  may be shaped like a sheave ( FIG. 4A ) or a double-coil ( FIG. 4B ), although it is contemplated that other anchor shapes may also be utilized in the present invention. The particular coils of the double-coil anchor  72  may both unwind in opposite directions as depicted in  FIG. 4B . When unwinding in opposite directions (e.g., clockwise and counter-clockwise) there will be counter-forces acting on the coils to prevent the anchor  72  from unraveling while deployed within the LAA wall  66 . Alternatively, the particular coils of the double-coil anchor  72  may both unwind in the same direction (not shown). The anchor  72  may be comprised of wire and/or wire mesh having a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape, and may be comprised of single or multiple wires. The anchor  72  may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The anchor  72  may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor  72  may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. The anchor  72  may have a lumen wherein the delivery wire  60  traverses therein, alternatively, the anchor  72  may not have a lumen. The anchor  72  may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. 
         [0055]    Illustrated in  FIGS. 4A, 4B and 4C , the anchor  72  may have a contracted first position ( FIG. 4C ) and a deployed second position ( FIG. 4A, 4B ). In the contracted first position ( FIG. 4C ), the first half  74 , second half  76 , and shaft  78  of the anchor  72  have a diameter of approximately 0.5-5 mm and a length of approximately 2-55 mm. In the deployed second position ( FIG. 4A, 4B ), the first half  74  and second half  76  of the anchor  72  may expand outwards a distance of approximately 5-25 mm in diameter, wherein the shaft  78  remains approximately 0.5-5 mm in diameter. The anchor  72  may self-expand from the contracted first position ( FIG. 4C ) to the deployed second position ( FIG. 4A, 4B ). Alternatively as illustrated in  FIG. 4D , the anchor  72  may be integral with the occluder device  80 . As shown in  FIG. 4D , the first half  74  of the anchor is connected to and formed integrally with the occluder device  80 . However, it is contemplated by the present invention that either half  74 ,  76  of the anchor may be formed integrally with the occluder device  80  as needed. 
         [0056]    Illustrated in  FIG. 5A , the method of the present invention comprises advancing the anchor  72  in the contracted first position ( FIG. 4A ) through the delivery catheter  58  using the anchor cable  82  and the delivery wire  60 , wherein the anchor  72  extends into the pericardial space  68 . The delivery catheter  58  may then be retracted, allowing the second half  76  of the anchor  72  to self-expand from the contracted first position to the deployed second position within the pericardial space  68 . While the second half  76  of the anchor  72  is in the deployed second position, the occluder device  80  including the shaft  78  and the first half  74  of the anchor  72  remain temporarily inside the delivery catheter  58 . Alternatively as shown in  FIG. 5B , the anchor  72  and occluder device  80  may be integral, wherein the integral anchor  72  in the contracted first position ( FIG. 4C ) may be advanced through the delivery catheter  58  using the anchor cable  82  and the delivery wire  60 , wherein the anchor  72  extends into the pericardial space  68  using the system  50  of the present invention described above. 
         [0057]    Illustrated in  FIG. 6A , the method of the present invention further comprises retracting the delivery catheter  58 , allowing the first half  74  of the anchor  72  to self-expand from the contracted first position to a partially deployed second position within the occluder device  80 , wherein the occluder device  80  remains inside the outer sheath  56 . The shaft  78  resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall  66 . The second half  76  of the anchor  72  remains in the deployed second position within the pericardial space  68 , wherein the first half  74  of the anchor  72  is in the partially deployed second position within the occluder device  80 . Alternatively as shown in  FIG. 6B , the anchor  72  and occluder device  80  may be integral, wherein the integral anchor  72  and occluder device  80  may be advanced together through the delivery catheter  58 , wherein the anchor  72  is implanted in the LAA wall  66  using the system  50  of the present invention described above. 
         [0058]    Illustrated in  FIG. 7A , the method of the present invention comprises retracting the outer sheath  56  to allow the occluder device  80  to expand inside the LAA  64 . Moreover, retracting the outer sheath  56  allows the first half  74  of the anchor  72  to fully expand into the deployed second position within the occluder device  80 . Thus, the shaft  78  of the anchor  72  may extend through the hole in the distal end of the occluder device  80 , wherein the distal end of the occluder device  80  pinches down on the shaft  78 . Furthermore, the first half of the anchor  74  in the deployed second position may pin the occluder device  80  against the LAA wall  66 , wherein the anchor  72  effectively moors the occluder device  80  inside the LAA  64 . At this time the expanded anchor  72  in the deployed second position covers a large surface area and therefore retains the occluder device  80  in an implanted position within the LAA  64 . Alternatively as shown in  FIG. 7B , the anchor  72  and occluder device  80  may be integral. By anchoring the occluder device  80  via the anchor  72  through all three layers of the LAA wall  66 —instead of merely latching onto the thin endocardium layer—the method of the present invention lowers the risk of embolization. Here, the anchor cable  82  remains attached to the anchor  72  and the occluder device  80  in case problems arise after deployment of the occluder device  80 . If no problems arise and it is determined that the occluder device  80  is in an optimal location of the LAA  64 , the anchor cable  82  may be detached from the occluder device  80  and the anchor  72  and removed from the LAA  64 . The buddy wire  62  and delivery wire  60  may also be withdrawn from the LAA  64 , leaving the occluder device  80  anchored securely in the LAA  64  by the method of the present invention. 
         [0059]      FIG. 8  illustrates the method of the present invention if problems arise after deployment of the occluder device  80 . For instance, the method comprises making a determination that the occluder device  80  is not placed in an optimal location of the LAA  64  after deployment to achieve maximum occlusion. In this situation—prior to release of the occluder cable  84  from the occluder device  80  and the anchor cable  82  from the anchor  72 —the outer sheath  56  may be advanced over the occluder device  80  to the LAA wall  66 , wherein the occluder device  80  is retracted inside the outer sheath  56  using the occluder cable  82 . The delivery catheter  58  may then be advanced to the LAA wall  66 , wherein the occluder device  80  and the first half  74  of the anchor  72  is retracted inside the delivery catheter  58  using the anchor cable  82 . Thus, using the anchor cable  82 , the first half  74  of the anchor  72  retracts from the deployed second position to the contracted first position to fit inside the delivery catheter  58  along with the occluder device  80 . The occluder device  80  may then be removed from the LAA  64 , or the occluder device  80  may be re-deployed in a more optimal location of the LAA  64 . If the occluder device  80  is removed from the LAA  64 , the first half  74  of the anchor  72  may be allowed to expand from the contracted first position to the deployed second position within the LAA  64 . Thus, the deployed anchor  72  remains inside the LAA  64  and allows for occlusion of the small hole  70  that was created by the pericardial catheter  54  through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall  66 . Alternatively, if the anchor  72  and the occluder device  80  are integral both may be removed simultaneously from the LAA  64  using the anchor cable  82  via the delivery catheter  58 . 
         [0060]    Illustrated in  FIG. 9 , if a determination is made that optimal placement of the anchor  72  was not achieved, the anchor  72  may be released from the anchor cable  82  and deployed alone within the LAA wall  66  to plug the small hole  70  and prevent fluids from entering the pericardial space  68 . The delivery wire  60  and buddy wire  62  may be subsequently removed from the LAA  64 . This allows for a new anchor  72  to be placed within the LAA wall  66  using the method cited above for achieving optimal placement of the occluder device  80  within the LAA  64 . On the other hand, if a determination is made that the anchor  72  is initially placed in an optimal location within the LAA wall  66  but there are problems with the occluder device  80 , a second occluder device may be advanced with the delivery catheter  58  and deployed within the LAA  64  using the method cited above. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device  80  into the LAA  64  using anchor  72 , safely retrieve or re-deploy the occluder device  80  if initial placement was improper or if complications arise, with an option to re-implant a new occluder device and new anchor in an optimal location of the LAA  24 . After optimal placement of the occluder device  80  within the LAA  64  is achieved, the delivery wire  60  and buddy wire  62  may be removed from the LAA  64 . 
         [0061]    The anchoring system and method of the present invention are universally applicable to occluder devices of all shapes and sizes, makes, models, and manufacturers. It is also intended that the anchoring system and method of the present invention may be used for other medical devices to be implanted in the cardiac or vascular system. For example, the anchoring system and method of the present invention may be used to implant medical devices that collect physiologic parameters inside the main or branch pulmonary arteries, the right or left ventricle or other intracardiac structures (e.g., atrial septum, aorta, etc.). Thus, using techniques described above various medical devices may be anchored in a free wall of an arterial, atrial or ventricular wall. While intended for humans, the anchoring system and method of the present invention may also be used for all manner of animals. Although the invention has been described and illustrated with respect to preferred aspects thereof, it is not to be so limited since changes and modifications may be made therein which are within the full intended scope of the invention.