Left atrial appendage occluder device anchoring system, anchor, and method of attachment

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.

What is claimed is: 
     
         1 . An anchoring system for implanting an occluder device within a left atrial appendage (LAA) of a heart, comprising:
 an outer sheath;   a pericardial catheter;   an occluder device for a LAA;   an anchor;   a contracted first position of the anchor;   a deployed second position of the anchor;   the outer sheath inserted into the LAA through a left atrium proper of the heart;   the pericardial catheter advanced through the outer sheath into the LAA;   the pericardial catheter perforates an inner endocardium layer, middle myocardium layer, and outer epicardium layer of an LAA wall of the heart;   the pericardial catheter creates a small hole through the LAA wall into a pericardial space;   a delivery wire and/or a buddy wire advanced through the pericardial catheter into the pericardial space of the heart through the small hole;   the pericardial catheter removed from the LAA through the outer sheath;   the occluder device and the anchor advanced into the LAA using the delivery wire, wherein the anchor is in the contracted first position;   the anchor in the contracted first position is advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall using the delivery wire;   the anchor in the contracted first position is advanced into the pericardial space through the small hole in the LAA wall using the delivery wire;   the anchor is expanded in the pericardial space from the contracted first position to the deployed second position; and   the occluder device is released from the outer sheath to occlude the LAA;   wherein the anchor moors the occluder device to the LAA wall.   
     
     
         2 . The anchoring system of  claim 1 , further comprising:
 the occluder device is detached from the anchor;   the anchor is left implanted in the LAA wall of the LAA;   the occluder device is retrieved;   a new anchor is inserted into the LAA;   the new anchor is implanted at another location in the LAA wall, wherein the new anchor is advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall;   the occluder device is released from the outer sheath to occlude the LAA; and   wherein the occluder device is moored to the LAA wall via the new anchor.   
     
     
         3 . The anchoring system of  claim 1 , further comprising:
 the occluder device is detached from the anchor;   the anchor is left implanted in the LAA wall of the LAA;   the occluder device is retrieved;   a new occluder device is inserted into the LAA via the outer sheath;   the new occluder device is attached to the anchor implanted in the LAA wall of the LAA;   the new occluder device is released from the outer sheath to occlude the LAA; and   wherein the occluder device is moored to the LAA wall via the new anchor.   
     
     
         4 . The anchoring system of  claim 1 , wherein the anchor has a diameter of approximately 1-5 mm in the contracted first position and a diameter of approximately 2-20 mm in the deployed second position. 
     
     
         5 . The anchoring system of  claim 1 , wherein the anchor is self-expanding. 
     
     
         6 . The anchoring system of  claim 1 , wherein the anchor comprises a sheave shape. 
     
     
         7 . The anchoring system of  claim 6 , wherein the anchor comprises a first half and a second half, wherein the first half is connected to the second half by a shaft. 
     
     
         8 . The anchoring system of  claim 7 , wherein the first half is inside the LAA, the second half is inside the pericardial space, and the shaft is through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall to moor the occluder device within the LAA. 
     
     
         9 . The anchoring system of  claim 8 , wherein the anchor comprises a coil. 
     
     
         10 . The anchoring system of  claim 9 , wherein the anchor comprises a first coil and a second coil, wherein the first coil is connected to the second coil by a shaft. 
     
     
         11 . The anchoring system of  claim 10 , wherein the first coil is inside the LAA, the second coil is inside the pericardial space, and the shaft is through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall to moor the occluder device within the LAA. 
     
     
         12 . An anchor for implanting an occluder device within a left atrial appendage (LAA) of a heart, comprising:
 an anchor comprising a contracted first position and a deployed second position;   wherein the anchor penetrates an inner endocardium layer, a middle myocardium layer, and an outer epicardium layer of a LAA wall;   wherein a portion of the anchor self-expands from a contracted first position to a deployed second position within a pericardial space of the heart;   wherein the occluder device is moored to the LAA wall via the anchor.   
     
     
         13 . The anchor of  claim 12 , further comprising:
 wherein the occluder device may be detached from the anchor;   wherein the anchor remains implanted through the LAA wall without harming the patient.   
     
     
         14 . The anchor of  claim 12 , further comprising:
 wherein the anchor retracts from the deployed second position to the contracted first position;   wherein the anchor re-penetrates at a different location of the LAA wall the inner endocardium layer, the middle myocardium layer, and the outer epicardium layer of the LAA wall;   wherein a portion of the anchor self-expands from a contracted first position to a deployed second position within the pericardial space of the heart; and   wherein the occluder device is moored to the LAA wall via the anchor at a new location.   
     
     
         15 . The anchor system of  claim 12 , wherein the anchor has a diameter of approximately 1-5 mm in the contracted first position and a diameter of approximately 2-20 mm in the deployed second position. 
     
     
         16 . The anchoring system of  claim 15 , wherein the anchor comprises a sheave shape. 
     
     
         17 . The anchoring system of  claim 15 , wherein the anchor comprises a coil. 
     
     
         18 . A method of anchoring an occluder device within a left atrial appendage (LAA) of a heart, comprising:
 providing an anchoring system for implanting the occluder device within the LAA, wherein the anchoring system comprises:
 a) an outer sheath; 
 b) a pericardial catheter; 
 c) an occluder device for a LAA; 
 d) an anchor; 
 e) a plurality of self-expanding anchor tines or a sheave shape or a coil; 
 f) a contracted first position of the anchor; and 
 g) a deployed second position of the anchor; 
   inserting the outer sheath into the LAA through a left atrium proper of the heart;   advancing the pericardial catheter through the outer sheath into the LAA;   perforating an inner endocardium layer, a middle myocardium layer, and an outer epicardium layer of an LAA wall of the heart using the pericardial catheter;   creating a small hole through the LAA wall into a pericardial space using the pericardial catheter;   advancing a delivery wire and/or a buddy wire through the pericardial catheter into the pericardial space of the heart through the small hole;   removing the pericardial catheter from the LAA through the outer sheath;   advancing the occluder device and anchor into the LAA using the delivery wire, wherein the anchor is in the contracted first position;   advancing the anchor in the contracted first position through the inner endocardium layer, the middle myocardium layer, and the outer epicardium layer of the LAA wall using the delivery wire;   further advancing the anchor in the contracted first position into the pericardial space through the small hole in the LAA wall using the delivery wire;   expanding the anchor from the contracted first position to the deployed second position; and   releasing the occluder device from the outer sheath to occlude the LAA;   wherein the occluder device is moored to the LAA wall via the anchor.   
     
     
         19 . The method of  claim 18 , further comprising:
 detaching the occluder device from the anchor;   leaving the anchor implanted in the LAA wall of the LAA;   retrieving the occluder device inside the outer sheath;   inserting a new occluder device in the outer sheath;   implanting the new occluder device in the LAA using the anchor;   releasing the occluder device from the outer sheath to occlude the LAA; and   removing the delivery wire, buddy wire, and outer sheath from the LAA.   
     
     
         20 . The method of  claim 18 , further comprising:
 retrieving the occluder device inside the outer sheath;   removing the anchor from the LAA wall, wherein the anchor retracts from the deployed second position to the contracted first position;   advancing the anchor through the inner endocardium layer, the middle myocardium layer, and the outer epicardium layer at a different location of the LAA wall; and   releasing the occluder device from the outer sheath to occlude the LAA.