Methods and devices for endoscopic access to the heart

Abstract

Disclosed are devices for cardioscopic and pericardioscopic access to the heart, including direct access to the left atrium. In certain embodiments, the device may comprise an atrial portal having a configuration such that the distal end of the atrial portal can access the atrium while the proximal end of the portal can extend to outside of the subject. The devices and methods may also include a pericardioscopic portal for emplacement of the atrial portal. Also, methods for using such atrial portals and pericardial portals to perform surgery on the heart, and in some cases to directly access the left atrium, and systems (e.g., kits) comprising these portals in combination with other therapeutic devices are disclosed.

1 .- 17 . (canceled) 
     
     
         18 . A device for accessing an atrium of a heart in a subject so as to perform a surgical procedure upon the atrium, the device comprising:
 an atrial portal having a proximal end, a distal end, a lumen formed therein, and a configuration such that said distal end of said atrial portal is configured for insertion into a pericardium of the subject via an incision in the pericardial sac to provide cardioscopic access to the atrium directly through the atrial wall while the proximal end of said atrial portal extends to outside of the subject;   a cap at the distal end of said atrial portal that is configured to secure the distal end of the atrial portal in the atrial wall via the incision in the pericardial sac; and   one or more tools included in the lumen of the atrial portal for performing procedures a region of the heart accessible via the atrium and through the atrial portal.   
     
     
         19 . The device of  claim 18 , wherein the atrium is the left atrium. 
     
     
         20 . The device of  claim 18 , further comprising a pericardial portal into which the atrial portal is inserted, the pericardial portal having a configuration such that the distal end of the atrial portal can access the atrium while the proximal end of the atrial portal can extend to outside of the subject. 
     
     
         21 . The device of  claim 20 , further comprising a cutting tool that extends from the distal end of the pericardial portal or the left atrial portal and configured to create an incision in the pericardial sac allow for the distal end of the portal to be inserted into the pericardial sac and positioned in the pericardial space. 
     
     
         22 . The device of  claim 20 , further comprising an imaging device that extends from the distal end of the pericardial portal or the atrial portal to provide an image of body structures present near the distal end of the atrial portal. 
     
     
         23 . The device of  claim 20 , further comprising a suture tool that extends from the distal end of the pericardial portal that is configured for emplacing sutures in the atrial wall to secure the atrial portal in the atrium wall. 
     
     
         24 . The device of  claim 23 , wherein the sutures are of a configuration so as to surround the atrial portal upon insertion of the atrial portal in the atrium such that tightening the sutures around the atrial portal secures the atrial portal in the atrium. 
     
     
         25 . The device of  claim 23 , further comprising a tourniquet configured to tighten the sutures around the atrial portal. 
     
     
         26 . The device of  claim 18 , wherein the atrial portal further comprises a needle within the lumen of the atrial portal, wherein the needle is configured to puncture the atrium so as to provide an opening for insertion of the portal into the atrium. 
     
     
         27 . The device of  claim 18 , wherein the atrial portal further comprises a guide wire, wherein the guide wire is configured to provide a path for insertion of the atrial portal into the atrium by threading the atrial portal over the guide wire and into the atrium. 
     
     
         28 . The device of  claim 18 , wherein the distal end of the atrial portal comprises a dilating introducer, wherein the dilating introducer is configured so as to be inserted in an opening in the atrial wall so as to enlarge the opening of the atrial wall for insertion of the atrial portal into the atrium. 
     
     
         29 . The device of  claim 18 , wherein the distal end of the atrial portal comprises a cap configured to secure the distal end of the atrial portal in the atrial wall. 
     
     
         30 . The device of  claim 29 , wherein at least a portion of the cap can be expanded laterally away from the central longitudinal axis of the atrial portal. 
     
     
         31 . The device of  claim 20 , further comprising at least one tool in the pericardial portal for performing procedures on the atrium or a region of the heart accessible via the atrium. 
     
     
         32 . The device of  claim 31 , wherein the tool is configured to be threaded over a guide wire that extends from the proximal end of the atrial portal to the distal end of the atrial portal. 
     
     
         32 . The device of  claim 31 , wherein the tool comprises at least one of an ablation element, an electrode, a stent, a valve, an expandable member, a debris capture device, or a barbed needle. 
     
     
         33 . The device of  claim 18 , wherein the cap comprises a distal portion and proximal portion, wherein the cap has a continuous external surface that widens continuously from the proximal portion to the distal portion such that an external diameter of the continuous external surface widens continuously from the proximal portion to the distal portion, wherein the cap distal portion is configured to be located within the atrium on a first side of the atrial wall and the cap proximal portion is configured to be located within the atrial wall. 
     
     
         34 . The device of  claim 33 , further comprising:
 a removable dilating introducer removably secured to the cap distal portion, wherein the dilating introducer has a conical concave shape that converges from a proximal end thereof to a distal free end, wherein the proximal end has an external diameter that is less than the external diameter of the cap distal portion, wherein the dilating introducer is configured so as to be inserted in an opening in the atrial wall so as to enlarge the opening of the atrial wall for insertion of the atrial portal into the atrium; and   at least two flat elements attached to and extending radially outward from an outer surface of the cap at the proximal portion of the cap, wherein the at least two flat elements are configured to engage an opposite second side of the atrial wall in contacting, flat face-to-face relationship to secure the cap in the atrial wall so as to prevent the atrial portal from being inserted further into the atrium   
     
     
         35 . A method to access the atrium of a heart in a subject so as to perform surgical procedures upon the atrium, the method comprising:
 (a) inserting the distal end of an atrial portal into the pericardium of the subject;   (b) manipulating the proximal end of the atrial portal to position the distal end of the atrial portal at the surface of the atrium;   (c) determining an entry location for the atrial portal to be inserted into the atrium;   (d) inserting the atrial portal into the atrium; and   (e) securing the position of the atrial portal in the atrium.