Access devices and methods for treatment of medical conditions and delivery of injectables

Abstract

Disclosed are access devices that can be used to safely guide instruments, such as EP ablation catheters, to a therapy site such one within the pericardial space of the heart. The access devices include integrated visualization, illumination, stabilization, and safety features in a single platform that can, for example, more safely and efficiently identify and ablate several ventricular tachycardia (VT) locations on the left ventricle of the heart.

1 . An access device for guiding instruments to a region within a human body, the access device comprising:
 a shaft comprising a proximal end and a distal end, the shaft defining a lumen comprising channels extending longitudinally between the proximal end and the distal end, the channels comprising an instrument channel, a balloon inflation channel, and a guide wire channel;   a head attached to the distal end of the shaft, the head comprising a top surface, a bottom surface opposite the top surface, and a port configured to allow an instrument extended through the instrument channel to interact with the region of the human body;   a camera attached to the head and commutatively coupled to a camera cable extending through the shaft, the camera oriented to capture images of the region of the human body; and   a balloon attached to the top surface of the head and in fluid communication with the balloon inflation channel, wherein the balloon is configured to expand adjacent to the top surface of the head without expanding adjacent to the bottom surface of the head.   
     
     
         2 . The access device of  claim 1 , wherein the head has a cylindrical shape and the balloon extends between 170 degrees and 190 degrees along a circumference of the top surface of the head. 
     
     
         3 . The access device of  claim 1  wherein the port is on the bottom surface of the head and the instrument channel connects to a vacuum. 
     
     
         4 . The access device of  claim 1 , wherein the channels further comprise a vacuum channel separate from the instrument channel, wherein the vacuum channel connects to a vacuum, wherein the head defines a vacuum port on the bottom surface of the head, the vacuum port fluidly connected to the vacuum channel. 
     
     
         5 . The access device of  claim 1 , wherein the instrument channel is configured to alternatively receive a diagnostic probe, an ablation instrument, and an injection instrument configured to deliver an injectable. 
     
     
         6 . The access device of  claim 1 , wherein the channels further comprise a diagnostic probe channel configured to receive an ultrasound transducer probe configured to determine tissue thickness and density in the region of the human body. 
     
     
         7 . The access device of  claim 1 , wherein the head further comprises an ultrasound transducer probe configured to determine tissue thickness and density in the region of the human body, wherein the ultrasound transducer probe is commutatively coupled to a diagnostic cable extending through the shaft. 
     
     
         8 . The access device of  claim 7 , wherein the ultrasound transducer probe comprises electronically interconnected piezoelectric crystals that vibrate in response to an applied electric current. 
     
     
         9 . The access device of  claim 1 , wherein the camera comprises a complementary metal-oxide semiconductor (CMOS) chip with optical fiber illumination. 
     
     
         10 . The access device of  claim 9 , wherein the access device comprises fiber optic cable configured to provide illumination for the camera. 
     
     
         11 . The access device of  claim 1 , wherein the camera is oriented at an angle of 1 to 30 degrees relative to a longitudinal axis of the head. 
     
     
         12 . The access device of  claim 1 , wherein the channels further comprise a camera flush channel and the head further comprises a camera flush port configured to pass fluid across a camera lens of the camera. 
     
     
         13 . The access device of  claim 1 , wherein the shaft and head of the access device are sized for insertion through a 2 centimeter (cm) or smaller opening in skin of the human body and pericardium during a surgical procedure, cardiology procedure, or EP cardiology catheterization laboratory procedure on the heart. 
     
     
         14 . The access device of  claim 1  further comprising a handle comprising controls configured to enable manual control of articulation of the head of the access device in at least one plane, the articulation comprising the head deflecting in at least one direction. 
     
     
         15 .- 22 . (canceled) 
     
     
         23 . An access device for guiding instruments to a region within a human body, the access device comprising:
 a shaft comprising a proximal end and a distal end, the shaft defining a lumen comprising channels extending longitudinally between the proximal end and the distal end, the channels comprising an instrument channel and a guide wire channel;   a head attached to the distal end of the shaft, the head comprising a top surface, a bottom surface opposite the top surface, and a port configured to allow an instrument extended through the instrument channel to interact with the region of the human body;   a camera attached to the head and commutatively coupled to a camera cable extending through the shaft, the camera oriented to capture images of the region of the human body; and   an ultrasound transducer positioned at the head and configured to determine tissue thickness or density in the region of the human body.   
     
     
         24 . The access device of  claim 23 , wherein the ultrasound transducer is positioned using a probe inserted through a diagnostic probe channel through the shaft. 
     
     
         25 . The access device of  claim 23 , wherein the ultrasound transducer is attached to the head and commutatively coupled to a diagnostic cable extending through the shaft. 
     
     
         26 . The access device of  claim 23 , wherein the access device further comprises a balloon attached to the head and in fluid communication with the balloon inflation channel. 
     
     
         27 . The access device of  claim 23 , wherein the access device further comprises a hinged shell attached to the top surface of the head and configured to extend upward adjacent to the top surface of the head without extending adjacent to the bottom surface of the head. 
     
     
         28 . The access device of  claim 1 , wherein the channels further comprise a camera flush channel and the head further comprises a camera flush port configured to pass fluid across a camera lens of the camera. 
     
     
         29 . A method for using an access device to perform a procedure within a pericardial space adjacent a heart within a human body, the method comprising:
 inserting a guidewire through a 2 centimeter (cm) or smaller sub-xiphoid incision in the skin of the human body or via percutaneous needle and into the pericardial space;   inserting a head of the access device into the pericardial space using the guidewire, wherein the access device comprises a shaft comprising a proximal end and a distal end, the shaft defining a lumen comprising channels extending longitudinally between the proximal end outside of the human body and the distal end attached to the head in the pericardial space;   determining a region of the heart to treat based on a mapping of the heart determined using an ultrasound transducer positioned at the head and configured to determine tissue thickness or density;   positioning the head of the access device adjacent the portion of the heart to treat;   extending a portion of the access device away from a top surface of the access device to separate the portion of the heart to treat from a surrounding portion of the pericardium;   viewing an image of the portion of the heart to treat adjacent the head of the access device, the image of the portion of the heart to treat captured by a camera at the head of the access device; and   treating heart tissue in the portion of the heart to treat.   
     
     
         30 . The method of  claim 29 , wherein treating the heart tissue comprises using an electrophysiology (EP) ablation catheter inserted through one of the channels in the shaft of the access device to ablate the heart tissue. 
     
     
         31 . The method of  claim 29 , wherein treating the heart tissue comprises injecting a substance adjacent to or in the portion of the heart using an injection catheter inserted through one of the channels in the shaft of the access device. 
     
     
         32 . The method of  claim 31 , wherein treating the heart tissue comprises injecting a substance adjacent to or in the portion of the heart using an injection catheter inserted through one of the channels in the shaft of the access device and positioned at an angle to a surface of the heart tissue, wherein the angle is approximately 45 degrees. 
     
     
         33 . The method of  claim 29 , wherein treating the heart tissue comprises articulating a treatment catheter to precisely position a tip of the treatment catheter relative to the heart tissue. 
     
     
         34 . The method of  claim 29  further comprising moving the access device with the pericardial space by retracting the portion of the access device away from the top surface of the access device, moving the access device within the pericardial space, and re-extending the portion of the access device away from the top surface of the access device.