Method and system for accessing a pericardial space

Abstract

A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.

1 . A device for accessing a pericardial space of a heart, the device comprising: 
 a shaft extending from a proximal end to a distal end, the shaft defining a cavity disposed near the distal end, and a suction lumen terminating in at least one distal suction port located within the cavity; and    a hollow needle extending through the shaft and fixed in position relative to a longitudinal axis of the shaft, the needle having a sharp distal end protruding into the cavity downwardly toward a heart surface at an angle with respect to a longitudinal axis of the shaft.    
   
   
       2 . The device of  claim 1  further comprising a guidewire adapted for advancing through a bore of the needle.  
   
   
       3 . The device of  claim 1  wherein the suction lumen terminates in a plurality of distal suction ports.  
   
   
       4 . The device of  claim 1  wherein the needle extends a distance of from about 0.5 to about 3 mm into the cavity.  
   
   
       5 . The device of  claim 1  wherein the angle is between about 15 and about 60 degrees.  
   
   
       6 . The device of  claim 1  wherein the angle is about 90 degrees.  
   
   
       7 . The device of  claim 1  wherein the cavity has a generally concave configuration with respect to the heart surface.  
   
   
       8 . The device of  claim 1  further comprising a flange structure formed on an inner wall of the shaft adapted to prevent longitudinal movement of the needle relative to the shaft and permit rotational movement of the needle relative to the shaft.  
   
   
       9 . A device for accessing a pericardial space of a heart, the device comprising: 
 a shaft extending from a proximal end to a distal end, the having a suction lumen terminating in at least one distal suction port near the distal end and an inflation lumen;    an inflatable member positioned near a distal end of the shaft, the inflatable member having a collapsed configuration and an inflated configuration defining a cavity, the inflatable member in communication with the inflation lumen; and    a hollow needle adapted for advancement through the shaft into the cavity.    
   
   
       10 . The device of  claim 9  further comprising a secondary lumen terminating in an access port located within the cavity.  
   
   
       11 . The device of  claim 10  wherein the needle is adapted for advancement through the secondary lumen.  
   
   
       12 . The device of  claim 9  wherein the inflatable member is ring or toroidal-shaped.  
   
   
       13 . The device of  claim 9  wherein the inflatable member is inflatable to at least a first intermediate configuration.  
   
   
       14 . The device of  claim 9  wherein the suction lumen terminates in a plurality of suction ports.  
   
   
       15 . The device of  claim 9  wherein the shaft further defines a recess adapted to hold the inflatable member while in the collapsed configuration.  
   
   
       16 . A method of accessing the pericardial space, the method comprising: 
 maneuvering a distal end of a shaft to the pericardial surface;    inflating an inflatable member disposed at the distal end of the shaft to an inflated configuration defining a cavity adjacent the pericardial surface;    applying suction within the cavity to draw the pericardium into the cavity and create an enlarged region;    piercing the pericardium within the cavity to access the pericardial space; and    inserting a payload through the pierced pericardium and into the pericardial space.    
   
   
       17 . The method of  claim 16  wherein piercing the pericardium further includes advancing a hollow needle having a sharp distal end through the shaft to the cavity.  
   
   
       18 . The method of  claim 16  wherein inserting the payload further includes advancing a guidewire through the needle and into the enlarged region.  
   
   
       19 . The method of  claim 16  further comprising removing the suction to release the pericardium from the cavity.  
   
   
       20 . The method of  claim 16  wherein inflating the inflatable member further includes inflating the inflatable member to an intermediate configuration.