Cardiac harness delivery device and method

Abstract

The apparatus includes and elongate body having a proximal portion and a distal portion. The body includes a cavity sized to contain a cardiac harness in a compacted configuration and also includes a plurality of elongate push rods movable with respect to the body. The cardiac harness is releasably connected to each of the push rods such that advancement of the push rods in a distal direction moves the harness from a compacted configuration, within the cavity, to an expanded configuration, outside the cavity. The apparatus also includes a releasing member for releasing the connections between the push rods and the harness upon actuation of the releasing member by a user.

1 - 25 . (canceled)  
     
     
         26 . An apparatus for creating a passage through the pericardium of a patient to permit access of a cardiac harness delivery device to the heart, comprising: 
 an introducer sleeve having an outer wall defining a proximal end and a distal end, the outer wall having a reduced-diameter portion adjacent to the distal end, the reduced-diameter portion defining a reduced orientation having a first diameter, the distal end being sized to be insertable through an incision in the pericardium of the heart; and    a dilator sleeve, the dilator sleeve being sized and shaped to be insertable into the introducer sleeve to dilate the reduced-diameter portion into an expanded orientation having a second diameter, larger than the first diameter, the second diameter being of a size sufficient to permit the cardiac harness delivery device to pass therethrough.    
     
     
         27 . An apparatus for creating a passage through the pericardium of a patient to permit access of a cardiac harness delivery device to the heart, comprising: 
 an introducer sleeve having an outer wall defining a proximal end and a distal end, the outer wall having a reduced-perimeter portion adjacent to the distal end, the reduced-perimeter portion defining a reduced orientation having a first perimeter, the distal end being sized to be insertable through an incision in the pericardium of the heart; and    a dilator sleeve, the dilator sleeve being sized and shaped to be insertable into the introducer sleeve to dilate the reduced-perimeter portion into an expanded orientation having a second perimeter, larger than the first perimeter, the second perimeter being of a size sufficient to permit the cardiac harness delivery device to pass therethrough.    
     
     
         28 . The apparatus of  claim 27 , additionally comprising a releasable lock for releasably engaging the dilator sleeve within the introducer sleeve.  
     
     
         29 . The apparatus of  claim 27 , wherein the introducer sleeve is a thin-walled tubular element having a substantially circular cross-sectional shape.  
     
     
         30 . The apparatus of  claim 27 , additionally comprising a biasing member surrounding the outer wall of the introducer sleeve, the biasing member being configured to bias the reduced-perimeter portion into the reduced orientation.  
     
     
         31 . The apparatus of  claim 30 , wherein the biasing member comprises an elastic ring.  
     
     
         32 . The apparatus of  claim 27 , wherein the outer wall of the introducer sleeve comprises a plurality of cut out portions extending parallel to a longitudinal axis of the outer wall, the cut out portions extending at least through the reduced-perimeter portion of the outer wall.  
     
     
         33 . The apparatus of  claim 27 , wherein the introducer sleeve has a plurality of elongate strips, the elongate strips extending from the distal end of the introducer sleeve through the reduced-perimeter portion.  
     
     
         34 . The apparatus of  claim 33 , wherein the elongate strips extend about the distal-most two-thirds of the length of the introducer sleeve.  
     
     
         35 . The apparatus of  claim 33 , wherein the elongate strips have flared portions at the distal end, the flared portions biased outwardly from a longitudinal axis of the introducer sleeve.  
     
     
         36 . The apparatus of  claim 35 , wherein the elongate strips are spaced apart from each other, the flared portions at the distal end widen in a direction generally transverse to a longitudinal axis of the introducer sleeve.  
     
     
         37 . The apparatus of  claim 27 , wherein the reduced orientation comprises the outer wall at the distal end of the introducer sleeve having a distal perimeter greater than the first perimeter at the reduced-perimeter portion of the introducer sleeve, the distal perimeter being sized to permit the distal end to engage the interior surface of the pericardium surrounding the incision.  
     
     
         38 . The apparatus of  claim 27 , wherein the expanded orientation comprises the outer wall at the distal end of the introducer sleeve having a distal perimeter greater than the second perimeter at the reduced-perimeter portion of the introducer sleeve, the distal perimeter being sized to permit the distal end to contact the interior surface of the pericardium surrounding the incision.  
     
     
         39 . The apparatus of  claim 27 , wherein the dilator sleeve is a thin-walled tubular element having a substantially circular cross-sectional shape.  
     
     
         40 . The apparatus of  claim 27 , wherein the dilator sleeve has an inner perimeter greater than an outer perimeter of the cardiac harness delivery device, thereby permitting the cardiac harness delivery device to be advanced therethrough.  
     
     
         41 . The apparatus of  claim 27 , wherein the dilator sleeve has a distal portion, the distal portion having an outer perimeter, the proximal end of the introducer sleeve having an inner perimeter slightly greater than the outer perimeter of the distal portion of the dilator sleeve, thereby permitting the dilator sleeve to be advanced within the introducer sleeve.  
     
     
         42 . The apparatus of  claim 41 , wherein the outer perimeter of the distal portion of the dilator sleeve is greater than the first perimeter of the reduced-perimeter portion of the introducer sleeve, thereby permitting the dilator sleeve to dilate the reduced-perimeter portion.  
     
     
         43 . The apparatus of  claim 27 , wherein the dilator sleeve has a proximal portion and a distal portion, the proximal portion having an enlarged perimeter portion relative to the distal portion, the proximal end of the introducer sleeve having an inner perimeter smaller than the perimeter of the enlarged perimeter portion, thereby limiting advancement of the dilator sleeve within the introducer sleeve.  
     
     
         44 . An apparatus for creating a passage through the pericardium of a patient to permit access of a cardiac harness device to the heart, comprising: 
 an introducer sleeve having a narrowing distal portion relative to the proximal portion, the distal portion having a plurality of elongate strips, the elongate strips having flared portions, the flared portions positioned at a distal end of the introducer sleeve for engaging an incision in the pericardium of the heart; and    a dilator sleeve, the dilator sleeve having an inner wall and an outer wall, the outer wall perimeter being sized to permit the dilator sleeve to slide within the introducer sleeve for deflecting the elongate strips of the introducer sleeve, the inner wall perimeter being sized to permit a cardiac harness delivery device to pass therethrough.    
     
     
         45 . An apparatus for creating a passage through the pericardium of a patient to permit access of a cardiac harness device to the heart, comprising: 
 an introducer sleeve, the introducer sleeve having a contracted distal end, the distal end having a plurality of flared portions for engaging an incision in the pericardium of the heart; and    a dilator sleeve, the dilator sleeve having an inner wall and an outer wall, the outer wall perimeter being sized to permit the dilator sleeve to slide within the introducer sleeve for expanding the distal end of the introducer sleeve, the inner wall perimeter being sized to permit a cardiac harness delivery device to pass therethrough.    
     
     
         46 . A method for creating a passage through the pericardium of a patient to permit access of a cardiac harness delivery device to the heart, comprising: 
 making an incision in the pericardium;    introducing through the incision a distal end of an introducer sleeve having a reduced orientation; and    dilating the distal end of the introducer sleeve into an expanded orientation thereby dilating the incision to a size sufficient to permit access of a cardiac harness delivery device to the heart.    
     
     
         47 . The method of  claim 46 , wherein making the incision comprises sizing the incision smaller than the perimeter of the distal end of the introducer sleeve in the reduced orientation.  
     
     
         48 . The method of  claim 46 , wherein introducing the introducer sleeve comprises: 
 positioning the distal end of the introducer sleeve adjacent to the incision;    inserting through the incision a first portion of the distal end of the introducer sleeve;    inserting through the incision a second portion of the distal end of the introducer sleeve; and    advancing the first portion and the second portion of the introducer sleeve through the incision to engage an inside edge of the incision.    
     
     
         49 . The method of  claim 48 , wherein positioning the distal end of the introducer sleeve comprises advancing the distal end through a minimally invasive pathway to the pericardium.  
     
     
         50 . The method of  claim 46 , wherein dilating the introducer sleeve into the expanded orientation comprises: 
 introducing a dilator sleeve within the introducer sleeve to dispose the dilator sleeve against a reduced-perimeter portion of the introducer sleeve;    advancing the dilator sleeve to overcome a biasing force exerted on the reduced-perimeter portion; and    further advancing the dilator sleeve into the reduced-perimeter portion of the introducer sleeve so that the distal end of the introducer sleeve expands to dilate the incision to a perimeter equal to or greater than the perimeter of the cardiac harness delivery device.    
     
     
         51 . The method of  claim 50 , further comprising: 
 advancing the dilator sleeve through the reduced-perimeter portion of the introducer sleeve so that the distal end of the introducer sleeve expands to push the interior surface of the pericardium surrounding the incision away from the heart;    engaging the dilator sleeve within the introducer sleeve so that the flared portions remain expanded when the dilator sleeve is released by the doctor.    
     
     
         52 . The method of  claim 51 , further comprising pulling the introducer sleeve slightly in a proximal direction to lift a portion of the pericardium surrounding the incision away from the heart to create a space.