Devices and methods for percutaneous access, hemostasis, and closure

Abstract

The present invention provides methods and devices for obtaining percutaneous access, maintaining hemostasis, and providing closure of openings in tissues of the body. In particular, the present invention provides methods and devices for maintaining hemostasis and providing closure surgical incisions of the left ventricular apex of the heart.

1 . A medical closure device comprising one or more elements, a proximal expanded element and a distal expanded element; wherein said distal expanded element is configured to adopt a reduced profile configuration upon inserting said distal expanded element into a confined space; wherein said distal expanded element is configured to readopt a high profile configuration upon exit from said confined space; and wherein said medical closure device comprises one or more impermeable surfaces configured to occlude blood flow through an opening in a body tissue. 
     
     
         2 . The medical closure device of  claim 1 , wherein said body tissue comprises the left ventricular apex. 
     
     
         3 . The medical closure device of  claim 2 , wherein said opening comprises a surgical incision. 
     
     
         4 . The medical closure device of  claim 1 , wherein said medical closure device is configured for insertion into said opening into said body tissue. 
     
     
         5 . The medical closure device of  claim 4 , wherein said insertion is assisted by a delivery device. 
     
     
         6 . The medical closure device of  claim 1 , wherein one or more elements comprise inner lumens. 
     
     
         7 . The medical closure device of  claim 6 , wherein said medical closure device comprises one element. 
     
     
         8 . The medical closure device of  claim 6 , wherein said medical closure device comprises a proximal cylinder element attached to said proximal expanded element and a distal cylinder element attached to said distal expanded element. 
     
     
         9 . The medical closure device of  claim 8 , wherein said distal cylinder element is configured to fit axially within said inner lumen of said proximal cylinder element. 
     
     
         10 . The medical closure device of  claim 9 , wherein said distal cylinder element is configured to lock in place within said proximal cylinder element. 
     
     
         11 . The medical closure device of  claim 6 , wherein one or more of said inner lumens comprise a one-way valve. 
     
     
         12 . The medical closure device of  claim 11 , wherein said one-way valve is configured to occlude the flow of blood through said one or more inner lumens. 
     
     
         13 . The medical closure device of  claim 12 , wherein said one-way valve is configured to provide access to medical instruments from the proximal end of said medical closure device to the distal end of said medical closure device through said one or more inner lumens. 
     
     
         14 . The medical closure device of  claim 1 , wherein said medical closure device comprises a metal fabric skeleton. 
     
     
         15 . The medical closure device of  claim 14 , wherein said wherein said metal fabric skeleton comprises one or more shape memory materials. 
     
     
         16 . The medical closure device of  claim 1 , wherein said wherein said medical closure device comprises a blood-impermeable skin. 
     
     
         17 . The medical closure device of  claim 16 , wherein said wherein said blood-impermeable skin comprises a polymer coating. 
     
     
         18 . A medical closure device comprising (a) a proximal unit, wherein said proximal unit comprises a proximal cylinder and a proximal expanded element; and (b) a distal unit, wherein said distal unit comprises a distal cylinder and a distal expanded element; wherein said proximal cylinder and said distal cylinder comprise inner lumens, wherein one or more of said inner lumens comprise a one-way valve; wherein said proximal cylinder is configured to attach to said distal cylinder; wherein said distal expanded element is configured to adopt a reduced profile configuration upon inserting said distal expanded element into a confined space;
 wherein said distal expanded element is configured to readopt a high profile configuration upon exit from said confined space; wherein said medical closure device is configured to be inserted into a surgical incision in a body tissue; and wherein said medical closure device comprises one or more impermeable surfaces configured to occlude blood flow.   
     
     
         19 . A medical closure device comprising a single unit comprising cylinder element, a proximal expanded element and a distal expanded element; wherein said cylinder element comprises an axial aperture; wherein said axial aperture comprises a one-way valve; wherein said proximal expanded element and said distal expanded element comprise a shape memory material; wherein said proximal expanded element and said distal expanded element are configured to adopt a reduced profile configuration under applied pressure; wherein said proximal expanded element and said distal expanded element are configured to readopt a high profile configuration upon release of applied pressure; wherein said medical closure device is configured to be deployed into an opening in a body tissue; and wherein said medical closure device comprises one or more impermeable surfaces configured to occlude blood flow.