Endoluminal medical access device

Abstract

An endoluminal medical access device ( 1 ) is disclosed that is devised for endoluminal delivery to an extravascular target site ( 5 ) at a vasculature site of a human or animal body vasculature, such as the microvasculature. The device ( 1 ) comprises a hollow body ( 112 ) arranged around a continuous channel ( 113 ) that ends in a distal end ( 100 ) and comprises a distal penetration portion ( 102 ) that is devised to extend across a tissue wall of said microvasculature said microvasculature site ( 4 ) at an extravascular target site in said body to provide communication with said extravascular target site through said channel ( 113 ) and devised for at least partly apposition to said tissue wall, and a proximal connection section ( 101 ), which proximally adjoins said penetration portion ( 102 ), and optionally comprises an intrusion depth limit unit ( 116, 118 ) and/or a hollow separation section ( 115 ) devised to provide a controllable separation of the penetration portion ( 102 ) from a connected proximal portion ( 110 ) of the hollow body.

1 - 25 . (canceled) 
     
     
         26 . A method of endoluminal access to an extravascular target site in a heart, said method comprising:
 perforating a vessel wall of a coronary artery or coronary vein at an extravascular target site in said heart with a distal portion of an endoluminal access device,   positioning said distal portion of said endoluminal access device extending across said vessel wall at least partly in apposition to said vessel wall,   limiting an intrusion distance of said distal portion through said vascular wall, and   providing communication with an extravascular space at said target site through a communication channel in said endoluminal access device.   
     
     
         27 . The method of  claim 26 , further comprising withdrawing said endoluminal access device. 
     
     
         28 . The method of  claim 26 , wherein said endoluminal access device comprises:
 a hollow body that is arranged around a continuous channel that ends in an opening at a distal end of said device;   a distal portion that is configured to perforate a tissue wall of said coronary artery or coronary vein at said target site to provide communication with said extravascular target site through said channel while said distal portion is at least partly in apposition to said tissue wall; and   an intrusion distance limitation unit that prevents perforation of said distal portion beyond an intrusion distance through said vascular wall.   
     
     
         29 . The method of  claim 28 , wherein said intrusion distance limitation unit comprises a flange configured to limit an intrusion distance of said endoluminal medical access device into said tissue wall. 
     
     
         30 . The method of  claim 29 , wherein said flange is foldable towards said hollow body. 
     
     
         31 . The method of  claim 28 , wherein said intrusion distance limitation unit is a recess in an outer wall of said hollow body. 
     
     
         32 . The method of  claim 26 , wherein said distal portion has an inner diameter to length ratio such that the flow of blood through said channel is zero at physiological pressures, whereby said endoluminal access device is adapted for delivery either in an arterial or a venous side of the vasculature. 
     
     
         33 . The method of  claim 26 , comprising navigating said endoluminal access into a vessel having a luminal diameter of 1 mm or less. 
     
     
         34 . The method of  claim 26 , wherein said perforating is performed with a sharp tip at a distal end of said distal portion. 
     
     
         35 . A method of communicating with a target site in a heart, said method comprising establishing communication with said target site by performing the method according to  claim 26 , and wherein said procedure is delivery of a substance to said target site or taking of a sample from said target site through said communication channel, wherein said delivery or taking of sample is made at a pressure higher than a physiological pressure in said vessel. 
     
     
         36 . The method of  claim 35 , wherein said substance comprises cells, thus endovascularly transplanting said cells into said target site. 
     
     
         37 . The method of  claim 35 , wherein said delivery or taking of sample is to or from heart muscle or to or from a vessel wall. 
     
     
         38 . The method of  claim 35 , wherein said delivery of a substance comprises local administration of said substance. 
     
     
         39 . The method of  claim 37 , wherein said substance comprises a stem cell, a fluid, a pharmaceutical agent, a cytostatic substance, a growth factor, a contrast agent, a radioactive agent, or radioactive isotope particle, or any combination of these. 
     
     
         40 . The method of  claim 35 , wherein said taking of said sample comprises a puncture of a cyst. 
     
     
         41 . The method of  claim 36 , further comprising subintimally passing an occlusion or stenosis of a vessel with said device. 
     
     
         42 . An endoluminal medical access device for endoluminal delivery to an extravascular target site at a vasculature site of a human or animal body vasculature, said device comprising:
 a hollow body that is arranged around a continuous channel that ends in an opening at a distal end of said device; wherein:   said hollow body comprises an elongate distal penetration portion that is configured to perforate a tissue wall of said vasculature at said vasculature site and to provide communication with said extravascular target site through said channel while at least partly in apposition to said tissue wall;   said device comprises an intrusion depth limitation unit configured to prevent introduction of said distal penetration portion beyond a desired insertion depth through said vascular wall into the extravascular target site;   said distal portion has an inner diameter to length ratio such that the flow of blood through said channel is zero at physiological pressures, whereby said endoluminal access device is adapted for delivery via coronary arteries or veins or via coronary sinus.   
     
     
         43 . The device of  claim 42 , wherein said hollow body comprises a fiducial marker. 
     
     
         44 . The device of  claim 42 , wherein said device is sized to access a coronary vessel having a luminal diameter of 1 mm or less. 
     
     
         45 . The device of  claim 42 , wherein said intrusion depth limitation unit comprises a flange configured to limit an intrusion depth of said device into said tissue wall or wherein said depth limitation unit comprises a flange that is foldable towards said hollow body.