Systems and methods for luminal access

Abstract

A luminal access system comprises an evertable, lubricious sleeve, a pusher tube, and optionally a lumen tube. The evertable, lubricious sleeve is attached to a non-evertable sheath which is coaxially received over the pusher tube. A distal portion of the evertable sleeve folds or everts into an axial passage of the pusher tube where it is connected to a lumen tube. A distal portion of the pusher tube may be bendable, typically comprising a relatively soft polymer which is circumferentially reinforced to enhance hoop strength.

1 . A luminal access system comprising: 
 an evertable, lubricious sleeve; and    a pusher tube having a distal end, a proximal end, and an axial passage between the distal and proximal ends, wherein the sleeve is positionable over the exterior of the tube to evert over the distal end into the axial passage, and wherein a distal portion of the pusher tube is circumferentially reinforced and relatively more bendable than a proximal portion of the tube.    
     
     
         2 . A luminal access system as in  claim 1 , wherein the sleeve comprises a polymeric tube.  
     
     
         3 . A luminal access system as in  claim 2 , wherein the polymeric tube has a length in the range from 5 cm to 90 cm, an inner diameter in the range from 2 mm to 12 mm, and a wall thickness in the range from 0.01 mm to 0.05 mm.  
     
     
         4 . A luminal access system as in  claim 2 , wherein the polymer is a lubricious polymer.  
     
     
         5 . A luminal access system as in  claim 2 , wherein the polymer is lubricated.  
     
     
         6 . A luminal access system as in  claim 2 , wherein the polymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polyethylene (PE), perfluoroalkoxy (PFA), polyurethane (PU), perfluoromethylvinylether (MFA), perfluoropropylvinylether (PPVE).  
     
     
         7 . A luminal access system as in  claim 6 , wherein the polymer comprises tensilized PTFE/PPVE copolymer.  
     
     
         8 . A system as in  claim 1 , wherein the pusher tube comprises a polymeric tube.  
     
     
         9 . A system as in  claim 8 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, and Pebax, and polyimide (PI).  
     
     
         10 . A system as in  claim 9 , wherein the distal portion of the pusher tube comprises a low density polyethylene and the proximal portion of the pusher tube comprises a high density polyethylene.  
     
     
         11 . A system as in  claim 10 , wherein the distal portion of the pusher tube is reinforced with a wire coil.  
     
     
         12 . A system as in  claim 11 , wherein the wire coil comprises a ribbon wire with adjacent turns spaced apart by a distance greater than the width of the ribbon.  
     
     
         13 . A system as in  claim 8 , wherein the pusher tube further comprises a radiopaque ring near its distal end.  
     
     
         14 . A system as in  claim 1 , wherein the sleeve comprises a sheath structure having a non-evertable portion attached proximal to the evertable, lubricious sleeve.  
     
     
         15 . A system as in  claim 14 , wherein the non-evertable portion of the sheath comprises a flexible but non-everting tube.  
     
     
         16 . A system as in  claim 15 , wherein the non-everting tube has a length in the range from 5 cm to 50 cm, an inner diameter in the range from 1 mm to 12 mm, and a wall thickness from 0.01 mm to 0.1 mm.  
     
     
         17 . A system as in  claim 16 , wherein the tube comprises a polymer.  
     
     
         18 . A system as in  claim 17 , wherein the polymer is selected from the group consisting of PE, flouropolymers, Pebax, and PI.  
     
     
         19 . A system as in  claim 1 , further comprising a lumen tube having a distal end, a proximal end, and a central passage therebetween, wherein the lumen tube is positionable within the axial passage of the pusher tube and is attached at its distal end to the distal end of the sleeve.  
     
     
         20 . A system as in  claim 19 , wherein the lumen tube comprises a polymer.  
     
     
         21 . A system as in  claim 20 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.  
     
     
         22 . A system as in  claim 18 , further comprising a luer fitting on the proximal end of the lumen tube.  
     
     
         23 . A luminal access system comprising: 
 a sheath structure having a non-evertable proximal portion and an evertable, lubricious distal sleeve portion; and    a pusher tube having a distal end, a proximal end, and an axial passage between the distal and proximal ends, wherein the distal sleeve portion of the sheath is positionable over the exterior of the tube to evert over the distal end into the axial passage.    
     
     
         24 . A system as in  claim 23 , wherein the non-evertable portion of the sheath comprises a flexible tube.  
     
     
         25 . A system as in  claim 24 , wherein the tube has a length in the range from 5 cm to 50 cm, an inner diameter in the range from 2 mm to 12 mm, and a wall thickness from 0.01 mm to 0.1 mm.  
     
     
         26 . A system as in  claim 25 , wherein the tube comprises a polymer.  
     
     
         27 . A system as in  claim 26 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.  
     
     
         28 . A luminal access system as in  claim 23 , wherein the lubricious, distal sleeve comprises a polymeric tube.  
     
     
         29 . A luminal access system as in  claim 28 , wherein the polymeric tube has a length in the range from 5 cm to 50 cm, an inner diameter in the range from 2 mm to 12 mm, and a wall thickness in the range from 0.01 mm to 0.05 mm.  
     
     
         30 . A luminal access system as in  claim 28 , wherein the polymer is a lubricious polymer.  
     
     
         31 . A luminal access system as in  claim 28 , wherein the polymer is lubricated.  
     
     
         32 . A luminal access system as in  claim 28 , wherein the polymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polyethylene (PE), perfluoroalkoxy (PFA), polyurethane (PU), perfluoromethylvinylether (MFA), and perfluoropropylvinylether (PPVE).  
     
     
         33 . A luminal access system as in  claim 32 , wherein the polymer comprises tensilized PTFE/PPVE copolymer.  
     
     
         34 . A system as in  claim 23 , wherein a distal portion of the pusher tube is circumferentially reinforced and relatively more bendable than a proximal portion of the tube.  
     
     
         35 . A system as in  claim 34 , wherein the pusher tube comprises a polymeric tube.  
     
     
         36 . A system as in  claim 35 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.  
     
     
         37 . A system as in  claim 36 , wherein the distal portion of the pusher tube comprises a low density polyethylene and the proximal portion of the pusher tube comprises a high density polyethylene.  
     
     
         38 . A system as in  claim 37 , wherein the distal portion of the pusher tube is reinforced with a wire coil.  
     
     
         39 . A system as in  claim 38 , wherein the wire coil comprises a ribbon wire with adjacent turns spaced apart by a distance greater than the width of the ribbon.  
     
     
         40 . A system as in  claim 35 , wherein the pusher tube further comprises a radiopaque ring near its distal end.  
     
     
         41 . A system as in  claim 23 , further comprising a lumen tube having a distal end, a proximal end, and a central passage therebetween, wherein the lumen tube is positionable within the axial passage of the pusher tube and is attached at its distal end to the inner end of the sleeve.  
     
     
         42 . A system as in  claim 41 , wherein the lumen tube comprises a polymer.  
     
     
         43 . A system as in  claim 42 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.  
     
     
         44 . A system as in  claim 41 , further comprising a luer fitting on the proximal end of the lumen tube.  
     
     
         45 . A luminal access system comprising: 
 an evertable, lubricious sleeve having a distal end and a proximal end;    a pusher tube having a distal end, a proximal end, and an axial passage between the distal and proximal ends, wherein the sleeve is positionable over the exterior of the tube to evert the distal end of the sleeve over the distal end of the tube into the axial passage; and    a lumen tube having a distal end, a proximal end, and a central passage between the distal end and the proximal end, wherein the lumen tube is positionable within the axial passage of the pusher tube and attached at its distal end to the distal end of the sleeve.    
     
     
         46 . A system as in  claim 45 , wherein the lumen tube comprises a polymer.  
     
     
         47 . A system as in  claim 46 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.  
     
     
         48 . A system as in  claim 45 , further comprising a luer fitting on the proximal end of the lumen tube.  
     
     
         49 . A system as in  claim 45 , wherein a distal portion of the pusher tube is circumferentially reinforced and relatively more bendable than a proximal portion of the tube.  
     
     
         50 . A system as in  claim 49 , wherein the pusher tube comprises a polymeric tube.  
     
     
         51 . A system as in  claim 50 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.  
     
     
         52 . A system as in  claim 51 , wherein the distal potion of the pusher tube comprises a low density polyethylene and the proximal portion of the pusher tube comprises a high density polyethylene.  
     
     
         53 . A system as in  claim 52 , wherein the distal portion of the pusher tube is reinforced with a wire coil.  
     
     
         54 . A system as in  claim 50 , wherein the pusher tube further comprises a radiopaque ring near its distal end.  
     
     
         55 . A system as in  claim 53 , wherein the wire coil comprises a ribbon wire with adjacent turns spaced apart by a distance in the range from 0.2 mm to 2 mm.  
     
     
         56 . A luminal access system as in  claim 45 , wherein the sleeve comprises a polymeric tube.  
     
     
         57 . A luminal access system as in  claim 56 , wherein the polymeric tube has a length in the range from  5  cm to 50 cm, an inner diameter in the range from 2 mm to 12 mm, and a wall thickness in the range from 0.01 mm to 0.05 mm.  
     
     
         58 . A luminal access system as in  claim 56 , wherein the polymer is a lubricious polymer.  
     
     
         59 . A luminal access system as in  claim 56 , wherein the polymer is lubricated.  
     
     
         60 . A luminal access system as in  claim 56 , wherein the polymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polyethylene (PE), perfluoroalkoxy (PFA), polyurethane (PU), perfluoromethylvinylether (MFA), and perfluoropropylvinylether (PPVE).  
     
     
         61 . A luminal access system as in  claim 60 , wherein the polymer comprises tensilized PTFE/PPVE copolymer.  
     
     
         62 . A system as in  claim 45 , wherein the sleeve comprises a sheath structure having a non-evertable portion attached proximal to the evertable, lubricious sleeve.  
     
     
         63 . A system as in  claim 62 , wherein the non-evertable portion of the sheath comprises a flexible tube.  
     
     
         64 . A system as in  claim 63 , wherein the tube has a length in the range from  5  cm to 50 cm, an inner diameter in the range from 1 mm to 12 mm, and a wall thickness from 0.01 mm to 0.1 mm.  
     
     
         65 . A system as in  claim 63 , wherein the tube comprises a polymer.  
     
     
         66 . A system as in  claim 65 , wherein the polymer is selected from the group consisting of PE, fluoropolymers, Pebax, and PI.