Systems and methods for endoluminal valve creation

Abstract

The present application pertains generally to medical systems and methods for creation of an autologous tissue valves within a mammalian body. In some embodiments, a system for creating an endoluminal valve from a blood vessel wall is provided. The system includes a tubular assembly having a longitudinal axis, a proximal end, a distal portion with a distal end, and a first lumen extending from the proximal end to a distal port located proximate the distal portion. The distal portion can have a supporting surface that extends in a longitudinal direction and is offset from a surface of the tubular assembly proximal the distal port. The system can further include a tissue dissection probe disposed within the first lumen.

1 . A system for creating an endoluminal valve from a blood vessel wall, the system comprising:
 a tubular assembly having a longitudinal axis, a proximal end, a distal portion with a distal end, and a first lumen extending from the proximal end to a distal port located proximate the distal portion, the distal port located along the longitudinal axis, the distal portion having a supporting surface on a same side of the tubular assembly as the distal port, the supporting surface extending in a longitudinal direction and offset from a surface of the tubular assembly proximal the distal port and configured to contact the blood vessel wall; and   a tissue dissection probe disposed within the first lumen, the tissue dissection probe having a fluid delivery lumen extending to a fluid delivery port located at a distal end of the tissue dissection probe, the tissue dissection probe configured to be inserted into the blood vessel wall.   
     
     
         2 . The system of  claim 1 , wherein the supporting surface is substantially parallel to the longitudinal axis of the tubular assembly. 
     
     
         3 . The system of  claim 1 , wherein the supporting surface is substantially flat. 
     
     
         4 . The system of  claim 1 , wherein a diameter of the tissue dissection probe is less than a thickness of the blood vessel wall. 
     
     
         5 . The system of  claim 1 , wherein the tissue dissection probe is configured to extend out of the distal port in an orientation that is substantially parallel to the supporting surface. 
     
     
         6 . The system of  claim 1 , wherein the supporting surface is offset from a longitudinal axis of the tissue dissection probe by about 0.010 inches to about 0.100 inches, the longitudinal axis of the tissue dissection probe extending through a tip portion of the tissue dissection probe. 
     
     
         7 . The system of  claim 1 , wherein the supporting surface is offset from a longitudinal axis of the tissue dissection probe by about 0.015 inches to about 0.060 inches, the longitudinal axis of the tissue dissection probe extending through a tip portion of the tissue dissection probe. 
     
     
         8 . The system of  claim 1 , wherein the supporting surface is offset from a longitudinal axis of the tissue dissection probe by about 0.020 inches to about 0.040 inches, the longitudinal axis of the tissue dissection probe extending through a tip portion of the tissue dissection probe. 
     
     
         9 . The system of  claim 1 , further comprising an expandable element that is slidably disposed over the tissue dissection probe. 
     
     
         10 . The system of  claim 1 , further comprising a mouth widening element that is slidably disposed over the tissue dissection probe. 
     
     
         11 . The system of  claim 1 , wherein the first lumen is configured to receive a tissue securement device. 
     
     
         12 . The system of  claim 1 , further comprising a second lumen and a tissue securement device disposed in the second lumen. 
     
     
         13 . The system of  claim 1 , further comprising a mechanism configured to eject hydrodissection fluid ahead of the tissue dissection probe while the tissue dissection probe is advanced. 
     
     
         14 . The system of  claim 1 , wherein the distal portion has a predetermined stiffness that is configured to reduce an amount of deformation of the distal portion in both a first direction and a second direction perpendicular to the first direction. 
     
     
         15 . The system of  claim 1 , further comprising an expandable element located on the distal portion of the tubular assembly, the expandable element located on an opposite side of the tubular assembly as the distal port. 
     
     
         16 . The system of  claim 15 , wherein the expandable element is selected from the group consisting of a balloon and a cage. 
     
     
         17 . The system of  claim 15 , wherein a portion of the expandable element is located distal the distal port and a portion of the expandable element is located proximal the distal port. 
     
     
         18 . A method of creating an endoluminal valve, the method comprising:
 conforming a first portion of a vessel wall to a supporting surface to create an offset between the first portion of the vessel wall and a second portion of the vessel wall, wherein both the first portion of the vessel wall and the second portion of the vessel wall are both oriented in substantially the same direction;   inserting a tissue dissection probe into a transitory portion of the vessel wall between the first portion and the second portion of the vessel wall, without going entirely through an adventitia of the vessel wall, to create an inlet, the vessel wall having a plurality of layers;   introducing hydrodissection fluid between the layers of the vessel wall to separate two layers of the vessel wall to form a pocket within the vessel wall;   widening the inlet to form a first valve flap, wherein a tip of the first valve flap is formed from the inlet and a body of the first valve flap is formed from the pocket; and   securing the first valve flap such that the body of the first valve flap is separated away from vessel wall from which the first valve flap was formed.   
     
     
         19 . The method of  claim 18 , wherein an insertion depth and an angle of the insertion of the tissue dissection probe into the vessel wall are controlled in part by the offset between the first portion of the vessel wall and the second portion of the vessel wall. 
     
     
         20 . The method of  claim 18 , wherein the tissue dissection probe has a diameter that is less than a thickness of the vessel wall. 
     
     
         21 . The method of  claim 18 , wherein the hydrodissection fluid is substantially sealed within the pocket prior to widening the inlet to form the first valve flap. 
     
     
         22 . The method of  claim 18 , further comprising maintaining a fluid space in front of the tissue dissection probe by controlling a flow of the hydrodissection fluid from the tissue dissection probe. 
     
     
         23 . The method of  claim 18 , further comprising enlarging the pocket using hydrodissection. 
     
     
         24 . The method of  claim 18 , further comprising enlarging the pocket by expanding an expandable element within the pocket. 
     
     
         25 . The method of  claim 18 , wherein the supporting surface is substantially flat. 
     
     
         26 . The method of  claim 18 , wherein the tissue dissection probe is inserted into the vessel wall in an orientation that is substantially parallel to the supporting surface. 
     
     
         27 . The method of  claim 18 , wherein the offset is about 0.1 mm to about 5 mm. 
     
     
         28 . The method of  claim 18 , wherein the offset is about 0.5 mm to about 3 mm. 
     
     
         29 . The method of  claim 18 , wherein the offset is about 0.75 mm to about 1.5 mm. 
     
     
         30 . The method of  claim 18 , wherein the inlet is widened to about at least 180 degrees around the circumference of the vessel. 
     
     
         31 . The method of  claim 18 , wherein a length of the pocket is about 1 to about 2 times a cross sectional width of the vessel. 
     
     
         32 . The method of  claim 18 , wherein the inlet is widened to about 180 degrees or less around a circumference of the vessel. 
     
     
         33 . The method of  claim 18 , wherein the length of the pocket is about 0.5 to about 1.5 times a cross sectional width of the vessel. 
     
     
         34 . The method of  claim 18 , wherein the first valve flap is secured to a portion of the vessel wall that is opposite of the first valve flap. 
     
     
         35 . The method of  claim 34 , wherein the first valve flap is loosely secured at about a center of an edge of the first valve flap. 
     
     
         36 . The method of  claim 34 , wherein the first valve flap is tightly secured at a first location near an edge of the first valve flap and within about 5 to about 40 degrees of a first end of the edge of the first valve flap, and wherein the first valve flap is tightly secured at a second location near the edge of the first valve flap and within about 5 to about 40 degrees of a second end of the edge of the first valve flap. 
     
     
         37 . The method of  claim 18 , wherein the first valve flap is tightly secured at about a center of an edge of the first valve flap to a second valve flap. 
     
     
         38 . The method of  claim 18 , further comprising:
 positioning a balloon within the inlet; and   inflating the balloon to widen the inlet.   
     
     
         39 . The method of  claim 18 , wherein the first portion of the vessel wall is conformed to the supporting surface by expanding an expandable element against a portion of the vessel wall opposite the first portion. 
     
     
         40 . The method of  claim 18 , further comprising reducing a deformation of the supporting surface in both a first direction normal the supporting surface and a second direction perpendicular to the first direction by providing the supporting surface with a predetermined stiffness.