System, apparatus, and method for creating a lumen

Abstract

An example system for creating a lumen according to the present disclosure includes, among other possible things a balloon wound in a generally helical shape having an inner surface and an outer surface, and a support attached to at least one of the inner surface and the outer surface of the generally helical shape and constraining the tubular balloon in the generally helical shape. The balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter. Other example systems for creating a lumen and methods for creating a lumen in an artery are also disclosed.

1 . A system for creating a lumen, comprising:
 a balloon wound in a generally helical shape having an inner surface and an outer surface; and   a support attached to at least one of the inner surface and the outer surface of the generally helical shape and constraining the balloon in the generally helical shape;   wherein the balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter.   
     
     
         2 . The system of  claim 1 , wherein the support has a generally cylindrical shape and is continuous. 
     
     
         3 . The system of  claim 1 , wherein the support is discontinuous, and wherein the support includes one or more strips. 
     
     
         4 . The system of  claim 3 , wherein the one or more strips are attached to the outer surface of the generally helical shape. 
     
     
         5 . The system of  claim 4 , wherein at least one or more strips includes an end portion folded to the inner surface of the generally helical shape. 
     
     
         6 . The system of  claim 1 , wherein the support is attached to the at least one of the inner surface and the outer surface of the generally helical shape by a connector. 
     
     
         7 . The system of  claim 1 , where in the support is a thin film. 
     
     
         8 . The system of  claim 1 , wherein the support is perforated. 
     
     
         9 . The system of  claim 1 , wherein the support includes a first support on the inner surface of the generally helical shape and a second support on the outer surface of the generally helical shape. 
     
     
         10 . A system for creating a lumen, comprising:
 a balloon wound in a generally helical shape having an inner surface and an outer surface; and   at least one clip constraining the balloon in the generally helical shape, the at least one clip including a center leaf and first and second receiving leaves on either side of the center leaf, each of the first and second receiving leaves including a first opening and a second opening, the first opening receiving a first turn of the generally helical shape and a second opening receiving a second turn of the generally helical shape;   wherein the balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter.   
     
     
         11 . The system of  claim 10 , wherein the center leaf rests along an outer surface of the generally helical shape. 
     
     
         12 . The system of  claim 10 , further comprising a first foldover leaf and a second foldover leaf flanking the first and second receiving leaves, respectively, and wherein the first and second foldover leaves are configured to fold towards the center leaf, thereby trapping the first and second turns of the generally helical shape. 
     
     
         13 . The system of  claim 10 , further comprising at least one cylindrical support surrounding a portion of at least one of the first and second turns of the helix balloon that is received in the first or second opening of the receiving portion. 
     
     
         14 . A system for creating a lumen, comprising:
 a balloon wound in a generally helical shape having an inner surface and an outer surface; and   at least one band connector constraining the balloon in the generally helical shape, the at least one band connector surrounding at least two successive turns of the generally helical shape;   wherein the balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter.   
     
     
         15 . The system of  claim 14 , wherein the system includes three band connectors, and each of the three band connectors are evenly circumferentially spaced about the generally helical shape. 
     
     
         16 . The system of  claim 14 , wherein the at least one band connector is folded around the at least two successive turns of the generally helical shape such that first and second opposed ends of the at least one band connector overlap one another at an overlapping portion. 
     
     
         17 . The system of  claim 16 , wherein the first and second opposed ends of the at least one band connector are secured to one another at the overlapping portion by an adhesive, by a thermal join, or by a pressurized join. 
     
     
         18 . A method of creating a lumen in an artery, comprising:
 inserting a balloon into the artery in a low-profile operating mode, the balloon having an inner surface and an outer surface, and a support attached to at least one of the inner surface and the outer surface;   forming a lumen within the generally helical shape by expanding the tubular balloon into a high-profile operating mode in which the inner surface of the generally helical shape defines the lumen, and in which the support constrains the balloon in the generally helical shape.   
     
     
         19 . (canceled) 
     
     
         20 . (canceled)