Balloon catheter and methods of use to reduce residual stenosis

Abstract

Systems and methods can involve wedge dissectors attached to strips in turn attached to medical balloons, for forming serrations within vascular wall tissue for angioplasty as well reducing vessel recoil, reducing residual stenosis, and increasing volumetric blood flow post angioplasty. The design, methods of use, intended outcomes, and process to build this type of balloon is described herein.

1 . An intravascular device comprising:
 a base balloon;   a plurality of strips, each strip of the plurality of strips including a plurality of wedge dissectors spaced apart along a surface of each strip; and   a prefabricated covering,   wherein the base balloon comprises a lower compliance and the prefabricated covering comprises a higher compliance.   
     
     
         2 . The intravascular device of  claim 1 , wherein the base balloon comprises a non-compliant balloon. 
     
     
         3 . The intravascular device of  claim 1 , wherein the base balloon comprises a semi-compliant balloon. 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . The intravascular device of  claim 1 , wherein the prefabricated covering is configured to minimize surface tearing along a portion of a strip of the plurality of strips. 
     
     
         7 . The intravascular device of  claim 1 , wherein the prefabricated covering is configured to minimize surface tearing between adjacent wedge dissectors. 
     
     
         8 . The intravascular device of  claim 1 , wherein the prefabricated covering is configured to minimize surface tearing by the wedge dissectors. 
     
     
         9 . The intravascular device of  claim 1 , wherein the prefabricated covering is configured to minimize surface tearing by calcified atherosclerosis. 
     
     
         10 . The intravascular device of  claim 1 , wherein the prefabricated covering is configured to retain the plurality of strips between the base balloon and the prefabricated covering. 
     
     
         11 . A method of manufacturing an intravascular device comprising:
 selecting a first extruded tube and blow molding a base balloon;   selecting a plurality of strips, each strip of the plurality of strips including a plurality of wedge dissectors spaced apart along a surface of each strip;   selecting a second extruded tube and blow molding a prefabricated covering; and   modifying the compliance of the base balloon, the prefabricated covering, or both the base balloon and the prefabricated covering during the process of manufacturing.   
     
     
         12 . The method of  claim 11 , wherein modifying the compliance comprises modifying a molecular orientation of polymer chains. 
     
     
         13 . (canceled) 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . The method of  claim 11 , wherein modifying the compliance comprises orienting polymer chains biaxially. 
     
     
         17 . The method of  claim 11 , wherein modifying the compliance comprises increasing the tear resistance of the prefabricated covering. 
     
     
         18 . The method of  claim 11 , wherein the base balloon comprises a lower compliance and the prefabricated covering comprises a higher compliance. 
     
     
         19 . The method of  claim 11 , wherein modifying the compliance comprises changing the temperature of the heating jaws. 
     
     
         20 . The method of  claim 11 , wherein modifying the compliance comprises changing a pre-pressure and/or warm-up time. 
     
     
         21 . The method of  claim 11 , wherein modifying the compliance comprises changing a forming pressure and/or forming time. 
     
     
         22 . The method of  claim 11 , wherein modifying the compliance comprises changing a distal and/or proximal stretching load. 
     
     
         23 . (canceled) 
     
     
         24 . The method of  claim 11 , wherein modifying the compliance comprises changing a speed of a gear pump during an extrusion process. 
     
     
         25 . The method of  claim 11 , wherein modifying the compliance comprises changing an inner and/or outer diameter of the first extruded tube or the second extruded tube. 
     
     
         26 . The method of  claim 11 , wherein modifying the compliance comprises changing a drawdown and die heads of the first extruded tube or the second extruded tube. 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . (canceled)