Balloon dilation catheter

Abstract

An apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus including a single lumen catheter having a proximal end and a distal end, and a high pressure balloon attached to the distal end of the catheter. The high pressure balloon is fabricated from a semi-compliant material that has an average rated burst pressure of between about 15 and about 27 atmospheres of pressure and exhibits a dumbbell-shaped outer periphery when inflated to a first atmospheric pressure and a substantially linear outer periphery when inflated to a second atmospheric pressure.

What is claimed is: 
     
         1 . A method of manufacturing a device for performing a balloon dilation procedure at the site of a stenosis within the airway of a patient, comprising:
 providing a single lumen catheter having a proximal end and a distal end;   forming a high pressure balloon from a semi-compliant material having an average rated burst pressure of between about 15 and about 27 atmospheres of pressure and a recommended inflation pressure, the balloon having a central portion positioned between proximal and distal hubbed ends that maintains a substantially linear profile when the balloon is inflated to an atmospheric pressure between about 1 and 6 atmospheres; and   coupling the high pressure balloon to the distal end of the catheter.   
     
     
         2 . The method of  claim 1 , further comprising coupling radiopaque markers to the single lumen catheter. 
     
     
         3 . The method of  claim 1 , further wherein the central portion of the high pressure balloon is formed to have a first wall thickness that is greater than a second wall thickness of the distal and proximal ends. 
     
     
         4 . The method of  claim 1 , wherein the high pressure balloon is formed to have a diameter of between about 5 millimeters and about 10 millimeters when filled with a fluid to an atmospheric pressure of between about 14 and 19. 
     
     
         5 . The method of  claim 1 , wherein the high pressure balloon is formed to have a diameter of between about 5 millimeters and about 10 millimeters when filled with a fluid to an atmospheric pressure of about 17. 
     
     
         6 . The method of  claim 1 , wherein the high pressure balloon is formed to have a diameter of between about 12 millimeters and about 16 millimeters when filled with a fluid to an atmospheric pressure of between about 8 and about 12. 
     
     
         7 . The method of  claim 1 , wherein the high pressure balloon is formed to have a diameter of between about 12 millimeters and about 16 millimeters when filled with a fluid to an atmospheric pressure of about 10. 
     
     
         8 . The method of  claim 1 , further comprising coupling indicia to the high pressure balloon, the indicia being viewable with an endoscope or a fluoroscope. 
     
     
         9 . The method of  claim 1 , further comprising cutting the catheter to have a length of from about 53 cm to about 55 cm. 
     
     
         10 . The method of  claim 1 , wherein the high pressure balloon is formed to have a diameter of between about 5 millimeters and about 10 millimeters and a working length of about 30 millimeters. 
     
     
         11 . The method of  claim 1 , wherein the high pressure balloon is formed to have a diameter of between about 12 millimeters and about 16 millimeters and a working length of about 40 millimeters. 
     
     
         12 . An apparatus for performing a balloon dilation procedure within the airway of a patient, comprising:
 a balloon having a proximal end, a distal end and a central portion, the balloon consisting of a single layer of polymeric material exhibiting dynamic shape memory properties; and   a single lumen catheter configured to position the balloon relative to a stenosis within the airway of the patient;   wherein both the proximal and distal ends of the balloon at least partially contact the airway of the patient when the balloon is inflated to a first atmospheric pressure and the central portion maintains a linear shape, and wherein the central portion of the balloon is configured to at least partially contact the airway and expand the stenosis of the patient when the balloon is inflated to a second atmospheric pressure that is greater than the first atmospheric pressure;   further wherein, the balloon exhibits a dumbbell-shaped outer periphery when inflated to the first atmospheric pressure and a substantially linear outer periphery when inflated to the second atmospheric pressure;   further wherein, the balloon is deflatable and re-inflatable when airway narrowing remains.   
     
     
         13 . The apparatus of  claim 12 , further comprising a stylet attachable to a proximal end of the catheter via a luer lock. 
     
     
         14 . The apparatus of  claim 12 , wherein the polymeric material used to fabricate the balloon is a semi-compliant material having an average rated burst pressure of between about 15 and about 27 atmospheres of pressure. 
     
     
         15 . The apparatus of  claim 14 , wherein the balloon has a recommended inflation pressure that is between about 6 and about 8 atmospheres less than the average rated burst pressure. 
     
     
         16 . The apparatus of  claim 14 , wherein the balloon has a diameter between about 5 millimeters and about 10 millimeters and an inflation pressure that is about 7.4 atmospheres less than the average rated burst pressure. 
     
     
         17 . The apparatus of  claim 14 , wherein the balloon has a diameter between about 12 millimeters and about 18 millimeters and an inflation pressure that is about 6.2 atmospheres less than the average rated burst pressure. 
     
     
         18 . The apparatus of  claim 14 , wherein the semi-compliant material used to fabricate the balloon is a blow-molded polyamide. 
     
     
         19 . The apparatus of  claim 18 , wherein the distal and proximal ends of the balloon are each allowed to stretch to a maximum expansion limit during the fabrication process, while the central portion is prevented from correspondingly stretching to the maximum expansion limit. 
     
     
         20 . An apparatus for performing a balloon dilation procedure at the site of a stenosis within the airway of a patient, consisting of:
 a single balloon having a proximal end, a distal end and a central portion, the balloon exhibiting an outer periphery having a dumbbell shape when inflated to a first atmospheric pressure and a substantially linear shape when inflated to a second atmospheric pressure; and   a single lumen catheter coupled to the balloon;   wherein, the balloon is formed from a semi-compliant polymeric material exhibiting dynamic shape memory properties and having an average rated burst pressure of between about 15 and about 27 atmospheres of pressure;   further wherein, the balloon is re-wrapped and compressed to execute additional inflations.