Catheter Having an Expandable Lumen and Method of Manufacture

Abstract

A single or multiple lumen catheter is disclosed which includes an expandable lumen. The expandable lumen is movable from a collapsed or sealed configuration to an open or expanded configuration. In the open configuration, the expandable lumen is dimensioned to receive a guidewire or stylet or facilitate the introduction of fluids into a patient.

1 . A catheter comprising:
 an elongated body having a proximal end and a distal end and defining at least one lumen, the body including a longitudinal slit which is expandable from a substantially sealed configuration to an expanded configuration to define an expandable lumen positioned adjacent the at least one lumen.   
     
     
         2 . The catheter according to  claim 1 , wherein the expandable lumen is dimensioned to receive a guidewire in the expanded configuration. 
     
     
         3 . The catheter according to  claim 1 , wherein the expandable lumen is configured to receive a stylet in the expanded configuration. 
     
     
         4 . The catheter according to  claim 1 , wherein the at least one lumen includes a single lumen. 
     
     
         5 . The catheter according to  claim 4 , wherein the expandable lumen extends longitudinally along an inner wall of the elongated body defining the single lumen. 
     
     
         6 . The catheter according to  claim 5 , wherein the expandable lumen is defined between the inner wall of the elongated body and a resilient membrane. 
     
     
         7 . The catheter according to  claim 6 , wherein the resilient membrane is formed integrally with the elongated body. 
     
     
         8 . The catheter according to  claim 1 , wherein the at least one lumen includes a first lumen and a second lumen. 
     
     
         9 . The catheter according to  claim 8 , wherein the elongated body includes a longitudinal septum positioned between the first lumen and the second lumen. 
     
     
         10 . The catheter according to  claim 9 , wherein the longitudinal slit extends along the longitudinal length of the septum, such that when the longitudinal slit is in the expanded configuration, the expandable lumen extends through the septum. 
     
     
         11 . The catheter according to  claim 10 , wherein the septum is positioned substantially along the diameter of the elongated body. 
     
     
         12 . The catheter according to  claim 1 , wherein the catheter is formed of a first material having a first coefficient of friction and a second material having a second coefficient of friction which is less than the first coefficient of friction, at least a portion of the elongated body defining the slit being formed of the second material. 
     
     
         13 . The catheter according to  claim 8 , wherein the first lumen and the second lumen are substantially D-shaped. 
     
     
         14 . A method of manufacturing a multi-lumen catheter, the method comprising the following steps:
 i) extruding a catheter body having a first lumen and a second lumen and a septum separating the first lumen from the second lumen, the septum including a removable material positioned within and extending along the length of the septum, wherein the septum is extruded from an elastomeric material; and   ii) removing the removable material from the septum to define a slit which extends through the septum along the length of the septum, the slit being expandable to define a third lumen.   
     
     
         15 . The method according to  claim 14 , wherein the step of removing the removable material from the septum includes pulling the removable material from the septum. 
     
     
         16 . The method according to  claim 14 , wherein the removable material is a dissolvable or degradable material and the step of removing the removable material from the septum includes exposing the catheter to a solvent to dissolve or degrade the removable material within the septum. 
     
     
         17 . The method according to  claim 16 , further including the following step:
 iii) flushing the third lumen to remove the dissolved/degraded material from the third lumen.   
     
     
         18 . A method of manufacturing a multi-lumen catheter, the method comprising the following steps:
 i) extruding a catheter body having a first lumen and at least one additional lumen, the catheter body being formed of a first material having a first melting temperature;   providing a second material on an inner surface of the first lumen, the second material having a melting temperature greater than the first material;   directing a fluid through the at least one additional lumen to move the first lumen to a collapsed configuration;   melting the first material without melting the second material while the first lumen is in the collapsed configuration; and   cooling the first material to allow the first material to set with the first lumen in the collapsed configuration.   
     
     
         19 . The method according to  claim 18 , wherein the at least one additional lumen includes second and third lumens. 
     
     
         20 . The method according to  claim 19 , wherein the step of extruding a catheter body includes providing a septum between the second and third lumens, the first lumen extending through the septum. 
     
     
         21 . A method of manufacturing a multi-lumen catheter, the method comprising the following steps:
 i) extruding a catheter body having a first lumen, a second lumen, and a third lumen positioned between the first and second lumens and extending through a septum of the catheter body, the catheter body being formed of a first material having a first melting temperature;   providing a layer of second material on an inner surface of the catheter body defining the first and second lumens, the second material having a melting temperature lower than the first material;   directing a fluid through the first and second lumens to move the third lumen to a collapsed configuration;   melting the second material without melting the first material while the third lumen is in the collapsed configuration; and   cooling the second material to allow the second material to set with the third lumen in the collapsed configuration.   
     
     
         22 . A method of manufacturing a multi-lumen catheter, the method comprising the following steps:
 i) extruding a catheter body from a first material, the catheter body having a first lumen, a second lumen, and a septum positioned between the first and second lumens; and   ii) positioning a flat tube extending longitudinally through the septum during the extrusion step.   
     
     
         23 . The method according to  claim 22 , wherein the extruding step does not include melting the flat tube. 
     
     
         24 . The method according to  claim 20 , wherein the flat tube is formed from a second material which has enhanced lubricity as compared to the first material forming the catheter body. 
     
     
         25 . The method according to  claim 20 , further including the following step:
 iii) forcing a fluid through the hollow tube to expand the hollow tube.