Reinforced multi-lumen catheter

Abstract

A reinforced multi-lumen catheter and method of manufacturing the same. An assembly for manufacturing the multi-lumen catheter includes a catheter body substrate including a septum, one or more mandrels, a reinforcing element and one or more sleeves. The septum may have a distal region with a cross-sectional thickness greater than that of a proximal region. The septum can be separately formed. The septum can be split along a length of the distal region. The reinforcing element can be positioned over at least a proximal region of the catheter body substrate.

1 . A reinforced multi-lumen catheter, comprising: 
 an elongate body including an outer wall and a septum, the outer wall and the septum defining first and second lumens, the septum comprising a proximal region and a distal region, the septum distal region including a cross-sectional thickness greater than a cross-sectional thickness of the septum proximal region;    a reinforcing region comprising a reinforcing element positioned over a length of the elongate body, the reinforcing region extending over the septum proximal region and at least a proximal portion of the septum distal region; and    a sleeve positioned over the reinforcing element and the elongate body,    the septum distal region being split from a distal end thereof to a dividing point to form a first tip section and a second tip section, the dividing point being located distal the reinforcing region.    
   
   
       2 . The reinforced multi-lumen catheter according to  claim 1 , wherein the elongate body, septum and sleeve are comprised of the same material.  
   
   
       3 . The reinforced multi-lumen catheter according to  claim 2 , wherein the material includes medical grade polyurethane, silicone, polyvinylchloride or polytetrafluoroethylene.  
   
   
       4 . The reinforced multi-lumen catheter according to  claim 2 , wherein the material includes Carbothane®.  
   
   
       5 . The reinforced multi-lumen catheter according to  claim 1 , wherein the reinforcing element comprises a wire, and wherein the reinforcing region comprises the wire wrapped around the elongate body.  
   
   
       6 . A method of making a multi-lumen catheter, comprising: 
 providing an assembly comprising: 
 a catheter body substrate comprising an outer wall and a septum, the outer wall and the septum defining first and second lumens, the septum comprising a proximal region and a distal region;  
 a first mandrel and a second mandrel inserted respectively into the first lumen and the second lumen;  
 a reinforcing element positioned over at least a proximal region of the catheter body substrate;  
 a sleeve positioned over the reinforcing element and catheter body substrate;  
 shrink tubing positioned over the sleeve;  
   heating the assembly; and    splitting the septum distal region from the distal end to a predetermined dividing point, the dividing point being distal of the septum proximal region.    
   
   
       7 . The method according to  claim 6 , wherein at least one of the mandrels include a stepped or tapered distal end, such that a cross-sectional area of the distal end of the mandrel is less than a cross-sectional area of a proximal end thereof, and wherein said assembly further comprises additional material positioned at a distal end of the catheter body substrate such that upon completion of the heating step, a cross-sectional thickness of the septum distal region is greater than a cross-sectional thickness of the septum proximal region.  
   
   
       8 . The method according to  claim 6 , wherein the catheter body substrate comprises a proximal catheter body substrate and a distal catheter body substrate, wherein the septum of the distal catheter body substrate includes a cross-sectional thickness that is greater that the septum of the proximal catheter body substrate.  
   
   
       9 . The method according to  claim 8 , wherein the reinforcing element is positioned substantially over the proximal catheter body substrate and at least a portion of the distal catheter body substrate.  
   
   
       10 . The method according to  claim 6 , wherein the catheter body substrate comprises a proximal catheter body substrate and a first and second distal catheter body substrate, wherein the first distal catheter body substrate comprises a lumen that is shaped substantially similar to the first lumen and the second distal catheter body substrate is shaped substantially similar to the second lumen.  
   
   
       11 . The method according to  claim 10 , wherein the reinforcing element is positioned substantially over the proximal catheter body substrate and at least a portion of the first and second distal catheter body substrates.  
   
   
       12 . A method of making a multi-lumen catheter, comprising: 
 providing a cylindrical tube including a reinforcing region;    inserting an independently-formed septum into the tube to define two or more lumens therein; and    bonding the septum to the tube.    
   
   
       13 . The method according to  claim 12 , wherein the inserting step comprises applying a longitudinal strain to the septum such that the septum is stretched for placement within the tube.  
   
   
       14 . The method according to  claim 12 , wherein the inserting step comprises inserting two or more mandrels into the tube along with the septum, the mandrels and septum together forming a substantially circular cross-sectional shape, and wherein the reinforcing region is provided by positioning a reinforcing element around the cylindrical tube, positioning a second tube over the reinforcing element to form an assembly and heating the assembly, wherein the bonding step is accomplished thereby.  
   
   
       15 . The method according to  claim 12 , wherein the cylindrical tube includes an inner surface with a recessed portion configured to receive a matching protrusion on an end of the septum, the inserting step further comprising aligning the septum protrusion with the tube recessed portion.  
   
   
       16 . A method of making a multi-lumen catheter, comprising: 
 combining an independently-formed septum with two or more mandrels, the mandrels and septum together forming a substantially circular cross-sectional shape;    wrapping an elongate member around the mandrels and septum to form an assembly, the elongate member comprising a coated reinforcing element;    heating the assembly.    
   
   
       17 . The method according to  claim 16 , further comprising the step of positioning a sleeve over the elongate member.  
   
   
       18 . The method according to  claim 16 , wherein the wrapping step comprises helically wrapping the elongate member such that adjacent windings of the elongate member are in contact with one another along the length of the assembly.  
   
   
       19 . A method of making a multi-lumen catheter, comprising: 
 creating an assembly, comprising: 
 providing a first catheter body substrate comprising a first lumen and a second catheter body comprising a second lumen, each substrate having a substantially semi-circular cross-sectional shape;  
 inserting a first mandrel into the first lumen and a second mandrel into the second lumen, wherein the first and second mandrels extend beyond both proximal and distal ends of the substrates;  
 arranging the first and second substrates to form a substantially circular cross-sectional shape;  
 positioning a reinforcing element over at least a proximal region of the first and second substrates;  
 positioning a sleeve over the reinforcing element and first and second substrates;  
 inserting a shim between the first and second substrates at a distal end thereof;  
   heating the assembly; and    cutting the sleeve along the position of the shim and removing the shim.    
   
   
       20 . The method according to  claim 19 , wherein the creating step further comprises the step of fixing the first and second mandrels to a fixture apparatus such that the first and second substrates are held in a fixed position.  
   
   
       21 . The method according to  claim 20 , wherein the heating step comprises rotating the assembly while heat is applied.  
   
   
       22 . The method according to  claim 19 , wherein the shim comprises sharp opposing edges, wherein the cutting step comprises utilizing only the shim.