Multi-lumen extrusion tubing

Abstract

A multi-lumen balloon for use in a fluted balloon centering catheter and method for providing the same. The multi-lumen balloon maintains a radiation source at the center of a cardiovascular artery, has improved blood perfusion capability, and has improved balloon refolding characteristics. The method of fabricating a multi-lumen balloon designed for a radiation centering catheter uses an improved extrusion process that allows the manufacture of the multi-lumen balloon sub-assembly to be done separately from the catheter shaft assembly.

What is claimed is:  
     
         1 . A multi-lumen tubing, comprising: 
 a tubing body having a central lumen and at least one outer lumen disposed around the central lumen, the outer lumen coupled with the central lumen by a shared wall; and    an undercut region disposed between the central lumen and the at least one outer lumen.    
     
     
         2 . The multi-lumen tubing of  claim 1 , wherein the outer lumen has an outer lumen wall thickness in a range of approximately 0.002-0.008 in.  
     
     
         3 . The multi-lumen tubing of  claim 1 , wherein the outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.  
     
     
         4 . The multi-lumen tubing of  claim 2 , wherein the shared wall has a shared wall thickness greater than 1% of the outer lumen wall thickness.  
     
     
         5 . The multi-lumen tubing of  claim 2 , wherein the shared wall has a shared wall thickness in the range of approximately 80% to 120% of the outer lumen wall thickness.  
     
     
         6 . The multi-lumen tubing of  claim 1 , wherein the multi-lumen tubing has an overall diameter in a range of approximately 0.020-0.050 in.  
     
     
         7 . The multi-lumen tubing of  claim 1 , wherein the multi-lumen tubing has an overall diameter in a range of approximately 0.034-0.048 in.  
     
     
         8 . The multi-lumen tubing of  claim 1 , wherein the central lumen has an inner diameter in a range of approximately 0.007-0.013 in.  
     
     
         9 . The multi-lumen tubing of  claim 1 , wherein the central lumen has an inner diameter of about 0.010 in.  
     
     
         10 . The multi-lumen tubing of  claim 1 , wherein the multi-lumen tubing is manufactured from a material selected from the group consisting of resin, nylon, Pebax, polyethylene, polyurethane and polyester.  
     
     
         11 . A multi-lumen tubing, comprising: 
 a tubing body having a central lumen and at least one outer lumen disposed around the central lumen, the at least outer lumen coupled with the central lumen by a shared wall; and    a fillet radius region disposed between the central lumen and the at least one outer lumen.    
     
     
         12 . The multi-lumen tubing of  claim 11 , wherein the outer lumen has an outer lumen wall thickness in a range of approximately 0.002-0.008 in.  
     
     
         13 . The multi-lumen tubing of  claim 11 , wherein the outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.  
     
     
         14 . The multi-lumen tubing of  claim 12 , wherein the shared wall has a shared wall thickness greater than 1% of the outer lumen wall thickness.  
     
     
         15 . The multi-lumen tubing of  claim 12 , wherein the shared wall has a shared wall thickness in the range of approximately 80% to 120% of the outer lumen wall thickness.  
     
     
         16 . The multi-lumen tubing of  claim 12 , wherein the multi-lumen tubing has an overall diameter in a range of approximately 0.020-0.050 in.  
     
     
         17 . The multi-lumen tubing of  claim 11 , wherein the multi-lumen tubing has an overall diameter in a range of approximately 0.034-0.048 in.  
     
     
         18 . The multi-lumen tubing of  claim 11 , wherein the central lumen has an inner diameter in a range of approximately 0.007-0.013 in.  
     
     
         19 . The multi-lumen tubing of  claim 11 , wherein the central lumen has an inner diameter of about 0.010 in.  
     
     
         20 . The multi-lumen tubing of  claim 11 , wherein the multi-lumen tubing is manufactured from a material selected from the group consisting of resin, nylon, Pebax, polyethylene, polyurethane and polyester.  
     
     
         21 . A multi-lumen tubing, comprising: 
 a tubing body having a central lumen and at least one outer lumen disposed around the central lumen, the outer lumen coupled with the central lumen by a shared wall; and    a standoff region disposed between the central lumen and the at least one outer lumen.    
     
     
         22 . The multi-lumen tubing of  claim 21 , wherein the outer lumen has an outer lumen wall thickness in a range of approximately 0.002-0.008 in.  
     
     
         23 . The multi-lumen tubing of  claim 21 , wherein the outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.  
     
     
         24 . The multi-lumen tubing of  claim 22 , wherein the shared wall has a shared wall thickness greater than 1% of the outer lumen wall thickness.  
     
     
         25 . The multi-lumen tubing of  claim 22 , wherein the shared wall has a shared wall thickness in the range of approximately 80% to 120% of the outer lumen wall thickness.  
     
     
         26 . The multi-lumen tubing of  claim 21 , wherein the multi-lumen tubing has an overall diameter in a range of approximately 0.020-0.050 in.  
     
     
         27 . The multi-lumen tubing of  claim 21 , wherein the multi-lumen tubing has an overall diameter in a range of approximately 0.034-0.048 in.  
     
     
         28 . The multi-lumen tubing of  claim 21 , wherein the central lumen has an inner diameter in a range of approximately 0.007-0.013 in.  
     
     
         29 . The multi-lumen tubing of  claim 21 , wherein the central lumen has an inner diameter of about 0.010 in.  
     
     
         30 . The multi-lumen tubing of  claim 21 , wherein the multi-lumen tubing is manufactured from a material selected from the group consisting of resin, nylon, Pebax, polyethylene, polyurethane and polyester.  
     
     
         31 . A multi-lumen tubing, the multi-lumen tubing having been made by a method comprising: 
 pushing a molten resin material through a tip and die assembly such that a plurality of resin material shafts are formed, the tip and die assembly including an extrusion die and a plurality of mandrels, wherein the extrusion die has at least one outer exit hole disposed adjacent to a central exit hole;    applying a pressurized medium to the plurality of resin material shafts so as to maintain a lumen running lengthwise along the plurality of resin material shafts; and    pulling the plurality of resin material shafts away from the extrusion die so as to cause the plurality of resin material shafts to fuse together lengthwise into the multi-lumen extrusion tubing having a central lumen and at least one outer lumen disposed adjacent to the central lumen.    
     
     
         32 . The method of  claim 31 , wherein the at least one outer exit hole has a substantially flat shape across a part of a periphery where the at least one outer exit hole is disposed adjacent to the central exit hole.  
     
     
         33 . The method of  claim 31 , wherein the central exit hole has a substantially flat shape across a part of a periphery where the central exit hole is disposed adjacent to the at least outer exit hole.  
     
     
         34 . The method of  claim 31  wherein said pulling the plurality of resin material shafts away from the extrusion die is done while the resin material is at a melt temperature in the range of about 370° F. to 440° F.  
     
     
         35 . The method of  claim 31  wherein said pulling the plurality of resin material shafts away from the extrusion die is done while the resin material is at a melt temperature in the range of about 380° F. to 410° F.  
     
     
         36 . The method of  claim 31  wherein the resin material is nylon.  
     
     
         37 . The method of  claim 31  wherein the resin material is polyethylene.  
     
     
         38 . The method of  claim 31  wherein the resin material is polyester.  
     
     
         39 . The method of  claim 31  wherein the pressurized medium comprises a pressurized gas.  
     
     
         40 . The method of  claim 31  wherein the pressurized medium comprises air.  
     
     
         41 . The method of  claim 39  wherein the pressurized gas applied to the plurality of resin material shafts is applied at a pressure of in a range of approximately 0-30 inches of water.  
     
     
         42 . The method of  claim 39  wherein the pressurized gas applied to the plurality of resin material shafts is applied at a pressure of 2 inches of water.  
     
     
         43 . The method of  claim 31  wherein said pushing a molten resin material through an extrusion die and said applying a pressurized fluid to the plurality of resin material shafts so as to maintain a lumen are performed concurrently.  
     
     
         44 . The method of  claim 31  wherein said pulling the plurality of resin material shafts away from the extrusion die is done at a pulling rate of about 25-100 feet per minute.  
     
     
         45 . The method of  claim 31  wherein said pulling the plurality of resin material shafts away from the extrusion die is done at a pulling rate of about 45-65 feet per minute.  
     
     
         46 . The method of  claim 31  wherein the at least one outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.  
     
     
         47 . The method of  claim 31  wherein the multi-lumen tubing has an overall diameter in a range of approximately {fraction (34/1000)} in. to {fraction (48/1000)} in.  
     
     
         48 . A multi-lumen tubing, the multi-lumen tubing having been made by a method comprising: 
 pushing a molten resin material through an tip and die assembly such that a multi-lumen resin material shaft having a radial cross-section that includes at least one fillet radius region is formed, wherein the tip and die assembly includes an extrusion die having a single exit hole profile and a plurality of mandrels; and    applying a pressurized medium to the multi-lumen resin material shaft so as to maintain a central lumen and at least one outer lumen disposed adjacent to a central lumen, the central lumen and the at least one outer lumen running lengthwise along the resin material shaft.    
     
     
         49 . The method of  claim 48 , further comprising: 
 pulling the multi-lumen resin material shaft away from the extrusion die.    
     
     
         50 . The method of  claim 49  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done while the resin material is at a melt temperature in the range of about 370° F. to 440° F.  
     
     
         51 . The method of  claim 49  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done while the resin material is at a melt temperature in the range of about 380° F. to 410° F.  
     
     
         52 . The method of  claim 48  wherein the resin material is nylon.  
     
     
         53 . The method of  claim 48  wherein the resin material is polyethylene.  
     
     
         54 . The method of  claim 48  wherein the resin material is polyester.  
     
     
         55 . The method of  claim 48  wherein the pressurized medium comprises a pressurized gas.  
     
     
         56 . The method of  claim 55  wherein the pressurized medium comprises air.  
     
     
         57 . The method of  claim 55  wherein the pressurized gas applied to the multi-lumen resin material shaft is applied at a pressure of in a range of approximately 0-30 inches of water.  
     
     
         58 . The method of  claim 55  wherein the pressurized gas applied to the multi-lumen resin material shaft is applied at a pressure of 2 inches of water.  
     
     
         59 . The method of  claim 48  wherein said pushing a molten resin material through a tip and die assembly and said applying a pressurized medium to the multi-lumen resin material shaft so as to maintain a central lumen and at least one outer lumen are performed concurrently.  
     
     
         60 . The method of  claim 49  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done at a pulling rate of about 25-100 feet per minute.  
     
     
         61 . The method of  claim 49  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done at a pulling rate of about 45-65 feet per minute.  
     
     
         62 . The method of  claim 48  wherein the at least one outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.  
     
     
         63 . The method of  claim 48  wherein the multi-lumen tubing has an overall diameter in a range of approximately {fraction (34/1000)} in. to {fraction (48/1000)} in.  
     
     
         64 . A multi-lumen tubing, the multi-lumen tubing having been made by a method comprising: 
 pushing a molten resin material through an tip and die assembly such that a multi-lumen resin material shaft having a radial cross-section that includes at least one standoff region is formed, wherein the tip and die assembly includes an extrusion die having a single exit hole profile and a plurality of mandrels; and    applying a pressurized medium to the multi-lumen resin material shaft so as to maintain a central lumen and at least one outer lumen disposed adjacent to a central lumen, the central lumen and the at least one outer lumen running lengthwise along the resin material shaft.    
     
     
         65 . The method of  claim 64 , further comprising: 
 pulling the multi-lumen resin material shaft away from the extrusion die.    
     
     
         66 . The method of  claim 65  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done while the resin material is at a melt temperature in the range of about 370° F. to 440° F.  
     
     
         67 . The method of  claim 65  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done while the resin material is at a melt temperature in the range of about 380° F. to 410° F.  
     
     
         68 . The method of  claim 64  wherein the resin material is nylon.  
     
     
         69 . The method of  claim 64  wherein the resin material is polyethylene.  
     
     
         70 . The method of  claim 64  wherein the resin material is polyester.  
     
     
         71 . The method of  claim 64  wherein the pressurized medium comprises a pressurized gas.  
     
     
         72 . The method of  claim 71  wherein the pressurized medium comprises air.  
     
     
         73 . The method of  claim 71  wherein the pressurized gas applied to the multi-lumen resin material shaft is applied at a pressure of in a range of approximately 0-30 inches of water.  
     
     
         74 . The method of  claim 71  wherein the pressurized gas applied to the multi-lumen resin material shaft is applied at a pressure of 2 inches of water.  
     
     
         75 . The method of  claim 64  wherein said pushing a molten resin material through a tip and die assembly and said applying a pressurized medium to the multi-lumen resin material shaft so as to maintain a central lumen and at least one outer lumen are performed concurrently.  
     
     
         76 . The method of  claim 65  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done at a pulling rate of about 25-100 feet per minute.  
     
     
         77 . The method of  claim 65  wherein said pulling the multi-lumen resin material shaft away from the extrusion die is done at a pulling rate of about 45-65 feet per minute.  
     
     
         78 . The method of  claim 64  wherein the at least one outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.  
     
     
         79 . The method of  claim 64  wherein the multi-lumen tubing has an overall diameter in a range of approximately {fraction (34/1000)} in. to {fraction (48/1000)} in.  
     
     
         80 . An extruder die, comprising: 
 at least one outer exit hole disposed adjacent to a central exit hole, the outer exit hole having a substantially flat shape across a part of an outer exit hole periphery where the outer exit hole is disposed adjacent to the central exit hole, the central exit hole having a substantially flat shape across a part of a central exit hole periphery where the central exit hole is disposed adjacent to the outer exit hole.    
     
     
         81 . The extruder die of  claim 80 , wherein a die region separating the outer exit hole from the central exit hole has a thickness in a range of approximately 0-{fraction (10/1000)} in.  
     
     
         82 . The extruder die of  claim 80 , wherein a die region separating the outer exit hole from the central exit hole has a thickness of about {fraction (5/1000)} in.  
     
     
         83 . An extruder die, comprising at least one outer exit hole disposed adjacent to a central exit hole, the outer exit hole separated from the central exit hole by an extruder die region having a thickness in a range of approximately 0-{fraction (10/1000)}.  
     
     
         84 . An extruder die, comprising: 
 a single exit hole profile such that a resin material shaft having a radial cross-section that includes at least one fillet radius region is formed.    
     
     
         85 . An extruder die, comprising: 
 a single exit hole profile such that a resin material shaft having a radial cross-section that includes at least one standoff region is formed.