Reinforced multiple-lumen catheter and apparatus and method for making the same

• US 5,374,245 A
• Filed: 04/28/1993
• Issued: 12/20/1994
• Est. Priority Date: 01/10/1990
• Status: Expired due to Term

• Current Assignee: Sakharam D. Mahurkar
• Original Assignee: Sakharam D. Mahurkar
• Inventors: Mahurkar, Sakharam D.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US08/055,830
• Time in Patent Office: 601 Days
• Field of Search: 604/43-45, 604/264, 604/280, 604/281, 604/282
• US Class Current: 604/43
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid

Abstract

A method of making a multiple-lumen catheter using a co-extrusion die comprises the step of forming an elongated cylindrical tube made of silicone and having an internal septum extending along the length thereof to form at least a pair of longitudinal lumens. While the elongated cylindrical tube is being formed, a nylon reinforcing strip is arranged inside the tube such that the strip extends along the length of the tube. The tube is solidified and cut into individual multiple-lumen catheters. The nylon strip includes a pair of orthogonal side plates which aid in anchoring the nylon strip within the solidified tube.

An apparatus for making the multiple-lumen catheter comprises a co-extrusion die, a silicon extruder for injecting silicone into the die, and a pair of rollers for feeding a nylon strip into the die. The co-extrusion die has a circular opening containing a pair of mandrels extending within the die for a predetermined length, the mandrels being arranged substantially parallel to each other with a gap therebetween. The rollers feed the nylon strip into the gap between the mandrels while the extruder is injecting the silicone into the die.

Claims

1. A method of making a multiple-lumen catheter using a co-extrusion die, comprising the steps of:

forming an elongated cylindrical tube made of a soft, elastic material which is compatible with the human body, said tube having an internal septum extending along the length thereof to form at least a pair of longitudinal lumens;

while the elongated cylindrical tube is being formed, arranging a diametral reinforcing member extending along the length of the tube and completely embedded within said soft compatible material of said tube and septum so that said reinforcing material is not exposed to blood passing through said lumens, the reinforcing member being made of a material which is substantially stiffer than the material of the tube; and

solidifying the tube.

2. The method of claim 1, further comprising the step of curing the tube.

3. The method of claim 1, further comprising the step of cutting the tube into individual multiple-lumen catheters.

4. The method of claim 3, further comprising the step of molding a tip directly onto an end of each of the individual multiple-lumen catheters.

5. The method of claim 3, further comprising the step of preforming a conical tip and bonding the tip to the end of each of the individual multiple-lumen catheters.

6. The method of claim 3, further comprising the step of slicing off a distal portion of one of the lumens of each of the individual multiple-lumen catheters with a beveled cut so as to form a sliced tip.

7. The method of claim 3, further comprising the step of blocking off one of the lumens short of the distal end of each of the individual multiple-lumen catheters.

8. The method of claim 3, further comprising the step of connecting a hub with a plurality of extension tubes to the proximal end of each of the individual multiple-lumen catheters, a separate extension tube being in fluid communication with each of the lumens.

9. The method of claim 3, further comprising the step of curing each of the individual multiple-lumen catheters and imparting a generally U-shaped bend to each of the individual multiple-lumen catheters during the curing.

10. The method of claim 1, further comprising the step of applying an adhesive to the material used for making the reinforcing member prior to forming the tube.

11. The method of claim 1, wherein the step of arranging the reinforcing member inside the tube and extending along the length of the tube includes interlocking the reinforcing member and the tube.

12. The method of claim 3, further comprising the step of terminating a first lumen of each of the individual multiple-lumen catheters at a distal aperture at the distal end of each of the individual multiple-lumen catheters, and terminating a second lumen at a distal aperture in the side wall of the tube which is longitudinally spaced from the distal end of each of the individual multiple-lumen catheters.

13. The method of claim 12, further comprising the step of providing the first lumen with an auxiliary aperture in the side wall of the tube of each of the individual multiple-lumen catheters, the auxiliary aperture being longitudinally spaced from the distal aperture in the first lumen.

14. The method of claim 12, further comprising the step of providing the second lumen with an auxiliary aperture in the side wall of the tube of each of the individual multiple-lumen catheters, the auxiliary aperture being spaced longitudinally and radially away from the distal aperture in the second lumen.

15. The method of claim 1, further comprising the step of providing the reinforcing member with a plurality of spaced apertures located along the length of the reinforcing member.

16. The method of claim 1, wherein the reinforcing member is arranged within the internal septum.

17. The method of claim 1, further including the step of providing the reinforcing member in the form of a flat strip prior to the step of arranging the reinforcing member along the length of the tube.

18. The method of claim 17, wherein the step of providing the reinforcing member in the form of a flat strip includes providing the reinforcing member in the form of a flat strip with orthogonal side plates.

19. A method of making a multiple-lumen catheter using a co-extrusion die, comprising the steps of:

forming an elongated cylindrical tube made of a soft, elastic material which is compatible with the human body, said tube having an internal septum extending along the length thereof to form at least a pair of longitudinal lumens;

while the elongated cylindrical tube is being formed, arranging a diametral reinforcing member such that the reinforcing member is completely embedded within said soft compatible material of said tube and septum so that said reinforcing material is not exposed to blood passing through said lumens, the reinforcing member being a flat strip and being made of a material which is substantially stiffer than the material of the tube; and

solidifying the tube.