Reinforced multi-lumen catheter

• US 7,972,465 B2
• Filed: 02/02/2010
• Issued: 07/05/2011
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Shang, Walter H., Patterson, Ryan C.
• Primary Examiner(s): Tucker; Philip C
• Assistant Examiner(s): Slawski; Brian R
• Application Number:
  US12/698,999
• Publication Number:
  US 20100132879A1
• Time in Patent Office: 518 Days
• Field of Search: 156/84, 156/86, 156/184, 156/185, 156/187, 156/188, 156/190, 156/191, 156/192, 156/195, 156/242, 156/243, 156/244.11, 156/244.13, 156/244.15, 156/244.18, 156/244.19, 156/244.24, 156/244.25, 156/244.27, 156/250, 156/254, 156/296, 156/297, 156/304.1, 156/304.2, 156/304.3, 156/304.6, 156/308.2, 156/309.6, 156/323, 604/264, 604/284, 604/523, 604/525, 604/526, 604/527
• US Class Current: 156/296
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• 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 25/0032 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 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 156/1082 Partial cutting bonded sandwich [e.g., grooving or incising]
• CPC Class Codes: Y10T 156/1142 Changing dimension during delaminating [e.g., crushing, expanding, warping, etc.]
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]

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.

Claims

1. 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 substrate 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.

2. The method according to claim 1, 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.

3. The method according to claim 2, wherein the heating step comprises rotating the assembly while heat is applied.

4. The method according to claim 1, wherein the shim comprises sharp opposing edges, wherein the cutting step comprises utilizing only the shim.