REINFORCED MULTI-LUMEN CATHETER

• US 20110192008A1
• Filed: 04/15/2011
• Published: 08/11/2011
• 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, Patterson, Ryan C.
• Granted Patent: US 8,430,988 B2
• Time in Patent Office: Days
• US Class Current: 29/447
• 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 proximal catheter body substrate including a septum, a first and second distal catheter body substrate, a first and second mandrel, a reinforcing element and a sleeve. The reinforcing element is positioned over the proximal catheter body substrate and at least a proximal region of the first and second distal catheter body substrates.

Claims

1. A method of making a multi-lumen catheter, comprising:

providing an assembly comprising;

a proximal 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 distal catheter body substrate comprising a third lumen shaped substantially similar to the first lumen;

a second distal catheter body substrate comprising a fourth lumen shaped substantially similar to the second lumen;

a first mandrel and a second mandrel inserted respectively through the first lumen and the second lumen, and into at least a portion of the third lumen and fourth lumen, the first distal catheter body substrate and second distal catheter body substrate placed in abutting relationship with the proximal catheter body substrate;

a reinforcing element positioned over the proximal catheter body substrate and at least a proximal region of the first and second distal catheter body substrates;

a sleeve positioned over the reinforcing element;

shrink tubing positioned over the sleeve;

heating the assembly; and

removing the shrink tubing.

2. The method according to claim 1, wherein the first, second, third, and fourth lumens each have a D-shaped configuration.

3. The method according to claim 1, wherein the first distal catheter body substrate has a length different from the second distal catheter body substrate, wherein the first and second mandrels are inserted respectively through the first and second distal catheter body substrates.

4. The method according to claim 1, further comprising the step of forming a tip on at least one of the first and second distal catheter body substrates following the removing step.

5. The method according to claim 1, further comprising the step of forming a tip on both of the first and second distal catheter body substrates following the removing step.

6. The method according to claim 5, wherein the forming includes using radio-frequency energy to form rounded ends on each of the first and second distal catheter body substrates.

7. The method according to claim 6, further comprising creating one or more side holes in the first and second distal catheter body substrates.

8. The method according to claim 1, further comprising attaching a connector system to a proximal end of the proximal catheter body substrate.

9. The method according to claim 1, further comprising the step of splitting the first distal catheter body substrate from the second distal catheter body substrate from a distal end to a predetermined dividing point, the dividing point being distal of the septum proximal region.

10. The method according to claim 1, wherein the shrink tubing comprises an FEP material, the heating step comprising heating a convection oven to a temperature between approximately 300°

C. and 360°

C., and inserting the assembly into the oven for a period of time between approximately 1 minute and 5 minutes.