REINFORCED MULTI-LUMEN CATHETER

• US 20100132879A1
• Filed: 02/02/2010
• Published: 06/03/2010
• 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: Patterson, Ryan C., Shang, Walter
• Granted Patent: US 7,972,465 B2
• Time in Patent Office: Days
• US Class Current: 156/192
• 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:

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.

2. The method according to claim 1, 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.

3. The method according to claim 1, 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.

4. The method according to claim 3, wherein the reinforcing element is positioned substantially over the proximal catheter body substrate and at least a portion of the distal catheter body substrate.

5. The method according to claim 1, 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.

6. The method according to claim 5, 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.

7. 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.

8. The method according to claim 7, wherein the inserting step comprises applying a longitudinal strain to the septum such that the septum is stretched for placement within the tube.

9. The method according to claim 7, 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.

10. The method according to claim 7, 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.

11. 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.

12. The method according to claim 11, further comprising the step of positioning a sleeve over the elongate member.

13. The method according to claim 11, 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.

14. 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.

15. The method according to claim 14, 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.

16. The method according to claim 15, wherein the heating step comprises rotating the assembly while heat is applied.

17. The method according to claim 14, wherein the shim comprises sharp opposing edges, wherein the cutting step comprises utilizing only the shim.