Catheter assembly including a multi-lumen configuration

• US 10,518,064 B2
• Filed: 02/24/2017
• Issued: 12/31/2019
• Est. Priority Date: 11/01/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Oborn, Kelli D., Moehle, Ryan T., Barron, William R, Crook, Christian W.
• Primary Examiner(s): Deak, Leslie R
• Application Number:
  US15/442,608
• Publication Number:
  US 20170165453A1
• Time in Patent Office: 1,040 Days
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2202/0021 removed from and reintroduced into the body, e.g. after treatment
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/02 : Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: B29C 2793/009 : after shaping
• CPC Class Codes: B29C 48/0022 : combined with cutting
• CPC Class Codes: B29C 48/11 : comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29C 48/12 : Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A catheter assembly for use in accessing a vasculature of a patient is disclosed. In one embodiment, the catheter assembly includes a catheter body that includes a flattened oval outer surface and defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and includes a distal-facing portion. The distal tip region further includes an arterial lateral opening that is in fluid communication with the second lumen, includes a distal-facing portion, and is substantially un-staggered with respect to the venous lateral opening. A distal end opening is in fluid communication with a power injectable third lumen. In another embodiment, the first and second lumens each generally include a reniform cross-sectional shape. In yet another embodiment, a dual-lumen catheter includes first and second lumens that each define a modified ellipse cross-sectional shape.

Claims

1. A method for making an elongate catheter tube, the method comprising:

extruding an extrusion material to define;

an outer surface having a flattened oval cross-sectional shape with opposing flat sides;

a first lumen and a second lumen separated by a septum; and

a third lumen between the first lumen and the second lumen, the third lumen configured to withstand pressures associated with power injection of a fluid therethrough.

2. The method for making according to claim 1, wherein the extruding further comprises defining the first lumen and the second lumen to each have a cross-sectional shape including:

a minor arc portion adjacent the septum;

a major arc portion adjacent an outer wall of the catheter tube; and

rounded first and second corners interposed between the minor arc portion and the major arc portion.

3. The method for making according to claim 2, wherein the extruding comprises defining the third lumen to be positioned adjacent the minor arc portion of each of the first lumen and the second lumen.

4. The method for making according to claim 1, wherein the extruding comprises defining a wall thickness adjacent the major arc portion to be substantially constant.

5. The method for making according to claim 1, wherein the extruding further comprises defining:

a first lateral opening in fluid communication with the first lumen, the first lateral opening defined by a first angled cross cut; and

a second lateral opening in fluid communication with the second lumen, the second lateral opening defined by a second angled cross cut.

6. The method for making according to claim 5, wherein the extruding comprises defining the first angled cross cut to include a first cut and a second cut opposite of the first cut, each of the first cut and the second cut having a long axis at an oblique angle with a longitudinal axis of the elongate catheter tube.

7. The method for making according to claim 1, wherein the extruding further comprises defining the first lumen and the second lumen to each have a cross-sectional shape including:

an arcuate portion;

rounded first and second corners disposed at either end of the arcuate portion; and

a concavity opposite the arcuate portion and interposed between the rounded first and second corners.

8. The method for making according to claim 7, wherein the extruding comprises defining the concavity in an offset configuration with respect to the rounded first and second corners.

9. The method for making according to claim 1, wherein the extruding comprises defining the septum to include a unified portion and a bifurcated portion, the third lumen bounded by the bifurcated portion.

10. The method for making according to claim 1, wherein the extruding comprises defining the septum on a center line of the catheter tube such that the first lumen and the second lumen are disposed in a mirror-image configuration about the center line.

11. The method for making according to claim 1, wherein the extruding comprises defining the first lumen and the second lumen to have substantially identical cross-sectional shapes disposed in a mirror image configuration about the septum.

12. The method for making according to claim 1, wherein the extruding comprises defining the first lumen and the second lumen to each have a cross-sectional shape including:

a major arc portion adjacent an outer wall of the catheter tube; and

flattened side opposite of the major arc portion.

13. The method for making according to claim 1, wherein the extruding comprises defining a tapered atraumatic distal tip region.