Multi-lumen, multi-parameter catheter

• US 6,036,654 A
• Filed: 09/23/1994
• Issued: 03/14/2000
• Est. Priority Date: 09/23/1994
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation, Transonic Systems, Inc. (Measurement Innovations Corp.)
• Original Assignee: Baxter International Inc.
• Inventors: Quinn, Michael D., Yelderman, Mark L., Siman, Jaime
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): YARNELL, BRYAN KEITH
• Application Number:
  US08/311,477
• Time in Patent Office: 1,999 Days
• Field of Search: 128/632, 128/634, 128/664-7, 128/672, 128/673, 128/691, 128/692, 128/713, 128/736, 128/693, 607/17, 607/21, 607/23, 600/339, 600/309, 600/310, 600/473-479, 600/485, 600/486, 600/504, 600/526, 600/549, 604/264, 604/280, 604/282, 604/93
• US Class Current: 600/526
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters

Abstract

A multi-lumen catheter capable of measuring cardiac output continuously, mixed venous oxygen saturation as well as other hemodynamic parameters. The catheter is also capable of undertaking therapeutic operations such as drug infusion and cardiac pacing. The catheter includes optical fibers for coupling to an external oximeter, an injectate port and thermistor for bolus thermodilution measurements, a heating element for inputting a heat signal and for coupling to an external processor for continuously measuring cardiac output, and a distal lumen for measuring pressure, withdrawing blood, guidewire passage or drug infusion. In a preferred embodiment, the catheter includes a novel lumen configuration permitting an additional infusion lumen for either fast drug infusion or cardiac pacing.

Claims

1. A multi-lumen catheter system configured to accommodate various diagnostic and therapeutic procedures, comprising:

a flexible elongated tubing portion having a longitudinal axis, an exterior wall and defining multiple lumens therein, including;

an interior lumen positioned off-center with respect to the longitudinal axis to be closer to a first side of the exterior wall, and farther from a second side of the exterior wall opposite the first side, wherein the interior lumen is elliptically shaped in cross-section;

a plurality of outer lumens defined within the tubing portion surrounding the interior lumen and generally between the interior lumen and the exterior wall, a pair of the outer lumens being positioned between the interior lumen and the first side and having smaller cross-sectional areas than the other outer lumens for an efficient lumen space utilization, and at least one outer lumen being larger than the interior lumen and being positioned generally between the interior lumen and the second side, wherein the offset interior lumen accommodates the differing sized outer lumens to optimize their relative sizes and positions.

2. The multi-lumen catheter system of claim 1, wherein the number of outer lumens equals at least six.

3. The multi-lumen catheter system of claim 1, wherein one of the pair of outer lumens comprises an inflation lumen sized to permit passage of an inflation fluid, the catheter further including a balloon affixed to the distal tip of the tubing portion wherein the inflation lumen is in fluid communication with the interior of the balloon.

4. The multi-lumen catheter system of claim 1, wherein one of the pair of outer lumens is sized to permit passage of a temperature measuring wire, the catheter further including a temperature measuring sensor positioned proximate the distal end of the tubing portion and in communication with a monitor via the temperature measuring wire.

5. The multi-lumen catheter system of claim 4, further including a cross-over port formed between the one of the pair of outer lumens and an adjacent outer lumen, the cross-over port allowing passage of the temperature measuring wire, the temperature measuring sensor comprising a thermistor bead positioned in the adjacent outer lumen and in electrical communication with the temperature measuring wire.

6. The multi-lumen catheter system of claim 1, wherein the interior lumen has a first focus proximate to the longitudinal axis of the tubing portion.

7. The multi-lumen catheter system of claim 1, wherein the interior lumen is a fiber optic lumen.

8. The multi-lumen catheter system of claim 7, wherein the pair of outer lumens define:

an inflation lumen having a smaller cross-sectional area than the fiber optic lumen, and catheter includes a balloon affixed to the distal tip of the tubing portion wherein the inflation lumen is in fluid communication with the interior of the balloon; and

a wire-conduit lumen having a smaller cross-sectional area than the fiber optic lumen.

9. The multi-lumen catheter system of claim 8, wherein the catheter includes a temperature measuring sensor positioned proximate the distal end of the tubing portion and in communication with a monitor via a temperature measuring wire positioned in the wire-conduit lumen.

10. The multi-lumen catheter system of claim 9, wherein the outer lumens other than the pair define:

a heater wire lumen having a cross-sectional area larger than the fiber optic lumen, and the catheter system includes a heater connected via wires extending through the heater wire lumen to a heating filament wound around the exterior wall;

a distal lumen having a cross-sectional area larger than the heater wire lumen and extending to the distal end of the tubing portion to permit passage of a guidewire;

an injectate lumen having a cross-sectional area larger than the heater wire lumen and terminating in an injectate port through the exterior wall and located proximally from the temperature measuring sensor; and

an infusion lumen having a cross-sectional area larger than all of the other lumens and terminating in an infusion port through the exterior wall and located proximally from the injectate port.

11. The multi-lumen catheter system of claim 8, wherein the catheter system includes a heater connected via wires extending through the wire-conduit lumen to a heating filament wound around the exterior wall.

12. A multi-lumen catheter system configured to accommodate various diagnostic and therapeutic procedures, comprising:

a flexible elongated tubing portion having an exterior wall and a plurality of webs defining multiple lumens within the catheter, including;

an interior, fiber optic lumen elliptically shaped in cross-section and positioned off-center to be closer to a first side of the exterior wall, and farther from a second side of the exterior wall opposite the first side; and

a plurality of outer lumens surrounding the fiber optic lumen and generally between the fiber optic lumen and the exterior wall, a pair of the outer lumens being positioned generally between the fiber optic lumen and the first side of the exterior wall and sized smaller in cross-sectional area than the other outer lumens for an efficient lumen space utilization, and at least one outer lumen being larger than the fiber optic lumen and being positioned generally between the fiber optic lumen and the second side of the exterior wall opposite the first side, wherein the relative sizes and positions of the lumens between the webs enhances use of the cross-sectional area and kink-resistance of the catheter.

13. The multi-lumen catheter system of claim 12, wherein the fiber optic lumen has a first focus proximate to the longitudinal axis of the tubing portion.

14. The multi-lumen catheter system of claim 12, further including a plurality of optical fibers substantially filling the fiber optic lumen so that when forces are imparted to the exterior wall they are transmitted through the webs on one side of the fiber optic lumen and across the fiber optic lumen to the webs on the opposite side of the fiber optic lumen and to the exterior wall by virtue of the solid optical fibers within the fiber optic lumen.

15. The multi-lumen catheter system of claim 12, wherein the outer lumens other than the pair define:

a heater wire lumen having a cross-sectional area larger than the fiber optic lumen, and the catheter system includes a heater connected via wires extending through the heater wire lumen to a heating filament wound around the exterior wall;

a distal lumen having a cross-sectional area larger than the heater wire lumen and extending to the distal end of the tubing portion to permit passage of a guidewire;

an injectate lumen having a cross-sectional area larger than the heater wire lumen and terminating in an injectate port through the exterior wall and located proximally from the heating filament; and

an infusion lumen having a cross-sectional area larger than all of the other lumens and terminating in an infusion port through the exterior wall and located proximally from the injectate port.