Multi-purpose multi-parameter cardiac catheter

• US 5,611,338 A
• Filed: 09/29/1994
• Issued: 03/18/1997
• Est. Priority Date: 07/16/1992
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Hughes, Timothy J., Sarge, Jeffrey A., Ambrisco, William A., Pantages, Anthony J., Gallup, David A., Sperinde, John M., Tsuchitani, Scott T.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US08/315,033
• Time in Patent Office: 901 Days
• Field of Search: 128/634, 128/691-2, 128/713, 128/736
• US Class Current: 600/342
• 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

Abstract

A multi-lumen, multi-purpose cardiac catheter which incorporates optical filaments and an optical coupler for use with external apparatus for determining the oxygen concentration in the blood of a patient under critical care conditions, as well as incorporating therein a thermal element useable with a second external apparatus for measurement of continuous cardiac output. The thermal element is disposed at a necked down portion of the catheter at the distal end thereof, with at least one of the lumens of the catheter substantially compressed at the necked down portion thereof. The catheter also includes a thermistor and at least one injectate port for enabling the user to also conduct thermal dilution readings and obtain intermittent measurements of cardiac output. The combination of a thermal dilution catheter with a SVO₂ catheter and a continuous cardiac output catheter gives the multi-purpose catheter above described substantial versatility as well as providing the user with a versatile cardiac catheter device which enables him to conduct multiple evaluations of disparate blood-related parameters which require the use of separate apparatus. Simply by switching from one external apparatus to the other, the user can obtain readings for different blood-related parameters useful in the treatment of the cardiac patient.

Claims

1. A multi-lumen multi-purpose cardiac catheter comprising a multi-lumen main body portion, a plurality of extension tubes, each connected to a respective lumen of the multi-lumen catheter and a manifold providing an interface between the main body portion of the catheter and the extension tubes, said catheter comprising:

at least one lumen for holding and supporting fiber optic filaments;

at least one lumen for receiving thermal element connectors;

at least one lumen for receiving a device for temperature measurement;

at least one lumen associated with a balloon mounted at a distal end of the catheter for assisting in placement of the catheter in a patient;

a fiber optic apparatus associated with the catheter including optical filaments disposed in the fiber optic lumen and extending the working length of the main body portion of the catheter, and into a fiber optic coupler associated with the catheter;

temperature measurement apparatus mounted at the distal end of the catheter, wiring extending the working length of the catheter and into a housing associated with the catheter;

a necked down portion of the main body portion of the catheter disposed near the distal end of the catheter and an external thermal element disposed in the necked down portion of the catheter, at least one of the lumens of the catheter substantially compressed at said necked down portion, to enable the remaining lumens to maintain a constant size for the entire working length of the catheter through said necked down portion and to the distal end thereof;

connectors extending from the thermal element along the working length of the catheter to be connected to a thermal element housing at a proximal end of the catheter; and

catheter positioning apparatus comprising a balloon mounted at the distal end of the catheter, a balloon lumen extending from the balloon along the working length of the main body portion of the catheter to a device providing access to the balloon;

wherein the thermal element apparatus is operative with an external apparatus to provide a measurement of continuous cardiac output and the fiber optic elements are cooperative with external apparatus for providing a measurement of oxygen concentration in blood (SVO₂).

2. The multi-lumen, multi-purpose cardiac catheter of claim 1 wherein the thermal element comprises a thermal element wound about the necked down portion of the main body portion.

3. The multi-lumen, multi-purpose cardiac catheter of claim 2, wherein the necked down portion of the main body portion is 10-15 centimeters in length and is disposed not less than 10-15 centimeters from the distal end of the catheter.

4. The multi-lumen, multi-purpose cardiac catheter of claim 3, wherein the thermal element wound about the necked down portion is pitched at a center-to-center spacing sufficient to separate adjacent coils.

5. The multi-lumen, multi-purpose cardiac catheter of claim 4, wherein the thermal element windings have a center-to-center spacing in a range of 0.1 to 0.2 inches.

6. The multi-lumen, multi-purpose cardiac catheter of claim 5, wherein the catheter includes a distal thermal pressure port disposed between a distal end of the thermal element and the distal end of the catheter.

7. The multi-lumen, multi-purpose cardiac catheter as claimed in claim 6, wherein the temperature measurement apparatus comprises a thermistor which is at least 10 centimeters downstream of the distal end of the thermal element.

8. The multi-lumen, multi-purpose cardiac catheter as claimed in claim 7, wherein the thermal element is coated with a material structurally similar to the main body portion of the catheter.

9. The multi-lumen, multi-purpose cardiac catheter as claimed in claim 8, wherein the thermal element and the coating thereof mounted in the necked down portion of the main body portion generally approximate the diameter of the main body portion of the catheter, thereby to effect a smooth insertion of the catheter into the body of the patient.

10. A multi-lumen, multi-purpose cardiac catheter as claimed in claim 9, wherein at least one lumen of the catheter comprises an injectate lumen having at least one injectate port provided upstream of the thermistor, thereby to enable injection of an injectate fluid into the blood stream of the patient to obtain thermal dilution readings at the thermistor to provide values for use in calculating intermittent cardiac output values.

11. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein the thermal element comprises a thin film member spirally wound about the catheter body near the distal end thereof.

12. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein the thermal element comprises a thin film sleeve having a single wire circuit embedded therein and overlying the catheter body near the distal end thereof.

13. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein the thermal element comprises a self-regulating conductive plastic sheath overlying the catheter main body portion near the distal end thereof.

14. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein the thermal element comprises a heat exchanger having an interior fluid jacket disposed next to the catheter body near the distal end thereof, with an exterior sheath overlying said fluid jacket.

15. The multi-lumen, multi-purpose cardiac catheter as claimed in claim 1 wherein the connection between the thermal element and the connectors extending through the main body portion includes separate windings for each thermal element ending at its junction with a respective connector and an exit point for the windings of the thermal element at a proximal end of the necked down portion of the main body portion, thereby providing improved flexibility and strain relief at the junction of the thermal element and the connectors.

16. A multi-lumen multi-purpose cardiac catheter comprising a multi-lumen main body portion, a plurality of extension tubes, each connected to a respective lumen of the multi-lumen catheter and a manifold providing an interface between the main body portion of the catheter and the extension tubes, said catheter comprising:

at least one lumen for holding and supporting fiber optic filaments;

at least one lumen for receiving thermal element connectors;

at least one lumen for receiving a device for temperature measurement;

at least one lumen associated with a balloon mounted at a distal end of the catheter for assisting in placement of the catheter in a patient;

a fiber optic apparatus associated with the catheter including optical filaments disposed in the fiber optic lumen and extending the working length of the main body portion of the catheter, and into a fiber optic coupler associated with the catheter;

temperature measurement apparatus mounted at the distal end of the catheter, wiring extending the working length of the catheter and into a housing associated with the catheter;

a necked down portion of the main body portion of the catheter, said necked down portion disposed near the distal end of the catheter, at least one of the lumens of the catheter substantially compressed at said necked down portion, to enable the remaining lumens to maintain a constant size for the entire working length of the catheter through said necked down portion and to the distal end thereof;

an external thermal element placed on the necked down portion of the catheter;

connectors extending from the thermal element along the working length of the catheter to be connected to a thermal element housing at a proximal end of the catheter; and

catheter positioning apparatus comprising a balloon mounted at the distal end of the catheter, a balloon lumen extending from the balloon along the working length of the main body portion of the catheter to a device providing access to the balloon;

wherein the thermal element apparatus is operative with an external apparatus to provide a measurement of continuous cardiac output and the fiber optic elements are cooperative with external apparatus for providing a measurement of oxygen concentration in blood (SVO₂).

17. A multi-lumen multi-purpose cardiac catheter comprising a multi-lumen main body portion, a plurality of extension tubes, each connected to a respective lumen of the multi-lumen catheter and a manifold providing an interface between the main body portion of the catheter and the extension tubes, said catheter comprising:

at least one lumen for holding and supporting fiber optic filaments;

at least one lumen for receiving thermal element connectors;

at least one lumen for receiving a device for temperature measurement;

at least one lumen associated with a balloon mounted at a distal end of the catheter for assisting in placement of the catheter in a patient;

a fiber optic apparatus associated with the catheter including optical filaments disposed in the fiber optic lumen and extending the working length of the main body portion of the catheter, and into a fiber optic coupler associated with the catheter;

temperature measurement apparatus mounted at the distal end of the catheter, wiring extending the working length of the catheter and into a housing associated with the catheter;

a necked down portion of the main body portion of the catheter, said necked down portion disposed near the distal end of the catheter, at least one of the lumens of the catheter substantially compressed at said necked down portion, to enable the remaining lumens to maintain a constant size for the entire working length of the catheter through said necked down portion and to the distal end thereof;

an external thermal element placed on the necked down portion of the catheter;

connectors extending from the thermal element along the working length of the catheter to be connected to a thermal element housing at a proximal end of the catheter;

at least one lumen of the catheter comprising an injectate lumen having at least one injectate port provided upstream of the temperature measurement apparatus;

catheter positioning apparatus comprising a balloon mounted at the distal end of the catheter, a balloon lumen extending from the balloon along the working length of the main body portion of the catheter to a device providing access to the balloon;

wherein the thermal element apparatus is operative with an external apparatus to provide a measurement of continuous cardiac output, the fiber optic elements are cooperative with external apparatus for providing a measurement of oxygen concentration in blood (SVO₂) and the injectate lumen enables injection of an injectate fluid into the blood stream of the patient to obtain thermal dilution readings at the temperature measurement apparatus to provide values for use in calculating intermittent cardiac output values.

18. A multi-lumen multi-purpose cardiac catheter comprising a multi-lumen main body portion, a plurality of extension tubes, each connected to a respective lumen of the multi-lumen catheter and a manifold providing an interface between the main body portion of the catheter and the extension tubes, said catheter comprising:

a fiber optic apparatus associated with the catheter including optical filaments disposed in a fiber optic lumen and extending the working length of the main body of the catheter, and into a fiber optic coupler associated with the catheter;

temperature measurement apparatus mounted at a distal end of the catheter, wiring extending the working length of the catheter and into a housing associated with the catheter;

a necked down portion of the main body portion of the catheter, said necked down portion 10-15 centimeters in length and disposed not less than 10-15 centimeters from the distal end of the catheter, said necked down portion having helical shoulders at opposite ends thereof, said shoulders including grooves tapering downward from the necked down surface;

an external longitudinal thermal element disposed in the necked down portion of the main body portion;

said thermal element comprising a thermal coil wound about said necked down portion, said thermal coil wound about the catheter and pitched at a center-to-center spacing sufficient to separate adjacent coils, the helical shoulders and adjacent grooves facilitating placement of the thermal element in the necked down portion of the catheter,

connectors extending from the thermal element along the working length of the catheter to be connected to a thermal element housing at a proximal end of the catheter;

at least one lumen for holding and supporting fiber optic filaments;

at least one lumen for receiving thermal element connectors;

at least one lumen for receiving a device for temperature measurement;

at least one lumen associated with a balloon mounted at the distal end of the catheter for assisting in placement of the catheter in a patient;

a distal thermal pressure port disposed between the distal end of the thermal element and the distal end of the catheter for waveform monitoring purposes; and

catheter positioning apparatus comprising a balloon mounted at the distal end of the catheter, a balloon lumen extending from the balloon along the working length of the main body portion of the catheter to a device providing access to the balloon;

wherein the thermal element apparatus is operative with an external apparatus to provide a measurement of continuous cardiac output and, alternatively, the fiber optic elements are cooperative with external apparatus for providing a measurement of oxygen concentration in blood (SVO₂).