Thermodilution catheter having a safe, flexible heating element

• US 7,254,946 B1
• Filed: 04/12/1995
• Issued: 08/14/2007
• Est. Priority Date: 01/29/1991
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Quinn, Michael D., Yelderman, Mark L.
• Primary Examiner(s): Nasser; Robert L.
• Application Number:
  US08/420,503
• Time in Patent Office: 4,507 Days
• Field of Search: 128/692, 128/713, 128/633, 128/634, 128/691, 128/736, 128664- 7
• US Class Current: 60/505
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape

Abstract

A thermodilution catheter having a heating filament which is fabricated so as to be thin and flexible enough to avoid contact with the patient'"'"'s blood. The heating filament is either inserted in a preformed catheter lumen, incorporated into a wall of the catheter body itself, or wrapped around the catheter body wall and surrounded by an external sheath. Generally, the covering of the heating filament is minimally thin so as to allow the heat from the heating filament to be transferred to the surrounding blood and to minimally increase the overall cross-sectional area. Since the heating filament does not directly touch the patient'"'"'s blood, the outer surface may be made smooth so as to prevent inducement of blood clots. In addition, the heating filament may be maintained at a safe temperature by forming the heating element of a flexible material having a high temperature coefficient of resistance, low thermal capacitance and high thermal conductivity. Preferably, the temperature coefficient of resistance of the material forming the heater filament is greater than 0.001 Ω/Ω-° C. and the resistance of the heating filament is proportional or inversely proportional to its temperature. By monitoring this resistance, the application of power to the heating filament may be regulated to prevent overheating of the heating filament. Calibration techniques are also disclosed whereby a memory containing encoded calibration information is disposed within or connected to a connector of the catheter. This memory may also include a program segment used by a cardiac output computer having a cardiac output calculation program, whereby the portion of code stored in the memory must be input into the cardiac output computer before the determination of the cardiac output can be performed. As a result of these improvements, the invention enables the thermodilution cardiac output calculation to be performed quite safely and accurately in a clinical setting.

Claims

1. A multi-lumen, multi-purpose cardiac catheter comprising:

(a) a multi-lumen main body portion;

(b) a plurality of extension tubes, each one of said plurality of extension tubes being connected to a respective lumen of said multi-lumen main body portion; and

(c) an interface connecting said multi-lumen main body portion and said plurality of extension tubes,

wherein;

(d) said multi-lumen main body portion comprises;

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

(ii) at least one lumen for receiving thermal element connectors;

(iii) at least one lumen for receiving a device for temperature measurement;

(iv) at least one lumen associated with a balloon mounted at the distal end of said multi-lumen main body portion for assisting in placement of said multi-lumen main body portion in a patient;

(v) a port defined by surfaces of one of the lumens of said multi-lumen main body portion, said port for injecting a fluid into a blood stream of a patient;

(vi) a fiber optic apparatus including said fiber optic filaments, said fiber optic filaments disposed in said at least one lumen for holding and supporting said fiber optic filaments, and said fiber optic filaments extending from inside said multi-lumen main body portion to a fiber optic coupler associated with the catheter; and

(vii) a necked-down portion near the distal end of said multi-lumen main body portion;

(e) a temperature measurement apparatus is mounted at the distal end of said multi-lumen main body portion;

(f) wiring extends from the temperature measurement apparatus along said multi-lumen main body portion to a housing associated with said multi-lumen main body portion;

(g) an external thermal element is mounted on said multi-lumen main body portion near the distal end of said multi-lumen main body portion; and

(h) connectors extend from said external thermal element along said multi-lumen main body portion for connection to a thermal element housing at the proximal end of said multi-lumen main body portion,

wherein;

(i) said external thermal element and said temperature measurement apparatus are operative with an external apparatus for providing a measurement of continuous cardiac output of a patient;

(j) said fiber optic apparatus is cooperative with said external apparatus for providing a measurement of mixed venous oxygen saturation of blood of the patient; and

(k) said external thermal element is mounted on said necked-down portion.

2. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein:

(a) said port is distal said interface and

(b) said lumen having the surfaces defining said port is an injectate lumen and said injectate lumen and said port enable injection of an injectate fluid into the blood stream of the patient.

3. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein said external thermal element comprises a thin film member spirally wound about said multi-lumen main body portion at approximately fourteen centimeters from the distal end of said multi-lumen main body portion.

4. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein:

(a) said external thermal element comprises a heating filament printed on a substrate and

(b) said substrate is a thin material that is capable of being incorporated into a filament material that is flexible and has the ability to bond with an adhesive.

5. The multi-lumen, multi-purpose cardiac catheter of claim 1, wherein said external thermal element comprises a layer of material with high thermal conductivity for providing temperature uniformity on a surface of said external thermal element.

6. A multi-lumen, multi-purpose cardiac catheter comprising:

(a) a multi-lumen main body portion;

(b) a plurality of extension tubes, each one of said plurality of extension tubes being connected to a respective lumen of said multi-lumen main body portion; and

(c) an interface connecting said multi-lumen main body portion and said plurality of extension tubes,

wherein;

(d) said multi-lumen main body portion comprises;

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

(ii) at least one lumen for receiving thermal element connectors;

(iii) at least one lumen for receiving a device for temperature measurement;

(iv) at least one lumen associated with a balloon mounted at the distal end of said multi-lumen main body portion for assisting in placement of said multi-lumen main body portion in a patient;

(v) a fiber optic apparatus including said fiber optic filaments, said fiber optic filaments in said at least one lumen for holding and supporting said fiber optic filaments, and said fiber optic filaments extending from inside said multi-lumen main body portion to a fiber optic coupler associated with the catheter; and

(vi) a necked-down portion near the distal end of said multi-lumen main body portion;

(e) a temperature measurement apparatus is mounted at the distal end of said multi-lumen main body portion;

(f) wiring extends from the temperature measurement apparatus along said multi-lumen main body portion to a housing associated with said multi-lumen main body portion;

(g) an external thermal element is mounted on said multi-lumen main body portion near the distal end of said multi-lumen main body portion;

(h) connectors extend from said external thermal element along said multi-lumen main body portion for connection to a thermal element housing at the proximal end of said multi-lumen main body portion;

(i) said external thermal element and said temperature measurement apparatus are operative with an external apparatus for providing a measurement of continuous cardiac output of a patient;

(j) said fiber optic apparatus is cooperative with said external apparatus for providing a measurement of mixed venous oxygen saturation of blood of the patient; and

(k) said external thermal element is mounted on said necked-down portion.

7. The multi-lumen, multi-purpose cardiac catheter of claim 6, wherein said necked-down portion is approximately 14–

15 centimeters from the distal end of said multi-lumen main body portion.

8. The multi-lumen, multi-purpose cardiac catheter of claim 7, wherein said multi-lumen main body portion further comprises at least one injectate lumen for injecting a fluid into the blood stream of the patient, said injectate lumen having surfaces defining a port.

9. The multi-lumen, multi-purpose cardiac catheter of claim 8, wherein

(a) said port is distal said interface and

(b) said injectate lumen and said port enable injection of an injectate fluid into the blood stream of the patient.

10. The multi-lumen, multi-purpose cardiac catheter of claim 6 wherein said external thermal element comprises a heater coil wound about said necked-down portion.

11. The multi-lumen, multi-purpose cardiac catheter of claim 10, wherein said temperature measurement apparatus comprises a thermistor which is distal said heater coil.

12. The multi-lumen, multi-purpose cardiac catheter of claim 10, wherein said heater coil comprises windings pitched at a center-to-center spacing sufficient to separate adjacent coils from one another.

13. The multi-lumen, multi-purpose cardiac catheter of claim 10, wherein said heater coil is surrounded by a thin outer sheath to prevent said external thermal element from directly contacting the patient'"'"'s blood.

14. The multi-lumen, multi-purpose cardiac catheter of claim 13, wherein an outer sheath diameter of said thin outer sheath approximates an outer main body portion diameter of said multi-lumen main body portion, thereby facilitating a smooth insertion of said multi-lumen main body portion into the body of the patient.

15. A multi-lumen, multi-purpose cardiac catheter comprising:

(a) a multi-lumen main body portion;

(b) a plurality of extension tubes, each one of said plurality of extension tubes being connected to a respective lumen of said multi-lumen main body portion; and

(c) an interface connecting said multi-lumen main body portion and said plurality of extension tubes,

wherein;

(d) said multi-lumen main body portion comprises;

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

(ii) at least one lumen for receiving thermal element connectors;

(iii) at least one lumen for receiving a device for temperature measurement;

(iv) at least one lumen associated with a balloon mounted at the distal end of said multi-lumen main body portion for assisting in placement of said multi-lumen main body portion in a patient;

(v) a first port defined by surfaces of one of the lumens of said multi-lumen main body portion, said first port for injecting a fluid into a blood stream of a patient;

(vi) a fiber optic apparatus including said fiber optic filaments, said fiber optic filaments disposed in said at least one lumen for holding and supporting said fiber optic filaments, and said fiber optic filaments extending from inside said multi-lumen main body portion to a fiber optic coupler associated with the catheter; and

(vii) a second port defined by surfaces of one of the lumens of said multi-lumen main body portion, said second port being adapted for injecting a fluid into a blood stream of the patient;

(e) a temperature measurement apparatus is mounted at the distal end of said multi-lumen main body portion;

(f) wiring extends from the temperature measurement apparatus along said multi-lumen main body portion to a housing associated with said multi-lumen main body portion;

(g) a necked-down portion of said multi-lumen main body portion is near the distal end of said multi-lumen main body portion;

(h) an external thermal element is mounted on said necked-down portion;

(i) connectors extend from said external thermal element along said multi-lumen main body portion for connection to a thermal element housing at the proximal end of said multi-lumen main body portion;

(j) said external thermal element and said temperature measurement apparatus are operative with an external apparatus for providing a measurement of continuous cardiac output of a patient; and

(k) said fiber optic apparatus is cooperative with said external apparatus for providing a measurement of mixed venous oxygen saturation of blood of the patient.

16. A multi-lumen, multi-purpose cardiac catheter comprising:

(a) a multi-lumen main body portion;

(b) a plurality of extension tubes, each one of said plurality of extension tubes being connected to a respective lumen of said multi-lumen main body portion; and

(c) an interface connecting said main body portion and said plurality of extension tubes,

wherein;

(d) said multi-lumen main body portion comprises;

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

(ii) at least one lumen for receiving thermal element connectors;

(iii) at least one lumen for receiving a device for temperature measurement;

(iv) at least one lumen associated with a balloon mounted at the distal end of said multi-lumen main body portion for assisting in placement of said multi-lumen main body portion in a patient; and

(v) a fiber optic apparatus including said fiber optic filaments, said fiber optic filaments in said at least one lumen for holding and supporting said fiber optic filaments, and said fiber optic filaments extending from inside said multi-lumen main body portion to a fiber optic coupler associated with the catheter;

(e) a temperature measurement apparatus is mounted at the distal end of said multi-lumen main body portion;

(f) wiring extends from the temperature measurement apparatus along said multi-lumen main body portion to a housing associated with said multi-lumen main body portion;

(g) a necked-down portion of said multi-lumen main body portion is near the distal end of said multi-lumen main body portion;

(h) an external thermal element is mounted on said necked-down portion;

(i) connectors extend from said external thermal element along said multi-lumen main body portion for connection to a thermal element housing at the proximal end of said multi-lumen main body portion;

(j) at least one lumen of said multi-lumen main body portion comprises an injectate lumen;

(k) said external thermal element and said temperature measurement apparatus are operative with an external apparatus for providing a measurement of continuous cardiac output of a patient;

(l) said fiber optic apparatus is cooperative with said external apparatus for providing a measurement of mixed venous oxygen saturation of blood of the patient; and

(m) said injectate lumen has surfaces defining a port, said port being positioned along said multi-lumen main body portion such that, when the distal tip of said main body portion is in a pulmonary artery of a patient, said port is in the right ventricle of the heart of the patient.

17. A multi-lumen, multi-purpose cardiac catheter comprising:

(a) a multi-lumen main body portion;

(b) a plurality of extension tubes, each one of said plurality of extension tubes being connected to a respective lumen of said multi-lumen main body portion; and

(c) an interface connecting said multi-lumen main body portion and said plurality of extension tubes,

wherein;

(d) said multi-lumen main body portion comprises;

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

(ii) at least one lumen for receiving thermal element connectors and associated with a balloon mounted at the distal end of said multi-lumen main body portion;

(iii) at least one lumen for receiving a device for temperature measurement;

(iv) at least one lumen dedicated to measuring distal catheter pressure;

(v) a fiber optic apparatus including said fiber optic filaments, said fiber optic filaments disposed in said at least one lumen for holding and supporting said fiber optic filaments, and said fiber optic filaments extending from inside said multi-lumen main body portion to a fiber optic coupler associated with the catheter;

(e) a temperature measurement apparatus is mounted at the distal end of said multi-lumen main body portion;

(f) wiring extends from the temperature measurement apparatus along said multi-lumen main body portion to a housing associated with said multi-lumen main body portion;

(g) an external thermal element is mounted on said multi-lumen main body portion near the distal end of said multi-lumen main body portion;

(h) connectors extend from said external thermal element along said multi-lumen main body portion for connection to a thermal element housing at the proximal end of said multi-lumen main body portion;

(i) said external thermal element and said temperature measurement apparatus are operative with an external apparatus for providing a measurement of continuous cardiac output of a patient;

(j) said fiber optic apparatus is cooperative with said external apparatus for providing a measurement of mixed venous oxygen saturation of blood of the patient; and

(k) said wiring and said fiber optic filaments are disposed in different lumens.

18. The multi-lumen, multi-purpose cardiac catheter of claim 17, wherein said at least one lumen dedicated to measuring distal catheter pressure comprises surfaces defining a port.

19. The multi-lumen, multi-purpose cardiac catheter of claim 18, wherein said port is for measuring distal catheter pressure.

20. A multi-lumen, multi-purpose cardiac catheter comprising:

(a) a multi-lumen main body portion;

(b) a plurality of extension tubes, each one of said plurality of extension tubes being connected to a respective lumen of said multi-lumen main body portion; and

(c) an interference connecting said main body portion and said plurality of extension tubes,

wherein,

(d) said multi-lumen main body portion comprises;

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

(ii) at least one lumen for receiving thermal element connectors;

(iii) at least one lumen for receiving a device for temperature measurement;

(iv) at least one lumen associated with a balloon mounted at the distal end of said multi-lumen main body portion for assisting in placement of said multi-lumen main body portion in a patient; and

(v) a fiber optic apparatus including said fiber optic filaments, said fiber optic filaments in said at least one lumen for holding and supporting said fiber optic filaments, and said fiber optic filaments extending from inside said multi-lumen main body portion to a fiber optic coupler associated with the catheter;

(e) a temperature measurement apparatus is mounted at the distal end of said multi-lumen main body portion;

(f) wiring extends from the temperature measurement apparatus along said multi-lumen main body portion;

(g) a necked-down portion of said multi-lumen main body portion is near the distal end of said multi-lumen main body portion;

(h) an external thermal element is mounted on said necked-down portion;

(i) connectors extend from said external thermal element along said multi-lumen main body portion for connection to a thermal element housing at the proximal end of said multi-lumen main body portion;

(j) at least one lumen of said multi-lumen main body portion comprises an injectate lumen;

(k) said external thermal element and said temperature measurement apparatus are operative with an external a apparatus for providing a measurement of continuous cardiac output of a patient;

(l) said fiber optic apparatus is cooperative with said external apparatus for providing a measurement of mixed venous oxygen saturation of blood of the patient; and

(m) said injectate lumen has surfaces defining a port, said port being positioned along said multi-lumen main body portion such that, when the distal tip of said main body portion is in a pulmonary artery of a patient, said port is in the right atrium or the superior vena cava of the heart of the patient.