Diagnostic catheter with memory

• US 5,720,293 A
• Filed: 05/18/1994
• Issued: 02/24/1998
• Est. Priority Date: 01/29/1991
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Quinn, Michael D., Yelderman, Mark L.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/245,727
• Time in Patent Office: 1,378 Days
• Field of Search: 128/692, 128/713, 128/673-5, 128/691-4, 128/632-15, 128/627
• US Class Current: 600/505
• 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

Abstract

A catheter assembly having a catheter (100) with at least one transducer (110) associated therewith for directly measuring physiological parameters of a patient or measuring an amount of a parameter indicative of a physiological condition of the patient and a memory (102) which resides at a predetermined location on said catheter (100). The memory (102) contains encoded calibration information for calibrating the transducers (110) and encoded patient specific information which can be accessed by an external processing system to which the catheter assembly is connected for processing. The memory (102) is further designed such that disconnection of the catheter assembly from the external processing system does not cause values stored in the memory to be lost so that the patient specific information need be reentered into the memory when the catheter assembly is reconnected to the same or another external processing system. By so providing the catheter assembly with memory (102), information for factory calibration, patient calibration and historical patient data may be stored with the catheter (100) for ease of use. The data in the memory (102) may also be coded to prevent easy replication of the catheter (100) by a competing manufacturer.

Claims

1. A thermodilution catheter assembly for use in determining a patient'"'"'s cardiac output, comprising:

(i) a catheter adapted to be inserted into a patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade; and

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising

(1) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, and

(3) heating filament temperature coefficient of resistance of said heating filament.

2. The thermodilution catheter assembly of claim 1, wherein

said thermodilution information further comprises

(b) a proprietary code, said heating filament calibration information that is stored in said memory is stored in said memory as encoded heating filament calibration information in an encoded form that is based upon said proprietary code such that said encoded heating filament calibration information can be decoded using said proprietary code, and

said catheter is adapted so that said memory is readable and decodable by the external processing system.

3. The thermodilution catheter assembly of claim 2, wherein

said memory stores said proprietary code in the form of a proprietary binary code,

said catheter and said memory being adapted so that said proprietary binary code is accessible by the external processing system and

said proprietary binary code and said encoded heating filament calibration information are interrelated so that said encoded heating filament calibration information is decodable using said proprietary binary code, by the external processing system.

4. The thermodilution catheter assembly of claim 1, wherein said predetermined location is within said catheter.

5. The thermodilution catheter assembly of claim 1, wherein said predetermined location is adjacent said heating filament.

6. The thermodilution catheter assembly of claim 1, wherein said catheter assembly has a proximal end and a distal end,

said catheter assembly further comprising

(iii) a connector at said proximal end of said catheter assembly, said connector being electrically connected to said heating filament, said connector being adapted to connect to the external processing system so that said heating filament can communicate with the external processing system, and

wherein said predetermined location is at said connector.

7. The thermodilution catheter assembly of claim 6, wherein said connector comprises electrical leads which are connected to said memory, said electrical leads and said connector are functionally interrelated to enable access through said connector via said electrical leads to said encoded heating filament calibration information and said proprietary code that are stored in said memory.

8. The thermodilution catheter assembly of claim 7, wherein

said connector is functionally interrelated to said memory via said electrical leads and

said connector is structured so that thermodilution information can be written into said memory via said leads by electrical signals received by said connector while said connector receives thermodilution signals from said catheter, thereby enabling in vivo calibration.

9. The thermodilution catheter assembly of claim 1, wherein said catheter assembly further comprises one of a thermistor and a thermocouple mounted on said catheter for measuring temperature changes in the patient'"'"'s bloodstream caused by heat generated in said heating filament.

10. The thermodilution catheter assembly of claim 9, wherein said heating filament is adapted to supply thermal energy to the patient'"'"'s bloodstream and the thermistor or thermocouple is adapted to measure the effects of thermal energy supplied to the patient'"'"'s bloodstream, for use by the external processing system to calculate one of blood flow of the patient and cardiac output of the patient.

11. A thermodilution catheter assembly system for calculating a patient'"'"'s cardiac output, comprising:

(A) a catheter assembly comprising

(i) a catheter adapted to be inserted into the patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade;

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing encoded thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising

(1) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, and

(3) heating filament temperature coefficient of resistance of said heating filament; and

(B) an external processing system which is connectable to said catheter assembly so that the external processing system can communicate with said memory and said heating filament, said external processing system comprising

(i) means for decoding said encoded heating filament calibration information stored in said memory for generating decoded heating filament calibration information and

(ii) means for calculating cardiac output using said decoded heating filament calibration information.

12. The thermodilution catheter assembly system of claim 11, wherein said catheter assembly further comprises:

(iii) means, mounted to said catheter and coupled to said external processing system, for measuring resistance of said heating filament and said catheter assembly system further comprises

(C) means, coupled to said external processing system and said heating filament, for controlling the temperature of said heating filament based upon said resistance of said heating filament and the decoded calibration information.

13. The thermodilution catheter assembly system of claim 12 wherein said means for controlling the temperature includes means for reducing electrical power transmitted to said heating filament when the resistance of said heating filament exceeds a predetermined resistance value.

14. The thermodilution catheter assembly system of claim 11, further comprising a battery located in proximity of said memory for providing power to said memory when said memory is not connected to said external processing system.

15. The thermodilution catheter assembly system of claim 11, wherein

said memory is adapted to be used with means for encoding calibration information in accordance with a proprietary code and to be written into with encoded calibration information encoded in accordance with said proprietary code and

said memory being further adapted to be read by said external processing system and used thereby to decode said encoded calibration information.

16. The thermodilution catheter assembly system of claim 15, wherein

said memory comprises means to store said proprietary code in the form of a proprietary binary code and

said memory and said catheter assembly are adapted so that said memory can be accessed by said external processing system and used thereby to decode said encoded calibration information.

17. The thermodilution catheter assembly system of claim 11, wherein said catheter assembly has a distal end and a proximal end, and

said catheter assembly further comprising

(iii) an electrical connector electrically connected to said heating filament and at said proximal end of said catheter assembly for enabling said heating filament to communicate with said external processing system, wherein said predetermined location is at said connector.

18. The thermodilution catheter assembly system of claim 17, wherein

said connector comprises electrical leads which are electrically connected to said memory and

said connector and said memory are functionally interrelated by said electrical leads to enable access to said encoded thermodilution information stored in said memory by said external processing system.

19. The thermodilution catheter assembly system of claim 18, wherein said electrical leads are electrically connected to said memory such that said external processing system can write calibration information for either said patient or said heating filament to said memory, for in vivo calibration.

20. The thermodilution catheter assembly system of claim 11, wherein said catheter assembly further comprises one of a thermistor and a thermocouple for measuring temperature changes in the patient'"'"'s bloodstream caused by heat generated in said heating filament.

21. The thermodilution catheter assembly system of claim 20, wherein

said heating filament is adapted to supply thermal energy to the patient'"'"'s bloodstream and

the thermistor or thermocouple is adapted to measure the effects of the thermal energy supplied to the patient'"'"'s bloodstream by heat generated in said heating filament,

said external processing system is adapted to calculate one of blood flow and cardiac output of said patient based upon measurements by said thermistor or thermocouple of said effects of the thermal energy supplied to the patient'"'"'s bloodstream.

22. A thermodilution catheter assembly system for calculating a patient'"'"'s cardiac output, comprising:

(A) a catheter assembly having a distal end and a proximal end and comprising

(i) a catheter adapted to be inserted into the patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade; and

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing encoded thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising

(1) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, and

(3) heating filament temperature coefficient of resistance of said heating filament;

(b) patient specific information;

(iii) an electrical connector electrically connected to said heating filament and at said proximal end of said catheter assembly for enabling said heating filament to communicate with said external processing system, wherein said predetermined location is at said connector and said connector comprises electrical leads which are electrically connected to said memory and

(B) an external processing system which is connectable to said catheter assembly so that the external processing system can communicate with said memory and said heating filament, said external processing system comprising;

(i) means for decoding said encoded heating filament calibration information stored in said memory for generating decoded heating filament calibration information and

(ii) means for calculating cardiac output using said decoded heating filament calibration information;

(iii) means for displaying said patient specific information as trending data;

wherein;

(i) said connector and said memory are functionally interrelated by said electrical leads to enable access to said encoded thermodilution information stored in said memory by said external processing system and system of claim 18,

(ii) said external processing system, said connector, and said memory are functionally interrelated so that said external processing system can access said patient specific information that is stored in said memory via said electrical leads.

23. A thermodilution catheter assembly system for calculating a patient'"'"'s cardiac output, comprising:

(A) a catheter assembly comprising

(i) a catheter adapted to be inserted into the patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade; and

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing encoded thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising

(2) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, and

(3) heating filament temperature coefficient of resistance of said heating filament and

(B) an external processing system which is connectable to said catheter assembly so that the external processing system can communicate with said memory and said heating filament, said external processing system comprising

(i) means for decoding said encoded heating filament calibration information stored in said memory for generating decoded heating filament calibration information and

(ii) means for calculating cardiac output using said decoded heating filament calibration information; and

wherein said memory further contains at least one of a computer program, a computer program segment, and a software subroutine which can be read by said external processing system and used thereby to verify, correct, or modify processing of said thermodilution information.

24. A thermodilution catheter assembly for use in determining a patient'"'"'s cardiac output comprising:

(i) a catheter adapted to be inserted into a patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of greater than 0.001 ohms per ohm-degree centigrade; and

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising at least one of

(1) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, or

(3) heating filament temperature coefficient of resistance of said heating filament, and

(b) patient specific information.

25. The thermodilution catheter assembly of claim 24, wherein said patient specific information comprises patient historical data.

26. The thermodilution catheter assembly of claim 24, wherein said thermodilution information further comprises catheter identification information.

27. A thermodilution catheter assembly for insertion in an artery or a vein for use in determining a patient'"'"'s cardiac output, comprising:

(i) a catheter adapted to be inserted into a patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade; and

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising at least one of

(1) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, or

(3) heating filament temperature coefficient of resistance of said heating filament, and

(b) operation information comprising at least one of

(1) a computer program,

(2) a computer program segment, and

(3) a software subroutine.

28. The thermodilution catheter assembly of claim 27, wherein said operation information comprises information for controlling processing of said thermodilution information.

29. The thermodilution catheter assembly of claim 28, wherein said operation information comprises information for controlling processing of said thermodilution information to verify, correct, or modify said thermodilution information.

30. The thermodilution catheter assembly of claim 28, wherein said operation information comprises information for controlling processing of said thermodilution information by an external processing system to verify, correct, or modify said thermodilution information.

31. The thermodilution catheter assembly of claim 28, wherein said operation information comprises information for controlling processing of said thermodilution information for calculating the patient'"'"'s cardiac output.

32. A thermodilution catheter assembly system for calculating a patient'"'"'s cardiac output, comprising:

(A) a catheter assembly comprising

(i) a catheter adapted to be inserted into a patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade;

(ii) a memory which resides at a predetermined location on or about said catheter, said memory storing thermodilution information comprising

(a) heating filament calibration information, said heating filament calibration information comprising at least one of

(1) heating filament electrical resistance of said heating filament at a given temperature,

(2) heating filament heat transfer efficiency of said heating filament, or

(3) heating filament temperature coefficient of resistance of said heating filament, and

(b) operation information comprising at least one of

(1) a computer program,

(2) a computer program segment, and

(3) a software subroutine;

(B) an external processing system adapted to communicate with said memory to read said thermodilution information and to communicate with said heating filament to determine resistance of said heating filament; and

wherein said external processing system and said operation information, in combination, comprise means for calculating the patient'"'"'s cardiac output by processing said thermodilution information.

33. The thermodilution catheter assembly system of claim 32, wherein said operation information comprises information for controlling processing of said thermodilution information.

34. The thermodilution catheter assembly system of claim 32, wherein said operation information comprises information for controlling processing of said thermodilution information to verify, correct, or modify said thermodilution information.

35. A thermodilution catheter assembly for providing data to an external processing system for calculating a patient'"'"'s cardiac output, comprising:

(i) a catheter adapted to be inserted into a patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade;

(ii) means, mounted to said catheter, for measuring data relating to cardiac output; and

(iii) a memory which resides at a predetermined location on or about said catheter, said memory storing operation information for controlling calculation of the patient'"'"'s cardiac output based upon data including said data relating to cardiac output that is measured by said means for measuring, said operation information comprising at least one of

(1) a computer program,

(2) a computer program segment, and

(3) a software subroutine.

36. The thermodilution catheter assembly of claim 35, wherein said operation information comprises information for controlling calculation of the patient'"'"'s cardiac output by an external processing system.

37. A thermodilution catheter assembly for use in determining a patient'"'"'s cardiac output, comprising:

a catheter adapted to be inserted into a patient'"'"'s bloodstream, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of at least 0.001 ohms per ohm-degree centigrade; and

a memory which resides at a predetermined location on or about said catheter, said memory storing thermodilution information comprising patient specific information.

38. A thermodilution catheter assembly of claim 37, wherein said patient specific information comprises patient historical data.

39. A thermodilution catheter assembly for use in determining a cardiac output of a patient, comprising:

a catheter adapted to be inserted into a bloodstream of the patient, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of greater than zero; and

a memory which resides at a predetermined location on or about said catheter, said memory storing thermodilution information comprising heating filament calibration information.

40. The thermodilution catheter assembly of claim 39, wherein said heating filament calibration information comprises heating filament electrical resistance of said heating filament at a given temperature.

41. The thermodilution catheter assembly of claim 40, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

42. The thermodilution catheter assembly of claim 39, wherein said heating filament calibration information comprises heating filament heat transfer efficiency of said heating filament.

43. The thermodilution catheter assembly of claim 41, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

44. The thermodilution catheter assembly of claim 39, wherein said heating filament calibration information comprises heating filament temperature coefficient of resistance of said heating filament.

45. The thermodilution catheter assembly of claim 42, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

46. A thermodilution catheter assembly for providing data to an external processing system for calculating a cardiac output of a patient, comprising:

a catheter adapted to be inserted into a bloodstream of the patient, said catheter having a heating filament made of a thin, flexible material having a temperature coefficient of resistance of greater than zero;

means, mounted to said catheter, for measuring data relating to cardiac output; and

a memory which resides at a predetermined location on or about said catheter, said memory storing operation information for controlling calculation of the patient'"'"'s cardiac output based upon data including said data relating to cardiac output that is measured by said means for measuring.

47. The thermodilution catheter assembly of claim 46, wherein said operation information comprises a computer program.

48. The thermodilution catheter assembly of claim 47, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

49. The thermodilution catheter assembly of claim 46, wherein said operation information comprises a computer program segment.

50. The thermodilution catheter assembly of claim 48, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

51. The thermodilution catheter assembly of claim 46, wherein said operation information comprises a software subroutine.

52. The thermodilution catheter assembly of claim 49, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

53. The thermodilution catheter assembly of claim 46, wherein said operation information comprises information for controlling calculation of the patient'"'"'s cardiac output by an external processing system.

54. The thermodilution catheter assembly of claim 50, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

55. A thermodilution catheter system for use in determining cardiac output of a patient, comprising:

(i) a catheter adapted to be inserted into a bloodstream of the patient, said catheter comprising

(A) a heating filament

(1) made of a thin and flexible material,

(2) having a resistance, and

(3) having a temperature coefficient of resistance of greater than zero and

(B) a memory, said memory storing thermodilution information comprising heating filament calibration information for said heating filament; and

(ii) means, coupled to said memory and said heating filament, for controlling the temperature of said heating filament based at least in part upon said heating filament calibration information stored in said memory.

56. The thermodilution catheter system of claim 55, wherein said heating filament calibration information stored in said memory comprises the heating filament electrical resistance of said heating filament at a given temperature.

57. The thermodilution catheter system of claim 56, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

58. The thermodilution catheter system of claim 55, wherein said heating filament calibration information stored in said memory comprises the heating filament heat transfer efficiency of said heating filament.

59. The thermodilution catheter system of claim 57, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

60. The thermodilution catheter system of claim 55, wherein said heating filament calibration information stored in said memory comprises the heating filament temperature coefficient of resistance of said heating filament.

61. The thermodilution catheter system of claim 58, wherein said temperature coefficient of resistance is at least 0.001 ohms per ohm-degree centigrade.

62. The thermodilution catheter system of claim 55, wherein said thermodilution information further comprises patient specific information.

63. The thermodilution catheter system of claim 55, wherein said memory further stores at least one of a computer program, a computer program segment, and a software subroutine.

64. The thermodilution catheter system of claim 63, wherein said at least one of a computer program, a computer program segment, and a software subroutine can be used to verify, correct, or modify processing of said thermodilution information.