Method, system and apparatus for evaluating hemodynamic parameters

• US 5,788,647 A
• Filed: 01/24/1997
• Issued: 08/04/1998
• Est. Priority Date: 01/24/1997
• Status: Expired due to Term

• Current Assignee: Cardiox Corporation
• Original Assignee: Philip E. Eggers
• Inventors: Eggers, Philip E.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/792,967
• Time in Patent Office: 557 Days
• Field of Search: 600/322, 600/341, 600/342, 600/368, 600/478, 600/479, 600/481, 600/508, 600/526, 600/486
• US Class Current: 600/526
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0275 using tracers, e.g. dye dilution
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement

Abstract

Method, system, and apparatus for evaluating hemodynamic parameters and, in particular, cardiac output. A pulmonary artery catheter is described which incorporates a diffuser of gas biocompatible with the body such as oxygen at an indwelling region such that the gas may be employed to carry out a dilution technique to measure cardiac output. A mixed venous blood gas level then is measured at the pulmonary artery using a gas sensor. The preferred gas sensor employs oximetry to derive values of mixed venous oxygen saturation. An alternate embodiment utilizes an electrode/electrolyte approach as the gas sensor to carry out measurement of dissolved oxygen in mixed venous blood. The system utilizes a microprocessor driven controller to develop multiple evaluations over sequential measurement intervals and to compute a variety of hemodynamic parameters including the noted cardiac output.

Claims

1. Apparatus for evaluating the hemodynaric state of the cardiovascular system of the body of a patient, comprising:

a pulmonary artery catheter having a distal end positionable within mixed venous blood at the pulmonary artery of said body and an indwelling region spaced rearwardly therefrom, said catheter extending to a proximal end;

a diffusion channel within said catheter having a gas input connectable with a controlled source of gas biocompatible with said body and extending to an infusion component located at said indwelling region and configured for infusing said gas into the bloodstream of said body; and

a gas sensor component mounted upon said catheter at said distal end and having an output corresponding with a level of said biocompatible gas within said mixed venous blood.

2. The apparatus of claim 1 in which:

said infusion component is a membrane impermeable to blood and permeable to oxygen; and

said source of gas is a source of oxygen.

3. The apparatus of claim 1 in which:

said source of gas is a source of oxygen;

said gas sensor component includes;

a transmission fiber optic component within said catheter in optical communication with said mixed venous blood at said pulmonary artery when said distal end is positioned thereat; and

a reflectance fiber optic component within said catheter in optical communication with said mixed venous blood and responsive to reflection therefrom induced by the transmission through said transmission fiber optic component of light at predetermined wavelengths to provide reflectance oximetry data at said proximal end as said output.

4. The apparatus of claim 3 in which:

said transmission fiber optic component is located at a light transmission channel within said catheter extending between said proximal end and said distal end;

said reflection fiber optic component is located at a reflection transmission channel within said catheter extending between said proximal end and said distal end.

5. The apparatus of claim 1 including:

a temperature sensor mounted upon said catheter at said distal end and having a temperature value output at said proximal end corresponding with the value of temperature of mixed venous blood at said pulmonary artery when said distal end is positioned thereat;

an auxiliary port within said catheter at said indwelling region; and

an auxiliary channel within said catheter extending in fluid transfer communication from said auxiliary port to said proximal end for delivering fluid through said auxiliary port.

6. The apparatus of claim 1 in which said catheter includes an incompressible fluid containing blood pressure measuring channel extending between said distal and proximal ends in open communication with mixed venous blood at said pulmonary artery when said distal end is positioned thereat.

7. The apparatus of claim 1 in which:

said source of gas is a source of oxygen; and

said infusion component is an oxygenator.

8. The apparatus of claim 7 in which:

said diffusion channel extends in gas flow communication to a gas outlet port formed within a wall of said catheter at said indwelling region; and

said oxygenator comprises a cylindrical membrane mounted over said gas outlet port and spaced from said wall to define an oxygen receiving gap, said membrane being impermeable to blood and permeable to oxygen.

9. The method for evaluating the hemodynamic state of the cardiovascular system of the body of a patient, comprising the steps of:

(a) providing a pulmonary artery catheter having a proximal end, a distal end and an indwelling region spaced rearwardly therefrom, a diffusion channel within said catheter having a gas input connectable with a source of gas biocompatible with said body and extending to an infusion component located at said indwelling region and configured for infusably conveying said gas into the bloodstream of said body, and a gas sensor component mounted upon said catheter at said distal end and having an output corresponding with a level of said biocompatible gas within blood at the location of said sensor;

(b) positioning said pulmonary artery catheter within the bloodstream of said body, locating said sensor component at the pulmonary artery and said infusion component upstream therefrom;

(c) deriving said output from said gas sensor to provide a baseline value corresponding with a level of said biocompatible gas within mixed venous blood;

(d) delivering said gas from said source into said diffusion channel at a predetermined mass flow rate;

(e) deriving said output from said gas sensor; and

(f) deriving a value for the cardiac output of the heart of said body by correlating said baseline value, said predetermined mass flow rate and said output derived in step (e).

10. The method of claim 9 in which:

said catheter is connectable with a source of oxygen as said gas;

said infusion component is provided as an oxygenator; and

said output from said sensor is derived in correspondence with the blood oxygen level of said mixed venous blood.

11. The method of claim 10 in which each said output from said sensor is derived as a level of mixed venous oxygen saturation.

12. The method of claim 11 in which:

said step (a) includes the step of;

(a1) determining the hemoglobin level of said bloodstream in the absence of dyshemoglobin;

said step (c) including the steps of;

(c1) determining the level of dissolved oxygen in said mixed venous blood;

(c2) deriving a baseline value for mixed venous oxygen content by correlating said level of mixed venous oxygen saturation with said hemoglobin level and with said level of dissolved oxygen in said mixed venous blood;

said step (e) including the step of;

(e1) deriving a subsequent value for mixed venous oxygen content by correlating said level of mixed venous oxygen saturation with said hemoglobin level and with said level of dissolved oxygen in said mixed venous blood; and

,

said step (f) includes the step of;

(f1) correlating said baseline value and said output derived in step (e1) by determining the difference between said subsequent value and said baseline value for mixed venous oxygen content.

13. The method of claim 12 in which said step (a1) includes the steps of:

(a1i) determining blood hemotocrit (Hct) in percent,

(a1ii) determining blood dyshemoglobin (DysHgb) concentration;

(a1iii) determining said hemoglobin level (Hgb) in correspondence with the expression;

space="preserve" listing-type="equation">Hgb=0.3718 (Hct)×

1.30-DysHgb.

14. The method of claim 13 in which said step (c1) is carried out in correspondence with the expression:

space="preserve" listing-type="equation">PvO.sub.2 =10 exp log P.sub.50 +(log (SvO.sub.2 /1-SvO.sub.2)))/2.7!

where PvO₂ is the value of dissolved oxygen in mixed venous blood, and SvO₂ is mixed venous oxygen saturation.

15. The method of claim 14 in which said steps (c2) and (e1) are carried out in correspondence with the expression:

space="preserve" listing-type="equation">CvO.sub.2 = Hgb*1.34*SvO.sub.2 !+ PvO.sub.2 *α

!

where CvO₂ is mixed venous oxygen content, Hgb is said hemoglobin level, SvO₂ is said mixed venous oxygen saturation, PvO₂ is said value of dissolved oxygen in mixed venous blood, and α

is a solubility coefficient of oxygen.

16. The method of claim 15 in which said step (f) is carried out in correspondence with the expression:

##EQU3## where CO is cardiac output, K is a constant, mO₂ is the value of mass flow rate of oxygen, CvO₂ (t_i) is said baseline value for mixed venous oxygen content and CvO'"'"'₂ (t_i '"'"') is said subsequent value for mixed venous oxygen content.

17. The method of claim 10 in which said output from said sensor is derived by blood reflectance oximetry.

18. The method of claim 10 in which said output from said sensor is derived as the level of dissolved oxygen in said mixed venous blood.

19. The method of claim 18 in which said output from said sensor is derived electrolytically.

20. The method of claim 18 in which said step (f) includes the step of:

(f1) determining blood hematocrit (Hct) in percent; and

said step (f) is carried out in correspondence with the expression;

##EQU4## where CO is cardiac output, W is a constant, mO₂ is the value of mass flow rate of oxygen, PvO₂ (t_i) is the dissolved oxygen in mixed venous blood corresponding with said baseline value and PvO₂ '"'"' (t_i)'"'"' is dissolved oxygen in mixed venous blood corresponding with said output of step (e), and Hct is said blood hematocrit.

21. A system for evaluating the hemodynamic state of the cardiovascular system of the body of a patient comprising:

a source of gas biocompatible with said body;

gas flow control apparatus coupled with said source of gas and controllable to provide a select mass flow rate of said gas at a gas output;

a pulmonary artery catheter having a distal end positionable within mixed venous blood at the pulmonary artery of said body and an indwelling region located rearwardly therefrom, said catheter extending to a proximal end;

a blood gas level sensor component mounted with said catheter at said distal end and controllable to provide a sensor output at said proximal end corresponding with a blood gas level within said mixed venous blood;

a diffusion channel within said catheter having an input adjacent said proximal end connectable in gas flow communication with said gas output and having an infusion component located at said indwelling region for diffusing said gas with blood flowing adjacent thereto;

a controller for controlling said gas flow control apparatus and said gas level sensor, and responsive to said sensor output for deriving a first output signal in correspondence therewith representing a value of cardiac output; and

a display responsive to said first output signal for displaying said value of cardiac output.

22. The system of claim 21 in which:

said source of gas is a source of oxygen;

said controller effects control of said sensor to derive a baseline blood oxygen level of said mixed venous blood and submits said base line blood oxygen level to a memory, then said controller effects control of said gas flow control apparatus to effect a select mass flow rate delivery of oxygen through said diffusion channel while simultaneously controlling said sensor to derive a subsequent value for blood oxygen level, and is responsive to correlate said baseline blood oxygen level, said select mass flow rate and said subsequent value for blood oxygen level to derive said first output signal representing a value of cardiac output.

23. The system of claim 22 in which said controller includes a timer and is responsive to a select measurement interval time value for carrying out derivations of said first output signal representing cardiac output for each select measurement interval of a succession of such intervals.

24. The system of claim 22 in which said blood gas level sensor is configured to derive said blood gas level sensor output by reflectance oximetry as a value for mixed venous blood oxygen saturation.

25. The system of claim 24 in which said controller is responsive to input values for hematocrit and dyshemoglobin concentration of the blood of said patient retained in said memory and to correlate these input values with said value for mixed venous blood oxygen saturation to derive said first output signal representing cardiac output.

26. The system of claim 25 in which said controller is responsive to inputted values representing the height and weight of said body retained in said memory to derive a value for body surface area therefrom, and is responsive to said value of cardiac output and said value for body surface area to derive a third output signal representing a value of cardiac index;

and

said display is responsive to said third output signal for displaying said derived value representing cardiac index.

27. The system of claim 26 in which said controller is responsive to an inputted lower threshold limit value for cardiac index retained in said memory and to said derived value of cardiac index to derive a fourth output signal when said derived value of cardiac index is below said threshold limit value for cardiac index;

and

said display is responsive to said fourth output signal for displaying alarm information with respect to said derived value of cardiac index.

28. The system of claim 27 in which said controller is responsive to an inputted upper limit value for cardiac index retained in said memory and to said derived value of cardiac index to derive a fifth output signal when said derived value of cardiac index is above said upper limit value for cardiac index;

and

said display is responsive to said fifth output signal for displaying alarm information with respect to said derived value of cardiac index.

29. The system of claim 26 in which said controller is responsive to an inputted value of heart rate of said patient retained in said memory and to said value of cardiac index to derive an eleventh output signal representing a value of stroke index;

and

said display is responsive to said eleventh output signal for displaying said value of stroke index.

30. The system of claim 26 in which said controller is responsive to inputted values for mean pulmonary arterial pressure and wedge pressure, retained in said memory and is responsive to said value of cardiac index to derive a thirteenth output signal representing a value of pulmonary vascular resistance index;

and

said display is responsive to said thirteenth output signal for displaying said value of pulmonary vascular resistance index.

31. The system of claim 24 in which said controller is responsive to input values for hematocrit, dyshemoglobin concentration, dissolved oxygen in mixed venous plasma and a solubility coefficient of oxygen retained in said memory and to correlate these input values with said value for mixed venous blood oxygen saturation to derive values for mixed venous oxygen content and said first output signal representing cardiac output.

32. The system of claim 31 in which said controller is responsive to said derived values for mixed venous oxygen content corresponding with said baseline blood oxygen level to derive a second output signal representing a value of mixed venous oxygen content;

and

said display is responsive to said second output signal for displaying said value of mixed venous oxygen content.

33. The system of claim 32 in which said controller is responsive to inputted values for mean arterial pressure and central venous pressure retained in said memory and is responsive to said value of cardiac index to derive a twelfth output signal representing a value of systemic vascular resistance index;

and

said display is responsive to said twelfth output signal for displaying said value of systemic vascular resistance index.

34. The system of claim 31 in which said controller is responsive to an inputted value for arterial oxygen content retained in said memory and is further responsive to a said derived value for mixed venous oxygen content corresponding with said baseline oxygen level to derive a sixth output signal for the value of arterial venous oxygen content difference;

and

said display is responsive to said sixth output signal for displaying said value of arterial-venous oxygen content difference.

35. The system of claim 31 in which said controller is responsive to an inputted value for arterial oxygen content retained in said memory and is further responsive to said derived value for mixed venous oxygen content corresponding with said baseline oxygen level and to said value of cardiac output to derive a ninth output signal for the value of oxygen consumption;

and

said display is responsive to said ninth output signal for displaying said value of oxygen consumption.

36. The system of claim 35 in which said controller is responsive to inputted values representing the length and weight of said body retained in said memory to derive a value for body surface area therefrom and is responsive to said value of oxygen consumption and to said value for body surface area to derive a tenth output signal representing a value of oxygen consumption index;

and

said display is responsive to said tenth output signal for displaying said value of oxygen consumption index.

37. The system of claim 24 in which said controller is responsive to said value for mixed venous blood oxygen saturation corresponding with said baseline blood oxygen level to derive a seventh output signal for the value of mixed venous blood oxygen saturation;

and

said display is responsive to said seventh output signal for displaying said value of mixed venous blood oxygen saturation.

38. The system of claim 24 in which said controller is responsive to an inputted value for arterial content retained in said memory and is further responsive to derived values of cardiac output to derive an eighth output signal for the value of oxygen transport;

and

said display is responsive to said eighth output signal for displaying said value of oxygen transport.

39. The system of claim 22 in which said blood gas level sensor is configured to derive said blood gas level sensor output electrolytically as a value for dissolved oxygen in mixed venous plasma.

40. The system of claim 22 in which said controller is responsive to an inputted lower threshold limit value for cardiac output retained in said memory and to said derived value of cardiac output to derive a 14th output signal when said derived value of cardiac output is below said threshold limit value for cardiac output;

and

said display is responsive to said 14th output signal for displaying alarm information with respect to said derived value of cardiac output.

41. The system of claim 22 in which said controller is responsive to an inputted upper limit value for cardiac output retained in said memory and to said derived value of cardiac output to derive a 15th output signal when said derived value for cardiac output is above said upper limit value for cardiac output;

and

said display is responsive to said 15th output signal for displaying alarm information with respect to said derived value of cardiac output.