Process for determining a patient's circulatory fill status

• US 5,526,817 A
• Filed: 10/31/1994
• Issued: 06/18/1996
• Est. Priority Date: 04/30/1992
• Status: Expired due to Term

• Current Assignee: Pulsion Medical Systems AG
• Original Assignee: Pulsion Verwaltungs GmbH & Company Medizintechnik KG
• Inventors: Knoll, Reinhold, Pfeiffer, Ulrich
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/325,347
• Time in Patent Office: 596 Days
• Field of Search: 128/668, 128/670, 128/691, 128/692, 128/713, 128/736
• US Class Current: 600/504
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

A process and a device for determining a patient'"'"'s circulatory fill status, particularly the global end-diastolic volume of the heart (GEDV), intrathoracic blood volume (ITBV), pulmonary blood volume (PBV), extravascular lung water volume (EVLW), and/or global cardiac function index (CFI) by means of thermo-dilution; with this process intrathoracic thermo-volume (ITTV) and pulmonary thermo-volume (PTV), for example, are obtained and the global end-diastolic volume of the heart (GEDV) is determined from the equation

GEDV=ITTV-PTV.

The other volumes can be calculated by means of this parameter, which is specific for the fill status of the heart, as well as other species-specific characteristics (a, a'"'"', b, b'"'"').

Claims

1. A process for determining a specific species of patient'"'"'s circulatory fill status-related parameters by calculating cardiac output according to the standard Stewart-Hamilton formula adapted for thermo-dilution measurement comprising the steps of:

(a) placing a measurement device in the patient'"'"'s artery;

(b) injecting over a period of time an injectable comprising a cold solution into the patient'"'"'s circulatory system;

(c) recording an arterial thermo-dilution curve TD with said measurement device and calculating an appearance time AT from said arterial thermo-dilution curve; and

(d) deriving a thermo-dilution measurement curve from said injected injectate according to equation (I) to determine a value for GEDV_AT TDart which reflects a sum of heart ventricle volumes without lung volume;

space="preserve" listing-type="equation">GEDV.sub.AT TDart =a×

AT-VOL.sub.TDart +b (I)

space="preserve" listing-type="equation">where AT-VOL.sub.TDar t =C. O..sub.TDart ×

AT.sub.TDart

and GEDV_AT TDart =global end-diastolic volume of the heart

C. O._TDart =cardiac output

AT_TDart =appearance time

a,b =species specific characteristics determined by comparing the value of GEDV determined by another process with the value of VOL_TDart for the specific species of patient.

2. Process according to claim 1, wherein the specific species of patient is a human and a=2.0 and b =-200.

3. Process according to claim 1, including the step of obtaining a value of a parameter ITBV which reflects intrathoracic blood volume from the equation:

space="preserve" listing-type="equation">ITBV.sub.TDart =a'"'"'[*]×

GEDV.sub.TDart +b'"'"'

where GEDV_TDart is the global end diastolic volume and a'"'"' and b'"'"' are species specific characteristics that are determined by determining the value of ITBV_TDart for each particular species by another process and comparing the value of GEDV_TDart obtained with the determined value of ITBV_TDart for the specific species of the patient.

4. Process according to claim 3, wherein when the specific species of patient is a human and a'"'"'=1.22 and b'"'"'=109.

5. Process according to claim 3, including the step of obtaining a value of a parameter PBV_TDart which reflects pulmonary blood volume from the equation:

space="preserve" listing-type="equation">PBV.sub.TDart =ITBV.sub.TDart -GEDV.sub.TDart

6. Process according to claim 5, including the step of obtaining a value of a parameter EVLW_TDart which reflects extravascular lung water volume from the equation:

space="preserve" listing-type="equation">EVLW.sub.Tdart =PTV.sub.Tdart -PBV.sub.Tart

where PTV_Tdart is pulmonary thermo-volume calculated from said arterial thermo-dilution curve.

7. Process according to claim 3, wherein the specific species of patient is a pig and a'"'"'=1.33 and b'"'"'=13.3.

8. Process according to claim 1, including the steps of determining a value of a parameter CFI_TDart which reflects a global cardiac function index from the equation:

space="preserve" listing-type="equation">i CFI.sub.TDart =C. O.T.sub.Dart /GEDV.sub.TDart.

9. Process according to claim 1, wherein the recording of .said arterial thermo-dilution curve of step (c) is initiated based on a flow rate of the cold solution injected.

10. Process according to claim 1, wherein a starting time for said process is determined from starting and ending times of the cold solution injection.

11. Process according to claim 1, including the steps of determining a time plot of base blood temperature and from the time plot extrapolating a base line for the thermo-dilution curve of step (c).

12. Process for determining a patient'"'"'s circulatory fill status-related parameters using thermo-dilution measurement, including the steps of placing a measurement device in and injecting a cold solution into a patient'"'"'s circulatory system, deriving a value of a parameter ITTV_TDart which reflects intrathoracic thermo-volume and a value of a parameter PTV_TDart which reflects pulmonary thermo-volume from an arterial thermo-dilution measurement curve of the cold solution injected into the patient'"'"'s circulatory system according to the equations:

space="preserve" listing-type="equation">ITTV.sub.TDart =C. O..sub.TDart [*]×

MTT.sub.TDart

space="preserve" listing-type="equation">PTV.sub.TDart =C. O..sub.TDart [*]×

DST.sub.TDart

where C. O._TDart is cardiac output determined according to the thermodilution adapted standard Stewart-Hamilton formula ##EQU2## and V_I =volume of injection T_B =blood temperature

T_I =temperature of injected substance

K=correction factor for specific weight and specific heat of the injected substance and of the blood

T=blood temperature

t=time;

MTT_TDart is mean transit time, and DST_TDart is exponential decay time;

and determining a value of a parameter GEDV_AT TDart which reflects a sum of heart ventricle volumes without lung volume by subtraction according to the equation

space="preserve" listing-type="equation">GEDV.sub.AT TDart =C. O..sub.TDart -PTV.sub.TDdart.

13. Process according to claim 12, including the step of determining a value of a parameter PBV_TDart which reflects pulmonary blood volume from the equation:

space="preserve" listing-type="equation">PBV.sub.TDart =ITBV.sub.TDart -GEDV.sub.AT Tdart

where ITBV_TDart is intrathoracic blood volume.

14. Process according to claim 13, including the step of determining a value of a parameter EVLW_Tdart which reflects extravascular lung water volume from the equation:

space="preserve" listing-type="equation">EVLW.sub.TDart =PTV.sub.TDart -PBV.sub.Tart

where PTV_TDart is pulmonary thermo-volume.

15. Process according to claim 12, including the step of determining a value of a parameter CFI_TDart which reflects a global cardiac function index from the equation:

space="preserve" listing-type="equation">CFI.sub.TDart =C. O..sub.TDart /GEDV.sub.TDart

16. Process according to claim 12, wherein commencement of the thermo-dilution measurement is initiated by the flow of the cold solution injected.

17. Process according to claim 12, wherein a starting time for determining said circulatory fill status-related parameters is determined from starting and ending times of the cold solution injection.

18. Process according to claim 12, including the steps of determining a time plot of base blood temperature and, extrapolating a base line for the thermo-dilution curve from the time plot.

19. Device for determining a patient'"'"'s circulatory fill status-related parameters comprising a thermo-dilution measurement arrangement having a thermo-dilution injector fluidically and electronically connected through a temperature sensor and a control and analysis unit to a pulmonary artery catheter and a femoral artery measuring device, wherein output values from the temperature sensor, the catheter and measuring device are directed to the control and analysis unit to generate intrathoracic thermo-volume values (ITTV_TDart) and pulmonary thermo-volume values (PTV_TDart) according to the equations:

space="preserve" listing-type="equation">ITTV.sub.TDdart =C. O..sub.Tdart *MTT.sub.TDart

space="preserve" listing-type="equation">PTV.sub.TDdart =C. O..sub.TDart *DST.sub.TDart

where C. O._TDart is cardiac output determined by the control and analysis unit according to the thermo-dilution adapted standard Stewart-Hamilton formula ##EQU3## and V_I =volume of injection T_B =blood temperature

T_I =temperature of injected substance

K=correction factor for specific weight and specific heat of the injected substance and of the blood

T=blood temperature

=time;

MTT_TDart is mean transit time, and DST_TDart is exponential decay time; and

wherein the analysis unit has a difference processor which receives the generated ITTV_TDart and PTV_TDart values as inputs and which produces an output value GEDV_TDart corresponding to a global end-diastolic volume of the heart which reflects the sum of the ventricle volumes without the lung volume.

20. Device according to claim 19, wherein the control and analysis device contains a division processor which receives the cardiac output C. O._TDart and the output value GEDV_TDart as inputs and which produces a quotient output value which reflects a global cardiac function index.

21. Device for determining a patient'"'"'s circulatory fill status-related parameters comprising a thermo-dilution measurement arrangement having a thermo-dilution injector fluidically and electronically connected through a temperature sensor to a pulmonary artery catheter and a femoral artery measuring device and a control and analysis device wherein output values from the temperature sensor, the catheter and measuring device generate an appearance time AT_TDart and a cardiac output C. O._TDart from a thermo-dilution curve of thermo-dilution measurements;

wherein lists of values of species-specific characteristics a, b are stored in the analysis device; and

wherein the analysis device has a computation element which multiplies the cardiac output C. O._TDart by the appearance time AT_TDart to obtain a first product, multiplies the first product by a value of species-specific characteristic a from those stored in the analysis device to obtain a second product, adds a value of species-specific characteristic b from those stored in the analysis device to the second product to obtain a resultant, and outputs the resultant as a global end-diastolic volume of the heart GEDV_TDart which reflects the sum of the ventricle volumes without the lung volume.

22. Device according to claim 21, wherein lists of values of species-specific characteristics a'"'"' and b'"'"' are stored in the analysis device, and the analysis device has a computation unit which produces a product by multiplying an accessed value of a'"'"' and the resultant GEDV_TDart and then adding an accessed value of b'"'"' thereto to generate a value of intrathoracic blood volume ITBV.

23. Device according to claim 22, wherein the control and analysis device contains a subtraction unit which processes the value ITBV and the resultant GEDV_TDart to produce an output value therefrom which reflects the pulmonary blood volume PBV.

24. Device according to claim 23, wherein the control and analysis device generates a pulmonary thermo-volume value PTV from the thermo-dilution curve and contains a second subtraction unit which processes the values PTV and PBV as input values to produce an output value reflecting an extravascular lung water volume value EVLW.

25. Device according to claim 22, wherein the analysis device generates an intrathoracic thermo-volume value ITTV from the thermo-dilution curve and contains a subtraction unit which processes the values ITTV and ITBV as input values to produce an output value reflecting an extravascular lung water volume value EVLW.

26. Device according to claim 21, wherein an injected-substance flow sensor is fluidically and electronically connected to said pulmonary artery catheter and to said control and analysis unit, to produce an output signal when a substance is injected, thereby generating a time plot for analysis by said control and analysis unit to control the initiation of thermo-dilution measurements.

27. Device according to claim 26, wherein said injected-substance flow sensor comprises a temperature sensor which heats up when the injected substance is stationary.

28. Device according to claim 27, wherein warming means comprising a measurement current associated with said temperature sensor is provided for warming the injected-substance flow sensor.