Method and apparatus for automatic autotransfusion

• US 5,116,312 A
• Filed: 11/03/1989
• Issued: 05/26/1992
• Est. Priority Date: 11/03/1989
• Status: Expired due to Term

• Current Assignee: UAB Research Foundation (University of Alabama System)
• Original Assignee: UAB Research Foundation (University of Alabama System)
• Inventors: Blankenship, Howard B., Wallace, Fred D.
• Primary Examiner(s): Smith, Jerry
• Assistant Examiner(s): Cass, Russell
• Application Number:
  US07/431,296
• Time in Patent Office: 935 Days
• Field of Search: 364/413.07, 604/4, 604/5, 604/6, 604/7, 604/50-53, 604/65-67, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/66
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir

Abstract

A method and system for closed-loop, automated, closed, autotransfusion having a computer in electronic communication with a bedside monitor, an infusion pump, wherein the infusion pump is controlled by the computer, a blood collection canister for receiving shed mediastinal blood from a patient, means for filtering the blood, means for transferring the blood from the canister to the infusion pump and then into the patient, means for automatically taking a set of time-spaced measurements of a hemodynamic variable of the patient wherein the hemodynamic variable is coded into a multiplicity of digitally coded signals that are transmitted to the computer, and programming means for analysis of the digitally coded signals to determine the rate of the infusion pump, wherein the blood is infused at a high rate intermittently.

Claims

1. A system for closed-loop, automated, closed autotransfusion, comprising:

(a) a computer;

(b) a first infusion pump having a first variable infusion rate that is controlled by said computer;

(c) a blood collection chamber;

(d) first conduit means for transferring shed mediastinal blood from a patient to said chamber;

(e) second conduit means for transferring said blood from said chamber to said first infusion pump;

(f) third conduit means for transferring said blood from said first infusion pump into a view of said patient, said first conduit means, said chamber, said second conduit means, and said third conduit means defining a path of travel;

(g) means for filtering said blood located along said path of travel;

(h) means for collecting first data relating to a hemodynamic variable of said patient over a period of time;

(i) means for encoding said first data into a plurality of first digitally coded signals;

(j) means for transmitting said first digitally coded signals to said computer;

(k) means in said computer for analyzing said first digitally coded signals to set said first rate of said first infusion pump, wherein said first rate is set for a preselected period of time and wherein said analyzing means comprise;

(i) means for storing the value for said hemodynamic variable in the memory of said computer;

(ii) means for determining if said infusion pump is an alarm state;

(iii) means for ascertaining the incremental volume of said blood pumped through said first infusion pump during said preselected period of time;

(iv) means for calculating the total volume of said blood infused by summing the respective said ascertained incremental volumes;

(v) means for computing the volume of said blood in said chamber;

(vi) means for calculating the volume difference in said chamber between said computed volume in said chamber and the volume of said blood in said chamber after the previous said preselected period of time;

(vii) means for computing the incremental volume of blood drainage from the mediastinum during said preselected period to time by summing said volume difference and said ascertained volume of blood pumped through said first infusion pump;

(viii) means for calculating the total amount of blood drainage from the mediastinum by summing said computed incremental volumes over a predetermined interval of time;

(ix) means for setting said first infusion rate at a predetermined low rate to keep said patient'"'"'s vein open upon the occurrence of a selected one of the following conditions;

(A) if the volume of said blood in said chamber is less than a predetermined acceptable volume;

(B) if said value for said hemodynamic variable does not fall within a predetermined acceptable range;

(C) if said volume of blood drainage from the mediastinum during said preselected period of time exceeds a predetermined acceptable value;

(x) means for setting said first infusion rate to deliver an aliquot of said blood at a predetermined acceptable rate unless said predetermined low rate was set in step (9); and

(xi) means for allowing the infusion of said blood at said first infusion rate unless said first pump is in said alarm state;

(l) a video display monitor in electronic communication with said computer for visually displaying information relating to said analyzing means; and

(m) a keyboard in electronic communication with said computer for providing bedside control of said system.

2. The system of claim 1, further comprising:

(a) a second infusion pump having a second variable infusion rate that is controlled by said computer;

(b) a reservoir containing a biocompatible fluid;

(c) fourth conduit means for transferring said biocompatible fluid from said reservoir to said second infusion pump;

(d) fifth conduit means for transferring said biocompatible fluid from said second infusion pump into the vein of said patient;

(e) means for collecting second data relating to a physiological variable of said patient over a period of time;

(f) means for encoding said second data into a plurality of second digitally coded signals;

(g) means for transmitting said second digitally coded signals to said computer; and

(h) means in said computer for analyzing said second digitally coded signals to set said second rate of said second infusion pump for a predetermined period of time.

3. The system of claim 2, wherein said biocompatible fluid is washed autologous blood.

4. The system of claim 1, wherein said first infusion pump is a volumetric infusion pump.

5. The system of claim 1, wherein said blood collection chamber is a cardiotomy reservoir.

6. The system of claim 1, wherein said hemodynamic variable is the right atrial pressure.

7. The system of claim 1, wherein said hemodynamic variable is the left atrial pressure.

8. The system of claim 1, wherein said first data provides the volume of said blood in said chamber at a particular time.

9. The system of claim 1, wherein said first data provides the volume of said blood pumped through said first infusion pump during said preselected period of time.

10. The system of claim 1, wherein said first rate of said first infusion pump is set by said computer through a point-to-point topology pump addressing scheme.

11. The system of claim 1, wherein said first infusion pump infuses a volume of said blood followed by a period of time during which said blood is not infused by said first infusion pump to allow the collecting of said first data without infusion-related distortion during said period of time.

12. A method of closed-loop, automated, closed autotransfusion, comprising the steps of:

(a) providing a closed autotransfusion system comprising;

(i) a first infusion pump having a first variable infusion rate;

(ii) a blood collection chamber;

(iii) first conduit means for transferring shed mediastinal blood from a patient to said chamber;

(iv) second conduit means for transferring said blood from said chamber to said first infusion pump;

(v) third conduit means for transferring said blood from said first infusion pump into the vein of said patient, said first conduit means, said chamber, said second conduit means, and said third conduit means defining a path of travel; and

(vi) means for filtering said blood located along said path of travel;

(b) automating said closed autotransfusion system by integrating a closed-loop regulatory system with said closed autotransfusion system, wherein said closed-loop regulatory system comprises;

(i) a computer, wherein said computer control said first infusion pump;

(ii) means for collecting first data relating to a hemodynamic variable of said patient over a period of time;

(iii) means for encoding said first data into a plurality of first digitally coded signals;

(iv) means for transmitting said first digitally coded signals to said computer;

(v) means in said computer for analyzing said first digitally coded signals to set said first rate of said first infusion pump, wherein said first rate is set for a preselected period of time and wherein said analyzing means comprise;

(A) repeating steps (B) through (L) at the end of successive periods of time, wherein said time period is the said preselected period of time over which said first rate is set, until a predetermined interval of time has elapsed;

(B) storing the value for said hemodynamic variable in the memory of said computer;

(C) determining if said infusion pump is in an alarm state;

(D) ascertaining the incremental volume of said blood pumped through said first infusion pump during said preselected period of time;

(E) calculating the total volume of said blood infused by summing the respective said ascertained incremental volumes;

(F) computing the volume of said blood in said chamber;

(G) calculating the volume difference in said chamber between said computed volume in said chamber and the volume of said blood in said chamber after the previous said preselected period of time;

(H) computing the incremental volume of blood drainage from the mediastinum during said preselected period to time by summing said volume difference and said ascertained volume of blood pumped through said first infusion pump;

(I) calculating the total amount of blood drainage from the mediastinum by summing said computed incremental volumes over a predetermined interval of time;

(J) setting said first infusion rate at a predetermined low rate to keep said patient'"'"'s vein open upon the occurrence of a selected one of the following conditions;

(i) if the volume of said blood in said chamber is less than a predetermined acceptable volume;

(ii) if said value for said hemodynamic variable does not fall within a predetermined acceptable range;

(iii) if said volume of blood drainage from the mediastinum during said preselected period of time exceeds a predetermined acceptable value;

(K) setting said first infusion rate to deliver an aliquot of said blood at a predetermined acceptable rate unless said predetermined low rate was set in step (J); and

(L) allowing the infusion of said blood at said first infusion rate unless aid first pump is in said alarm state;

(vi) a monitor in electronic communication with said computer for visually displaying information relating to said analyzing means; and

(vii) a keyboard in electronic communication with said computer for providing bedside control of said system.

13. The method of claim 12, further comprising the steps

(a) providing a secondary infusion system to infuse a circulatory supportive fluid comprising:

(i) a second infusion pump having a second variable infusion rate that is controlled by said computer;

(ii) a reservoir containing a biocompatible fluid;

(iii) fourth conduit means for transferring said biocompatible fluid from said reservoir to said second infusion pump; and

(iv) fifth conduit means for transferring said biocompatible fluid from said second infusion pump into the vein of said patient.

(b) automating said secondary infusion system by integrating a second closed-loop regulatory system with said secondary infusion system, wherein said second closed-loop regulatory system comprises;

(i) means for collecting second data relating to a physiological variable of said patient over a period of time;

(ii) means for encoding said second data into a plurality of second digitally coded signals;

(iii) means for transmitting said second digitally coded signals to said computer; and

(iv) means in said computer for analyzing said second digitally coded signals to set said second rate of said second infusing pump for a predetermined period of time.

14. The method of claim 13, wherein said biocompatible fluid is washed autologous blood.

15. The method of claim 12, wherein said first infusion pump is a volumetric infusion pump.

16. The method of claim 12, wherein said blood collection chamber is a cardiotomy reservoir.

17. The method of claim 12, wherein said hemodynamic variable is the right atrial pressure.

18. The method of claim 12, wherein said hemodynamic variable is the left atrial pressure.

19. The method of claim 12, wherein said first data provides the volume of said blood in said chamber at a particular time.

20. The method of claim 12, wherein said first data provides the volume of said blood pumped through said first infusion pump during said preselected period of time.

21. The method of claim 12, wherein said first rate of said first infusion pump is set by said computer through a point-to-point topology pump addressing scheme.

22. The method of claim 12, wherein said first infusion pump infuses a volume of said blood followed by a period of time during which said blood is not infused by said first infusion pump to allow the collecting of said first data without infusion-related distortion during said period of time.

23. The method of claim 12, wherein said preselected period of time is one minute.

24. A method for closed-loop, automated, closed autotransfusion by means of a computer, a first infusion pump having a first variable infusion rate that is controlled by said computer, a blood collection chamber, first conduit means for transferring shed mediastinal blood from a patient to said chamber, second conduit means for transferring said blood from said chamber to said first infusion pump, third conduit means for transferring said blood from said first infusion pump into the vein of said patient, said first conduit means, said chamber, said second conduit means, and said third conduit means defining a path of travel, means for filtering said blood located along said path of travel, means for collecting first data relating to a hemodynamic variable of said patient over a period of time, means for encoding said first data into a plurality of first digitally coded signals, means for transmitting said first digitally coded signals to said computer, a monitor in electronic communication with said computer for visually displaying information relating to said first data, and a keyboard in electronic communication with said computer for providing bedside control of said system, comprising:

(a) repeating steps (b) through (1) at the end of successive periods, of time, wherein said time period is a preselected period of time, until a predetermined interval of time has elapsed;

(b) storing the value for said hemodynamic variable in the memory of said computer;

(c) determining if said infusion pump is in an alarm state;

(d) ascertaining the incremental volume of said blood pumped through said first infusion pump during said preselected period of time;

(e) calculating the total volume of said blood infused by summing the respective said ascertained incremental volumes;

(f) computing the volume of said blood in said chamber;

(g) calculating the volume difference in said chamber between said computed volume in said chamber and the volume of said blood in said chamber after the previous said preselected period of time;

(h) computing the incremental volume of blood drainage from the mediastinum during said preselected period to time by summing said volume difference and said ascertained volume of blood pumped through said first infusion pump;

(i) calculating the total amount of blood drainage from the mediastinum by summing said computed incremental volumes over a predetermined interval of time;

(j) setting said first infusion rate at a predetermined low rate to keep said patient'"'"'s vein open upon the occurrence of a selected one of the following conditions;

(i) if the volume of said blood in said chamber is less than a predetermined acceptable volume;

(ii) if said value for said hemodynamic variable does not fall within a predetermined acceptable range;

(iii) if said volume of blood drainage from the mediastinum during said preselected period of time exceeds a predetermined acceptable value;

(k) setting said first infusion rate to deliver an aliquot of said blood at a predetermined acceptable rate unless said predetermined low rate was set in step (j); and

(l) allowing the infusion of said blood at said first infusion rate unless said first pump is in said alarm state.

25. The method of claim 24 to further provide for infusing of circulatory supportive fluids by means of a second infusion pump having a second variable infusion rate that is controlled by said computer, a reservoir containing a biocompatible fluid, fourth conduit means for transferring said biocompatible fluid from said reservoir to said second infusion pump, fifth conduit means for transferring said biocompatible fluid from said second infusion pump into the vein of said patient, means for collecting second data relating to a physiological variable of said patient over a period of time, means for encoding said second data into a plurality of second digitally coded signals, and means for transmitting said second digitally coded signals to said computer, comprising analyzing in said computer said second digitally coded signals to set said rate of said second infusion pump for a preselected period of time.

26. The method of claim 25, wherein said biocompatible fluid is washed autologous blood.

27. The method of claim 24, wherein said first infusion pump is a volumetric infusion pump.

28. The method of claim 24, wherein said blood collection chamber is a cardiotomy reservoir.

29. The method of claim 24, wherein said hemodynamic variable is the right atrial pressure.

30. The method of claim 24, wherein said hemodynamic variable is the left atrial pressure.

31. The method of claim 24, wherein said first data provides the volume of said blood in said chamber at a particular time.

32. The method of claim 24, wherein said first data provides the volume of said blood pumped through said first infusion pump during said preselected period of time.

33. The method of claim 24, wherein said first rate of said first infusion pump is set by said computer through a point-to-point topology pump addressing scheme.

34. The method of claim 24, wherein said first infusion pump infuses a volume of said blood followed by a period of time during which said blood is not infused by said first infusion pump to allow the collecting of said first data without infusion-related distortion during said period of time.

35. The method of claim 24, wherein said preselected period of time is one minute.