Blood infusion control system

• US 5,984,893 A
• Filed: 03/27/1998
• Issued: 11/16/1999
• Est. Priority Date: 03/27/1997
• Status: Expired due to Fees

• Current Assignee: Roger T. Ward
• Original Assignee: Roger T. Ward
• Inventors: Ward, Roger T.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/049,414
• Time in Patent Office: 599 Days
• Field of Search: 604/131, 604/141, 604/151, 604/152, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/131
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

The Blood Infusion Control System of the present invention integrates components of rapid infusion systems with a computer controller designed to synchronize two infusion pumps in a manner that produces a pre-selected patient hematocrit (HCT*) while reporting the patient'"'"'s estimated blood volume (BV_E). In order to attain HCT*, the Blood Replacement Controller (BRC) drives a dual-pump assembly to deliver streams of asanguinous fluid and blood through flexible conduits into intravenous (IV) catheters to mix with the patient'"'"'s blood volume having an initial hematocrit (HCT_i). The BRC utilizes measured patient data as feedback input to control flowrates of the two-pump infusion assembly. The patient'"'"'s estimated blood volume is extrapolated from hematocrit changes in response to the fluid and blood infusion. The major components that comprise BICS are two infusion pumps, a microcomputer controller to actuate the two pumps, a heat exchanger, a bubble trap-filter, air/temperature/pressure sensors, and disposable tubing conduits. The design methodology represents a blood infusion device that can rapidly deliver filtered, bubble free, warmed volumes to patients with significant hypovolemia. This subject invention is a sample data control system that rapidly dispenses crystalloid/colloid fluids and red blood cells by venous infusion in a manner that 1) achieves HCT* in the patient and 2) reports the patient'"'"'s BV_E. BICS could enhance the ability of clinical teams in operating rooms and trauma receiving areas to stabilize patients suffering cardiovascular deterioration from acute blood loss.

Claims

1. A blood infusion control system for venous infusion of physiologic fluid for achieving pre-set hematocrit levels in a patient and reporting the patient'"'"'s blood volume during administration of transfusion therapy, said system comprising:

an infusion assembly having a first infusion pump for propelling a first physiologic fluid into the body of a patient and a second infusion pump for propelling a second physiologic fluid into the body of the patient, said first and second infusion pumps having variable flowrates and operating in sychronized relationship to each other; and

a controller for controlling the operation of said first and second infusion pumps to regulate the flowrates of said first and second physiologic fluids being propelled by said first and second infusion pumps, said controller synchronizing the flowrate of said first and second infusion pumps to control the total flowrate of said first and second infusion pumps in response to a patient'"'"'s hematocrit levels and blood volume.

2. The system of claim 1 in which said first physiologic fluid is blood.

3. The system of claim 1 in which said second physiologic fluid includes crystalloid/colloid fluids.

4. The system of claim 1 further comprising a heat exchanger for controlling the temperature of said first and second physiologic fluids.

5. The system of claim 1 further comprising a gas vent.

6. The system of claim 1 further comprising sensors for monitoring properties of said first and second physiologic fluids.

7. The system of claim 1 further comprising means for inputting patient data into said controller.

8. The system of claim 1 further comprising an in-line conditioning unit for creating a warmed, bubble-free stream of first and second physiologic fluid mixture for delivery into intravenous patient catheters.

9. The system of claim 1 further comprising at least one cannula for infusing a first and second physiologic fluid mixture into the venous system of the patient.

10. The system of claim 1 further comprising means for measuring patient data and inputting said data into said controller.

11. The system of claim 1 further comprising means for estimating blood volume from hematocrit changes in a patient in response to infusion of said first and second physiologic fluids.

12. A system for administering transfusion therapy to a patient, comprising a computer processor programmed to control the conjoined cyclical motion of first and second infusion pumps operating at variable flowrate ratios in combination with elements to condition physiologic fluids and blood to be acceptable for delivery through flexible tubing into patient catheters.

13. The system of claim 12 further comprising:

(a) said first infusion pump propelling physiologic fluids through said tubing and said second infusion pump propelling blood through said tubing;

(b) a controller that uses variational algorithms to specify the conjoined cyclical motion of said first and second infusion pumps that produce said variable flowrate ratios of said physiologic fluids and blood delivered through said tubing; and

(c) elements to produce warm physiologic fluids and blood which is devoid of air before being delivered through said tubing.

14. The system of claim 12 wherein said first infusion pump delivers physiologic fluids, which includes crystalloid solutions and colloid suspensions and said second infusion pump delivers various forms of blood.

15. The system of claim 13 wherein said first and second infusion pumps operate at variable flowrate ratios, in relation to each other, as commanded by said controller.

16. The system of claim 13 wherein said first and second infusion pumps vary infusion rates in response to programmable variables that are input into said controller.

17. The system of claim 13 wherein said controller drives said first and second infusion pumps by determining metered flowrates for coupled administration of the physiologic fluids and blood that achieves pre-selected hematocrit levels in a patient according to inputs provided by an operator.

18. The system of claim 13 wherein said controller drives said first and second infusion pumps by determining metered flowrates for coupled administration of the physiologic fluids and blood that achieves pre-selected hematocrit levels in a patient according to inputs provided by an operator with inclusion of inputs from automatic sensors.

19. The system of claim 12 further comprising:

(a) an inline heat exchanger element to control temperatures of the infused physiologic fluids and blood;

(b) an inline evacuation element to remove air from the infused physiologic fluids and blood;

(c) inline elements to sense hydrostatic parameters within the flexible tubing and hemodynamic parameters within the patient; and

(d) elements to warn an operator or to automatically shut off said system when unacceptable conditions exist in the physiologic fluids and blood delivered to the patient.

20. A method for specifying variable flowrate ratios of infusion pumps comprising the steps of:

(a) providing a computer processor programmed to control the conjoined cyclical motion of first and second infusion pumps operating at variable flowrate ratios in combination with elements to condition physiologic fluids and blood to be acceptable for delivery through flexible tubing into patient catheters;

(b) achieving a variable total flowrate, as set by an operator, of said physiologic fluids and blood;

(c) regulating said patient'"'"'s hematocrit level to achieve a value pre-selected by the operator; and

(d) reporting an estimate of the patient'"'"'s blood volume and other related hemodynamic parameters whereby the operator can simultaneously infuse the physiologic fluids and blood into the patient without having to pre-mix these components in a mixing chamber before delivery through a single pump.