Blood component collection system with optimizer

• US 5,970,423 A
• Filed: 09/12/1997
• Issued: 10/19/1999
• Est. Priority Date: 03/04/1992
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Langley, Robert W., Keller, John J., Urdahl, Steven Gage
• Primary Examiner(s): WACHSMAN, HAL D
• Application Number:
  US08/928,329
• Time in Patent Office: 767 Days
• Field of Search: 364/528.01, 364/528.17, 702/19, 702/21, 702/22, 702/30, 702/45, 702/50, 702/100, 604/4-6, 604/30, 356/39, 356/42, 422/67, 210/645-647, 210/781, 210/782, 210/651, 128/DIG. 13, 377/20, 377/21, 436/10, 436/177, 436/63, 436/69, 436/70, 436/174, 435/2, 382/133, 382/134
• US Class Current: 702/21
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/307 Time control
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 1/385 taking into account of the patient characteristics
• CPC Class Codes: A61M 1/387 taking into account of the needs or inventory
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

A blood component collection system with optimization capabilities. In one embodiment, process parameters are derived from an input/configured predetermined blood component yield and which is based upon the maximization of at least one process parameter. Thereafter, the blood component collection procedure is performed with these derived process control parameters. In another embodiment, process parameters are derived from an input total procedure time from a maximized value for at least one of the other process control parameters so as to maximize blood component yield in this fixed time. Thereafter, the blood component collection procedure is performed with these derived parameters.

Claims

1. A computer-readable storage medium for use in performing a blood component collection procedure on blood comprising a plurality of blood component types and with a blood component collection system comprising a blood component collection device, said collection procedure comprising a plurality of control parameters and said collection procedure collecting at least one of said blood component types, said computer-readable storage medium comprising:

means for requesting biological data relating to a donor comprising a source of said blood;

means for associating a magnitude with each said control parameter based upon at least said means for requesting biological data;

means for optimizing said magnitude of at least one of said control parameters in relation to both donor constraints and system constraints, said means for optimizing comprising means for selecting between at least first and second optimized procedures,

said first optimized procedure being collecting a predetermined quantity of said at least one of said blood component types in a minimum amount of time, wherein said predetermined quantity of said at least one of said blood component types has been input by an operator of said blood component collection system before an initiation of said blood component collection procedure, and

said second optimized procedure being collecting a maximum quantity of said at least one of said blood component types in a predetermined amount of time, wherein said predetermined amount of time has been input by said operator of said blood component collection system before said initiation of said blood component collection procedure; and

means for selecting said magnitudes of said control parameters, for use in said blood component collection procedure using said blood component collection system, from said means for optimizing.

2. A computer-readable storage medium, as claimed in claim 1, wherein:

said source comprises said donor and said data comprises at least one of said donor'"'"'s hematocrit, height, weight and sex.

3. A computer-readable storage medium, as claimed in claim 1, wherein:

said means for requesting allows an operator to input a magnitude of a desired yield for each said blood component collection procedure which is performed using said computer-readable storage medium.

4. A computer-readable storage medium, as claimed in claim 1, wherein:

said means for associating comprises first means for deriving a magnitude for at least one of said control parameters from said means for requesting biological data and second means for requesting a desired yield.

5. A computer-readable storage medium, as claimed in claim 1, wherein:

said biological data comprises said donor'"'"'s hematocrit, height, weight, and sex.

6. A computer-readable storage medium, as claimed in claim 1, wherein:

one of said control parameters is an inlet flow to said blood component collection device and another of said control parameters is a flow of anticoagulant into said blood component collection system, wherein said inlet flow comprises a flow of whole blood from said source and said flow of anticoagulant, wherein said source of said blood has a volume, wherein at least part of said flow of anticoagulant is provided to said source, wherein an anticoagulant ratio is a ratio of said inlet flow to said flow of anticoagulant, and wherein an anticoagulant infusion rate is a flow of said anticoagulant provided to said source per said volume of said source.

7. A computer-readable storage medium, as claimed in claim 6, wherein said means for associating comprises a means for deriving a magnitude of said inlet flow associated with a predetermined magnitude of said anticoagulant infusion rate.

8. A computer-readable storage medium, as claimed in claim 7, wherein said means for deriving said magnitude of said inlet flow uses said predetermined magnitude of said anticoagulant infusion rate and a current magnitude for a total procedure time, said total procedure time being another of said control parameters.

9. A computer-readable storage medium, as claimed in claim 8, wherein said means for deriving said magnitude of said inlet flow further comprises:

means for performing a first iteration procedure comprising means for calculating a current magnitude for said anticoagulant infusion rate from at least said current magnitude of said inlet flow, wherein a first said magnitude of said inlet flow is initially assumed, said means for performing a first iteration procedure further comprising means for evaluating convergence criteria relating to said magnitude of said inlet flow, and means for adjusting said magnitude of said inlet flow, and means for repeating said first iteration procedure until at least one of first and second conditions is established, said first condition being that said convergence criteria is established and said second condition being that said first iteration procedure has been performed a predetermined number of times.

10. A computer-readable storage medium, as claimed in claim 9, wherein:

said means for deriving said magnitude of said inlet flow comprises means for deriving a current magnitude for said anticoagulant infusion rate, and means for performing a second iteration procedure comprising means for calculating a current yield of at least one of said blood component types from said current magnitude of said inlet flow, said current magnitude of said anticoagulant infusion rate, and said current magnitude of said total procedure time, means for comparing said current yield with a desired yield, means for exiting said means for performing a second iteration procedure, means for adjusting said current magnitude of said total procedure time when said current yield differs from desired yield by more than a predetermined amount, means for repeating said deriving a magnitude of said inlet flow after said means for adjusting said current magnitude of said total procedure time, and means for repeating said second iteration procedure until at least one of third and fourth conditions is satisfied, said third condition being that predetermined convergence criteria relating to said current total procedure time is established, said fourth condition being that said second iteration procedure has been performed a predetermined number of times.

11. A computer-readable storage medium, as claimed in claim 10, wherein:

said means for deriving said magnitude of said inlet flow further comprises means for performing a third iteration procedure comprising means for adjusting said anticoagulant ratio, means for repeating said first and second iteration procedures, and means for repeating said third iteration procedure until at least one of fifth and sixth conditions is satisfied, said fifth condition being that predetermined convergence criteria relating to said magnitude of said anticoagulant ratio is established and said sixth condition being that said means for performing a third iteration procedure has been performed a predetermined number of times.

12. A computer-readable storage medium, as claimed in claim 11, wherein:

said magnitude of said anticoagulant infusion rate is increased by a predetermined amount when said sixth condition associated with said third iteration procedure is satisfied, wherein said means for deriving said magnitude of said inlet flow further comprises means for repeating said first, second, and third iteration procedures using said increased anticoagulant infusion rate.

13. A computer-readable storage medium, as claimed in claim 8, wherein:

said means for deriving said magnitude of said inlet flow comprises means for deriving a current magnitude for said anticoagulant infusion rate, and means for iteratively calculating a current blood component yield using at least a current magnitude of said inlet flow and said current magnitude of said anticoagulant infusion rate and by using said means for requesting biological data and by iteratively adjusting said magnitude of said current total procedure time until at least one of first and second conditions is established, said first condition being within a predetermined variance of a desired yield of blood components and said second condition being when said magnitude of said current total procedure time has been adjusted a predetermined number of times.

14. A computer-readable storage medium, as claimed in claim 8, wherein said means for deriving said magnitude of said inlet flow further comprises means for deriving said total procedure time, which provides a current yield within a predetermined amount of a desired yield of at least one of said blood component types.

15. A computer-readable storage medium, as claimed in claim 7, wherein:

said means for associating comprises means for selecting a maximum magnitude for said anticoagulant infusion rate and means for generating a calculated magnitude of said inlet flow using at least said maximum magnitude of said anticoagulant infusion rate.

16. A computer-readable storage medium, as claimed in claim 15, wherein said means for deriving said magnitude of said inlet flow further comprises:

means for calculating a theoretical magnitude of said inlet flow which provides a maximum yield of said at least on blood component type and means for comparing said theoretical and calculated magnitudes of said inlet flow, wherein said storage medium further comprises means for selecting the lesser of said theoretical magnitude and said calculated magnitude of said inlet flow.

17. A computer-readable storage medium, as claimed in claim 16, wherein:

another of said control parameters is a total procedure time, wherein a current magnitude for said total procedure time is assumed, and wherein said means for deriving said magnitude of said inlet flow further comprises means for performing a first iteration procedure, said means for performing a first iteration procedure comprising means for calculating a current blood component yield using the lesser of said calculated and theoretical magnitudes of said inlet flow of whole blood, said current magnitude of said total procedure time, and said maximum anticoagulant infusion rate, means for comparing said current blood component yield with a desired blood component yield, and means for repeating said first iteration procedure using an adjusted current total procedure time until at least one of first and second conditions is satisfied, said first condition being that until said current blood component yield is within a predetermined amount of a desired blood component yield, said second condition being that said first iteration procedure has been performed a predetermined number of times.

18. A computer-readable storage medium, as claimed in claim 16, wherein:

another of said control parameters is a total procedure time and said means for deriving said magnitude of said inlet flow further comprises means for assuming a current magnitude for said total procedure time and means for performing a first iteration procedure, said means for performing a first iteration procedure comprising means for calculating a current yield of at least one of said blood component types from the lesser of said calculated and theoretical magnitudes of said inlet flows, a maximum magnitude for said anticoagulant ratio, and said maximum magnitude of said anticoagulant infusion rate, and said current magnitude of said procedure time, means for comparing said current yield with a desired yield, means for incrementally adjusting said current magnitude of said total procedure time when said current yield differs from desired yield by more than a predetermined amount, and means for repeating said first iteration procedure until at least one of a first and second condition is satisfied, said first condition being that said current yield is within said predetermined amount of said desired yield and said second condition being that said first iteration procedure has been performed a predetermined number of times.

19. A computer-readable storage medium, as claimed in claim 7, wherein:

said at least one of said control parameters is a total procedure time, said means for deriving said magnitude of said inlet flow comprising means for maximizing said inlet flow and means for minimizing said total procedure time.

20. A computer-readable storage medium, as claimed in claim 1, wherein:

one of said control parameters is a total procedure time, and wherein said means for associating comprises means for minimizing the magnitude of said total procedure time based upon the magnitude of at least one of said control parameters other than said total procedure time.

21. A computer-readable storage medium, as claimed in claim 20, wherein:

one of said control parameters is an inlet flow to said blood collection device and another of said control parameters is a flow of anticoagulant into said blood component collection system, wherein said inlet flow comprises a flow of whole blood from said source and said flow of anticoagulant, wherein said blood from said source has a volume, wherein at least part of said flow of anticoagulant is provided to said source, wherein an anticoagulant ratio is a ratio of said inlet flow to said flow of anticoagulant, wherein an anticoagulant infusion rate is said at least part of said flow of anticoagulant per said volume, and wherein said at least one of said control parameters associated with said means for minimizing comprises said anticoagulant infusion rate and said inlet flow.