Blood component collection system with optimizer

• US 5,712,798 A
• Filed: 05/12/1995
• Issued: 01/27/1998
• 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): Voeltz, Emanuel T.
• Assistant Examiner(s): CHOI, KYLE JAEHUN
• Application Number:
  US08/439,649
• Time in Patent Office: 991 Days
• Field of Search: 364/496, 364/500, 364/502, 364/413.07, 364/413.08, 128/DIG. 13, 604/4-6, 604/30, 210/645-647, 210/781, 210/782, 356/39, 422/67
• US Class Current: 700/266
• 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 having a plurality of control parameters associated therewith using a blood component collection system comprising a blood component collection device, said computer-readable storage medium comprising:

means for requesting biological data relating to a source of blood comprising a plurality of blood component types, said source comprising a donor and said data comprising at least one of said donor'"'"'s hematocrit, height, weight and sex;

means for requesting a desired yield for at least one predetermined blood component type to be collected, said means for requesting a desired yield allowing an operator to input a magnitude for said desired yield for each said blood component collection procedure which is performed using said computer-readable storage medium; and

means for associating a magnitude with each said control parameter, said means for associating comprising first means for deriving a magnitude for at least one of said control parameters from said means for requesting biological data and said means for requesting a desired yield.

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

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

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

one of said parameters is an inlet flow to said blood collection device and another of said 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 AC ratio is a ratio of said inlet flow to said flow of anticoagulant, and wherein an AC infusion rate is a flow of said anticoagulant provided to said source per said volume of said source.

4. A storage medium, as claimed in claim 3, wherein said first means for deriving comprises:

means for deriving said magnitude of said inlet flow associated with a predetermined magnitude of said AC infusion rate.

5. A storage medium, as claimed in claim 4, wherein said means for deriving said magnitude of said inlet flow uses said predetermined magnitude of said AC infusion rate and a current magnitude for a total procedure time, said total procedure time being another of said parameters.

6. A storage medium, as claimed in claim 5, 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 AC infusion rate from at least said current magnitude of said inlet flow, wherein a first said current 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 current magnitude of said inlet flow, and means for adjusting said current magnitude of said inlet flow, and means for repeating said means for performing 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 means for performing a first iteration procedure has been performed a predetermined number of times.

7. A storage medium, as claimed in claim 6, wherein:

said means for deriving said magnitude of said inlet flow comprises means for deriving a current magnitude for said AC infusion rate, said first means for deriving further comprising means for performing a second iteration procedure after said means for deriving said magnitude of said inlet flow, said means for performing a second iteration procedure comprising means for calculating a current yield from said current magnitude of said inlet flow, said current magnitude of said AC infusion rate, and said current magnitude of said procedure time, means for comparing said current yield with said desired yield, means for exiting said means for performing a second iteration procedure after said means for comparing and when said current yield is within a predetermined amount of said desired yield, means for adjusting said current magnitude of said total procedure time when said current yield differs from desired yield by more than said predetermined amount, means for repeating said means for 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 means for performing a 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 means for performing a second iteration procedure has been performed a predetermined number of times.

8. A storage medium, as claimed in claim 7, wherein:

said first means for deriving further comprises means for performing a third iteration procedure after said means for performing a second iteration procedure and when said fourth condition associated with said means for performing a second iteration procedure is satisfied, said means for performing a third iteration procedure comprising means for adjusting said magnitude of said AC ratio, means for repeating said means for performing said first and second iteration procedures, and means for repeating said means for performing a 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 AC 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.

9. A storage medium, as claimed in claim 8, wherein:

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

10. A storage medium, as claimed in claim 5, wherein:

said means for deriving said magnitude of said inlet flow comprises means for deriving a current magnitude for said AC infusion rate, said first means for deriving further comprising means for iteratively calculating a current blood component yield using at least said current magnitude of said inlet flow and said current magnitude of said AC 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 said 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.

11. A storage medium, as claimed in claim 5, wherein said first means for deriving further comprises means for deriving said total procedure time, after said means deriving said magnitude of said inlet flow, which provides a current yield within a predetermined amount of said desired yield.

12. A storage medium, as claimed in claim 3, wherein:

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

13. A storage medium, as claimed in claim 12, wherein said first means for deriving further comprises:

means for calculating a theoretical magnitude of said inlet flow which provides a maximum yield of said at least one predetermined blood component 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.

14. A storage medium, as claimed in claim 13, wherein:

another of said parameters is a total procedure time, wherein a current magnitude for said total procedure time is assumed, and wherein said first means for deriving 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 AC infusion rate, means for comparing said current blood component yield with said desired blood component yield, and means for repeating said means for performing a 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 magnitude of said blood component yield is within a predetermined amount of said desired blood component yield, said second condition being that said means for performing a first iteration procedure has been performed a predetermined number of times.

15. A storage medium, as claimed in claim 13, wherein:

another of said parameters is a total procedure time and said first means for deriving 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 from the lesser of said actual and theoretical magnitudes of said inlet flows, a maximum magnitude for said AC ratio, and said maximum magnitude of said AC infusion rate, and said current magnitude of said procedure time, means for comparing said current yield with said 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 means for performing a 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 first predetermined amount of said desired yield and said second condition being that said first iteration procedure has been performed a predetermined number of times.

16. A storage medium, as claimed in claim 3, wherein:

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

17. A storage medium, as claimed in claim 1, wherein:

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

18. A storage medium, as claimed in claim 17, wherein:

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

19. A storage medium, as claimed in claim 1, wherein:

said means for associating comprises means for optimizing said magnitude of at least one of said parameters.

20. A storage medium, as claimed in claim 1, further comprising:

means for requesting a type of collection procedure having a plurality of parameters associated therewith; and

means for selecting said magnitude of each said parameter for use in said blood component collection procedure using said blood component collection system.

21. A storage medium, as claimed in claim 1, further comprising:

means for requesting an optimization selection from at least a time-based optimization and a product-based optimization, said time-based optimization allowing for collecting a maximum quantity of said at least one predetermined blood component type to be collected in an amount of time which is input by said operator, and said product-based optimization using said means for requesting a desired yield and said first means for deriving a magnitude for collecting said magnitude of said at least one predetermined blood component type which is input by the operator in a minimum amount of time.

22. A computer-readable storage medium for use in performing a blood component collection procedure with a blood component collection system, wherein an inlet flow to said blood component collection system comprises a flow of blood from a source and a flow of anticoagulant, said blood comprising a plurality of blood component types and said blood component collection procedure being used to collect at least one of said blood component types, said computer-readable storage medium comprising:

means for requesting a total procedure time for said collection procedure, said means for requesting a total procedure time allowing an operator to input a magnitude for said total procedure time for each said blood component collection procedure performed using said computer-readable storage medium;

means for deriving a first inlet flow to said collection system which provides a maximum yield of said at least one of said blood component types;

means for deriving a second inlet flow to said collection system using at least said magnitude of said total procedure time which has been entered by said operator via said means for requesting a total procedure time;

means for identifying a smallest magnitude of said first and second inlet flows as an actual inlet flow to said blood component collection system; and

means for selecting said total procedure time and said actual inlet flow for use in said blood component collection procedure using said blood component collection system.

23. 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 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 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; and

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