Control of a multi-channel drug infusion pump using a pharmacokinetic model

• US 5,522,798 A
• Filed: 10/17/1994
• Issued: 06/04/1996
• Est. Priority Date: 10/17/1994
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Huang, Jyh-yi T., Chang, Tao, Johnson, Noel L.
• Primary Examiner(s): Maglione, Corrine M.
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/324,392
• Time in Patent Office: 596 Days
• Field of Search: 604/30, 604/31, 604/49, 604/53, 604/65-67, 604/246, 604/247, 604/151, 604/118
• US Class Current: 604/65
• 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 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A host controller (10) selectively predicts and controls drug concentrations for each of a plurality of channels delivered through multiple drug channels of a multi-channel drug delivery system. The host controller includes a controller (32) that is coupled to each drug channel of the multi-channel drug delivery system to receive actual drug delivery rate information. Delivery of each drug can be selectively separately controlled by a PK model (the same PK model for each channel or different PK models for different channels) to achieve either a desired setpoint for a blood plasma drug concentration or a setpoint for an effect compartment drug concentration. Control of the drug delivery by the PK model can be selectively interrupted during operation of the multi-channel drug delivery system, to switch to a manual mode in order to administer a bolus dose or a continuous infusion, and then, control of drug infusion using the PK model can be subsequently resumed. The blood plasma and/or effect compartment drug concentrations for any drug predicted in accordance with a PK model are selectively displayed to a user on an electroluminescent (EL) display (36), even during operation of the multi-channel drug delivery system in the manual mode, or after the drug delivery has been terminated. Prediction of drug concentration is tracked for each drug administered, enabling multiple drugs to successively administered in the same drug channel and control of a drug delivery by the PK model to continue when the drug channel used to administer the drug is changed.

Claims

1. A control for a multi-channel drug delivery system with which a plurality of drugs are selectively administered to a patient through a plurality of drug channels in accordance with a PK model, comprising:

(a) a processor that is controlled in accordance with a set of program instructions that determine the steps implemented by said PK model;

(b) a memory, coupled to the processor, said memory storing the set of program instructions and a plurality of parameters used by the PK model;

(c) a display, coupled to the processor, on which are displayed the parameters and PK model data, including a concentration of a drug within the patient as a function of time;

(d) a user interface, coupled to the processor, said user interface enabling a user to input at least some of the plurality of parameters used by the PK model in controlling administration of each drug to the patient, and including identification means for identifying the drug that is being administered in each of the drug channels; and

(e) PK model prediction means, embodied in the processor executing said set of program instructions, for determining a drug concentration within the patient over time for each drug, as each drug is administered by the multi-channel drug delivery system, said PK model prediction means determining the drug concentration;

(i) during any interruption and after a termination of the drug delivery; and

(ii) regardless of any change in the drug channel through which any drug is delivered.

2. The control of claim 1, wherein the processor is controlled by the program instructions to selectively model and control one of an effect compartment drug concentration of a drug in the patient, and a blood plasma drug concentration of the drug in the patient.

3. The control of claim 1, wherein the memory stores blood plasma drug concentrations over time for the plurality of drugs.

4. The control of claim 3, wherein the display selectively shows at least one of a predicted and a historical blood plasma drug concentration over time for any of the plurality of drugs.

5. The control of claim 1, wherein the memory stores effect compartment drug concentrations over time for the plurality of drugs.

6. The control of claim 5, wherein the display selectively shows at least one of a predicted and a historical effect compartment drug concentration for any of the plurality of drugs over time.

7. The control of claim 1, wherein the user interface includes a mode switch enabling the user to select between a manual mode and a PK model control mode for controlling the delivery of any of the plurality of drugs by the multi-channel drug delivery system, said PK prediction means continuing to determine and track at least one of a blood plasma drug concentration and an effect compartment drug concentration for over time while operating in the manual mode, thereby enabling the processor to control administration of a drug in the PK model control mode if said mode is selected after the manual mode was used to control delivery of the drug by the multi-channel drug delivery system.

8. The control of claim 7, wherein the display shows at least one of the blood plasma drug concentration and the effect compartment drug concentration of said drug during operation of the multi-channel drug delivery system in the manual mode.

9. The control of claim 8, wherein the display shows for said drug, at least one of a historical and a predicted blood plasma drug concentration level over time, and of a historical and a predicted effect compartment drug concentration over time, during operation of the multi-channel infusion system in the manual mode.

10. The control of claim 8, wherein the display shows for the drug, at least one of a historical and a predicted blood plasma drug concentration over time, and of a historical and a predicted effect compartment drug concentration over time:

(a) after delivery of the drug is terminated;

or

(b) after a different drug is delivered in the same drug channel as said drug, and then delivery of said drug is resumed in said drug channel;

or

(c) after delivery of the drug is resumed in a different drug channel.

11. A control for a multi-channel drug delivery system with which any of a plurality of drugs are selectively administered to a patient through a plurality of drug channels in accordance with a PK model, comprising:

(a) a processor that is controlled in accordance with a set of program instructions that determine the steps of said PK model;

(b) a memory, coupled to the processor, said memory storing the set of program instructions and a plurality of parameters used in the PK model;

(c) a display, coupled to the processor, on which are displayed the parameters and data indicative of a state of the PK model; and

(d) a user interface, coupled to the processor, said user interface enabling a user to input at least some of the plurality of parameters used by the PK model in controlling administration of a drug to the patient and including a selector switch that selectively determines whether the control uses the PK model to achieve either;

(i) a desired blood plasma drug concentration;

or

(ii) a desired effect compartment drug concentration.

12. The control of claim 11, wherein the memory stores blood plasma drug concentrations over time for the plurality of drugs.

13. The control of claim 12, wherein the display is controlled by the processor to selectively display at least one of a predicted and a historical blood plasma drug concentration.

14. The control of claim 11, wherein the memory stores effect compartment drug concentrations over time.

15. The control of claim 14, wherein the display selectively shows at least one of a predicted and a historical effect compartment drug concentration over time.

16. The control of claim 11, wherein the user interface includes a mode switch enabling the user to select between a manual mode and a PK model control mode for controlling the multi-channel drug delivery system, said processor continuing to model and track at least one of a blood plasma drug concentration and an effect compartment drug concentration for the plurality of drugs over time while operating in the manual mode, thereby enabling the processor to control administration of any drug in the PK model control mode if said mode is selected after the manual mode was used to control delivery of the drug.

17. The control of claim 16, wherein the processor causes the display to show at least one of the blood plasma drug concentration and the effect compartment drug concentration of a drug during operation of the multi-channel drug delivery system to deliver the drug in the manual mode.

18. The control of claim 17, wherein the display shows at least one of a historical and a predicted blood plasma drug concentration level for the drug over time, and of a historical and a predicted effect compartment drug concentration for the drug over time, during operation of the multi-channel infusion system to delivery the drug in the manual mode.

19. The control of claim 17, wherein the display shows at least one of a historical and a predicted blood plasma drug concentration level over time, and of a historical and a predicted effect compartment drug concentration over time, after delivery of the drug is terminated.

20. The control of claim 11, wherein the user interface includes means for selectively determining the PK model used for each of the plurality of drugs, enabling the user to select a different PK model for different drugs.

21. The control of claim 11, wherein the user interface includes means for identifying the drug channel through which a specific drug is being delivered, enabling the PK model to control the delivery of said specific drug regardless of any change in the drug delivery channel through which it is delivered.

22. A control for a drug delivery system with which a drug is selectively administered to a patient in accordance with a PK model, comprising:

(a) a processor that is controlled in accordance with a set of program instructions that determine the steps of said PK model;

(b) a memory, coupled to the processor, said memory storing the set of program instructions and a plurality of parameters used in the PK model;

(c) a display, coupled to the processor, on which are displayed the parameters and data indicative of a state of the PK model; and

(d) a user interface, coupled to the processor, said user interface enabling a user to input at least some of the plurality of parameters used by the PK model in controlling administration of the drug to the patient and including a selector switch that selectively determines whether the control uses the PK model to achieve;

(i) a desired blood plasma drug concentration;

or

(ii) a desired effect compartment drug concentration.

23. The control of claim 22, wherein the memory stores blood plasma drug concentrations over time for the drug.

24. The control of claim 23, wherein the display selectively shows at least one of a predicted and a historical blood plasma drug concentration of the drug over time.

25. The control of claim 22, wherein the memory stores effect compartment drug concentrations over time for the drug.

26. The control of claim 25, wherein the display is controlled by the processor to selectively display at least one of a predicted and a historical effect compartment drug concentration for the drug over time.

27. The control of claim 22, wherein the user interface includes a mode switch enabling the user to select between a manual mode and a PK model control mode for controlling the drug delivery system, said processor continuing to model and track at least one of a blood plasma drug concentration and an effect compartment drug concentration over time while operating in the manual mode, thereby enabling the processor to resume controlling administration of the drug in the PK model control mode if said mode is selected after control of the drug delivery system in the manual mode.

28. The control of claim 27, wherein the processor causes the display to show at least one of the blood plasma drug concentration and the effect compartment drug concentration during operation of the drug delivery system in the manual mode.

29. The control of claim 22, wherein the display shows at least one of a historical and a predicted blood plasma drug concentration level over time, and of a historical and a predicted effect compartment drug concentration over time, after delivery of the drug is terminated.

30. A method for controlling a multi-channel drug delivery system with which a plurality of drugs are selectively administered to a patient through a plurality of drug channels in accordance with a PK model, comprising the steps of:

(a) enabling a user to input a plurality of parameters used by the PK model in controlling administration of a drug to the patient;

(b) determining a drug concentration within the patient over time for each drug, as each drug is administered by the multi-channel drug delivery system;

(i) during any interruption and after a termination of the drug delivery; and

(ii) regardless of any change in the drug channel through which any drug is delivered.

31. The method of claim 30, further comprising the step of selectively modeling and controlling one of an effect compartment drug concentration for the plurality of drugs in the patient, and a blood plasma drug concentration for the plurality of drugs in the patient.

32. The method of claim 31, wherein the PK model controls an effect compartment drug concentration for each drug, further comprising the step of storing effect compartment drug concentrations over time for the plurality of drugs.

33. The method of claim 32, further comprising the step of selectively displaying at least one of a predicted and a historical effect compartment drug concentration over time for the plurality of drugs.

34. The method of claim 31, wherein the PK model controls a blood plasma drug concentration for each drug, further comprising the step of storing blood plasma drug concentrations over time for the plurality of drugs.

35. The method of claim 34, further comprising the step of selectively displaying at least one of a predicted and a historical blood plasma drug concentration for the plurality of drugs over time.

36. The method of claim 30, further comprising the steps of enabling the user to select between a manual mode and a PK model control mode for controlling delivery of any of the plurality of drugs by the multi-channel drug delivery system;

and continuing to model and track at least one of a blood plasma drug concentration and an effect compartment drug concentration over time while operating in the manual mode, thereby enabling administration of a drug in the PK model control mode to occur if said mode is selected after the manual mode was used to control delivery of the drug by the multi-channel drug delivery system.

37. The method of claim 36, further comprising the step of displaying at least one of the blood plasma drug concentration and the effect compartment drug concentration over time, during operation of the multi-channel drug delivery system in the manual mode.

38. The method of claim 36, further comprising the step of displaying for the drug, at least one of a historical and a predicted blood plasma drug concentration level over time, and of a historical and a predicted effect compartment drug concentration over time:

(a) after delivery of a drug is terminated;

or

(b) after a different drug is delivered in the same drug channel as said drug, and then delivery of said drug is resumed;

or

(c) after delivery of the drug is resumed in a different drug channel.

39. A method for controlling a multi-channel drug delivery system with which a plurality of drugs are selectively administered to a patient in accordance with a PK model, comprising the steps of:

(a) enabling a user to input at least some of a plurality of parameters used by the PK model;

(b) controlling administration of the plurality of drugs to the patient using the PK model; and

(c) enabling the user to selectively determine whether the control uses the PK model to achieve either;

(i) a desired blood plasma drag concentration;

or

(ii) a desired effect compartment drug concentration.

40. The method of claim 39, further comprising the step of storing blood plasma drug concentrations over time for the plurality of drugs.

41. The method of claim 40, further comprising the step of selectively displaying at least one of a predicted and a historical blood plasma drug concentration over time.

42. The method of claim 39, further comprising the step of storing effect compartment drug concentrations over time.

43. The method of claim 40, further comprising the step of selectively displaying at least one of a predicted and a historical effect compartment drug concentration over time.

44. The method of claim 39, further comprising the step of enabling the user to select between a manual mode and a PK model control mode for controlling the multi-channel drug delivery system;

and continuing to model and track at least one of a blood plasma drug concentration and an effect compartment drug concentration over time while operating in the manual mode, thereby enabling administration of a drug in the PK model control mode to be used to control delivery of a drug if said mode is selected after the manual mode was used to control delivery of the drug.

45. The method of claim 44, further comprising the step of displaying at least one of the blood plasma drug concentration and the effect compartment drug concentration during operation of the multi-channel drug delivery system in the manual mode.

46. The method of claim 44, further comprising the step of displaying at least one of a historical and a predicted blood plasma drug concentration level over time, and of a historical and a predicted effect compartment drug concentration over time, after delivery of a drug is terminated.

47. The method of claim 39, further comprising the step of enabling the user to selectively determine whether a different PK model is used to control the delivery of different drugs.

48. A method for controlling a drug delivery system with which a drug is administered to a patient in accordance with a PK model, comprising:

(a) enabling a user to input a plurality of parameters used by the PK model in controlling administration of the drug to the patient;

(b) operating the drug delivery system to administer the drug to the patient in accordance with said parameters; and

(c) selectively determining whether the control uses the PK model to achieve either;

(i) a desired blood plasma drug concentration;

or

(ii) a desired effect compartment drug concentration within the patient.

49. The method of claim 48, further comprising the step of storing blood plasma drug concentrations over time for the drug.

50. The method of claim 49, further comprising the step of selectively displaying at least one of a predicted and a historical blood plasma drug concentration over time for the drug.

51. The method of claim 48, further comprising the step of storing effect compartment drug concentrations over time for the drug.

52. The method of claim 51, further comprising the step of selectively displaying at least one of a predicted and a historical effect compartment drug concentrations over time for the drug.

53. The method of claim 49, further comprising the steps of enabling the user to select between a manual mode and a PK model control mode for controlling the drug delivery system;

and continuing to model and track at least one of a blood plasma drug concentration and an effect compartment drug concentration over time while operating in the manual mode, thereby enabling the processor to control administration of the drug in the PK model control mode if said mode is selected after the manual mode was used to control administration of the drug.

54. The method of claim 53, further comprising the step of displaying at least one of the blood plasma drug concentration and the effect compartment drug concentration during operation of the drug delivery system in the manual mode.

55. The method of claim 53, further comprising the step of displaying at least one of a historical and a predicted blood plasma drug concentration level over time, and of a historical and a predicted effect compartment drug concentration over time, after delivery of the drug is terminated.