Decision information system for drug delivery devices

• US 6,928,338 B1
• Filed: 08/09/2002
• Issued: 08/09/2005
• Est. Priority Date: 08/10/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dummann, Brian T., Buchser, Eric E., Schultz, Brenda K., Valine, Thomas J., Crowley, Thomas P.
• Primary Examiner(s): Bahta, Kidest
• Application Number:
  US10/215,464
• Time in Patent Office: 1,096 Days
• Field of Search: 700264-265, 700/281, 700/285, 604/67, 604/66, 128/200
• US Class Current: 700/265
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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

Decision information systems, methods, and computer programs for better informing decisions to use multiple drugs in drug delivery devices, including implantable devices, for drug administration. Executable computer programs and logic embodying methods of the invention can calculate consistent multiple drug mixture amounts and drug delivery flow rates. One program accepts user input indicating a desired first drug dose rate, an initial first drug concentration, a desired second drug dose rate, an initial second drug concentration, and the reservoir size of the drug delivery device. The program method calculates a first drug amount and a second drug amount to combine in a mixture as well as a first drug true concentration in the mixture. The drugs can be mixed consistent with the physician'"'"'s instructions using the program output. The first drug true concentration can be entered into a programmer device as the only drug concentration entered. Another program calculates a consistent first drug, second drug, and diluent amount to be added to a mixture for injection into a fixed flow rate, implantable drug delivery device. Methods preferably output true concentrations and dose rates for all drugs to be added and most preferably show all calculations used to arrive at the flow rate and mixture amount calculations. Yet another program receives a new desired drug dose rate for a previously filled device. The program accepts the existing mixture volume and true drug concentrations for a partially depleted device and calculates a new mixture flow rate to achieve the desired dose rate using the existing mixture. The methods can be implemented as executable computer programs in programmer devices, general purpose computers, servers, handheld computers, and personal digital assistants.

Claims

1. A computer program for execution in a computer device for providing information about a decision to mix at least a first drug and a second drug in an implantable drug delivery device having an adjustable flow rate, the program comprising instructions for:

receiving a desired dose rate and an initial concentration for the first drug;

receiving a desired dose rate and an initial concentration for the second drug;

receiving a desired drug mixture volume for at least partial transfer to the implantable drug delivery device;

calculating a first drug volume and a second drug volume to combine in the drug mixture, wherein the first and second drug volumes are consistent with the desired first and second drug dose rates when delivered at a proper mixture flow rate and combine to substantially fill the desired mixture volume;

calculating the first drug true concentration in the drug mixture; and

outputting the calculated first and second drug volumes and the first drug true concentration in the mixture.

2. A computer program as in claim 1, further comprising instructions for calculating a second drug true concentration.

3. A computer program as in claim 1, further comprising instructions for calculating and outputting the proper mixture flow rate for the implantable drug delivery device.

4. A computer program as in claim 1, further comprising instructions for outputting a dose rate for the second drug.

5. A computer program as in claim 1, wherein the calculating first drug true concentration includes calculating the formula

Caf=(Cai×

Cbi)/((Cbi+(Tb/Ta)×

Cai),

wherein Caf represents the true concentration of the first drug,

Cai represents the initial concentration of the first drug,

Cbi represents the initial concentration of the second drug,

Ta represents the desired dose rate for the first drug, and

Tb represents the desired dose rate for the second drug.

6. A computer program as in claim 2, wherein the calculating second drug true concentration includes calculating the formula

Cbf=(Ta/Tb)×

Caf,

wherein Cbf represents the true concentration of the second drug,

Caf represents the true concentration of the first drug,

Ta represents the desired dose rate for the first drug, and

Tb represents the desired dose rate for the second drug.

7. A computer program as in claim 3, wherein the calculating proper mixture flow rate includes calculating the formula

FlowMix=Ta/Caf;

wherein FlowMix represents the Flow rate for the mixture,

Caf represents the true concentration of the first drug, and

Ta represents the desired dose rate for the first drug.

8. A computer program as in claim 1, wherein the calculating volume includes calculating the formula:

Vai=(Caf/Cai)×

MixVol; and

Vbi=(Cbf/Cbi)×

MixVol;

wherein Vai represents the volume of the first drug to add to the mixture,

Vbi represents the volume of the second drug to add to the mixture

Caf represents the true concentration of the first drug,

Cai represents the initial concentration of the first drug,

Cbf represents the true concentration of the second drug,

Cbi represents the initial concentration of the second drug, and

MixVol represents the total volume of the mixture.

9. A computer program as in claim 1, further comprising instructions for receiving an implantable drug delivery device reservoir size and for calculating a refill interval as a function of the reservoir size and the desired dose rates.

10. A computer program as in claim 1, further comprising instructions for calculating and outputting a bolus dose and volume for each drug in the mixture.

11. A computer program as in claim 1, further comprising instructions for outputting the calculations used in the calculating of claim 1.

12. A computer program as in claim 1, wherein the drugs are selected from the group consisting of morphine, baclofen, clonidine, bupivacaine, and adrenaline.

13. A computer program as in claim 1, further comprising instructions for receiving drug names into a drug name list and instructions allowing a user to modify the drug name list.

24. A method as in claim 20, further comprising executing computer program instructions in the computer for visually outputting the calculations used to determine the outputs of claim 1.

14. A computer program for execution in a computer device for providing information about a decision to mix at least a first drug and a second drug in an implantable drug delivery device having a fixed flow rate, the program comprising instructions for:

receiving the fixed flow rate;

receiving a desired dose rate and an initial concentration for the first drug;

receiving a desired dose rate and an initial concentration for the second drug;

receiving a desired drug mixture volume for at least partial transfer to the implantable drug delivery device;

calculating a first drug volume, a second drug volume, and a diluent volume to combine in the drug mixture, wherein the first drug, second drug, and diluent volumes are consistent with the desired first and second drug dose rates when delivered at the fixed flow rate, and combine to substantially fill the desired mixture volume;

calculating the first drug true concentration in the drug mixture; and

outputting the calculated first drug, second drug, and diluent volumes and the first drug true concentration in the mixture.

15. A computer program as in claim 14, further comprising instructions for calculating a second drug true concentration.

16. A computer program as in claim 14, further comprising instructions for calculating and outputting a dose rate for the second drug.

17. A computer program as in claim 14, further comprising instructions for receiving an implantable drug delivery device reservoir size and for calculating and outputting a refill interval for the implantable device.

18. A computer program as in claim 14, further comprising instructions for outputting the calculations used in the calculating of claim 14.

19. A computer program as in claim 14, wherein the drugs are selected from the group consisting of morphine, baclofen, clonidine, bupivacaine, and adrenaline.

20. In an implantable drug delivery system including an implantable drug deliver device having an adjustable flow rate and a reservoir volume, a programmer device for setting the adjustable flow rate via telemetry, and a computer device for executing a computer program having instructions, a method for setting the adjustable flow rate comprising:

entering into the computer device a desired dose rate and initial concentration for a first drug;

entering into the computer a desired dose rate and initial concentration for a second drug;

entering into the computer the reservoir volume for the implantable drug delivery device;

executing the computer program instructions in the computer to calculate and output a first drug amount and a second drug amount to combine to form a drug mixture having a mixture volume, wherein the first and second drug amounts are consistent with the first and second drug desired dose rates and wherein the mixture volume is sufficient to at least substantially fill the reservoir;

executing the computer program in the computer to calculate and output a first drug true concentration in the drug mixture;

entering the first drug true concentration in the programmer device;

entering the first drug desired dose rate into the programmer device;

combining the first and second drug amounts into the mixture in the implantable device; and

transmitting a flow rate to satisfy the first drug desired dose rate to the implantable device using the programmer device.

21. A method as in claim 20, further comprising calculating and outputting a second drug dose rate.

22. A method as in claim 20, further comprising calculating and outputting volumetric flow rates for the first drug and the second drug.

23. A method as in claim 20, further comprising calculating and outputting a second drug true concentration in the mixture.

25. A method as in claim 20, wherein the programmer device and the computer device are the same device.

26. A method as in claim 20, wherein the programmer device and the computer device are different devices.

27. A method as in claim 20, further comprising obtaining a desired dose rate and initial concentration for a third drug and executing computer program instructions to calculate a third drug amount to add to the mixture, wherein the first, second, and third drug amounts are consistent with the desired dose rates of the first, second, and third drugs.

28. A computer program for execution in a computer device for providing information about a decision to change the dose rate of one drug in an implantable device having an adjustable flow rate and having a mixture including at least a first drug and a second drug, the program comprising instructions for:

receiving an existing mixture volume in the implantable device;

receiving existing true concentrations of the first drug and the second drug in the mixture;

receiving a desired dose rate of a selected one of the drugs in the mixture; and

calculating and outputting a proper mixture flow rate for the implantable drug delivery device consistent with the existing mixture and the desired dose rate of the selected drug in the mixture.

29. A computer program as in claim 28, further comprising instructions for calculating and outputting a refill interval for the implantable device.

30. A computer program as in claim 28, further comprising instructions for calculating and outputting a reference dose rate for a drug selected as a reference drug from among the drugs in the mixture, where the selected reference drug is not the same drug as the drug having the desired dose rate.

31. A computer program as in claim 28, further comprising instructions for outputting the calculations used in the calculating of claim 28.

32. A computer program as in claim 28, wherein the receiving existing true concentrations of the first drug and the second drug in the mixture includes retrieving previously stored true concentrations.

33. A computer program as in claim 28, wherein the receiving an existing mixture volume in the implantable device includes retrieving a previously stored previous mixture volume, previous mixture flow rate, and previous fill date, and calculating the mixture volume as a function of the previous mixture volume, previous mixture flow rate, and previous fill date.

34. A computer program for execution in a computer device for providing information about a decision to mix at least a first drug and a second drug in a drug delivery device having an adjustable flow rate, the program comprising instructions for:

receiving a desired dose rate and an initial concentration for the first drug;

receiving a desired dose rate and an initial concentration for the second drug;

receiving a desired drug mixture volume for at least partial transfer to the drug delivery device;

calculating a first drug volume and a second drug volume to combine in the drug mixture, wherein the first and second drug volumes are consistent with the desired first and second drug dose rates when delivered at a proper mixture flow rate and combine to substantially fill the desired mixture volume;

calculating the first drug true concentration in the drug mixture; and

outputting the calculated first and second drug volumes and the first drug true concentration in the mixture.

35. A computer program as in claim 34, further comprising instructions for calculating a second drug true concentration.

36. A computer program as in claim 34, further comprising instructions for calculating and outputting the proper mixture flow rate for the drug delivery device.

37. A computer program as in claim 34, further comprising instructions for outputting a dose rate for the second drug.

38. A computer program as in claim 34, further comprising instructions for receiving a drug delivery device reservoir size and for calculating a refill interval as a function of the reservoir size and the desired dose rates.

39. A computer program as in claim 34, further comprising instructions for calculating and outputting a bolus dose and volume for each drug in the mixture.

40. A computer program as in claim 34, further comprising instructions for outputting the calculations used in the calculating of claim 34.

41. A computer program for execution in a computer device for providing information about a decision to mix at least a first drug and a second drug in a drug delivery device having a fixed flow rate, the program comprising instructions for:

receiving the fixed flow rate;

receiving a desired dose rate and an initial concentration for the first drug;

receiving a desired dose rate and an initial concentration for the second drug;

receiving a desired drug mixture volume for at least partial transfer to the drug delivery device;

calculating a first drug volume, a second drug volume, and a diluent volume to combine in the drug mixture, wherein the first drug, second drug, and diluent volumes are consistent with the desired first and second drug dose rates when delivered at the fixed flow rate, and combine to substantially fill the desired mixture volume;

calculating the first drug true concentration in the drug mixture; and

outputting the calculated first drug, second drug, and diluent volumes and the first drug true concentration in the mixture.

42. A computer program as in claim 41, further comprising instructions for calculating a second drug true concentration.

43. A computer program as in claim 41, further comprising instructions for calculating and outputting a dose rate for the second drug.

44. A computer program as in claim 41, further comprising instructions for receiving a drug delivery device reservoir size and for calculating and outputting a refill interval for the drug delivery device.

45. A computer program as in claim 41, further comprising instructions for outputting the calculations used in the calculating of claim 41.