Drug delivery safety system

• US 9,440,023 B2
• Filed: 03/24/2014
• Issued: 09/13/2016
• Est. Priority Date: 08/09/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medallion Therapeutics, Inc.
• Inventors: Villegas, Daniel Hernandez, Shelton, Brian Michael, Gibson, Scott Robert
• Primary Examiner(s): PITARO, RYAN F
• Application Number:
  US14/223,828
• Publication Number:
  US 20140207122A1
• Time in Patent Office: 904 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.

Claims

1. A method of controlling a drug delivery safety system, said system having an implantable infusion pump configured to facilitate Patient Controlled Analgesia (PCA) and including a medication reservoir for holding one or more medications, and a programmer including a display and a communications device adapted to communicate with the implantable infusion pump, the method comprising:

accessing at or via the programmer a database of information comprising a list of clinician-approved medications and associated clinician-approved drug delivery protocols; and

utilizing the programmer to receive and process a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug mixture containing at least one medication that is not already stored in the database as a clinician-approved medication.

2. The method of claim 1, further comprising:

refilling the medication reservoir while the implantable infusion pump is within the patient.

3. The method of claim 1, further comprising:

controlling the graphical user interface to display, in response to requests to refill the implantable infusion pump, a list of clinician-approved medications in the database of information for the implantable infusion pump and an option to use or specify a drug that is not on the list.

4. The method of claim 1, wherein the information is clinic-specific.

5. The method of claim 1, wherein the information is patient-specific.

6. The method of claim 1, further comprising:

denying a requested drug delivery protocol that is not clinician-approved.

7. The method of claim 1, further comprising:

limiting a requested drug delivery protocol that is not clinician-approved to conform with the clinician-approved drug delivery protocol.

8. The method of claim 1, further comprising:

controlling the graphical user interface to prompt the user for a verification of a requested change to a drug delivery protocol.

9. The method of claim 8, wherein the requested change is a therapeutic change.

10. The method of claim 8, wherein the requested change is a concentration change.

11. The method of claim 8, wherein the requested change is a rate change.

12. The method of claim 1, further comprising:

controlling the graphical user interface to prompt the user for a verification of a request to add a new drug delivery protocol to the database.

13. The method of claim 12, wherein the new drug delivery protocol is for a new drug that is not already associated with any clinician-approved drug delivery protocol stored in the database.

14. The method of claim 1, further comprising:

controlling the graphical user interface to generate a warning to the user that the requested change to a drug delivery protocol is not clinician-approved.

15. The method of claim 14, wherein the warning is generated when the requested change exceeds a permitted change to a dosage for a particular drug.

16. The method of claim 15, wherein the dosage is a daily dosage.

17. The method of claim 15, wherein the dosage is a Patient Controlled Analgesia (PCA) dosage.

18. The method of claim 15, wherein the permitted change is a fixed percentage increase.

19. The method of claim 15, wherein the permitted change is a fixed percentage decrease.

20. The method of claim 15, wherein the permitted change is approximately 20%.

21. The method of claim 14, wherein the warning is generated when the requested change exceeds a maximum rate limit for a particular drug.

22. The method of claim 21, wherein the maximum rate limit is a maximum basal rate.

23. The method of claim 21, wherein the maximum rate limit is a maximum temporary rate.

24. The method of claim 21, wherein the maximum rate limit is a maximum Patient Controlled Analgesia (PCA) bolus rate.

25. The method of claim 14, wherein the warning prompts the user to indicate whether the user wishes to override the warning.

26. The method of claim 14, wherein the warning prompts the user to indicate whether the user wishes to modify the clinician-approved drug delivery protocol.

27. The method of claim 14, wherein the warning prompts the user to indicate whether the user wishes to create a new drug delivery protocol.

28. The method of claim 1, further comprising:

controlling the graphical user interface to generate a confirmation window relating to data that is to be written to the implantable infusion pump.

29. The method of claim 28, wherein the confirmation window displays both previous and new values for a drug delivery protocol.

30. The method of claim 28, wherein the confirmation window displays programming changes as highlighted.

31. The method of claim 28, wherein the confirmation window prompts the user to indicate whether the user wishes to accept programming changes before data is written to the implantable infusion pump.

33. The method of claim 1, further comprising:

controlling the graphical user interface to indicate, in relation to an attempt to enable a Patient Controlled Analgesia (PCA) dosage, medication defined not to be suitable for PCA in a clinical formulary.

34. The method of claim claim 1, further comprising:

controlling the graphical user interface to indicate, in relation to an attempt to enable a Patient Controlled Analgesia (PCA) dosage, a requested PCA dosage which is not less than an allowed threshold percentage.

35. The method of claim 34, wherein the allowed threshold percentage is a percentage of a Base Dose.

36. The method of claim 34, wherein the graphical user interface includes a field which, when actuated, confirms a request by the user for a particular PCA dosage.

37. The method of claim 1, wherein the graphical user interface includes a field which when actuated verifies that PCA is allowed for the requested medication.

38. The method of claim 1, further comprising:

providing confirmation dialogs relating to requested PCA dosages.

39. The method of claim 1, further comprising:

preventing users of the s stem from enabling PCA when at least one of the medications in the drug mixture has been defined not to be suitable for PCA.

40. The method of claim 1, further comprising:

preventing users of the system from configuring a PCA Bolus rate which exceeds a threshold rate.

32. A method of controlling a drug delivery safety system, said system having an implantable infusion pump containing a mixture of medications, the implantable infusion pump being configured to facilitate Patient Controlled Analgesia (PCA), and a programmer including a display and a communications device adapted to communicate with the implantable infusion pump, the method comprising:

accessing at or via the programmer a database of information comprising a list of clinician-approved medications and associated clinician-approved drug delivery protocols; and

utilizing the programmer to receive and process a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol that is not already stored in the database as a clinician approved drug delivery protocol.

41. The method of claim 32, wherein the requested drug delivery protocol involves one or more of

exceeding the maximum daily dose for at least one drug in the drug mixture,

exceeding the maximum base rate at least one drug in the drug mixture, and

exceeding the maximum concentration for at least one drug in the drug mixture.

42. A method of controlling a drug delivery safety system, said system having an implantable infusion pump configured to facilitate Patient Controlled Analgesia (PCA) and including a medication reservoir for holding one or more medications, and a programmer including a display and a communications device adapted to communicate with the implantable infusion pump, the method comprising:

accessing at or via the programmer a database of information comprising a list of clinician-approved medications and associated drug delivery protocols; and

utilizing the programmer to receive and process a user input and to control the display to provide a warning or indication when the user input requests a refill of the medication reservoir with a drug mixture containing at least one medication that is not associated with a clinician-approved drug delivery protocol stored in the database.