Drug Delivery Safety System

• US 20090043290A1
• Filed: 08/09/2007
• Published: 02/12/2009
• Est. Priority Date: 08/09/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medallion Therapeutics, Inc.
• Inventors: Shelton, Brian Michael, Gibson, Scott Robert, Villegas, Daniel Hernandez
• Granted Patent: US 8,683,381 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• 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 drug delivery safety system, comprising:

a programmer including a display and a communications device adapted to communicate with an ambulatory medical device, the programmer having access to a database of information, the programmer being 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.

2. The drug delivery safety system of claim 1, wherein the ambulatory medical device is an implantable medical device.

3. The drug delivery safety system of claim 1, wherein the ambulatory medical device is an implantable drug pump.

4. The drug delivery safety system of claim 1, wherein the information is clinic-specific.

5. The drug delivery safety system of claim 1, wherein the information is patient-specific.

6. The drug delivery safety system of claim 1, wherein the programmer is adapted to deny a requested drug delivery protocol that is not clinician-approved.

7. The drug delivery safety system of claim 1, wherein the programmer is adapted to limit a requested drug delivery protocol that is not clinician-approved to conform with the clinician-approved drug delivery protocol.

8. The drug delivery safety system of claim 1, wherein the programmer is adapted to control the graphical user interface to prompt the user for a verification of a requested change to the drug delivery protocol.

9. The drug delivery safety system of claim 8, wherein the requested change is a therapeutic change.

10. The drug delivery safety system of claim 8, wherein the requested change is a concentration change.

11. The drug delivery safety system of claim 8, wherein the requested change is a rate change.

12. The drug delivery safety system of claim 1, wherein the programmer is adapted to control 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 drug delivery safety system 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 drug delivery safety system of claim 1, wherein the programmer is adapted to control the graphical user interface to generate a warning to the user that the requested change to the drug delivery protocol is not clinician-approved.

15. The drug delivery safety system 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 drug delivery safety system of claim 15, wherein the dosage is a daily dosage.

17. The drug delivery safety system of claim 15, wherein the dosage is a Patient Controlled Analgesia (PCA) dosage.

18. The drug delivery safety system of claim 15, wherein the permitted change is a fixed percentage increase.

19. The drug delivery safety system of claim 15, wherein the permitted change is a fixed percentage decrease.

20. The drug delivery safety system of claim 15, wherein the permitted change is approximately 20%.

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

22. The drug delivery safety system of claim 21, wherein the maximum rate limit is a maximum basal rate.

23. The drug delivery safety system of claim 21, wherein the maximum rate limit is a maximum temporary rate.

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

25. The drug delivery safety system of claim 14, wherein the warning prompts the user to indicate whether the user wishes to override the warning.

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

28. The drug delivery safety system of claim 1, wherein the programmer is adapted to control the graphical user interface to generate a confirmation window relating to data that is to be written to the ambulatory medical device.

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

30. The drug delivery safety system of claim 28, wherein the confirmation window displays programming changes as highlighted.

31. The drug delivery safety system 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 ambulatory medical device.

32. A drug delivery safety system, comprising:

a programmer including a display and a communications device adapted to communicate with an implantable drug pump, the programmer having access to a database of therapeutic limits information relating to the implantable drug pump, the programmer being adapted to receive and process the therapeutic limits information and a user input relating to a requested change to a drug delivery protocol currently associated with the implantable drug pump, and to control the display to provide an indication of an estimated date in which the implantable drug pump will experience a low reservoir condition.

33. The drug delivery safety system of claim 32, wherein the requested change is to a daily dosage.

34. The drug delivery safety system of claim 32, wherein the programmer is adapted to control the display to generate a graphical user interface.

35. The drug delivery safety system of claim 34, wherein the graphical user interface includes a field in which the indication of an estimated date is presented.

36. The drug delivery safety system of claim 34, wherein the graphical user interface provides a graphical indication of a reservoir volume for the implantable drug pump.

37. The drug delivery safety system of claim 36, wherein the graphical indication is a gage.

38. The drug delivery safety system of claim 34, wherein the graphical user interface allows a user of the programmer to input a parameter associated with the drug delivery protocol.

39. The drug delivery safety system of claim 38, wherein the programmer controls the graphical user interface to automatically update the indication of an estimated date depending upon the parameter.

40. The drug delivery safety system of claim 38, wherein the parameter specifies a daily dosage volume.

41. The drug delivery safety system of claim 34, wherein the graphical user interface includes a button which can be actuated by a user of the programmer to request a standard refill for the implantable drug pump.