Non-conformance monitoring and control techniques for an implantable medical device

• US 7,054,782 B2
• Filed: 10/31/2001
• Issued: 05/30/2006
• Est. Priority Date: 12/29/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hartlaub, Jerome T.
• Primary Examiner(s): Bui, Bryan
• Assistant Examiner(s): Lau, Tung S.
• Application Number:
  US10/001,357
• Publication Number:
  US 20020087115A1
• Time in Patent Office: 1,672 Days
• Field of Search: 702/188, 702/41, 702/181, 702/113, 702/141, 702/38, 604/65, 604/132, 604/66, 602/86, 204/547, 204/454, 204/450, 166/53, 435/40.5, 435/40, 435/6, 600/316, 600/309, 600/366, 600/486, 600/500, 514/44, 417/474, 705/2, 422/70, 601/294, 607/28, 607/9, 607/17, 607/6, 607/24, 382/128, 436/135
• US Class Current: 702/138
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• 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 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Disclosed is a method and apparatus for determining whether an implantable drug delivery device is conforming to the performance requirements of the device or the needs of the patient. The system includes an implantable drug delivery device having stored therein at least one drug, a nonconformance monitor module monitoring pump parameters, an external programmer in telemetric communication with the implantable drug delivery device and having a nonconformance management module for determining whether the the device is conforming to performance requirements, and to determine what action should be taken if non-conformance is determined. If the nonconformance management module identifies nonconformance, it determines what action should be taken for the particular non-conformance. The nonconformance management module will either invoke a pump programming change, or schedule and appointment or notify the patient that a non-programming change should be made.

Claims

1. A computing device in communication with an implantable drug delivery device for delivering at least one drug to a patient, the drug delivery device having a reservoir containing at least one drug and a nonconformance monitor module configured to monitor at least one performance parameter, the computing device comprising in combination:

(a) a memory having stored therein pump performance acquisition instructions;

(b) a telemetry module providing bi-directional communication between the computing device and the implantable drug delivery device and providing the pump performance acquisition instructions to the implantable drug delivery device and receiving pump performance data from the implantable drug delivery device, the pump performance data is selected from the group consisting of pump reservoir pressure, fluid outlet pressure, propellant pressure, fluid flow rate, battery current drain, motor current drain, motor drive current profile, battery voltage, and physiologic sensor output level; and

(c) a nonconformance management module contained within the memory receiving the pump performance data and determining whether the pump is conforming to performance requirements, and determining what action should be taken if non-conformance is determined.

2. The computing device of claim 1, wherein the memory includes patient performance requirements information.

3. The computing device of claim 1, wherein the memory includes pump manufacturer requirements information.

4. The computing device of claim 1, wherein the memory includes a scheduling module for scheduling an appointment to service the device.

5. The computing device of claim 4, wherein the scheduling module is capable of contacting at least one entity for the appointment, wherein the entity is selected from the group consisting of a pharmacy, a caregiver, a physician, a hospital, and the patient.

6. The computing device of claim 5, wherein the computing device is operatively coupled to the entity via a computing network.

7. The computing device of claim 6, wherein the computing network is an Internet.

8. The computing device of claim 1, wherein the nonconformance management module further determines whether the pump performance data is indicative of a non-programming change to the pump.

9. The computing device of claim 8, wherein the nonconformance management module further performs the non-programming change to the pump.

10. The computing device of claim 1, wherein the nonconformance management module further determines whether the pump performance data is indicative of a programming change to the pump.

11. The computing device of claim 10, wherein the nonconformance management module further performs the programming change to the pump.

12. The computing device of claim 10, wherein the nonconformance management module reports the pump performance data to an external device through the telemetry module.

13. The computing device of claim 1, further comprising:

a storage device that receives an event indication that is associated with the pump performance data.

14. The computing device of claim 1, wherein the pump performance data comprises pump reservoir pressure.

15. The computing device of claim 1, wherein the pump performance data comprises fluid outlet pressure.

16. The computing device of claim 1, wherein the pump performance data comprises propellant pressure.

17. The computing device of claim 1, wherein the pump performance data comprises fluid flow rate.

18. The computing device of claim 1, wherein the pump performance data comprises battery current drain.

19. The computing device of claim 1, wherein the pump performance data comprises motor current drain.

20. The computing device of claim 1, wherein the pump performance data comprises motor drive current profile.

21. The computing device of claim 1, wherein the pump performance data comprises battery voltage.

22. The computing device of claim 1, wherein the pump performance data comprises physiologic senor output.

23. An implantable drug delivery device having performance data reporting capability comprising in combination:

(a) a memory having stored therein pump performance acquisition instructions;

(b) at least one nonconformance monitor module for monitoring at least one pump operation variable in accordance with the pump performance acquisition instructions to produce pump performance data, wherein the pump operation variable is selected from the group consisting of pump reservoir pressure, fluid outlet pressure, propellant pressure, fluid flow rate, battery current drain, motor current drain, motor drive current profile, battery voltage, and physiologic sensor output level; and

(c) a non-conformance management module receiving the pump performance data, determining whether the pump is conforming to performance requirements, and determining what action should be taken if non-conformance is determined.

24. The implantable drug delivery device of claim 23, further comprising:

(d) at least one reporting module to report the pump performance data via telemetry to an external device.

25. The implantable drug delivery device of claim 23, wherein the memory has stored therein patient performance requirements information that is also received by the non-conformance management module.

26. The implantable drug delivery device of claim 23, wherein the memory has stored therein pump telemetry data that is also received by the non-conformance management module.

27. An implantable drug delivery device having performance data reporting capability comprising in combination:

(a) a memory having stored therein pump performance acquisition instructions;

(b) at least one nonconformance monitor module for monitoring at least one pump operation variable in accordance with the pump performance acquisition instructions to produce pump performance data, wherein the pump performance data is selected from the group consisting of pump reservoir pressure, fluid outlet pressure, propellant pressure, fluid flow rate, battery current drain, motor current drain, motor drive current profile, battery voltage, and physiologic sensor output level; and

(c) a non-conformance management module receiving the pump performance data, determining whether the pump is conforming to performance requirements, and determining what action should be taken if non-conformance is determined.

28. The implantable drug delivery device of claim 27, wherein the non-conformance management module further determines whether the pump performance data is indicative of a non-programming change to the implantable drug delivery device.

29. The implantable drug delivery device of claim 28, wherein the non-conformance management module further performs the non-programming change to the implantable drug delivery device.

30. The implantable drug delivery device of claim 27, wherein the non-conformance management module further determines whether the pump performance data is indicative of a programming change to the implantable drug delivery device.

31. The implantable drug delivery device of claim 30, wherein the non-conformance management module further performs the programming change to the implantable drug delivery device.

32. The implantable drug delivery device of claim 27, further comprising:

(d) at least one reporting module to report the pump performance data via telemetry to an external device.

33. The implantable drug delivery device of claim 27, wherein the memory has stored therein patient performance requirements information that is also received by the non-conformance management module.

34. The implantable drug delivery device of claim 27, wherein the memory has stored therein pump telemetry data that is also received by the non-conformance management module.

35. The implantable drug delivery device of claim 27, further comprising:

(d) at least one reporting module to report the pump performance data via telemetry to an external device.

36. The implantable drug delivery device of claim 27, wherein the memory has stored therein pump telemetry data that is also received by the non-conformance management module.

37. An implantable drug delivery device having performance data reporting capability comprising in combination:

(a) a memory having stored therein pump performance acquisition instructions;

(b) at least one nonconformance monitor module for monitoring at least one pump operation variable in accordance with the pump performance acquisition instructions to produce pump performance data; and

(c) a non-conformance management module receiving the pump performance data, determining whether the pump is conforming to performance requirements, and determining what action should be taken if non-conformance is determined, wherein the memory has stored therein pump manufacturer requirements information that is a so received by the non-conformance management module.

38. The implantable drug delivery device of claim 37, wherein the memory has stored therein patient performance requirements information that is also received by the non-conformance management module.