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

• US 7,505,869 B2
• Filed: 02/21/2006
• Issued: 03/17/2009
• 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): Lau; Tung S
• Application Number:
  US11/358,607
• Publication Number:
  US 20060161376A1
• Time in Patent Office: 1,120 Days
• Field of Search: 702/182
• US Class Current: 702/182
• 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

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 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 system for providing treatment therapy to a patient comprising in combination:

(a) an implantable drug delivery device comprising;

(i) a housing;

(ii) at least one drug reservoir within the housing and each configured to contain at least one drug;

(iii) a flow control module configured to control a flow of drug from the drug reservoir through an infusion port;

(iv) electronics coupled to the flow control module and configured to adjust the flow of drug with the flow control module;

(v) a telemetry module coupled to the electronics and configured to provide bi-directional communication between the delivery device and an external programmer; and

(vi) a nonconformance monitor module coupled to the electronics, the nonconformance monitor module configured to monitor a pump outlet pressure and to generate pump performance data that includes the pump outlet pressure; and

(b) an external programmer comprising;

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

(ii) a telemetry module configured to provide bi-directional communication between the external programmer and the implantable drug delivery device and to provide the pump performance acquisition instructions to the implantable drug delivery device and configured to receive pump performance data from the implantable drug delivery device; and

(iii) a nonconformance management module stored in the memory, the nonconformance management module configured to determine whether the pump is conforming to performance requirements, based upon the pump performance data from the nonconformance monitor module, and to determine what action should be taken if non-conformance is determined.

2. The system of claim 1, further comprising:

(c) at least one server located at an entity selected from the group consisting of an insurance provider, a pharmacy, a hospital, a caregiver, a physician, and a device manufacturer; and

(d) a computing network coupling the external programmer to the at least one server.

3. The system of claim 1, wherein the memory of the external programmer further includes patient performance requirements information.

4. The system of claim 1, wherein the memory of the external programmer further includes pump manufacturer requirements information associated with pump outlet pressure values.

5. The system of claim 1, wherein the memory of the external programmer further includes a scheduling module for scheduling an appointment to perform a non-programming change.

6. The system of claim 5, 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 hospital, and the patient.

13. The system of claim 1, wherein the pump performance data further includes data corresponding to at least one selected from the group consisting of battery current drain, motor current drain and motor drive current profile.

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

(a) a housing;

(b) a drug reservoir carried in the housing configured to contain at least one drug;

(c) a flow control module coupled to the drug reservoir for controlling the flow of the drug from the drug reservoir through an infusion port;

(d) electronics coupled to the flow control and a power source;

(e) a telemetry module coupled to the electronics;

(f) a memory coupled to the electronics, the memory containing pump performance acquisition instructions;

(g) at least one monitoring module coupled to the memory and the electronics that is configured to monitor at least one pump operation variable according to the pump performance acquisition instructions to produce performance data, wherein the performance data is stored in the memory;

(h) a non-conformance management module configured to retrieve the performance data from memory and to determine whether the pump is conforming to performance requirements and to further determine what action should be taken if non-conformance is determined; and

(i) at least one reporting module coupled to the memory and the electronics, the reporting module configured to activate the telemetry module to report the performance data.

8. The implantable drug delivery device of claim 7, wherein the non-conformance management module is further configured to determine whether the pump performance data is indicative of a need for a non-programming change to the implantable drug delivery device.

9. The implantable drug delivery device of claim 7, wherein the non-conformance management module is further configured to determine whether the pump performance data is indicative of a programming change to the implantable drug delivery device.

10. The implantable drug delivery device of claim 7, wherein the pump performance data is selected from the group consisting of fluid outlet pressure, battery current drain, motor current drain, motor drive current profile, pump humidity and battery voltage.

11. The implantable drug delivery device of claim 7, wherein the non-conformance management module is configured to report the pump performance data to an external device through the telemetry module.

12. The implantable drug delivery device of claim 7, wherein the performance data includes at least one selection from the group consisting of pump humidity and pump outlet pressure.

14. The implantable drug delivery device of claim 8, wherein the non-conformance management module is further configured to initiate the non-programming change to the implantable drug delivery device.

15. The implantable drug delivery device of claim 9, wherein the non-conformance management module is further configured to perform the programming change to the implantable drug delivery device.