Therapy management techniques for an implantable medical device

• US 6,799,149 B2
• Filed: 10/31/2001
• Issued: 09/28/2004
• Est. Priority Date: 12/29/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hartlaub, Jerome T.
• Primary Examiner(s): Barlow, John
• Assistant Examiner(s): LAU, TUNG S
• Application Number:
  US10/000,712
• Publication Number:
  US 20020087114A1
• Time in Patent Office: 1,063 Days
• Field of Search: 702/188, 607/60, 607/486, 607/18, 607/30, 604/65, 600/5, 600/410, 600/300, 600/486, 600/487, 705/2, 700/2, 340/573
• US Class Current: 702/188
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• 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

Disclosed is a method and apparatus for automatically adjusting drug infusion rate to optimize treatment therapy. The implantable medical device communicates with a database or algorithm controlled by a caregiver or physician. Thus, the caregiver may request a therapy change (e.g., infusion rate versus time, pump clock settings, etc.) or a therapy management module may automatically activate the therapy change at some future time for convenience, or for technical or clinical reasons.

Claims

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

(a) a therapy management module for determining management of medical therapy based upon the performance parameter from the therapy monitor module;

(b) a memory for storing therein the therapy management module; and

(c) a telemetry module providing bi-directional communication between the computing device and the implantable device,

wherein the computing device is operatively coupled to an Internet.

2. The computing device of claim 1, wherein the therapy management module includes a therapy management algorithm to manage the therapy to the patient.

3. The computing device of claim 1, wherein the therapy management module determines management of medical therapy based upon at least one requirement parameter and the memory stores therein the and at least one requirement parameter.

4. The computing device of claim 1, wherein the performance parameter is selected from the group consisting of drug flow rate, drug quantity in reservoir, drug type, and drug usage.

5. The computing device of claim 1, wherein the therapy management module makes determinations selected from the group consisting of reprogramming the implantable device, warning an entity of the therapy, and changing drug formulation.

6. The computing device of claim 1, wherein the computing device communicates via the Internet with an entity regarding any determinations made by the therapy management module.

7. The computing device of claim 3, wherein the requirement parameter stored in the memory is selected from the group consisting of device manufacturer requirements, patient requirements, and physician requirements.

8. The computing device of claim 4, wherein the drug usage is selected from the group consisting of drug quantity consumed, rate of drug quantity consumed, and estimated date of drug exhaustion.

9. The computing device of claim 6, wherein the entity is selected from the group consisting of a patient, a caregiver, a physician, a hospital, a pharmacy, an insurance provider, a device manufacturer, and a database.

27. The computing device of claim 1, wherein the therapy management module is capable of contacting at least one entity, wherein the entity is selected from the group consisting of a pharmacy, a caregiver, a physician, a hospital, and the patient.

10. A computing device in communication with an implantable device for delivering therapy a patient, the device having a therapy monitor module configured to monitor at least one performance parameter, the computing device comprising in combination:

(a) a therapy management module for determining management of medical therapy based upon the performance parameter from the therapy monitor module wherein the therapy management module is capable of contacting at least one entity, wherein the entity is selected from the group consisting of a pharmacy, a caregiver, a physician, a hospital, and the patient;

(b) a memory for storing therein the therapy management module and at least one requirement parameter; and

(c) a telemetry module providing bi-directional communication between the computing device and the implantable device.

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

(a) an implantable device comprising;

(i) a housing;

(ii) electronics contained in the housing for adjusting the therapy provided by the implantable device;

(iii) a telemetry module coupled to the electronics for providing bi-directional communication between the delivery device and an external programmer;

(iv) a first memory coupled to the electronics; and

(v) a therapy monitor module coupled to the electronics, the therapy monitor configured to monitor at least one performance parameter; and

(b) an external programmer comprising

(i) a second memory for storing at least one requirements parameter;

(ii) a telemetry module providing bi-directional communication between the external programmer and the implantable device;

(iii) a therapy management module stored in the second memory for determining management of the medical therapy provided by the implantable device; and

(iv) an interface for coupling the external programmer to at least one entity via a computing network.

12. The system of claim 11, wherein the therapy management module determines management based on the performance parameter and the requirements parameter.

13. The system of claim 11, wherein the therapy management module includes a therapy management algorithm to manage the therapy to the patient.

14. The system of claim 11, wherein the entity is selected from the group consisting of a patient, a caregiver, a physician, a hospital, a pharmacy, an insurance provider, a device manufacturer, and a database.

15. The system of claim 11, wherein the therapy management module makes determinations selected from the group consisting of reprogramming the implantable device, warning an entity of the therapy, and changing drug formulation.

16. The system of claim 11, wherein the external programmer communicates via the Internet with an entity regarding any determinations made by the therapy management module.

17. The system of claim 12, wherein the requirements parameter is selected from the group consisting of device manufacturer requirements, patient requirements, and physician requirements.

18. The system of claim 12, wherein the performance parameter is selected from the group consisting of drug flow rate, drug quantity in reservoir, drug type, and drug usage.

19. The system of claim 18, wherein the drug usage is selected from the group consisting of drug quantity consumed, rate of drug quantity consumed, and estimated date of drug exhaustion.

20. A method for reporting performance data of an implantable drug delivery device, comprising:

(a) establishing patient parameters;

(b) establishing a base therapy;

(c) performing the base therapy;

(d) acquiring patient data related to the base therapy;

(e) calculating at least one relationship among the patient parameters, base therapy, and patient data;

(f) deciding whether a therapy issue should be reported; and

(g) reporting the therapy issue from the implantable drug delivery device to an entity via an Internet.

21. Computer executable instructions for performing the steps recited in claim 20.

22. The method of claim 20, wherein the step of deciding whether a therapy issue should be reported is performed by a therapy management algorithm.

23. The method of claim 20, wherein the step of reporting comprises the step of reporting to an entity selected from the group consisting of a patient, a caregiver, a physician, a hospital, a pharmacy, an insurance provider, a device manufacturer, and a database.

24. A method for reporting performance data of an implantable drug delivery device, comprising:

(a) establishing patient parameters;

(b) establishing a base therapy;

(c) performing the base therapy;

(d) acquiring patient data related to the base therapy;

(e) calculating at least one relationship among the patient parameters, base therapy, and patient data;

(f) deciding whether a therapy issue should be reported; and

(g) reporting the therapy issue from the implantable drug delivery device into a communications medium, wherein the step of reporting the therapy issue includes the step of contacting a party selected from the group consisting of a pharmacy, a caregiver, a physician, a hospital, and the patient.

25. The method of claim 24, wherein the step of contacting is performed via a computing network.

26. The method of claim 24, wherein the step of contacting is performed via an Internet.