Systems and methods for drug therapy enhancement using expected pharmacodynamic models

• US 8,150,509 B2
• Filed: 10/21/2004
• Issued: 04/03/2012
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kadhiresan, Veerichetty, Brockway, Marina V., Carlson, Gerrard M.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US10/970,449
• Publication Number:
  US 20060089592A1
• Time in Patent Office: 2,721 Days
• Field of Search: 607/62, 607/4
• US Class Current: 607/4
• 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 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: Y10S 128/923 by comparison of patient data to other data

Abstract

A system or method including a device configured to measure at least one pharmacological effect of a drug on a patient. The measured pharmacological effect is compared to an expected pharmacodynamic model. The system can allow for real-time monitoring of positive and side-effects of drugs as well as drug resistance to optimize individual therapy. The system can also enable patient compliance monitoring.

Claims

1. A patient management system for monitoring a patient, the system comprising:

an implantable device configured to measure data associated with at least one pharmacological effect of a drug on the patient and comprising a cardiac rhythm management (CRM) device including one or more pacemakers or one or more cardioverter defibrillators;

a communication network;

a host including a database module, an analysis module, and a delivery module, the database module configured to receive and store the measured data through the communication network, the analysis module configured to compare the measured data to an expected pharmacodynamic model and to predict and determine issues or failures of the implantable device using the measured data, the delivery module configured to manage the implantable device through the communication network using the measured data, wherein the expected pharmacodynamic model is selected based on at least one characteristic of the patient selected from the group consisting of age, race, national origin, gender, and genetic factors;

a device configured to provide an alert using an outcome of the comparison of the measured data and the expected pharmacodynamic model; and

interrogator/transceiver units each including an interrogator configured to receive the measured data from the implantable device wirelessly and a transceiver configured to send the received measured data to the host through the communication network.

2. The system of claim 1, further comprising drug dispensers in communication with the interrogator/transceiver units, the drug dispensers each dispensing the drug and communicating a time that the drug is dispensed to the host.

3. The system of claim 2, wherein the drug dispensers comprise one or more implantable drug dispensers.

4. The system of claim 3, wherein the drug dispensers each dispense the drug based on a result of the comparison.

5. The system of claim 1, wherein the analysis module determines drug therapy regimen compliance based on a result of the comparison.

6. The system of claim 5, wherein the analysis module generates a compliance report based on the drug therapy regimen compliance.

7. The system of claim 1, wherein the analysis module identifies an unexpected effect based on a result of the comparison.

8. The system of claim 7, wherein the analysis module generates a side-effect report based on the unexpected effect.

9. The system of claim 7, wherein the analysis module generates a drug resistance report based on the unexpected effect.

10. The system of claim 7, wherein the analysis module generates an alarm based on the unexpected effect.

11. The system of claim 10, wherein the host communicates the alarm to the patient.

12. The system of claim 1, wherein the analysis module is configured to suggest modification of the drug therapy regimen based on a result of the comparison.

13. The system of claim 1, wherein the CRM device comprises the one or more pacemakers.

14. The system of claim 1, wherein the CRM device comprises the one or more cardioverter defibrillators.

15. The system of claim 1, wherein the pharmacological effect is at least one selected from the group consisting of activity level, weight, brachial and intracardiac or systemic blood pressure, heart rate, thoracic impedance, heart sounds, and heart rate variability.

16. The system of claim 1, wherein the analysis module creates the expected pharmacodynamic model for the patient based on the data measured.

17. The system of claim 1, wherein the analysis module automatically selects the expected pharmacodynamic model based on the data measured by the implantable device.

18. The system of claim 1, wherein the interrogator/transceiver units each comprise a hand-held device wirelessly coupled to the communication network.

19. The system of claim 1, further comprising an external device configured to measure and record subjective patient data.

20. The system of claim 1, wherein the analysis module comprises a patient analysis module configured to predict an oncoming event based on the measured data.

21. The system of claim 20, which delivers a therapy based on the predicted event.

22. The system of claim 21, wherein the event is a cardiovascular event.

23. The system of claim 1, further comprising a device configured to communicate with the implantable device and communicate with the patient using sound or visual prompts.

24. The system of claim 1, wherein the analysis module is configured to identify early degradation or imminent failure of the implantable device.