Drug titration utilizing an implantable medical device

• US 8,043,215 B2
• Filed: 08/07/2007
• Issued: 10/25/2011
• Est. Priority Date: 08/07/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yi, Zhang, Yunlong
• Primary Examiner(s): Mallari; Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/834,792
• Publication Number:
  US 20090043289A1
• Time in Patent Office: 1,540 Days
• Field of Search: 604/891.1, 604502-507, 600/301
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

A method for titrating a drug to provide a medical therapy to a patient. The method includes the steps of providing an implantable medical device having a controller, providing one or more implantable sensors configured to sense physical parameters of the patient and configured to transmit signals to the controller. The method further includes the step of receiving signals from the one or more sensors at the controller. The method additionally includes processing the received signals to determine at least two cardiopulmonary characteristics of the patient. The method also includes determining a composite index based on the at least two cardiopulmonary characteristics. In addition, the method includes generating a signal based on the composite index. Medical device systems are also disclosed.

Claims

1. A method comprising:

(i) providing an implantable medical device having a controller;

(ii) providing one or more implantable sensors configured to sense physical parameters of the patient and configured to transmit signals to the controller;

(iii) receiving signals from the one or more sensors at the controller;

(iv) processing the received signals to determine at least two cardiopulmonary characteristics of the patient;

(v) determining a composite index based on the at least two cardiopulmonary characteristics; and

(vi) generating a signal based on the composite index by a controller, where the signal provides an indication of the effectiveness of a beta-blocker or side effects of the beta blocker.

2. The method of claim 1, further comprising the step of assigning an index value to each cardiopulmonary characteristic based on its nature or degree.

3. The method of claim 1, where the implantable sensor is a blood pressure sensor.

4. The method of claim 1, where the implantable sensor is a respiration sensor.

5. The method of claim 4, where the respiration sensor is an intra-thoracic impedance sensor.

6. The method of claim 1, where the implantable sensor is an electrocardiogram sensor that receives cardiac electrical signals.

7. The method of claim 1, where processing the signals includes determining a heart rate from a cardiac electrical signal.

8. The method of claim 1, where processing the signals includes determining the presence and degree of arrhythmias.

9. The method of claim 1, where processing the signals includes determining mean arterial pressure.

10. The method of claim 1, where processing the signals includes determining pulmonary edema status.

11. The method of claim 1, where processing the signals includes determining the presence and degree of dyspnea.

12. The method of claim 1, where processing the signals includes determining CSR/AHI burden.

13. The method of claim 1, further comprising providing a non-implantable sensor that is configured to transmit signals.

14. The method of claim 1, where the one or more implantable sensors comprises a sensor for determining a patient'"'"'s posture and activity level, and where the step of determining a composite index occurs only when the sensor indicates that the patient is in a pre-selected state.

15. The method of claim 14, where the pre-selected state corresponds to the patient being at rest and supine.

16. The method of claim 1, further comprising the step of determining if a scheduled titration event timing has been exceeded, and if so, generating a signal that is indicative of the fact that the schedule titration event timing has been exceeded.

17. The method of claim 1, where the step of processing the received signals to determine at least two cardiopulmonary characteristics of the patient occurs in the controller.

18. The method of claim 1, further comprising the step of providing a second, non-implantable controller.

19. The method of claim 18, where the step of processing the received signals to determine at least two cardiopulmonary characteristics of the patient occurs in the second, non-implantable controller.

20. A medical device system for use with a drug titration protocol, the medical device system comprising:

(i) an implantable controller;

(ii) one or more implantable sensors configured to sense physical parameters of the patient and configured to transmit signals to the controller; and

(iii) wherein the system is configured to

(a) receive signals from the one or more sensors and process the received signals to determine at least two cardiopulmonary characteristics of the patient;

(b) determine a composite index based on the at least two cardiopulmonary characteristics; and

(c) generate a signal based on the composite index, where the signal provides an indication of the effectiveness of a beta-blocker or side effects of the beta blocker.

21. The medical device system of claim 20, wherein the system is further configured to assign an index value to each cardiopulmonary characteristic based on its nature or degree.

22. The medical device system of claim 20, where processing a signal includes determining the presence and degree of arrhythmia.

23. The medical device system of claim 20, where processing a signal includes determining mean arterial pressure.

24. The medical device system of claim 20, where processing a signal includes determining pulmonary edema status.

25. The medical device system of claim 20, where processing a signal includes determining the presence and degree of dyspnea.

26. The medical device system of claim 20, where processing a signal includes determining Cheyne-Stokes Respiration/Apnea Hypopnea Index burden.

27. The medical device system of claim 20, where the implantable sensor is an electrocardiogram sensor that receives cardiac electrical signals.

28. The medical device system of claim 27, where processing a signal includes determining a resting heart rate from a cardiac electrical signal.

29. A medical device system for use with a drug titration protocol, the medical device system comprising:

(i) an implantable controller;

(ii) a plurality of implantable sensors configured to sense physical parameters of the patient and configured to transmit signals to the controller, the plurality of implantable sensors including at least;

(a) an electrocardiogram sensor that receives cardiac electrical signals;

(b) a blood pressure sensor; and

(c) an intra-thoracic impedance sensor; and

(iii) wherein the controller is configured to

(a) receive signals from the plurality of sensors and process the received signals to determine associated physical characteristics of the patient, including determining;

(A) heart rate;

(B) mean arterial blood pressure;

(C) the presence and degree of atrio-ventricular block;

(D) pulmonary edema status;

(E) the presence and degree of dyspnea; and

(F) CSR/AHI burden;

(b) assign an index value to each physical characteristic based on its nature or degree;

(c) determine a composite index of physical characteristics by combining the individual index values; and

(d) generate a signal based on the composite index, where the signal provides an indication of side effects of a beta-blocker or the effectiveness of a beta-blocker.