Quantifying hemodynamic response to drug therapy using implantable sensor

• US 7,927,284 B2
• Filed: 05/10/2006
• Issued: 04/19/2011
• Est. Priority Date: 09/16/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kuenzler, Richard O., Dalal, Yousufali H., Brockway, Marina
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US11/431,806
• Publication Number:
  US 20070065363A1
• Time in Patent Office: 1,805 Days
• Field of Search: 600/481, 600/483, 600/504
• US Class Current: 600/504
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Systems and methods provide for assessing a patient'"'"'s hemodynamic response to a drug therapy. A patient'"'"'s hemodynamic response to a drug therapy is monitored using sensor data acquired using one or more sensors. The patient'"'"'s hemodynamic response to the drug therapy is quantified, such as by quantifying a patient'"'"'s sensitivity or refractoriness to the drug therapy. The quantified data may be used to optimize a patient'"'"'s drug therapy, among other uses.

Claims

1. A system for monitoring drug therapy sensitivity with information concerning administration of a drug therapy to a patient and the patient'"'"'s hemodynamic response to the drug therapy, the system comprising:

an implantable sensor arrangement configured to acquire sensor data indicative of the patient'"'"'s hemodynamic response to the drug therapy; and

a processor configured to receive the sensor data and the information concerning administration of the drug therapy to the patient, the processor further configured to generate a trending curve based on the sensor data and the information concerning administration of the drug therapy and quantify a sensitivity of the hemodynamic response of the patient to the drug therapy using the trending curve, the processor configured to determine the information concerning delivery of the drug therapy to the patient based on the sensor data.

2. The system of claim 1, wherein the processor is disposed within an implantable medical device.

3. The system of claim 1, wherein the processor is disposed within a patient-external system.

4. The system of claim 1, wherein the processor is configured to quantify the sensitivity of the patient'"'"'s hemodynamic response to the drug therapy based on flattening of the trending curve, wherein trending curve flattening is indicative of reduced sensitivity of the patient'"'"'s hemodynamic response to the drug therapy.

5. The system of claim 1, wherein the processor is configured to fit an n^th-order polynomial to the trending curve as part of quantifying the sensitivity of the hemodynamic response of the patient to the drug therapy, wherein n is an integer greater than or equal to 1.

6. The system of claim 5, wherein the processor is configured to use a highest order coefficient of the n^th-order polynomial to indicate an extent of trending curve flattening to quantify the sensitivity of the hemodynamic response.

7. The system of claim 5, wherein the processor is configured to ensemble average the n^th-order polynomial to cumulatively monitor change in drug sensitivity over a period of time.

8. The system of claim 1, wherein the processor is configured to compare the trending curve to a trending curve previously generated during high patient sensitivity to a drug of the drug therapy or during initiation or calibration associated with sensor data acquisition.

9. The system of claim 1, wherein the processor is configured to determine a degree of patient refractoriness to the drug therapy based on the trending curve.

10. The system of claim 1, wherein the information concerning administration of the drug therapy to the patient comprises dosage and time of delivery of a drug to the patient.

11. The system of claim 1, further comprising an implantable drug delivery device configured to deliver the drug therapy.

12. The system of claim 11, wherein the sensor arrangement is coupled to the implantable drug delivery device.

13. The system of claim 11, wherein the implantable drug delivery device is a drug pump device.

14. The system of claim 11, wherein the processor is configured to adjust delivery of the drug therapy by the implantable drug delivery device based on the quantification of the sensitivity of the hemodynamic response of the patient.

15. The system of claim 1, wherein the processor is configured to identify a change in heart failure status of the patient based on the quantification of the sensitivity of the hemodynamic response of the patient.

16. The system of claim 1, wherein the trending curve represents days, weeks, or months of hemodynamic response data.

17. The system of claim 1, further comprising a user interface device in communication with the processor, wherein the processor is further configured to cause the user interface device to display an indication of the quantification of the sensitivity of the hemodynamic response of the patient to the drug therapy.

18. The system of claim 1, wherein the processor is configured to adjust the drug therapy delivered to the patient based on the quantification of the sensitivity of the hemodynamic response of the patient to the drug therapy.

19. The system of claim 1, wherein the processor is configured to generate an alert indicating a need for drug therapy adjustment based on the quantification of the hemodynamic response of the patient to the drug therapy.

20. The system of claim 1, wherein the implantable sensor arrangement is configured to sense internal filling blood pressure.

21. The system of claim 1, wherein the implantable sensor arrangement is configured to sense blood flow.

22. The system of claim 1, wherein the implantable sensor arrangement is configured to sense blood temperature.

23. The system of claim 1, wherein the implantable sensor arrangement is configured to measure one or more blood chemicals.

24. The system of claim 1, wherein the implantable sensor arrangement is configured to measure heart sounds.

25. The system of claim 1, wherein the drug therapy comprises administration of a diuretic.

26. A system for monitoring drug therapy sensitivity with information concerning administration of a drug therapy to a patient and the patient'"'"'s hemodynamic response to the drug therapy, the system comprising:

an implantable sensor arrangement configured to acquire sensor data indicative of the patient'"'"'s hemodynamic response to the drug therapy; and

a processor configured to receive the sensor data and the information concerning administration of the drug therapy to the patient, the processor further configured to generate a trending curve based on the sensor data and the information concerning administration of the drug therapy and quantify a sensitivity of the hemodynamic response of the patient to the drug therapy using the trending curve, the processor configured to monitor drug therapy compliance of the patient using the quantification of the sensitivity of the hemodynamic response of the patient to the drug therapy.