Quantifying hemodynamic response to drug therapy using implantable sensor

• US 20070065363A1
• Filed: 05/10/2006
• Published: 03/22/2007
• 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: Dalal, Yousufali, Brockway, Marina, Kuenzler, Richard
• Granted Patent: US 7,927,284 B2
• Time in Patent Office: Days
• US Class Current: 424/9.100
• 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 method, comprising:

delivering a drug therapy to a patient;

acquiring sensor data using an implantable medical device; and

quantifying a hemodynamic response of the patient to the drug therapy using the acquired sensor data.

2. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises quantifying a sensitivity of the patient'"'"'s hemodynamic response to the drug therapy.

3. The method of claim 1, wherein:

delivering the drug therapy comprises delivering a predetermined dosage of a drug at a known time to the patient; and

quantifying the hemodynamic response of the patient comprises quantifying patient sensitivity to the drug delivered at the predetermined dosage and known time using the acquired sensor data.

4. The method of claim 1, wherein:

delivering the drug therapy comprises determining information concerning the drug delivery using acquired sensor data and detecting patient response to the drug therapy; and

quantifying the hemodynamic response of the patient comprises quantifying patient sensitivity to the drug delivered based on the determined information.

5. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises indicating a degree of patient refractoriness to the drug therapy.

6. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises trending the acquired sensor data.

7. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises:

generating a trending curve using the acquired sensor data; and

fitting an n^th-order polynomial to the trending curve, where n is an integer greater than or equal to 1.

8. The method of claim 7, wherein a highest order coefficient of the n^th-order polynomial is used to indicate an extent of trending curve flattening, wherein trending curve flattening is indicative of reduced sensitivity of the patient'"'"'s hemodynamic response to the drug therapy.

9. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises:

generating a trending curve using the acquired sensor data;

fitting an n^th-order polynomial to the trending curve, where n is an integer greater than or equal to 1; and

ensemble averaging the fitting curve to cumulatively monitor the change in drug sensitivity over days, weeks, or months of drug therapy.

10. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises:

generating a trending curve using the acquired sensor data;

fitting an n^th-order polynomial to the trending curve, where n is an integer greater than or equal to 1; and

comparing 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.

11. The method of claim 1, wherein quantifying the hemodynamic response of the patient comprises calculating a rate of change in acquired sensor data from pre- to post-drug therapy.

12. The method of claim 1, wherein quantifying the hemodynamic response of the patient is performed within the implantable medical device.

13. The method of claim 1, wherein quantifying the hemodynamic response of the patient is performed using a patient-external system.

14. The method of claim 1, comprising monitoring for drug therapy compliance of the patient using the quantified hemodynamic response of the patient to the drug therapy.

15. The method of claim 1, wherein delivering the drug therapy to the patient comprises delivering the drug therapy using an implantable drug delivery device.

16. The method of claim 1, comprising adjusting the drug therapy delivered to the patient based on the quantified hemodynamic response of the patient to the drug therapy.

17. The method of claim 1, comprising informing one or both of a clinician and the patient of the patient'"'"'s hemodynamic status based on the quantified hemodynamic response of the patient to the drug therapy.

18. The method of claim 1, comprising alerting one or both of a clinician and the patient of a need for drug therapy adjustment based on the quantified hemodynamic response of the patient to the drug therapy.

19. The method of claim 1, wherein the implantable medical device comprises a sensor arrangement configured to measure one or a plurality of hemodynamic parameters of the patient.

20. The method of claim 1, wherein the implantable medical device comprises a sensor arrangement configured to measure one or more of internal filling blood pressure, blood flow, and blood temperature.

21. The method of claim 1, wherein the implantable medical device comprises a sensor arrangement configured to measure one or more blood chemicals.

22. The method of claim 1, wherein the implantable medical device comprises a sensor arrangement configured to measure electrical activity of the patient'"'"'s heart.

23. The method of claim 1, wherein the implantable medical device comprises a sensor arrangement configured to measure impedance changes within the patient.

24. The method of claim 1, wherein the implantable medical device comprises a sensor arrangement configured to measure heart sounds.

25. A system for monitoring a patient'"'"'s hemodynamic response to a drug therapy, the system comprising:

an implantable medical device comprising a sensor arrangement configured to acquire sensor data; and

a processor coupled to the sensor arrangement, the processor configured to quantify a hemodynamic response of the patient to the drug therapy using the acquired sensor data.

26. The system of claim 25, wherein the processor is disposed within the implantable medical device.

27. The system of claim 25, wherein the processor is disposed within a patient-external system.

28. The system of claim 25, comprising an implantable drug delivery device configured to deliver the drug therapy.

29. A system for monitoring a patient'"'"'s hemodynamic response to a drug therapy, the system comprising:

means for acquiring sensor data from within the patient'"'"'s body; and

means for quantifying a hemodynamic response of the patient to the drug therapy using the acquired sensor data.

30. The system of claim 29, further comprising means for delivering the drug therapy from within the patient.