Methods for guiding heart failure decompensation therapy

• US 9,943,236 B2
• Filed: 09/30/2009
• Issued: 04/17/2018
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bennett, Tommy D., Cho, Yong K.
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/571,091
• Publication Number:
  US 20110077616A1
• Time in Patent Office: 3,121 Days
• Field of Search: 604 65- 67, 604503-505
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2210/125 Heart
• 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: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3655 controlled by body or blood temperature
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

An implantable medical device system and associated method for use in guiding an acute decompensated heart failure therapy set an optimal fluid status measurement level. A physiological sensor signal sensed by an implantable medical device is used to compute the fluid status measurement. A target rate of change of the fluid status measurement is computed for guiding the therapy.

Claims

1. An implantable medical device method, comprising:

setting an optimal level of a fluid status measurement of a volemic state of a patient;

sensing a physiological signal;

computing from the sensor signal the fluid status measurement;

administering a therapy;

establishing a target profile of a time-based curve of the fluid status measurement using an expected time period of the therapy, the fluid status measurement and the optimal level;

determining an actual profile of a time-based curve of the fluid status measurement during the therapy administration;

comparing the actual profile to the target profile; and

generating a notification if the actual profile of the fluid status measurement subsequent to initiating the administered therapy does not match the target profile.

2. The method of claim 1 further comprising displaying the computed fluid status measurement over time.

3. The method of claim 1 wherein setting the optimal fluid status measurement level comprises:

storing a fluid status measurement corresponding to acute decompensated heart failure events; and

computing the optimal fluid status measurement level in response to the stored fluid status measurement.

4. The method of claim 1 wherein setting the optimal fluid status measurement level comprises using a distribution of previously computed fluid status measurements.

5. The method of claim 1 wherein sensing the physiological sensor signal comprises sensing one of an impedance signal and a blood pressure signal.

6. The method of claim 1 wherein establishing the target profile of the fluid status measurement comprises establishing a duration of the therapy and a target change in the fluid status measurement during the duration of the therapy.

7. The method of claim 1 further comprising automatically adjusting the therapy administration in response to exceeding the target rate.

8. The method of claim 1 further comprising adjusting the therapy administration to maintain the actual profile of the fluid status measurement within a range of the target profile.

9. The method of claim 8 wherein adjusting the therapy administration to maintain the actual profile of the time-based curve of the fluid status measurement comprises adjusting the therapy to prevent the fluid status measurement from falling below the optimal level.

10. The method of claim 1 wherein the therapy comprises intravenous infusion of one of a diuretic and a vasodilator.

11. The method of claim 1 wherein computing the target profile comprises computing a first target rate of change over a first time period and second target rate of change over a second time period, the second target rate of change being different than the first target rate of change.

12. The method of claim 11 wherein the second target rate of change is slower than the first target rate of change and further comprising adjusting the therapy to maintain the actual rate of change within a range of the second target rate of change after the computed fluid status measurement reaches an intermediate fluid status measurement greater than the optimal fluid status measurement level.

13. The method of claim 1 wherein the fluid status measurement is a measurement or index derived from an implantable physiological sensor signal and is correlated to a blood volume of a patient.

14. The method of claim 1, wherein the fluid status measurement is an estimated pulmonary artery diastolic pressure.

15. An implantable medical device method, comprising:

setting an optimal level of a fluid status measurement of a volemic state of a patient;

sensing a physiological sensor signal;

computing from the sensor signal the fluid status measurement;

administering a therapy;

establishing a target profile of a time-based curve of the fluid status measurement using an expected time period of the therapy, the fluid status measurement and the optimal level;

determining an actual profile of a time-based curve of the fluid status measurement during the therapy administration; and

comparing the actual profile to the target profile,

wherein setting the optimal fluid status measurement level comprises;

storing the fluid status measurement corresponding to acute decompensated heart failure events; and

computing the optimal fluid status measurement level in response to the stored fluid status measurement.

16. A method, comprising:

setting an optimal level of a fluid status measurement of a volemic state of a patient;

sensing a physiological sensor signal;

computing the fluid status measurement from the sensor signal;

administering a therapy; and

establishing a target profile of a time-based curve of the fluid status measurement using an expected time period of the therapy, the fluid status measurement and the optimal level,

determining an actual profile of a time-based curve of the fluid status measurement during the therapy administration;

comparing the actual profile to the target profile;

wherein setting the optimal fluid status measurement level comprises using a distribution of previously computed fluid status measurements.

17. An implantable medical device method, comprising:

setting an optimal level of a fluid status measurement of a volemic state of a patient in an implantable medical device;

sensing a physiological sensor signal from an implantable sensor;

computing from the sensor signal the fluid status measurement;

administering a therapy through the implantable medical device;

establishing a target profile of a time-based curve of the fluid status measurement using an expected time period of the therapy, the fluid status measurement and the optimal level;

determining an actual profile of a time-based curve of the fluid status measurement during the therapy administration; and

comparing the actual profile to the target profile;

wherein sensing the physiological sensor signal comprises sensing one of an impedance signal and a blood pressure signal.