Absolute intrathoracic impedance based scheme to stratify patients for risk of a heart failure event

• US 10,368,774 B2
• Filed: 07/28/2016
• Issued: 08/06/2019
• Est. Priority Date: 07/30/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sharma, Vinod, Redemske, Jodi L
• Primary Examiner(s): Cerioni, Daniel L
• Application Number:
  US15/222,461
• Publication Number:
  US 20170027474A1
• Time in Patent Office: 1,104 Days
• Field of Search: 600547
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37258 Alerting the patient

Abstract

A health care system acquires data determines whether a patient is at risk of hypervolemia or hypovolemia. The method comprises (a) acquiring from a device memory a patient'"'"'s absolute intrathoracic impedance data over a pre-specified time period, (b) determining a running average of the intrathoracic impedance data over the pre-specified time period, and (c) determining by the system whether the running average of the intrathoracic impedance data over the pre-specified time period exceeds one of a first and second range, the first range being a higher value boundary of intrathoracic electrical impedance and the second range being a lower value boundary of intrathoracic electrical impedance.

Claims

1. A method of operation of a medical system for determining whether a patient is at risk of exhibiting excessive fluid or dehydration, the method comprising:

(a) acquiring from an implantable medical device memory a patient'"'"'s absolute intrathoracic impedance data over a time period;

(b) determining, through a processor, an average of the intrathoracic impedance data over the time period;

(c) defining, through the processor, a target impedance range bounded by a first range and a second range, the first range being a lower value intrathoracic electrical impedance and the second range being a higher value of intrathoracic electrical impedance;

(d) determining, through the processor, whether the average of the intrathoracic impedance data is outside one of the first and second ranges;

(e) in response to step d, the processor determines a level of heart failure (HF) event risk based upon whether the average of impedance is outside the targeted impedance range; and

(f) in response to step d, adjusting therapy delivered to a patient;

wherein the system comprises a cardiac pacemaker and wherein the therapy is adjusted by switching to one of fusion pacing, biventricular pacing, and multisite pacing and using the pacemaker to deliver the adjusted therapy.

2. The method according to claim 1 wherein the patient is determined to exhibit excessive fluid in response to determining that the average of intrathoracic impedance data is outside of the target impedance range and extends outside the first range.

3. The method according to claim 1 wherein the patient is determined to be dehydrated in response to determining the average of the intrathoracic impedance data is outside of the target impedance range and outside the second range.

4. The method according to claim 1 further comprising:

(g) generating a notification to one of a patient and health care worker.

5. The method according to claim 4 wherein the notification being displayed on a graphical user interface of a device or generated as an alarm.

6. The method according to claim 1 wherein the first and second ranges are asymmetrical to each other relative to a target impedance reference.

7. The method according to claim 1 wherein the average of the intrathoracic impedance data is a running average.

8. The method according to claim 1 wherein the first and second ranges are symmetrical when the first and second ranges are equidistant away, or about equidistant away, from the target impedance reference.

9. The method according to claim 1 wherein medication dosage is adjusted.

10. The method according to claim 9 wherein the medication is a diuretic or a nitrate.

11. The method according to claim 1 wherein the processor determines risk of a HF event which comprises one of hospitalization for heart failure (HFH), IV, and diuresis.

12. The method according to claim 11 wherein HFH comprises one of an emergency room visit and a visit to a clinic.

13. The method according to claim 1 wherein the first range extends up to +10% of a baseline mean impedance for a hypovolemia diagnosis and the second range extends up to −

10% on a hypervolemia diagnosis.