Monitoring device and method for operating a monitoring device

• US 8,939,904 B2
• Filed: 03/04/2011
• Issued: 01/27/2015
• Est. Priority Date: 03/11/2010
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Lippert, Michael, Vollkron, Michael, Czygan, Gerald, Paule, Stefan
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US13/041,025
• Publication Number:
  US 20110224748A1
• Time in Patent Office: 1,425 Days
• Field of Search: 600/301
• US Class Current: 600/301
• 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 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A monitoring device for a patient for predicting a cardiovascular anomaly and a method for operating a monitoring device is provided. Furthermore, an implantable electrotherapy device, such as an implantable cardiac pacemaker, an implantable cardioverter, or an implantable defibrillator, having a monitoring device are also provided. In an embodiment, the monitoring device acquires a value change of a hemodynamic parameter, which occurs as a result of a detected value change of a state parameter, for example, as a result of an activation or deactivation of a cardiac resynchronization therapy. By suitable evaluation of the value change of the hemodynamic parameter, the monitoring device can output an evaluation result signal which is indicative of an imminence of a cardiovascular anomaly, such as a cardiac decompensation, long beforehand and with high specificity.

Claims

1. A monitoring device for a patient for predicting a cardiovascular anomaly, the monitoring device comprising:

a first input;

a sensor connectable to the first input and configured to acquire a value of a physiological parameter based on a cardiovascular anomaly, the first input and the sensor being implantable;

a second input;

a detection unit connectable to the second input and configured to detect a value change of a state parameter that is different from the physiological parameter, the state parameter being a different physiological parameter or a parameter characterizing a state of a medical device connected to the patient or a parameter characterizing another physical or pharmacotherapeutic state of the patient;

an analysis unit operationally linked to the implantable sensor and the detection unit, the analysis unit configured to, upon a detection of the value change of the state parameter, determine a value change of the physiological parameter occurring upon the value change of the state parameter and configured to provide a first differential signal as a function of the determined value change of the physiological parameter;

a transformation unit configured to receive the first differential signal and to transform it into a characteristic variable as a function of a chronological correlation of the value changes of the state parameter and the physiological parameter and/or as a function of an absolute value and/or a direction of the detected value change of the state parameter and to provide it; and

a prediction unit configured to receive and evaluate the characteristic variable and to provide an evaluation result signal indicative of an imminence of a cardiovascular anomaly as a function of the evaluation,

wherein the analysis unit is configured to ascertain a time duration between the beginning of the value change of the state parameter and the end of the value change of the physiological parameter and wherein the transformation unit is configured to relate the first differential signal to the ascertained time duration and to provide the time-related first differential signal as the characteristic variable.

2. The monitoring device according to claim 1, wherein the analysis unit is configured to continuously record the value of the physiological parameter and to chronologically average it for a short time and to store the short-term average value of the physiological parameter and continuously update it and to determine the value change of the physiological parameter as the difference between a currently acquired value of the physiological parameter and the previously stored value of the physiological parameter.

3. The monitoring device according to claim 1, further comprising an implantable first component configured to cause an intentional value change of the state parameter.

4. The monitoring device according to claim 3, wherein the implantable sensor and the analysis unit for determining the value change of the physiological parameter are configured to acquire a value of the physiological parameter before, during, and after the intentional value change of the state parameter.

5. The monitoring device according to claim 4, wherein the analysis unit is configured to provide the first differential signal as a mean value of a plurality of determined value changes of the physiological parameter, which occur upon a plurality of detected value changes of the state parameter.

6. The monitoring device according to claim 1, wherein the implantable sensor is configured to acquire a value of a hemodynamic parameter as the physiological parameter.

7. The monitoring device according to claim 1, wherein the detection unit is configured to detect a change of a stimulation mode of a medical device connected to the patient as a value change of a state parameter.

8. The monitoring device according to claim 1, wherein the transformation unit is configured to transform the first differential signal into a plurality of characteristic variables as a function of the chronological correlation of the value changes of the state parameter and the physiological parameter and/or as a function of the absolute value and/or the direction of the detected value change of the state parameter and to provide this plurality, and wherein the prediction unit is configured to receive and evaluate the plurality of characteristic variables and to provide an evaluation result signal indicative of an imminence of a cardiovascular anomaly as a function of the plurality of evaluations.

9. The monitoring device according to claim 1, wherein the transformation unit is configured to average the characteristic variable and to provide the chronologically averaged characteristic variable to the prediction unit for evaluation.

10. An implantable electrotherapy device, which is operationally linked to a monitoring device according to claim 1 and comprises a second component for outputting an electrical therapy signal.

11. A cardiac pacemaker, which is operationally linked to a monitoring device according to claim 1.

12. An implantable cardioverter or implantable defibrillator, which is operationally linked to a monitoring device according to claim 1.

13. The monitoring device according to claim 1, wherein the transformation unit is located downstream of the analysis unit.

14. A method for operating a monitoring device, the method comprising:

acquiring a value of a physiological parameter based on a cardiovascular anomaly;

detecting a value change of a state parameter that is different from the physiological parameter, the state parameter being a different physiological parameter or a parameter characterizing a state of a medical device connected to the patient or a parameter characterizing another physical or pharmacotherapeutic state of the patient;

determining, upon the detection of the value change of the state parameter, a value change of the physiological parameter occurring upon the value change of the state parameter;

providing a first differential signal as a function of the acquired value change of the physiological parameter;

transforming the differential signal into a characteristic variable as a function of a chronological correlation of the value changes of the state parameter and the physiological parameter and/or as a function of an absolute value and/or a direction of the detected value change of the state parameter and providing the characteristic variable; and

evaluating the characteristic variable and providing an evaluation result signal, which is indicative of an imminence of a cardiovascular anomaly, as a function of the evaluation,

wherein a time duration is ascertained between the beginning of the value change of the state parameter and the end of the value change of the physiological parameter and wherein the first differential signal is related to the ascertained time duration and the time-related first differential signal is provided as the characteristic variable.