HEART MONITORING SYSTEM

• US 20090062878A1
• Filed: 08/30/2007
• Published: 03/05/2009
• Est. Priority Date: 08/30/2007
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: LANG, Volker
• Granted Patent: US 7,890,160 B2
• Time in Patent Office: Days
• US Class Current: 607/30
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• 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
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

Heart monitoring system includes implantable medical device and service center. Implantable medical device includes stimulation pulse generator, ventricular sensing stage, activity sensor, impedance determination unit with a constant current or voltage source to generate sub-threshold measuring current pulses having constant current strength or constant voltage, measuring unit for measuring a voltage corresponding to a current fed through a body, impedance value determination unit connected with measuring unit adapted to determine impedance value for each measuring current pulse, and perform intrathoracic impedance measurement, a control unit adapted to collect data representing values of changes, and initiate data transmission, implant transceiver unit communicating with the service center with a data evaluation module including data trending of stored data with a user interface and said data evaluation module adapted to allow a physician to set for each data trend trigger criteria for decompensation detection and generate a decompensation indicator signal.

Claims

1. A heart monitoring system comprising:

an implantable medical device;

a service center;

said implantable medical device comprising

a stimulation pulse generator adapted to generate electric stimulation pulses and being connected or being connectable to at least a ventricular stimulation electrode for delivering electric stimulation pulses to at least a ventricle of a heart;

a ventricular sensing stage connected or being connectable to an electrode for picking up electric potentials inside said at least said ventricle of said heart, said sensing stage being adapted to sense an excitation or a contraction of ventricular myocardium;

an activity sensor;

an impedance determination unit comprising

a constant current source or a constant voltage source having current feed terminals that are connected or can be connected to electrodes for intracorporeal placement and that is adapted to generate sub-threshold measuring current pulses having a constant current strength or a constant voltage, respectively, for causing a current to be fed through a body via intracorporeally placed electrodes;

a measuring unit for measuring a voltage corresponding to a current fed through said body by said constant current source or a current strength of a current fed through said body by said constant voltage source, respectively;

an impedance value determination unit that is connected to said constant current source or said constant voltage source and said measuring unit that is adapted to determine an impedance value for each measuring current pulse;

said impedance determination unit being adapted to perform an intrathoracic impedance measurement via a first and a second electrode combination wherein said second electrode configuration is different from said first electrode configuration;

a control unit that is connected to said battery, said stimulation pulse generator, said sensing stage, said activity sensor and said impedance determination unit and that is adapted to collect data representing values of;

DC thoracic impedance from said first electrode combination,

DC thoracic impedance from said second electrode combination,

cardiac output,

heart rate at a resting state of a patient,

heart rate during exercise of a patient,

activity level of a patient,

ventricular extra systoles (VES) per time unit,

breathing rate,

tidal volume;

an implant transceiver unit for communication with said service center;

said service center comprising another data communication interface adapted to allow at least an indirect data communication with said implantable medical device and is connected to a central data base and to a user interface;

wherein said control unit that is adapted to initiate transmission of said collected data to said data center;

said service center further comprises a data evaluation module connected to said data base and adapted to evaluate data stored in said data base wherein said evaluation includes data trending of stored data; and

,

said user interface and said data evaluation module are adapted to allow a physician to set for each data trend trigger criteria for detection of decompensation and said data evaluation module is further adapted to generate a decompensation indicator signal whenever trigger criteria are met by trended data.

2. The heart monitoring system according to claim 1, wherein said heart monitoring system further comprises an external transceiver device said external transceiver device comprises an external transceiver unit for wireless communication with said implant transceiver unit and a data communication interface adapted to allow a data communication with said service center.

3. The heart monitoring system according to claim 1, wherein said trigger criteria includes an offset versus baseline or slope of said trended data as to trigger generation of said decompensation indicator signal whenever said offset is exceeded.

4. The heart monitoring system according to claim 1, wherein said data evaluation module is adapted to generate a decompensation indicator signal whenever a combination of trigger criteria are met by said trended data.

5. The heart monitoring system according to claim 4, wherein said data evaluation module is adapted to generate a decompensation indicator signal whenever a plurality of trigger criteria are met in a preset timely coincidence.

6. The heart monitoring system according to claim 4, wherein user interface is adapted so that a user can set trigger combination and/or its timely coincidence.

7. The heart monitoring system according to claim 4, wherein said data evaluation module is adapted to generate a decompensation indicator signal if said change DC thoracic impedance from said first electrode combination and said DC thoracic impedance from said second electrode combination show a preset increase and activity level shows a preset decrease and said breathing rate shows a preset increase.

8. The heart monitoring system according to claim 1, wherein said service center is to transmit a decompensation alarm message adapted whenever said data evaluation module generates a decompensation indicator signal.

9. The heart monitoring system according to claim 1, wherein said implantable medical device is adapted to transmit collected raw data daily to said service center.

10. The heart monitoring system according to claim 1, wherein said data evaluation module is adapted to trend said data with one datapoint per day for each trend.

11. The heart monitoring system according to claim 1, wherein said data evaluation module and said user interface and their interaction are designed to allow a user to be able to activate or deactivate trigger for each trend.

12. The heart monitoring system according to claim 1, wherein said data evaluation module and said user interface and their interaction are configured to allow a user to be able to combine trigger to trigger logic comprising a combination of trigger criteria to be met.

13. The heart monitoring system according to claim 1, wherein said data evaluation module and said user interface and their interaction are adapted to generate a display of data wherein graph-lines changes colors for each trend separately if trigger is not reached (“

green”

) versus trigger is reached (“

red”

).

14. The heart monitoring system according to claim 1, wherein said data evaluation module and said user interface and their interaction are adapted to generate a display of data wherein a graph background changes colors for times for which trigger logic produces an alarm.

15. The heart monitoring system according to claim 1, wherein said service center is adapted to indicate a decompensation alarm via said user interface connected to said service center and to allow the physician to initiate therapy changes actively via several remote activities including:

change of pacing parameters via remote programming via the user interface;

change of diet via telephone call to a patient;

change of medication via telephone call to a patient; and

,

change of medication via remote programming of a drug pump using the user interface of the service center.

16. The heart monitoring system according to claim 1, further including a feedback channel from an individual patient to said user interface that allows for feedback to indicate whether a therapy change was successful or not.