Detection of apex motion for monitoring cardiac dysfunction

• US 20040260346A1
• Filed: 01/30/2004
• Published: 12/23/2004
• Est. Priority Date: 01/31/2003
• Status: Abandoned Application

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Overall, William Ryan, Francis, Daniel, Mead, R. Hardwin, Angel, Aimee Brigitte
• Application Number:
  US10/769,405
• Publication Number:
  US 20040260346A1
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/02444 Details of sensor A61B5/02427 takes precedence
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Methods and devices for detection and monitoring of cardiac dysfunction and means for deployment of same are disclosed, including implanted sensor devices and methods for sensing one or more mechanical, electrical, hemodynamic, or chemical properties of cardiac tissue or blood, with apparatus and methods for analyzing or interpreting signals generated by the sensing elements, producing a physiologic or environmental effect or output as a result of the analysis, and methods and devices for the delivery of such sensors into the body. A preferred embodiment is integrated into a subcutaneously implantable medical device such as a pacemaker or defibrillator, and includes one or more electrical leads placed into the cardiac veins via the coronary sinus with motion and/or electrogram sensors at their ends. Another preferred embodiment is an implanted device residing entirely within the right-ventricular apex, with apparatus for communication with an external device for signal analysis, display, and patient notification.

Claims

1. A system for monitoring cardiac function in a human patient, the system comprising:

(a) an intracorporal motion sensor positioned at the apex of the heart, which is in operable connection with

(b) a motion analysis element comprising analog-to-digital converter circuitry;

central processing unit for processing signals from said motion sensor;

memory for storing at least one baseline motion parameter; and

an element for transmitting information to an alarm system.

2. The system according to claim 1, further comprising:

(c) a programmer for analyzing and setting motion parameters.

3. The system according to claim 2, further comprising one or more non-motion sensors.

4. The system according to claim 2, further comprising a motion sensor at other than the cardiac apex.

5. The system according to claim 1, further comprising a reference sensor.

6. The system according to claim 1, wherein said motion sensor is implanted at said apex of the heart.

7. The system according to claim 6, wherein said motion sensor is implanted endocardially at the right-ventricular apex, the epicardial apex, or an apical cardiac vein.

8. The system according to claim 1, wherein said operable connection between said motion sensor and said motion analysis element comprises an electrical lead.

9. The system according to claim 1, wherein said operable connection between said motion sensor and said motion analysis element comprises a telemetry connection.

10. The system according to claim 9, wherein said motion analysis element is an external device.

11. The system according to claim 1, further comprising a catheter for delivery of said system.

12. The system according to claim 1, wherein said motion analysis element is substantially integrated with another intracorporeal device.

13. The system according to claim 12, wherein said another intracorporeal device is an implantable pacemaker, defibrillator, cardioverter, ventricular assist device, infusion pump, implantable event monitor, annuloplasty ring, atrial-appendage occlusion device, or catheter.

14. The system according to claim 1, further comprising an alarm capable of warning a preset threshold for a motion parameter has been exceeded.

15. The system of claim 2, further comprising two-way wireless communication between said programmer and said motion analysis element.

16. The system of claim 15, wherein said programmer comprises software for analysis of motion sensing data.

17. The system of claim 1, wherein said motion sensor is an accelerometer.

18. The system of claim 1, wherein said motion sensor is a MEMS strain gyro.

19. The system of claim 1, wherein said motion analysis element is configured to receive data input from one or more of a magnet sensor;

timing circuit; and

telemetry sub-system.

20. The system of claim 1, wherein said motion analysis element is configured to transmit data output to one or more of a pacemaker circuit;

defibrillator circuit, and timing circuit.

21. A method for monitoring of cardiac function in a patient, the method comprising:

sensing the path that cardiac ventricular apex traverses over time with a motion sensor;

interpreting signals generated by said sensors; and

producing an output as a result of said interpreting.

22. The method according to claim 21, wherein said motion sensor is an intracorporal motion sensor positioned at the apex of the heart, which is in operable connection with a motion analysis element comprising analog-to-digital converter circuitry;

central processing unit for processing signals from said motion sensor;

memory for storing at least one baseline motion parameter; and

an element for transmitting information to an alarm system.

23. The method according to claim 22, wherein said baseline motion parameter is determined from data collected from said patient during a timepoint determined to be normal.

24. The method according to claim 23, wherein said interpreting step comprises:

inputting motion data into a memory slot;

calculating the axis of motion of the apex;

comparing the axis of motion to a baseline normal axis of motion;

evaluating said comparison to a preset threshold of maximum allowable deviation in the axis of motion from the baseline normal value.

25. The method according to claim 23, wherein said sensing comprises

differentially measuring motion of the apex by comparing sensing data from a measuring sensor and a reference sensor.

26. The method according to claim 23 wherein said sensing comprises

differentially measuring motion of the apex by comparing sensing data from an extended sensor where physiologic conditions vary along the length of the sensor.

27. The method according to claim 23, wherein said motion sensor is implanted at said apex of the heart.

28. The method according to claim 27, wherein said motion sensor is implanted endocardially at the right-ventricular apex, the epicardial apex, or an apical cardiac vein.

29. The method according to claim 23, wherein said motion sensor and said motion analysis element are operably connected by an electrical lead.

30. The method according to claim 23, wherein said motion sensor and said motion analysis element are operably connected by a telemetry connection.

31. The method according to claim 23, wherein said cardiac function includes assessment of heart rate, the presence of arrhythmias, detection of pacing signal capture, and volume overload.

32. The method according to claim 23, wherein said sensing of the path that cardiac ventricular apex traverses over time is combined with sensing from one or more non-motion sensors.

33. The method of claim 23, wherein said sensing of the path that cardiac ventricular apex traverses over time is used to aid in the function of an integrated therapeutic device.

34. The method of claim 23, wherein said motion analysis element is substantially integrated with another intracorporeal device.

35. The system according to claim 34, wherein said another intracorporeal device is an implantable pacemaker, defibrillator, cardioverter, ventricular assist device, infusion pump, implantable event monitor, annuloplasty ring, atrial-appendage occlusion device, or catheter.

36. The method according to 23, wherein said sensing comprises detection of the direction of deflection of the apex.

37. The method according to claim 36, wherein said sensing is analyzed to determine the location of a cardiac infarct.

38. The method according to claim 23, wherein said sensing comprises detection of apex motion and twist, and is analyzed to detect acute ischemia throughout the ventricle.

39. The method according to claim 23, wherein said producing an output as a result of said interpreting comprises producing an alarm.

40. The method according to claim 23, wherein said producing an output as a result of said interpreting comprises delivery of a therapeutic agent.

41. The method according to claim 23, wherein data from said patient is stored in a data repository.