Methods and apparatus for enhancing cardiac pacing

• US 7,738,958 B2
• Filed: 02/28/2007
• Issued: 06/15/2010
• Est. Priority Date: 01/24/2003
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Biomedical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Ruggio, Joseph M., Zdeblick, Mark
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US11/680,509
• Publication Number:
  US 20070219591A1
• Time in Patent Office: 1,203 Days
• Field of Search: 607/4, 607/9, 607 17- 28
• US Class Current: 607/17
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6883 Sutures
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36528 the parameter being measured by means of ultrasound
• 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 1/36571 controlled by blood flow rate, e.g. blood velocity or cardiac output
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

Methods, apparatus and systems for enhancing cardiac pacing generally provide for measuring at least one cardiac characteristic, calculating at least one cardiac performance parameter based on the measured characteristic(s), and adjusting at least one functional parameter of a cardiac pacing device. Devices may include at least one catheter (such as a multiplexed catheter with one or more sensors and/or actuators), at least one implant (such as a sensor implantable in a heart wall), or a combination of both. Various cardiac performance parameters and/or pacing device performance parameters may be weighted, and the parameters and their respective weights may be used to determine one or more adjustments to be made to the pacing device. In some instances, the adjustments are made automatically.

Claims

1. An apparatus for enhancing a cardiac pacing device, the apparatus comprising:

at least one measuring device to measure at least one characteristic of a heart; and

a processor coupled with the at least one measuring device configured to calculate at least one cardiac performance parameter based on the at least one characteristic of the heart, accept at least one command assigning a relative weight to each of the at least one cardiac performance parameter, and determine at least one adjustment to be made to at least one functional parameter of the cardiac pacing device based on the at least one cardiac performance parameter and the relative weight to the each of the at least one cardiac performance parameter.

2. The apparatus as in claim 1, wherein the at least one functional parameter of the cardiac pacing device comprises a pulse width, a pulse amplitude, a pulse duration, a number of pulses per one cycle of the heart, a pulse polarity, a pulse duty cycle, or a timing of pulses relative to a cycle of the heart, with the at least one functional parameter obtained via an active electrode coupled to the cardiac pacing device.

3. The apparatus as in claim 1, wherein the at least one measuring device comprises at least one sensor implantable within at least one wall of the heart.

4. The apparatus as in claim 3, wherein the at least one sensor comprises a pressure sensor, a volume sensor, a dimension sensor, a temperature sensor, a thermal sensor, an oxygen sensor, a carbon dioxide sensor, an electrical conductivity sensor, an electrical potential sensor, a pH sensor, a chemical sensor, a flow rate sensor, an optical sensor, an acoustic sensor, a hematocrit sensor, or a viscosity sensor.

5. The apparatus as in claim 1, wherein the at least one measuring device comprises at least one catheter positionable within at least one chamber of the heart.

6. The apparatus as in claim 5, wherein the at least one catheter comprises at least one multiplexed catheter.

7. The apparatus as in claim 6, wherein the at least one multiplexed catheter comprises a pressure sensor, a volume sensor, a dimension sensor, a temperature sensor, a thermal sensor, an oxygen sensor, a carbon dioxide sensor, an electrical conductivity sensor, an electrical potential sensor, a pH sensor, a chemical sensor, a flow rate sensor, an optical sensor, an acoustic sensor, a hematocrit sensor, or a viscosity sensor.

8. The apparatus as in claim 6, wherein the at least one multiplexed catheter comprises an actuator to perform at least one of:

providing an electrical current or voltage;

setting an electrical potential;

generating a biopotential;

pacing a heart;

heating a substance or area;

inducing a pressure change;

releasing or capturing a material;

emitting light;

emitting sonic or ultrasound energy; and

emitting radiation.

9. The apparatus as in claim 1, wherein the at least one measuring device further comprises at least one sensor implantable within at least one wall of the heart.

10. The apparatus as in claim 9, wherein the at least one sensor comprises a pressure sensor, a volume sensor, a dimension sensor, a temperature sensor, a thermal sensor, an oxygen sensor, a carbon dioxide sensor, an electrical conductivity sensor, an electrical potential sensor, a pH sensor, a chemical sensor, a flow rate sensor, an optical sensor, an acoustic sensor, a hematocrit sensor, or a viscosity sensor.

11. The apparatus as in claim 1, wherein the at least one cardiac performance parameter comprises ejection fraction, cardiac output, cardiac index, stroke volume, stroke volume index, pressure reserve, volume reserve, cardiac reserve, cardiac reserve index, stroke reserve index, myocardial work, myocardial work index, myocardial reserve, myocardial reserve index, stroke work, stroke work index, stroke work reserve, stroke work reserve index, systolic ejection period, stroke power, stroke power reserve, stroke power reserve index, myocardial power, myocardial power index, myocardial power reserve, myocardial power reserve index, myocardial power requirement, dP/dt, d²P/dt, ejection contractility, cardiac efficiency, cardiac amplification, valvular gradient, valvular gradient reserve, valvular area, valvular area reserve, valvular regurgitation, or valvular regurgitation reserve.

12. The apparatus as in claim 1 wherein the processor receives at least one cardiac pacing device performance parameter from the cardiac pacing device, and wherein the processor further assigns an additional relative weight to each of the at least one cardiac pacing device performance parameter and calculates the at least one adjustment further based on the at least one cardiac pacing device performance parameter and the additional relative weight to the each of the at least one cardiac pacing device performance parameter.

13. The apparatus as in claim 12, wherein the at least one cardiac pacing device performance parameter comprises an energy consumption rate, a maximum current, or a maximum voltage of the cardiac pacing device.

14. The apparatus as in claim 1, wherein the processor is coupled with the cardiac pacing device, and wherein the processor is configured to automatically adjust the at least one functional parameter of the cardiac pacing device.

15. The apparatus as in claim 1, wherein the processor is configured to wirelessly transmit the at least one adjustment to the cardiac pacing device.

16. The apparatus as in claim 1, wherein the processor is coupled with a display device, and wherein the processor is configured to transmit the at least one cardiac performance parameter to the display device.

17. The apparatus as in claim 1, wherein the at least one command is further used to perform at least one of:

selecting the at least one cardiac performance parameter;

selecting at least one cardiac pacing device performance parameter; and

assigning an additional relative weight to each of the at least one cardiac pacing device performance parameter.

18. The apparatus as in claim 1, further comprising an input device to perform the accepting of the at least one command.

19. The apparatus as in claim 1, further comprising a display device coupled with the processor to display the at least one cardiac performance parameter.

20. The apparatus as in claim 1, wherein the cardiac pacing device is configured to apply electrical stimuli to the heart.

21. The apparatus as in claim 1, wherein the cardiac pacing device comprises at least one pacing lead.

22. The apparatus as in claim 21, wherein each of the at least one pacing lead comprises at least two electrodes disposed along its length.

23. The apparatus as in claim 22, wherein the at least two electrodes are configured to multiplex a signal via the each of the at least one pacing lead.

24. A system for enhancing cardiac pacing, the system comprising:

a cardiac pacing device;

at least one measuring device to measure at least one characteristic of a heart; and

a processor coupled with the at least one measuring device and the cardiac pacing device, wherein the processor is configured to calculate at least one cardiac performance parameter based on the at least one characteristic of the heart, accept at least one command assigning a relative weight to each of the at least one cardiac performance parameter, and determine at least one adjustment to be made to at least one functional parameter of the cardiac pacing device based on the at least one cardiac performance parameter and the relative weight to the each of the at least one cardiac performance parameter.

25. The system as in claim 24, wherein the cardiac pacing device comprises at least one pacing lead.

26. The system as in claim 25, wherein each of the at least one pacing lead comprises at least two electrodes disposed along its length.

27. The system as in claim 26, wherein the at least two electrodes are configured to multiplex a signal via the each of the at least one pacing lead.

28. The system as in claim 24, further comprising a display device to display the at least one cardiac performance parameter.

29. The system as in claim 28, wherein the display device is further configured to display at least one cardiac pacing device performance parameter.

30. The system as in claim 24, wherein the at least one measuring device comprises at least one sensor implantable within at least one wall of the heart.

31. The system as in claim 24, wherein the at least one measuring device comprises at least one catheter positionable within at least one chamber of the heart.

32. The system as in claim 31, wherein the at least one catheter comprises at least one multiplexed catheter.

33. The system as in claim 32, wherein the at least one multiplexed catheter comprises a pressure sensor, a volume sensor, a dimension sensor, a temperature sensor, a thermal sensor, an oxygen sensor, a carbon dioxide sensor, an electrical conductivity sensor, an electrical potential sensor, a pH sensor, a chemical sensor, a flow rate sensor, an optical sensor, an acoustic sensor, a hematocrit sensor, or a viscosity sensor.

34. The system as in claim 32, wherein the at least one multiplexed catheter includes an actuator to perform at least one of:

providing an electrical current or voltage;

setting an electrical potential;

generating a biopotential;

pacing a heart;

heating a substance or area;

inducing a pressure change;

releasing or capturing a material;

emitting light;

emitting sonic or ultrasound energy; and

emitting radiation.

35. The system as in claim 31, wherein the at least one measuring device further comprises at least one sensor device implantable within at least one wall of the heart.

36. The system as in claim 35, wherein the at least one sensor device implantable within the at least one wall of the heart comprises a pressure sensor, a volume sensor, a dimension sensor, a temperature sensor, a thermal sensor, an oxygen sensor, a carbon dioxide sensor, an electrical conductivity sensor, an electrical potential sensor, a pH sensor, a chemical sensor, a flow rate sensor, an optical sensor, an acoustic sensor, a hematocrit sensor, or a viscosity sensor.

37. The system as in claim 24, wherein the at least one cardiac performance parameter comprises ejection fraction, cardiac output, cardiac index, stroke volume, stroke volume index, pressure reserve, volume reserve, cardiac reserve, cardiac reserve index, stroke reserve index, myocardial work, myocardial work index, myocardial reserve, myocardial reserve index, stroke work, stroke work index, stroke work reserve, stroke work reserve index, systolic ejection period, stroke power, stroke power reserve, stroke power reserve index, myocardial power, myocardial power index, myocardial power reserve, myocardial power reserve index, myocardial power requirement, dP/dt, d²P/dt, ejection contractility, cardiac efficiency, cardiac amplification, valvular gradient, valvular gradient reserve, valvular area, valvular area reserve, valvular regurgitation, or valvular regurgitation reserve.

38. The system as in claim 24, wherein the processor receives at least one cardiac pacing device performance parameter from the cardiac pacing device, and wherein the processor further assigns an additional relative weight to each of the at least one cardiac pacing device performance parameter and calculates the at least one adjustment further based on the at least one cardiac pacing device performance parameter and the additional relative weight to the each of the at least one cardiac pacing device performance parameter.

39. The system as in claim 24, wherein the processor is wirelessly coupled to the cardiac pacing device.

40. The system as in claim 24, wherein the processor is coupled with a display device, and wherein the processor is configured to transmit the at least one cardiac performance parameter to the display device.

41. The system as in claim 24, wherein the at least one command is further used to perform at least one of:

selecting the at least one cardiac performance parameter;

selecting at least one cardiac pacing device performance parameter; and

assigning an additional relative weight to each of the at least one cardiac pacing device performance parameter.

42. The system as in claim 24, further comprising an input device to perform the accepting of the at least one command.