Cardiac harness having diagnostic sensors and method of use

• US 20070197859A1
• Filed: 05/09/2006
• Published: 08/23/2007
• Est. Priority Date: 11/07/2003
• Status: Abandoned Application

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: Schaer, Alan, Fishler, Matthew
• Application Number:
  US11/430,638
• Publication Number:
  US 20070197859A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/0597 Surface area electrodes, e.g. cardiac harness

Abstract

A cardiac harness adapted to fit generally around a least a portion of a heart includes at least one elastic spring member forming an annular portion that is elastically deformable and at least one sensor disposed on the annular portion for providing a sensor signal representative of cardiac function. The cardiac harness applies a compressive force on the heart during diastole and systole. The sensor is configured to take a measurement of impedance across the heart, impedance across a lung, evoked response of the heart, activation patterns of the heart, acceleration of a portion of the heart, position of a portion of the heart relative to an ultrasonic transmitter, pH on the heart'"'"'s epicardial surface, blood oxygen saturation of a portion of the heart, or position of a portion of the heart relative to a magnetic field generating device. The cardiac harness and sensor are delivered and implanted on the heart by minimally invasive access.

Claims

1. A cardiac harness adapted to be fitted generally around at least a portion of a heart, the cardiac harness, comprising:

at least one elastic spring member forming an annular portion that is elastically deformable from a compacted orientation having a first radial dimension to an implanted orientation having a second radial dimension larger than the first radial dimension, the annular portion in the implanted orientation being adapted to exert a circumferential load in response to continuous cardiac cycling, the circumferential load defined by a load-versus-expansion curve that remains substantially unchanged through the continuous cardiac cycling; and

at least one sensor disposed on the annular portion and configured for providing a sensor signal representative of cardiac function.

2. The cardiac harness of claim 1, wherein the at least one sensor is configured and positioned on the annular portion for measuring impedance across the heart.

3. The cardiac harness of claim 1, further comprising:

a current source for producing electrical currents; and

an electrode disposed on the annular portion, the electrode coupled to the current source and adapted for delivering an electrical current across the heart.

4. The cardiac harness of claim 1, wherein the at least one sensor is configured and positioned on the annular portion for measuring impedance across a lung.

5. The cardiac harness of claim 1, further comprising:

a current source for producing electrical currents; and

a remote electrode disposed remotely from the annular portion, the remote electrode coupled to the current source and adapted for delivering an electrical current across a lung.

6. The cardiac harness of claim 1, wherein the at least one sensor is configured for measuring an evoked response of the heart.

7. The cardiac harness of claim 1, wherein the at least one sensor is configured for detecting activation patterns of the heart.

8. The cardiac harness of claim 1, wherein the at least one sensor comprises an accelerometer configured for measuring acceleration in at least one direction at a portion of the heart adjacent to the at least one sensor.

9. The cardiac harness of claim 1, wherein the at least one sensor comprises a piezo-electric crystal and is configured for measuring position relative to an ultrasonic transmitter of a portion of the heart adjacent to the at least one sensor.

10. The cardiac harness of claim 1, wherein the at least one sensor is configured to detect ultrasound waves, and further comprising a transmitter disposed on the annular portion and configured to fire an ultrasound transmission, and a digital counter in operational communication with the at least one sensor and the transmitter, the digital counter configured to start when the transmitter fires and to stop when the at least one sensor detects an ultrasound wave.

11. The cardiac harness of claim 1, wherein the at least one sensor is configured to detect ultrasound waves, and further comprising a remote transmitter disposed remotely from the annular portion and configured to fire an ultrasound transmission, and a digital counter in operational communication with the at least one sensor and the transmitter, the digital counter configured to start when the transmitter fires and to stop when the at least one sensor detects an ultrasound wave.

12. The cardiac harness of claim 1, wherein the at least one sensor is configured for measuring pH between the epicardial surface of the heart and the pericardial sac of the heart.

13. The cardiac harness of claim 1, wherein the at least one sensor comprises a light emitter and a light detector, both for measuring blood oxygen saturation in myocardium adjacent to the at least one diagnostic sensor.

14. The cardiac harness of claim 1, wherein the at least one sensor comprises a current-carrying conductor adapted to generate a voltage in the presence of an electromagnetic field, the voltage representative of a position of the at least one sensor.

15. The cardiac harness of claim 1, wherein the first radial dimension of the compacted configuration is sized to allow the annular portion to pass through an opening between two ribs adjacent to each other.

16. The cardiac harness of claim 1, wherein the at least one sensor is moveable through an incision in the pericardial sac of the heart when the annular portion is urged from the compacted orientation inside a delivery device housing to the implanted orientation outside the delivery device housing.

17. The cardiac harness of claim 1, wherein the at least one sensor is configured to be covered and held by the pericardial sac of the heart at a fixed point on the epicardial surface of the heart.

18. The cardiac harness of claim 1, wherein the elastic spring member comprises at least one undulating row of wire adapted to exhibit superelasticity when the annular portion is in its implanted orientation.

19. The cardiac harness of claim 1, wherein annular portion comprises undulating rows of wire, the wire comprising a nickel-titanium alloy.

20. A cardiac harness adapted to be fitted generally around at least a portion of a heart, the cardiac harness, comprising:

at least one superelastic annular portion that is elastically deformable from a compacted orientation having a first radial dimension to an implanted orientation having a second radial dimension larger than the first radial dimension, the first radial dimension sized to allow the annular portion to pass through an opening between two ribs adjacent to each other; and

at least one sensor disposed on the annular portion and configured for providing a sensor signal representative of cardiac function.

21. The cardiac harness of claim 20, wherein the at least one sensor is configured to take a measurement chosen from the group consisting of impedance across the heart, impedance across a lung, evoked response of the heart, activation patterns of the heart, acceleration of a portion of the heart, position of a portion of the heart relative to an ultrasonic transmitter, pH on the heart'"'"'s epicardial surface, blood oxygen saturation of a portion of the heart, and position of a portion of the heart relative to a magnetic field generating device.

22. A method, comprising:

forming an annular portion with at least one elastic spring member and at least one sensor, the annular portion being elastically deformable from a compacted configuration having a first radial dimension to an implanted orientation having a second radial dimension greater than the first radial dimension, the at least one sensor configured for providing sensor signals representative of cardiac function;

applying a circumferential load from the annular portion in response to continuous cardiac cycling, the circumferential load defined by a load-versus-expansion curve that remains substantially unchanged through the continuous cardiac cycling; and

obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion.

23. The method of claim 22, further comprising moving the at least one sensor through an incision in a heart'"'"'s pericardial sac, including urging the annular portion from the compacted orientation inside a delivery device housing to the implanted orientation outside the delivery device housing.

24. The method of claim 22, wherein obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion comprises measuring impedance across the heart, including applying an electrical current from an electrode on the annular portion.

25. The method of claim 22, wherein obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion comprises measuring impedance across the lung, including applying an electrical current from a remote electrode disposed remotely from the annular portion

26. The method of claim 22, wherein obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion comprises measuring acceleration in at least one direction of a portion of the heart.

27. The method of claim 22, wherein obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion comprises taking a sonometric measurement from a portion of the heart.

28. The method of claim 27, wherein taking a sonometric measurement from a portion of the heart comprises:

firing an ultrasound transmission from a transmitter disposed on the annular portion;

starting a digital counter in response to the transmitter firing the ultrasound transmission;

detecting an ultrasound wave at the at the least one sensor on the annular portion; and

stopping the digital counter in response to the at least one sensor detecting the ultrasound wave.

29. The method of claim 27, wherein taking a sonometric measurement from a portion of the heart comprises:

firing an ultrasound transmission from a remote transmitter disposed remotely from the annular portion;

starting a digital counter in response to the transmitter firing the ultrasound transmission;

detecting an ultrasound wave at the at least one sensor on the annular portion; and

stopping the digital counter in response to the at least one sensor detecting the ultrasound wave.

30. The method of claim 22, wherein obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion comprises measuring pH on the pericardial sac of the heart.

31. The method of claim 22, wherein obtaining a sensor signal representative of cardiac function from the at least one sensor on the annular portion comprises:

providing a current to a conductor of the at least one sensor, the conductor adapted to generate a voltage in the presence of a magnetic field;

generating a magnetic field in the space occupied by the conductor; and

measuring voltage from the at least one sensor, the voltage proportional to the strength of the magnetic field at the location occupied by the conductor.