Portable device for monitoring electrocardiographic signals and indices of blood flow

• US 7,899,526 B2
• Filed: 05/10/2005
• Issued: 03/01/2011
• Est. Priority Date: 05/10/2004
• Status: Active Grant

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Benditt, David G., Lurie, Keith G., Patterson, Robert F.
• Primary Examiner(s): Hoekstra; Jeffrey G
• Application Number:
  US11/127,055
• Publication Number:
  US 20050267381A1
• Time in Patent Office: 2,121 Days
• Field of Search: 600/547, 600481-528, 607/8
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/6837 Sutures

Abstract

Embodiments of the present invention are directed to a physiological monitoring device which is configured to record signals that reflect blood flow and/or blood pressure, and which may also record ECG signals. In one embodiment, a portable monitoring device comprises a plurality of impedance electrodes configured to be coupled to a patient'"'"'s body and to generate an AC current with an electrical field to detect local electrical impedance of a portion of the patient'"'"'s body encompassed by the electrical field, the local electrical impedance being a surrogate measure of local blood flow of the portion of the patient'"'"'s body. At least a portion of the portable monitoring device is configured to be insertable subcutaneously into the patient'"'"'s body.

Claims

1. An implantable monitoring device comprising:

a device body configured to be implanted subcutaneously into a patient;

a plurality of impedance electrodes configured on or near the device body and for implantation into the patient with the device body, the plurality of impedance electrodes being configured to be positioned less than about 5 centimeters from an extra-cardiac artery or extra-cardiac tissue that pulsates in response to pulses in the extra-cardiac artery, the plurality of impedance electrodes adapted to inject a current across the extra-cardiac artery or extra-cardiac tissue and measure a resulting voltage across the extra-cardiac artery or extra-cardiac tissue to determine an extra-cardiac arterial electrical impedance measure across a path that traverses the extra-cardiac artery or extra-cardiac tissue, the extra-cardiac arterial electrical impedance measure being indicative of pressure in the extra-cardiac artery;

a plurality of electrocardiographic, ECG, electrodes configured on or near the device body and for implantation into the patient with the device body, the plurality of ECG electrodes adapted to detect an ECG signal of the patient;

a memory in operable communication with a processor programmed to store in the memory information from which a hypotension episode of the patient is identifiable and from which it is determinable whether an ECG signal accompanying an identified hypotension episode was normal during the identified hypotension episode, the information comprising both the extra-cardiac arterial electrical impedance measures and the accompanying ECG signal obtained over a period of time by, respectively, the plurality of impedance electrodes and the plurality of ECG electrodes, the processor being programmed to store the extra-cardiac arterial electrical impedance measures and the accompanying ECG signal for the period of time in a manner such that the extra-cardiac arterial electrical impedance measures and the accompanying ECG signal are correlated with one another in time, wherein the memory and the processor are each disposed within the device body; and

a telemetry component disposed inside the body of the device, wherein the processor is programmed to control the telemetry component to transmit the stored and time correlated extra-cardiac arterial electrical impedance measures and the accompanying ECG signal for the period of time to a device external of the patient.

2. The implantable monitoring device of claim 1 wherein the impedance electrodes include two electrodes that are configured to be positioned such that the two electrodes are spaced from one another in a direction generally parallel to the artery.

3. The implantable monitoring device of claim 1 wherein the impedance electrodes include two electrodes that are configured to be positioned such that the two electrodes are spaced from one another in a direction generally transversely across the artery.

4. The implantable monitoring device of claim 1 further comprising a temperature sensor configured to measure local tissue temperature of a patient'"'"'s body in a region adjacent the temperature sensor.

5. The implantable monitoring device of claim 1 further comprising a battery.

6. The implantable monitoring device of claim 1 further comprising a warning component to provide warning based on the stored information.

7. The implantable monitoring device of claim 1 wherein the impedance electrodes protrude from an outer surface of the body of the device.

8. The implantable monitoring device of claim 7 further comprising a set of one or more auxiliary leads for placing a set of one or more additional electrodes.

9. The implantable monitoring device of claim 1 wherein the processor is programmed to store data in memory based on instructions delineating criteria for data to be stored.

10. The implantable monitoring device of claim 1 wherein the memory has looping memory capability.

11. The implantable monitoring device of claim 1 wherein the processor is programmed to store in the memory data temporally proximate to an event based on information detected by the impedance electrodes or based on a telemetry instruction of patient-activated triggering of an external device.

12. The implantable monitoring device of claim 1 wherein the impedance electrodes are adapted to be positioned within the vascular system.

13. The implantable monitoring device of claim 1 wherein the plurality of impedance electrodes are configured to be positioned about 3-4 centimeters from the extra-cardiac artery or extra-cardiac tissue.

14. The implantable monitoring device of claim 1 wherein the extra-cardiac artery or extra-cardiac tissue with respect to which the plurality of impedance electrodes are configured to be positioned is distal of the major vessel of the aorta.

15. The implantable monitoring device of claim 14 wherein the extra-cardiac artery or extra-cardiac tissue with respect to which the plurality of impedance electrodes are configured to be positioned is a subclavian artery.

16. The implantable monitoring device of claim 1 wherein the extra-cardiac artery or extra-cardiac tissue with respect to which the plurality of impedance electrodes are configured to be positioned is a pectoralis muscle.

17. The implantable monitoring device of claim 16 wherein the plurality of impedance electrodes are configured to be positioned against the pectoralis muscle.

18. The implantable monitoring device of claim 1, wherein the ECG signal being normal is the ECG signal indicating a normal heart rhythm for the patient.