Active Electrode, Bio-Impedance Based, Tissue Discrimination System and Methods of Use

• US 20110082383A1
• Filed: 12/07/2010
• Published: 04/07/2011
• Est. Priority Date: 10/20/2004
• Status: Abandoned Application

• Current Assignee: Nervonix, Inc.
• Original Assignee: Nervonix, Inc.
• Inventors: Ray, Paul L., Cory, Philip C., Kramer, Daniel A., Cory, Joan M., Schulz, Waldean A.
• Application Number:
  US12/962,382
• Publication Number:
  US 20110082383A1
• Time in Patent Office: Days
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4893 Nerves

Abstract

Systems and methods for discriminating and locating tissues within a body involve applying a waveform signal to tissue between two electrodes and measuring the electrical characteristics of the signal transmitted through the tissue. At least one of the electrodes is constrained in area so that localized electrical characteristics of the tissue are measured. Such localized electrical characteristics are determined over a portion of a body of the subject by using an array of electrodes or electrodes that can be moved over the body. A controller may implement the process and perform calculations on the measured data to identify tissue types and locations within the measured area, and to present results in graphical form. Results may be combined with other tissue imaging technologies and with image-guided systems.

Claims

1. A tissue discrimination system, comprising:

a sensor circuit selected from the group of a voltage sensor, a current sensor and a combination of a voltage and a current sensor;

a waveform electrode having an area no more than approximately 10 mm², the waveform electrode electrically coupled to the sensor circuit;

a return electrode electronically coupled to the sensor circuit;

a display; and

a controller electronically coupled to the sensor circuit and display, wherein the controller is configured to;

cause an electrical signal to be applied to the waveform electrode and the return electrode, the electrical signal having a frequency between approximately 500 Hz and approximately 2500 Hz;

receive a signal from the sensor circuit;

using the signal received from the sensor circuit, calculate a result useful for discriminating tissue; and

send control signals to the display to cause the calculated result to be presented on the display.

2. The tissue discrimination system of claim 1, further comprising:

a signal generator electronically coupled to the controller and electrically coupled to the waveform electrode and the return electrode, the signal generator being configured to receive a control signal from the controller and, in response to the control signal, generate the electrical signal applied to the waveform electrode and the return electrode.

3. The tissue discrimination system of claim 1, further comprising a memory coupled to the controller, wherein the controller is further configured to store the calculated result in the memory.

4. The tissue discrimination system of claim 1, further comprising:

an array assembly containing a plurality of waveform electrodes; and

a first switch assembly electronically coupled to the plurality of waveform electrodes, to the sensor circuit and to the controller, the first switch assembly being configured to electrically connect a selected waveform electrode to the sensor circuit in response to a control signal received from the controller.

5. The tissue discrimination system of claim 1, further comprising:

an array assembly containing a plurality of return electrodes; and

a second switch assembly electronically coupled to the plurality of return electrodes, to the sensor circuit and to the controller, the second switch assembly being configured to electrically connect a selected return electrode to the sensor circuit in response to a control signal received from the controller.

6. The tissue discrimination system of claim 1, further comprising:

a first wireless data transceiver coupled to the sensor circuit; and

a second wireless data transceiver coupled to the controller, wherein the first and second wireless data transceivers are configured to communicate control signals and data signals between the controller and the sensor circuit.

7. The tissue discrimination system of claim 1, further comprising:

a first wireless data transceiver coupled to the display; and

a second wireless data transceiver coupled to the controller, wherein the first and second wireless data transceivers are configured to communicate control signals and display signals between the controller and the display.

8. The tissue discrimination system of claim 1, further comprising:

an array containing a plurality of waveform electrodes; and

a first switch assembly electronically coupled to the plurality of waveform electrodes and to the controller, the first switch assembly being configured to electrically connect a selected waveform electrode to the sensor circuit in response to a control signal received from the controller.

9. The tissue discrimination system of claim 8, wherein the array containing a plurality of waveform electrodes comprises:

an under layer;

an insulating over layer having a plurality of holes therethrough; and

a plurality of electrical conductors positioned on the under layer such that each of the plurality of electrical conductors is located within a corresponding one of the plurality of holes in the insulating layer, each of the plurality of electrical conductors being electrically coupled to the control circuitry by a corresponding one of a plurality of electrical leads; and

electrolyte substantially filling the volume of each of the plurality of holes in the insulating over layer, the electrolyte being electrically coupled with one of the plurality of electrical conductors within the corresponding one of the plurality of holes in the insulating layer.

10. The tissue discrimination system of claim 1, further comprising:

an array containing a plurality of return electrodes; and

a second switch assembly electronically coupled to the plurality of return electrodes and to the controller, the second switch assembly being configured to electrically connect a selected return electrode to the sensor circuit in response to a control signal received from the controller.

11. The tissue discrimination system of claim 1, further comprising:

an ultrasound imaging system; and

a processor configured to receive data from the controller and the ultrasound imaging system and combine the calculated result with image data from the ultrasound imaging system.

12. The tissue discrimination system of claim 1, further comprising:

a data storage device comprising a database configured to receive and store the calculated result; and

a server coupled to the data storage device and configured to provide access to the database via a network.

13. The tissue discrimination system of claim 1, wherein the calculated result is one of impedance, resistance and reactance.

14. The tissue discrimination system of claim 1, further comprising:

an array of a plurality of waveform electrodes positioned about a cylinder, each of the plurality of waveform electrodes electrically respectively coupled to a plurality of electrical leads;

a handle rotatably coupled to the cylinder;

a cable coupled to the handle; and

a rotatable connector assembly electrically coupled to the electrical leads and to the cable.

15. The tissue discrimination system of claim 1, further comprising:

a sheet comprising a plurality of holes at least some of which are of an area equal to or less than approximately 10 mm², wherein the waveform electrode is configured to be positioned in one or more of the plurality of holes.

16. The tissue discrimination system of claim 1, further comprising:

a fiducial reference marker coupled to the waveform electrode; and

a position sensing system, comprising a processor, and a position sensor configured to sense the fiducial reference marker and provide a signal to the processor, wherein the processor is configured to determine a position of the waveform electrode based upon the signal provided by the position sensor.

17. The tissue discrimination system of claim 1, wherein the waveform electrode comprises:

a body configured to be held by an operator; and

an electrical contactor having a distal and proximal end, where the electrical contactor is coupled to the body at the proximal end, and the distal end comprises an energized portion having an area equal to or less than approximately 10 mm² when placed in contact with skin of a subject.

18. The tissue discrimination system of claim 4, wherein the system is assembled as a unitary package further comprising:

a power supply coupled to the controller; and

a cable coupled between the return electrode and the sensor circuit and configure to permit the return electrode to be separate from but electrically connected to the unitary package,

wherein;

the array assembly containing a plurality of waveform electrodes are positioned on a first side of the unitary package; and

the display is positioned on a second side of the unitary package opposite the first side.

19. A wireless electrode array system suitable for tissue discrimination applications, comprising:

a controller;

a sensor circuit electronically coupled to the controller, the sensor circuit being selected from the group of a voltage sensor, a current sensor and a combination of a voltage and a current sensor;

an electrode array assembly containing a plurality of waveform electrodes, each of the plurality of waveform electrodes having an area no more than approximately 10 mm²;

a switch assembly electronically coupled to the plurality of waveform electrodes, to the sensor circuit and to the controller;

a return electrode electrically coupled to the sensor circuit;

a signal generator electronically coupled to the controller and electrically coupled to the switch assembly and the return electrode, the signal generator being configured to receive a control signal from the controller and, in response to the control signal, generate an electrical signal applied to the waveform electrode and the return electrode; and

a wireless datalink coupled to the controller, the wireless datalink being configured to receive data from the controller and transmit the data via datalink communications, and to receive commands via datalink communications and provide the commands to the controller,

wherein;

the switch assembly is configured to electrically connect a selected waveform electrode to the sensor circuit and to the signal generator in response to a control signal received from the controller; and

the controller is configured to send control signals to the signal generator and the switch assembly, receive data signals from the sensor circuit, receive commands provided by the wireless datalink, and send data signals to the wireless datalink for transmission.

20. The wireless electrode array assembly of claim 19, further comprising:

a housing enclosing the controller, signal generator and wireless datalink; and

a cable electrically coupling the switch assembly to each of the plurality of waveform electrodes in the array assembly,

wherein the return electrode is positioned on an external surface of the housing.