Active electrode, bio-impedance based, tissue discrimination system and methods of use

• US 7,865,236 B2
• Filed: 10/19/2005
• Issued: 01/04/2011
• Est. Priority Date: 10/20/2004
• Status: Expired due to Fees

• Current Assignee: Nervonix, Inc.
• Original Assignee: Nervonix, Inc.
• Inventors: Cory, Phillip C., Cory, Joan M., Schulz, Waldean A.
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): HOLMES, REX R
• Application Number:
  US11/252,568
• Publication Number:
  US 20060085049A1
• Time in Patent Office: 1,903 Days
• Field of Search: 607/2, 607/48, 600/547
• US Class Current: 600/547
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/046 in a matrix array
• 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 method of discriminating a location of nerve tissue within a subject, comprising:

placing a waveform electrode array on skin of the subject, wherein each electrode in the waveform electrode array has an area of no more than approximately 10 mm²;

placing a return electrode on skin of the subject at a position on the skin removed from the waveform electrode array at a linear inter-electrode separation distance that falls within a tail region of an impedance v. distance curve for the subject;

applying a signal serially to each of the electrodes in the waveform electrode array and the return electrode;

measuring a change in a characteristic of the signal resulting from transmission through tissue between each electrode in the waveform array and the return electrode; and

discriminating a location of nerve tissue located beneath the waveform electrode array by processing the measured change in the characteristics of the signal to identify anisotropic features in underlying tissue.

2. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein the applied signal employs a single frequency between approximately 500 Hz and approximately 2500 Hz.

3. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein the measured change in the characteristics of the signal comprises voltage.

4. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein the measured change in the characteristics of the signal comprises current.

5. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein the measured change in the characteristics of the signal comprises a phase shift.

6. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein:

measuring a change in a characteristic of the signal comprises measuring an electrical characteristic at discrete times to generate a data series; and

processing the measured change in the characteristics of the signal to identify anisotropic features in underlying tissue comprises;

using the data series to derive coefficients of a mathematical function approximating the signal resulting from transmission through nerve tissue between each individual electrode in the waveform electrode array and the return electrode; and

using the derived coefficients of the mathematical function to calculate an electrical characteristic of the nerve tissue between each individual electrode in the waveform electrode array and the return electrode.

7. The method of discriminating a location of nerve tissue within a subject of claim 6, wherein the characteristic of the signal resulting from transmission through tissue between each electrode in the waveform array and the return electrode is impedance.

8. The method of discriminating a location of nerve tissue within a subject of claim 6, wherein the characteristic of the signal resulting from transmission through tissue between each electrode in the waveform array and the return electrode is conductance.

9. The method of discriminating a location of nerve tissue within a subject of claim 6, wherein the characteristic of the signal resulting from transmission through tissue between each electrode in the waveform array and the return electrode is susceptance.

10. The method of discriminating a location of nerve tissue within a subject of claim 6, wherein the characteristic of the signal resulting from transmission through tissue between each electrode in the waveform array and the return electrode is reactance.

11. The method of discriminating a location of nerve tissue within a subject of claim 6, wherein the characteristic of the signal resulting from transmission through tissue between each electrode in the waveform array and the return electrode is capacitance.

12. The method of discriminating a location of nerve tissue within a subject of claim 6, wherein

the method is accomplished for each electrode within the waveform electrode array, and

the measured change in the characteristic of the signal associated with each electrode in the waveform electrode array is used to image a discriminated location of nerve tissue beneath the array of waveform electrodes by processing the measured change in the characteristics of the signal to identify anisotropic features in tissue underlying each electrode in the waveform electrode array.

13. The method of discriminating a location of nerve tissue within a subject of claim 12, wherein the image of the discriminated location of nerve tissue is presented on a display device.

14. The method of discriminating a location of nerve tissue within a subject of claim 12, wherein the image is used to generate a data set representing a location of the discriminated nerve tissue within the subject, further comprising storing the data set in a database.

15. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein

the method is repeated a number of times with a number of waveform electrode arrays positioned on a number of different locations on the skin of the subject,

the location of each waveform electrode array is recorded each time,

and the discriminated location of nerve tissue located beneath the waveform electrode array associated with each waveform electrode array location is used to generate a plurality of discriminated locations of nerve tissue beneath the skin of the subject.

16. The method of discriminating a location of nerve tissue within a subject of claim 15, wherein the recorded locations of the waveform electrode array and the plurality of discriminated locations of nerve tissue are used to generate an image of nerve tissue beneath the skin of the subject.

17. The method of discriminating a location of nerve tissue within a subject of claim 16, wherein the generated image of nerve tissue is used to generate a data set representing locations of nerve tissue within the subject, further comprising storing the data set in a database.

18. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein the applied signal employs a single frequency between approximately 1700 Hz and approximately 2000 Hz.

19. The method of discriminating a location of nerve tissue within a subject of claim 1, wherein the linear inter-electrode separation distance is approximately 20 cm.