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Publication numberUS20040158167 A1
Publication typeApplication
Application numberUS 10/722,509
Publication dateAug 12, 2004
Filing dateNov 28, 2003
Priority dateNov 27, 2002
Also published asCA2450968A1, CA2450968C, CA2450971A1, CA2451054A1, CA2451059A1, CA2451059C, EP1571981A2, EP1571982A1, EP1571996A1, EP1573343A1, US7212852, US7457660, US20040171961, US20040181164, US20040243018, WO2004047627A2, WO2004047627A3, WO2004047636A1, WO2004047643A1, WO2004048983A1
Publication number10722509, 722509, US 2004/0158167 A1, US 2004/158167 A1, US 20040158167 A1, US 20040158167A1, US 2004158167 A1, US 2004158167A1, US-A1-20040158167, US-A1-2004158167, US2004/0158167A1, US2004/158167A1, US20040158167 A1, US20040158167A1, US2004158167 A1, US2004158167A1
InventorsKenneth Smith, Frank Zhang, Joel Ironstone
Original AssigneeSmith Kenneth Carless, Frank Zhang, Ironstone Joel Steven
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Apparatus and method for performing impedance measurements
US 20040158167 A1
Abstract
An impedance module for calculating the impedance of a body part creates stimulus currents for injection into the body part and receives resulting voltages generated by the body part The impedance module includes a current generator for generating the stimulus currents, the stimulus currents including a current signal and a complementary current signal thereby forming a differential current signal. The impedance module also includes voltage processing circuitry for pre-processing the received voltages and amplifying the received voltages to generate a measured voltage signal; processing circuitry for creating a current control voltage signal for controlling parameters related to the stimulus currents, and for calculating an impedance value based on the stimulus current and the measured voltage signal, and interface circuitry for interconnecting the components of the impedance module.
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Claims(58)
1. A system for detecting the possibility of disease in one of a first body part and a second substantially similar body part by impedance measurements, the system comprising:
a) a main module for controlling the operation of the system;
b) a front-end module connected to the main module and at least one of the first and second body parts for injecting stimulus currents into the at least one of the first and second body parts and receiving voltages generated by the at least one of the first and second body parts in response to the stimulus currents; and,
c) an impedance module connected to the main module and the front-end module for creating the stimulus currents and determining the impedance of the at least one of the first and second body parts based on the received voltages, wherein the stimulus currents comprise a current signal and a complementary current signal thereby forming a differential current signal.
2. A system as claimed in claim 1, wherein the impedance module comprises a current generator for generating the stimulus currents, the current generator comprising:
a) a first current generation module for generating an internal current signal;
b) a first output impedance unit connected to the first current generation module for generating the current signal based on the internal current signal;
c) a second current generation module connected to the first current generation module for generating an internal complementary current signal; and,
d) a second output impedance unit connected to the second current generation module for generating the complementary current signal based on the internal complementary current signal.
3. A system as claimed in claim 2, wherein the current generator further comprises:
a) a first current shield generator for generating a current shield signal related to the current signal; and,
b) a second current shield generator for generating a complementary current shield signal related to the complementary current signal;
wherein, the current shield signal and complementary current shield signals are provided to the front-end module to shield the current signal and complementary current signal from noise.
4. A system as claimed in claim 3, wherein the first current shield generator includes an amplifier having a gain factor for amplifying the current signal to generate the current shield signal, the gain factor being chosen to provide a negative capacitance.
5. A system as claimed in claim 3, wherein the second current shield generator includes an amplifier having a gain factor for amplifying the complementary current signal to generate the complementary current shield signal, the gain factor being chosen to provide a negative capacitance.
6. A system as claimed in claim 2, wherein the impedance module further comprises:
a) a processing unit for creating a current control voltage signal for controlling parameters related to the stimulus currents; and,
b) a digital-to-analog converter connected to the processing unit for receiving the current control voltage signal and generating an analog current control voltage signal;
wherein, the current generator further comprises:
c) a single-ended differential conversion unit connected to the digital-to-analog converter and the first current generation module for converting the analog current control voltage signal to a differential current control voltage signal.
7. A system as claimed in claim 6, wherein one of the parameters is frequency and the frequency of the generated stimulus currents is given by Fn=F1*Kn where K is a constant and n is an integer greater than or equal to 2.
8. A system as claimed in claim 6, wherein the first current generation module comprises a first gain stage comprising:
a) an amplification stage for amplifying the differential current control voltage signal and converting the amplified differential current control voltage signal to a single-ended amplified current control voltage signal;
b) a filter stage connected to the amplification stage for filtering noise in the single-ended amplified current control voltage signal; and,
c) a feedback stage connected to the amplification stage and the filter stage for feeding back an integrated version of the filtered single-ended amplified current control voltage signal to ensure that the single-ended amplified current control voltage is centered about ground.
9. A system as claimed in claim 8, wherein the first current generation module further comprises a current generation stage connected to the first gain stage for creating the internal current signal, the current generation stage comprising:
a) a second amplification stage for amplifying a difference between the filtered single-ended amplified current control voltage and an integrated version of the internal current signal to generate the internal current signal; and,
b) a second feedback stage connected to the second amplification stage for providing the integrated version of the internal current signal thereto, the second feedback stage comprising:
i) a voltage follower connected to the second amplification stage for following the output of the second amplification stage; and,
ii) an integrator connected to the voltage follower and the second amplification stage for integrating the output of the voltage follower and providing the integrated output to the second amplification stage, the integrated output being the integrated version of the internal current signal.
10. A system as claimed in claim 6, wherein the second current generation module comprises:
a) a phase adjusting stage for receiving the internal current signal and generating a phase-adjusted internal current signal; and,
b) an inverting stage connected to the phase adjusting stage for inverting the phase-adjusted internal current signal to create the internal complementary current signal.
11. A system as claimed in claim 1, wherein the impedance module comprises:
a) a signal conditioning unit for pre-processing the received voltages to produce a single-ended processed measured voltage, the received voltages forming a differential signal and including a first measured voltage signal and a second measured voltage signal; and,
b) a programmable gain unit connected to the signal conditioning unit for providing a plurality of gain levels to the single-ended processed measured voltage to generate a single-ended amplified measured voltage, the gain levels being defined according to Gn=G1*Kn where K is a constant and n is an integer greater than or equal to 2.
12. A system as claimed in claim 11, wherein the signal conditioning unit further comprises
a) a first voltage shield generator for generating a first voltage shield signal related to the first measured voltage signal; and,
b) a second voltage shield generator for generating a second voltage shield signal related to the second measured voltage signal; wherein, the first and second voltage shield signals are provided to the front-end module to shield the first and second measured voltage signals from noise.
13. A system as claimed in claim 12, wherein the first voltage shield generator includes an amplifier having a gain factor for amplifying the first measured voltage signal to generate the first voltage shield signal, the gain factor being chosen to provide a negative capacitance.
14. A system as claimed in claim 12, wherein the second voltage shield generator includes an amplifier having a gain factor for amplifying the second measured voltage signal to generate the second voltage shield signal, the gain factor being chosen to provide a negative capacitance.
15. A system as claimed in claim 11, wherein the signal conditioning unit comprises:
a) a differential input network including:
i) a first filtering stage for removing noise from the first and second measured voltage signals to generate first filtered measured voltages;
ii) a common-mode rejection stage connected to the first filtering stage for removing high frequency common mode noise to generate second filtered measured voltages; and,
iii) a second filter stage connected to the common-mode rejection stage for removing noise from the second filtered measured voltages;
b) a differential voltage amplifier including:
i) an amplification stage for amplifying a difference between the second filtered measured voltages and generating a single-ended measured voltage signal;
ii) a filter stage connected to the amplification stage for filtering the single-ended measured voltage signal; and,
iii) a feedback stage connected to the amplification stage for providing an integrated version of the single-ended amplified measured voltage to the amplification stage.
16. A system as claimed in claim 15, wherein the impedance module further comprises:
a) a processing unit for calculating impedance values based on the stimulus currents and a corresponding digitized single-ended measured voltage signal;
b) an analog-to-digital converter connected to the processing unit for converting the single-ended measured voltage signal to create the digitized single-ended measured voltage signal; and, the programmable gain unit comprises:
c) a programmable gain amplifier including:
i) an amplification stage for amplifying the filtered single-ended measured voltage signal;
ii) a second filter stage connected to the amplification stage for filtering the output of the amplification stage; and,
iii) a variable resistance stage connected to the amplification stage for providing the plurality of gain levels, the variable resistance stage including a multiplexer and a plurality of resistor configurations connected to the output paths of the multiplexer; each resistor configuration being related to each other by the factor K;
d) an output stage connected to the programmable gain amplifier for amplifying and shifting the DC level of the output of the second filter stage to create the single-ended amplified measured voltage.
17. A system as claimed in claim 11, wherein the signal conditioning unit includes a common-mode voltage measurement stage for measuring a common-mode voltage of the received voltages, the impedance module further including a processing unit comprising:
a) a calculator module for calculating impedance values based on the stimulus currents and the received voltages; and,
b) a calibrator module for correcting the calculated impedance values, the calibrator module applying a common-mode calibration step and an impedance calibration step.
18. A system as claimed in claim 17, wherein, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a weighted version of the measured common-mode voltage from the calculated impedance value, the weight being defined by the amount of common-mode voltage rejection provided by the signal conditioning unit.
19. A system as claimed in claim 17, wherein, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a common-mode calibration number obtained from a lookup table, the common-mode calibration value being indexed by the magnitude and phase of the measured common-mode voltage.
20. A system as claimed in claim 17, wherein, for a given calculated impedance value, the impedance calibration step includes correcting the calculated impedance value by applying an impedance calibration factor from a calibration table, the impedance calibration factor being indexed by the gain that is applied by the programmable gain unit, the measurement frequency and the magnitude of the calculated impedance value.
21. A system as claimed in claim 20, wherein the impedance calibration factor is also indexed by the phase of the calculated impedance value.
22. A system as claimed in claim 20, wherein the system further includes a calibration board for generating the calibration table, the calibration board including a plurality of calibration resistors and a plurality of calibration capacitors selectively connectable with one another to form a plurality of calibration impedances, wherein the resistance of the plurality of calibration resistors are related to one another according to Rn=R1*Kn and the capacitance of the calibration capacitors are related to one another according to Cn=C1*Kn and calibration is performed at calibration frequencies related to one another according to Fn=F1*Kn
23. An impedance module for calculating the impedance of a body part, the impedance module creating stimulus currents for injection into the body part and receiving voltages generated by the body part in response to the stimulus currents, the impedance module comprising:
a) a current generator for generating the stimulus currents, the stimulus currents comprising a current signal and a complementary current signal thereby forming a differential current signal;
b) voltage processing circuitry for pre-processing the received voltages and amplifying the received voltages to generate a measured voltage signal;
c) processing circuitry connected to the current generator and the voltage processing circuitry for directing the operation of the impedance module, the processing circuitry including a processing unit for creating a current control voltage signal for controlling parameters related to the stimulus currents, and for calculating an impedance value based on the stimulus current and the measured voltage signal; and,
d) interface circuitry connected to the current generator, the voltage processing circuitry and the processing circuitry.
24. An impedance module as claimed in claim 23, wherein the current generator comprises:
a) a first current generation module for generating an internal current signal;
b) a first output impedance unit connected to the first current generation module for generating the current signal based on the internal current signal;
c) a second current generation module connected to the first current generation module for generating an internal complementary current signal; and,
d) a second output impedance unit connected to the second current generation module for generating the complementary current signal based on the internal complementary current signal.
25. An impedance module as claimed in claim 24, wherein the current generator further comprises:
a) a first current shield generator for generating a current shield signal related to the current signal; and,
b) a second current shield generator for generating a complementary current shield signal related to the complementary current signal;
whereby, in use, the current shield signal and complementary current shield signals are used to shield the current signal and complementary current signal from noise.
26. An impedance module as claimed in claim 25, wherein the first current shield generator includes an amplifier having a gain factor for amplifying the current signal to generate the current shield signal, the gain factor being chosen to provide a negative capacitance.
27. An impedance module as claimed in claim 25, wherein the second current shield generator includes an amplifier having a gain factor for amplifying the complementary current signal to generate the complementary current shield signal, the gain factor being chosen to provide a negative capacitance.
28. An impedance module as claimed in claim 24, wherein the interface circuitry comprises:
a) a digital-to-analog converter connected to the processing unit for receiving the current control voltage signal and generating an analog current control voltage signal; and,
wherein, the current generator further comprises:
b) a single-ended differential conversion unit connected to the digital-to-analog converter and the first current generation module for converting the analog current control voltage signal to a differential current control voltage signal.
29. An impedance module as claimed in claim 23, wherein one of the parameters is frequency and the frequency of the generated stimulus currents is given by Fn=F1*Kn where K is a constant and n is an integer greater than or equal to 2.
30. An impedance module as claimed in claim 24, wherein the first current generation module comprises a first gain stage comprising:
a) an amplification stage for amplifying the differential current control voltage signal and converting the amplified differential current control voltage signal to a single-ended amplified current control voltage signal;
b) a filter stage connected to the amplification stage for filtering noise in the single-ended amplified current control voltage signal; and,
c) a feedback stage connected to the amplification stage and the filter stage for feeding back an integrated version of the filtered single-ended amplified current control voltage signal to ensure that the single-ended amplified current control voltage is centered about ground.
31. An impedance module as claimed in claim 30, wherein the first current generation module further comprises a current generation stage connected to the first gain stage for creating the internal current signal, the current generation stage comprising:
a) a second amplification stage for amplifying a difference between the filtered single-ended amplified current control voltage and an integrated version of the internal current signal to generate the internal current signal; and,
b) a second feedback stage connected to the second amplification stage for providing the integrated version of the internal current signal thereto, the second feedback stage comprising:
i) a voltage follower connected to the second amplification stage for following the output of the second amplification stage; and,
ii) an integrator connected to the voltage follower and the second amplification stage for integrating the output of the voltage follower and providing the integrated output to the second amplification stage, the integrated output being the integrated version of the internal current signal.
32. An impedance module as claimed in claim 24, wherein the second current generation module comprises:
a) a phase adjusting stage for receiving the internal current signal and generating a phase-adjusted internal current signal; and,
b) an inverting stage connected to the phase adjusting stage for inverting the phase-adjusted internal current signal to create the internal complementary current signal.
33. An impedance module as claimed in claim 23, wherein the voltage processing circuitry comprises:
a) a signal conditioning unit for pre-processing the received voltages to produce a single-ended processed measured voltage, the received voltages forming a differential signal and including a first measured voltage signal and a second measured voltage signal; and,
b) a programmable gain unit connected to the signal conditioning unit for providing a plurality of gain levels to the single-ended processed measured voltage to generate a single-ended amplified measured voltage, the gain levels being defined according to Gn=G1*Kn where K is a constant and n is an integer greater than or equal to 2.
34. An impedance module as claimed in claim 33, wherein the signal conditioning unit comprises:
a) a first voltage shield generator for generating a first voltage shield signal related to the first measured voltage signal; and,
b) a second voltage shield generator for generating a second voltage shield signal related to the second measured voltage signal; whereby, in use, the first and second voltage shield signals shield the first and second measured voltage signals from noise.
35. An impedance module as claimed in claim 34, wherein the first voltage shield generator includes an amplifier having a gain factor for amplifying the first measured voltage signal to generate the first voltage shield signal, the gain factor being chosen to provide a negative capacitance.
36. An impedance module as claimed in claim 34, wherein the second voltage shield generator includes an amplifier having a gain factor for amplifying the second measured voltage signal to generate the second voltage shield signal, the gain factor being chosen to provide a negative capacitance.
37. An impedance module as claimed in claim 33, wherein the signal conditioning unit comprises:
a) a differential input network including:
i) a first filtering stage for removing noise from the first and second measured voltage signals to generate first filtered measured voltages;
ii) a common-mode rejection stage connected to the first filtering stage for removing high frequency common mode noise to generate second filtered measured voltages; and,
iii) a second filter stage connected to the common-mode rejection stage for removing noise from the second filtered measured voltages;
b) a differential voltage amplifier including:
i) an amplification stage for amplifying a difference between the second filtered measured voltages and generating a single-ended measured voltage signal;
ii) a filter stage connected to the amplification stage for filtering the single-ended measured voltage signal; and,
iii) a feedback stage connected to the amplification stage for providing an integrated version of the single-ended amplified measured voltage to the amplification stage.
38. An impedance module as claimed in claim 37, wherein the interface circuitry further comprises:
a) an analog-to-digital converter connected to the processing unit for converting the single-ended measured voltage signal to create the digitized single-ended measured voltage signal; and the programmable gain unit comprises:
b) a programmable gain amplifier including:
i) an amplification stage for amplifying the filtered single-ended measured voltage signal;
ii) a second filter stage connected to the amplification stage for filtering the output of the amplification stage; and,
iii) a variable resistance stage connected to the amplification stage for providing the plurality of gain levels, the variable resistance stage including a multiplexer and a plurality of resistor configurations connected to the output paths of the multiplexer; each resistor configuration being related to each other by the factor K;
c) an output stage connected to the programmable gain amplifier for amplifying and shifting the DC level of the output of the second filter stage to create the single-ended amplified measured voltage.
39. An impedance module as claimed in claim 33, wherein the signal conditioning unit includes a common-mode voltage measurement stage for measuring a common-mode voltage of the received voltages, and the processing unit includes:
a) a calculator module for calculating the impedance value; and,
b) a calibrator module for correcting the calculated impedance value, the calibrator module applying a common-mode calibration step and an impedance calibration step.
40. An impedance module as claimed in claim 39, wherein, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a weighted version of the measured common-mode voltage from the calculated impedance value, the weight being defined by the amount of common-mode voltage rejection provided by the signal conditioning unit.
41. An impedance module as claimed in claim 39, wherein, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a common-mode calibration value from a lookup table, the common-mode calibration value being indexed by the magnitude and phase of the measured common-mode voltage.
42. An impedance module as claimed in claim 39, wherein, for a given calculated impedance value, the impedance calibration step includes correcting the calculated impedance value by applying an impedance calibration factor from a calibration table, the impedance calibration factor being indexed by the gain that is applied by the programmable gain unit, the measurement frequency and the magnitude of the calculated impedance value.
43. An impedance module as claimed in claim 42, wherein the impedance calibration factor is indexed by the phase of the calculated impedance value.
44. An impedance module as claimed in claim 39, wherein the impedance module is connectable to a calibration board for generating the calibration table, the calibration board including a plurality of calibration resistors and a plurality of calibration capacitors selectively connectable with one another to form a plurality of calibration impedances, wherein the resistance of the plurality of calibration resistors are related to one another according to Rn=R1*Kn and the capacitance of the calibration capacitors are related to one another according to Cn=C1*Kn and calibration is performed at calibration frequencies related to one another according to Fn=F1*Kn.
45. A method of calculating the impedance of a body part, the method comprising:
a) providing stimulus currents for injection into the body part, the stimulus currents comprising a current signal and a complementary current signal thereby forming a differential current signal;
b) receiving voltages generated by the body part in response to the stimulus currents;
c) pre-processing the received voltages and amplifying the received voltages to generate a measured voltage signal; and,
d) calculating an impedance value based on the stimulus currents and the measured voltage signal.
46. A method as claimed in claim 45, wherein the complementary current signal is 180 degrees out of phase with respect to the current signal.
47. A method as claimed in claim 46, wherein providing the stimulus currents includes generating a first current shield signal related to the current signal for shielding the first current signal, and a second current shield signal related to the complementary current signal for shielding the complementary current signal.
48. A method as claimed in claim 47, wherein the first current shield signal is related to the first current signal by a gain factor, the gain factor being chosen to provide a negative capacitance.
49. A method as claimed in claim 47, wherein the second current shield signal is related to the complementary current signal by a gain factor, the gain factor being chosen to provide a negative capacitance.
50. A method as claimed in claim 46, wherein the frequency of the generated stimulus currents is given by Fn=F1*Kn where K is a constant and n is an integer greater than or equal to 2 and a plurality of gain levels are used for amplifying the received voltages, the gain levels being defined by Gn=G1*Kn.
51. A method as claimed in claim 46, wherein the received voltages form a differential pair including a first received voltage signal and a second received voltage signal, and the method further comprises generating a first voltage shield signal related to the first received voltage signal for shielding the first received voltage signal, and generating a second voltage shield signal related for the second received voltage signal for shielding the second received voltage signal.
52. A method as claimed in claim 51, wherein the first voltage shield signal is related to the first received voltage signal by a gain factor, the gain factor being chosen to provide a negative capacitance.
53. A method as claimed in claim 51, wherein the second voltage shield signal is related to the second received voltage signal by a gain factor, the gain factor being chosen to provide a negative capacitance.
54. A method as claimed in claim 50, wherein pre-processing the received voltages includes measuring a common-mode voltage of the received voltages and calculating the impedance value includes correcting the calculated impedance value by applying a common-mode calibration step and an impedance calibration step.
55. A method as claimed in claim 54, wherein, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a weighted version of the measured common-mode voltage from the calculated impedance value, the weight being defined by the amount of common-mode voltage rejection provided by the pre-processing step.
56. A method as claimed in claim 54, wherein, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a common-mode calibration value obtained from a lookup table, the common-mode calibration value being indexed by the magnitude and phase of the measured common-mode voltage.
57. A method as claimed in claim 54, wherein, for a given calculated impedance value, the impedance calibration step includes correcting the calculated impedance value by applying an impedance calibration factor from a calibration table, the impedance calibration value factor being indexed by the gain level, the measurement frequency and the magnitude of the calculated impedance value.
58. A method as claimed in claim 57, wherein the impedance calibration factor is indexed by the phase of the calculated impedance value.
Description
CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority from provisional application serial No. 60/429,316 filed Nov. 27, 2002.

FIELD OF THE INVENTION

[0002] This invention relates to a system for medical diagnosis of disease and specifically relates to a system for measuring electrical impedances of body parts to diagnose medical disease.

BACKGROUND OF THE INVENTION

[0003] The onset of disease is often accompanied by physical changes in a body part. Some physical changes, while not discernible by a patient, can be detected with appropriate diagnostic equipment, often at a relatively early stage of the disease.

[0004] For example, the electrical impedances of various body tissues are well known through studies on intact humans or from excised tissue made available following therapeutic surgical procedures. In addition, it is well documented that a decrease in electrical impedance occurs in tissue as it undergoes cancerous changes. This finding is consistent over many animal species and tissue types, including, for example human breast cancers. Consequently, electrical impedance may be used to diagnose disease.

[0005] A method that permits comparisons of electrical properties for diagnostic purposes has been developed that involves homologous body parts, i.e., body parts that are substantially similar, such as a left breast and a right breast. In this method, the impedance of a body part of a patient is compared to the impedance of the homologous body part of the same patient. One technique for screening and diagnosing diseased states within the body using electrical impedance is disclosed in U.S. Pat. No. 6,122,544, which is incorporated herein by reference. In this patent, data are obtained from two anatomically homologous body regions, one of which may be affected by disease. Differences in the electrical properties of the two homologous body parts could signal disease.

[0006] Published international patent application, PCT/CA01/01788, which is incorporated herein by reference, discloses a breast electrode array for diagnosing the presence of a disease state in a living organism, wherein the electrode array comprises a flexible body, a plurality of flexible arms extending from the body, and a plurality of electrodes provided by the plurality of flexible arms, wherein the electrodes are arranged on the arms to obtain impedance measurements between respective electrodes. In one embodiment, the plurality of flexible arms are spaced around the flexible body and are provided with electrode pairs, which can be used to make tetrapolar impedance measurements.

[0007] Tetrapolar impedance measurements are associated with injecting current between so called current injection electrodes and measuring a voltage drop between associated electrodes. In a preferred embodiment, the differences between corresponding homologous impedance measurements in the two body parts are compared in a variety of ways that allows the calculation of metrics that can serve either as an indicator of the presence of disease or to localize the disease to a specific breast quadrant or sector.

SUMMARY OF THE INVENTION

[0008] In an RC circuit, the impedance Z, is a complex number, whose real part is the resistance R and whose imaginary part is the capacitive reactance Xc=(ωC)−1, where ω is the frequency at which the voltage (or current) oscillates and C is the capacitance of the circuit. The magnitude of the impedance Z is given by: |Z|=|V|/|/|, and the phase, φ, of the impedance Z is given by: |φ|=|arg (V)−arg (l)|=|tan−1[Xc(ω)/R]|, where / denotes the current and V denotes the voltage.

[0009] A bioelectrical impedance diagnostic system can be used to measure several impedances of a body part, such as a human breast, to diagnose the possibility of disease therein. The diagnostic system includes various leads that connect to the body part via electrodes. The leads are used to inject current and to measure resultant voltages; the currents and voltages thereafter being used to calculate impedances. These impedances may then be used for diagnostic purposes because as disease in a body part progresses, the impedance of the body part changes in a predictable fashion. The greater the number of impedances obtained for different electrical pathways, the better the diagnosis can be.

[0010] In a first aspect, the present invention provides a system for detecting the possibility of disease in one of a first body part and a second substantially similar body part by impedance measurements. The system comprises a main module for controlling the operation of the system, and a front-end module connected to the main module and at least one of the first and second body parts for injecting stimulus currents into the at least one of the first and second body parts and receiving voltages generated by the at least one of the first and second body parts in response to the stimulus currents. The system further comprises an impedance module connected to the main module and the front-end module for creating the stimulus currents and determining the impedance of the at least one of the first and second body parts based on the received voltages. The stimulus currents comprise a current signal and a complementary current signal thereby forming a differential current signal.

[0011] The impedance module preferably comprises a current generator for generating the stimulus currents. The current generator includes a first current generation module for generating an internal current signal; a first output impedance unit connected to the first current generation module for generating the current signal based on the internal current signal; a second current generation module connected to the first current generation module for generating an internal complementary current signal; and, a second output impedance unit connected to the second current generation module for generating the complementary current signal based on the internal complementary current signal.

[0012] The current generator further may comprise a first current shield generator for generating a current shield signal related to the current signal; and, a second current shield generator for generating a complementary current shield signal related to the complementary current signal. The current shield signal and complementary current shield signals are provided to the front-end module to shield the current signal and complementary current signal from noise. The first current shield generator preferably includes an amplifier having a gain factor for amplifying the current signal to generate the current shield signal, the gain factor being chosen to provide a negative capacitance. The second current shield generator preferably includes an amplifier having a gain factor for amplifying the complementary current signal to generate the complementary current shield signal, the gain factor being chosen to provide a negative capacitance.

[0013] The impedance module preferably further comprises a processing unit for creating a current control voltage signal for controlling parameters related to the stimulus currents; and, a digital-to-analog converter connected to the processing unit for receiving the current control voltage signal and generating an analog current control voltage signal. The current generator further preferably comprises a single-ended differential conversion unit connected to the digital-to-analog converter and the first current generation module for converting the analog current control voltage signal to a differential current control voltage signal.

[0014] Preferably, one of the parameters is frequency and the frequency of the generated stimulus currents is given by Fn=F1*Kn where K is a constant and n is an integer greater than or equal to 2.

[0015] The first current generation module comprises a first gain stage that includes an amplification stage for amplifying the differential current control voltage signal and converting the amplified differential current control voltage signal to a single-ended amplified current control voltage signal; a filter stage connected to the amplification stage for filtering noise in the single-ended amplified current control voltage signal; and, a feedback stage connected to the amplification stage and the filter stage for feeding back an integrated version of the filtered single-ended amplified current control voltage signal to ensure that the single-ended amplified current control voltage is centered about ground.

[0016] The first current generation module further preferably comprises a current generation stage connected to the first gain stage for creating the internal current signal. The current generation stage includes a second amplification stage for amplifying a difference between the filtered single-ended amplified current control voltage and an integrated version of the internal current signal to generate the internal current signal; and, a second feedback stage connected to the second amplification stage for providing the integrated version of the internal current signal thereto. The second feedback stage includes a voltage follower connected to the second amplification stage for following the output of the second amplification stage; and, an integrator connected to the voltage follower and the second amplification stage for integrating the output of the voltage follower and providing the integrated output to the second amplification stage, the integrated output being the integrated version of the internal current signal.

[0017] The second current generation module comprises a phase adjusting stage for receiving the internal current signal and generating a phase-adjusted internal current signal; and, an inverting stage connected to the phase adjusting stage for inverting the phase-adjusted internal current signal to create the internal complementary current signal.

[0018] The impedance module further comprises a signal conditioning unit for pre-processing the received voltages to produce a single-ended processed measured voltage, the received voltages forming a differential signal and including a first measured voltage signal and a second measured voltage signal; and, a programmable gain unit connected to the signal conditioning unit for providing a plurality of gain levels to the single-ended processed measured voltage to generate a single-ended amplified measured voltage, the gain levels being defined according to Gn=G1*Kn where K is a constant and n is an integer greater than or equal to 2.

[0019] The signal conditioning unit further comprises a first voltage shield generator for generating a first voltage shield signal related to the first measured voltage signal; and, a second voltage shield generator for generating a second voltage shield signal related to the second measured voltage signal. The first and second voltage shield signals are provided to the front-end module to shield the first and second measured voltage signals from noise. The first voltage shield generator preferably includes an amplifier having a gain factor for amplifying the first measured voltage signal to generate the first voltage shield signal, the gain factor being chosen to provide a negative capacitance. The second voltage shield generator preferably includes an amplifier having a gain factor for amplifying the second measured voltage signal to generate the second voltage shield signal, the gain factor being chosen to provide a negative capacitance.

[0020] The signal conditioning unit comprises a differential input network including a first filtering stage for removing noise from the first and second measured voltage signals to generate first filtered measured voltages; a common-mode rejection stage connected to the first filtering stage for removing high frequency common mode noise to generate second filtered measured voltages; and, a second filter stage connected to the common-mode rejection stage for removing noise from the second filtered measured voltages. The signal conditioning unit further comprises a differential voltage amplifier including: an amplification stage for amplifying a difference between the second filtered measured voltages and generating a single-ended measured voltage signal; a filter stage connected to the amplification stage for filtering the single-ended measured voltage signal; and, a feedback stage connected to the amplification stage for providing an integrated version of the single-ended amplified measured voltage to the amplification stage.

[0021] The impedance module further comprises a processing unit for calculating impedance values based on the stimulus currents and a corresponding digitized single-ended measured voltage signal; and an analog-to-digital converter connected to the processing unit for converting the single-ended measured voltage signal to create the digitized single-ended measured voltage signal. The programmable gain unit comprises a programmable gain amplifier including: an amplification stage for amplifying the filtered single-ended measured voltage signal; a second filter stage connected to the amplification stage for filtering the output of the amplification stage; and, a variable resistance stage connected to the amplification stage for providing the plurality of gain levels, the variable resistance stage including a multiplexer and a plurality of resistor configurations connected to the output paths of the multiplexer; each resistor configuration being related to each other by the factor K. The programmable gain amplifier further comprises an output stage connected to the programmable gain amplifier for amplifying and shifting the DC level of the output of the second filter stage to create the single-ended amplified measured voltage.

[0022] The signal conditioning unit preferably includes a common-mode voltage measurement stage for measuring a common-mode voltage of the received voltages. The impedance module further includes a processing unit comprising: a calculator module for calculating impedance values based on the stimulus currents and the received voltages; and, a calibrator module for correcting the calculated impedance values, the calibrator module applying a common-mode calibration step and an impedance calibration step.

[0023] For a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a weighted version of the measured common-mode voltage from the calculated impedance value, the weight being defined by the amount of common-mode voltage rejection provided by the signal conditioning unit.

[0024] Alternatively, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a common-mode calibration number obtained from a lookup table, the common-mode calibration value being indexed by the magnitude and phase of the measured common-mode voltage.

[0025] For a given calculated impedance value, the impedance calibration step includes correcting the calculated impedance value by applying an impedance calibration factor from a calibration table, the impedance calibration factor being indexed by the gain that is applied by the programmable gain unit, the measurement frequency and the magnitude of the calculated impedance value. The impedance calibration factor may also be indexed by the phase of the calculated impedance value.

[0026] The system further includes a calibration board for generating the calibration table, the calibration board including a plurality of calibration resistors and a plurality of calibration capacitors selectively connectable with one another to form a plurality of calibration impedances, wherein the resistance of the plurality of calibration resistors are related to one another according to Rn=R1*Kn and the capacitance of the calibration capacitors are related to one another according to Cn=C1*Kn and calibration is performed at calibration frequencies related to one another according to Fn=F1*Kn.

[0027] The system as defined above can be used for detecting the possibility of disease in a patient.

[0028] In a second aspect, the present invention provides an impedance module for calculating the impedance of a body part, the impedance module creating stimulus currents for injection into the body part and receiving voltages generated by the body part in response to the stimulus currents. The impedance module comprises a current generator for generating the stimulus currents, the stimulus currents comprising a current signal and a complementary current signal thereby forming a differential current signal; voltage processing circuitry for pre-processing the received voltages and amplifying the received voltages to generate a measured voltage signal; and, processing circuitry connected to the current generator and the voltage processing circuitry for directing the operation of the impedance module, the processing circuitry including a processing unit for creating a current control voltage signal for controlling parameters related to the stimulus currents, and for calculating an impedance value based on the stimulus current and the measured voltage signal; and, interface circuitry connected to the current generator, the voltage processing circuitry and the processing circuitry.

[0029] The current generator comprises: a first current generation module for generating an internal current signal; a first output impedance unit connected to the first current generation module for generating the current signal based on the internal current signal; a second current generation module connected to the first current generation module for generating an internal complementary current signal; and, a second output impedance unit connected to the second current generation module for generating the complementary current signal based on the internal complementary current signal.

[0030] The current generator further comprises: a first current shield generator for generating a current shield signal related to the current signal; and, a second current shield generator for generating a complementary current shield signal related to the complementary current signal. In use, the current shield signal and complementary current shield signals are used to shield the current signal and complementary current signal from noise. The first current shield generator includes an amplifier having a gain factor for amplifying the current signal to generate the current shield signal, the gain factor being chosen to provide a negative capacitance. The second current shield generator includes an amplifier having a gain factor for amplifying the complementary current signal to generate the complementary current shield signal, the gain factor being chosen to provide a negative capacitance.

[0031] The interface circuitry comprises a digital-to-analog converter connected to the processing unit for receiving the current control voltage signal and generating an analog current control voltage signal. The current generator further comprises a single-ended differential conversion unit connected to the digital-to-analog converter and the first current generation module for converting the analog current control voltage signal to a differential current control voltage signal.

[0032] One of the parameters is frequency and the frequency of the generated stimulus currents is given by Fn=F1*Kn where K is a constant and n is an integer greater than or equal to 2.

[0033] The first current generation module comprises a first gain stage comprising an amplification stage for amplifying the differential current control voltage signal and converting the amplified differential current control voltage signal to a single-ended amplified current control voltage signal; a filter stage connected to the amplification stage for filtering noise in the single-ended amplified current control voltage signal; and, a feedback stage connected to the amplification stage and the filter stage for feeding back an integrated version of the filtered single-ended amplified current control voltage signal to ensure that the single-ended amplified current control voltage is centered about ground.

[0034] The first current generation module further comprises a current generation stage connected to the first gain stage for creating the internal current signal, the current generation stage comprising: a second amplification stage for amplifying a difference between the filtered single-ended amplified current control voltage and an integrated version of the internal current signal to generate the internal current signal; and, a second feedback stage connected to the second amplification stage for providing the integrated version of the internal current signal thereto. The second feedback stage comprising: a voltage follower connected to the second amplification stage for following the output of the second amplification stage; and, an integrator connected to the voltage follower and the second amplification stage for integrating the output of the voltage follower and providing the integrated output to the second amplification stage, the integrated output being the integrated version of the internal current signal.

[0035] The second current generation module comprises: a phase adjusting stage for receiving the internal current signal and generating a phase-adjusted internal current signal; and, an inverting stage connected to the phase adjusting stage for inverting the phase-adjusted internal current signal to create the internal complementary current signal.

[0036] The voltage processing circuitry comprises: a signal conditioning unit for pre-processing the received voltages to produce a single-ended processed measured voltage, the received voltages forming a differential signal and including a first measured voltage signal and a second measured voltage signal; and, a programmable gain unit connected to the signal conditioning unit for providing a plurality of gain levels to the single-ended processed measured voltage to generate a single-ended amplified measured voltage, the gain levels being defined according to Gn=G1*Kn where K is a constant and n is an integer greater than or equal to 2.

[0037] The signal conditioning unit optionally comprises: a first voltage shield generator for generating a first voltage shield signal related to the first measured voltage signal; and, a second voltage shield generator for generating a second voltage shield signal related to the second measured voltage signal. In use, the first and second voltage shield signals shield the first and second measured voltage signals from noise. The first voltage shield generator includes an amplifier having a gain factor for amplifying the first measured voltage signal to generate the first voltage shield signal, the gain factor being chosen to provide a negative capacitance. The second voltage shield generator includes an amplifier having a gain factor for amplifying the second measured voltage signal to generate the second voltage shield signal, the gain factor being chosen to provide a negative capacitance.

[0038] The signal conditioning unit comprises a differential input network including: a first filtering stage for removing noise from the first and second measured voltage signals to generate first filtered measured voltages; a common-mode rejection stage connected to the first filtering stage for removing high frequency common mode noise to generate second filtered measured voltages; and, a second filter stage connected to the common-mode rejection stage for removing noise from the second filtered measured voltages. The signal conditioning unit also includes a differential voltage amplifier including: an amplification stage for amplifying a difference between the second filtered measured voltages and generating a single-ended measured voltage signal; a filter stage connected to the amplification stage for filtering the single-ended measured voltage signal; and, a feedback stage connected to the amplification stage for providing an integrated version of the single-ended amplified measured voltage to the amplification stage.

[0039] The interface circuitry further comprises an analog-to-digital converter connected to the processing unit for converting the single-ended measured voltage signal to create the digitized single-ended measured voltage signal. The programmable gain unit comprises a programmable gain amplifier including: an amplification stage for amplifying the filtered single-ended measured voltage signal; a second filter stage connected to the amplification stage for filtering the output of the amplification stage; and, a variable resistance stage connected to the amplification stage for providing the plurality of gain levels, the variable resistance stage including a multiplexer and a plurality of resistor configurations connected to the output paths of the multiplexer; each resistor configuration being related to each other by the factor K. The programmable gain unit also comprises an output stage connected to the programmable gain amplifier for amplifying and shifting the DC level of the output of the second filter stage to create the single-ended amplified measured voltage.

[0040] The signal conditioning unit includes a common-mode voltage measurement stage for measuring a common-mode voltage of the received voltages, and the processing unit includes: a calculator module for calculating the impedance value; and, a calibrator module for correcting the calculated impedance value, the calibrator module applying a common-mode calibration step and an impedance calibration step.

[0041] For a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a weighted version of the measured common-mode voltage from the calculated impedance value, the weight being defined by the amount of common-mode voltage rejection provided by the signal conditioning unit.

[0042] Alternatively, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a common-mode calibration value from a lookup table, the common-mode calibration value being indexed by the magnitude and phase of the measured common-mode voltage.

[0043] For a given calculated impedance value, the impedance calibration step includes correcting the calculated impedance value by applying an impedance calibration factor from a calibration table, the impedance calibration factor being indexed by the gain that is applied by the programmable gain unit, the measurement frequency and the magnitude of the calculated impedance value. The impedance calibration factor may also be indexed by the phase of the calculated impedance value.

[0044] The impedance module is connectable to a calibration board for generating the calibration table, the calibration board including a plurality of calibration resistors and a plurality of calibration capacitors selectively connectable with one another to form a plurality of calibration impedances, wherein the resistance of the plurality of calibration resistors are related to one another according to Rn=R1*Kn and the capacitance of the calibration capacitors are related to one another according to Cn=C1*Kn and calibration is performed at calibration frequencies related to one another according to Fn=F1*Kn.

[0045] The impedance module as defined above can be used for calculating the impedance of a body part of a patient or other biological entity.

[0046] In a third aspect, the present invention provides a method of calculating the impedance of a body part, the method comprising:

[0047] a) providing stimulus currents for injection into the body part, the stimulus currents comprising a current signal and a complementary current signal thereby forming a differential current signal;

[0048] b) receiving voltages generated by the body part in response to the stimulus currents;

[0049] c) pre-processing the received voltages and amplifying the received voltages to generate a measured voltage signal; and,

[0050] d) calculating an impedance value based on the stimulus currents and the measured voltage signal.

[0051] The complementary current signal is 180 degrees out of phase with respect to the current signal.

[0052] The step of providing the stimulus currents optionally includes generating a first current shield signal related to the current signal for shielding the first current signal, and a second current shield signal related to the complementary current signal for shielding the complementary current signal. The first current shield signal is related to the first current signal by a gain factor, the gain factor being chosen to provide a negative capacitance. The second current shield signal is related to the complementary current signal by a gain factor, the gain factor being chosen to provide a negative capacitance.

[0053] The frequency of the generated stimulus currents is given by Fn=F1*Kn where K is a constant and n is an integer greater than or equal to 2 and a plurality of gain levels are used for amplifying the received voltages, the gain levels being defined by Gn=G1*Kn.

[0054] The received voltages form a differential pair including a first received voltage signal and a second received voltage signal, and the method further comprises optionally generating a first voltage shield signal related to the first received voltage signal for shielding the first received voltage signal, and generating a second voltage shield signal related for the second received voltage signal for shielding the second received voltage signal. The first voltage shield signal is related to the first received voltage signal by a gain factor, the gain factor being chosen to provide a negative capacitance. The second voltage shield signal is related to the second received voltage signal by a gain factor, the gain factor being chosen to provide a negative capacitance.

[0055] The step of pre-processing the received voltages includes measuring a common-mode voltage of the received voltages and calculating the impedance value includes correcting the calculated impedance value by applying a common-mode calibration step and an impedance calibration step.

[0056] For a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a weighted version of the measured common-mode voltage from the calculated impedance value, the weight being defined by the amount of common-mode voltage rejection provided by the pre-processing step.

[0057] Alternatively, for a given calculated impedance value, the common-mode calibration step includes identifying the magnitude and phase of the measured common-mode voltage at a pre-defined measurement frequency and correcting the calculated impedance value by subtracting a common-mode calibration value obtained from a lookup table, the common-mode calibration value being indexed by the magnitude and phase of the measured common-mode voltage.

[0058] For a given calculated impedance value, the impedance calibration step includes correcting the calculated impedance value by applying an impedance calibration factor from a calibration table, the impedance calibration value factor being indexed by the gain level, the measurement frequency and the magnitude of the calculated impedance value. The impedance calibration factor may also be indexed by the phase of the calculated impedance value.

[0059] The method as defined above can be used for calculating the impedance of a body part of a patient or other biological entity.

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] For a better understanding of the present invention and to show more clearly how it may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings which show an exemplary embodiment of the present invention and in which:

[0061]FIG. 1 is a block diagram of a medical diagnostic system for diagnosing the possibility of disease;

[0062]FIG. 2 is a block diagram of an impedance module of the medical diagnostic system of FIG. 1;

[0063]FIG. 3a is a block diagram of a current generator of the impedance module of FIG. 2;

[0064]FIG. 3b is a circuit schematic of the single-ended to differential conversion unit of the current generator of FIG. 3a;

[0065]FIG. 3c is a circuit schematic of the first current generation module of the current generator of FIG. 3a;

[0066]FIG. 3d is a circuit schematic of the second current generation module of the current generator of FIG. 3a;

[0067]FIG. 3e is a circuit schematic of the output impedance network of the current generator of FIG. 3a;

[0068]FIG. 3f is a circuit schematic of the current shield generator of the current generator of FIG. 3a;

[0069]FIGS. 3g-1 and 3 g-2 show a circuit schematic of the exemplary embodiments of the sub-blocks of the current generator of FIG. 3a;

[0070]FIG. 4a is a block diagram of the voltage processing modules of the impedance module of FIG. 2;

[0071]FIG. 4b is a circuit schematic of the differential input network of FIG. 4a;

[0072]FIG. 5c is a circuit schematic of the differential voltage amplifier of FIG. 4a;

[0073]FIG. 5d is a circuit schematic of the programmable gain amplifier of FIG. 4a;

[0074]FIG. 4e is a circuit schematic of the output stage of FIG. 4a; and,

[0075]FIGS. 4f-1 and 4 f-2 show a circuit schematic showing of the exemplary embodiments of the components of the voltage processing modules of the impedance module of FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

[0076] Referring to FIG. 1, shown therein is a medical diagnostic system 10 for diagnosing the possibility of disease in one of a first body part and a second substantially similar body part by utilizing impedance measurements. The first body part and the second substantially similar body part can be a homologous anatomical pair, such as, for example, a right breast (i.e. the first body part) and a left breast (i.e. the second body part). The medical diagnostic system 10 interfaces to the parallel and serial data ports of a computing device 12 by means of a parallel and serial data cable, respectively, shown collectively as connection cable 14 (standard IEEE-1284 parallel cables and RS-232 serial cables can be used). Alternatively, the medical diagnostic system 10 may be modified to utilize a different means of connection to the computing device 12, as is commonly known to those skilled in the art, such as a USB connection or the like. The computing device 12 may be a personal computer, laptop or other suitable computing device that is capable of running a medical diagnostic program 16 that employs the homologous impedance measurement method of detecting disease. The computing device 12 can also include means for printing and saving the data that is acquired by the medical diagnostic system 10.

[0077] The medical diagnostic system 10 includes a main module 18, an impedance module 20 and a front-end module 22. The front-end module 22 interfaces to a first electrode array 24 and a second electrode array 26 via a first cable connector 28 and a second cable connector 30 respectively. The first and second cable connectors 28 and 30 may be ribbon cables or the like. The connectors 28 and 30 may be physically connected to one another at the ends that connect with the front-end module 22 and then split apart from one another at the ends that connect with the first and second electrode arrays 24 and 26.

[0078] There are three types of signals pass through each electrode array 24 and 26: current, voltage and ground signals. Conductors for the ground signals are placed, wherever possible, between conductors for every current and every voltage signal in order to isolate the current and voltage signals from each other. The ground signals also allow for an electrical test to confirm that the first and second electrode arrays 24 and 26 have been attached correctly to the cable connectors 28 and 30.

[0079] The computing device 12, when running the medical diagnostic program 16, provides information signals to the medical diagnostic system 10. In particular, the computing device 12 preferably provides information for measurements performed by the front-end module 22, and the power delivered to the medical diagnostic system 10 via the parallel port. The parallel port is used to transfer data signals, control signals and status signals. The computing device 12 also communicates with the impedance module 20 by signals transferred via the serial port.

[0080] The main module 18 controls the operation of the medical diagnostic system 10 and is responsible for system interface, power supply management, and electrical isolation. Accordingly, every other module (i.e. sub-system) of the medical diagnostic system 10 derives its power from the main module 18. The impedance module 20 is responsible for generating currents and measuring voltage signals. The front-end module 22 is responsible for selecting the appropriate electrodes on the first and second electrode arrays 24 and 26 to which generated currents are sent to and measured voltage signals are obtained from. The first and second electrode arrays 24 and 26 are in contact with the respective body parts in order to obtain voltage measurements for calculating the impedances of those body parts.

[0081] The main module 18 includes an interface/control unit 32, a power supply unit 34 and an isolation unit 36. The interface/control unit 32 provides an interface between the computing device 12 and the medical diagnostic system 10. In one embodiment, the interface/control unit 32 includes an RS-232 transceiver 38, a parallel port power generator 40 and a diagnostic multiplexer 42. The RS-232 transceiver 38 provides a bi-directional serial data link between the computing device 12 and the medical diagnostic system 10.

[0082] The parallel port power generator 40 provides a parallel combination of several of the parallel-port signals to provide sufficient current to initiate the operation of an AC line switch 44 which resides within the power supply unit 34. Accordingly, the computing device 12 controls the amount of power that is delivered to the rest of the medical diagnostic system 10 via the parallel port connection. When power is established in the medical device system 10, a feedback connection can be used to maintain the power level. One bit may be used for this feedback.

[0083] The diagnostic multiplexer 42 provides status information regarding the status of the medical diagnostic system 10 to the medical diagnostic program 16. The diagnostic multiplexer 42 can select diagnostic signals related to the connection between the computing device 14 and the main module 18 as well as the quality of the power supply voltages that are provided by the power supply unit 34.

[0084] The power supply unit 34 provides power-supply verification and regulation for the other components of the medical diagnostic system 10. In one embodiment, the power supply unit 34 comprises the AC line switch 44 which is connected to an AC/DC converter 46 by which AC power to the remainder of the medical diagnostic system 10 can be fully controlled. The AC line switch 44 is connected to the AC/DC converter 46 by a fuse 48 in order to provide an acceptable upper limit on the AC current that is provided to the AC/DC converter 46. The AC/DC converter 46 preferably provides two channels of DC signals to the remainder of the medical diagnostic system 10.

[0085] The isolation unit 36 electrically isolates the remainder of the medical diagnostic system 10 from the computing device 12 and the mains supply. Accordingly, the computing device 12 and a portion of the medical diagnostic system 10, which includes the interface/control unit 32 and the power supply unit 34, can be considered to be a ground side and the remainder of the medical diagnostic system 12 can be considered to be an isolated side. The isolation unit 36 comprises opto-couplers 48 through which data and control signals are exchanged between the isolated side and the ground-side. In one embodiment, the number of such signals is eight. The isolation unit 36 also includes an isolated DC/DC converter 50 to transfer power from the ground-side to the isolated side. Accordingly, the power that is supplied to the isolated side is electrically monitored and controlled separately from the power that is supplied to the ground-side. More than one DC/DC converter can be used to provide a larger amount of power to the isolated side. The electrical isolation of the components on the isolated side from the ground-side is approximately 5 kV.

[0086] The impedance module 20 comprises processing circuitry 52, interface circuitry 54, voltage processing circuitry 56 and a current generator 58. The processing circuitry 52 controls the operation of the impedance module 20. In particular, the processing circuitry 52 controls parameters related to the generation of current stimulus signals, the measurement of the resulting voltage signals and the analysis of the voltage and current stimulus signals to calculate impedance values for the first and second body parts. The processing circuitry 52 also includes circuitry for communicating with the main module 18. The voltage processing circuitry 56 processes voltages that are measured by the front-end module 22 at one of the first and second body parts. The voltage processing circuitry 56 includes circuitry for filtering noise from the measured voltages and amplifying the measured voltages. The current generator 58 includes circuitry for generating the stimulus currents for injection to at least one of the first and second body parts. The processing circuitry 52, the voltage processing circuitry 56 and the current generator 58 are connected by the interface circuitry 54. It should be understood by those skilled in the art that the term circuitry includes discrete circuit components as well as integrated circuits such as memory chips, data conversion chips (i.e. analog-to-digital converters, etc.) and programmable logic arrays, for example.

[0087] The front-end module 22 includes a multiplexer controller 22 a, a first multiplexer unit 22 b and a second multiplexer unit 22 c. The first multiplexer unit 22 b is connected to the first electrode array 24 and the second multiplexer unit 22 c is connected to the second electrode array 26. The multiplexer controller 22 a determines which electrodes in the first and second electrode arrays 24 and 26 are used for injecting current into the first and second body parts and which electrodes in the first and second electrode arrays 24 and 26 are used to obtain voltage measurements. The multiplexer controller 22 a provides digital address control to the first and second multiplexer units 22 b and 22 c to select the four connections. The multiplexer controller 22 a is controlled by a processing unit contained within the impedance module 20 or by the computing device 12.

[0088] For each impedance measurement, four connections are preferably made at a time. For instance, using the first electrode array 24 as an example, two connections are made to current injection electrodes and two connections are made to voltage measurement electrodes. The current injection electrodes are used to inject current into the first body part and to output current from the first body part, respectively. The voltage measurement electrodes are used to measure the voltage that is produced across the first body part tissue by the injected current. By using separate electrode pairs for current injection and voltage measurement, polarization effects at the voltage measurement electrodes are minimized and a more accurate measurement of impedance can be produced. In addition, the series resistance of the signal pathways up to and including the skin does not impact the measurement. Furthermore, the electrodes that are used for current injection and those that are used for voltage measurement can be interchanged to provide more measurement data. To facilitate impedance measurement, the front-end module 22 returns the patient input current and the measured voltage from the patient to the impedance module 20 (as well as the computing device 12 for storage and analysis). The front-end module 22 can also return the common-mode voltage of the measured voltage signal, as well as current-shield and voltage-shield voltages (which are further described below).

[0089] Referring now to FIG. 2, shown therein is a block diagram of an embodiment of the impedance module 20. The processing circuitry 52 of the impedance module 20 includes a UART (universal asynchronous receiver/transmitter) 60, a complex programmable logic device (CPLD) 61, a processing unit 62 and a memory unit 64. The interface circuitry 54 includes a bus 66, an analog to digital converter (ADC) 68, and a digital to analog converter (DAC) 70. The voltage processing circuitry 56 includes a signal conditioning unit 72 and a programmable gain unit 74.

[0090] The UART 60 converts serial signals received from the computing device 12 to memory-mapped parallel signals. The UART 60 uses the TTL or a RS232 serial communication standard. The processing unit 62 runs a data acquisition software module (i.e. the DAF module described in more detail below). The processing unit 62 obtains the data signals from the UART 60 via the bus 66. The memory unit 64 is used to store the DAF module so that the instruction code is not lost when there is no power provided to the medical diagnostic system 10. The memory unit 64 also stores calibration information that is used to calibrate raw calculated impedances. In one embodiment, a TI 5400 digital signal processor is used as the processing unit 62 and a FLASH ROM is used as the memory unit 64.

[0091] The CPLD 61 is programmed to include control registers to determine the selection of peripherals, memory mapped registers for controlling other peripherals (such as multiplexers) and memory mapped registers for controlling the communication between the processing unit 62 and the computing device 12.

[0092] The processing unit 62 includes a calculator module 62 a, for calculating impedance values from measured voltage signals and injected current signals, and a calibrator module 62 b for calibrating the measured impedance values. The processing unit 62 includes on chip random access memory (RAM) and controls the ADC 68, the DAC 70, the programmable gain unit 74, and the current generator 58. The function of the processing unit 62 can be controlled by software instructions from the medical diagnostic program 16 as well as the DAF module. In this manner, the performance of the medical diagnostic system 10 can be easily adjusted.

[0093] The memory unit 64 stores the DAF module which is loaded into the on chip RAM of the processing unit 62 upon reset and power-up. The memory unit 64 also stores software that allows the processing unit 62 to poll the UART 60 for new communications data, and to use the new data to direct the action of the processing unit 62. The DAF module allows the processing unit 62 to constantly monitor all signals while polling the UART 60, and to change the following features based on information received from the computing device 12: the shape, magnitude and frequency of the generated current waveform, data sampling parameters, whether to return calibrated or uncalibrated data to the medical diagnostic program 16, and the gain of the programmable gain unit 74.

[0094] The processing unit 62 can vary a number of parameters related to data acquisition. For example, the processing unit 62 can adjust the inter sample delay as well as the number of samples per cycle in order to achieve stimulation and measurement at a wide variety of frequencies. The processing unit 62 can also adjust the number of cycles during which data samples are recorded. This minimizes the effect of noise on the measured voltage signals since the signal to noise ratio of a particular spectral range is proportional to the data acquisition time, as is commonly known to those of skilled in the art. In addition, the processing unit 62 can acquire data for performing a second impedance measurement at saturation to calculate a more precise impedance phase.

[0095] The processing unit 62 can also employ under-sampling analog to digital (A/D) and digital-to-analog (D/A) conversion techniques to record results with more equivalent samples/cycle by employing longer acquisition times. Relevant to under-sampled A/D conversion is the Nyquist criterion, which states that Fs>2*Fb where Fs is the sampling rate and Fb is the bandwidth of the signal in question. When measuring sinusoids, the bandwidth is zero. The only sampling rates that cannot be used to record a sinusoid are integer divisions of the frequency of the sinusoid, i.e. a 10 Hz sinusoid cannot be sampled at a rate of 5 Hz or 2.5 Hz but can be sampled at a rate of 1.76 Hz for example. If an integer division of the frequency of the sinusoid is used, sampling at the same place occurs each period leading to a DC result. Otherwise, missing samples are picked up from the next successive periods of the signal to make a single period of the sampled signal. By not sampling at the same corresponding place every time, every sample yields refining information about the sinusoidal signal.

[0096] In the special case where the sampling rate is given by Fs=Fsinusoid*K(a/a+1), where K is a constant ratio related to the gain values that are provided by the programmable gain unit 74 and a is some positive integer, a signal is acquired that looks exactly like the desired signal to be measured with a sampling rate of K*a samples per cycle. But, in fact, each sample is recorded from a different period. Such results are best obtained with accurate sample timing and a band limited signal. A similar method can be used for D/A conversion. However, a band pass filter instead of the low pass filter is employed resulting in a harmonic generated at the frequency |Fsinusoid-Fs|.

[0097] The ADC 68 and the DAC 70 are connected to the bus 66. The ADC 68 and DAC 70 can be any suitable data converters that provide sufficient resolution and number of channels. For example, the ADC 68 can have 12 bit resolution and 8 channels while the DAC 70 can have 10 bit resolution and 8 channels. The ADC 68 receives both AC and DC diagnostic signals from a multiplexer (the diagnostic signal selector) in the front-end module 22 and relays the diagnostic signals to the processing unit 62 via the bus 66. Diagnostic signals related to current levels can be measured through current measuring resistors. The DC diagnostic signals include +5 V and −5 V power supply voltages, the ADC 68 reference signal voltage, one-half of the ADC 68 reference signal voltage, and the DC offset voltage of the output signal from the DAC 70. The AC diagnostic signals include driven-shield voltages for all current and voltage measuring electrodes, and voltage and current output signal offsets from their nominal values.

[0098] The current generator 58 is connected to the ADC 68 and the DAC 70. The current generator 58 generates current signals in response to control signals that are received from the processing unit 62 via the bus 66 and the DAC 70. The rate at which the control signals are generated by the DAC 70 can be kept relatively low to reduce the power expended. The current generator 58 is also connected to the front-end module 22 to provide a current signal (I+) and a complementary current signal (I−). The current generator 58 is also connected to the ADC 68 to provide signals indicative of the operation of the current generator 76 as well as the complementary current signal I− so that the processing unit 62 can calculate the impedance from corresponding voltage measurements.

[0099] The current generator 58 includes a variable capacitor that controls the phase shift of the complementary current signal (I−), and large series resistors and series capacitors through which the current (I+) and complementary current (I−) signals pass to ensure that variations in load resistance do not significantly affect the operating point of the medical diagnostic system 10. Adjustment of the variable capacitor assures that the current (I+) and complementary current (I−) signals are as balanced as possible to reduce the common mode signal between them. The series resistors and series capacitors also protect the patient from large fault currents. The current generator 76 also includes optional circuitry for generating current shield voltages for both the current (I+) and complementary current (I−) signals, which are the voltages on the current leads themselves reproduced and multiplied by a set factor between 0.5 and 2 using an amplifier. The complementary current signal I− is measured in amplitude and phase and used for the impedance calculation. The current generator 58 is discussed in more detail below.

[0100] The signal conditioning unit 72 is connected to the front-end module 22 and the programmable gain unit 74. The signal conditioning unit 72 includes circuitry for providing differential voltage pre-amplification, common-mode rejection, common-mode measurement and filtering. The signal conditioning unit 72 includes a passive common-mode rejection network into which the measured differential voltage signals V+ and V− are supplied. Shield voltages may be generated, as an option, from the returning voltage signals using circuitry similar to that used to generate the shield signals for the current and complementary current signals I+ and I− The signal conditioning unit 72 is described in more detail below.

[0101] The signal conditioning unit 72 receives the measured voltage signals from the front end module 22 and processes the measured voltage signals, as described above, to produce processed measured voltage signals. The signal conditioning unit 72 then sends the processed measured voltage signals to the programmable gain unit 74. The programmable gain unit 74 amplifies the processed measured voltage signals to produce amplified measured voltage signals which are sent to the processing unit 62 via the ADC 68 and the bus 66.

[0102] The programmable gain unit 74 provides multiple levels of gains which are multiples of one another. In this particular embodiment, six levels of gains are provided according to 1, K, K2, K3, K4, and K5 where K is a constant. This range of gains allows for small processed measured voltage signals to occupy as many bits of the ADC 68 as possible in order to reduce magnitude dependent noise. A programmable gain amplification algorithm is used in conjunction with the programmable gain unit 74 to actively adjust the gain to provide maximum gain while not saturating the output voltage of the programmable gain unit 74. Saturation can be determined by analysis of the second and third harmonics of the amplified measured voltage signals.

[0103] Referring now to FIG. 3a, shown therein is a block diagram of an embodiment 100 of the current generator 58. The current generator 100 includes a single-ended to differential conversion unit 110, a first current generation module 112, a second current generation module 114, a current measurement unit 116, a first output impedance network 118, a second output impedance network 120, a first current shield signal generator 122 and a second current shield signal generator 124. A single-ended current control voltage signal 126 from the DAC 70 is provided single-endedly to differential conversion unit 110 which, in response, generates a differential current control voltage signal 128. Accordingly, the current generator 76 is driven by the output of the DAC 70 which can send arbitrary current waveforms of any frequency.

[0104] The single-ended current control voltage signal 126 is at the same frequency as the generated current and complementary current signals I+ and I− and is preferably a sinusoid. The frequency is chosen to be suitable for bio-impedance applications such as 50 kHz. However, there is an extended range of frequencies that may be used For example, the frequency may be selected according to (50 kHz)*Kn, where K is a constant ratio and is not necessarily an integer, such as 1.7 for example, and n is any positive or negative integer.

[0105] The first current generation module 112 receives the differential current control voltage signal 128 and generates an internal current signal I+int. The internal current signal I+int is provided to the second current generation module 114 which generates an internal complementary current signal I−int which is 180 degrees out of phase with the internal current signal I+int. The internal complementary current signal I−int is measured by the current measuring unit 116 and used as a diagnostic signal for the medical diagnostic program 16 to monitor the operation of the current generator 76. The current measuring unit 116 may include any current measuring circuitry as is commonly known to those skilled in the art. In the embodiment shown in FIG. 4a, the current measuring unit 116 includes a current measuring resistor Rcm, through which the internal complementary current I−int generates a voltage that is measured by a common-mode rejecting instrumentation amplifier 130 (other amplifier arrangements may be used).

[0106] The internal current signal I+int and the complementary internal current signal I−int are sent to the first and second impedance networks 118 and 120 respectively which generate current signal I+ and complementary current signal I−. The first and second impedance networks 118 and 120 preferably have high-output impedance. Consequently, the current and complimentary current signals I+ and I− are each load-independent currents. The first and second impedance networks 118 and 120 are also used to limit the magnitude of the internal current signal I+int and the complementary internal current signal I−int in order to protect the patient. Accordingly, the current signal I+ and complementary current signal I− are limited magnitude versions of the internal current signal I+int and the complementary internal current signal I−int respectively.

[0107] The voltage levels of the current signal I+ and complementary current signal I− are then provided to the first and second current shield generators 122 and 124, respectively, to generate the current shield signal I+S and the complementary current shield signal I−S. The current shield generators 122 and 124 are optional. However, the current shield generators 122 and 124 provide noise and capacitance load reduction in the generated stimulus currents. The current shield generators 122 and 124 can be driven with the same signal that they are shielding or with an amplified or attenuated version of the signal that they are shielding. However, driving a current shield generator with a slightly amplified version of the signal to be shielded allows capacitance above that associated with the measurement leads to be cancelled out. The current shield generators 122 and 124 provide negative capacitance to cancel out the capacitance that is associated with long measurement leads and other stray elements. The current shield signal I+S and the complementary current shield signal I−S are amplitude-adjusted versions of the voltage levels on the leads of the current signal I+ and complementary current signal I− respectively.

[0108] The connection cable between the impedance module 20 and the front-end module 22 comprises four wires. Two of the wires are used for transmitting the current signal I+ and complementary current signal I− to the multiplexer controller 52. The remaining two wires are used for transmitting the current shield signal I+S and the complementary current shield signal I−S. The orientation of the four wires is such that the current shield signal I+S and the complementary current shield signal I−S are used to shield the current and complementary current signals I+ and I− from noise as well as stray capacitance. This is important since the connection cable between the impedance module 20 and the front-end module 22 can be quite long in some cases.

[0109] The current generator 100 generates the current and complementary current signals I+ and I− and provides these signals to the patient as a differential current. This allows a virtual ground to exist between the two current injection points and the voltage measurement points (the current injection points and measurement points correspond to electrodes). This is beneficial for providing a differential voltage measurement in which firstly, there is less common-mode voltage between the two voltage measurements and secondly, the input range of the voltage processing circuitry 56 can be made smaller since the measured voltages are centered about ground and a differential voltage measurement is made. A set of controlled impedances are used in the I+ and I− signal pathways of the current generator 100 so that sources of the current and complementary current signals I+ and I− are balanced with respect to one another. In this way, a virtual ground (or zero voltage) appears between the current and complementary current signals I− and I+. Furthermore, the voltages related to the current signals I+ and I− vary depending on the load in order to maintain a constant current.

[0110] Referring now to FIG. 3b, shown therein is a circuit schematic for an exemplary embodiment 110′ of the single-ended to differential conversion unit 110. The single-ended to differential conversion unit 110′ comprises a network of resistors R5, R6 and R7 and a capacitor C9. One end of the resistor R5 is tied to ground and one end of the resistor R7 is connected to the single-ended current control voltage signal 126. The other ends of the resistors R5 and R7 are connected across the resistor R6. The capacitor C9 is in parallel with the resistor R6. The resistors R5, R6 and R7 act as a voltage divider and the resistor R6 and the capacitor C9 act as a filter.

[0111] Referring now to FIG. 3c, shown therein is a circuit schematic for an exemplary embodiment 112′ of the first current generation unit 112. The first current generation unit 112′ includes a first gain stage 132 and a current generation stage 134. The first gain stage 132 and the first current generation stage 134 collectively employ instrumentation amplifiers U2 and U4 and operational amplifiers U3A, U5A and U5B. Each of the operational amplifiers used in the circuitry shown in FIGS. 3b-4 g are Burr-Brown OPA2743 operational amplifiers. Each of the instrumentation amplifiers used in the circuitry shown in FIGS. 3b-4 g are Burr-Brown INA 128 instrumentation amplifiers. Other suitable operational and instrumentation amplifiers may be used. However, the Burr-Brown instrumentation amplifiers are low power, general-purpose instrumentation amplifiers that offer excellent accuracy. The resistor connected between the ± gain inputs of the Burr-Brown instrumentation amplifiers set the gain and the input R of the Burr-Brown instrumentation amplifiers provide a reference level about which the output of the instrumentation amplifiers is centered.

[0112] In addition, in FIGS. 3b-4 g, resistors are generally added in series with the inputs of amplifiers to limit the current that may flow to the leads connected to the patient in the event that the amplifiers' internal circuitry fails.

[0113] The first gain stage 132 comprises an amplification stage 136, a filter stage 138 and a feedback stage 140. The first gain stage 132 also includes measurement node ROM as shown. The amplification stage 136 comprises the instrumentation amplifier U2 with a resistor R8 connected between the ± gain inputs and the output of the feedback stage 140 providing the reference voltage for the amplifier U2. The input of the instrumentation amplifier U2 is the differential current control voltage signal 128 which the amplifier U2 amplifies with a low gain factor and converts to a single-ended amplified current control voltage signal 128 b.

[0114] The filter stage 138 comprises a resistor R9 and a capacitor C12 connected as a first order low pass filter. The filter stage 138 filters the single-ended amplified current control voltage signal 128 b to remove noise and provide a filtered single-ended current control voltage signal 128 c. Other suitable low-pass filter configurations may be used.

[0115] The filtered single-ended current control voltage signal 128 c is then provided to the feedback stage 140 which processes this signal to provide a reference signal RU2 for the amplifier U2. In this embodiment, the feedback stage comprises an amplifier U3A connected with a resistor R10 and a capacitor C11 in the integrator configuration. The filtered single-ended current control voltage signal 128 c is integrated to generate the reference signal RU2. The integrator configuration of the amplifier U2 acts as an averaging filter. Accordingly, the DC or average value of the filtered single-ended current control voltage signal 128 c is inverted and used as the reference signal RU2 to eliminate any DC bias. The amplifier U3A is an operational amplifier.

[0116] The current generation stage 134 comprises a second amplification stage 142 and a second feedback stage 144. The current generation stage 134 also includes measurement node OSI as shown. The second amplification stage 142 comprises an amplifier U4 with a resistor R11 connected between the ± gain inputs. The second feedback stage 144 provides the reference voltage for the amplifier U4 as well as one of the inputs of the amplifier U4. One input of the amplifier U4 is the filtered single-ended current control voltage signal 128 c and the other input is an integrated version of the a voltage related to the generated internal current signal I+int. The amplifier U4 an instrumentation amplifier that provides a low gain factor. The output current of the amplifier U4 is the internal current signal I+int.

[0117] The second feedback stage 144 comprises a voltage follower 144 a and an integrator 144 b. The voltage follower 144 a includes an operational amplifier U5A having a resistor R13 connected to the non-inverting input of the amplifier U5A and the output of the amplifier U4. The amplifier U5A also has a parallel combination of a resistor R163 and a capacitor C109 connected between the output of the amplifier U5A and the inverting input of the amplifier U5A. The capacitor C109 and the resistor R163 eliminate unwanted oscillations in the output of the amplifier U5A. The internal current signal I+int passes through the resistor R13 to create a voltage that is proportional to the internal current signal I+int. Assuming that amplifier U5A is an ideal op-amp, this voltage appears at the inverting input of amplifier U5A and is provided to the reference voltage input R of the instrumentation amplifier U4 and the input of the integrator 144 b. The voltage follower 144 a is used to ensure that the operation of the instrumentation amplifier U4 is independent of its loading.

[0118] The integrator 144 b comprises an operational amplifier U5B with a resistor R12 and capacitor C13 connected to the amplifier U5B in an integrating configuration. A voltage that is proportional to the internal current signal I+int is integrated by the integrator 144 b and provided to the positive input of the instrumentation amplifier U4.

[0119] Referring now to FIG. 3d, shown therein is a circuit schematic for an exemplary embodiment 114′ of the second current generation module 114. The second current generation module 114′ includes a phase adjusting stage 150, an inverting stage 152 and a current measurement stage 154. The second current generation module 114′ also includes measurement node CH1. The phase adjusting stage 150 adjusts the phase of the internal current signal I+int before it is inputted to the inverting stage 152. The inverting stage 152 inverts the phase of the internal current signal I+int to generate the internal complementary current signal I−int. The current measurement stage 154 is used to measure the internal complementary current signal I−int. The measurement of the current signal I−int is used by the processing unit 62 to calculate impedance values.

[0120] The phase adjusting stage 150 can comprise any phase shifting network. In this exemplary embodiment, the phase adjusting stage 150 comprises a variable capacitor C14 and a resistor R14 connected in series to provide a phase-lead for the internal current signal I+int and generate the phase-adjusted internal current signal I+int,a. The phase adjusting stage 150 is needed to correct for any phase lag that results from the creation of the internal complementary current signal I−int from the internal current signal I+int or from impedance imbalances in the I+ and I− signal pathways.

[0121] The inverting stage 152 comprises an operational amplifier U3B with resistors R16 and R15 configured in the inverting configuration. The resistor R16 is connected between the inverting input and output of the amplifier U3B and the resistor R15 is connected to the inverting input of the amplifier U3B. The negative input of the amplifier U3B receives the phase-adjusted internal current signal I+int,a and provides a phase shift of 180, by applying a gain of −1, thus generating the internal complementary current signal I−int.

[0122] The current measurement stage 154 comprises an instrumentation amplifier U6 and resistors R18, R31, and R32. The resistor R31 is connected between the G−/G+ inputs of the amplifier U6. The amplifier U6 provides a low gain factor of approximately 2. The amplifier U6 is used to measure the current in the I− signal pathway and provide this current to the processing unit 62 via the ADC 68. Accordingly, the voltage RM that provides a voltage reference for the amplifier U6 is the center voltage of the input voltage range of the ADC 68 to ensure that the signal measured at node CH1 is not clipped when being converted by the ADC 68. The measured current refers directly to the amount that has been sent to the load.

[0123] Referring now to FIG. 3e, shown therein is a circuit schematic for an exemplary embodiment of an output impedance network 118′ that can be used for both the first and second output impedance networks 118 and 120. The output impedance network 118′ receives one of the internal current signals (I+int or I−int) and respectively generates the current signal I+ or the complementary current signal I−. The output impedance network 118′ includes a series combination of resistors R17 and R19 with capacitor C15 and a resistor R20 shunted to ground. The resistors R17 and R19 limit the current that is provided to the patient for safety reasons. Both resistors R17 and R19 have to fail in order for a large current to be sent to the patient. The capacitor C15 removes the DC current that is sent to the patient. The resistor R20 provides a DC path to ground so that the voltage on the I+/I− signal pathway does not increase too much as well as providing a DC path to ground for amplification circuitry in the current shield generators 122 and 124.

[0124] Referring now to FIG. 3f, shown therein is a circuit schematic for an exemplary embodiment of a current shield generator 122′ that can be used for both the first and second current shield generators 122 and 124. The current shield generator 122′ comprises an operational amplifier U7B that is in a voltage follower configuration. Resistors R27 and R28 are connected to the non-inverting and inverting inputs of the amplifier U7B. A capacitor C105 is connected between the output and inverting input of the amplifier U7B. Resistors R159 and R30 are connected in series at the output of the amplifier U7B. A variable resistor R29 is connected from the inverting input of the amplifier U7B to between the series resistors R159 and R30. The resistance of the resistor R29 determines the gain of the amplifier U7B (when the resistance of the resistor R29 is zero, the gain of the amplifier U7B is 1). The gain of the amplifier U7B provides flexibility in allowing the current shield generator 122′ to generate a negative capacitance to cancel out the capacitance that occurs in the connection cable between the impedance module 20 and the front-end module 22 as well as capacitance that occurs in circuitry (such as the multiplexers in the front-end module 22 ) that is downstream from the current generator 100. Generally, the gain of the amplifier U7B is in the range of 1.0 to 1.5. Care must be taken in not choosing a high gain since this may lead to the current shield generator 122′ providing too much negative capacitance which will lead to oscillations.

[0125] The output of the current shield generator 122′ is taken from the external node of resistor R30 and a capacitor C103 is shunted to ground at the external node of resistor R30. The resistor R158 and the capacitor C105 eliminate unwanted oscillations from the output of the amplifier U7B and provide a path to ground for very high frequency signals coupled externally to the shield. The resistor R22 is used for protection to the patient in the event that the input resistance of the amplifier U7B degrades. The resistor R24 along with the capacitor C102 provide low-pass filtering. As previously mentioned, these current shield generators are optional.

[0126] Referring now to FIGS. 3g-1 and 3 g-2, shown therein is a circuit schematic showing all of the exemplary embodiments for the sub-blocks of the current generator 76. Additional elements have been added at the output of the first and second impedance networks 122′ and 124′ prior to the connection nodes for the current and complementary current signal I+ and I−. In particular, a capacitor C17, shunted to ground, and in parallel with a ferrite bead L3 has been added in the I+ signal path and a capacitor C18, shunted to ground, and in parallel with a ferrite bead L4 has been added in the I− signal path. The ferrite beads L3 and L4 are used to remove unwanted high-frequency signals/noise from the I+ and I− signal paths. An example for the dimension of the ferrite beads that can be used is a length of 0.2 inches and a diameter of 0.1 inches. The capacitors C17 and C18, along with resistors R19 and R25, respectively, provide low-pass filtering. For the exemplary embodiment shown in FIGS. 4g-1 and 4 g-2, an example of values for the resistors and capacitors that can be used are given in Table 1-1. Relationships that should preferably be maintained between particular components are shown in Table 1-2.

TABLE 1-1
Exemplary component values used in current generator
R5: 4.75
R6: 1
R7: 4.75
R8: 20
R9: 1
R10: 100
R11: 10
R12: 100
R13: 1
R14: 10
R15: 10
R16: 10
R17: 1
R18: 1
R19: 7.5
R20: 1
R21: 100
R22: 100
R23: variable
R24: 100 Ω
R25: 7.5
R26: 1
R27: 100
R28: 100
R29: variable
R30 100 Ω
R31: 50
R32: 100 Ω
R158: 100 Ω
R159: 100 Ω
R163: 100 Ω
C9: 1 nF
C11: 4.7 nF
C12: 470 pF
C13: 4.7 nF
C14: 5-40 pF
C15: 10 nF
C16: 10 nF
C17: 100 pF
C18: 100 pF
C102: 100 pF
C103: 100 pF
C104: 10 pF
C105: 10 pF
C109: 10 pF

[0127]

TABLE 1-2
Component relationships in current generator
R5 = R7
R15 = R16
R17 = R18
R19 = R25
R20 = R26 (≧R19)
R21 = R27 (≧10 kΩ)
R22 = R28 (≦100 kΩ)
R23 = R29 (≧0, ≦1.2 * R22)
R24 = R30
R45 = R46
R158 = R159
C15 = C16
C17 = C18 (≦100 pF)
C102 = C103 (≦100 pF)

[0128] Referring now to FIG. 4a, shown therein is a block diagram of the voltage processing modules of the impedance module 20. In particular, the signal conditioning unit 72 is implemented by a first voltage shield generator 160, a second voltage shield generator 162, a differential input network 164, and a differential voltage amplifier 166. The programmable gain unit 74 is implemented by a programmable gain amplifier 168, and an output stage 170.

[0129] A measured differential voltage signal 172 consists of the measured voltage signals V+ and V− which are each provided by an electrode in at least one of the first and second electrode arrays 24 and 26. The differential input network 164 processes the measured differential voltage signal 172 by filtering and rejecting common-mode voltages to generate a processed differential voltage signal 174. The differential voltage amplifier 166 receives the processed differential voltage signal 174, and amplifies this signal as well as providing a differential to single-ended conversion to generate a single-ended measured voltage signal 176. The programmable gain amplifier 168 amplifies the single-ended voltage signal 176 by applying a variable gain factor to generate an amplified single-ended measured voltage signal 178. The magnitude of the variable gain factor is chosen so that the magnitude of the amplified single-ended measured voltage signal 178 is adjusted to fully occupy the input range of the ADC 68. The output stage 170 then processes the amplified single-ended voltage signal 178 by shifting the DC level of the signal 178 to generate output signal 179. The output stage 170 ensures that the output signal 179 is centered within the input range of the ADC 68 so that the signal 179 can be sampled by the ADC 68 without being clipped.

[0130] The first voltage shield generator 160 and the second voltage shield generator 162 operate on an internal version of the measured differential voltage signal 172 to generate voltage shield signals V+S and V−S for the measured voltage signals V+ and V− respectively. The voltage shield signal V+S and V−S are fed back to the connection cable between the impedance module 20 and the front-end module 22 to reduce the effects of stray capacitance and other noise on the measured differential signals V+ and V− as was done previously for the current and complementary current signals I+ and I−. Accordingly, the current shield generator 122′ (see FIG. 3f) can be used to implement the first and second voltage shield generators 160 and 162. The first and second voltage shield generators 162 and 164 are optional, however, they increase the fidelity of the measurement process by providing a negative capacitance to cancel out stray capacitance in the connection cable between the impedance module 20 and the front-end module 22 as well as capacitance from electronic components that are upstream from the voltage processing circuitry 56.

[0131] Referring now to FIG. 4b, shown therein is a circuit schematic for an exemplary embodiment 164′ of the differential input network 164. The differential input network 164′ includes a first filtering stage 180, a common-mode measurement stage 182, a common-mode rejection stage 184 and a second filter stage 186. The first filter stage 180 comprises ferrite beads L5 and L6 which are followed respectively by capacitors C21 and C22 shunted to ground. The ferrite beads L5 and L6 are used to remove high-frequency noise from the measured voltage signals V+ and V− respectively. An example for the dimension of the ferrite beads that can be used is a length of 0.2 inches and a diameter of 0.1 inches. The capacitors C21 and C22 also filter out high-frequency noise. The first filter stage 180 provides a first filtered measured signals V+f and V−f.

[0132] The common-mode measurement stage 182 includes a series connection of resistors R164 and R165 connected in parallel with the signal paths for the first filtered measured voltage signals V+f1 and V−f1. The node between the resistors R164 and R165 provides a measurement node CM for measuring a voltage signal that is directly proportional to the common mode voltage of the first filtered measured signal V+f1 and V−f1. The measured common-mode voltage is monitored by the processing unit 62 and the medical diagnostic program 16. The measured common-mode voltage is used by the processing unit 62 to correct the calculated impedance values since the common-mode voltage is not entirely removed from the measured voltages by the voltage processing circuitry 56.

[0133] The common-mode rejection stage 184 includes a parallel connection of a capacitor C23 and along with series-connected resistors R41 and R42. The resistors R41 and R42 are used to provide a ground reference at the inputs and a current path to ground for the bias currents of the voltage shield generators 160 and 162. The capacitor C23 is used to filter out the high-frequency difference-mode components of the first filtered measured voltage signals V+f1 and V−f1 to produce second filtered measured voltage signals V+f2 and V−f2. The upper node where the capacitor C23 is connected to the V+ signal path is used to provide an input voltage for the first voltage shield generator 160 and the lower node where the capacitor C23 is connected to the V− signal path is used to provide an input voltage for the second voltage shield generator 162.

[0134] The second filtering stage 186 receives the second filtered measured voltage signals V+f2 and V−f2 and performs low-pass filtering on these signals to generate a third measured voltage signal which corresponds to the processed differential voltage signal 174. The second filtering stage 186 begins with a series connection of capacitor C24 and resistor R45 in the V+ signal path and a series connection of capacitor C25 and resistor R46 in the V− signal path. A series connection of resistors R43 and R44 is connected across the V+ signal path (between the capacitor C24 and the resistor R45) and the V− signal path (between the capacitor C25 and the resistor R46). The node between the resistors R43 and R44 is connected to ground. In the V+ signal path, a capacitor C26 is shunted to ground and connected to the other node of resistor R45. Likewise, in the V− signal path, a capacitor C28 is shunted to ground and connected to the other node of resistor R46. A capacitor C27 is connected between the capacitors C26 and C28.

[0135] The capacitors C24 and C25 remove the DC components in the measured voltage signals V+f2 and V−f2. The resistors R43 and R44 provide a DC path to ground for the differential voltage amplifier 166. The resistor R45 and the capacitor C26 provide low-pass filtering in the V+ signal path. Likewise, the resistor R46 and the capacitor C28 provide low-pass filtering in the V− signal path. The capacitor C27 reinforces coupling of noise that is common to both the V+ and V− signal paths and filters differential noise, thereby restricting the amount by which the common-mode signals are converted to difference-mode signals by the ground-connected filter capacitors.

[0136] Referring now to FIG. 4c, shown therein is a circuit schematic for an exemplary embodiment 166′ of the differential voltage amplifier 166. The differential voltage amplifier 166′ includes an amplification stage 190, a feedback stage 192 and a filter stage 192. The amplification stage 190 includes an instrumentation amplifier U9 with a high common-mode rejection ratio. The amplifier U9 amplifies the processed differential voltage signal 174 and generates a single-ended measured voltage signal Vs. The amplifier U9 has resistor R49 connected across the gain inputs G+/G−. The amplifier U9 also has input resistors R47 and R48 connected to the inverting and non-inverting inputs respectively for limiting the input current to the amplifier U9.

[0137] The feedback stage 192 includes an operational amplifier U10B which has the non-inverting input tied to ground, a feedback capacitor C30 connected between the inverting terminal and the output terminal and a resistor R54 connected to the inverting input. Accordingly, the amplifier U10B is configured in an integrator configuration. The resistor R54 is also connected to an internal node within the programmable gain amplifier 168 to provide an indication of the amplified single-ended measured voltage signal 178. This signal is integrated by the amplifier U10B and used as the reference input to the amplifier U9. In this fashion, the amplifier U10B can track changes in the DC level of the amplified single-ended measured voltage signal 178 and adjust the output signal Vs to ensure that this signal is centered about ground. A measurement node OSV is connected to the output of the amplifier U10B to monitor the performance of the amplifier U10B.

[0138] The filter stage 192 receives the single-ended measured voltage signal Vs and filters this signal to generate the single-ended measured voltage signal 176. The filter stage 192 is a single-order low-pass filter network comprising a series connected resistor R50 and a capacitor C29 shunted to ground. Other low-pass filter networks may also be used, however care must be taken with higher-order filter networks since they may present an increasingly indefinite phase lag to the measured voltages.

[0139] Referring now to FIG. 4d, shown therein is a circuit schematic for an exemplary embodiment 168′ of the programmable gain amplifier 168. The programmable gain amplifier 168′ includes an amplifier stage 200, a variable resistance stage 202 and a filter stage 204. The amplifier stage 200 includes an operational amplifier U10A configured as a voltage follower. The non-inverting input of the amplifier U10A receives the single-ended measured voltage signal 176 and the inverting input receives feedback from the output of the amplifier U10A via a capacitor C108. The output terminal of the amplifier U10A is connected to a first node of series resistor 162. The inverting terminal of the amplifier U10A is also connected to the variable resistance stage 202 so that the amplifier U10A can provide a variable amount of gain to the single-ended measured voltage signal 176. The capacitor C108 and the resistor R162 eliminate unwanted oscillations from the output of the amplifier U10A.

[0140] The gain of the amplifier U10A is determined by the variable resistance stage 202. The variable resistance stage 202 includes a plurality of resistors R55, R56, R57, R58, R59 and R60 with different resistance values connected to a multiplexer U12. The input of the multiplexer U12 is connected to the inverting input of the amplifier U10A and one of the eight output paths of the multiplexer U12 (i.e. outputs X0, X1, X2, X3, X4, X5, X6 or X7) is connected to the second node of the resistor R162 through a variety of combinations of the resistors R55, R56, R57, R58, R59 and R60. The selection inputs of the multiplexer U12 (inputs A, B, C) are connected to control signals provided by the processing unit 62. The processing unit 62 selects one of the eight output paths of the multiplexer U12 based on the desired gain for the amplifier U10A. The desired output path is selected in accordance with a variable gain algorithm that is implemented by the processing unit 62.

[0141] The paths associated with outputs X1, X2, X3, X4, X5, X6 or X7 provides an equivalent resistor Req that is the parallel combination of two combination resistors RC1 and RC2. The combination resistors RC1 and RC2 are formed from a series combination of resistors selected from R55, R56, R57, R58, R59 and R60. For instance the output path associated with output X0 results in combination resistor RC2 equal to the series combination of resistors R55, R56, R57, R58, R59 and R60 and combination RC1 equal to 0 Ω. The output path associated with output X1 results in combination resistor RC2 equal to the series combination of resistors R56, R57, R58, R59 and R60 and combination RC1 equal to resistor R55. The output path associated with output X2 results in combination resistor RC2 equal to the series combination of resistors R57, R58, R59 and R60 and combination RC1 equal to the series combination of resistors R55 and R56. The output path associated with output X3 results in combination resistor RC2 equal to the series combination of resistors R58, R59 and R60 and combination RC1 equal to the series combination of resistors R55, R56, and R57. The output path associated with output X4 results in combination resistor RC2 equal to the series combination of resistors R59 and R60 and combination RC1 equal to the series combination of resistors R55, R56, R57 and R58. The output path associated with outputs X5, X6 or X7 results in combination resistor RC2 equal to resistor R60 and combination RC1 equal to the series combination of resistors R55, R56, R57, R58 and R59.

[0142] The combination resistor RC1 is effectively connected between the inverting input of the amplifier U10A and the second node of resistor R162 and the combination resistor RC2 is effectively connected between the inverting terminal of the amplifier U10A and ground. The values of the combination resistors RC1 and RC2 are selected to ensure that the gains provided by the amplifier U10A is in accordance with GN=G1*KN as well as for calibration.

[0143] The filter stage 204 receives the output of the amplifier U10A and filters this signal to provide the amplified single-ended measured voltage signal 178. The filter stage 204 is a first order low pass filter network which includes a series resistor R51 and a capacitor C31 shunted to ground. However, the filter stage 204 can be any low-pass filter stage.

[0144] Referring now to FIG. 4e, shown therein is a circuit schematic for an exemplary embodiment 170′ of the output stage 170. The output stage 170′ includes an instrumentation amplifier U11 configured for unity gain. A resistor R53 is connected to the output of the amplifier U11. The output signal 179 is provided to the ADC 68. Accordingly, the reference input RM of the amplifier U11 is provided by the reference of the ADC 68 to ensure that the output signal 179 is centered about the mid-point of the input range of the ADC 68 so that the ADC 68 can sample the output signal 179 without clipping.

[0145] Referring now to FIGS. 4f-1 and 4 f-2, shown therein is a circuit schematic showing all of the exemplary embodiments of the components of the voltage processing modules of the impedance module 20. For the exemplary embodiment shown in FIGS. 5f-1 and 5 f-2, an example of the values of the resistors and capacitors that can be used are given in Table 2-1. Relationships that should preferably be maintained between particular components are shown in Table 2-2.

TABLE 2-1
Exemplary component values used in voltage measurement
R33: 100 Ω
R34: variable
R35: 100
R36: 100
R37: 100 Ω
R38: variable
R39: 100
R40: 100
R41: 1
R42: 1
R43: 1
R44: 1
R45: 10
R46: 10
R47: 100
R48: 100
R49: 11
R50: 1
R51: 1
R42: 1
R52: 10
R53: 100 Ω
R54: 100
R55: 4.12
R56: 2.43
R57: 1.43
R58: 845 Ω
R59: 499 Ω
R60: 698 Ω
R160: 100 Ω
R161: 100 Ω
R162: 100 Ω
R164: 50
R165: 50
C19: 100 pF
C20: 100 pF
C21: 10 pF
C22: 10 pF
C23: 10 pF
C24: 10 nF
C25: 10 nF
C26: 10 pF
C27: 47 pF
C28: 10 pF
C29: 100 pF
C30: 4.7 nF
C31: 100 pF
C106: 10 pF
C107: 10 pF
C108: 10 pF

[0146]

TABLE 2-2
Component relationships in voltage measurement
R33 = R37
R34 = R38 (≦1.2 Ω)
R35 = R39 (≦100 kΩ)
R36 = R40 (≧10 kΩ)
R41 = R42
R43 = R44
R45 = R46
R47 = R48 (≦100 kΩ)
R55 = K4 (K − 1) * R60
R56 = K3 (K − 1) * R60
R57 = K2 (K − 1) * R60
R58 = K (K − 1) * R60
R59 = (K − 1) * R60
R160 = R161
R164 = R165
C19 = C20
C21 = C22 (≦C23)
C24 = C25
C26 = C28 (≦C27)

[0147] The design of the current generator 58, the signal conditioning unit 72 and the programmable gain unit 74 shown herein allow the impedance module 20 to be attached to the front-end module 22 through a highly parasitic interface as well as configurations that have a high common mode while continuing to measure both magnitude and phase correctly.

[0148] The processing unit 62 includes a calculator module 62 a for converting measured voltages and currents into impedance values. The calculator module 62 a may be implemented in software or hardware. To calculate an impedance value, the calculator module 62 a calculates, at the measurement frequency, the ratio of the magnitude of the measured return voltage and magnitude of the generated current, and the difference between the phase of the measured return voltage and the generated current.

[0149] The processing unit 62, in conjunction with the calculator module 62 a, may vary the number of samples/cycle and the number of acquisition cycles to maintain a minimum signal to noise ratio. The processing unit 62 may also instruct the ADC 68 to perform under-sampling since the measured signals are sinusoids that ideally have zero bandwidth. High-speed analog-to-digital converters and digital-to-analog converters are power hungry and therefore unsuitable for most biomedical instrumentation applications. Accordingly, under-sampling, which involves using a lower sampling rate, results in lower power consumption.

[0150] The processing unit 62 also includes the calibrator module 62 b for correcting calculated impedances for systematic imperfections in the measurement system. The calibrator module 62 b may be implemented in software or hardware. The calibration performed by the calibrator module 62 b allows the impedance module 20 to be connected to a wide variety of interfaces while retaining precision and accuracy in voltage measurement. The calibration process includes two-steps: 1) impedance calibration and 2) common-mode calibration. The sequence of these steps does not matter as long as one always uses the same sequence of steps.

[0151] The common-mode calibration step involves reducing the common-mode in the measured voltage signal. Although, the instrumentation amplifiers used in the signal conditioning unit 72 have a high common-mode rejection ratio, the rejection is not perfect. In addition, as frequencies increase, the common-mode rejection ratio of these amplifiers degrades. Consequently, a common-mode voltage, which generally has a different phase from the impedance phase, remains in the processed measured voltages and prevents the accurate measurement of differential voltage phase. To improve common-mode rejection, the calibrator module 62 b calculates the magnitude and the phase of the measured common-mode signal at the frequency of the current signals I+ and I− (see node CM between resistors R164 and R165 in the differential input network 164′ shown in FIG. 4b). The measured voltage is then corrected with the measured common-mode signal in one of two fashions. The first way to correct the measured voltage signal for common-mode voltage is to use a weighted subtraction of the measured common-mode signal. The second way to correct the measured voltage signal for common-mode voltage is to use a lookup table indexed with the magnitude and phase of the measured common-mode signal. Either of these common-mode calibration schemes can be used.

[0152] In the weighted subtraction common-mode calibration method, the weight used is related to the common-mode rejection ratio of the differential voltage amplifier 166 and the amount of filtering provided by the common-mode rejection stage 184. For instance, if the common-mode rejection stage 184 provides 20 dB of attenuation and the common-mode rejection ratio of the differential voltage amplifier 166 is 100 dB, then the weight is −120 dB or 10−6.

[0153] In the second method of common-mode voltage correction, the lookup table can be generated by presenting a variety of known common-mode voltages on a standard measurement load, at the input of the voltage processing circuitry 56 and then measuring the common-mode voltage in the processed measured voltages to obtain complex correction numbers. The lookup table is constructed by using the magnitude and phase of the known common-mode voltages as indices into the lookup table and the entries in the lookup table are the corresponding common-mode calibration values (which are generally complex numbers). The common-mode calibration value is subtracted from the measured common-mode voltage. If the measured common-mode voltage has a magnitude and phase that falls between the magnitude and phase indices used to create the lookup table, then interpolation can be used to obtain the common-mode calibration value. The interpolation may be linear, logarithmic or polynomial.

[0154] The impedance calibration step involves converting measured complex impedance values to “true” impedance values by reducing systematic errors (due to the measurement circuitry) from the measured voltage values. These errors exist as a result of the reactive and resistive elements in the measurement signal path. In particular, the impedance calibration step reduces the effects of phase shifts and attenuations in all of the amplifiers in the signal conditioning unit 72 and the dependence of these effects on the frequency, load magnitude, and the gain of the programmable gain unit 74. To facilitate impedance calibration, the impedance calibration step employs the use of a set of multipoint calibration tables. A set of such tables is required since at each gain, at each stimulus frequency and at each load, the systematic errors are different and calibration is required at all possible operating points. The calibration step is done before the medical diagnostic system 10 is used to obtain impedance measurements. Thereafter, the calibration step can be done periodically to ensure that the calibration tables are up-to-date. The set of calibration tables can be stored in the memory unit 64. The appropriate calibration table, as determined by the frequency used for the injection current, can then be retrieved from the memory unit 64 as required by the processing unit 62 when calculating impedance values.

[0155] Calibration values for a particular calibration table are generated by keeping the stimulus frequency constant and varying the magnitudes of the calibration impedance and the gain levels provided by the programmable gain unit 74. The calibration values in a column of the calibration table can be obtained by performing measurements with a constant gain while increasing the magnitude of the calibration impedance. The calibration values in a row of the calibration table can be obtained by performing measurements on a constant calibration impedance while increasing the gain of the programmable gain unit 74. This measurement process is repeated for different stimulus frequencies. The result is a set of calibration tables with each table corresponding to a particular stimulus frequency.

[0156] While performing the calibration measurements, a common constant ratio K is used to guarantee monotonicity across all gain ranges, and the use of a minimal set of calibration impedances. The constant ratio K preferably has a value that is greater than one and generally less than two. The calibration is performed for gain levels defined by GN=G1*KN where G1 may be 1 for example. Likewise, the frequencies at which calibration is done is also related by the constant factor K in as defined by FN=F1*KN where the frequency F1 is 50 kHz for example. Accordingly, the constant ratio K is used to determine the various combinations and values of the resistors R55, R56, R57, R58, R59 and R60 in the variable resistance stage 202 (see FIG. 4d) of the programmable gain amplifier 168 as well as the spacing of the frequency that is used for the current and complementary current I+ and I− (stimulus) injection signals generated by the current generator 58.

[0157] The result of the constant ratio K is a unique diagnostic calibration table in which, if all system components were ideal, the calibration values in a given row of the calibration table would be K times the calibration values in the row just above the given row and the calibration values in a given column of the calibration table would be K times the calibration values in the column just to the left of the given column. Accordingly, the calibration table can be verified for validity by basing one or more metrics on the self-consistency of the data in the calibration table since the calibration table can be approximately predicted by knowing any single value in it and the factor K. Correspondingly, an enormous amount of data can be extracted from a single calibration table in this way, and errors in calibration (which would certainly cause measurement problems) will be easily identified. Overall, the calibration table provides data on how the system performs at different frequencies while measuring different loads with a certain phase at different gains, and can be used to completely characterize the medical diagnostic system 10 as a whole.

[0158] The impedance calibration step involves connecting a calibration board (not shown) that has a calibration impedance network to either one of the first multiplexer unit 54 or the second multiplexer unit 56 instead of the first and second electrode arrays 24 and 26. The calibration board may be internal or external to the medical diagnostic system 10. Alternatively, the calibration board may be connected to the voltage processing circuitry 56 of the impedance module 22 via selection circuitry such as a multiplexer or the like or via connection leads that are manually connected to the different calibration impedances on the calibration board. The calibration network comprises a plurality of resistors and capacitors that are selectively connected in series to form a calibration impedance. The resistance of the calibration resistors are related to one another according to RN=R1*KN where the resistance R1 can be 10 Ω, for example, and the capacitance of the capacitors are related to one another according to CN=C1*KN where the capacitance C1 can be 0.1 μF for example.

[0159] The result of using the constant ratio K for the selection of the calibration resistor values and the calibration capacitor values is the optimum reuse of the calibration resistors and the calibration capacitors for calibration at different calibration frequencies. For instance, at a particular operating frequency F=FN, for a calibration impedance consisting of a series combination of a calibration resistor RN and a calibration capacitor CN, the phase is phase1=tan−1 (RN*CN*FN) At an operating frequency F=FN+1, the same load has a phase of phase2=tan−1 (RN*CN*FN+1). In order for the measured calibration loads to have an identical phase at both frequencies (i.e. phase2=phase1), since FN+1=K*FN the required value of the calibration capacitance is CN/K. The capacitance value of CN/K is provided by the capacitor CN−1 which exists on the calibration board. Similarly, the value of the calibration capacitor required for a calibration resistor having a resistance value of RN+1 when the operating frequency is FN, is the same calibration capacitor that is required by a calibration resistor having a resistance value of RN when the operating frequency is FN+1. Accordingly, a small set of calibration resistors and calibration capacitors on the calibration board can span the complete required set of calibration impedances.

[0160] As an example, if 16 calibration elements are used for the calibration network, there can be 12 calibration resistors and 4 calibration capacitors or alternatively 11 calibration resistors and 5 calibration capacitors. Generally, there are more calibration resistors on the calibration board than calibration capacitors because in practice the magnitude range for measured impedance values is larger than the phase range. In this example, there are 12 completely reactive possibilities, 131 purely resistive possibilities and 48 mixed reactive/resistive possibilities.

[0161] In general, the rows of a given calibration table are indexed by the impedance magnitude and the columns of the calibration table are indexed by the gain of the programmable gain unit 168. When an impedance value is calculated, the frequency of the stimulus current determines which table is used and the gain of the programmable gain unit 168 determines which column is used to obtain an impedance correction factor from the table. The row of the table is given by the magnitude of the measured impedance. The calculated impedance value is then multiplied by the correction value to obtain a corrected or “true” impedance value. However, if the magnitude of the measured impedance does not correspond with the magnitude of one of the calibration impedances, then interpolation is used on the correction values within the appropriate column of the calibration table to determine a suitable correction value. The interpolation may be linear, exponential or the like.

[0162] Thus far, the generation of the calibration tables have assumed that there are only magnitude variations in the measurement of an impedance value as the gain or frequency used by the impedance module 20 is varied. However, there can also be instances in which there are also phase variations in the measurement of an impedance value as the gain or frequency used by the impedance module 20 is varied. In this case, the calibration tables may be generated such that there is a variation in the calibration impedance. It is assumed that the phase variation is linear and so two calibration tables are generated for each stimulus frequency in which the phase of the calibration impedances is kept constant for each table but there is a phase difference between the calibration impedance for the pair of calibration tables. For instance, one calibration table may be generated based on calibration impedances that have a phase of 0 degrees the other calibration table may be generated based on calibration impedances that have a phase of 10 degrees, for example. In this case, when obtaining the correction factor based on the magnitude and phase of a measured impedance, if the phase does not correspond to one of the phases used to generate the tables at a particular stimulus frequency, then linear interpolation can be used to obtain an appropriate correction value. This interpolation may also include an interpolation on the impedance magnitudes used to generate the calibration tables thus resulting in a interpolation across two dimensions.

[0163] The medical diagnostic software program 16 comprises two software modules: the TAS (Test and Analysis software) and DAS (Data Acquisition software) modules that operate on the computing device 12. The TAS module is a graphical user interface that provides an interface to allow a user to initiate impedance testing and view and analyze the resulting impedance values. The DAS module operates in conjunction with the TAS module to set test parameters and obtain test data for analysis and viewing. The TAS module interfaces with the DAF (Data Acquisition Firmware) which resides in the impedance module 20 and directs the activities of the impedance module 20. The DAS and the DAF modules communicate through the serial interface between the computing device 12 and the medical diagnostic system 10.

[0164] The DAF module remains in an idle state until commands are received which cause it to act. While idle, the DAF module constantly monitors all system information available to it. The magnitude of each DC voltage supply level as well as the ripple of each DC voltage supply level is available to the DAF module through the ADC 68. The most recent measurements of these signals is stored in the memory unit 64 and can be accessed through commands sent to the DAF module via the serial link from the computing device 12. If any of these measurements is outside a pre-defined acceptable range, the next measurement returned to the DAF module will be an error code detailing the problem.

[0165] When the impedance module 20 is first powered-on or reset, the DAF module is loaded into the on-chip memory of the processing unit 62 from the memory unit 64. The on-chip program memory of the processing unit 62 is compared to that in the memory unit 64 to ensure that this process was completed successfully. Once this is verified, the DAF module verifies all impedance module 20 power levels and initializes the impedance module 20 to perform voltage measurements at a pre-determined frequency such as 50 kHz for example. The initialization at the pre-determined frequency involves downloading a calibration table from the memory unit 64 into the on-chip memory of the processing unit 62 as well as the pre-calculation of a period of an appropriate sinusoid to be used for current injection. Before the calibration table is used for impedance calibration, the calibration table is screened for the integrity of the calibration values. Any problem with the calibration table results in an error code being returned to the DAS module in place of the calibrated impedance data. The processing unit 62 can also send the calibration data to the processing device 12.

[0166] The DAF module generates the input current signal by writing a digital control signal to the DAC 70 which in turn provides a corresponding analog signal to the current generator 58. The digital control signal comprises a pre-calculated sinusoidal period that is repeated, sample-by-sample, for a predetermined number of periods. In one embodiment, the current generator 58 converts 16 samples/cycle at frequencies below 75 kHz and 8 samples/cycle at frequencies above 75 kHz. The impedance module 20 then sends the generated current signal to the selected electrodes.

[0167] The DAF module directs data acquisition by instructing the ADC 68 to sample a data value between each converted output of the DAC 70 to the current generator 76. The ADC 68 alternates between acquiring a differential voltage data sample and a current data sample. Accordingly, in this embodiment, the data acquisition sampling rate is half the stimulus (i.e. current injection) sampling rate. For higher frequencies, and in other cases where higher acquisition sampling rates are required for data acquisition, all current samples can be acquired first, followed by all voltage samples. In the second case, the data acquisition occurs for twice the number of sinusoidal periods. The total number of acquired data samples in both cases is exactly the same.

[0168] The DAF module calculates an impedance value at a particular frequency by either performing a decimation-in-time FFT to acquire the complex impedance at each frequency or performing a simple correlation with a pre-defined sinusoid with the stimulus sinusoid phase shifted by 45° to calculate the real and imaginary components of the voltage for a certain frequency component. The resulting complex voltage value is divided by the complex current value to produce the raw impedance results. In addition, Bartlett, Hamming, Hanning, and Blackman windows can be applied to the signals before further processing. When the FFT is used, spectral information of the voltage and current waveform can be obtained to calculate the total harmonic distortion of the voltage measurement, and, by using the second and third harmonics, to determine whether saturation of the measured voltage signals has occurred. The spectral information can also be used to determine the magnitude and phase of each spectral component of the voltage and current signals, from which can be calculated the complex impedance at a frequency of interest (Fo) using the relationships: |ZFo|=|VFo|/|IFo| and arg (ZFo)=arg(VFo)−arg(IFo) where | | denotes magnitude and arg( ) denotes phase.

[0169] The magnitude of the raw impedance, as calculated above, directly reflects the magnitude of the measured voltage signal as acquired by the ADC 68. Accordingly, if the measured voltage signal is too large, then the ADC 68 will saturate. Alternatively, if the measured voltage signal is too small, then the ADC 68 will use fewer bits in its conversion and the resulting measurements will be less accurate. In order to maximize the number of bits used in data conversion while preventing saturation, an automatic gain control algorithm is used in conjunction with the programmable gain unit 74. When a raw impedance value is too large, the gain of the programmable gain unit 74 is reduced, and the load is re-measured. When a raw impedance value is too small, the gain of the programmable gain unit 74 is increased and the load is re-measured. Saturation can be determined by analysis of the second and third harmonics of the measured voltage signals (the second harmonic identifies slew-rate limiting and the third identifying clipping).

[0170] It should be understood that the computing device 12, the main module 18 and the front end-module 22 described herein illustrate a particular application of the impedance module 20. Other embodiments are possible in which the components of the computing device 12, main module 18 and front-end module 22 are different. Accordingly, it should be understood that the impedance module 20 is a stand-alone device which can be used to measure impedance values. The impedance module 20 simply requires connection leads to provide the stimulus current to a load and connection loads to receive the resulting voltages.

[0171] It should also be understood that various modifications can be made to the embodiments described and illustrated herein, without departing from the present invention, the scope of which is defined in the appended claims. For example, although emphasis has been placed on describing a system for diagnosing breast cancer, the principles of the present invention can also be advantageously applied to other diseases of other body parts. In addition, the main module 18, the impedance module 20 and the front-end module 22 may be integrated with the computing device 12 to form a single unit.

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Classifications
U.S. Classification600/547
International ClassificationA61B5/0408, A61B5/0424, A61B5/053, A61B10/00, A61B17/00
Cooperative ClassificationA61B2017/00026, A61B5/0424, A61B10/0041, A61B2018/0016, A61B5/6843, A61B5/4312, A61B5/04085, A61B5/0531, A61B5/053, A61B2019/465, A61B2562/0219
European ClassificationA61B5/43F2, A61B5/68B5, A61B10/00G, A61B5/053, A61B5/053B
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