Method for diagnosing a disease

• US 7,603,171 B2
• Filed: 10/25/2007
• Issued: 10/13/2009
• Est. Priority Date: 10/25/2007
• Status: Active Grant

• Current Assignee: Prolung Incorporated
• Original Assignee: Fresh Medical Laboratories, Inc.
• Inventors: Eror, Steven C., Satterthwaite, Lynn H.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/978,045
• Publication Number:
  US 20090124924A1
• Time in Patent Office: 719 Days
• Field of Search: 600/547, 731/05, 250/306, 250/307, 977/873
• US Class Current: 600/547
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes

Abstract

A method to determine presence of a disease condition in a medical patient by evaluating conductivity information. Point-attributes values obtained from highly accurate conductivity data-sets taken as a function of time, over a period of time, are compared to previously determined threshold values. Z-scores may be determined to combine a plurality of point-attribute values in formulation of a composite score for a patient. Sometimes, z-scores are weighted by overall accuracy of the point-attribute in predicting presence of the disease.

Claims

1. A method to diagnose lung cancer in a medical patient, the method comprising:

providing a measurement device operable to measure conductivity between a first reference point and a first interrogation point on the body of said patient;

measuring the conductivity, between said first reference point and said first interrogation point, to obtain a first data-set as a function of time and over a period of time; and

comparing at least one attribute value obtained from said first data-set to a previously determined corresponding attribute threshold in a table look-up operation to determine if said patient has lung cancer, wherein

said measurement device is structured and arranged to provide computer control of contact pressure between a measurement electrode tip and the surface of said body at an interrogation point, and probe contact pressure is increased until the conductivity index shows a zero slope, at which point probe contact pressure remains substantially constant during a period of time, and further comprising;

measuring the conductivity, between said first reference point and a first plurality of interrogation points, to obtain a first plurality of data-sets, each such data-set comprising conductivity values as a function of time and over a period of time;

comparing a plurality of point-attribute values obtained from said first plurality of data-sets to corresponding previously determined attribute thresholds in a table look-up operation to determine if said patient has lung cancer;

measuring the conductivity, between a second reference point and a second plurality of interrogation points, to obtain a second plurality of data-sets, each such data-set comprising conductivity values as a function of time and over a period of time; and

comparing a plurality of point-attribute values obtained from said second plurality of data-sets to corresponding previously determined attribute thresholds in a table look-up operation to determine if said patient has lung cancer, wherein;

the sum of said first plurality of interrogation points and said second plurality of interrogation points populate at least three point-attributes for use in said comparing step.

2. The method of claim 1, wherein:

said computer control incorporates real-time conductivity measurement in a feedback loop effective to adjust said pressure.

3. The method of claim 1, wherein:

the sum of said first plurality of interrogation points and said second plurality of interrogation points populate at least twelve point-attributes for use in said comparing step.

4. The method of claim 1, wherein:

the sum of said first plurality of interrogation points and said second plurality of interrogation points populate at least thirty point-attributes for use in said comparing step.

5. A method to diagnose lung cancer in a medical patient, the method comprising:

providing a measurement device operable to measure conductivity between a first reference point and a first interrogation point on the body of said patient;

measuring the conductivity, between said first reference point and said first interrogation point, to obtain a first data-set as a function of time and over a period of time; and

comparing at least one attribute value obtained from said first data-set to a previously determined corresponding attribute threshold in a table look-up operation to determine if said patient has lung cancer, wherein;

said measurement device is structured and arranged to provide computer control of contact pressure between a measurement electrode tip and the surface of said body at an interrogation point, and probe contact pressure is increased until the conductivity index shows a zero slope, at which point probe contact pressure remains substantially constant during a period of time, and the method further comprising;

measuring the conductivity, between said first reference point and a first plurality of interrogation points, to obtain a first plurality of data-sets, each such data-set comprising conductivity values as a function of time and over a period of time; and

comparing a plurality of point-attribute values obtained from said first plurality of data-sets to corresponding previously determined attribute thresholds in a table look-up operation to determine if said patient has lung cancer; and

developing a composite score for a patient by converting a portion of obtained point-attribute values to corresponding z-scores, and combining said z-scores.

6. The method of claim 5, wherein:

developing said composite score includes applying a previously determined overall accuracy of each point-attribute for indicating presence of cancer in a population of patients by weighting each z-score by a corresponding overall accuracy.

7. A method to determine a rule-set for point-attribute data effective for diagnosis of a disease condition in a patient, the method comprising:

a) providing a first arm group of medical patients that have been diagnosed with the disease;

b) providing a second arm group of medical patients that are free from the disease;

c) using a conductivity-detecting apparatus to obtain a plurality X of data-sets corresponding to respective time-based conductivity measurements between similar points on the body of each patient;

d) parsing said data-sets to determine a plurality Y of attributes, each attribute being effective to characterize a portion of a plot of a time-based conductivity measurement;

e) expanding X data-sets by Y attributes to obtain (X)*(Y) point-attributes;

f) determining if a threshold value exists for each point-attribute that would predict, above a threshold criteria, if a patient whose measured point-attribute value is compared to the threshold value would be in the first arm group or in the second arm group;

g) discarding from further consideration each point-attribute for which such a threshold value can not be determined;

h) retaining for further consideration at least one point-attribute for which such a threshold value can be determined; and

i) populating said rule-set by the threshold value corresponding to each attribute at each retained point-attribute where the threshold criteria is satisfied.

8. The method of claim 7, further comprising:

j) developing a composite score for a patient by converting a portion of retained point-attribute data to corresponding z-scores to develop an overall prediction score.

9. The method of claim 8, wherein:

step f) includes determining overall accuracy of each point-attribute for indicating presence of said disease condition; and

step j) includes weighting each z-score by a corresponding overall accuracy.

10. The method of claim 7, wherein:

step c) being blind to a patient'"'"'s membership in an arm group; and

step f) having visibility to a patient'"'"'s membership in an arm group.

11. The method of claim 7, wherein:

prior to step i), determining potential disease sidedness and discarding all opposite-side point-attribute data based upon disease side-bias.

12. The method of claim 7, wherein:

said measurements comprise conductivity measurements made between a first reference point disposed on one lateral side of the body of each patient in both the first arm group and the second arm group and a plurality of interrogation points distributed over an area of that body.

13. The method of claim 12, wherein:

said measurements comprise conductivity measurements made between a second reference point disposed on the other lateral side of the body of each patient in both the first arm group and the second arm group and a plurality of interrogation points distributed over an area of that body.

14. A system adapted to assist in making a diagnosis of

a disease condition in a medical patient, the system comprising:

a computer assembly including a processor, a memory, and a display terminal;

software loaded into said memory as program comprising an instruction set;

a measurement device in communication with said computer assembly and operable to measure conductivity of the body of said patient between a ground point and a measurement point, said measurement device being capable of measuring conductivity as a function of time, and over a period of time, to obtain a conductivity data-set corresponding to each such measurement;

said processor being programmed to;

extract point-attribute values from at least one data-set;

compare at least one attribute value obtained from a data-set to a previously determined corresponding attribute threshold in a table look-up operation;

convert a portion of obtained point-attribute values to corresponding z-scores;

weight each z-score by a corresponding predetermined overall accuracy; and

combine each weighted z-score to develop a composite score for a patient.

15. The system according to claim 14, wherein:

said measurement device is structured and arranged to provide computer control of contact pressure between a measurement electrode tip and the surface of said body at a measurement point, said computer control comprising real-time conductivity measurement in a feedback loop effective to adjust said pressure; and

said program;

causes display of visible prompts on said display terminal corresponding to ground and measurement points;

is adapted to confirm validity of a measured data collection event; and

causes user perceptible feedback corresponding to completion of obtaining a valid data collection event.