Tissue examination

• US 5,833,634 A
• Filed: 11/09/1995
• Issued: 11/10/1998
• Est. Priority Date: 11/09/1995
• Status: Expired due to Term

• Current Assignee: Medical Tactile, Inc.
• Original Assignee: UroMed Corporation
• Inventors: Woolfson, Steven B., Schiff, Jonathan D., Laird, John D., Iorio, Michael J., Wisnosky, Carl J., Coats, David E.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/556,161
• Time in Patent Office: 1,097 Days
• Field of Search: 128/774, 128/782, 128/744, 128/630
• US Class Current: 600/587
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/4381 Prostate evaluation or disorder diagnosis
• CPC Class Codes: A61B 5/6806 Gloves
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives

Abstract

Tissue is examined with a device that includes one or more transducer elements, each of which generates a signal in response to force imposed on the transducer element in accordance with varying properties of an underlying tissue structure as the transducer element is pressed against and moved over the tissue. The tissue examination device further includes circuitry for detecting a variation in the signals as an indication of a composition of the underlying tissue structure.

Claims

1. A tissue examination device comprising:

a transducer element for generating a signal in response to force imposed on the transducer element as the transducer element is pressed against and moved over the tissue, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting a variation in the signal generated by the transducer element and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

2. The tissue examination device of claim 1, wherein said circuitry comprises:

a processor for performing said analyzing and for determining therefrom whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure.

3. The tissue examination device of claim 2, further comprising:

circuitry for notifying the user in response to the processor determining that the transducer element has been moved over the localized area of stiffer tissue.

4. The tissue examination device of claim 2, wherein the processor includes:

a comparator for comparing the detected variation in the signal generated by the transducer element to a predetermined threshold to determine whether the transducer element has been moved over the localized area of stiffer tissue within the underlying tissue structure.

5. The tissue examination device of claim 2, wherein the processor includes:

a comparator for comparing the detected variation in the signal generated by the transducer element to a predetermined pattern to determine whether the transducer element has been moved over the localized area of stiffer tissue within the underlying tissue structure.

6. The tissue examination device of claim 1, further comprising:

a pressure sensing circuit, responsive to the signal generated by the transducer element, for detecting whether the force imposed on the transducer element exceeds a predetermined minimum threshold and for notifying the user when the force imposed on the transducer element does not exceed the predetermined minimum threshold.

7. The tissue examination device of claim 1, further comprising:

a pressure sensing circuit, responsive to the signal from the transducer element, for detecting whether the force imposed on the transducer element exceeds a predetermined maximum threshold and for notifying the user when the force imposed on the transducer element exceeds the predetermined maximum threshold.

8. The tissue examination device of claim 1, wherein the transducer element comprises a carbon microphone.

12. The tissue examination device of claim 2 further comprising:

a storage device for storing the results of the processor'"'"'s determination.

13. The tissue examination device of claim 12 further comprising:

circuitry for comparing the results of different examinations of the same tissue.

14. The tissue examination device of claim 1, further comprising:

a second transducer element for generating a signal in response to force imposed on the second transducer element as the second transducer element is pressed against and moved over the tissue, wherein the force varies in accordance with varying properties of the underlying tissue structure.

15. The tissue examination device of claim 14, wherein the detecting circuitry further detects a variation of the signal generated by the second transducer element as another indication of the composition of the underlying tissue structure.

52. The tissue examination device of claims 1 or 16 further comprising:

a lubricant disposed between the tissue examination device and the tissue.

53. The tissue examination device of claims 1 or 16, wherein the circuitry for detecting and the processor include analog circuitry.

54. The tissue examination device of claims 1 or 16, wherein the circuitry for detecting and the processor include a microprocessor.

55. The tissue examination device of claims 1 or 16, wherein the tissue is breast tissue.

93. The tissue examination device of claim 1 further comprising a hand-held housing that contains said transducer element and said circuitry.

9. A tissue examination device comprising:

a transducer element for generating a signal in response to force imposed on the transducer element as the transducer element is pressed against and moved over the tissue, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting a rate of change of the signal generated by the transducer element as an indication of a composition of the underlying tissue structure.

10. The tissue examination device of claim 9, wherein the circuitry includes:

a dual differentiator for determining a second derivative of the signal generated by the transducer element to detect the rate of change of the signal.

11. The tissue examination device of claim 10, wherein the circuitry further includes:

a low pass filter for integrating the second derivative of the signal.

16. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting a variation in the signals generated by the transducer elements and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

18. The tissue examination device of claim 16, wherein said circuitry comprises:

a processor for performing said analyzing and for determining therefrom whether at least one transducer element of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure.

22. The tissue examination device of claim 18, further comprising:

a comparator for comparing the detected variation in the signals generated by the transducer elements to a predetermined pattern to determine whether at least one of the transducer elements has been moved over the localized area of stiffer tissue within the underlying tissue structure.

23. The tissue examination device of claim 18, further comprising:

a comparator for comparing the detected variation in the signals generated by the transducer elements to predetermined patterns to determine whether at least one of the transducer elements has been moved over the localized area of stiffer tissue within the underlying tissue structure and to determine what type of localized area of stiffer tissue the at least one transducer element has been moved over.

24. The tissue examination device of claim 16, further comprising:

a pressure sensing circuit, responsive to the signals generated by the transducer elements, for detecting whether the forces imposed on the transducer elements exceed a predetermined minimum threshold and for notifying the user when the forces imposed on the transducer elements do not exceed the predetermined minimum threshold.

25. The tissue examination device of claim 16, further comprising:

a pressure sensing circuit, responsive to the signals generated by the transducer elements, for detecting whether the forces imposed on the transducer elements exceed a predetermined maximum threshold and for notifying the user when the forces imposed on the transducer elements exceed the predetermined maximum threshold.

26. The tissue examination device of claim 16, further comprising:

a pressure sensing circuit, responsive to the signals generated by the transducer elements, for detecting whether the forces imposed on the transducer elements exceed a variable threshold and for notifying the user when the forces imposed on the transducer elements do not exceed the variable threshold.

28. The tissue examination device of claim 16, wherein the transducer elements comprise carbon microphones.

29. The tissue examination device of claim 16, wherein the transducer elements comprise saline microphones.

30. The tissue examination device of claim 16, wherein the transducer elements comprise piezo-electric elements.

34. The tissue examination device of claim 16, further comprising:

a hand-held assembly, attached to the transducer elements, for moving the transducer elements over the tissue.

35. The tissue examination device of claim 16, further comprising:

a glove, attached to the transducer elements, for moving the transducer elements over the tissue.

36. The tissue examination device of claim 16, further comprising:

an adhesive strip, attached to the transducer elements, for moving the transducer elements over the tissue.

37. The tissue examination device of claim 16, further comprising:

a roller ball assembly, attached to the transducer elements, for moving the transducer elements over the tissue.

50. The tissue examination device of claims 3 or 18, wherein the localized area of stiffer tissue comprises a lump.

94. The tissue examination device of claim 16 further comprising a hand-held housing that contains said plurality of transducer elements and said circuitry.

17. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

difference circuitry for determining a difference between the signals generated by the transducer elements, wherein the detecting circuitry detects a variation in the difference between the signals generated by the transducer elements.

39. The tissue examination device of claim 17 further comprising:

a storage device for storing the results of the difference circuitry.

40. The tissue examination device of claim 39 further comprising:

circuitry for comparing the results of different examinations of the same tissue.

41. The tissue examination device of claim 17, wherein the plurality of transducer elements comprise a plurality of pairs of transducer elements, and wherein the difference circuitry determines a difference between the signals generated by the transducer elements of each pair of transducer elements and the circuitry for detecting detects a variation in the difference between the signals of each pair of transducer elements as an indication of the composition of the underlying tissue structure.

42. The tissue examination device of claim 41, further comprising:

coordinating circuitry, connected to the plurality of pairs of transducer elements, for coordinating the variations in the differences between the signals of each pair of transducer elements to provide spacial information regarding the location of the localized area of stiffer tissue within the underlying tissue structure.

47. The tissue examination device of claims 42, 44, or 46, further comprising:

a display device, connected to the coordinating circuitry, for displaying the location of the localized area of stiffer tissue within the underlying tissue structure.

19. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

circuitry for notifying the user in response to the processor determining that at least one transducer element has been moved over the localized area of stiffer tissue.

48. The tissue examination device of claims 3 or 19, wherein the notifying circuitry includes:

a light emitting diode.

49. The tissue examination device of claims 3 or 19, wherein the notifying circuitry includes:

a sound generator.

20. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

a processor for determining, based on the detected variation in the signals generated by the transducer elements, whether at least one transducer element of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure;

said processor including a comparator for comparing the detected variation in the signals generated by the transducer elements to a predetermined threshold to determine whether at least one transducer element has been moved over the localized area of stiffer tissue within the underlying tissue structure.

21. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

a processor for determining, based on the detected variation in the signals generated by the transducer elements, whether at least one transducer element of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure;

said processor including a comparator for comparing the detected variation in the electrical signals generated by the transducer elements to a variable threshold to determine whether at least one transducer element has been moved over the localized area of stiffer tissue within the underlying tissue structure.

27. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

a pressure sensing circuit, responsive to the signals generated by the transducer elements, for detecting whether the forces imposed on the transducer elements exceed a variable minimum threshold and whether the forces imposed on the transducer elements exceed a variable maximum threshold, and for notifying the user when the forces imposed on the transducer elements do not exceed the variable minimum threshold or exceed the variable maximum threshold.

31. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

difference circuitry for determining a difference between the signals generated by the transducer elements; and

circuitry for detecting a rate of change of the difference between the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure.

32. The tissue examination device of claim 31, wherein the detecting circuitry includes:

a differentiator for determining a derivative of the difference between the signals generated by the transducer elements to detect the rate of change of the difference between the signals generated by the transducer elements.

33. The tissue examination device of claim 32, wherein the detecting circuitry further includes:

a low pass filter for integrating the derivative of the difference between the signals generated by the transducer elements.

38. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

a mechanism, attached to the transducer elements, for automatically moving the transducer elements over the tissue.

43. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure, wherein the plurality of transducer elements comprise two pairs of transducer elements, the transducer element pairs having an orthogonal configuration with respect to each other, and wherein the difference circuitry determines a difference between the signals generated by the transducer elements of each pair of transducer elements and the circuitry for detecting detects a variation in the difference between the signals of each pair of transducer elements as an indication of the composition of the underlying tissue structure.

44. The tissue examination device of claim 43, further comprising:

coordinating circuitry, connected to the two pairs of transducer elements, for coordinating the variations in the differences between the signals of each pair of transducer elements to provide spacial information regarding the location of the localized area of stiffer tissue within the underlying tissue structure.

45. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure;

a processor for determining, based on the detected variation in the signals generated by the transducer elements, whether at least one transducer element of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure; and

a measuring device for measuring a parameter of the motion of the transducer elements over the tissue.

46. The tissue examination device of claim 45, further comprising:

coordinating circuitry, connected to the measuring device, for coordinating the variations in the difference in the signals generated by the transducer elements to provide spacial information regarding the location of the localized area of stiffer tissue within the underlying tissue structure.

90. The tissue examination device of claim 45 wherein the parameter of motion includes a velocity of the transducer elements.

91. The tissue examination device of claim 45 wherein the parameter of motion includes a change in a position of the transducer elements with respect to the tissue being examined.

51. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

a cap attached to the tissue examination device.

92. The tissue examination device of claim 51 or 84 wherein said cap is disposable.

56. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

self-test circuitry for determining whether the tissue examination device is operating properly.

57. A breast tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the breast tissue, wherein the forces vary in accordance with varying properties of an underlying breast tissue structure;

difference circuitry for determining a difference between the signals generated by the transducer elements;

circuitry for detecting a variation in the difference between the signals generated by the transducer elements as an indication of a composition of the underlying breast tissue structure;

a processor for comparing the detected variation in the difference between the signals generated by the transducer elements to a predetermined pattern to determine whether at least one transducer element of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying breast tissue structure; and

circuitry for notifying the user in response to the processor determining that at least one transducer element has been moved over the localized area of stiffer breast tissue.

58. A method of examining tissue comprising:

moving a transducer element over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signal generated by the transducer element and analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

59. The method of claim 58, further comprising:

determining, based on said detecting and analyzing, whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure.

60. The method of claim 59, further comprising:

notifying the user when the transducer element has been moved over the localized area of stiffer tissue.

67. The method of claim 59 further comprising:

comparing the determinations as to whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure between different examinations of the same tissue.

78. The method of claims 58 or 68 wherein the tissue is breast tissue.

61. A method of examining tissue comprising:

moving a transducer element over tissue to be examined while also dressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure;

detecting a variation in the signal generated by the transducer element as an indication of a composition of the underlying tissue structure; and

comparing the detected variation in the signal generated by the transducer element to a predetermined threshold to determine whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure.

62. A method of examining tissue comprising:

moving a transducer element over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure;

detecting a variation in the signal generated by the transducer element as an indication of a composition of the underlying tissue structure; and

determining, based on the detected variation in the signal, whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure; and

if the transducer element is determined to have been moved over the localized area of stiffer tissue, comparing the detected variation in the signal generated by the transducer element to at least one predetermined pattern to determine what type of localized area of stiffer tissue within the underlying tissue structure the transducer element has been moved over.

63. A method of examining tissue comprising:

moving a transducer element over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure;

detecting a variation in the signal generated by the transducer element as an indication of a composition of the underlying tissue structure; and

comparing the detected variation in the signal generated by the transducer element to a predetermined pattern to determine whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure.

64. A method of examining tissue comprising:

moving a transducer element over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

detecting a rate of change in the signal generated by the transducer element as an indication of a composition of the underlying tissue structure.

65. The method of claim 64, wherein detecting includes:

applying the signal generated by the transducer element to a dual differentiator to detect the rate of change of the signal.

66. The method of claim 65, wherein detecting further includes:

applying the output of the dual differentiator to a low pass filter.

68. A method of examining tissue comprising:

moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

detecting variations in the signals generated by the transducer elements and analyzing a shape of said variations between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

70. The method of claim 68, wherein detecting includes:

detecting whether at least one of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure based on said detecting and analyzing steps.

71. The method of claim 70, further comprising:

notifying the user when at least one of the plurality of transducer elements has been moved over the localized area of stiffer tissue.

77. The method of claim 70 further comprising:

comparing the detections as to whether at least one of the transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure between different examinations of the same tissue.

69. A method of examining tissue comprising:

moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

detecting variations in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure; and

determining a difference between the signals generated by the plurality of transducer elements, wherein detecting variations includes detecting variations in the difference between the signals generated by the plurality of transducer elements.

72. A method of examining tissue comprising:

moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

determining a difference between the signals generated by the plurality of transducer elements and detecting variations in the difference between said signals as an indication of a composition of the underlying tissue structure; and

comparing the detected variations in the difference between the signals generated by the plurality of transducer elements to a predetermined threshold to determine whether at least one of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure.

73. A method of examining tissue comprising:

moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

determining a difference between the signals generated by the plurality of transducer elements and detecting variations in the difference between said signals as an indication of a composition of the underlying tissue structure; and

comparing the detected variations in the difference between the signals generated by the plurality of transducer elements to a predetermined pattern to determine whether at least one of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure.

74. A method of examining tissue comprising:

moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying Properties of an underlying tissue structure;

determining a difference between the signals generated by the plurality of transducer elements and detecting a rate of change of the difference between said signals as an indication of a composition of the underlying tissue structure.

75. The method of claim 74, wherein determining includes:

applying the difference between the signals to a differentiator.

76. The method of claim 75, wherein determining further includes:

applying the output of the differentiator to a low pass filter.

79. A method of examining tissue comprising:

performing a manual tissue examinations;

thereafter moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

detecting variations in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure.

80. A method of examining tissue comprising:

moving a plurality of transducer elements over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

detecting variations in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure;

detecting whether at least one of the plurality of transducer elements has been moved over a localized area of stiffer tissue within the underlying tissue structure based on the detected variations in the signals generated by the plurality of transducer elements;

notifying the user when at least one of the plurality of transducer elements has been moved over the localized area of stiffer tissue; and

after said notifying, performing a manual tissue examination to re-check the tissue.

81. A method of examining tissue comprising:

initiating a tissue examination device self-test;

moving a plurality of transducer elements of the tissue examination device over tissue to be examined while also pressing the plurality of transducer elements against the tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

detecting variations in the signals generated by the transducer elements as an indication of a composition of the underlying tissue structure.

82. A method of examining tissue comprising:

applying lubricant to the tissue in an area to be examined;

moving a plurality of transducer elements over the tissue in said area while also pressing the plurality of transducer elements against the tissue, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

detecting variations in the signals generated by the transducer elements and analyzing a shape of said variations between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

83. A method of examining breast tissue comprising:

moving a plurality of transducer elements over the breast tissue to be examined while also pressing the plurality of transducer elements against the breast tissue to be examined, the transducer elements generating signals in response to forces detected by the transducer elements, wherein the forces vary in accordance with varying properties of an underlying breast tissue structure;

detecting variations in the signals generated by the transducer elements as an indication of a composition of the underlying breast tissue structure;

comparing the detected variation in the difference between the signals generated by the plurality of transducer elements to a predetermined pattern to determine whether at least one of the plurality of transducer elements has been moved over the localized area of stiffer tissue within the underlying breast tissue structure; and

notifying the user when at least one of the plurality of transducer elements has been moved over the localized area of stiffer tissue.

84. A tissue examination device Ad comprising:

a transducer element for generating a signal in response to force imposed on the transducer element as the transducer element is pressed against and moved over the tissue, wherein the force varies in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signal generated by the transducer element and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure; and

a cap attached to the tissue examination device.

85. A tissue examination device comprising:

a transducer element for generating a signal in response to force imposed on the transducer element as the transducer element is pressed against and moved over the tissue, wherein the force varies in accordance with varying properties of an underlying tissue structure;

circuitry for detecting a variation in the signal generated by the transducer element and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure; and

self-test circuitry for determining whether the tissue examination device is operating properly.

86. A method of examining tissue comprising:

performing a manual tissue examination;

thereafter moving a transducer element over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signal generated by the transducer element and analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

87. A method of examining tissue comprising:

moving a transducer element over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure;

detecting a variation in the signal generated by the transducer element as an indication of a composition of the underlying tissue structure;

determining, based on the detected variation in the signal, whether the transducer element has been moved over a localized area of stiffer tissue within the underlying tissue structure;

notifying the user when the transducer element has been moved over the localized area of stiffer tissue; and

after said notifying, performing a manual tissue examination to re-check the tissue.

88. A method of examining tissue comprising:

initiating a tissue examination device self-test;

moving a transducer element of the tissue examination device over tissue to be examined while also pressing the transducer element against the tissue to be examined, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signal generated by the transducer element and analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

89. A method of examining tissue comprising:

applying lubricant to the tissue in an area to be examined;

moving a transducer element over the tissue in such area while also pressing the transducer element against the tissue, the transducer element generating a signal in response to a force detected by the transducer element, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signal generated by the transducer element and analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

95. Apparatus comprising

a tissue examination device that includes a transducer element and that is configured to press said transducer element against the tissue and move said transducer element over the tissue to cause said transducer element to generate a signal in response to force imposed on the transducer element as the transducer element is pressed against and moved over the tissue, such force varying in accordance with varying properties of an underlying tissue structure;

and

circuitry associated with said tissue examination device for detecting a variation in the signal generated by the transducer element and for analyzing a share of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

96. Apparatus comprising

a tissue examination device that includes a plurality of transducer elements and that is configured to press said transducer elements against the tissue and move said transducer elements over the tissue to cause said transducer elements to generate signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, such forces varying in accordance with varying properties of an underlying tissue structure;

and

circuitry associated with said tissue examination device for detecting a variation in the signals generated by the transducer elements and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

97. A tissue examination device comprising:

a transducer element for generating a signal in response to force imposed on the transducer element as the transducer element is pressed against and moved over the tissue, wherein the force varies in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting as a function of the movement of said transducer element a variation in the signal generated by the transducer element and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

98. A tissue examination device comprising:

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting as a function of the movement of said transducer elements a variation in the signals generated by the transducer elements and for analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

99. A method of examining tissue comprising:

pressing and moving a transducer element along the tissue to be examined while maintaining the transducer element in substantially continuous contact with the tissue to cause the transducer element to generate a signal in response to a force detected by the transducer element, such force varying in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signal generated by the transducer element and analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

100. A method of examining tissue comprising:

pressing and moving a plurality of transducer elements along the tissue to be examined while maintaining the transducer elements in substantially continuous contact with the tissue to cause the transducer elements to generate signals in response to a force detected by the transducer element, such force varying in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signals generated by the transducer elements and analyzing a shape of said variation between signal levels of different amplitudes to provide an indication of a composition of the underlying tissue structure.

101. A tissue examination device comprising:

a transducer element for generating signals in response to forces imposed on the transducer element as the transducer element is pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure; and

circuitry for detecting a variation in the signal generated by the transducer element, for analyzing a shape of said variation between signal levels of different amplitudes, and for detecting therefrom that said transducer element has been moved over an edge of the underlying tissue structure.

102. A tissue examination device comprising

a plurality of transducer elements for generating signals in response to forces imposed on the transducer elements as the transducer elements are pressed against and moved over the tissue, wherein the forces vary in accordance with varying properties of an underlying tissue structure;

and

circuitry for detecting a variation in the signals generated by the transducer elements, for analyzing a shape of said variation between signal levels of different amplitudes, and for detecting therefrom that at least one of said transducer elements has been moved over an edge of the underlying tissue structure.

103. A metho d of examining tissue comprising:

moving a transducer element over the tissue to be examined while also pressing the transducer element against the tissue to cause the transducer element to generate a signal in response to a force detected by the transducer element, such force varying in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signal generated by the transducer element, analyzing a shape of said variation between signal levels of different amplitudes, and detecting therefrom that said transducer element has been moved over an edge of the underlying tissue structure.

104. A method of examining tissue comprising:

moving a plurality of transducer elements over the tissue to be examined while also pressing the transducer elements against the tissue to cause the transducer elements to generate signals in response to a force detected by the transducer element, such force varying in accordance with varying properties of an underlying tissue structure; and

detecting a variation in the signals generated by the transducer elements, analyzing a shape of said variation between signal levels of different amplitudes, and detecting therefrom that at least one of said transducer elements has been moved over an edge of the underlying tissue structure.