Tissue examination

• US 5,989,199 A
• Filed: 11/27/1996
• Issued: 11/23/1999
• Est. Priority Date: 11/27/1996
• Status: Expired due to Term

• Current Assignee: Medical Tactile, Inc.
• Original Assignee: Assurance Medical, Inc.
• Inventors: Theriault, Richard H., Noble, Brian D., West, Alan I., Cundari, Michael A., Widder, David R.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/757,466
• Time in Patent Office: 1,091 Days
• Field of Search: 600/587, 600/594, 600/595
• US Class Current: 600/587
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• 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 5/444 Evaluating skin marks, e.g. mole, nevi, tumour, scar
• CPC Class Codes: A61B 5/4533 Ligaments

Abstract

A tissue examination device includes a plurality of sensors, each of which produces a signal in response to pressure imposed on the sensor in accordance with the properties of different types of underlying tissue structures as the sensor is pressed against the tissue. A plurality of processing tests are performed on the signals, and the different types of the underlying tissue structures are discriminated from each other based on the results of the tests.

Claims

1. A tissue examination device comprising

a plurality of sensors, arranged in an array, each of said sensors producing a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, such pressure varying in accordance with properties of different types of underlying tissue structures, and

a processor for performing a plurality of processing tests on the signals produced by said sensors and discriminating between the different types of the underlying tissue structures based on results of said tests, said tests comprising

a first test that includes said processor comparing amplitudes of the signals produced by said sensors to a threshold, and evaluating signals that exceed said threshold differently than signals that do not exceed said threshold, and

a second test in which said processor determines relative locations in said array of sensors that produce signals which exceed said threshold, and a number of said sensors that produce signals that exceed said threshold and which are located adjacent to another one of said sensors in said array that produces a signal which exceeds said threshold.

2. The device of claim 1 wherein said processor determines whether the underlying tissue structure is a normal tissue structure or a potentially foreign tissue structure based on the results of said tests, and further comprising

circuitry responsive to the determination made by said processor for notifying a user whether the underlying tissue structure is a potentially foreign tissue structure.

3. The device of claim 2 wherein the normal tissue structure includes breast tissue and the potentially foreign tissue structure includes non-breast tissue.

4. The device of claim 3 wherein the normal tissue structure includes a nipple, a rib, or a ligament, and the potentially foreign tissue structure includes a cyst or a solid mass.

5. The device of claim 2 further comprising an indicator actuatable by said circuitry in response to said processor determining that the underlying tissue structure is a potentially foreign tissue structure.

6. The device of claim 5 further comprising a second indicator actuatable by said circuitry in response to said processor determining that the underlying tissue structure is a normal tissue structure.

7. The device of claim 1 wherein said processor generates said threshold based on the amplitudes of said signals.

8. The device of claim 1 wherein said first test further includes said processor determining an average of the amplitudes of said signals that exceed said threshold, and determining whether said average is within a predetermined range of amplitudes.

9. The device of claim 1 wherein said first test further includes said processor determining an average of the amplitudes of said signals that do not exceed said threshold, and determining whether said average exceeds a selected minimum amplitude.

10. The device of claim 9 wherein said processor determines that said first test has passed if said average of the amplitudes of said signals that exceed said threshold is within said predetermined limits and said average of the amplitudes of said signals that do not exceed said threshold exceeds said selected minimum amplitude, and otherwise determines that said first test has failed.

15. The device of claim 1 wherein said processor determines that said second test has failed if said number of said sensors does not exceed a selected minimum number.

16. The device of claim 1 wherein said second test further comprises said processor determining whether said number of sensors exceeds by a selected amount an aggregate of said number of sensors and a number of nonadjacent sensors in said array that produce signals that exceed said threshold.

17. The device of claim 16 wherein said processor determines that said second test has passed if said number of sensors exceeds by the selected amount the aggregate of said number of sensors and the number of nonadjacent sensors in said array that produce signals that exceed said threshold, and otherwise determines that said second test has failed.

18. The device of claim 1 wherein said plurality of tests includes a third test in which said processor determines a difference between amplitudes of said signals that exceed said threshold.

19. The device of claim 18 wherein said difference is a ratio between the signal having a highest amplitude and the signal having a lowest amplitude.

20. The device of claim 19 wherein said processor determines that said third test has passed if said ratio exceeds a second threshold, and otherwise determines that said third test has failed.

21. The device of claim 18 further comprising circuitry for successively acquiring a plurality of sets of said signals from said sensors at successively different times as said array is moved over the tissue, each of said sets of signals representing the underlying tissue structures at said times, and a memory for storing said sets of signals, said processor performing said plurality of processing tests on each one of said sets of signals.

22. The device of claim 21 wherein said processor is adapted to perform additional said processing tests on a selected number of said sets of said signals that have passed said first, second, and third tests.

23. The device of claim 22 wherein said processor is adapted to perform said additional processing tests only if said selected number of said sets of said signals are consecutively acquired without interruption by a set of said signals that do not pass either said first, second, or third test.

24. The device of claim 22 wherein said additional tests include a fourth test in which said processor, for each of said sets of said signals:

analyzes the amplitudes of said signals that exceed said threshold to develop for each of the underlying tissue structures a pair of pressure profiles each of which comprises signals produced by sensors in said array that are arranged along a selected dimension of a corresponding underlying tissue structure, a first said pressure profile being oriented along a dimension of maximum flatness of the structure, and a second said pressure profile being oriented along a dimension of minimum flatness of the structure, and

determines an edge profile, a relative stiffness, and a relative curvature of each said underlying tissue structure based on said first and second pressure profiles.

25. The device of claim 24 wherein said processor is adapted to determine said edge profile based on an amount that the amplitude of said signals change from sensor to sensor along said second pressure profile.

26. The device of claim 24 wherein said processor is adapted to determine said relative stiffness based on a difference between the signal having a highest amplitude and the signal having a lowest amplitude in said first pressure profile.

27. The device of claim 24 wherein said processor is adapted to determine said relative curvature based on a flatness of said first pressure profile.

28. The device of claim 24 wherein said processor is adapted to evaluate said edge profile, said relative stiffness, and said relative curvature of each said underlying tissue structure with respect to each other and, based on said evaluation, develop an outcome that indicates a degree of membership of each said underlying tissue structure in a class of foreign tissue structures.

29. The device of claim 28 wherein said processor is adapted to give selective amounts of weights to said edge profile, said relative stiffness, and said relative curvature of each said underlying tissue structure in developing said outcome.

30. The device of claim 24 wherein said additional tests include a fifth test in which said processor evaluates said sets of said signals to determine a manner in which each of the underlying tissue structures move with respect to said array as said array is moved over the tissue.

31. The device of claim 30 wherein said fifth test includes said processor determining

a distance by which each said underlying tissue structure moves with respect to said array, and

a trajectory along which each said underlying tissue structure moves with respect to said array.

32. The device of claim 31 wherein said processor is adapted to evaluate said distance and said trajectory of motion of each said underlying tissue structure with respect to each other and, based on said evaluation, develop an outcome that indicates a degree of membership of each said underlying tissue structure in a class of foreign tissue structures.

33. The device of claim 32 wherein said processor is adapted to give selective amounts of weights to said distance and said trajectory of motion of each said underlying tissue structure in developing said outcome.

34. The device of claim 32 wherein said processor is further adapted to evaluate said edge profile, said relative stiffness, and said relative curvature of each said underlying tissue structure with respect to each other in developing said outcome.

35. The device of claim 34 further comprising circuitry responsive to said outcome developed by said processor for notifying a user whether the underlying tissue structure is a potentially foreign tissue structure.

36. The device of claim 1 further comprising a display for displaying signals that correspond to said amplitudes of said signals generated by said sensors, thereby to enable a user to visualize said distribution.

37. The device of claim 1 wherein said processor is further responsive to said signals generated by said sensors to determine an amount of pressure applied to said plurality of sensors when said sensors are pressed against the body, said processor performing said plurality of processing tests only if the amount of pressure is within a selected range of pressures.

38. The device of claim 37 further comprising circuitry for notifying a user that the amount of pressure is within a selected range of pressures.

39. The device of claim 1 wherein said plurality of sensors are arranged in an array that includes multiple rows of said sensors.

40. The device of claim 1 wherein said plurality of sensors are arranged in an array that includes a single row of said sensors.

41. The device of claim 1 wherein said plurality of sensors include resistive elements.

42. The device of claim 1 wherein said plurality of sensors include piezoelectric elements.

43. The device of claim 1 wherein said plurality of sensors include capacitive sensors.

11. A tissue examination device comprising

a plurality of sensors, arranged in an array, each of said sensors producing a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, such pressure varying in accordance with properties of different types of underlying tissue structures, and

a processor for performing a plurality of processing tests on the signals produced by said sensors and discriminating between the different types of the underlying tissue structures based on results of said tests, said tests comprising a first test that includes said processor comparing amplitudes of the signals produced by said sensors to a threshold, and evaluating signals that exceed said threshold differently than signals that do not exceed said threshold,

said processor further being adapted to analyze signals that exceed said threshold to determine whether signals produced by sensors arranged on a periphery of said array are valid.

12. The device of claim 11 wherein said processor performs said analysis by comparing a first number of sensors arranged on the periphery that produce signals which exceed said threshold to a second number of sensors arranged in an interior of said array that produce signals which exceed said threshold, and determining that said signals produced by sensors arranged on the periphery are valid if said second number exceeds said first number by a selected amount.

13. The device of claim 12 wherein said first number of sensors are located adjacent to each other on the periphery, and said second number of sensors are located adjacent to said sensors on the periphery or to each other.

14. The device of claim 12 wherein said processor is further adapted to reduce the amplitudes of said signals produced by said sensors arranged on a periphery of said array below said threshold if said processor determines that said signals are not valid.

44. A method of examining tissue, comprising

pressing a plurality of sensors, arranged in an array, against the tissue to cause each of said sensors to produce a signal in response to pressure imposed on the sensor by said pressing, such pressure varying in accordance with properties of different types of underlying tissue structures, and

performing a plurality of processing tests on the signals produced by said sensors and discriminating between the different types of the underlying tissue structures based on results of said tests, said tests comprising

a first test that includes comparing amplitudes of the signals produced by said sensors to a threshold, and evaluating signals that exceed said threshold differently than signals that do not exceed said threshold, and

a second test that includes determining relative locations in said array of sensors that produce signals which exceed said threshold, and a number of said sensors that produce signals that exceed said threshold and which are located adjacent to another one of said sensors in said array that produces a signal which exceeds said threshold.

45. The method of claim 44 further comprising

determining whether the underlying tissue structure is a normal tissue structure or a potentially foreign tissue structure based on the results of said tests, and

responding to said determination by notifying a user whether the underlying tissue structure is a potentially foreign tissue structure.

46. The method of claim 45 wherein the normal tissue structure includes breast tissue and the potentially foreign tissue structure includes non-breast tissue.

47. The method of claim 46 wherein the normal tissue structure includes a nipple, a rib, or a ligament, and the potentially foreign tissue structure includes a cyst or a solid mass.

48. The method of claim 44 further comprising generating said threshold based on the amplitudes of said signals.

49. The method of claim 44 wherein said first test further includes determining an average of the amplitudes of said signals that exceed said threshold, and determining whether said average is within a predetermined range of amplitudes.

50. The method of claim 44 wherein said first test further includes determining an average of the amplitudes of said signals that do not exceed said threshold, and determining whether said average exceeds a selected minimum amplitude.

51. The method of claim 50 further comprising determining that said first test has passed if said average of the amplitudes of said signals that exceed said threshold is within said predetermined limits and said average of the amplitudes of said signals that do not exceed said threshold exceeds said selected minimum amplitude, and otherwise determining that said first test has failed.

56. The method of claim 44 further comprising determining that said second test has failed if said number of said sensors does not exceed a selected minimum number.

57. The method of claim 44 wherein said second test further comprises determining whether said number of sensors exceeds by a selected amount an aggregate of said number of sensors and a number of nonadjacent sensors in said array that produce signals that exceed said threshold.

58. The method of claim 57 further comprising determining that said second test has passed if said number of sensors exceeds by the selected amount the aggregate of said number of sensors and the number of nonadjacent sensors in said array that produce signals that exceed said threshold, and otherwise determining that said second test has failed.

59. The method of claim 46 wherein said plurality of tests includes a third test comprising determining a difference between amplitudes of said signals that exceed said threshold.

60. The method of claim 59 wherein said difference is a ratio between the signal having a highest amplitude and the signal having a lowest amplitude.

61. The method of claim 60 further comprising determining that said third test has passed if said ratio exceeds a second threshold, and otherwise determines that said third test has failed.

62. The method of claim 59 further comprising

successively acquiring a plurality of sets of said signals from said sensors at successively different times as said array is moved over the tissue, each of said sets of signals representing the underlying tissue structures at said times,

storing said sets of signals, and

performing said plurality of processing tests on each one of said sets of signals.

63. The method of claim 62 further comprising performing additional said processing tests on a selected number of said sets of said signals that have passed said first, second, and third tests.

64. The method of claim 63 further comprising performing said additional processing tests only if said selected number of said sets of said signals are consecutively acquired without interruption by a set of said signals that do not pass either said first, second, or third test.

65. The method of claim 62 wherein said additional tests include a fourth test that comprises, for each of said sets of said signals:

analyzing the amplitudes of said signals that exceed said threshold to develop for each of the underlying tissue structures a pair of pressure profiles each of which comprises signals produced by sensors in said array that are arranged along a selected dimension of a corresponding underlying tissue structure, a first said pressure profile being oriented along a dimension of maximum flatness of the structure, and a second said pressure profile being oriented along a dimension of minimum flatness of the structure, and

determining an edge profile, a relative stiffness, and a relative curvature of each said underlying tissue structure based on said first and second pressure profiles.

66. The method of claim 65 further comprising determining said edge profile based on an amount that the amplitude of said signals change from sensor to sensor along said second pressure profile.

67. The method of claim 65 further comprising determining said relative stiffness based on a difference between the signal having a highest amplitude and the signal having a lowest amplitude in said first pressure profile.

68. The method of claim 65 further comprising determining said relative curvature based on a flatness of said first pressure profile.

69. The method of claim 65 further comprising evaluating said edge profile, said relative stiffness, and said relative curvature of each said underlying tissue structure with respect to each other and, based on said evaluation, developing an outcome that indicates a degree of membership of each said underlying tissue structure in a class of foreign tissue structures.

70. The method of claim 69 further comprising giving selective amounts of weights to said edge profile, said relative stiffness, and said relative curvature of each said underlying tissue structure in developing said outcome.

71. The method of claim 65 wherein said additional tests include a fifth test comprising evaluating said sets of said signals to determine a manner in which each of the underlying tissue structures moves with respect to said array as said array is moved over the tissue.

72. The method of claim 71 wherein said fifth test includes determining

a distance by which each said underlying tissue structure moves with respect to said array, and

a trajectory along which each said underlying tissue structure moves with respect to said array.

73. The method of claim 72 further comprising evaluating said distance and said trajectory of motion of each said underlying tissue structure with respect to each other and, based on said evaluation, developing an outcome that indicates a degree of membership of each said underlying tissue structure in a class of foreign tissue structures.

74. The method of claim 73 further comprising giving selective amounts of weights to said distance and said trajectory of motion of each said underlying tissue structure in developing said outcome.

75. The method of claim 73 further comprising evaluating said edge profile, said relative stiffness, and said relative curvature of each said underlying tissue structure with respect to each other in developing said outcome.

76. The method of claim 75 further comprising responding to said developed outcome by notifying a user whether the underlying tissue structure is a potentially foreign tissue structure.

77. The method of claim 44 further comprising displaying signals that correspond to said amplitudes of said signals generated by said sensors, thereby to enable a user to visualize said distribution.

78. The method of claim 44 further comprising responding to said signals produced by said sensors by determining an amount of pressure applied to said plurality of sensors when said sensors are pressed against the body, and performing said plurality of processing tests only if the amount of pressure is within a selected range of pressures.

79. The method of claim 78 further notifying a user that the amount of pressure is within a selected range of pressures.

80. The method of claim 44 further comprising arranging said plurality of sensors in an array that includes multiple rows of said sensors.

81. The method of claim 44 further comprising arranging said plurality of sensors in an array that includes a single row of said sensors.

52. A method of examining tissue comprising

pressing a plurality of sensors, arranged in an array, against the tissue to cause each of said sensors to produce a signal in response to pressure imposed on the sensor by said pressing, such pressure varying in accordance with properties of different types of underlying tissue structures, and

performing a plurality of processing tests on the signals produced by said sensors and discriminating between the different types of the underlying tissue structures based on results of said tests, said tests comprising a first test that includes comparing amplitudes of the signals produced by said sensors to a threshold, and evaluating signals that exceed said threshold differently than signals that do not exceed said threshold, and

analyzing signals that exceed said threshold to determine whether signals produced by sensors arranged on a periphery of said array are valid.

53. The method of claim 52 further comprising performing said analysis by comparing a first number of sensors arranged on the periphery that produce signals which exceed said threshold to a second number of sensors arranged in an interior of said array that produce signals which exceed said threshold, and determining that said signals produced by sensors arranged on the periphery are valid if said second number exceeds said first number by a selected amount.

54. The method of claim 53 wherein said first number of sensors are located adjacent to each other on the periphery, and said second number of sensors are located adjacent to said sensors on the periphery or to each other.

55. The method of claim 53 further comprising reducing the amplitudes of said signals produced by said sensors arranged on a periphery of said array below said threshold if said signals are determined to be not valid.

82. A tissue examination device comprising

a plurality of sensors each of which produces a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, the signals representing pressure signatures associated with different types of underlying tissue structures, and

a processor for processing the signals to determine a plurality of characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including shapes of the pressure signatures.

83. The device of claim 82 wherein the shapes are characterized by at least one of edge profile, relative stiffness, and relative curvature of the pressure signatures.

84. A tissue examination device comprising

a plurality of sensors each of which produces a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, the signals representing pressure signatures associated with different types of underlying tissue structures, and

a processor for processing the signals to determine a plurality of characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including a manner in which the pressure signatures change as the sensors are moved over the tissue.

85. A tissue examination device comprising

a plurality of sensors each of which produces a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, the signals representing pressure signatures associated with different types of underlying tissue structures, and

a processor for processing the signals to determine a plurality of characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including continuity of the signals having an amplitude greater than a selected threshold in the pressure signatures.

86. A tissue examination device comprising

a plurality of sensors each of which produces a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, the signals representing pressure signatures associated with different types of underlying tissue structures, and

a processor for processing the signals to determine a plurality of characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including size of the pressure signatures.

87. A tissue examination device comprising

a plurality of sensors each of which produces a signal in response to pressure imposed on the sensor as the sensors are pressed against the tissue, the signals representing pressure signatures associated with different types of underlying tissue structures, and

a processor for processing the signals to determine a plurality of characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including peakness or flatness of the pressure signatures.

88. A method of examining tissue comprising

pressing a plurality of sensors against the tissue to cause each of the sensors to produce a signal in response to the pressure imposed on the sensor by said pressing, the signals representing pressure signatures associated with different types of underlying tissue structures, and

processing the signals to determine characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including shapes of the pressure signatures.

89. The method of claim 88 wherein the shapes are characterized by at least one of edge profile, relative stiffness, and relative curvature of the pressure signatures.

90. A method of examining tissue comprising

pressing a plurality of sensors against the tissue to cause each of the sensors to produce a signal in response to the pressure imposed on the sensor by said pressing, the signals representing pressure signatures associated with different types of underlying tissue structures, and

processing the signals to determine characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including a manner in which the pressure signatures change as the sensors are moved over the tissue.

91. A method of examining tissue comprising

pressing a plurality of sensors against the tissue to cause each of the sensors to produce a signal in response to the pressure imposed on the sensor by said pressing, the signals representing pressure signatures associated with different types of underlying tissue structures, and

processing the signals to determine characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including continuity of the signals having an amplitude greater than a selected threshold in the pressure signatures.

92. A method of examining tissue comprising

pressing a plurality of sensors against the tissue to cause each of the sensors to produce a signal in response to the pressure imposed on the sensor by said pressing, the signals representing pressure signatures associated with different types of underlying tissue structures, and

processing the signals to determine characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including size of the pressure signatures.

93. A method of examining tissue comprising

pressing a plurality of sensors against the tissue to cause each of the sensors to produce a signal in response to the pressure imposed on the sensor by said pressing, the signals representing pressure signatures associated with different types of underlying tissue structures, and

processing the signals to determine characteristics of the pressure signatures and discriminating between the different types of the underlying tissue structures based on the determined characteristics, the plurality of characteristics including peakness or flatness of the pressure signatures.