Clinical tissue examination

• US 6,091,981 A
• Filed: 09/16/1997
• Issued: 07/18/2000
• Est. Priority Date: 09/16/1997
• Status: Expired due to Term

• Current Assignee: Medical Tactile, Inc.
• Original Assignee: Assurance Medical, Inc.
• Inventors: Noble, Brian David, Roberts, Troy William, West, Alan Irving, Cundari, Michael Anthony, Widder, David Raymond
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US08/931,573
• Time in Patent Office: 1,036 Days
• Field of Search: 600/407, 600/567, 600/561, 600/587, 600/437-444
• US Class Current: 600/407
• 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: G06T 7/0012 Biomedical image inspection

Abstract

This invention concerns performing clinical tissue examination with a device that includes sensors which produces signals in response to pressure imposed on the sensors as the sensors are pressed against the tissue. The sensors generate signals in response to pressure imposed on the sensors when pressed against a selected region of tissue. That pressure varies in accordance with properties of underlying tissue structures. An image of the region of tissue is generated based on the signals generated by the sensors. The image is then displayed. The image represents the pressure imposed on the sensors. The image that is displayed may be a three dimensional image of the region of tissue. The signals produced by the sensors can also be processed to detect an underlying tissue structure in the region of tissue. A location or a map of the detected underlying tissue structure relative to a reference point is generated and displayed. The results of a current examination are compared to those of a previous examination.

Claims

1. A method for performing tissue examination comprising:

pressing a plurality of sensors against a surface of a selected region of tissue to impose on the sensors pressure that varies in accordance with properties of tissue structures underlying the surface in the region and cause the sensors to respectively generate signals having levels that represent the pressure imposed thereon,

generating an image from the signals generated by the sensors, the image comprising areas that respectively correspond to relative locations of the sensors and have attributes according to the levels of the signals generated by the respective sensors so that the image represents a spatial pressure profile of the selected region of tissue, and displaying said image, and

processing the signals generated by the sensors to detect an underlying tissue structure in the selected region of tissue.

2. The method of claim 1 wherein the image comprises a 3-dimensional image, said areas being arranged in two of the dimensions and said attributes being arranged in the third dimension.

3. The method of claim 1 wherein the processing step comprises discriminating the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures.

4. The method of claim 3 wherein the discriminating step comprises discriminating the detected tissue structure based on characteristics corresponding to the detected tissue structure.

5. The method of claim 4 wherein the characteristics comprise at least one of a manner of movement of the detected underlying structure as the plurality of sensors are moved over the tissue, an edge profile, a relative stiffness, and a relative curvature of the detected tissue structure.

6. The method of claim 4 wherein the discriminating step further comprises determining a degree of membership of the detected tissue structure in a preselected class of tissue structures corresponding to the discriminated type.

7. The method of claim 1 further comprising determining a location of the detected underlying tissue structure relative to a reference point, and storing a record in a database, wherein the record includes a result of the processing step and the location of the detected tissue structure relative to a reference point.

8. The method of claim 1 wherein the attributes comprise at least one graphical feature that represents variance in the pressure imposed on the sensors.

9. A method for performing tissue examination comprising:

pressing a plurality of sensors against a selected region of tissue of a person to cause the sensors to generate signals in response to pressure imposed thereon by the pressing, the pressure varying in accordance with properties of different types of underlying tissue structures,

processing the signals generated by the sensors to detect an underlying tissue structure in the region of tissue,

generating positional signals indicative of a position of the sensors, and

processing the positional signals to determine a location of the detected underlying tissue structure relative to an anatomical feature of the person.

10. The method of claim 9 further comprising storing a record in a database, wherein the record includes a characteristic corresponding to the detected tissue structure and the location of the detected tissue structure.

11. The method of claim 10 wherein the characteristic comprises at least one of size, manner of movement of the detected underlying structure as the plurality of sensor is moved over the tissue, an edge profile, a relative stiffness, and a relative curvature of the detected tissue structure.

12. The method of claim 10 further comprising storing a plurality of records in a database, one of the records comprising a characteristic corresponding to the detected tissue structure and the location of the detected.

13. The method of claim 12 wherein the processing step comprises discriminating the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures and storing a result of the discriminating step in the one of the records.

14. The method of claim 13 wherein the discriminating step comprises discriminating the detected tissue structure based on characteristics corresponding to the detected tissue structure.

15. The method of claim 14 wherein the discriminating step further comprises determining a degree of membership of the detected tissue structure in a class of tissue structures corresponding to the discriminated type.

16. The method of claim 9 further comprising:

processing the determined location to produce a map of the location of the detected tissue structure.

17. The method of claim 16 further comprising displaying the map.

18. The method of claim 17 wherein the displaying step comprises printing the map.

19. The method of claim 17 wherein the displaying step comprises displaying the map on a visual display.

20. The method of claim 17 wherein the displaying step comprises displaying a characteristic of a group of the signals corresponding to the detected tissue structure in relation to the location of the detected tissue structure.

21. The method of claim 20 wherein the characteristic of the detected tissue structure comprises at least one of size, edge profile, relative stiffness, relative curvature of the detected tissue structure, and a manner of movement of the detected underlying structure as the plurality of sensor is moved over the tissue.

22. The method of claim 17 wherein the processing step comprises discriminating the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures and the displaying step comprises displaying a result of the discriminating step in relation to the detected tissue structure.

23. The method of claim 22 wherein the discriminating step further comprises determining a degree of membership of the detected tissue structure in a preselected class of tissue structures corresponding to the discriminated type and the displaying step comprises displaying the degree of membership in relation to the detected tissue structure.

24. The method of claim 9 further comprising:

retrieving data representing a previous tissue examination, wherein the data was previously stored during the previous examination, and

using the data with the determined location.

25. The method of claim 24 wherein the retrieved data comprises data representative of signals generated by sensors during a previous examination.

26. The method of claim 24 wherein the retrieved data comprises a result of processing signals in the previous tissue examination to discriminate an underlying tissue structure as one of a plurality of different types of underlying tissue structures.

27. The method of claim 24 wherein the retrieved data further comprises a location of a detected tissue structure in the previous tissue examination relative to the anatomical feature.

28. The method of claim 24 wherein the retrieved data further comprises a degree of membership of a detected tissue in the previous tissue examination in a preselected class of tissue structures.

29. The method of claim 24 further comprising the step of:

processing the retrieved data to generate a first map of a location of a tissue structure detected based on the previously stored data, wherein the first map is generated relative to the anatomical feature,

processing the determined location to produce a second map of the location of the detected tissue structure, and

displaying the first and second maps.

30. The method of claim 24 wherein the processing further comprises discriminating the first-mentioned detected underlying tissue structure as one of a plurality of different types of underlying tissue structures and the method further comprises:

discriminating the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures,

processing the retrieved data to discriminate a second underlying tissue structure in the region of the tissue as the one of the plurality of different types of underlying tissue structures

determining whether the first mentioned underlying tissue structure and the second underlying tissue structure are a same underlying tissue structure.

31. The method of claim 30 further comprising:

if the first-mentioned and second discriminated underlying tissue structures are determined to be the same underlying tissue structure, processing signals corresponding to the first-mentioned discriminated underlying tissue structure with the data corresponding to the second discriminated underlying tissue structure to determine changes corresponding to the same underlying tissue structure between the previous and a current examination.

32. A method for examining tissue, comprising

pressing a plurality of sensors against a surface of a selected region of tissue to impose on the sensors pressure that varies in accordance with properties of tissue structures underlying the surface in the region and cause the sensors to respectively generate signals having levels that represent the pressure imposed thereon,

generating an image from the signals generated by the sensors, the image comprising areas that respectively correspond to relative locations of the sensors and have attributes according to the levels of the signals generated by the respective sensors so that the image represents a spatial pressure profile of the selected region of tissue, and

displaying the generated image.

33. The method of claim 32 wherein the step of displaying the image comprises displaying the image attributes as a pre-selected range of colors that correspond to the attributes.

34. The method of claim 32 wherein the step of displaying of the image comprises displaying a shape representative of an underlying tissue structure in the region as part of the image.

35. The method of claim 34 further comprising detecting the underlying tissue structure and displaying an outline of the shape based on the detecting step.

36. The method of claim 32 wherein the step of displaying the image comprises displaying a value corresponding to a peak pressure represented in the image.

37. The method of claim 32 wherein the step of displaying the image comprises displaying a gradient of a portion of the image.

38. The method of claim 32 wherein the step of displaying the image comprises printing the image.

39. The method of claim 32 wherein the step of displaying the image comprises displaying the image on a visual display.

40. The method of claim 32 wherein the attributes comprise at least one graphical feature that represents variance in the pressure imposed on the sensors.

41. The method of claim 32 wherein the image comprises a 3-dimensional image, said areas being arranged in two of the dimensions and said attributes being arranged in the third dimension.

42. The method of claim 41 wherein the step of displaying the image comprises displaying a top view of the three dimensional image.

43. The method of claim 41 wherein the step of displaying the image comprises displaying a perspective view of the three dimensional image.

44. The method of claim 32 wherein the pressing step comprises:

pressing the sensors, at a first position, against the selected region of tissue to cause the sensors to generate a first plurality of signals that represent the pressure imposed thereon;

moving the sensors from the first position to a second position,

generating positional signals indicative of the first and second positions of the sensors,

pressing the sensors, at the second position, against the selected region of tissue to cause the sensors to generate a second plurality of signals that represent the pressure imposed thereon,

processing the positional signals, the first plurality of signals, and the second plurality of signals, to generate the image so that the image represents a composite of spatial pressure profiles of the selected region with the sensors in the first and second positions, respectively.

45. The method of claim 44 wherein said processing includes correlating a portion of the first plurality of signals to a portion of the second plurality of signals based on the positional signals.

46. A method for performing a clinical breast examination using a tissue examination device, wherein the tissue examination device comprises a plurality of sensors, a processor, and a display, comprising

pressing the plurality of sensors against a surface of a selected region of tissue to impose on the sensors pressure that varies in accordance with properties of tissue structures underlying the surface in the region and cause the sensors to respectively generate signals having levels that represent the pressure imposed thereon,

processing, by the processor, the signals generated by the sensors to generate an image from the signals, the image comprising areas that respectively correspond to relative locations of the sensors and have attributes according to the levels of the signals generated by the respective sensors so that the image represents a spatial pressure profile of the selected region of tissue,

displaying the image with the display, and

examining a shape in the displayed image of the spatial pressure profile to identify a selected type of underlying tissue structures.

47. The method of claim 46 wherein the step of examining the shape comprises attempting to identify a characteristic of the shape, wherein the characteristic suggests a degree of membership of an underlying tissue structure in a class of tissue structures.

48. The method of claim 47 wherein the characteristic is selected among a plurality of characteristics including:

size of the shape;

height of the shape'"'"'s various areas;

flatness of the shape;

peakedness of the shape;

whether the shape has a plateau;

outline of the shape;

contour of the shape;

a gradient along any part of the shape;

movement of the shape in response to the moving or rolling the sensors over the tissue; and

change in the shape in response to changing the imposed pressure.

49. The method of claim 47 wherein the class of tissue structures is selected among a group of classes of tissue structures including carcinoma, ribs, cysts, inframammary ridges, hard lumps, and soft lumps.

50. The method of claim 46 wherein examining the shape further comprises identifying a discrete, dominant, or different characteristic of the shape.

51. The method of claim 46 wherein the selected type of underlying tissue structure comprises carcinoma, and examining a displayed shape comprises identifying a characteristic selected among a plurality of carcinoma characteristics including:

peaked shape,

low gradient between edges and a peak of the displayed shape, relative to other shapes,

small movement of the shape in response to moving of the sensors over the tissue, relative to the other shapes,

small change in the shape in response to changing the imposed pressure, relative to the other shapes, and

growth of the shape over time.

52. The method of claim 51, wherein examining a the shape comprises identifying a discrete, dominant, or different carcinoma characteristic of the shape, and

determining whether the shape represents an underlying carcinoma based on the identified discrete, dominant, or different carcinoma characteristic in the shape.

53. The method of claim 46 wherein the image comprises a 3-dimensional image, said areas being arranged in two of the dimensions and said attributes being arranged in the third dimension.

54. A tissue examination device comprising:

a plurality of sensors which generate signals when pressed against a surface of a selected region of tissue to impose on the sensors pressure that varies in accordance with properties of tissue structures underlying the surface in the region, the signals having levels that represent the pressure imposed on the respective sensors,

a processor for (1) generating an image from the signals generated by the sensors, the image comprising areas that respectively correspond to relative locations of the sensors and have attributes according to the levels of the signals generated by the respective sensors so that the image represents a spatial pressure profile of the selected region of tissue, and (2) processing the signals generated by the sensors to detect an underlying tissue structure in the selected region of tissue, and a display for displaying the image.

55. The device of claim 54 wherein the image comprises a 3-dimensional image, said areas being arranged in two of the dimensions and said attributes being arranged in the third dimension.

56. The device of claim 54 wherein the processor discriminates the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures.

57. The device of claim 56 wherein the processor discriminates the detected tissue structure based on characteristics corresponding to the detected tissue structure.

58. The device of claim 57 wherein the characteristics comprise at least one of a manner of movement of the detected underlying structure as the plurality of sensor are moved over the tissue, an edge profile, a relative stiffness, and a relative curvature of the detected tissue structure.

59. The device of claim 57 wherein the processor determines a degree of membership of the detected tissue structure in a preselected class of tissue structures corresponding to the discriminated type.

60. The device of claim 54 wherein the processor determines a location of the detected underlying tissue structure relative to a reference point, and stores a record in a database, wherein the record includes a result of the processing by the processor and the location of the detected tissue structure relative to a reference point.

61. The device of claim 54 wherein the attributes comprise at least one graphical feature that represents variance in the pressure imposed on the sensors.

62. A device for performing tissue examination comprising:

a plurality of sensors which generate signals in response to pressure imposed thereon when pressed against a selected region of tissue of a person, the pressure varying in accordance with properties of underlying tissue structures,

a position indicator generating positional signals indicative of a position of the sensors, and

a processor for processing the signals generated by the sensors to detect an underlying tissue structure in the region of tissue, and processing the positional signals to determine a location of the detected underlying tissue structure relative to an anatomical feature of the person.

63. The device of claim 62 wherein the processor stores a record in a database, wherein the record includes a characteristic corresponding to the detected tissue structure stored and the location of the detected tissue structure.

64. The device of claim 63 wherein the characteristic comprises at least one of size, manner of movement of the detected underlying structure as the plurality of sensor is moved over the tissue, an edge profile, a relative stiffness, and a relative curvature of the detected tissue structure.

65. The device of claim 63 wherein the processor stores a plurality of records in a database, one of the records comprising a characteristic corresponding to the detected tissue structure and the location of the detected.

66. The device of claim 65 wherein the processor discriminates the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures and stores a result of the discriminating by the processor in the one of the records.

67. The device of claim 66 wherein the processor discriminates the detected tissue structure based on characteristics corresponding to the detected tissue structure.

68. The device of claim 67 wherein the processor determines a degree of membership of the detected tissue structure in a class of tissue structures corresponding to the discriminated type.

69. The device of claim 62 further comprising the processor processing the determined location to produce a map of the location of the detected tissue structure.

70. The device of claim 69 further comprising a display for displaying the map.

71. The device of claim 70 wherein the display comprises a printer for printing the map.

72. The device of claim 71 wherein the display comprises a visual display for displaying the map.

73. The device of claim 70 wherein the display displays a characteristic of a group of the signals corresponding to the detected tissue structure in relation to the location of the detected tissue structure.

74. The device of claim 73 wherein the characteristic of the detected tissue structure comprises at least one of size, edge profile, relative stiffness, relative curvature of the detected tissue structure, and a manner of movement of the detected underlying structure as the plurality of sensor is moved over the tissue.

75. The device of claim 70 wherein the processor discriminates the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures and the display displays a result of the processor discriminating in relation to the detected tissue structure.

76. The device of claim 75 wherein the processor determines a degree of membership of the detected tissue structure in a preselected class of tissue structures corresponding to the discriminated type and the display displays the degree of membership in relation to the detected tissue structure.

77. The device of claim 62 wherein the processor retrieves data representing a previous tissue examination, wherein the data was previously stored during the previous examination, and uses the data with the determined location.

78. The device of claim 77 wherein the retrieved data comprises data representative of signals generated by sensors during a previous examination.

79. The device of claim 77 wherein the retrieved data comprises a result of processing signals in the previous tissue examination to discriminate an underlying tissue structure as one of a plurality of different types of underlying tissue structures.

80. The device of claim 77 wherein the retrieved data further comprises a location of a detected tissue structure in the previous tissue examination relative to the anatomical feature.

81. The device of claim 77 wherein the retrieved data further comprises a degree of membership of a detected tissue in the previous tissue examination in a preselected class of tissue structures.

82. The device of claim 77 wherein the processor:

discriminates the detected underlying tissue structure as one of a plurality of different types of underlying tissue structures,

processes the retrieved data to generate a first map of a location of a tissue structure detected based on the previously stored data, wherein the map of the location is generated relative to the anatomical feature, and

processes the determined location to produce a second map of the location of the detected tissue structure, and

wherein the display displays the first and second maps.

83. The device of claim 77 wherein the processor:

discriminates the first-mentioned detected underlying tissue structure as one of a plurality of different types of underlying tissue structures,

processes the retrieved data to discriminate a second underlying tissue structure in the region of the tissue as the one of the plurality of different types of underlying tissue structures, and

determines whether the first mentioned underlying tissue structure and the second underlying tissue structure are a same underlying tissue structure.

84. The device of claim 83 wherein if the first-mentioned and second discriminated underlying tissue structures are determined to be the same underlying tissue structure, the processor processes signals corresponding to the first-mentioned discriminated underlying tissue structure with the data corresponding to the second discriminated underlying tissue structure to determine changes corresponding to the same underlying tissue structure between the previous and a current examination.

89. The device of claim 82 wherein the display displays a value corresponding to a peak pressure represented in the image.

85. A tissue examination device comprising

a plurality of sensors which generate signals when pressed against a surface of a selected region of tissue to impose on the sensors pressure that varies in accordance with properties of tissue structures underlying the surface in the region, the signals having levels that represent the pressure imposed on the respective sensors,

a processor for generating an image from the signals generated by the sensors, the image comprising areas that respectively correspond to relative locations of the sensors and have attributes according to the levels of the signals generated by the respective sensors so that the image represents a spatial pressure profile of the selected region of tissue, and

a display for displaying the image.

86. The device of claim 85 wherein the display displays the image attributes as a pre-selected range of colors that correspond to the attributes.

87. The device of claim 85 wherein the display displays a shape representative of an underlying tissue structure in the region as part of that image.

88. The device of claim 87 wherein the processor detects the underlying tissue structure and displays an outline of the shape based on the detection.

90. The device of claim 85 wherein the display displays a gradient of a portion of the image.

91. The device of claim 85 wherein the display comprises a printer for printing the image.

92. The device of claim 85 wherein the display displays the image on a visual display.

93. The device of claim 85 wherein the attributes comprise at least one graphical feature that represents variance in the pressure imposed on the sensors.

94. The device of claim 85 wherein the image comprises a 3-dimensional image, said areas being arranged in two of the dimensions and said attributes being arranged in the third dimension.

95. The device of claim 94 wherein the display displays a top view of the three dimensional image.

96. The device of claim 94 wherein the display displays a perspective view of the three dimensional image.

97. The device of claim 85 further comprising a position indicator, wherein

the sensors when pressed at a first position against the selected region of tissue generate a first plurality of signals that represent the pressure imposed thereon, and the sensors when moved to a second position and pressed against the selected region of tissue generate a second plurality of signals that represent the pressure imposed thereon,

the position indicator generates positional signals indicative of the first and second positions of the sensors, and

the processor processes the positional signals, the first plurality of signals, and the second plurality of signals, to generate the image so that the image represents a composite of spatial pressure profiles of the selected region with the sensors in the first and second positions, respectively.

98. The device of claim 97 wherein the processor correlates a portion of the first plurality of signals to a portion of the second plurality of signals, based on the positional signals, to generate the pressure profile of the selected region.