Layer of material for use with tissue examination device

• US 6,179,790 B1
• Filed: 10/20/1997
• Issued: 01/30/2001
• Est. Priority Date: 10/20/1997
• Status: Expired due to Term

• Current Assignee: Medical Tactile, Inc.
• Original Assignee: Assurance Medical, Inc.
• Inventors: Roberts, Troy William, West, Alan Irving, Cundari, Michael Anthony
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/954,454
• Time in Patent Office: 1,198 Days
• Field of Search: 600/587, 600/592, 600/595
• US Class Current: 600/587
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0048 Detecting, measuring or recording by applying mechanical forces or stimuli A61B5/021, A61B5/4884 and A61B9/00 take precedence
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 8/0825 for diagnosis of the breast, e.g. mammography

Abstract

A layer of material is provided for covering a plurality of sensors when using those sensors to examine tissue. The layer material is used with a tissue examination device that has a plurality of pressure sensors that produce signals in response to pressure imposed on the sensor as the sensors are pressed against tissue. The device also has a processor for processing those signals to detect whether an underlying tissue structure is present in the tissue being examined. The layer of material is configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner. The processor can also process the signals to generate an image representative of the underlying tissue structure and a display then can display that image.

Claims

1. Apparatus comprising

a tissue examination device that includes a plurality of pressure sensors that produce signals in response to pressure imposed thereon as the sensors are pressed against tissue, a housing having a distal region defining a maximum dimension, the pressure sensors being disposed on said distal region of the housing, and a processor for processing said signals to detect whether an underlying tissue structure is present in the tissue being examined, and

a layer of material comprising

a sensor covering portion configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner, and

an attachment portion extending the sensor covering portion to define a cavity for receiving the distal region of the housing, said attachment portion being smaller than the maximum dimension defined by the distal region of the housing and being flexible so that the attachment portion can be stretched over the distal region of the housing when the distal region is inserted into the cavity and tends to return to its original size to cause the attachment portion to engage against the housing.

2. The apparatus of claim 1 wherein the sensor covering portion distributes pressure imposed on a sensor to an adjacent sensor.

3. The apparatus of claim 2 wherein the sensor covering portion distributes the pressure imposed on the sensor to surrounding sensors.

4. The apparatus of claim 2, wherein the sensors have a top layer and the sensor covering portion is configured to reduce a deflection of the top layer in response to the imposed pressure.

5. The apparatus of claim 1 wherein the imposed pressure comprises shear stress imposed by the tissue on the sensors when the sensors are moved over the tissue and the sensor covering portion distributes the shear stress to reduce the shear stress imposed on the sensors.

6. The apparatus of claim 5 wherein the sensors have a top and a bottom layer, the top layer being capable of moving relative to the bottom layer in response to the shear stress, wherein the sensor covering portion is configured to reduce a movement of the top layer relative to the bottom layer caused by the shear stress.

7. The apparatus of claim 6 further comprising a lubricant between the top layer of the sensors and the sensor covering portion.

8. The apparatus of claim 5 wherein the sensor covering portion is configured to distribute the shear stress imposed on the sensor covering portion to the housing of the tissue examination device through the attachment portion to reduce the shear stress on the sensors.

9. The apparatus of claim 1 wherein the housing further comprises a neck connected to the distal region of the housing and the attachment portion is configured to frictionally engage the neck.

10. The apparatus of claim 1 wherein the housing further comprises a neck connected to the distal region and the attachment portion adhesively attaches to the neck.

11. The apparatus of claim 1 wherein the layer of material is constructed from a material selected for distributing pressure imposed on one of the sensors to surrounding sensors.

12. The apparatus of claim 11, wherein the layer of material is constructed from polyurethane.

13. The apparatus of claim 12, wherein the polyurethane has a thickness of 0.001-0.005 inch.

14. The apparatus of claim 1 wherein the layer of material is constructed from a material selected for operating with a selected lubricant.

37. The apparatus of claim 1 wherein the attachment portion is sized such that the attachment portion remains in an at least partially stretched condition when engaged against the distal region of the housing.

38. The apparatus of claim 1 wherein the sensor covering portion is sized smaller than the distal region of the housing and is flexible such that the sensor covering portion is disposed over the sensors in at least a partially stretched condition.

39. The apparatus of claim 1 wherein the distal region of the housing is characterized by a general contour, the sensor covering portion being configured to substantially follow the general contour when attached to the housing.

40. The apparatus of claim 9 wherein the attachment portion is sized smaller than the neck such that the attachment portion is in an at least partially stretched condition when engaged thereagainst.

15. A layer of material for a tissue examination device that includes a plurality of pressure sensors that produce signals in response to pressure imposed thereon as the sensors are pressed against tissue, a housing having a distal region defining a maximum dimension, the pressure sensors being disposed on said distal region of the housing, and a processor for processing said signals to detect whether an underlying tissue structure is present in the tissue being examined, the layer of material comprising

a sensor covering portion configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner, and

an attachment portion extending from the sensor covering portion to define a cavity for receiving the distal region of the housing, said attachment portion being smaller than the maximum dimension defined by the distal region of the housing and being flexible so that the attachment portion can be stretched over the distal region of the housing when the distal region is inserted into the cavity and tends to return to its original size to cause the attachment portion to engage against the housing.

16. The layer of material of claim 15, wherein the sensor covering portion, when disposed over the sensors of the tissue examination device, distributes pressure imposed on a sensor to an adjacent sensor.

17. The layer of material of claim 16, wherein the sensor covering portion, when disposed over the sensors of the tissue examination device, distributes the pressure imposed on the sensor to surrounding sensors.

18. The layer of material of claim 17, wherein the sensors have a top layer and the sensor covering portion, when disposed over the sensors of the tissue examination device, is configured to reduce a deflection of the top layer in response to the imposed pressure.

19. The layer of material of claim 16, wherein the imposed pressure comprises shear stress imposed by the tissue on the sensors when the sensors are moved over the tissue and the sensor covering portion, when disposed over the sensors of the tissue examination device, distributes the shear stress to reduce the shear stress imposed on the sensors.

20. The layer of material of claim 19, the sensors have a top and a bottom layer, the top layer being capable of moving relative to the bottom layer in response to the shear stress, wherein the sensor covering portion is configured to reduce a movement of the top layer relative to the bottom layer caused by the shear stress, when the sensor covering portion is disposed over the sensors of the tissue examination device.

21. The layer of material of claim 19, wherein the sensor covering portion is configured so that, when disposed over the sensors of the tissue examination device, the sensor covering portion distributes the shear stress imposed on the sensor covering portion to the housing of the tissue examination device through the attachment portion to reduce the shear stress on the sensors.

22. The layer of material of claim 15, wherein the housing further comprises a neck connected to the distal region of the housing, and the attachment portion is configured to frictionally engage the neck.

23. The layer of material of claim 15, wherein the layer of material is constructed from a material selected for distributing pressure imposed on one of the sensors to surrounding sensors, when the sensor covering portion is disposed over the sensors of the tissue examination device.

24. The layer of material of claim 15, wherein the layer of material is constructed from a material selected for operating with a selected lubricant.

41. The layer of material of claim 15, wherein the attachment portion is sized such that the attachment portion remains in an at least partially stretched condition when engaged against the distal region of the housing.

42. The layer of material of claim 15, wherein the sensor covering portion is sized smaller than the distal region of the housing and is flexible such that the sensor covering portion is disposed over the sensors in at least a partially stretched condition.

43. The layer of material of claim 15, wherein the distal region of the housing is characterized by a general contour, the sensor covering portion being configured to substantially follow the general contour when attached to the housing.

44. The layer of material of claim 22, wherein the attachment portion is sized smaller than the neck such that the attachment portion is in an at least partially stretched condition when engaged thereagainst.

45. The layer of material of claim 23, wherein the layer of material is constructed from polyurethane.

46. The layer of material of claim 45, wherein the polyurethane has a thickness of 0.001-0.005 inch.

25. Apparatus comprising

a tissue examination device that includes a plurality of pressure sensors that produce signals in response to pressure imposed thereon as the sensors are pressed against tissue, and a housing having a distal region defining a maximum dimension, the pressure sensors being disposed on said distal region or the housing, and

a layer of material comprising

a sensor covering portion configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner, and

an attachment portion extending from the sensor covering portion to define a cavity for receiving the distal region of the housing, said attachment portion being smaller than the maximum dimension defined by the distal region of the housing and being flexible so that the attachment portion can be stretched over the distal region of the housing when the distal region is inserted into the cavity.

26. The apparatus of claim 25, wherein the tissue examination device further comprises a processor for processing the signals generated by the sensors to generate an image representative of the underlying tissue structure, and a display for displaying said image.

27. The apparatus of claim 25, wherein the sensor covering portion distributes pressure imposed on a sensor to an adjacent sensor.

28. The apparatus of claim 27, wherein the sensors have a top layer and the sensor covering portion is configured to reduce a deflection of the top layer in response to the imposed pressure.

29. The apparatus of claim 28, wherein the imposed pressure comprises shear stress imposed by the tissue on the sensors when the sensors are moved over the tissue and the sensor covering portion distributes the shear stress to reduce the shear stress imposed on the sensors.

30. The apparatus of claim 29, wherein the sensor covering portion is configured to distribute the shear stress imposed on the sensors to the housing of the tissue examination device through the attachment portion to reduce the shear stress.

47. The apparatus of claim 25, wherein the housing further comprises a neck connected to the distal region of the housing and the attachment portion is configured to frictionally engage the neck.

48. The apparatus of claim 47, wherein the attachment portion is sized smaller than the neck such that the attachment portion is in an at least partially stretched condition when engaged thereagainst.

49. The apparatus of claim 25, wherein the layer of material is constructed from a material selected for distributing pressure imposed on one of the sensors to surrounding sensors.

50. The apparatus of claim 49, wherein the layer of material is constructed from polyurethane.

51. The apparatus of claim 50, wherein the polyurethane has a thickness of 0.001-0.005 inch.

52. The apparatus of claim 25, wherein the layer of material is constructed from a material selected for operating with a selected lubricant.

53. The apparatus of claim 25, wherein the attachment portion is sized such that the attachment portion remains in an at least partially stretched condition when engaged against the distal region of the housing.

54. The apparatus of claim 25, wherein the sensor covering portion is sized smaller than the distal region of the housing and is flexible such that the sensor covering portion is disposed over the sensors in at least a partially stretched condition.

55. The apparatus of claim 25, wherein the distal region of the housing is characterized by a general contour, the sensor covering portion being configured to substantially follow the general contour when attached to the housing.

31. A layer of material for a tissue examination device that includes a plurality of pressure sensors that produce signals in response to pressure imposed thereon as the sensors are pressed against tissue, and a housing having a distal region defining a maximum dimension, the pressure sensors being disposed on said distal region of the housing, the layer of material comprising

a sensor covering portion configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner, and

an attachment portion extending from the sensor covering portion to define a cavity for receiving the distal region of the housing, said attachment portion being smaller than the maximum dimension defined by the distal region of the housing, and being flexible so that the attachment portion can be stretched over the distal region of the housing when the distal region is inserted into the cavity and tends to return to its original size to cause the attachment portion to engage against the housing.

32. The layer of material of claim 31, wherein the sensor covering portion, when disposed over the sensors of the tissue examination device, distributes pressure imposed on a sensor to surrounding sensors.

33. The layer of material of claim 32, wherein the sensors have a top layer and the sensor covering portion is configured to reduce a deflection of the top layer in response to the imposed pressure, when the sensor covering portion is disposed over the sensors of the tissue examination device.

34. The layer of material of claim 31, wherein the imposed pressure comprises shear stress imposed by the tissue on the sensors when the sensors are moved over the tissue and the sensor covering portion, when disposed over the sensors of the tissue examination device, distributes the shear stress to reduce the shear stress imposed on the sensors.

35. The layer of material of claim 34, wherein the sensor covering portion, when disposed over the sensors of the tissue examination device, distributes pressure imposed on a sensor to the housing of the tissue examination device through the attachment portion to reduce the shear stress.

56. The layer of material of claim 31, wherein the housing of the tissue examination device further comprises a neck connected to the distal region of the housing and the attachment portion is configured to frictionally engage the neck.

57. The layer of material of claim 56, wherein the attachment portion is sized smaller than the neck such that the attachment portion is in an at least partially stretched condition when engaged thereagainst.

58. The layer of material of claim 31, wherein the layer of material is constructed from a material selected for distributing pressure imposed on one of the sensors to surrounding sensors, when the sensor covering portion is disposed over the sensors of the tissue examination device.

59. The layer of material of claim 58, wherein the layer of material is constructed from polyurethane.

60. The layer of material of claim 59, wherein the polyurethane has a thickness of 0.001-0.005 inch.

61. The layer of material of claim 31, wherein the layer of material is constructed from a material selected for operating with a selected lubricant.

62. The layer of material of claim 31, wherein the attachment portion is sized such that the attachment portion remains in an at least partially stretched condition when engaged against the distal region of the housing.

63. The layer of material of claim 31, wherein the sensor covering portion is sized smaller than the distal region of the housing and is flexible such that the sensor covering portion is disposed over the sensors in at least a partially stretched condition.

64. The layer of material of claim 31, wherein the distal region of the housing is characterized by a general contour, the sensor covering portion being configured to substantially follow the general contour when attached to the housing.

36. A method for examining tissue comprising

providing a tissue examination device that includes a plurality of pressure sensors that produce signals in response to pressure imposed thereon as the sensors are pressed against tissue, and a housing having a distal region defining a maximum dimension, the pressure sensors being disposed on said distal region of the housing,

providing a layer of material that comprises

a sensor covering portion, and

a flexible attachment portion extending from the sensor covering portion to define a cavity for receiving the distal region of the housing, said attachment portion being smaller than the maximum dimension defined by the distal region of the housing,

inserting the distal region of the housing into the cavity and stretching the attachment portion over the distal region of the housing so that the attachment portion tends to return to its original size to cause the attachment portion to engage against the housing with the sensor covering portion being disposed over the sensors to distribute the imposed pressure in a selected manner, and

pressing the sensors against the tissue to examine the tissue.

65. The method of claim 36, further comprising

processing said signals to detect whether an underlying tissue structure is present in the tissue being examined.

66. The method of claim 36, further comprising

processing said signals to generate an image representative of an underlying tissue structure, and

displaying said image.

67. The method of claim 36, further comprising

stretching the proximal end of the attachment portion over the distal region of the housing to remove the distal region of the housing from the cavity through the opening.