Method and apparatus for detecting very small breast anomalies

• US 6,507,663 B2
• Filed: 06/05/2001
• Issued: 01/14/2003
• Est. Priority Date: 10/24/1997
• Status: Expired due to Fees

• Current Assignee: Ultra Touch Corporation
• Original Assignee: Ultra Touch Corporation
• Inventors: Souluer, Farid
• Primary Examiner(s): Johns, Andrew W.
• Assistant Examiner(s): NAKHJAVAN, SHERVIN K
• Application Number:
  US09/874,077
• Publication Number:
  US 20010031077A1
• Time in Patent Office: 588 Days
• Field of Search: 382/128, 382/131, 382/325, 600/382, 600/424, 600/550, 600/587, 335/11, 335/12, 434/262, 434/267, 434/275, 128/915, 128/920, 128/923, 378/37
• US Class Current: 382/128
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/0064 Body surface scanning
• CPC Class Codes: A61B 5/0091 for mammography
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• 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 5/444 Evaluating skin marks, e.g. mole, nevi, tumour, scar
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61B 5/704 Tables
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors

Abstract

A computer controlled apparatus for detecting breast tumors by mechanically palpating a breast in a full scan manner to detect small lumps or anomalies. The patient is positioned on a fully adjustable bed and oriented relative to the apparatus. A detection head mounted for movement in three dimensions is positioned above the bed. A palpation finger is brought into pressure contact with a sequence of small areas across the entire breast, palpating each area to measure tissue density. Concurrent with the palpation scan, a scan of breast color and temperature is conducted. A locator head positions the detector for the scan in a manner that assures repeatability during each of a series of periodic examinations. This system detects very small lumps and allows easy, accurate monitoring of suspicious areas over an extended time period. Several different embodiments of the detection head and location head are described.

Claims

1. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance; and

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue.

2. The apparatus of claim 1, wherein the controller further records a location of the palpation finger in each of three-dimensions and the force used during palpation at the location to determine the at least one characteristic of the breast tissue for the location.

3. The apparatus of claim 1, wherein the controller positions the at least one palpation finger to a pre-determined location on the surface of the breast tissue.

4. The apparatus of claim 1, wherein the at least one characteristic of the breast tissue includes density.

5. The apparatus of claim 1, wherein the at least one characteristic of the breast tissue includes dimensions of tissue having similar, pre-determined density.

6. The apparatus of claim 1, further comprising a location device that aligns a longitudinal axis of the palpation finger perpendicular to the surface of the breast tissue.

7. The apparatus of claim 3, further comprising a movable bed upon which a patient lies face up for examination, wherein the location device positions the bed to align breasts of the patient in a same location as in a prior examination.

8. The apparatus of claim 1, wherein the palpation finger is movable in three-dimensions across an entire breast surface, allowing perpendicular alignment of the palpation finger to any breast surface location providing sequential palpation capability for the entire breast surface.

9. The apparatus of claim 1, wherein the palpation finger is operably connected with a solenoid.

10. The apparatus of claim 9, wherein the controller applies a predetermined voltage to the solenoid to move the palpation finger a distance determined by resistance of the breast tissue.

11. The apparatus of claim 1, wherein the palpation finger is operably connected with an electromagnetic or electromechanical actuator.

12. The apparatus of claim 11, wherein the controller produces a signal causing the actuator to move the palpation finger a distance with a force against the surface of the breast tissue.

13. The apparatus of claim 1, wherein the detection device includes an optical encoder or a magnetic encoder.

14. The apparatus of claim 1, further comprising at least one sensor to map the surface of the breast tissue and to position the at least one palpation finger relative to the surface of the breast tissue.

15. The apparatus of claim 14, wherein the at least one sensor determines a distance the palpation finger is positioned relative to the surface of the breast tissue.

16. The apparatus of claim 14, wherein the at least one sensor determines an angle between a longitudinal axis of the palpation finger and the surface of the breast tissue.

17. The apparatus of claim 1, wherein the palpation finger is operably connected with a plurality of electromagnetic coils.

18. The apparatus of claim 17, wherein the electromagnetic coils are individually and sequentially actuated to increase the force of the palpation finger against the breast tissue, whereby the increased force of the palpation finger further advances the distance traveled by the palpation finger.

19. The apparatus of claim 18, wherein the electromagnetic coils continue to be individually and sequentially actuated until a pre-determined tissue resistance is reached, whereby increased tissue resistance lessens the advance of the palpation finger during increased force of the palpation finger against the breast tissue.

20. The apparatus of claim 19, wherein the distance traveled by the palpation finger is recorded when the pre-determined tissue resistance is reached.

21. The apparatus of claim 20, wherein the at least one characteristic of the breast tissue is determined based upon the force of the palpation finger against the breast tissue when the pre-determined tissue resistance is reached, the distance traveled by the palpation finger when the pre-determined tissue resistance is reached, and the pre-determined tissue resistance.

22. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance; and

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue;

wherein the controller directs the at least one palpation finger in a continuous, automatic scanning pattern to palpate an entire surface of a breast.

23. The apparatus of claim 22, wherein the controller further stores in memory the continuous, automatic scanning pattern and the at least one characteristic of breast tissue determined for each location thereof creating a first examination result.

24. The apparatus of claim 23, wherein the controller compares the first examination with at least one subsequent examination result having the same scanning pattern to determine changes over time in the at least one characteristic of the breast tissue for each location thereof.

25. The apparatus of claim 23, wherein the controller produces an image of the breast tissue using the at least one characteristic of the breast tissue.

26. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue; and

d. at least one sensor to map the surface of the breast tissue or to positionally locate the at least one palpation finger relative to the surface of the breast tissue;

wherein the at least one sensor includes a camera, an autofocus system, a rangefinder, an acoustic sensor, or an optical sensor.

27. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue; and

d. at least one sensor to map the surface of the breast tissue or to positionally locate the at least one palpation finger relative to the surface of the breast tissue;

wherein the at least one sensor includes a digital camera and grid to establish investigation coordinates for use in comparing measurements made at some other time.

28. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue; and

d. at least one sensor to map the surface of the breast tissue or to positionally locate the at least one palpation finger relative to the surface of the breast tissue;

wherein the at least one sensor measures color, or temperature, or both, of the breast tissue.

29. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a location device that provides positional data to align the palpation finger relative to the surface of the breast tissue and produce an image of the breast tissue; and

d. a controller in communication with the palpation finger, the detection device and the location device, to position the palpation finger at a pre-determined location on the surface of the breast tissue, record the location of the palpation finger on the surface of the breast tissue, record a distance traveled by the palpation finger and determine at least one characteristic of the breast tissue for each location thereof.

30. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a location device that provides positional data to align the palpation finger relative to the surface of the breast tissue and produce an image of the breast tissue; and

d. a controller in communication with the palpation finger, the detection device and the location device, to position the palpation finger at a pre-determined location on the surface of the breast tissue, record the location of the palpation finger on the surface of the breast tissue, record a distance traveled by the palpation finger and determine at least one characteristic of the breast tissue for each location thereof;

wherein the controller directs the at least one palpation finger in a continuous, automatic scanning pattern to palpate an entire surface of a breast.

31. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a location device that provides positional data to align the palpation finger relative to the surface of the breast tissue and produce an image of the breast tissue, wherein the location device includes a white light source and movable lens; and

d. a controller in communication with the palpation finger, the detection device and the location device, to position the palpation finger at a pre-determined location on the surface of the breast tissue, record the location of the palpation finger on the surface of the breast tissue, record a distance traveled by the palpation finger and determine at least one characteristic of the breast tissue for each location thereof.

32. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance;

c. a location device that provides positional data to align the palpation finger relative to the surface of the breast tissue and produce an image of the breast tissue, wherein the location device includes a laser scanner having a laser emitter and focussing system; and

d. a controller in communication with the palpation finger, the detection device and the location device, to position the palpation finger at a predetermined location on the surface of the breast tissue, record the location of the palpation finger on the surface of the breast tissue, record a distance traveled by the palpation finger and determine at least one characteristic of the breast tissue for each location thereof.

33. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a predetermined force against a tissue resistance;

c. a location device that provides positional data to align the palpation finger relative to the surface of the breast tissue and produce an image of the breast tissue, wherein the location device includes at least one laser diode and light sensor unit and an optical, focussing lens assembly; and

d. a controller in communication with the palpation finger, the detection device and the location device, to position the palpation finger at a pre-determined location on the surface of the breast tissue, record the location of the palpation finger on the surface of the breast tissue, record a distance traveled by the palpation finger and determine at least one characteristic of the breast tissue for each location thereof.

34. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a predetermined force against a tissue resistance;

c. a location device that provides positional data to align the palpation finger relative to the surface of the breast tissue and produce an image of the breast tissue, wherein the location device is incorporated with the detection device; and

d. a controller in communication with the palpation finger, the detection device and the location device, to position the palpation finger at a pre-determined location on the surface of the breast tissue, record the location of the palpation finger on the surface of the breast tissue, record a distance traveled by the palpation finger and determine at least one characteristic of the breast tissue for each location thereof.

35. A method for detecting anomalies in breast tissue, the method comprising the steps of:

a. depressing a surface of the breast tissue with a probe;

b. detecting a distance traveled by the probe; and

c. determining at least one breast tissue characteristic value based upon the distance traveled by the probe, the value indicative of a presence of an anomaly in the breast tissue.

36. The method of claim 35, wherein the probe is moved incrementally and steps (a) through (c) are performed at each of multiple locations.

37. The method of claim 36, wherein the multiple locations encompass an entire surface of a breast.

38. The method of claim 36, further including the step of storing positional information regarding each location and the at least one characteristic of breast tissue determined for each location thereby creating a first examination result.

39. The method of claim 38, further including the step of comparing the first examination result with at least one subsequent examination result having the same multiple locations to determine changes over time in the at least one characteristic of the breast tissue for each location.

40. The method of claim 39, wherein the at least one characteristic of the breast tissue is density.

41. The method of claim 35, wherein a force upon which the probe depresses the surface of the breast tissue is sequentially increased, whereby the sequentially increasing force of the probe further advances the distance traveled by the probe.

42. The apparatus of claim 41, wherein the force upon which the probe depresses the surface of the breast tissue continues to be increased until a pre-determined tissue resistance is reached, whereby increased tissue resistance lessens the advance of the probe during increased force of the probe against the breast tissue.

43. The apparatus of claim 42, wherein the distance traveled by the probe is detected when the pre-determined tissue resistance is reached.

44. The apparatus of claim 43, wherein determining the at least one breast tissue characteristic is further based upon the force of the probe against the breast tissue when the pre-determined tissue resistance is reached, the distance traveled by the probe when the pre-determined tissue resistance is reached, and the pre-determined tissue resistance.

45. A method for detecting anomalies in breast tissue, the method comprising the steps of:

a. positioning a probe at a predetermined location against a surface of breast tissue;

b. depressing the probe with a predetermined force against the surface of the breast tissue;

c. measuring a distance traveled by the probe;

d. determining a density value for the breast tissue based upon the distance traveled by the probe, the density value indicative of a presence of an anomaly in the breast tissue; and

e. storing the predetermined probe location, or the predetermined force, or the density value, or a combination thereof, to create an examination result, whereby the examination result can be compared to prior or subsequent examination results.

46. The method of claim 45, wherein steps (a) through (e) are performed for each of multiple predetermined locations.

47. The method of claim 46, wherein the multiple locations encompass an entire surface of a breast.

48. The method of claim 47, further comprising the step of comparing the examination result with at least one prior or subsequent examination result to determine a change over time in the density value of the breast tissue for each respective location, the change over time in the density value for each location being indicative of a presence of an anomaly in the breast tissue at the respective location.

49. The method of claim 46, further comprising the step of identifying a region of breast tissue having a predetermined density value.

50. The method of claim 45, further comprising the step of comparing the examination result with at least one prior or subsequent examination result to determine a change over time in the density value of the breast tissue, the change over time in the density value being indicative of a presence of an anomaly in the breast tissue.

51. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined, mechanically applied force against a tissue resistance; and

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue.

52. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined force against a tissue resistance, the distance traveled referring to a distance the finger advances along its longitudinal axis; and

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue.

53. An apparatus for detecting anomalies in breast tissue, comprising:

a. at least one palpation finger that palpates a surface of breast tissue;

b. at least one detection device that measures and transmits a distance traveled by the palpation finger while depressing the surface of the breast tissue at a pre-determined, and sequentially increasing, force until a pre-determined tissue resistance is reached; and

c. a controller in communication with the palpation finger and the detection device that records the distance traveled by the palpation finger and determines at least one characteristic of the breast tissue.