Method and apparatus for spectral transmissibility examination and analysis

• US 4,570,638 A
• Filed: 10/14/1983
• Issued: 02/18/1986
• Est. Priority Date: 10/14/1983
• Status: Expired due to Term

• Current Assignee: Somanetics Corporation (Medtronic Plc)
• Original Assignee: Somanetics Corporation (Medtronic Plc)
• Inventors: Stoddart, Hugh F., Lewis, Gary D.
• Primary Examiner(s): Doll, John
• Assistant Examiner(s): MCFARLANE, ANTHONY R
• Application Number:
  US06/542,022
• Time in Patent Office: 858 Days
• Field of Search: 128/665, 128/666, 128/633, 128/664
• US Class Current: 600/476
• CPC Class Codes: A61B 5/0091 for mammography
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence

Abstract

Methodology and apparatus for the clinical evaluation of biological matter, in particular the human breast, in situ and in vivo, by spectral light transmissivity. An optical probe introduces selected light spectra into the examination subject at a first position and resulting light is detected at a second position located some distance from the infusion point; also, reception preferably occurs at another location, and the distances of these locations from the infusion point are determined. The light energy received at the distant points is quantified and conditioned by use of the determined distances from the infusion point and also by contrasting the data from the two differently-located reception points, such that the resulting data is compensated or normalized to characterize intrinsic internal tissue characteristics in an absolute sense, devoid of individual characteristics such as skin pigmentation, breast thickness, etc. The methodology further includes analytical or diagnostic treatment of the conditioned data by specific comparison of conditioned data taken from different regions of the same subject, of conditioned data taken from the same region on physiologically paired and/or different subjects, and also provides for meaningful accumulation of large-scale "background" or "average" values based upon identified and selected patient populations.

Claims

1. Apparatus for obtaining optical response data from selected body portions of individual subjects indicative of the intrinsic internal physiological state of tissue within such body portions, comprising:

a manually-manipulatable test instrument having at least first and second component members mounted for movement relative to one another and support means disposed therebetween for holding such members in selected mutually spaced relative positions;

said first component member including light source means for emitting selected light from said first member;

said first component member being adapted to fit closely against a selected body portion from which clinical data is desired to be obtained, in a manner to project said emitted light into the interior of such body portion;

light-receiving means carried by at least said second component member for receiving at least part of the light projected into said selected body portion;

said support means including position-variable elements for movement of one of said component members relative to the other to change the nominal optical distance between said source and said light-receiving means;

means operatively coupled between said light source means and said light-receiving means for measuring the particular length of said nominal optical distance at various positions of said relative movement which effects change in such distance;

and means for producing signals for computation representative of the nominal optical distance determined by said length-measurement means.

2. Apparatus for obtaining optical response data from selected body portions of individual subjects indicative of the intrinsic internal physiological state of tissue within such body portions, comprising:

a manually-manipulatable test instrument having at least first and second component members and supportive guide means disposed therebetween for movably positioning such members in a plurality of differently-spaced but consistently-aligned relative positions;

said first component member including light source means for emitting selected light from said first member;

said first component member being adapted to fit closely against a selected body portion from which clinical data is desired to be obtained, so as to project said emitted light thereinto;

light-receiving means carried by said second component member for receiving at least part of the light projected into said selected body portion;

light-receiver means carried with said first component member at a known distance from said light source, for receiving certain of said light emitted by said source after projection thereof into said selected body portion and following reflection and back-scatter effects upon said light occurring within said body portion, such that the emitted and projected light is received at both a far point on said body portion spaced from that at which said light is introduced into the body portion and also at a near point spaced at least slightly less than the far point from the point at which the light is initially introduced to the body portion;

said far and near points of light reception being separated by a particular optical distance determinable from the respective locations of such points and the nominal distances thereof from the point of light injection, and said apparatus including means for operatively determining a value for said particular optical distance.

3. Optical response apparatus according to claim 2 wherein said second component member includes first and second light-receiver means, said first light-receiver means being positioned generally along a first axis with respect to said light source and said second light-receiver means being spaced from the first light-receiver means so as to be positioned along a second and different axis with respect to said light source.

4. Optical response apparatus according to claim 3 wherein said second light-receiver means is disposed generally opposite and in general alignment with said light-receiver means carried with said first component member.

5. Apparatus according to claim 2 and including at least a pair of mutually cooperative light detectors associated with at least one of said component members, each having portions for receiving light wavelengths arriving at such component member from said source and through said body portion, and each of said detectors being adapted to provide electrical signals representative of at least certain of the light so received.

6. Apparatus according to claim 5 including at least a pair of said mutually cooperative light detectors associated with both of said component members to receive light from said source arriving at each component member after introduction into a body portion and undergoing reflection, scatter and transmission effects within said body portion.

7. Apparatus according to claim 6 wherein each of said mutually cooperative detectors in each such pair is of a type having specific differences from the other detector in that pair and effective at least in part over differing wavelength spectra.

8. Apparatus according to claim 6 wherein each of said mutually cooperative detectors in each such pair is of a type having specific differences from the other detector in that pair and effective at least in part over at least certain of the same wavelength spectra.

9. A method of obtaining optical response data from selected body portions of living beings indicative of the intrinsic internal physiological state of tissue within such body portions, comprising the steps of:

placing at least first and second optical probe members in optical engagement with different areas on the surface of the selected body portion in a manner effective to project light into and receive such light out of the interior of said body portion from between the optically-active portions of such probe members;

using position-fixing support means at least in part to hold said optical probe members in their said position of optical engagement, and determining the particular separation distance between said optically-active portions of said probe members while the latter are so held;

sending selected light from at least one of said probe member active portions into the selected body portion which is in optical engagement therewith, and receiving resulting light energy at least at the other probe member active portion;

quantifying and conditioning the said light energy received at said other probe member active portion by using said particular determined separation distance to condition such light energy data, for meaningful comparison with other such conditioned data obtained at other body portions and other separation distances.

10. The method of obtaining optical response data according to claim 9, and including the steps of moving said active portions of said first and second optical probe members from their said position of optical engagement with different areas on said selected body portion into other positions of optical engagement with the same body portion but at other locations thereon;

holding said optical probe members in position at such other locations while maintaining their said optical engagement there;

and repeating said steps of determining particular separation distance, sending selected light, receiving resulting light energy, and quantifying and conditioning received light energy by using the particular separation distance determinations to condition the light energy received at the other positions, for comparison with other such data.

11. The method of obtaining optical response data according to claim 10, wherein said selected body portion is the breast of a human female and said steps of placing the active portions of said optical probe members and obtaining conditioned data are carried out at a plurality of particular locations for an individual breast including at least one side portion thereof and generally centrally thereof.

12. The method of obtaining optical response data according to claim 11, wherein said step of placing said active portions of said optical probe members and obtaining data at a plurality of locations on the same breast includes at least a location generally centrally of the breast near the chest wall and a location generally centrally of the breast outward from the chest wall toward the nipple.

13. The method of obtaining optical response data according to claim 9, including the steps of receiving said resulting light energy from said body portion at a first location nearer that at which said selected light is sent into said body portion at said one optical probe member as compared to a second such location, as well as receiving said resulting light energy at said other optical probe member at a second location farther from that at which the light is sent into the body portion as compared to said first location, quantifying the resulting light energy received at said nearer location, and using at least said quantification of resulting light energy received at said nearer location as a conditioning factor for the quantifications of resulting light energy received at said second location, to condition the latter such quantifications for optical effects on the received light resulting from impingement of the light upon and passage thereof through the skin of the selected body portion at the place of light entry.

14. The method of obtaining optical response data according to claim 13, wherein said step of receiving resulting light at said location includes receiving such light at a point within not more than about two-to-three centimeters from the place at which said selected light is introduced to said selected body portion.

15. The method of obtaining optical response data according to claim 14, wherein said step of quantifying said resulting light received at at least one of said locations includes impinging such light upon two different types of light detector elements each having an active response over at least some of the same wavelengths.

16. A method of appraising the physiologic state o f selected body portions of living beings by optical response, comprising the steps of:

using at least first and second optical probe members to inject light into and receive injected light from the selected body portion at a plurality of predetermined different mutually-spaced positions thereon;

maintaining said optical probe members fixed in each of their said positions of physcial contact, and determining a measure of the nominal optical distance between said optically-active portions of said probe members while the latter are so maintained at each of said positions;

sending selected light spectra from at least one of said probe member active portions into the selected body portion and receiving resulting light energy at least at the other probe member active portion at each of said different positions, and producing corresponding valuations from the light energy so received at each such position;

using the said nominal optical distance measure determined at each such position to condition the light energy valuations produced for each such position;

and mutually comparing the conditioned light energy valuation data corresponding to the various different positions and different nominal optical distance measures which have been determined.

17. The method of optically appraising physiologic state as recited in claim 16, including the steps of sending selected wavelengths of said light into the selected body portion, correlating individual component parts of the said conditioned light energy valuation data obtained for individual instances of the said different optical probe positions with the particular selected ligh t wavelength for which such individual valuation data component parts are responsive and representative, and using such correlated valuation data component parts and particular selected wavelengths as the basis for said step of mutually comparing the conditioned light energy valuation data obtained at the various different positions and nominal optical distances which have been determined.

18. The method of optically appraising physiologic state as recited in claim 17, including the step of graphically plotting coordinates representative of at least certain of said correlated valuation data component parts and their corresponding wavelengths for different ones of said positions, and performing said step of mutually comparing by contrasting at least portions of one or more such graphical plots with others thereof.

19. The method recited in claim 17 as applied to human female breast anatomy, wherein said first and second optical probe members are placed generally opposite one another on the top and bottom surfaces of a breast, respectively, and periodically shifted from one to another predetermined location on said top and bottom surfaces, said one and another predetermined locations on said top and bottom breast surfaces comprising said plurality of different positions on the surface of the selected body portion.

20. The method as recited in claim 19, wherein said predetermined locations include at least one along the outer side portion of the breast and at least one generally centrally of that same breast.

21. The method as recited in claim 17 as applied to human female breast anatomy, including the steps of placing said first and second optical probe members in a plurality of particular different mutually-spaced positions with respect to each breast of the same human subject, with the said particular positions for one breast generally corresponding to those for the other;

holding said optical probe members in fixed position at each of such positions and establishing a measure of said nominal optical distance for each;

carrying on said steps of sending selected wavelengths of light and receiving resulting light energy at each of said plurality of particular positions for both breasts, and using the particular nominal optical distance established for each such position to condition the light energy valuation data produced for each such position;

and including the step of mutually comparing the conditioned light energy valuation data produced for various ones of said particular different positions on one breast with the conditioned data produced for the corresponding positions of the other breast.

22. The method as recited in claim 21, including the steps of correlating individual component parts of the said conditioned light energy valuation data for individual ones of the said different positions and nominal optical distances with the particular selected light wavelength for which such individual valuation data component parts are responsive and respresentative, and using such correlated valuation data component parts and particular selected wavelengths as the basis for said step of mutually comparing the conditioned light energy valuation data produced for the various different positions and different nominal optical distances.

23. The method as recited in claim 22, including the step of graphically plotting coordinates representative of at least certain of said correlated valuation data component parts and their respective wavelengths for selected corresponding positions on the two different breasts of the same human subject, said step of mutually comparing being carried out by contrasting at least portions of such graphical plots for at least one set of corresponding positions on opposite breasts of the same subject.

24. The method as recited in claim 23, wherein said step of graphically plotting coordinates is carried on for a plurality of sets of said selected corresponding positions on the two opposite breasts.

25. The method as recited in claim 24, wherein said step of graphically plotting coordinates is carried out at sets of corresponding positions on the two opposite breasts which include at least a first position located generally centrally of the breast and near the chest wall, and at least one other position located outwardly from said first position.

26. The method as recited in claim 25, wherein said other positions include one located generally centrally of the breast and outward and away from the chest wall, and another disposed along a marginal edge of the breast.

27. The method as recited in claim 16, and including the step of receiving said resulting light energy from said body portion at at least first and second locations which are disposed at different distances from the point where said light is sent into said body portion at said one optical probe member, one of said locations for receiving said resulting light energy being closer to the point where said light is sent into said body portion than the other such location, at least at certain of said different positions;

and using a representative valuation of said resulting light energy received at said closer location as a conditioning factor for producing conditioned valuations of said resulting light energy received at said other location, to condition the valuation data so produced for optical effects on the received light caused by impingement of the light upon and passage thereof through the skin of the selected body portion at the place of light entry, in addition to using the said nominal optical distance measure determined for the different optical probe positions to condition the valuation data produced for light energy received by said other optical probe member at such different positions.

28. The method as recited in claim 27, including the steps of sending selected wavelengths of said light into the selected body portion, correlating individual component parts of the said conditioned light energy data produced for individual instances of the said different optical probe positions with the particular selected light wavelength for which such individual data component parts are responsive and representative, and using such correlated data component parts and particular selected wavelengths as coordinates to graphically plot the conditioned light energy valuation data obtained at the various different positions and different nominal optical distances.

29. The method recited in claim 28 as applied to human female breast anatomy, wherein said first and second optical probe members are placed generally opposite one another on the top and bottom surfaces of a breast, respectively, and periodically shifted from one to another predetermined location on said top and bottom surfaces, said one and another predetermined locations on said top and bottom breast surfaces comprising said plurality of different positions on the surface of the selected body portion, said predetermined locations including at least one along the outer side portion of the breast and at least one generally centrally of that same breast.

30. The method as recited in claim 29, wherein said first and second optical probe members are placed in a plurality of particular different mutually-spaced positions with respect to each breast of the same human sunject and the said predetermined locations for one breast generally correspond to those for the other;

said optical probe members being held in fixed position at each of such locations and said nominal optical distance being determined for each;

said steps of sending selected wavelengths of light and receiving resulting light energy being carried out at each of said plurality of predetermined locations for both breasts, and the particular nominal optical distance determined for each such location being used to condition the light energy valuation data produced at each such position;

and including the step of mutually comparing the conditioned light energy data produced for various ones of said predetermined different locations for one breast with the conditioned data produced for the corresponding predetermined locations for the other breast.

31. The method as recited in claim 30, including the steps of correlating individual component parts of the said conditioned light energy data for individual ones of the said different locations and different nominal optical distances with the particular selected light wavelength for which such individual data component parts are responsive and representative, and using such correlated data component parts and particular selected wavelengths as the basis for said step of mutually comparing the conditioned light energy data produced for the various different locations and nominal optical distances.

32. The method as recited in claim 31, including the step of graphically plotting coordinates representative of at least certain of said correlated data component parts and their respective wavelengths for selected corresponding locations for the two different breasts of the same human subject, said step of mutually comparing being carried out by contrasting at least portions of such graphical plots for at least one set of corresponding locations for opposite breasts of the same subject.

33. The method as recited in claim 32, wherein said step of graphically plotting coordinates is carried on for a plurality of sets of said selected corresponding locations for the two opposite breasts.

34. The method as recited in claim 33, wherein said step of graphically plotting coordinates is carried out at sets of corresponding locations for the two opposite breasts which include at least a first location generally centrally of the breast and near the chest wall, and at least one other location located outwardly from said first location.

35. The method as recited in claim 34, wherein said other locations include one located generally centrally of the breast and outward and away from the chest wall, and another disposed along a marginal edge of the breast.

36. A method of appraising the physiologic state of selected body portions of living beings, comprising the steps of:

placing first and second optical probe members in operative light-injecting and receiving engagement with a selected body portion of each of a plurality of different living beings, at a selected location on each of said body portions

holding said first and second optical probe members fixed in each of their said locations of operative light-injecting and receiving engagement, and determining the nominal optical distance between optically-active portions of said probe members while the latter are so held in each of said locations;

sending selected light from at least one of said probe member active portions into the selected body portion with which it is in operative engagement, receiving resulting light energy at the other probe member active portion at each of said selected locations and determining representative light energy data for the light energy so received at each such different location;

using said determined nominal optical distance for each such location to condition the light energy data determined for that location;

receiving said resulting light energy from said body portion at a location nearer that at which said selected light is sent into said body portion at said one optical probe member than the location of said other optical probe member, at least at certain of said different selected locations;

using a representative valuation of said resulting light energy received at said nearer location as a conditioning factor for the said resulting light energy data determined for light received at said other optical probe member, to condition such data for optical effects on the received light resulting from impingement of the light upon and passage thereof into the selected body portion at the place of light entry, in addition to using the nominal optical distance determined for each of said certain optical probe locations to also condition the data for light energy received by said other optical probe member at such locations;

and mutually comparing the conditioned light energy data determined for the selected location on the selected body portion of one such living being with like conditioned data obtained at like locations on the like selected body portion of other such living individuals.

37. The method as recited in claim 36, wherein said step of mutually comparing the conditioned optical data from different living individuals is done by coordinating the data determined for a given such individual with respect to selected wavelengths of light sent into the selected body portion of that individual to which the data determinations correspond, and by comparing a given such data coordination from one such individual with other such data coordinations from other individuals.

38. The method as recited in claim 37, wherein said step of comparing a given such data coordination with others thereof comprises comparing the coordinated data determinations for a selected body portion of a particular one such living individual with a composite data coordination prepared by combining data determinations made for the same selected body portion of a plurality of different living individuals.

39. An optical probe for use in apparatus for obtaining physiological condition data from selected body portions of individual subjects, comprising:

a generally rigid body defining a laterally-enclosed internal space and having a generally tubular nosecone at a forward end adapted to contact said selected body portions in light-sealing relation, a generally planar partition member disposed diametrically across said nosecone at a position spaced inward from the end extremity thereof, thereby walling off said internal space and providing a projecting tubularly-enclosed area;

a septum extending forwardly from said partition member and dividing said tubularly-enclosed area;

said nosecone, partition member and septum being substantially impervious to infrared and near infrared light, and having surfaces within said tubularly-enclosed area of diffusely-reflecting material;

at least one light-detector means disposed at least partially within said tubularly-enclosed area and adjacent said septum;

and signal-carrying cable means coupled to said light-detector means for transmitting light-reception signals therefrom, said cable means extending out of said body.

40. The optical probe as defined in claim 39, and including a light source disposed at least partially within said tubularly-enclosed area and arranged to emit light out from the forward end of said nosecone, said light source being located on the opposite side of said septum from said light-detector means.

41. The optical probe as defined in claim 39, and including a pair of light-detector elements on at least one side of said septum and at least partially within said tubular area.

42. The optical probe as defined in claim 39, and including light-detector means located on both sides of said septum and at least partially within said tubularly-enclosed area.

43. The optical probe as defined in claim 42, and including a pair of light-detector elements on at least one side of said septum and at least partially within said tubular area.

44. The optical probe according to claim 43, wherein said pair of light-detector elements includes two different types of detectors.

45. The optical probe according to claim 40, and including an optical mask element disposed diametrically across said tubular nosecone forwardly of said partition and spaced therefrom;

said mask enclosing said light-detector means between the mask, the partition and the tubular nosecone;

said source and mask being adapted to emit light from said source through and beyond said mask.

46. The optical probe according to claim 45, wherein said mask includes a light-transmissive portion aligned with said detection means for admitting light through the mask and to such detection means.

47. The optical probe according to claim 46, wherein said light-transmissive portion comprises an aperture extending through the mask, and wherein said aperture is arcuate in form and concave with respect to a light source which is disposed across the septum from the light-detection means.