A method and apparatus for spectrophotometric in vivo monitoring of blood metabolites such as hemoglobin oxygen concentration at a plurality of different areas or regions on the same organ or test site on an ongoing basis, by applying a plurality of spectrophotometric sensors to a test subject at each of a corresponding plurality of testing sites and coupling each such sensor to a control and processing station, operating each of said sensors to spectrophotometrically irradiate a particular region within the test subject; detecting and receiving the light energy resulting from said spectrophotometric irradiation for each such region and conveying corresponding signals to said control and processing station, analyzing said conveyed signals to determine preselected blood metabolite data, and visually displaying the data so determined for each of a plurality of said areas or regions in a comparative manner.
REEXAMINATION RESULTS
The questions raised in reexamination proceeding No. 90/010,128, filed Mar. 31, 2008, have been considered, and the results thereof are reflected in this reissue patent which constitutes the reexamination certificate required by 35 U.S.C. 307 as provided in 37 CFR 1.570(e) for ex parte reexaminations, or the reexamination certificate required by 35 U.S.C. 316 as provided in 37 CFR 1.997(e) for inter partes reexaminations.
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0. 159. A method for substantially simultaneous comparative in vivo monitoring of blood metabolites in each of a plurality of different internal regions in a selected test subject, comprising the steps of:
spectrophotometrically irradiating each of a plurality of different testing sites on said test subject via electronic control, in sequence on a substantially simultaneous basis, in a manner that reduces cross-talk between said spectrophotometric irradiation of said testing sites;
detecting light energy resulting from said spectrophotometric irradiation of said testing sites, and providing separate sets of signals to a control and processing station which are representative of the light energy received by each of said testing sites and which cooperatively define blood metabolite data for an individual one of at least two different internal regions;
analyzing said separate signals to determine a blood metabolite level representative of at least one defined region within said at least one test subject for each of at least two different of said testing sites, each said defined region being different from the other; and
substantially simultaneously displaying information determined from data sets for each of said at least two different internal regions at substantially the same time for direct mutual comparison.
0. 85. A method for substantially simultaneous comparative in vivo monitoring of blood metabolites in each of a plurality of different internal regions in a selected test subject, comprising the steps of:
spectrophotometrically irradiating, in sequence on a substantially simultaneous basis, each of a plurality of different testing sites on said test subject via electronic control in a manner that reduces cross-talk between said spectrophotometric irradiation of said testing sites;
detecting light energy resulting from said spectrophotometric irradiation of said testing sites, and providing separate sets of signals to a control and processing station which are representative of the light energy received by each of said testing sites and which cooperatively define blood metabolite data for an individual one of at least two different internal regions located within different brain hemispheres of said test subject;
analyzing said separate signals to determine a blood metabolite level representative of at least one defined region within said at least one test subject for each of at least two different of said testing sites, each said defined region being different from the other; and
substantially simultaneously displaying data sets for each of said at least two different internal regions at substantially the same time for direct mutual comparison.
0. 135. A method for substantially simultaneous comparative in vivo monitoring of blood metabolites in each of a plurality of different internal regions in a selected test subject, comprising the steps of:
spectrophotometrically irradiating each of a plurality of different testing sites on said test subject via electronic control, in sequence on a substantially simultaneous basis, in a manner that reduces cross-talk between said spectrophotometric irradiation of said testing sites, said sites being locations on the body at which blood metabolite measurements are made;
detecting light energy resulting from said spectrophotometric irradiation of said testing sites, and providing separate sets of signals to a control and processing station which are representative of the light energy received by each of said testing sites and which cooperatively define blood metabolite data for an individual one of at least two different internal regions;
analyzing said separate signals to determine a blood metabolite level representative of at least one defined region within said at least one test subject for each of at least two different of said testing sites, each said defined region being different from the other; and
substantially simultaneously displaying data sets for each of said at least two different internal regions at substantially the same time for direct mutual comparison and observation of relative changes.
0. 142. A method for comparative spectrophotometric in vivo monitoring and display of selected blood metabolites present in a plurality of different internal regions of the same test subject on a continuing and substantially simultaneous basis, comprising the steps of:
applying separate spectrophotometric sensors to a test subject at each of a plurality of separate testing sites and coupling each of said sensors to a control and processing station;
electronically controlling a selected number of said sensors in sequence on a substantially simultaneous basis to spectrophotometrically irradiate at least two separate internal regions of the test subject during a common time interval in a manner that reduces cross-talk between said sensors, each of said regions being associated with different ones of said testing sites;
separately detecting and receiving light energy resulting from said spectrophotometric irradiation for each of said at least two separate internal regions, and conveying separate sets of signals to said control and processing station which correspond to the separately detected light energy from said at least two separate internal regions;
separately and simultaneously analyzing said conveyed separate sets of signals to separately determine data representative of a blood metabolite level in each of said at least two separate internal regions; and
substantially simultaneously visually displaying information reflecting said separately determined data for each of said at least two separate internal regions for direct simultaneous mutual comparison.
0. 50. A method for comparative spectrophotometric in vivo monitoring and display of selected blood metabolites present in a plurality of different internal regions of the same test subject on a continuing and substantially simultaneous basis, comprising the steps of:
applying separate spectrophotometric sensors to a test subject at each of a plurality of separate testing sites on a head of said test subject and coupling each of said sensors to a control and processing station;
electronically controlling a selected number of said sensors in sequence on a substantially simultaneous basis to spectrophotometrically irradiate at least two separate internal regions within a brain of the test subject during a common time interval in a manner that reduces cross-talk between said sensors, each of said regions being associated with different ones of said testing sites;
separately detecting and receiving light energy resulting from said spectrophotometric irradiation for each of said at least two separate internal regions, and conveying separate sets of signals to said control and processing station which correspond to the separately detected light energy from said at least two separate internal regions;
separately and simultaneously analyzing said conveyed separate sets of signals to separately determine data representative of a blood metabolite level in each of said at least two separate internal regions; and
substantially simultaneously visually displaying said separately determined data for each of said at least two separate internal regions for direct simultaneous mutual comparison.
0. 118. A method for comparative spectrophotometric in vivo monitoring and display of selected blood metabolites present in a plurality of different internal regions of the same test subject on a continuing and substantially simultaneous basis, comprising the steps of:
applying separate spectrophotometric sensors to a test subject at each of a plurality of separate testing sites on the body at which blood metabolite measurements may be made and coupling each of said sensors to a control and processing station;
electronically controlling a selected number of said sensors in sequence on a substantially simultaneous basis to spectrophotometrically irradiate at least two separate internal regions of the test subject during a common time interval in a manner that reduces cross-talk between said sensors, each of said regions being associated with different ones of said testing sites;
separately detecting and receiving light energy resulting from said spectrophotometric irradiation for each of said at least two separate internal regions, and conveying separate sets of signals to said control and processing station which correspond to the separately detected light energy from said at least two separate internal regions;
separately and simultaneously analyzing said conveyed separate sets of signals to separately determine data representative of a blood metabolite level in each of said at least two separate internal regions; and
substantially simultaneously visually displaying said separately determined data for each of said at least two separate internal regions for direct simultaneous mutual comparison and observation of relative changes.
0. 166. Apparatus for spectrophotometric in vivo monitoring of a selected metabolic condition in each of a plurality of different test subject regions on a substantially simultaneous basis, comprising:
a plurality of spectrophotometric emitters, each configured to separately spectrophotometrically irradiate a designated region within a test subject from a test location on said test subject;
a controller and circuitry coupling each of said emitters to said controller configured for individually operating selected ones of said emitters in sequence on a substantially simultaneous basis to separately spectrophotometrically irradiate at least two particular regions within the test subject in a manner that reduces cross-talk between said spectrophotometric irradiation of said at least two particular regions;
a plurality of detectors, each configured to separately receive light energy resulting from the spectrophotometric irradiation of an associated one of said at least two particular regions, and to produce at least one separate set of signals for said associated one of said at least two particular regions; and circuitry acting to convey said at least one separate set of signals to said controller for analytic processing;
said controller configured to analytically process said at least one separate set of signals to determine separate sets of data representative of a blood metabolite level in said at least two particular regions; and
a visual display coupled to said controller and configured to display separate representations of said separate sets of data for each of said at least two particular regions in a mutually-comparative manner and on a substantially simultaneous basis.
0. 99. Apparatus for spectrophotometric in vivo monitoring of a selected metabolic condition in each of a plurality of different test subject regions on a substantially simultaneous basis, comprising:
a plurality of spectrophotometric emitters, each configured to separately spectrophotometrically irradiate a designated region within a test subject from a test location on said test subject;
a controller and circuitry coupling each of said emitters to said controller configured for individually operating selected ones of said emitters in sequence on a substantially simultaneous basis to separately spectrophotometrically irradiate at least two particular regions within the test subject in a manner that reduces cross-talk between said spectrophotometric irradiation of said at least two particular regions;
a plurality of detectors, each configured to separately receive light energy resulting from the spectrophotometric irradiation of an associated one of said at least two particular regions, and to produce at least one separate set of signals for said associated one of said at least two particular regions; and circuitry acting to convey said at least one separate set of signals to said controller for analytic processing;
said controller configured to analytically process said at least one separate set of signals to determine separate sets of data representative of a blood metabolite level in said at least two particular regions; and
a visual display coupled to said controller and configured to display separate representations of said separate sets of data for each of said at least two particular regions in a mutually-comparative manner and on a substantially simultaneous basis, wherein at least two of said at least two particular regions are located in mutually separate regions of a brain of said test subject.
0. 139. Apparatus for spectrophotometric in vivo monitoring of a selected metabolic condition in each of a plurality of different test subject regions on a substantially simultaneous basis, comprising:
a plurality of spectrophotometric emitters, each configured to separately spectrophotometrically irradiate a designated region within a test subject from a test location on said test subject, said test location being a site on the body at which a blood metabolite measurement may be made;
a controller and circuitry coupling each of said emitters to said controller configured for individually operating, in sequence on a substantially simultaneous basis, selected ones of said emitters to separately spectrophotometrically irradiate at least two particular regions within the test subject in a manner that reduces cross-talk between said spectrophotometric irradiation of said at least two particular regions;
a plurality of detectors, each configured to separately receive light energy resulting from the spectrophotometric irradiation of an associated one of said at least two particular regions, and to produce at least one separate set of signals for said associated one of said at least two particular regions; and circuitry acting to convey said at least one separate set of signals to said controller for analytic processing;
said controller configured to analytically process said at least one separate set of signals to determine separate sets of data representative of a blood metabolite level in said at least two particular regions; and
a visual display coupled to said controller and configured to display separate representations of said separate sets of data for each of said at least two particular regions in a mutually-comparative manner and on substantially simultaneous basis through direct simultaneous mutual comparison and observation of relative changes.
0. 151. An apparatus for substantially simultaneous comparative spectrophotometric in vivo monitoring of selected blood metabolites present in each of a plurality of different internal regions on a continuing basis, comprising:
a plurality of spectrophotometric sensors, each attachable to a test subject at different test locations in the body and configured to separately but substantially simultaneously spectrophotometrically irradiate at least two different internal regions within the test subject associated with each of said test locations;
a controller and circuitry coupling each of said sensors to said controller configured for separately and individually but substantially simultaneously operating certain of said sensors in sequence to spectrophotometrically irradiate each of said different internal regions within the test subject associated with each of said test locations in a manner that reduces cross-talk between said sensors;
said sensors each further configured to receive light energy resulting from the separate spectrophotometric irradiation of said sensors' associated one of said at least two different internal regions on a substantially simultaneous basis with other said sensors, and to produce separate signals corresponding to the light energy received, said circuitry acting to convey said separate signals to said controller for separate analytic processing;
said controller configured to analytically process said conveyed signals separately and determine separate blood metabolite levels therefrom for each of said sensors and said sensors' associated one of said at least two different internal regions; and
a visual display coupled to said controller and configured to separately but substantially simultaneously display information reflecting the blood metabolite levels determined for each of said sensors in a mutually-comparative manner.
0. 65. An apparatus for substantially simultaneous comparative spectrophotometric in vivo monitoring of selected blood metabolites present in each of a plurality of different internal regions on a continuing basis, comprising:
a plurality of spectrophotometric sensors, each attachable to a test subject at different test locations on a head of said subject and configured to separately but substantially simultaneously spectrophotometrically irradiate at least two different internal regions within a brain of the test subject associated with each of said test locations;
a controller and circuitry coupling each of said sensors to said controller configured for separately and individually but substantially simultaneously operating certain of said sensors in sequence to spectrophotometrically irradiate each of said different internal regions within the test subject associated with each of said test locations in a manner that reduces cross-talk between said sensors;
said sensors each further configured to receive light energy resulting from the separate spectrophotometric irradiation of said sensors' associated one of said at least two different internal regions on a substantially simultaneous basis with other said sensors, and to produce separate signals corresponding to the light energy received, said circuitry acting to convey said separate signals to said controller for separate analytic processing;
said controller configured to analytically process said conveyed signals separately and determine separate blood metabolite levels therefrom for each of said sensors and said sensors' associated one of said at least two different internal regions; and
a visual display coupled to said controller and configured to separately but substantially simultaneously display the blood metabolite levels determined for each of said sensors in a mutually-comparative manner.
0. 127. An apparatus for substantially simultaneous comparative spectrophotometric in vivo monitoring of selected blood metabolites present in each of a plurality of different internal regions on a continuing basis, comprising:
a plurality of spectrophotometric sensors, each attachable to a test subject at different test locations on the body at which blood metabolite measurements may be made and configured to separately but substantially simultaneously spectrophotometrically irradiate at least two different internal regions within the test subject associated with each of said test locations;
a controller and circuitry coupling each of said sensors to said controller configured for separately and individually but substantially simultaneously operating certain of said sensors in sequence to spectrophotometrically irradiate each of said different internal regions within the test subject associated with each of said test locations in a manner that reduces cross-talk between said sensors;
said sensors each further configured to receive light energy resulting from the separate spectrophotometric irradiation of said sensors' associated one of said at least two different internal regions on a substantially simultaneous basis with other said sensors, and to produce separate signals corresponding to the light energy received, said circuitry acting to convey said separate signals to said controller for separate analytic processing;
said controller configured to analytically process said conveyed signals separately and determine separate blood metabolite levels therefrom for each of said sensors and said sensors' associated one of said at least two different internal regions; and
a visual display coupled to said controller and configured to separately but substantially simultaneously display the blood metabolite levels determined for each of said sensors in a mutually-comparative manner through direct simultaneous mutual comparison and observation of relative changes.
0. 1. A method for comparative spectrophotometric in vivo monitoring and display of selected blood metabolites present in a plurality of different internal regions of the same test subject on a continuing and substantially concurrent basis, comprising the steps of:
applying separate spectrophotometric sensors to a test subject at each of a plurality of separate testing sites and coupling each of said sensors to a control and processing station;
operating a selected number of said sensors on a substantially concurrent basis to spectrophotometrically irradiate at least two separate internal regions of the test subject during a common time interval, each of said regions being associated with a different of said testing sites;
separately detecting and receiving light energy resulting from said spectrophotometric irradiation for each of said at least two separate internal regions, and conveying separate sets of signals to said control and processing station which correspond to the separately detected light energy from said at least two separate internal regions;
separately and concurrently analyzing said conveyed separate sets of signals to separately determine quantified data representative of a blood metabolite in each of said at least two separate internal regions; and
concurrently visually displaying said separately determined quantified data for each of said at least two separate internal regions for direct concurrent mutual comparison, wherein said sensors are applied to a head of the test subject and are used to monitor two mutually separate regions within a brain of the test subject.
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0. 11. An apparatus for concurrent comparative spectrophotometric in vivo monitoring of selected blood metabolites present in each of a plurality of different internal regions on a continuing basis, comprising:
a plurality of spectrophotometric sensors, each attachable to a test subject at different test locations and adapted to separately but concurrently spectrophotometrically irradiate at least two different internal regions within the test subject associated with each of said test locations;
a controller and circuitry coupling each of said sensors to said controller for separately and individually but concurrently operating certain of said sensors to spectrophotometrically irradiate each of said different internal regions within the test subject associated with each of said test locations;
said sensors each further adapted to receive light energy resulting from the separate spectrophotometric irradiation of said sensors' associated one of said at least two different internal regions on a substantially concurrent basis with other said sensors, and to produce separate signals corresponding to the light energy received, said circuitry acting to convey said separate signals to said controller for separate analytic processing;
said controller adapted to analytically process said conveyed signals separately and determine separate quantified blood metabolite data therefrom for each of said sensors and said sensors' associated one of said at least two different internal regions; and
a visual display coupled to said controller and adapted to separately but concurrently display the quantified blood metabolite data determined for each of said sensors in a mutually-comparative manner, wherein said sensors are adapted to be applied to a head of the test subject and to monitor a brain of the test subject.
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0. 26. A method for concurrent comparative in vivo monitoring of blood metabolites in each of a plurality of different internal regions in a selected test subject, comprising the steps of:
spectrophotometrically irradiating each of a plurality of different testing sites on said test subject;
detecting light energy resulting from said spectrophotometric irradiation of said testing sites, and providing separate sets of signals to a control and processing station which are representative of the light energy received by each of said testing sites and which cooperatively define blood metabolite data for an individual one of at least two different internal regions;
analyzing said separate signals to determine quantified blood metabolite data representative of at least one defined region within said at least one test subject associated with each of at least two different of said testing sites, each said defined region being different from the other; and
concurrently displaying data sets for each of said at least two different internal regions at substantially the same time for direct mutual comparison, wherein said at least two different internal regions are located within different brain hemispheres of said test subject.
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0. 35. Apparatus for spectrophotometric in vivo monitoring of a selected metabolic condition in each of a plurality of different test subject regions on a substantially concurrent basis, comprising:
a plurality of spectrophotometric emitters, each adapted to separately spectrophotometrically irradiate a designated region within a test subject from a test location on said test subject;
a controller and circuitry coupling each of said emitters to said controller for individually operating selected ones of said emitters to spectrophotometrically irradiate at least two particular regions within the test subject;
a plurality of detectors, each adapted to separately receive light energy resulting from the spectrophotometric irradiation of said at least two particular regions, and to produce at least one separate set of signals for each one of said at least two particular regions; and circuitry acting to convey said at least one separate set of signals to said controller for analytic processing;
said controller adapted to analytically process said at least one separate set of signals to determine separate sets of quantified data representative of a metabolic condition in said at least two particular regions; and
a visual display coupled to said controller and adapted to display separate representations of said separate sets of quantified data for each of said at least two particular regions in a mutually-comparative manner and on a substantially concurrent basis, wherein at least two of said at least two particular regions are located in mutually separate regions of a brain of said test subject.
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0. 51. The method of claim 50, wherein said step of analyzing comprises quantitative determination of blood oxygenation levels within each of said at least two separate internal regions.
0. 52. The method of claim 51, wherein said analyzing step includes producing separate quantitative value determinations for hemoglobin oxygen saturation for each of said at least two separate internal regions.
0. 53. The method of claim 52, wherein said analyzing step includes production of ongoing graphical traces representing a plurality of said quantitative value determinations made at successive points in time.
0. 54. The method of claim 53 including the step of visually displaying a plurality of said graphical traces at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 55. The method of claim 54, including the step of visually displaying a plurality of said quantitative value determinations at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 56. The method of claim 52, including the step of visually displaying a plurality of said quantitative value determinations at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 57. The method of claim 50, wherein said metabolite comprises hemoglobin oxygen.
0. 58. The method of claim 50, wherein said sensors are positioned in locations proximate to different brain hemispheres and said two mutually separate regions are located in a different brain hemisphere.
0. 59. The method of claim 58, wherein said metabolite comprises cerebral blood hemoglobin oxygenation.
0. 60. The method of claim 50, wherein said data representative of a blood metabolite level includes regional blood oxygen saturation.
0. 61. The method of claim 50, wherein said light energy is detected after traveling each of at least two different distances through tissue of the test subject.
0. 62. The method of claim 50, wherein said electronically controlling in sequence comprises actuating said sensors in an alternating manner.
0. 63. The method of claim 50, wherein said data is determined so as to principally characterize blood metabolite within each of the separate internal regions without effects attributable to adjacent tissue overlying said separate internal regions.
0. 64. The method of claim 63, wherein said effects attributable to said adjacent tissue are minimized by comparing spectrophotometric irradiation that penetrates different depths into said test subject.
0. 66. The apparatus of claim 65, wherein said controller is adapted to analyze said data to quantitatively determine blood oxygenation within said at least two different internal regions.
0. 67. The apparatus of claim 66, wherein said controller is adapted to produce separate numeric value designations for hemoglobin oxygen saturation for said at least two different internal regions.
0. 68. The apparatus of claim 67, wherein said controller and said display are adapted to produce ongoing graphical traces representing a plurality of said numeric value designations for the same region taken over a period of time.
0. 69. The apparatus of claim 68, wherein said controller and said display are adapted to visually display at least two of said graphical traces on a substantially simultaneous basis and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 70. The apparatus of claim 69, wherein said controller and said display are adapted to visually display at least two of said numeric value designations as well as at least two of said graphical traces on a substantially simultaneous basis and in proximity to one another to facilitate rapid and accurate visual comparison.
0. 71. The apparatus of claim 67, wherein said controller and said display are adapted to visually display at least two of said numeric value designations on a substantially simultaneous basis and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 72. The apparatus of claim 65, wherein said sensors are adapted to provide signals to said controller which comprise at least two separate data sets that cooperatively define at least portions of a particular area within a given one of said at least two different internal regions.
0. 73. The apparatus of claim 72, wherein said data sets provided by said sensors include a first set characterizing a first part of said particular area and a second set characterizing a second part of said particular area.
0. 74. The apparatus of claim 73, wherein said second part of said particular area characterized by said second set includes at least part of said first part of said area.
0. 75. The apparatus of claim 65, wherein said controller is adapted to determine blood oxygenation saturation in said brain.
0. 76. The apparatus of claim 65, wherein at least two of said different test locations are associated with mutually different hemispheres of the brain and at least two of said plurality of sensors are operable to separately monitor at least portions of each of said different hemispheres.
0. 77. The apparatus of claim 76, wherein said controller is adapted to determine cerebral blood oxygenation saturation within each of said different hemispheres.
0. 78. The apparatus of claim 77, wherein said sensors are adapted to provide signals to said controller which comprise at least two data sets that cooperatively define at least portions of a particular area within the same hemisphere of said brain.
0. 79. The apparatus of claim 78, wherein said sensors are adapted to be applied to the outside periphery of the test subject and to operate non-invasively.
0. 80. The apparatus of claim 65, wherein said blood metabolite levels represent regional blood oxygen saturation.
0. 81. The apparatus of claim 65, wherein said sensors are adapted to receive light energy that has traveled each of at least two different distances through tissue of the test subject.
0. 82. The apparatus of claim 65, wherein said controller is adapted to operate said sensors to spectrophotometrically irradiate out of phase with one another.
0. 83. The apparatus of claim 65, wherein said blood metabolite levels are determined by said controller so as to principally characterize blood metabolite within each of the different internal regions without effects attributable to adjacent tissue overlying said different internal regions.
0. 84. The apparatus of claim 83, wherein said effects attributable to said adjacent tissue are minimized by said controller comparing signals for spectrophotometric irradiation that penetrates different depths into said test subject.
0. 86. The method of claim 85, wherein said data sets include a first set which characterizes a first zone within one of said at least two different internal regions and a second set which characterizes a second zone that is at least partially within the same one of said at least two different internal regions.
0. 87. The method of claim 85, wherein said spectrophotometric irradiation comprises application of at least two different wavelengths applied in an alternating sequence of timed pulses, and wherein detection of light energy corresponding to each of said at least two different wavelengths is done on a timed periodic basis using detection periods whose occurrence generally corresponds to that of said applied spectrophotometric irradiation.
0. 88. The method of claim 87, wherein the duration of each of said detection periods is limited to a length which is less than that of each pulse of applied spectrophotometric irradiation.
0. 89. The method of claim 88, wherein the duration of each of said detection periods is less than half that of a pulse of said applied spectrophotometric irradiation.
0. 90. The method of claim 89, wherein a plurality of said detection periods are used during pulses of said applied spectrophotometric irradiation, and a corresponding energy detection occurs during each of a plurality of said detection periods.
0. 91. The method of claim 90, further including the steps of averaging a selected number of energy detection event values to obtain a resultant value therefor, and using said resultant value to compute a metabolite value which is representative thereof.
0. 92. The method of claim 91, wherein said display includes said computed representative metabolite value.
0. 93. The method of claim 92, wherein said display is refreshed periodically by using a sequence of computed representative metabolite values which are based upon and represent the averaged detection event values produced during the different time intervals corresponding to the intervals of said periodic display refreshment.
0. 94. The method of claim 85, wherein said determining of blood metabolite levels includes determining regional blood oxygen saturation.
0. 95. The method of claim 85, wherein said light energy is detected after traveling each of at least two different distances through tissue of the test subject.
0. 96. The method of claim 85, wherein said spectrophotometrically irradiating comprises emitting light at said testing sites where said emitting at one of said testing sights is out of phase with said emitting at another of said testing sites.
0. 97. The method of claim 85, wherein said blood metabolite levels are determined so as to principally characterize blood metabolite within each of the different internal regions without effects attributable to adjacent tissue overlying said different internal regions.
0. 98. The method of claim 97, wherein said effects attributable to said adjacent tissue are minimized by comparing spectrophotometric irradiation that penetrates different depths into said test subject.
0. 100. The apparatus of claim 99, wherein said controller includes a computer programmed to analyze said signals to separately determine a blood oxygenation state within each of said at least two particular regions.
0. 101. The apparatus of claim 100, wherein said computer comprises a processor, data buffers, and a timing signal generator, said data buffers adapted to store data representative of said blood oxygenation state and said timing signal generator adapted to control actuation of said emitters and detectors.
0. 102. The apparatus of claim 101, wherein said controller comprises a unitary device which includes said computer and said display.
0. 103. The apparatus of claim 102, wherein said unitary device further includes a keyboard interface to said computer.
0. 104. The apparatus of claim 102, wherein said unitary device further includes a data output interface.
0. 105. The apparatus of claim 104, wherein said unitary device further includes an integral keyboard interface to said computer.
0. 106. The apparatus of claim 102, wherein said display comprises a flat electroluminescent visual display screen.
0. 107. The apparatus of claim 106, wherein said unitary device further includes an integral keyboard interface to said computer.
0. 108. The apparatus of claim 99, wherein at least certain of said detectors and certain of said emitters comprise operational pairs, and said controller is arranged to operate the emitters and detectors of at least certain of said operational pairs in predetermined timed relationship while maintaining the emitters and detectors of other of said operational pairs in a non-operating condition.
0. 109. The apparatus of claim 108, wherein said controller is adapted to sequence the operation of said at least certain of said operational pairs.
0. 110. The apparatus of claim 109, wherein at least one of said operational pairs include a plurality of said detectors arranged at mutually spaced locations which are spaced at differing distances from the emitter of said at least one of said operational pairs.
0. 111. The apparatus of claim 110, wherein said controller is adapted to operate the emitter and a selected number less than all of the detectors of at least one of said operational pairs substantially in unison while holding the other detectors of said at least one of said operational pairs in a non-operating condition, and said controller is further arranged to operate said other detectors substantially in unison with said emitter at another time during which said selected number of said detectors are maintained in a non-operating condition.
0. 112. The apparatus of claim 108, wherein at least one of said operational pairs includes a first detector and a second detector, and wherein the first detector is located nearer the emitter than the second detector to thereby provide near and far detector groupings for said at least one of said operational pairs.
0. 113. The apparatus of claim 112, wherein said controller is adapted to sequence the operation of said at least one of said operational pairs.
0. 114. The apparatus of claim 99, wherein said blood metabolite levels represent regional blood oxygen saturation.
0. 115. The apparatus of claim 99, wherein said detectors are adapted to receive light energy that has traveled at least two different distances through tissue of the test subject.
0. 116. The apparatus of claim 99, wherein said data is determined by said controller so as to principally characterize blood metabolite within each of the different internal regions without effects attributable to adjacent tissue overlying said different internal regions.
0. 117. The apparatus of claim 116, wherein said effects attributable to said adjacent tissue are minimized by said controller comparing signals for spectrophotometric irradiation that penetrates different depths into said test subject.
0. 119. The method of claim 118, including the step of visually displaying a plurality of graphical traces at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison and the observation of relative changes.
0. 120. The method of claim 118, including the step of visually displaying a plurality of quantified value determinations at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison and the observation of relative changes.
0. 121. The method of claim 118, wherein said analyzing step includes producing separate quantitative value determinations for regional hemoglobin oxygen saturation for each of said at least two separate internal regions.
0. 122. The method of claim 121, including the step of visually displaying a plurality of said quantitative value determinations at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison and the observation of relative changes.
0. 123. The method of claim 118, wherein said data representative of a blood metabolite level includes regional blood oxygen saturation.
0. 124. The method of claim 118, wherein said two separate regions are hemispheres within said brain of the test subject.
0. 125. The method of claim 118, wherein said light energy is detected after traveling each of at least two different distances through tissue of the test subject.
0. 126. The method of claim 118, wherein said electronically controlling in sequence comprises actuating said sensors in an alternating manner.
0. 128. The apparatus of claim 127, wherein said controller and said display are adapted to visually display at least two graphical traces representative of said levels on a substantially simultaneous basis and in predetermined relationship to one another to facilitate rapid and accurate visual comparison and the observation of relative changes.
0. 129. The apparatus of claim 128, wherein said controller and said display are adapted to visually display at least two numeric value designations representative of said levels as well as said at least two graphical traces on a substantially simultaneous basis and in proximity to one another to facilitate rapid and accurate visual comparison and the observation of relative changes.
0. 130. The apparatus of claim 127, wherein said controller is adapted to produce separate numeric value designations for regional hemoglobin oxygen saturation for said at least two different internal regions.
0. 131. The apparatus of claim 130, wherein said controller and said display are adapted to visually display at least two of said numeric value designations on a substantially simultaneous basis and in predetermined relationship to one another to facilitate rapid and accurate visual comparison and the observation of relative changes.
0. 132. The apparatus of claim 127, wherein said blood metabolite levels represent regional blood oxygen saturation.
0. 133. The apparatus of claim 127, wherein said sensors are adapted to receive light energy that has traveled each of at least two different distances through tissue of the test subject.
0. 134. The apparatus of claim 127, wherein said controller is adapted to operate said sensors to spectrophotometrically irradiate out of phase with one another.
0. 136. The method of claim 135, wherein said determining of quantified blood metabolite levels includes determining regional blood oxygen saturation.
0. 137. The method of claim 135, wherein said light energy is detected after traveling each of at least two different distances through tissue of the test subject.
0. 138. The method of claim 135, wherein said spectrophotometrically irradiating comprises emitting light at said testing sites where said emitting at one of said testing sights is out of phase with said emitting at another of said testing sites.
0. 140. The apparatus of claim 139, wherein said blood metabolite levels represent regional blood oxygen saturation.
0. 141. The apparatus of claim 139, wherein said detectors are adapted to receive light energy that has traveled at least two different distances through tissue of the test subject.
0. 143. The method of claim 142, wherein said data representative of a blood metabolite level includes regional blood oxygen saturation.
0. 144. The method of claim 142, wherein said two separate regions are hemispheres within said brain of the test subject.
0. 145. The method of claim 142, further comprising visually displaying a plurality of graphical traces representing a plurality of quantitative value determinations made at successive points in time, said displaying of said plurality of graphical traces occurring at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 146. The method of claim 142, further comprising visually displaying a plurality of quantitative value determinations at substantially the same time and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 147. The method of claim 142, wherein said sensors are positioned in locations proximate to different brain hemispheres and said two mutually separate regions are located in a different brain hemisphere.
0. 148. The method of claim 142, wherein said light energy is detected after traveling each of at least two different distances through tissue of the test subject.
0. 149. The method of claim 142, wherein said electronically controlling in sequence comprises actuating said sensors in an alternating manner.
0. 150. The method of claim 142, wherein said step of applying separate spectrophotometric sensors to the test subject further comprises individually applying said separate spectrophotometric sensors.
0. 152. The apparatus of claim 151, wherein said blood metabolite levels represent regional blood oxygen saturation.
0. 153. The apparatus of claim 151, wherein said controller is adapted to produce separate numeric value designations for hemoglobin oxygen saturation for said at least two different internal regions.
0. 154. The apparatus of claim 151, wherein said controller and said display are adapted to produce ongoing graphical traces representing a plurality of said numeric value designations for the same region taken over a period of time, and wherein said controller and said display are adapted to visually display at least two of said graphical traces on a substantially simultaneous basis and in predetermined relationship to one another to facilitate rapid and accurate visual comparison.
0. 155. The apparatus of claim 151, wherein at least two of said sensors are adapted to be positioned in locations associated with mutually different hemispheres of the brain and each of said sensors is operable to separately monitor at least portions of each of said different hemispheres.
0. 156. The apparatus of claim 151, wherein said sensors are adapted to receive light energy that has traveled each of at least two different distances through tissue of the test subject.
0. 157. The apparatus of claim 151, wherein said controller is adapted to operate said sensors to spectrophotometrically irradiate out of phase with one another.
0. 158. The apparatus of claim 151, wherein said spectrophotometric sensors attachable to the test subject at different test locations in the body are each configured to be attached individually to said test subject.
0. 160. The method of claim 159, wherein said determining of blood metabolite levels includes determining regional blood oxygen saturation.
0. 161. The method of claim 159, wherein said testing sites are selected as being proximate to different brain hemispheres and said defined regions are two mutually separate regions located in different brain hemispheres of the test subject.
0. 162. The method of claim 159, further comprising averaging a selected number of energy detection event values to obtain a resultant value therefor, and using said resultant value to compute a metabolite value which is representative thereof, and wherein said display includes said computed representative metabolite value.
0. 163. The method of claim 162, wherein said display is refreshed periodically by using a sequence of computed representative metabolite values which are based upon and represent the averaged detection event values produced during the different time intervals corresponding to the intervals of said periodic display refreshment.
0. 164. The method of claim 159, wherein said light energy is detected after traveling each of at least two different distances through tissue of the test subject.
0. 165. The method of claim 159, wherein said irradiating and said detecting is performed by a plurality of spectrophotometric sensors, and wherein said spectrophotometric sensors are each applied individually to said test subject.
0. 167. The apparatus of claim 166, wherein said blood metabolite levels represent regional blood oxygen saturation.
0. 168. The apparatus of claim 166, wherein at least certain of said detectors and certain of said emitters comprise operational pairs, and said controller is arranged to operate the emitters and detectors of at least certain of said operational pairs in predetermined timed relationship while maintaining the emitters and detectors of other of said operational pairs in a non-operating condition.
0. 169. The apparatus of claim 166, wherein said controller is adapted to sequence the operation of said at least certain of said operational pairs.
0. 170. The apparatus of claim 169, wherein said controller is adapted to operate the emitter and a selected number less than all of the detectors of at least one of said operational pairs substantially in unison while holding the other detectors of said at least one of said operational pairs in a non-operating condition, and said controller is further arranged to operate said other detectors substantially in unison with said emitter at another time during which said selected number of said detectors are maintained in a non-operating condition.
0. 171. The apparatus of claim 166, wherein at least two of said emitters are adapted to be positioned in locations associated with mutually different hemispheres of the brain such that said apparatus is operable to separately monitor at least portions of each of said different hemispheres.
0. 172. The apparatus of claim 166, wherein said detectors are adapted to receive light energy that has traveled at least two different distances through tissue of the test subject.
0. 173. The apparatus of claim 166, wherein said separate representations comprise actual or relative values corresponding to said quantified data.
0. 174. The apparatus of claim 166, wherein a plurality of spectrophotometric sensors are formed by said emitters and said detectors, and wherein said spectrophotometric sensors are each configured to be attached individually to said test subject.
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This application is a national stage of International Application No. PCT/US99/22940, filed Oct. 13, 1999, which claims the benefit of U.S. Provisional Application Ser. No. 60/103,985, filed Oct. 13, 1998.
This invention relates generally to in vivo spectrophotometric examination and monitoring of selected blood metabolites or constituents in human and/or other living subjects, e.g., medical patients, and more particularly to spectrophotometric oximetry, by transmitting selected wavelengths (spectra) of light into a given area of the test subject, receiving the resulting light as it leaves the subject at predetermined locations, and analyzing the received light to determine the desired constituent data based on the spectral absorption which has occurred, from which metabolic information such as blood oxygen saturation may be computed for the particular volume of tissue through which the light spectra have passed.
A considerable amount of scientific data and writings, as well as prior patents, now exist which is/are based on research and clinical studies done in the above-noted area of investigation, validating the underlying technology and describing or commenting on various attributes and proposed or actual applications of such technology. One such application and field of use is the widespread clinical usage of pulse oximeters as of the present point in time, which typically utilize sensors applied to body extremities such as fingers, toes, earlobes, etc., where arterial vasculature is in close proximity, from which arterial hemoglobin oxygenation may be determined non-invasively. A further and important extension of such technology is disclosed and discussed in U.S. Pat. No. 5,902,235, which is related to and commonly owned with the present application and directed to a non-invasive spectrophotometric cerebral oximeter, by which blood oxygen saturation in the brain may be non-invasively determined through the use of an optical sensor having light emitters and detectors that is applied to the forehead of the patient. Earlier patents commonly owned with the '235 patent and the present one pertaining to various attributes of and applications for the underlying technology include U.S. Pat. Nos. 5,139,025; 5,217,013; 5,465,714; 5,482,034; and 5,584,296.
The cerebral oximeter of the aforementioned '235 patent has proved to be an effective and highly desirable clinical instrument, since it provides uniquely important medical information with respect to brain condition (hemoglobin oxygen saturation within the brain, which is directly indicative of the single most basic and important life parameter, i.e. brain vitality). This information was not previously available, despite its great importance, since there really is no detectable arterial pulse within brain tissue itself with respect to which pulse oximetry could be utilized even if it could be effectively utilized in such an interior location (which is very doubtful), and this determination therefore requires a substantially different kind of apparatus and determination analysis. In addition, there are a number of uniquely complicating factors, including the fact that there is both arterial and venous vasculature present in the skin and underlying tissue through which the examining light spectra must pass during both entry to and exit from the brain, and this would distort and/or obscure the brain examination data if excluded in some way. Furthermore, the overall blood supply within the skull and the brain itself consists of a composite of arterial, venous, and capillary blood, as well as some pooled blood, and each of these are differently oxygenated. In addition, the absorption and scatter effects on the examination light spectra are much greater in the brain and its environment than in ordinary tissue, and this tends to result in extremely low-level electrical signal outputs from the detectors for analysis, producing difficult signal-to-noise problems.
Notwithstanding these and other such problems, the cerebral oximeter embodying the technology of the aforementioned issued patents (now available commercially from Somanetics Corporation, of Troy, Mich.) has provided a new type of clinical instrument by which new information has been gained relative to the operation and functioning of the human brain, particularly during surgical procedures and/or injury or trauma, and this has yielded greater insight into the functioning and state of the brain during such conditions. This insight and knowledge has greatly assisted surgeons performing such relatively extreme procedures as carotid endarterectomy, brain surgery, and other complex procedures, including open-heart surgery, etc. and has led to a greater understanding and awareness of conditions and effects attributable to the hemispheric structure of the human brain, including the functional inter-relationship of the two cerebral hemispheres, which are subtly interconnected from the standpoint of blood perfusion as well as that of electrical impulses and impulse transfer.
The present invention results from the new insights into and increased understanding of the human brain referred to in the preceding paragraph, and provides a methodology and apparatus for separately (and preferably simultaneously) sensing and quantitatively determining brain oxygenation at a plurality of specifically different locations or regions of the brain, particularly during surgical or other such traumatic conditions, and visually displaying such determinations in a directly comparative manner. In a larger sense, the invention may also be used to monitor oxygenation (or other such metabolite concentrations or parameters) in other organs or at other body locations, where mere arterial pulse oximetry is a far too general and imprecise examination technique.
Further, and of considerable moment, the invention provides a method and apparatus for making and displaying determinations of internal metabolic substance, as referred to in the preceding paragraph, at a plurality of particular and differing sites, and doing so on a substantially simultaneous and continuing basis, as well as displaying the determinations for each such site in a directly comparative manner, for immediate assessment by the surgeon or other attending clinician, on a real-time basis, for direct support and guidance during surgery or other such course of treatment.
In a more particular sense, the invention provides a method and apparatus for spectrophotometric in vivo monitoring of blood metabolites such as hemoglobin oxygen concentration in any of a preselected plurality of different regions of the same test subject and on a continuing and substantially instantaneous basis, by applying a plurality of spectrophotometric sensors. In a more particular sense, the invention provides a method and apparatus for spectrophotometric in vivo monitoring of blood metabolites such as hemoglobin oxygen concentration in any of a preselected plurality of different regions of the same test subject and on a continuing and substantially instantaneous basis, by applying a plurality of spectrophotometric sensors to the test subject at each of a corresponding plurality of testing sites, coupling each such sensor to a control and processing station, operating each such sensor to spectrophotometrically irradiate a particular region within the test subject associated with that sensor, detecting and receiving the light energy resulting from such spectrophotometric irradiation for each such region, conveying signals corresponding to the light energy so received to the control and processing station, analyzing the conveyed signals to determine preselected blood metabolite data, and displaying the data so obtained from each of a plurality of such testing sites and for each of a plurality of such regions, in a region-comparative manner.
The foregoing principal aspects and features of the invention will become better understood upon review of the ensuing specification and the attached drawings, describing and illustrating preferred embodiments of the invention.
FIGS, 5, 6, and 7 are graphs representing data displays obtained in accordance with the invention which represent actual surgical procedure results from actual patients;
The general nature of a typical structure and arrangement for the sensors 16,116 (which are identical in nature and which may if desired be incorporated into a single physical unit) is illustrated in
Inside the skull 34 is the Periosteal Dura Mater, designated by the numeral 36, and inside that is the brain tissue 38 itself, which is comprised of two distinct hemispheres 38′, 38″ that are separated at the center of the forehead inwardly of the superior sagital sinus by a thin, inwardly-projecting portion 36a of the Dura 36. Thus, in the arrangement illustrated in
As explained at length in various of the above-identified prior patents, the preferred configuration of sensors 16, 116 includes both a “near” detector 26, which principally receives light from source 24 whose mean path length is primarily confined to the layers of skin, tissue, skull, etc., outside brain 38, and a “far” detector 28, which receives light spectra that have followed a longer mean path length and traversed a substantial amount of brain tissue in addition to the bone and tissue traversed by the “near” detector 26. Accordingly, by appropriately differentiating the information from the “near” (or “shallow”) detector 26 (which may be considered a first data set) from information obtained from the “far” (or “deep”) detector 28 (providing a second such data set), a resultant may be obtained which principally characterizes conditions within the brain tissue itself, without effects attributable to the overlying adjacent tissue, etc. This enables the apparatus to obtain metabolic information on a selective basis, for particular regions within the test subject, and by spectral analysis of this resultant information, employing appropriate extinction coefficients, etc. (as set forth in certain of the above-identified patents), a numerical value, or relative quantified value, may be obtained which characterizes metabolites or other metabolic data (e.g., the hemoglobin oxygen saturation) within only the particular region or volume of tissue actually examined, i.e., the region or zone generally defined by the curved mean path extending from source 24 to the “far” or “deep” detector 28, and between this path and the outer periphery of the test subject but excluding the analogous region or zone defined by the mean path extending from source 24 to “near” detector 26. As will be understood, particularly in view of Applicants' above-identified prior patents as well as is explained further hereinafter, this data analysis carried out by the “control and processing unit” 20 is accomplished by use if an appropriately programmed digital computer, as is now known by those skilled in the art (exemplified in particular by the Somanetics® model 4100 cerebral oximeter).
The present invention takes advantage of the primarily regional oxygen saturation value produced by each of the two (or more) sensors 16, 116, together with the natural hemispheric structure of brain 38, by use of a comparative dual or other multi-channel examination paradigm that in the preferred embodiment or principal example set forth herein provides a separate but preferably comparatively displayed oxygen saturation value for each of the two brain hemispheres 38′, 38″. Of course, it will be understood that each such regional index or value of oxygen saturation is actually representative of the particular region within a hemisphere actually subjected to the examining light spectra, and while each such regional value may reasonably be assumed to be generally representative of the entire brain hemisphere in which it is located, and therefor useful in showing and contrasting the differing conditions between the two such hemispheres of the brain 38, the specific nature and understanding of these hemispheric interrelationships and of interrelationships between other and different possible sensor locations relative to each different hemisphere 38′, 38″ are not believed to be fully known and appreciated as of yet. Consequently, it may be useful or advantageous in at least some cases, and perhaps in many, to employ a more extensive distribution and array of sensors and corresponding inputs to the oximeter 20, such as is illustrated for example in
Thus, as seen in
It may also be possible to use only a single source position and employ a series of mutually spaced detector sets, or individual detectors, disposed at various selected distances from the single source around all or a portion of the perimeter of the subject. Each such single source would actually illuminate the entire brain since the photons so introduced would scatter throughout the interior of the skull (even though being subject to increased absorption as a function of distance traversed), and each such emitter/detector pair (including long-range pairs) could produce information characterizing deeper interior regions than is true of the arrays illustrated in
The dual or bilateral examination arrangement depicted in
Graphic displays 42, 44 may also advantageously be arranged in the form shown in
With further reference to
As will be understood, the various differences in cerebral blood oxygenation shown by the superimposed traces of
The importance and value of the information provided in accordance with the present invention is believed self-apparent from the foregoing, particularly the graphical presentations of and comments provided with respect to
As also shown in
While implementation of a system such as that shown in
In a multi-site (multiple sensor) system, such as that shown in
A system as described above may readily be implemented to obtain on the order of about fifteen data samples per second even with the minimal detector “on” time noted, and a further point to note is that the preferred processing involves windowing of the detector “on” time so that data samples are taken alternatingly during times when the emitters are actuated and the ensuing time when they are not actuated (i.e., “dark time”), so that the applicable background signal level may be computed and utilized in analyzing the data taken during the emitter “on” time. Other features of the preferred processing include the taking of a fairly large number (e.g., 50) of data samples during emitter “on” time within a period of not more than about five seconds, and processing that group of signals to obtain an average from which each updated rSO2 value is computed, whereby the numeric value displayed on the video screen 40 is updated each five seconds (or less). This progression of computed values is preferably stored in computer memory over the entire length of the surgical procedure involved, and used to generate the graphical traces 42,44 on a time-related basis as discussed above. Preferably, non-volatile memory is utilized so that this data will not be readily lost, and may in fact be downloaded at a convenient time through the data output interface 54 of CPU 50 noted above in connection with
As will be understood, the foregoing disclosure and attached drawings are directed to a single preferred embodiment of the invention for purposes of illustration; however, it should be understood that variations and modifications of this particular embodiment may well occur to those skilled in the art after considering this disclosure, and that all such variations etc., should be considered an integral part of the underlying invention, especially in regard to particular shapes, configurations, component choices and variations in structural and system features. Accordingly, it is to be understood that the particular components and structures, etc. shown in the drawings and described above are merely for illustrative purposes and should not be used to limit the scope of the invention, which is defined by the following claims as interpreted according to the principles of patent law, including the doctrine of equivalents.
Scheuing, Richard S., Barrett, Bruce J., Gonopolsky, Oleg
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