Method and apparatus for noninvasively monitoring parameters of a region of interest in a human body

• US 20060247506A1
• Filed: 09/12/2004
• Published: 11/02/2006
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: OrNim Medical, Ltd. (OrNim, Inc.)
• Original Assignee: OrNim Medical, Ltd. (OrNim, Inc.)
• Inventors: Balberg, Michal, Olshansky, Michal, Pery-Schechter, Revital
• Granted Patent: US 8,126,524 B2
• Time in Patent Office: Days
• US Class Current: 600/323
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0097 by applying acoustic waves and detecting light, i.e. acoustooptic measurements
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G01S 15/8968 using acoustical modulation of a light beam acousto-optical light control devices G02F1/11, G02F1/33

Abstract

A method and system for noninvasive monitoring of at least one parameter of a region of interest in a human body. The system comprises a measurement unit and a control unit. The measurement unit comprises an optical unit having an illumination assembly (101A) and a light detection assembly (101B) to generate measured data indicative of collected light; and an acoustic unit (110) configured to generate acoustic waves of a predetermined ultrasound frequency range. The measurement unit provides an operating condition such that the acoustic waves overlap with an illuminating region within the region of interest and substantially do not overlap outside the region of interest. The measured data is indicative of scattered light having both ultrasound tagged and untagged light portions, enabling to distinguish between light responses of the region of interest and the region outside the region of interest.

Claims

1-101. -101. (canceled)

102. A monitoring system for use in non-invasively monitoring at least one parameter of a region of interest in a human body, the system comprising:

a measurement unit comprising an optical unit having an illumination assembly configured to define at least one output port for illuminating light, and a light detection assembly configured to define at least one light input port for collecting light scattered from the illuminated body portion and to generate measured data indicative of the collected light; and

an acoustic unit configured to generate acoustic waves of a predetermined ultrasound frequency range;

the measurement unit being configured and operable to provide an operating condition such that the acoustic waves of the predetermined frequency range overlap with an illuminating region within the region of interest and substantially do not overlap with a region outside the region of interest, and that the detection assembly collects light scattered from the region of interest and light scattered from the region outside the region of interest, the measured data being thereby indicative of scattered light having both ultrasound tagged and untagged light portions, thereby enabling to distinguish between light responses of the region of interest and the region outside the region of interest;

a control unit, which is connectable to the optical unit and to the acoustic unit to operate these units, the control unit being responsive to the measured data and preprogrammed to process and analyze the measured data to extract therefrom a data portion associated with the light response of the region of interest and determine said at least one parameter of the region of interest.

103. The system of claim 102, wherein the acoustic unit is configured for generating ultrasound radiation being either unfocused radiation, or focused radiation with a focal length corresponding to a distance from the acoustic unit to the region of interest.

104. The system of claim 102, configured to determine oxygen saturation of the region of interest.

105. The system of claim 102, configured to utilize principles of oximetry or pulse oximetry to determine the desired parameter of the region of interest.

106. The system of claim 102, wherein the measurement unit is configured and operable to generate the measured data indicative of variations of the ultrasound tagged light signal as a function of at least one of time and wavelength of the illuminating light, the control unit being configured to analyze the variations of the ultrasound tagged light signal to determine at least one predetermined characteristic of the signal and calculate oxygen saturation, said at least one predetermined characteristic of the signal including maxima, minima and average of the signal.

107. The system of claim 102, wherein the control unit is preprogrammed and operable to provide optimal positioning of the optical unit and the acoustic unit, said optimal positioning satisfying said operating condition.

108. The system of claim 107, wherein the control unit is operable to provide a relative displacement between a direction of propagation of the acoustic radiation and at least one of the illumination and detection assemblies so as to provide said optimal positioning.

109. The system of claim 102, wherein the illumination assembly is configured to define at least two spaced-apart light output ports.

110. The system of claim 109, wherein the control unit is operable to select at least one of the light output ports for measurements, to provide said operating condition.

111. The system of claim 102, wherein the detection assembly has one of the following configurations:

(a) is configured to define at least two spaced-apart light input ports; and

(b) is configured to define an array of at least two spaced-apart light input ports, such that when in the operating condition, at least one of the light input ports collects the tagged light coming from the region of interest, and at least one other of the light input ports collects the untagged light scattered from the region outside the region of interest.

112. The system of claim 111, wherein the control unit is operable to select at least one of the light input ports for measurements, to provide said operating condition.

113. The system of claim 110, wherein the detection assembly is configured to define at least two spaced-apart light input ports.

114. The system of claim 113, wherein the control unit is operable to select at least one of the light input ports for measurements, to provide said operating condition.

115. The system of claim 108, wherein the control unit is operable to displace at least one of the light input or output ports with respect to the direction of the acoustic waves propagation.

116. The system of claim 102, wherein the illumination assembly is configured and operable to generate the illuminating light of at least two different wavelengths.

117. The system of claim 116, wherein the two different wavelengths are determined by at least one of the following conditions:

(i) to be differently absorbable by oxygenated and deoxygenated hemoglobin in the body;

(ii) to be characterized by the same absorption by tissue or fluid components in the body;

(iii) to be characterized by a different absorption by tissue or fluid components in the body; and

(iv) to be differently scattered by tissue or fluid components in the body.

118. The system of claim 116, wherein the illumination assembly is operable to generate said at least two different wavelengths at different times.

119. The system of claim 116, wherein the at least two wavelengths are differently modulated by at least one of frequency and phase characteristics.

120. The system of claim 118, wherein the at least two wavelengths are differently modulated by at least one of frequency and phase characteristics.

121. The system of claim 102, wherein the detection assembly is configured to define the light input port which, when in the operating condition, detects both the light scattered from the region of interest and the light scattered from the outside of the region of interest.

122. The system of claim 102, wherein the control unit is preprogrammed for operating the optical unit a predetermined time after the operation of the acoustic unit, thereby providing said operating condition.

123. The system of claim 122, wherein said predetermined time corresponds to a time needed for the acoustic waves of the predetermined frequency to reach the region where the overlapping with the illuminating light is to be provided.

124. The system of claim 111, wherein the arrangement of said at least two light input ports is such that at least one of the light input ports is located proximate of the light output port thereby collecting untagged light scattered from the region outside of the region of interest;

and the at least one other light input port is located at a larger distance from the light output port thereby collecting ultrasound tagged light coming from the region of interest through the outside region.

125. The system of claim 124, wherein the control unit is preprogrammed to process and analyze the first measured data generated by said at least one light input port to determine data indicative of a characteristic of a light response of the region outside of the region of interest to the illuminating light;

and to utilize said data indicative of the light response characteristic in the processing and analyzing of the second measured data generated by said at least one other input port to thereby extract the light response of the region of interest.

126. The system of claim 111, wherein the control unit is preprogrammed for operating at least one of the light input ports a predetermined time after the operation of the acoustic unit, thereby providing said operating condition.

127. The system of claim 126, wherein said predetermined time corresponds to a time needed for the acoustic waves of the predetermined frequency range to reach the region where the overlapping with the illuminating light is to be provided.

128. The system of claim 102, wherein the control unit is configured and operable to actuate the optical and acoustic units to irradiate with the acoustic radiation a plurality of regions in the illuminated part of the body and detect scattered photons;

and to analyze the measured data to identify tagged and untagged light signals associated with each of said plurality of regions to determine a parameter indicative of the light response of each of said plurality of regions, thereby enabling identification of said region of interest.

129. The system of claim 127, wherein said at least one of the light input ports is located proximate of the light output port thereby collecting untagged light scattered from the region outside of the region of interest;

and said at least one other light input port is located at a larger distance from the light output port as compared to a location of at least one other light input port thereby collecting tagged light coming from the region of interest through the region outside of the region of interest.

130. The system of claim 129, wherein the control unit is preprogrammed to process and analyze the first measured data generated by said at least one light input port to determine data indicative of a characteristic of a light response of the region outside of the region of interest to the illuminating light;

and to utilize said data indicative of the light response characteristic in the processing and analyzing of the second measured data generated by said at least one other input port to thereby extract the light response of the region of interest.

131. The system of claim 102, comprising a support structure carrying at least the light output and light input ports of the illumination and detection assemblies.

132. The system of claim 131, wherein said support structure has at least one of the following configurations:

(i) is configured for carrying the illumination and detection assemblies;

(ii) is configured for carrying the acoustic unit;

(iii) is configured for carrying an output port of the acoustic unit;

(iv) is flexible to wrap the body portion.

133. The system of claim 102, wherein the acoustic unit is configured for generating ultrasound radiation in the form of one of the following:

continuous wave, pulse, burst.

134. The system of claim 102, wherein the control unit is configured and operable to apply a frequency filtering to the output of the detection assembly to correspond to a frequency bandwidth of the acoustic waves irradiating the region of interest.

135. The system of claim 102, wherein the acoustic unit comprises a phased array of ultrasound transducers.

136. The system of claim 102, wherein the control unit is configured for carrying out at least one of the following:

receiving data indicative of reflections of the ultrasound waves from an irradiated volume inside of the body for creating data indicative of an image of the irradiated volume, and analyzing said image data to provide said operating condition for measurements; and

receiving data indicative of reflections of the ultrasound waves from an irradiated volume inside the body for determining data indicative of a Doppler shift in the ultrasound radiation reflections.

137. The system of claim 102, wherein said predetermined frequency range of the ultrasound radiation is from 50 kHz to 8 MHz.

138. The system of claim 102, wherein the ultrasound radiation is of a frequency lower than 1 MHz.

139. The system of claim 102, configured for use in monitoring at least one of the following parameters:

oxygen saturation level of the region of interest, and concentration of a substance or structure in the region of interest.

140. A probe device for use in a system for monitoring at least one parameter of a region of interest in a human body, the probe comprising a support structure having one of the following configurations:

(i) carrying at least two light output ports optically coupled to a light source assembly, at least one light input port optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

(ii) carrying at least one light output port optically coupled to a light source assembly, at least two light input ports optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

(iii) carrying an array of at least two light output ports arranged in a spaced-apart relationship and being optically coupled to a light source assembly, an array of light input ports arranged in a spaced-apart relationship and being optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

the arrangement of the light and acoustic ports being such as to allow selection of at least one of said light output ports, at least one of the light input ports and at least one of the acoustic output ports such that acoustic waves of a predetermined frequency range coming from said at least one selected acoustic output port and illuminating light coming from said at least one selected light output port overlap within a region of interest in the body, and such that said at least one light input port collects light scattered from the overlapping region and light scattered from outside the region of interest.

141. A method for use in noninvasive monitoring at least one parameter of a region of interest in a human body, the method comprising:

operating an optical unit and an acoustic unit so as to provide that ultrasound waves of a predetermined frequency range and illuminating light overlap within the region of interest and substantially do not overlap with a region outside the region of interest, thereby producing measured data indicative of collected light including scattered light having ultrasound tagged and untagged light portions, thereby enabling extraction of a light response of the region of interest from all the other light portions in the collected light.

142. The method of claim 141, comprising irradiating the region of interest with unfocused or focused ultrasound radiation.

143. The method of claim 141, for determining oxygen saturation of the region of interest.

144. The method of claim 141, utilizing principles of oximetry or pulse oximetry to determine the desired parameter of the region of interest.

145. The method of claim 141, comprising applying the illumination of at least two different wavelengths, and generating the measured data indicative of variations of the ultrasound tagged light signal as a function of at least one of time and wavelength of the illuminating light.

146. The method of claim 145, comprising analyzing the time variations to determine at least one predetermined characteristic of the signal and calculate oxygen saturation of the region of interest, said at least one predetermined characteristic including maxima, minima and average of the signal.

147. The method of claim 141, comprising providing a relative displacement between a direction of propagation of the acoustic radiation and at least one of illumination and detection assemblies of the optical unit.

148. The method of claim 147, comprising carrying out one of the following:

(a) inserting the acoustic unit into the body through an opening, and locating the optical unit outside the body, during the monitoring procedure;

or (b) inserting the optical unit into the body through an opening, and locating the acoustic unit outside the body, during the monitoring procedure.

149. The method of claim 148 wherein the opening is a vaginal track.

150. The method of claim 141, comprising selecting for measurements at least one light output port, from a plurality of spaced-apart light output ports, of the optical unit.

151. The method of claim 141, comprising selecting for measurements at least one light input port from a plurality of spaced-apart light input ports of the optical unit.

152. The method of claim 150, comprising selecting for measurements at least one light input port from a plurality of spaced-apart light input ports of the optical unit.

153. The method of claim 147, comprising displacing at least one of light input or light output ports of the optical unit with respect to the direction of the acoustic waves propagation.

154. The method of claim 141, comprising applying ultrasound imaging to the region of interest surrounded by the outside region.

155. The method of claim 154, wherein the imaging is carried out using said acoustic unit.

156. The method of claim 141, comprising monitoring at least one parameter of the region of interest during therapeutic application of ultrasound radiation or light radiation thereto.

157. The method of claim 156, wherein the ultrasound radiation for therapy is applied using said acoustic unit.

158. The method of claim 141, comprising detecting reflections of the ultrasound radiation from the irradiated body portion and determining a Doppler shift in the detected reflections.

159. The method of claim 141, comprising operating an illumination assembly of the optical unit to carry out at least one of the following:

(a) generate the illuminating light of at least two different wavelengths;

(b) generate the illuminating light of at least two different wavelengths at different times;

(c) generate the illuminating light of at least two different wavelengths differently modulated by at least one of frequency and phase characteristics.

160. The method of claim 159, wherein said at least two different wavelengths are selected to satisfy at least one of the following conditions:

. (i) to be differently absorbed by oxygenated and deoxygenated hemoglobin;

(ii) to be equally absorbed by tissue or fluid components;

(iii) to be differently absorbed by tissue or fluid components in the body;

(iv) to be equally absorbed by tissue or fluid components and differently scattered by tissue or fluid components.

161. The method of claim 141, comprising detecting both the light scattered from the region of interest and the light scattered from the outside of the region of interest.

162. The method of claim 141, comprising operating at least two spaced-apart light input ports of the optical unit to provide at least one of the following light collection conditions:

(i) at least one of the light input ports collects the light scattered from the region of interest, and at least one other of the light input ports collects the light scattered from the outside region;

(ii) at least one of the light input ports collects the untagged light scattered from the region outside the region of interest, and at least one other of the light input ports collects the tagged light coming from the region of interest through the region outside the region of interest.

163. The method of claim 141, comprising operating the optical unit a predetermined time after the operation of the acoustic unit, said predetermined time corresponding to a time needed for the acoustic waves of the predetermined frequency range to reach the region of interest where the overlapping with the illumination light is to be provided.

164. The method of claim 162, comprising collecting the untagged light scattered from the region outside of the region of interest by said at least one light input port located proximate of the light output port, and collecting the tagged light coming from the region of interest through the region outside the region of interest by said at least one other light input port located at a larger distance;

from the light output port.

165. The method of claim 164, comprising processing and analyzing the first measured data generated by said at least one light input port to determine data indicative of a characteristic of a light response of the region outside the region of interest to the illuminating light;

and utilizing said data indicative of the light response characteristic in the processing and analyzing of the second measured data generated by said at least one other light input port, to thereby extract from the second measured data the data indicative of the light response of the region of interest.

166. The method of claim 141, wherein said at least one desired parameter includes at least one of the following:

oxygen saturation level; and

concentration of a substrate or structure in the region of interest.

167. The method of claim 141, for use in noninvasive monitoring a fetus condition.

168. The method of claim 167, wherein said at least one desired parameter includes at least one of the following:

a fetus blood parameter;

an oxygen saturation level of the fetus;

concentration of a substance or a structure within the fetus;

concentration of a substance or a structure within amniotic fluid;

presence of meconium in the amniotic fluid and concentration thereof;

presence of blood in the amniotic fluid and concentration thereof; and

a level of lung maturity of the fetus.

169. The method of claim 167, wherein said at least one desired parameter includes the level of lung maturity of the fetus, the method comprising determining presence and concentration of lamellar bodies in the amniotic fluid.

170. The method of claim 141, for noninvasive monitoring optical properties of an extravascular fluid, such as pleural, pericardial, peritoneal and synovial fluids.

171. A method for use in noninvasive monitoring oxygen saturation level, the method comprising:

applying ultrasound tagging of light in pulse oxymetric measurements, obtaining measured data indicative of variations of ultrasound tagged light signals scattered from a region of interest as a function of at least one of time and wavelength of illuminating light, and analyzing the measured data to calculate the oxygen saturation level.

172. A method for use in noninvasive monitoring at least one parameter of a fetus-related region of interest, the method comprising:

providing an optical unit having an illumination assembly configured to define at least one output port for the illuminating light; and

a light detection assembly configured to define at least one light input port for collecting light, and to generate measured data indicative of the collected light; and

providing an acoustic unit configured to generate acoustic waves of a predetermined ultrasound frequency range;

providing an optimal positioning of the optical and acoustic units with respect to each other and with respect to the fetus-related region of interest, said optimal positioning satisfying an operating condition resulting in that the ultrasound waves of the predetermined frequency range overlap with the illuminating light within the fetus-related region of interest, while substantially not overlapping in a maternal tissues region outside the fetus-related region of interest, and in that the detection assembly collects light scattered from the fetus-related region of interest and from the maternal tissues region;

operating the optical and acoustic units, when in the optimal positioning, and generating measured data indicative of collected light including scattered light having ultrasound tagged and untagged light portions, thereby enabling extraction from the measured data a data portion indicative of a light response of the fetus-related region of interest.

173. The method of claim 172, wherein the fetus-related region of interest includes the fetus only or the fetus and amniotic fluid regions.

174. The method of claim 173, wherein said at least one parameter includes at least one of oxygen saturation level and concentration of a substance or structure in the fetus region.

175. The method of claim 174, wherein said at least one parameter includes at least one of the following:

a level of lung maturity of the fetus;

presence of lamellar bodies;

concentration of lamellar bodies;

presence of meconium;

concentration of meconium;

presence of blood; and

concentration of blood.