# US 7,407,486 B2 · Method and an apparatus for pulse plethysmograph based detection of nociception during anesthesia or sedation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,407,486 B2 - Document ID: US7407486B2 - Status: Granted - Kind: B2 - Application number: 10/474,786 - Filed: 2002-10-14 - Published: 2005-06-30 - Granted: 2008-08-05 - Earliest claimed: 2002-10-14 - Assignees: GE Healthcare Finland Oy - Inventors: Matti Veli Tapani Huiku; Ilkka Korhonen; Marcus Johannis Van Gils; Mikko Oskari Jousi; Jyrki Mika Petteri Lötjönen - Web page: https://patentgrep.com/patent/US7407486B2 ## CPC - A61B 5/4035: {Evaluating the autonomic nervous system} - A61B 5/14551: {for measuring blood gases} - A61B 5/4821: {Determining level or depth of anaesthesia (based on movements A61B5/1106)} - A61B 5/7239: {using differentiation including higher order derivatives} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The invention concerns a method and an apparatus for monitoring a condition of a patient under anesthesia or sedation. For this purpose there is a sensor for acquiring a signal that represents peripheral cardiovascular flow in the patient. Successive heart beat pulses are detected and predetermined pulse wave parameters are measured repeatedly in said signal, and predefined pulse wave parameters within said heart beat pulses are measured, too. At first, said predetermined pulse wave parameters in a number of successive heart beat pulses are compared in respect to possible occurrence of a substantial alteration. At second, if the alteration is noticed, a statistical reference value is calculated by deriving values from at least said predefined pulse wave parameters, and the change(s) between at least one predefined pulse wave parameter and said reference value is quantified. The results and/or intermediate results are finally displayed and/or recorded. ## Claims ### Claim 1 A method for monitoring a condition of a patient under anesthesia or sedation, the method comprising the steps of: acquiring a pulse wave signal representing peripheral cardiovascular flow in the patient; detecting individual heart beat pulses in said signal; measuring predetermined pulse wave parameters of said signal within said individual heart beat pulses; repeating the measuring of said pulse wave parameters in the successive heart beat pulses; recording said measured pulse wave parameters; calculating a reference value over a predetermined time period or over a predetermined number of heart beat pulses by deriving values of at least one predefined pulse wave parameter from said recorded pulse wave parameters; quantifying change(s) between one or several prevailing predefined pulse wave parameter(s) and said reference value; and displaying and/or recording said change(s) in said at least one pulse wave parameter. ### Claim 2 (depends on 1) A method according to claim 1, wherein said displaying and/or recording is in a form, which can be utilized for evaluating an adequacy of analgesia in the patient. ### Claim 3 (depends on 1) A method according to claim 1, wherein said predetermined pulse wave parameters are one or several parameter(s) selected from the following group of parameters: peak amplitude(s) within said individual heart beat pulse(s), and temporal position(s) of said pulse amplitude(s), and basal signal value(s) between said heart beat pulse(s), and dicrotic notch signal value(s) within said individual heart beat pulses, and temporal position(s) of said dicrotic notch value(s), and pulse area(s) of said heart beat pulse(s), and area(s) under curve(s) of said heart beat pulse(s). ### Claim 4 (depends on 1) A method according to claim 1, wherein said predefined pulse wave parameter is at least: dicrotic notch signal value(s) or virtual signal value(s) approaching dicrotic notch respectively, within successive heart beat pulses. ### Claim 5 (depends on 1) A method according to claim 1, the method further comprising, prior to said quantifying change(s), the step of: observing a possible suppression of any of said pulse wave parameters in their absolute value scale; and in case there is a suppression larger than a predetermined amount, deeming said quantified change(s) and/or optional evaluation and/or displaying and/or recording valid. ### Claim 6 (depends on 3) A method according to claim 3, the method further comprising, prior to said calculating change(s), the steps of: equalizing said pulse wave parameter(s) within pulse beat period(s); and proportionating said measured dicrotic notch signal value(s) and temporal position(s) thereof, and the calculated notch reference value(s) and temporal position(s) thereof to respect said equalized region of parameter(s) and period(s). ### Claim 7 (depends on 6) A method according to claim 6, the method further comprising the step of evaluation: 1) if the equalized and proportionated dicrotic notch signal value(s) has lower value than said reference value, evidencing presence of nociception in the patient, 2) if the equalized and proportionated dicrotic notch signal value(s) has a same or higher value than said reference value, evidencing lack of nociception in the patient. ### Claim 8 (depends on 1) A method according to claim 1, wherein said signal representing peripheral cardiovascular flow is a photoplethysmographic pulse wave signal, or a signal dependent on blood volume and/or a signal dependent on blood pressure. ### Claim 9 (depends on 1) A method according to claim 1, wherein said reference value is calculated specifically for the patient under anesthesia or sedation; and that said reference value is a constant average value over said time period or over said number of heart beat pulses prior to the present measuring time, or a moving weighted or non-weighted average value over said time period or over said number of heart beat pulses during operation of the patient, or a constant group average over certain patient type(s). ### Claim 10 (depends on 1) A method according to claim 1, wherein the recorded pulse wave parameters include parameters describing shape of the said individual heart beat pulses. ### Claim 11 (depends on 1, 10) A method according to claim 1 or 10, wherein said signal representing peripheral cardiovascular flow is a photoplethysmographic wave obtained from a pulse oximeter. ### Claim 12 (depends on 1, 2, 3) A method according to claims 1, 2, 3, or 5, the method comprising: a first step, in which suppression of the wave parameters is detected; a second step, initiated after the first step if the suppression exceeds a certain second predetermined threshold value, in which step the change of the shape of the pulse is detected; and a third step, in which, based on the first and second steps, a nociception and/or adequacy of analgesia is assessed. ### Claim 13 A method for monitoring a condition of a patient under anesthesia or sedation, the method comprising the steps of: acquiring a pulse wave signal representing peripheral cardiovascular flow in the patient; detecting successive heart beat pulses in said signal; measuring predetermined pulse wave parameters repeatedly in said signal within said successive heart beat pulses; comparing said predetermined pulse wave parameters in a number of successive heart beat pulses, and if a substantial alteration is occurred: calculating a statistical reference value by deriving values from at least said predefined pulse wave parameters; quantifying change(s) between at least one predefined pulse wave parameter and said reference value; and displaying and/or recording said change(s) or lack of change(s) respectively in said at least one predefined pulse wave parameter. ### Claim 14 (depends on 13) A method according to claim 13, wherein said displaying and/or recording is in a form, which can be utilized for evaluating an adequacy of analgesia in the patient. ### Claim 15 (depends on 13) A method according to claim 13, wherein said predetermined pulse wave parameters are one or several parameter(s) selected from the following group of parameters: peak amplitude(s) within said individual heart beat pulse(s), and temporal position(s) of said pulse amplitude(s), and basal signal value(s) between said heart beat pulse(s), and dicrotic notch signal value(s) within said individual heart beat pulses, and temporal position(s) of said dicrotic notch value(s), and pulse area(s) of said heart beat pulse(s), and area(s) under curve(s) of said heart beat pulse(s). ### Claim 16 (depends on 13) A method according to claim 13, wherein said predefined pulse wave parameter is at least: dicrotic notch signal value(s) or virtual signal value(s) approaching dicrotic notch respectively, within successive heart beat pulses. ### Claim 17 (depends on 13) A method according to claim 13, wherein the said substantial alteration is at least a suppression of the pulse amplitude(s) within said individual heart beat pulses compared in their absolute value scale. ### Claim 18 (depends on 16) A method according to claim 16, the method further comprising, prior to said calculating change(s), the steps of: equalizing said pulse wave parameter(s) within pulse beat period(s); and proportionating said measured dicrotic notch signal value(s) and temporal position(s) thereof, and the calculated notch reference value(s) and temporal position(s) thereof to respect said equalized region of parameter(s) and period(s). ### Claim 19 (depends on 18) A method according to claim 18, the method further comprising the step of evaluation: 1) if the equalized and proportionated dicrotic notch signal value(s) has a lower value than said reference value, evidencing presence of nociception in the patient, 2) if the equalized and proportionated dicrotic notch signal value(s) has a same or higher value than said reference value, evidencing lack of nociception in the patient. ### Claim 20 (depends on 13) A method according to claim 13, wherein said signal representing peripheral cardiovascular flow is a photoplethysmographic pulse wave signal, or a signal dependent on blood volume and/or a signal dependent on blood pressure. ### Claim 21 (depends on 13) A method according to claim 13, wherein said reference value is calculated specifically for the patient under anesthesia or sedation; and that said reference value is a constant average value calculated over a predetermined time period or over a predetermined number of heart beat pulses prior to the present measuring time, or a moving weighted or non-weighted average value over said time period or over said number of heart beat pulses during operation of the patient, or a constant group average over certain patient type(s). ### Claim 22 (depends on 13) A method according to claim 13, wherein the recorded pulse wave parameters include parameters describing shape of the said individual heart beat pulses. ### Claim 23 (depends on 13, 22) A method according to claim 13 or 22, wherein said signal representing peripheral cardiovascular flow is a photoplethysmographic wave obtained from a pulse oximeter. ### Claim 24 (depends on 13, 14, 15) A method according to claims 13, 14, 15, or 17, said steps comprising: detecting the suppression of the wave parameters; if suppression exceeds a certain second predetermined threshold value, detecting the change in the shape of the heart beat pulse; and assessing a nociception and/or adequacy of analgesia if said suppression and said change in shape is detected. ### Claim 25 An apparatus for monitoring a condition of a patient under anaesthesia or sedation, the apparatus comprising: a photoplethysmographic or a pulse oximeter sensor for receiving a substantially continuous electrical signal representing a cardiovascular flow of the patient; time measuring means and a voltage/current dependent circuit connected with said sensor means; first memory means storing criteria of predetermined pulse wave parameter(s); first calculation means and/or selection means connected to said first memory means, said voltage/current dependent circuit for detecting predefined pulse wave parameter(s) of said predetermined pulse wave parameter(s) in said signal; quantifying means providing quantified change(s) of at least one predefined pulse wave parameter in respect to values of said predefined pulse wave parameter prior to the present moment; and a display and/or connections into other possible devices. ### Claim 26 (depends on 25) An apparatus according to claim 25, the apparatus further comprising: second memory means for storing said measured and/or selected pulse wave parameter(s) at least temporarily; and second calculation means providing at least one reference value from a series of at least one predefined pulse wave parameter of said predetermined pulse wave parameters received prior to the present moment. ### Claim 27 (depends on 26) An apparatus according to claim 26, said quantifying means comprising: third memory means for storing threshold value for at least one of said predetermined pulse wave parameters; and first comparison means for detecting an exceeding or underrunning of said at least one predetermined pulse wave parameter as compared to said threshold value. ### Claim 28 (depends on 27) An apparatus according to claim 27, said quantifying means further comprising: third calculation means for equalizing and proportionating at least predefined pulse wave parameter(s) of said predetermined pulse wave parameter(s); and second comparison means for detecting a difference between prevailing value(s) of said at least one predefined pulse wave parameter and said at least one reference value. ### Claim 29 (depends on 25) An apparatus according to claim 25, wherein at least said quantifying means is a program for data processor. ### Claim 30 (depends on 25) An apparatus according to claim 25, wherein said quantifying means operates either on the basis of signal levels analysis and derivatives analysis, or on the basis of curvatures analysis. ### Claim 31 (depends on 25) An apparatus according to claim 25, wherein said sensor means is a photoplethysmographic unit. ### Claim 32 (depends on 31) An apparatus according to claim 31, wherein said sensor means is a pulse oximeter, or a peripheral continuous blood pressure meter.