JP2003503125A - System for displaying medical process diagrams - Google Patents

Abstract

(57) [Summary] A non-invasive system that measures the oxygenation status of a patient in real time and displays it as a graphic. The system presents information to doctors in an intuitive way. Various display objects are described to illustrate the output of oxygenation values. The display object reflects the in-vivo function to be measured, which makes the interpretation of the measured value very intuitive.

Description

Detailed Description of the Invention

TECHNICAL FIELD The present invention relates to a display system. More specifically, it relates to a system for displaying graphical information, especially in a medical setting.

BACKGROUND ART Medical display systems provide information to physicians in a clinical setting.
Typical display systems provide data as numbers and unitary signal waveforms, but the attending physician must evaluate them in real time. Such systems may include alarms to warn the physician of unsafe conditions, such as when a number exceeds recommended values. In the field of anesthesiology, for example, an anesthesiologist monitors the patient's condition during anesthesia, while at the same time (i) recognizing the problem, (ii) identifying the cause of the problem, and (iii) coordinating measures. I have to take it. Misjudgments can be fatal.

[0002] Anesthesia-related deaths amount to more than 2000 cases annually, of which approximately 50% have been found to be due to inadequate selection during surgery. Human anesthesia in anesthesia generally means that the anesthesiologist is not aware of the problem (abnormal physiology), does not identify the cause of the problem, and does not take appropriate regulatory steps when anesthetizing the patient. It is due to. Anesthesia performance models, models showing causal relationships with mistakes, incidents and accidents, and models developing accidents in anesthesia all point to the fact that anesthesia is a complex situation that is prone to error.

The display of physiological data regarding a patient's condition plays a central role in allowing anesthesiologists to observe the patient's problematic condition and infer the likely causes of the problematic condition during surgery. As you can predict, the Australian Incident Monitoring Stu
63% of reported accidents in the dy (AIMS) database were considered detectable by standard data monitors. Some have tried to solve these problems, but the results have been limited.

For example, Cote et al. Developed a set of objects for displaying respiratory physiology of ventilated patients in an intensive care unit (ICU). This set of displays integrates information from the patient and ventilator, respiratory rate, respiratory volume and inspiratory oxygen content (%) information. By using the information from the object display, ICU physicians were able to interpret the data faster and more accurately than when using the alphanumeric display. Cole published a paper on how physicians used tabular data and printed graphic data to interpret data. However, Cole's work was not concerned with systems that receive analog data channels and drive real-time graphic displays on medical monitors.

In addition, Ohmeda, a company that manufactures anesthesia related equipment, manufactures modular CD machines with the option of displaying data as graphics. This display has been called a glyph. Physiological data is mapped onto the hexagon. The six data channels make up six sides of the hexagon. Although this display is graphic, alphanumeric information dominates. There is no clear reason why physiological data should be assigned to one side of a hexagon. Moreover, it is very difficult for a person to identify the symmetric changes to the various signs of this geometric shape.

In the surgical and post-surgical setting, decisions regarding the need for transfusion usually depend on hemoglobin (Hb) or hematocrit levels (Hct). Hematocrit is usually defined as the percentage by volume of concentrated red blood cells after centrifugation of a blood sample. If the patient's hemoglobin level per dl of blood is high, the physician can infer that the patient has sufficient capacity to deliver oxygen to the tissue. During surgery, this value is often used as a trigger, that is, more blood is given to the patient if the value falls below a certain point. Although these parameters indicate arterial oxygen content, they do not provide information on total oxygen delivered (or delivered) to tissue or oxygen content from tissue.

For example, it has been shown that low postoperative hematocrit is associated with postoperative ischemia in patients with systemic atherosclerosis. Although many researchers have attempted to limit the critical Hc level, most authorities should avoid empirical and automatic transfusion triggers, whether based on Hb or Hct, and avoid red blood cell transfusion for individual patients. You will agree that it should be adapted. Therefore, the transfusion trigger should be activated based on the patient's response to anemia rather than a predetermined value.

That is partly due to the fact that a number of parameters are important in determining how well a patient's tissue is actually oxygenated. In this regard, the patient's heart rate output is also an important factor in relating hemoglobin level to tissue oxygenation status. Heart rate output or CO is the time unit (ml / m
It is defined as the volume of blood ejected from the left ventricle of the heart into the aorta per in) and can be measured by the thermodilution technique. For example, if the patient has internal bleeding, the total blood volume may be low even though the hemoglobin concentration in the blood is normal. Therefore, simply measuring the amount of hemoglobin in the blood without measuring other parameters such as heart rate output is not always sufficient to infer the actual oxygenation status of the patient.

More specifically, the oxygenation state of a tissue is reflected by the oxygen supply / demand relationship of the tissue, that is, the relationship between the total oxygen consumption amount (VO ₂ ) and the total oxygen delivery amount (DO ₂ ). Hemoglobin is oxygenated in the pulmonary capillaries to oxyhemoglobin, which is then delivered to the tissue by the cardiac output, where it is consumed. When oxyhemoglobin releases oxygen to tissues, the oxygen partial pressure (PO ₂ ) decreases until sufficient oxygen is released to meet oxygen consumption (VO ₂ ). How to measure the oxygenation status of a specific organ bed (
Although intestinal tonometry; near infrared spectroscopy, etc.) have progressed, it is difficult to apply these methods in the clinical setting. Therefore, a parameter that reflects the oxygenation state of blood from the tissue, namely the oxygen tension of mixed venous blood (PvO ₂ ; also known as the oxygen tension of mixed venous blood) or the mixed venous blood oxyhemoglobin saturation (SvO ₂ ), has become a generally accepted method for assessing the overall oxygenation status of tissues.

Unfortunately, more accurate tissue oxygenation levels require relatively invasive techniques. From this point, pulmonary artery catheterization is used to directly measure the oxygenation status of mixed venous blood during surgery. To fully assess global oxygen delivery and delivery, one catheter (Directed Pulmonary Artery (PA) catheter) is placed in the pulmonary artery and another in the peripheral artery. A blood sample is then taken from each catheter to measure pulmonary artery and arterial blood oxygen levels. As discussed above, PA catheters can also be used to measure cardiac output. The physician then estimates from the measured oxygen content of the blood sample how well the patient's tissue is oxygenated.

Although these methods have proven to be relatively accurate, they are also extremely invasive. For example, the Swan-Ganz thermodilution catheter (Baxter Internat
The use of devices such as ional, Santa Ana, CA) increases the risk of infection, pulmonary arterial hemorrhage, pneumothorax and other complications. In addition, the risks and costs associated with PA catheters limit their use in surgery to high-risk or surgery with high blood loss (eg, heart surgery, liver transplantation, curative treatment of malignant lesions), and Limited to at-risk patients (eg, elderly patients, diabetic patients, atherosclerotic patients).

Among other variables, measuring the oxygenation status of a tissue should include an assessment of the amount of blood released to the tissue (CO) and the oxygen content of that blood (arterial blood) (CaO ₂ ). Is. The product of these variables can also be used to measure total oxygen delivery (DO ₂ ). Evaluation of DO ₂ currently requires the use of the invasive monitoring devices mentioned above. Therefore, measurement of DO ₂ is not possible in most surgical cases. However, in the intensive care unit (ICU), invasive monitoring tends to be part of the routine management of patients, thus making DO ₂ measurements easier to obtain in this patient group.

Mixed venous oxygen tension or mixed venous oxygen tension (PvO ₂ ) is another important parameter that can be measured using PA catheters. The equilibrium that exists between venous blood and the partial pressure of oxygen (PO ₂ ) in the tissue allows the physician to estimate the tissue oxygenation status of the patient. More specifically, as arterial blood flows through the tissue, there is a partial pressure gradient between the arterial blood flowing through the tissue and the PO _{2 in} the blood of the tissue itself. Due to this oxygen partial pressure gradient, oxygen is released from hemoglobin in the red blood cells and the solution in plasma, and the released O ₂ diffuses into the tissue. In general, blood PO ₂ (PvO ₂ ) generated from the venous end of a capillary closely reflects PO ₂ at the distal (venous) end of the tissue through which the capillary passes.

Closely associated with mixed venous oxygen tension (PvO ₂ ) is mixed venous oxyhemoglobin saturation (SvO ₂ ) expressed as a percentage of available oxygen-bound hemoglobin. Generally, oxyhemoglobin dissociation curves are plotted using SO ₂ and PO ₂ values. When the partial pressure of oxygen (PO ₂ ) in the blood decreases (ie blood passes through capillaries), the oxygen saturation of hemoglobin (SO ₂ ) decreases correspondingly. When the values of PO ₂ and SO ₂ in arterial blood are near 95 mmHg and 97%, respectively, the oxygen value (PvO ₂ , SvO ₂ ) of mixed venous blood is approximately 45 mmHg and 75%, respectively. Thus, SvO ₂ suggests a global tissue oxygenation state similar to PvO ₂ . Unfortunately, as with PvO ₂ SvO ₂ also it can only be measured with a relatively measurements invasive.

Another parameter that provides information about the oxygenation status of a patient is deliverable oxygen (dDO ₂ ). dDO ₂ is the amount of oxygen delivered to the tissue that can be delivered to the tissue (ie, the oxygen consumed by the tissue) before the PvO ₂ (implicitly the overall tissue oxygen tension) drops below a certain value. Amount). For example, dDO ₂ (40) is PvO ₂ 40
The amount of oxygen that can be delivered to the tissue before reaching mmHg. dDO ₂ (35) has a PvO _{2 of} 35 mmHg.
It shows the amount of oxygen consumed before dropping to.

Furthermore, several relevant parameters can be measured non-invasively. For example, the whole body oxygen consumption (VO ₂ ) can be calculated from the difference between the inspiratory volume of oxygen, the mixed expiratory volume of oxygen and the minute volume of artificial respiration. The heartbeat output can also be estimated to be non-invasive by measuring arterial blood pressure instead of relying on a thermodilution catheter. For example,
Kraiden et al. (US Pat. No. 5,183,501, described herein as a precedent) uses a blood pressure monitor to continuously measure arterial blood pressure. These data are converted into a pulse contour contour waveform. From this waveform, Kraiden and colleagues calculated the patient's heart rate output.

[0017]   No matter how the individual parameters are obtained, the person skilled in the art is well established.
Understand that new parameters can be derived from various relationships
Will do. For example, Fick's formula (Fick, A. Wurzburg, Physikalisch edizinis
che Gesellschaft Sitzungsbericht 16 (1870)) is an arterial oxygen concentration, venous acid
It correlates elementary concentration and heart rate output with the patient's total oxygen consumption and is expressed as follows:
Will be; (CaO₂・ CvO₂) × CO = VO₂ Where CaO₂Is arterial oxygen content, CvO₂Is venous oxygen content, CO is heart rate output, VO ₂ Represents total body oxygen consumption.

While non-invasively eliciting such parameters is useful in clinical settings, a more definitive “transfusion trigger” would clearly be useful. When PvO ₂ or DO ₂ is accepted as a valid indicator of patient safety, the question arises as to what constitutes the “safe” level of these parameters. Despite the existence of data on critical oxygen delivery levels in animal models, few have shown what is critical PvO ₂ in the clinical setting. The data available show that the levels are highly variable. For example, in patients about to undergo cardiopulmonary bypass surgery, critical PvO ₂ is varied between 30～45MmHg, the latter value is well within the range of values found in normal, healthy patients. Safe DO ₂ values show similar variability.

For practical purposes, a PvO ₂ value of 35 mmHg or higher is considered to indicate a sufficient overall oxygen supply to the tissue, which is due to the vasomotor system Implicitly based on the assumption that it is normal and working. Similarly,
Accurate measurement of DO ₂ relies on normal cardiovascular system. It is probably best to maintain a wide margin of safety during surgery and choose a transfusion trigger (DO ₂ , PvO ₂ , SvO ₂ or a derivative thereof) when the patient is clearly in good condition as far as oxygen dynamics are concerned. Is. In practice, only certain patients are monitored with a pulmonary artery catheter. Therefore, the above parameters are not available for all patients and the majority of patients will have incomplete and sometimes dangerous triggers of Hb concentration monitored.

Efforts have been made in the past to solve these problems with little success. For example, Faithfull et al. ( Oxygen Transport to Tissue XVI , Ed. M. Hogan, P
lenum Press, 1994, pp. 41-49) describe a model for deriving the oxygenation state of tissues under various conditions. However, this model is merely a static simulation, which allows the operator to measure how changes in various cardiovascular or physical parameters affect tissue oxygenation status. There is no provision for continuous data acquisition and evaluation to provide a dynamic indication of what may actually happen. Therefore, this model cannot be used to measure the patient's tissue oxygenation status in real time under varying clinical conditions.

Thus, what is needed in the art is a means for intuitively displaying physiological information to the physician. In this regard, the methods and systems described below provide a novel approach to physician patient data. Other aspects of the invention will be apparent from the description below.

DISCLOSURE OF THE INVENTION Embodiments of the invention provide for measurement and display of one or more values that accurately reflect the physiological condition of a patient. Preferred values include the patient's overall oxygenation status and cardiovascular status. Each value is displayed as an intuitive medical process diagram to help the physician understand the patient's medical condition. Moreover, the majority of the displayed values can be beneficially measured without invasive methods on the patient. As such, the display systems and methods discussed herein can be used to safely and intuitively monitor a patient's physiological condition and adjust therapeutic parameters based on the displayed values.

It will be appreciated that the display system of the present invention can be used in conjunction with a variety of medical devices to provide the desired physiological information. More specifically, the disclosed displays can be operatively and effectively associated with any medical device or device used to monitor or treat a patient. In this regard, such devices include, but are not limited to, anesthesia machines, ventilators, heart-lung machines and oxygenation monitors of the type described herein.
Exemplary values displayed are oxygenation parameters oxidation parameters and analog information for anesthesia machines, heart-lung machines, ventilators, oxygenation monitors, or cardiodynamic information for heart-lung machines. In each case, the disclosed displays effectively present quantitative data in such a way that it can be quickly understood by medical personnel.

[0024]   In a preferred embodiment, the present invention is a physiologically important indicator of tissue oxygenation status in a patient.
Oxygenation parameters, such as total oxygen delivery (DO₂), Deliverable oxygen delivery (dDO ₂ ), Mixed venous blood oxyhemoglobin saturation (SvO2) and mixed venous oxygen tension
(PvO₂) Etc. and provide real time display. Also,
Ming is another oxygenation parameter, supply / demand ratio (dDO₂/ VO2) to get
Used by physicians to accurately monitor and adjust patient oxygen status using a single number
To be able to.

It will be appreciated that the oxygenation parameters obtained may be used alone, or more preferably in combination, to indicate the overall tissue oxygenation level.
As such, the present invention can be used as a simple, real-time intervention trigger in a clinical setting without the risks associated with conventional invasive monitoring devices.

[0026] More specifically, by establishing a minimum PvO _2, the SvO2 or DDO ₂ that can tolerate for each patient, the attending physician will obtain a simple trigger points indicating the time intervention.
For example, based on clinical experience, the attending physician may need to provide the patient with sufficient oxygenation to provide adequate oxygenation.
It can be decided that PvO ₂ should not be below 35 mmHg or DO ₂ should be above 600 ml / min. Preferably, the clinician has access to each oxygenation parameter and can display the desired one or more values. In a particularly preferred embodiment, the system supply / demand ratio PvO ₂ selected (DDO ₂ / V
O2) to allow physicians to address patient needs based on a single value. In this example, one or more values indicate that PvO ₂ (overall tissue oxygenation) is higher than the established trigger point.

In a particularly preferred embodiment, input from an indwelling catheter placed in a peripheral artery is used to provide a continuous (beat interval) measurement of cardiac output (CO). In this regard, Mo
Instruments such as the delflow system (TNO-Biomedical Instrumentation, Amsterdam) are optionally used in conjunction with the present invention to provide continuous CO measurements in real time. Heart rate output can be calculated using an algorithm that simulates the behavior of the human aorta and arterial system through a three-dimensional nonlinear model of aortic input impedance. The cardiac output calculated using this model is confirmed against the cardiac output measured by the thermodilution method. In addition to the heartbeat output, the following hemodynamic information based on beat intervals
low, such as systolic, diastolic and mean blood pressure, pulse rate, stroke volume and peripheral vascular resistance.

Embodiments of the present invention also measure the patient's arterial oxygen content (CaO ₂ ) used to derive the desired value. Specifically, in measuring arterial blood oxygen content (CaO ₂ ), one or two corresponding to patient hemoglobin concentration, arterial blood oxygen tension (PaO 2), arterial blood carbon dioxide tension (PaCO 2), arterial blood pH and body temperature The above numerical values can be used. These numbers can be obtained from a blood chemistry monitor or entered manually. In a particularly preferred embodiment, a blood chemistry monitor is used to obtain the desired value at the same time as the heart rate output value is measured. In addition, the patient's oxygen consumption (VO
2) is preferably measured by gas analysis or metabolic rate measurement.

As noted above, embodiments of the present invention further provide methods and devices that can be used to monitor the tissue oxygenation status of a patient using the supply / demand ratio. further,
One embodiment of the present invention includes a measurement of the supply / demand ratio (DDO ₂ / VO2), are directed to relatively non-invasive method of monitoring tissue oxygenation status of the patient in real time. Similarly, other embodiments are directed to relatively non-invasive devices for measuring tissue oxygenation status in a patient in real time. Such a device can supply / demand (dDO ₂ / V
It contains instructions for measuring O2). The calculations, values and equipment necessary to obtain the desired ratio are as described herein throughout.

In all cases, preferred embodiments of the invention include blood chemistry monitors and / or pressure transducers (ie pressure transducers for CO, etc.), but they are not an essential component of the invention, It must also be emphasized that it is not necessary to carry out the disclosed method. For example, a doctor can manually measure blood gas levels, temperature and Hg concentration and enter this information into the system from a keyboard. Other methods of measuring heart rate output can be used, such as ultrasound, chest impedance or CO2 partial pressure breathing.

One of ordinary skill in the art will further appreciate that the oxygenation constant is a number primarily related to the physical properties of the oxygen carrier or the physiological properties of the patient. Such oxygenation constants include, but are not limited to, blood volume, oxygen solubility in plasma, oxygen content of desired units of saturated oxyhemoglobin. Preferably, in the present invention one or more oxygenation constants are used to obtain the selected oxygenation parameters. The present invention provides that the values obtained using oxygenation constants (CaO ₂ , VO ₂ and CO 2 ) From the patient's mixed venous oxygen content (CvO ₂ ), Fick's formula VO2 = (CaO ₂ · CvO ₂ ) ×
Solve CO. Once CvO ₂ is determined, SvO ₂ can be calculated and the Kelman equation (Kelm
an, J.Appl.Physiol, 1966, 21 (4): 1375-1376; described here as a prior example) using an algorithm for calculating the position of the oxyhemoglobin dissociation curve.
You can easily pull out PvO ₂ . Similarly, it is possible to draw from the DO _2, DDO ₂ and DDO ₂ / VO ₂ is also obtained value other parameters such as.

The anesthesiologist can continuously obtain real-time data (ie, the oxygenation parameters discussed above) using the methods disclosed herein, revealing a complete picture of the patient's overall oxygenation status. . If any of the selected parameters reach the established trigger point, take sufficient time to stabilize the target,
Appropriate measures can be taken, such as pharmacological intervention, fluid administration, blood transfusion, and adjustment of the ventilation profile. Thus, this continuous stream of data makes it easier for physicians to determine the etiology of hypoxia (including but not limited to anemia, reduced cardiac output, hypoxia) and adapt its response appropriately. It is possible.

In the aspect of the present invention, a high-risk environment (medical treatment, etc.) for reducing human error is provided.
Is focused on graphically displaying data to the user. In particular, the system and display of the present invention helps map the operator's cognitive needs to the graphical elements of the display. Thus, in a particular aspect, the present invention mimics the physiology of the body so that the display data better represent patient data and physical function.

In one aspect, the present invention utilizes task analysis methodologies to transform data into information and display physiological data of oxygen delivery. Doctor is information (not raw data)
Can interpret this data to diagnose pathological conditions and take appropriate corrective action, which is less error prone than the interpretation of data obtained by other systems. In one particular aspect, the invention produces an object display that provides a set of information from one or more sensors that collect data from a patient. These object displays may, for example, (1) relate data to other data, (2) data in context, (3) reference frame of data, (4) rate of information change to data, and / or (5 ) Indicates event information. The system constructed in accordance with the present invention is thus particularly useful in presenting physicians with oxygen-transporting physiology.

In another aspect of the invention, the system comprises data acquisition hardware (eg,
Patient probe), computer, object display algorithms and software. In one preferred aspect, the software and algorithms compose a set of object displays that represent the physiology of oxygen delivery using digital representations of analog data channels (eg, those obtained from patient monitoring signals or probes). However, it should be noted that aspects of the invention relating to an intuitive medical process diagram do not require special monitoring equipment. Any known patient monitoring device can be used for data collection for display as an intuitive medical process diagram.

The present invention offers several advantages over the prior art. As an example, the data display of the present invention maps patient information to a meaningful mental model. Therefore, physicians using such mental models can better understand complex physiology, such as oxygen transport physiology. In one aspect, mental models use analogical forms to describe complex processes. Thus, a suitable model of the physiology of oxygen delivery of the present invention is (1) filling the lungs with fuel in the form of oxygen, (2) pumping oxygenated blood from the heart to organs and tissues, (3). It involves delivering oxygen from red blood cells to the tissue, and (4) oxygen and oxygen utilization by the tissue.

By analogy, this model is used to (1) load fuel in the form of coal on a covered wagon in a coal storage area, and (2) transport a fueled covered wagon to a furnace some distance away by a locomotive, This can be contrasted with (3) dropping coal from a covered wagon into a furnace, and (4) burning coal in the furnace. In this analogy, the coal yard represents an oxygen-inflated lung. Boxed wagons represent red blood cells filled with oxygen. A locomotive represents the heart that pumps oxygen-carrying red blood cells around a circulation path between the lungs and tissues. The percentage of each boxcar coal dropped in the furnace represents the fractional extraction of oxygen by cells within the tissue. Finally, the burning coal in the furnace represents the utilization of oxygen by cells and tissues.

As mentioned above, the present invention is compatible with many different types of medical devices. Similarly, aspects of the invention can be used in several settings. First, the system can be used with sensor sets driving data displays from different manufacturers. For the object display, the display can be used partially or wholly. For example, examples of medical areas that monitor all or part of the physiology of oxygen delivery include intensive care units, operating rooms, emergency rooms and all treatment rooms. The display system of the present invention can also be used to provide medical teams with information regarding the physiology of oxygen delivery while a patient is undergoing cardiopulmonary bypass. The system can also be attached to medical simulation devices such as surgical dummies for the education and training of persons involved in oxygen transport physiology.

The software of the present invention may be installed on medical devices currently used for data acquisition, especially those used in connection with oxygen transport physiology or cardiac mechanics. The present invention can also be used to monitor oxygen delivery physiology in veterinary medicine or in animal laboratories.

In one aspect, the invention can be a module that interacts with displays of other physiology, such as respiratory physiology. It can also be used to implement research protocols and better perform complex control tasks. Further uses may also include interfaces for large dataset analysis of oxygen transport information.

One embodiment of the present invention is a method of displaying physiological data from a patient. In this example, data from a patient's organ is measured via a probe or other device. The measured data is then used to determine a physiological quantity of data such as the patient's blood oxygenation level and cardiomechanical values. The physiological quantity is displayed as an object, and the shape of the displayed object reflects the structure of the organ.

Another embodiment of the invention is a method of displaying a patient's physiological data.
In this example, the patient's blood oxygenation level is first measured by conventional means. A circular shape is displayed and shaded to represent the percentage of oxygenated patient blood.

Another aspect of the present invention is a method of displaying physiological data obtained from a patient, wherein the blood oxygenation level of the patient is first measured by a conventional method, and a plurality of shapes are monitored. Each of the plurality of shapes represents a structure of an organ in the human body.

A further embodiment of the invention is a method of displaying physiological data from a patient, using an analog gauge such as a dial or needle to represent the physiological data.

Another aspect of the invention is a display system that represents physiological data from a patient. The display system includes a set of display objects,
Each object represents a different but relevant measurement taken from the patient. The integrated display is formed by a set of four objects. The first object represents the patient's heartbeat output, the second object represents the patient's arterial oxygenation level, the third object represents the patient's venous oxygenation level, and the fourth object represents the patient's arteries, capillaries and veins. Shows the tension of.

The present invention will now be further described with reference to preferred embodiments, but it will be apparent that one skilled in the art can make various additions, deletions and modifications without departing from the scope of the present invention. Will be.

BEST MODE FOR CARRYING OUT THE INVENTION The present invention relates to a method and system for obtaining medical information from a patient and displaying the information in an intuitive format to a physician. This intuitive format can be referred to as a medical process diagram because the physician reading the displayed information can quickly perceive the importance of changing values for the patient. Medical process diagrams have been developed by others in the non-anesthesia field to take advantage of advances in research on cognition.

Studies in Applied Human Factors focus on the use of graphic displays in high-risk environments similar to high-risk environments such as operating rooms (eg, nuclear control rooms and flight decks) to reduce human error. Have been adjusted. The success of the medical process diagram is believed to be a function of how well the semantics of the operator's cognitive needs are mapped to the graphic elements of the display. Explains how physicians interpret oxygen transport physiological data to diagnose pathological conditions and then take appropriate coordinative measures for patients using accepted task analysis methods A system was developed.
Efforts to create the large amount of data that physicians need to interpret have led to the development of a more informative set of object displays.

A set of display objects are: 1) the association of data with other data, 2
) Developed to illustrate data in context, 3) frames of reference for data, 4) rate of information change to data, and 5) information about events. Specifically, the system was developed to present physicians with the physiology of oxygen delivery. The system uses data acquisition hardware, a computer, oxygen transport calculation software and object display software. In one embodiment, the object display software uses the data provided by the oxygen delivery calculation software to build a set of four objects representing the physiology of oxygen delivery, as described in detail below.

Unfortunately, current display systems that present physicians with physiological data in critical care require a great deal of cognitive work on the physician to interpret that data. In contrast, the display system described below utilizes visual memory cues and perceptual diagrams to graphically map complex data. These data maps are then displayed to match the mental model used by physicians to interpret the physiology of oxygen delivery. The patient data is used to drive the display in real time, as the system receives an analog signal from the patient and then calculates some physiological quantities.

As noted above, the present invention can be used in conjunction with various medical devices such as ventilators, anesthesia machines, partial or total fluid ventilation systems, cardiac mechanics monitors and heart-lung machines. . More generally, the present invention can be used in conjunction with computerized laboratory information systems found in operating rooms and intensive care units.
In the preferred embodiment, there are one or two displayed parameters or values.
Obtained by one or more devices and transmitted to a centralized display (ie video monitor). In another embodiment, the device operates as a stand-alone system with a self-contained display. Either way, it is preferable that the operator be able to manipulate the display parameters to optimize the presentation of the desired data. It will be appreciated that the operator can adjust the appropriate device based on the displayed data.

With respect to the ventilator, the display is compatible with some systems currently in use. Either a volume-based timed ventilator or a pressure-based timed ventilator is appropriate. As alluded to above, conventional ventilators such as these can be used in conjunction with the present invention and traditional gas or partial liquid ventilators. Similarly, the present invention can be used with various commercially available cardiopulmonary bypass devices or blood oxygen and hemoglobin monitoring devices (ie, lung catheters, EKG). In another preferred embodiment, the display of the present invention is powered by a commercially available integrated anesthetic delivery and monitoring device. In yet another embodiment, it can be used in conjunction with a closed circuit liquid ventilation system, such as the system described in WO 97/19719 described herein as a prior example. Regardless of the type of medical system selected, one of ordinary skill in the art will appreciate that the present invention enables an intuitive display of relevant parameters. As evidenced by the above, the display of the present invention is compatible with several types of medical devices. However, for purposes of explanation, the discussion below considers the display of oxygenation parameters in conjunction with a novel real-time oxygenation analyzer. It is to be understood that in the following description of the invention relating to the invention, other modifications are conceivable within the scope of the invention, since only exemplary embodiments are disclosed. Therefore, the present invention is not limited to the particular embodiments described in detail below.

I. Hardware System FIG. 1 illustrates a system 10 constructed in accordance with an embodiment of the present invention directed to measuring oxygenation parameters. The set of probes 12 is, for example, a heart rate probe 12a, which is connected to various monitoring activities associated with the patient 14. These probes are well known and generally generate an analog signal 16 representative of monitor activity. The signal 16 is converted through a well-known A / D device 18 of the data conversion module 20 to generate a digital signal corresponding to the analog signal 16. This data is available on the data bus 22.

The processing module 24 not only produces usable quantitative measurements of patient activity, but also associates specific data with a display of interest, eg (1) other data; (2) data in context. On the bus 22 for sending out and comparing (3) associating the data with a reference frame; (4) measuring the conversion rate of the information in the data; and / or (5) presenting the event information. Process the data.

One embodiment of module 24 thus includes a plurality of data processing sections 26 that analyze and / or quantify the data input from probe 12. For example, one section 26a is connected to the probe 12a in a data chain and processes data on bus 22 to provide an indication of heart rate in the form of digital words. As the patient's heart rate changes, the digital word changes. The memory module 28 is used to store selection data, such as a digital word corresponding to heart rate activity, so that the module 24 contains a record of the patient's heart rate and current values. The memory 28 also stores information such as the nominal value of the data that compares the data to a reference window and the extreme value that represents the desired patient threshold. The display driver section 30 is connected to the section 26 and thus directs the display of heart rate data in the context of the display on the display 32 and / or causes the data in memory 28 to be relative to the reference frame. .

The data from section 26 can also be compared to other data within the evaluation module 34 or associated with recorded thresholds. As an example, the data corresponding to the probe 12a is transmitted through the process of the digital section in the module 34 to the probe.
Can be compared against 12b. The driver 30 can then command this related data to be displayed on the display 32. As another example, the evaluation module 34 can compare other data with the data stored in the memory 28; and, if the comparison exceeds a set threshold, display a warning event on the display 32. You can

Those skilled in the relevant art should recognize that certain probes 12 may have self-contained A / D conversion capabilities and data manipulation. Moreover, such a probe can be easily connected directly to the evaluation module 34 and the memory 28 by known techniques.

The system 10 is controlled by input at a user interface 36, such as a keyboard, and the display driver 30 formats the data on the display 32 into various destination formats 40. Thus, by directing a selected process within the evaluation module 34-like comparison of other data with particular data-such data is automatically displayed on the display 32 in the desired destination format. . The special purpose format according to the present invention is as described below. Preferably, these target formats are preferably displayed simultaneously on the same display to give the operator a comprehensive data profile.

FIG. 2 is a representative computer system that may be used with the system 10 of FIG.
Shows 155. The system 155 can operate as a stand-alone configuration or as part of a network of computer systems. System 155 is an integrated system that collects data from the patient and displays the processed data on a display for viewing by a physician.

The computer system 155 may be a computer 160, such as Microsoft
Includes blood-monitoring software implemented in conjunction with an operating system such as Windows 95 available from Corporation. Other embodiments may use different operating environments and / or different computers.

In another embodiment of the invention, computer 160 is a wide area network (WAN).
) Through the connection, it is possible to connect to other doctors or hospitals. A WAN connection to other healthcare facilities allows for real-time review of the patient's course during surgery or in the intensive care unit.

Referring again to FIG. 2, one embodiment of computer 160 includes an Intel Pentium or similar microprocessor operated at 300 MHz and 32 megabytes (Mb) of RAM memory (not shown). System 155 includes storage device 165, such as a hard disk drive connected to processor 170. The hard drive 165 is an option in a network configuration, that is, the workstation uses a hard disk or other storage device with the file server. If computer 160 is used in a stand-alone configuration, hard drive 165 is preferably 100 Mb or greater. However, the system is not limited to a particular type of computing device. Any computer equipment capable of operating the display system described herein is expected to function within the scope of the present invention.

Computer 160 is integrated with computer peripherals and is connected to a VGA (Video Graphic Array) display standard, or better, a color video monitor that provides the display output of system 155. The display 175 may be a 17 inch monitor operated at 1024 x 768 pixels with 65,536 colors.
A keyboard 180 compatible with an IBM AT type computer may be connected to the computer 160. A pointing device 185, such as a two or three button mouse, may also be connected to the computer 160. The use of mouse is not meant to exclude the use of another type of pointing device.

Printer 190 is connected to provide a way to produce hardcopy output, such as a printout for file recording. In one configuration, Colorado Memory
A backup device 195, preferably a Jumbo 250 Mb cartridge tape backup unit available from System, is preferably connected to the computer 160.

In another embodiment, as one of the stand-alone or networked workstations, the system 155 may be a laptop or notebook computer, such as the Premium Executive 386SX / 20, available from AST Research, or various. It may also include a portable computer, such as other computers available from commercial vendors. A computer 160 for a portable computer (not shown)
Are equipped with components similar to those described in connection with.

It will be appreciated by those skilled in the art that a programmed computer may also be implemented with full or partial custom circuitry. therefore,
The set of instruments selected should not be considered as limiting in any way.

II. Software Many different ways of implementing the software of the present invention will be appreciated by those skilled in the art. For example, programming languages such as Labview, C ++, Basic, Cobol, Fortran or Modula-2 can be used to combine the features of the present invention into a single software package. Another way to describe the software of the present invention is to use a spreadsheet program to collect and measure patient PvO _{2 in} real time. This method is described in detail below.

A. Blood Gas Level Measurements As noted above, the systems and methods of the present invention collect data from a patient and measure various tissue oxygenation parameters of the patient in real time. Software is used to direct this process. Those of ordinary skill in the art will appreciate that the desired parameters can be obtained and displayed using various software structures written in any one of a number of languages. FIG. 3 illustrates a software scheme that can be used with the disclosed method and system.

As shown in FIG. 3, when a start signal is sent to the system by the user in the start state 200, the process is started. The start signal can be a keystroke of a mouse command that activates the software to start collecting data. After receiving the start command in state 200, the arterial pressure data is in state 202
Collected from patients at. Arterial pressure data can be collected by connecting the patient to an arterial pressure monitor, as is well known.

Once the data is collected from the patient in state 202, “in range data”
Is determined in the determination state 204. At this stage, the software compares the data collected in state 202 to a known and suitable range of arterial pressure values. A suitable range for arterial pressure data is, for example, between 70/40 and 250/140.

If the data collected at process state 200 is not within the range programmed at decision state 204, or if the arterial pressure wave is abnormal, then an error / exception process routine is started at state 206. It The error process routine at state 206 loops the software back to process state 202 to recollect arterial pressure data. In this way erroneous arterial data readings are not passed on to the rest of the program. If the data collected at process state 202 is in the proper range at decision state 204, the software pointer moves to process state 208, which contains instructions for collecting arterial pressure. Preferably, the data collected includes patient temperature, arterial blood pH, hemoglobin levels, PaO ₂ and PaCO ₂ . Further, the data is preferably generated by an adjunct blood chemistry monitor that can provide information on the patient's blood gas levels, acid-base status and hematology status. In such an embodiment, data is collected in a computer by receiving a stream of data via a series connection from a blood chemistry monitor. Alternatively, the relevant value can be obtained from the access data manually entered from the keyboard.

As mentioned above, the blood chemistry monitor preferably continuously samples arterial blood from the patient and measures some characteristics of the patient's blood from each sample. The data corresponding to each characteristic collected from the blood chemistry monitor at process state 208 is checked at decision state 210 for in-range. A suitable range of pH is 7.15 to 7.65
Is. A suitable range of hemoglobin levels is 0 to 16 g / dl. A suitable range for PCO ₂ is 15 mmHg to 75 mmHg, while a suitable range for PaO ₂ is 50 mmHg to 650 mmHg.
It is g.

If at decision state 210 the data is not within the proper range for each particular variable, then at state 212 an error / exception process routine is initiated. The error / exception process routine at state 212 individually analyzes the variables collected at state 208 to determine if they are within range. If the selection variables collected in state 208 are not in the proper range, error / exception process routine 212 loops the software pointer back to state 208 so that the correct data is collected. If the selection data in decision box 210 is within range, the software obtains the CaO ₂ value along with the cardiac output (CO) from the first arterial pressure data previously obtained in state 214.

As mentioned above, cardiac output can also be obtained from arterial pressure measurements by several methods. For example, TNO Biochemical's Model flow system can obtain a heartbeat output in real time from an arterial pressure signal. The other methods described above are also used in process step 214 of measuring heart rate output. Once the cardiac output value is measured in process step 214, the patient's total oxygen delivery (DO ₂ ) is obtained in process step 215. As mentioned above, the patient's total oxygen delivery is the product of heart rate output and arterial oxygen content. This parameter is optionally displayed and can terminate the program when the software receives a stop command, as indicated by the decision state 217. However, at decision state 217, if the software does not receive keyboard or mouse input to stop data collection, the pointer directs the program to process state 216 for further parameters. In particular, process state 216 is associated with measuring or inputting VO ₂ for a patient.

Patient VO ₂ is measured by attaching a suitable ventilator to the patient or measuring oxygen uptake through a system such as the Physioflex described above or Sensormedi.
It can be calculated using numerous other devices, such as the system manufactured by cs and Puritan Bennett. By measuring oxygen inspiration and expiration, the ventilator can also be used to calculate the total amount of oxygen absorbed by the patient.
After the patient's VO ₂ value is measured in process step 216, these variables are
Apply to Fick's formula to get real-time CVO ₂ . Fick's formula is given above.

Once CvO ₂ is known, mixed venous oxyhemoglobin saturation (SvO ₂ ) and mixed venous oxygen tension (PvO ₂ ) are obtained at state 220. As explained above, the mixed venous blood pH and PCO ₂ values were used to define the location of the oxyhemoglobin dissociation curve in Kelma.
It is assumed to have constants (but variable) associated with arterial blood pH and PaCO ₂ , respectively, which are used in conjunction with other variables in the n equation. Alternatively, an algorithm is available to calculate these values. Knowing the Hb concentration gives PvO ₂ and then a total CvO ₂ (including contributions from Hb, plasma and PFC) equal to CvO ₂ determined by Fick's equation. If the CvO ₂ value “does not fit” Fick's formula, then another Pv
Select the O ₂ value. This process is repeated until Fick's equation is balanced and the true PvO ₂ is known.

Those skilled in the art will recognize that the same formulas and algorithms can be used to obtain and optionally display mixed venous blood oxyhemoglobin saturation SvO ₂ . That is, SvO ₂ is closely related to PvO ₂ and can be easily obtained from the oxygen-hemoglobin dissociation curve using conventional techniques. It is further appreciated that SvO ₂ as well as PvO ₂ can be used to monitor patient oxygenation status and as an intervention trigger, if desired by the clinician. right. As mentioned above, the mixed venous blood oxyhemoglobin saturation can be used alone in this volume or, more preferably, in combination with other derived parameters.

After obtaining a value for PvO ₂ , SvO ₂ or both, that value or both values are set in step 22
2 can be displayed on the computer. If the software does not receive a keyboard or mouse input to stop data collection at state 224, the pointer loops the program back to process state 202 and begins collecting arterial pressure data again. The method continues the real-time data loop so that the patient's mixed venous oxygen tension (PvO ₂ ) or saturation (SvO ₂ ) is periodically updated in state 222 and displayed on the computer. If the software receives a stop command from keyboard or mouse input in decision state 224, then the termination routine 228 is initiated.

B. Oxygen Delivery Value Calculations The following system collects information from patients and displays a large Microsoft EXCEL® spread to display the desired parameters including PvO ₂ , SvO ₂ , and DO _2. I am using a sheet. A number of oxygenation constants are entered into the system prior to receiving real-time input of cardiovascular and oxygenation variables. These constants preferably include the patient's estimated blood volume, oxygen solubility in plasma and oxygen content in 1 g of saturated oxyhemoglobin. The oxygenation constant is then stored in computer memory and used for later calculations.

Table 1 collects patient data and also obtains values for desired oxygenation parameters from Microso
ft EXCEL® Shows commands from a portion of the spreadsheet. The program is initialized by assigning names to various oxygenation constants used throughout the software. In the examples shown here, blood volume (BV), oxygen solubility of perfluorocarbon emulsion (O2SOL), specific gravity of any perfluorocarbon emulsion (SGPFOB), intravascular half-life (HL) in perfluorocarbon emulsion, perfluorocarbon Emulsion weight / volume (CONC),
The oxygenation constants corresponding to barometric pressure (BARO) at sea level, ml oxygen / g hemoglobin g (HbO), and ml oxygen / 100 ml plasma / 100 mm mercury (PIO) are all entered. When a perfluorocarbon blood substitute is administered to the patient, the perfluorocarbon related constants are entered.

An example of starting values for a Kelman constant for a subset of oxygenation constants is also shown in Table 1. These starting values are used in subsequent calculations to obtain the patient's mixed venous oxygenation status or other desired parameter such as mixed venous blood oxyhemoglobin saturation. The Kelman constants, like the other oxygenation constants, are also assigned names as shown in Table 1.

[0082]

[Table 1]                                 table 1 ┌──────────────────────┬───────────┐ │Assumption                                        │Starting value:      │ │ ├───────────┤ │Blood volume (ml / kg) ・ BV │70 │ │ O in PFB₂Solubility (ml / dl @ 37 ℃) −O2SOL │52.7 │ │ Specific gravity of PFDB − SGPFOB │ 1.92 │ │Intravascular half-life (hours) of Oxygent HT −HL │ = 1/2 life of Oxygent │PFOB emulsion weight / volume / 100-CONC │0.6 │ │ Barometric pressure @ Sea level − BARO │ 760 │ │ ml O₂Per g saturated Hb-HbO │1.34 │ │ ml O₂Every 100 ml Plasma 100 mm Hg Saturated Hb-HlO │ 0.3 │ ├──────────────────────┼───────────┤ │ ├───────────┤ └──────────────────────┴───────────┘ KELMAN constant:                                 Starting value:                                               ┌───────────┐  Ka1 │ = -8.5322289 * 1000 │  Ka2 │ = 2.121401 * 1000 │  Ka3 │ = -6.7073989 * 10 │  Ka4 │ = 9.3596087 * 100000 │  Ka5 │ = -3.1346258 * 10000 │  Ka6 │ = 2.3961674 * 1000 │  Ka7 │-67.104406 │                                               └───────────┘   After the oxygenation constants, including Kelman's constant, assign a name, arterial pressure line and blood
The real-time input from the liquid chemistry monitor is initialized and begins supplying data. Table 2
The system described in this example, as shown in FIG.
Sum percentage (SaO₂) Induces or receives data related to Special
In addition, the saturation percentage is the oxygen tension (PaO₂), PH (pHa), carbon dioxide tension (PaCO ₂ ), And body temperature (TEMP) arterial blood data. The invention, if desired by the clinician
SvO for use in monitoring tissue oxygenation status in patients.₂Value (calculated Pv
O₂, PHv, PvCO₂And a real-time display of values obtained from body temperature). The above
Street, PvCO₂The values of pH and pHv are determined by the algorithm, respectively, by a fixed amount.
PaCO₂And is related to the value of pHa. Heart rate output (CO) is also VO₂Entered to be
Be done. FIG. 4 provides a schematic representation of this procedure and the resulting data.

Once Hb concentration, arterial blood gas and acid / base parameters were entered into the program (
It is possible to measure the O ₂ supply and consumption variables of both Hb-containing red blood cells and the plasma phase (automatically or manually). It is also possible to measure variables related to PFC (in the case of blood substitutes) or related to Hb-based oxygen carriers.

[0084]   Again referring to Figure 4, CaO₂Useful values for calculating Hb concentration, arterial oxygen tension (PaO ₂ ), Arterial blood carbon dioxide tension (PaCO₂), Arterial blood pH (pHa) and body temperature. oxygen
-The position of the hemoglobin dissociation curve is the Ke entered in the program as the oxygenation constant.
It is calculated using the lman formula. These calculations are described here as a precedent
Comprehensive Severinghaus (J. Appl. Physiol. 1966, 21: 11088-1116)
Indistinguishable from the proposed parent curve, O₂Produces a curve that spans the physiological range of tension
. As shown in the schematic diagram in Fig. 4, Hb, plasma, and fluorocarbon must meet Fick's equation.
PvO, resulting in the required mixed venous oxygen content in Bonn₂ (SvO₂Through
Iterative methods can be used to calculate).

[0085]

[Table 2]

[0086]

[Table 3]

[0087]

[Table 4] Based on the numbers supplied, the program can
Calculate oxygenation parameters like vO ₂ and SvO ₂ . These values are then fed into the display system described below to generate the perceptual diagram. These diagrams are used by physicians, for example, to determine when to transfuse a patient or to change clinical management of a patient. The displayed values can also be used to monitor the physiological effects of blood transfusions that deliver hemoglobin or perfluorinated chemicals.

Tables 3 and 4 are additional information demonstrating the utility and applicability provided by the present invention. In particular, Table 3 provides various oxygenation values calculated using the methods disclosed herein and Table 4 provides indicators of oxygen consumption and oxygen delivery that are useful in optimal patient treatment.

A closer examination of Table 3 shows that the system of the present invention can be used to provide the individual oxygen content of different components in a mixed oxygen delivery system. In particular, Table 3 provides calculations to give the oxygen content of arterial blood or venous blood which calculates hemoglobin, plasma and fluorinated drugs respectively. Such values may be particularly useful when intravenously transfusing a fluorinated drug emulsion blood substitute associated with a surgical procedure.

Table 4 illustrates that the present invention may be used to provide real-time information on oxygen consumption and delivery. As mentioned above, Hb or Hct measurements are
Not a proper reflection of tissue oxygenation. This is the total oxygen delivery to the tissues used (
It does not provide information on DO ₂ ) but only indicates the potential arterial O ₂ content (CaO ₂ ). However, as shown in Table 4, the present invention solves this problem by providing oxygen delivery information online based on CaO ₂ and cardiac output (CO).

Currently, heart rate output is calculated using thermodilution and CaO ₂ is calculated by calculating arterial blood oxyhemoglobin saturation (SaO ₂ ) and hemoglobin levels and inserting these values into the following equation: ing. : CaO ₂ = ([Hb] × 1.34 × SaO ₂ ) + (PaO ₂ × 0.003),
Here, [Hb] = hemoglobin concentration (g / dl unit); 1.34 = 1 g of fully saturated hemoglobin
Oxygen delivery in the medium; PaO ₂ = arterial pressure; and 0.003 is the oxygen delivery by plasma (per deciliter per oxygen pressure mmHg).

The present invention combines the continuous heart rate output algorithm with the Kelman equation that gives the position of the oxygen hemoglobin dissociation curve. With on-line and off-line inputs of body temperature, hemoglobin and venous blood gas, the present invention can trend DO ₂ on a continuous basis. The factors used to measure DO ₂ are displayed along with their product; thus, the etiology of decreased DO ₂ (insufficient cardiac output, anemia, or hypoxia) is It is readily apparent, the decision on the appropriate intervention can be made quickly, and the outcome of the procedure is clear and easy to follow.

More specifically, the preferred embodiment of the invention provides for real-time DO ₂ , arterial blood gas,
Using to provide and display hemoglobin concentration and CO (also other hemodynamic data already discussed such as BP, heart rate, systemic vascular resistance, velocity pressure product and heart work) You can As shown in Table 3, this example also shows that Hb
, Can give individual readouts of the contribution of plasma and PFC (if in circulation) to DO ₂ . That is, the oxygen contribution of each component can be accurately monitored and adjusted throughout some therapeutic diet. Such data would be particularly useful in both OR and ICU to provide a safe cushion for patient oxygenation.

The importance of maximizing DO ₂ for a particular patient in the ICU has been highlighted by recent studies. The present invention can also be used to determine when such interventions are indicated and provide the necessary data to achieve the desired outcome. Once DO ₂ is known, the maximum O ₂ consumption (VO ₂ ) that can be the basis for a particular (and also arterial blood) PvO ₂ can be calculated. As mentioned above, this value can be referred to as the deliverable oxygen amount (dDO ₂ ). For example, 36 mmHg of PvO ₂ is selected for a healthy 25-year-old patient, but 42 mmHg or More PvO ₂ will be needed. Oxygen consumption varies under anesthesia, but in most cases it is in the range of 1.5 to 2.5 ml / kg / min. If the VO ₂ sustainable in the chosen PvO ₂ was well above this range, then everything would be healthy and no intervention would be needed. The more deliverable VO ₂ approaches to a range of normal VO _2, intervention is more quickly taken into account.

This relationship is used to give a single value based on deliverable oxygen (dDO ₂ ) versus oxygen consumption (VO ₂ ). As mentioned above, dDO ₂ is the amount of oxygen delivered to the tissue, which can be delivered before the venous oxygen partial pressure (PvO ₂ ) and the tissue oxygenation tension drops below a defined level. Thus, the PvO ₂ value is 40 (this number is
DO ₂ (and dDO ₂ ) should be kept at sufficient levels if desired not to drop below (depending on the general medical condition of the patient).

The supply / demand ratio (dDO ₂ / VO ₂ ) for the selected PvO ₂ has only one value indicating that the amount of oxygen applied is sufficient to maintain the desired oxygenation state. Can be used to give. For example, the dD required to hold 40 PvO ₂
Assuming that O ₂ is 300 ml / min and the actual measurement (VO ₂ ) is 200 ml / min, it can be seen that the patient is supplied with sufficient oxygen required. That is, the supply / demand ratio is 300 ml / min / 200 ml / min or 1.5. A supply / demand ratio of 1 means that PvO ₂ (or other particular parameter, eg SvO ₂ ) is at the selected trigger value (here 40 mmHg). Conversely, when dDO ₂ (deliverable oxygen amount) is 200 ml / min and VO ₂ (oxygen consumption amount) is 300 ml / min, the ratio is 0.66, and the patient cannot obtain sufficient oxygen ( That is, PvO ₂ is 40 or less). By continuously monitoring and displaying this ratio, the clinician will be able to observe values approaching 1 and intervene appropriately.

III. Display of Objects for Physiological Numerical Values As mentioned above, the computer system 155 of FIG. 2 includes software and system for displaying a medical process diagram for the calculated values.

The display system collects oxygen delivery values and creates a display object that is presented to the physician. Some data are derived from reading raw analog or digital data from the patient's monitor, but many numbers can be read from the calculated data, as shown in Tables 1-4.

The system samples the data 200 times per second and updates the display every 2 seconds. However, the system allows for faster sampling and display updates to present the doctor with the latest data.

As mentioned above, the perceptual diagram constitutes a series of data objects that represent the physiological processes of the body. Examples of these data objects include red blood cell objects, heart pump objects, vascular resistance objects, alveolar-arterial blood objects, acid-base objects, and metabolic objects. These objects are displayed alone or together to provide a physiological diagram of the patient's oxygen delivery system, as described below.

C. Red Blood Cell Object This graphical display object contains information on the amount of red blood cells (as hemoglobin), the oxygen loading of red blood cells (as percent oxygen saturation), and the oxygen content (using the accepted formula). The size of the circle correlates with hemoglobin. The black circles from the bottom correlate with oxygen saturation. The product of hemoglobin and oxygen saturation correlates with the oxygen content (CaO ₂ ) pointer on the left. Specifically, in FIG. 5, the red blood cell object 300 displays information regarding the amount of hemoglobin in the patient's blood, the amount of oxygen loaded on the red blood cells, the temperature effect of blood viscosity, and the oxygen content of blood. In some circumstances, this relationship is defined by the following formula: arterial oxygen content = (arterial oxygen saturation) × (hemoglobin) × 1.
34. In FIG. 5, the arterial blood saturation is classified as “SaO ₂ ” and the hemoglobin is “HB”.
", And the arterial oxygen content is classified as" CaO _2. "

These red blood cell related values are then converted into a set of non-concentric circle sets 310a, 310b in a perceptual diagram (eg, computer display 32 of FIG. 1). As shown in FIG. 5, there are arterial blood portion 314 and venous blood portion 316 of red blood cell object 300. In arterial part 314, the patient's CaO ₂ value is indicated by diamond 320, Y
Maps to the axis. The patient's hemoglobin level, the volume percentage of red blood cells in whole blood, is mapped on the X-axis. In the venous section 316, the patient's CvO ₂ is indicated by the diamond 330 and is mapped to the Y axis. Hemoglobin levels are mapped on the X axis.

The non-coaxial circles 310a, b are made using the Y-axis to define the tangents along the left end points 340a, b of the relative coaxial circles 310a, b. Each non-coaxial circle has a similar left end point 340a along the Y axis.
, B are included.

As the level of arterial blood oxygen increases, the CaO ₂ diamond 320 moves upward along the Y axis. The horizontal oxygen extraction line 350 defines the upper boundary of the shaded area 360 formed on the arterial red blood cell type object 310a and indicates the level of arterial oxygenation. Red blood cell type objects 310a, b, as illustrated in FIG. 5 which illustrates the percentage of patients' red blood cells filled with oxygen (eg, half shaded, cells are half filled with oxygen). Can be partially or totally shaded. As the patient's hemoglobin (Hb) level increases, the shadows also increase with respect to the circumference of the red blood cell type objects 310a, b.

Similarly, for the venous blood red blood cell type object 310b, the CvO ₂ diamonds 330 move up and down along the Y axis as the venous oxygenation level in the patient rises and falls. When the CvO ₂ rhombus 330 moves upward and downward, the amount of the shaded area 370 changes within the formation of the venous blood red blood cell type object 310b. Thus, venous oxygenation of the annulus of the blood vessel is quickly shown to the physician. Relatively shaded areas 360 (arterial blood side) and 362 (
The venous blood side) reveals a rapid perceptual understanding of oxygen extraction when the oxygen content of arterial blood and venous blood are compared. As is well known, oxygen extraction = (arterial blood oxygen content) · (venous blood oxygen content). Thus, by comparing the opposing shaded areas of the red blood cells that form the red blood cell type object 310a and 310b, the physician can perceptually understand the patient's oxygen extraction.

The oxygen extraction line 350 extends from the arterial blood cell 310a to the oxygen extraction slide scale 364. The oxygen extraction slide scale 364 holds the CvO ₂ diamond 330 at the lower border. As the CaO ₂ level increases, the oxygen extraction slide scale 364 increases. Similarly, as the level of CvO ₂ falls, the oxygen extraction slide scale 364 also rises. This makes sense, as it is expected that the oxygen extraction will increase due to increased arterial oxygen tension or decreased venous oxygen tension. The physician may therefore refer to the Oxygen Extraction Slide Scale 364 to quickly measure oxygen extraction on behalf of the patient. The method by which the red blood cell object 300 mimics the actual in-vivo action of red blood cells makes the red blood cell object 300 extremely intuitive for a physician.

In FIG. 6, the process 370 of updating the red blood cell object 300 begins at 372.
Begins with. The process 370 then transitions to a state 374 where the patient's CaO ₂ value is read. As mentioned above, this value can be read from some form of data table or memory storage of the computer system. When the CaO ₂ value is read in state 374, process 370 determines if the CaO ₂ value has changed from the last sampling,
Go to decision state 376 to make a decision. When the CaO ₂ value is changing, process 370 determines whether the CaO ₂ value is increasing or decreasing to determine state 378.
Move to. When the CaO ₂ value is increasing, the CaO ₂ indicator 320 and the oxygen extraction line 350 move vertically up along the Y axis in state 382. However, when the CaO ₂ value is decreasing, the process 370 causes the CaO ₂ indicator 320 and the oxygen extraction line 35.
0 transitions to state 380, which is a downward movement along the Y axis in state 382. Process 370 then transitions to state 384, which reads the CvO ₂ value.

Next, it is determined whether or not the CvO ₂ value has changed since the last data sampling.
Judge with 6. If the value has changed, process 370 transitions to decision state 387 to determine if the CvO ₂ value is increasing or decreasing. If it is determined that the CvO ₂ value is increasing, the process 370 transitions to a state 390 where the CvO ₂ indicator 330 moves upward along the Y axis. Similarly, if the determination is at decision state 387 that the CvO ₂ value is decreasing, then process 370 transitions to state 389 where CvO ₂ indicator 330 transitions downward along the Y axis. Process 370 then transitions to state 391 where the patient's hemoglobin value is read.

Process 370 then transitions to decision state 392 to determine if the hemoglobin value has changed from the last sampling. If it is determined that the hemoglobin level is changing, the process 370 transitions to a decision state 394, which determines if the hemoglobin value has increased or decreased. If the hemoglobin level is increasing, the process 370 transitions to state 397 where the shaded area 360 increases in size to indicate a large amount of red blood cells in the patient's blood. However, if the decision state 394 is a decision that the hemoglobin level is decreasing, then the process 370 transitions to the state 395 where the shaded areas 360-362 are circumferentially reduced. The process 370 ends at end 399.

Cardiac Pump Object A graphical display object contains information about blood flow (as a cardiac output), pulse rate (generated from an arterial blood transducer), and stroke volume (using an acceptable equation). The resulting rectangle (defined by pulse rate and stroke volume) is filled black during diastole of the cardiac cycle. During systole of the cardiac cycle, the rectangle empties from top to bottom at a rate determined by its correlation with myocardial contractility (such as dP / dt).

In particular, in FIG. 7, the heart pump object 400 shows the following relationship: Heart rate output = (stroke volume) × (heart rate). In one situation, the heart pump object 400 is shown as a rectangle 410, the extent of the rectangle 410 of which represents the patient's cardiac output. The volume of blood pumped with each stroke of the heart, the stroke volume (SV), is indicated by the diamond 420 on the X-axis. Heart rate (HR) is shown as a diamond 430 along the X axis. At each heart beat, heart rate and stroke volume were calculated and plotted in this diagram. The rectangle 410 is divided into a right ventricle (RV) metaphor 440 and a left ventricle (LV) metaphor 450 by dividing the size of the rectangle 410 in half along the X axis. The shape of the ventricle with low stroke volume will be represented by the short, wide rectangle 410, while the bradycardia shape of a normal SV is shown by the long, thin rectangle 410.

Filling pressure or volume information, or (left and right) ventricular contractility, is in the form of a central venous pressure (CVP) analog gauge 452 and a pulmonary artery capillary wedge pressure (WP) analog gauge 454 located on the X-axis. Shown. For both analog meters 452, 454, the 12 o'clock position is defined as normal. Therefore, when CVP and WP are read as normal, the rectangle becomes a square.

However, since the CVP analog meter 452 draws an arc along the X-axis, the left side 456 of the rectangle 410 will bow outward or inward if the CVP read is not normal. If the left side 456 bows outward due to high CVP, it indicates a left ventricle that has inflated and filled. Similarly, when the left side 456 bows inward due to low CVP, it represents an empty, deflated left ventricle. As can be seen, the bulging shape of the left side 456 of the rectangle 410 quickly reminds us of the image of the in-vivo heart filled with blood.

When the WP is not normal, the WP analog meter 454 draws an arc along the right side of the rectangle 410. As WP increases, it shows the patient's inflated and filled right ventricle and bulges outward.
In addition, as WP decreases, the WP analog meter 454 follows a corrugated arc along the right side 458, so that the right ventricle is depicted as an empty, deflated ventricle. Right side 458 and left side 456
Is in agreement with the image of the heart seen in the four longitudinal chambers using transesophageal echocardiography. Thus, noting the relative outside dimensions of rectangle 410 as well as the shape of its sides, it will be immediately apparent to the anesthesiologist if the right or left ventricle is deflated or swollen during surgery.

FIG. 8 describes a process 460 of adjusting the heart pump object 400. The process 460 begins at start 462 and then transitions to state 463 where the stroke volume (SV) is read. As can be inferred, the stroke volume can be read by a computer system from a table or buffer. Process 460 then transitions to decision state 465 to determine if stroke volume has changed since the last read. If the stroke volume has changed, transition to decision state 466 to determine if the stroke volume has increased or decreased.

If the stroke volume is decreasing, the process 460 transitions to state 468 where the stroke volume indicator 420 moves down along the Y-axis. As the stroke volume indicator 420 moves downwards along the Y-axis, the shaded rectangle 410 contracts in height, as illustrated in FIG. If at decision state 466 a determination is made that stroke volume is increasing, then process 460 transitions to state 469 where:
The stroke volume indicator 420 moves upward along the Y-axis. Subsequently, this reduces the height of the shaded rectangle 410. Process 460 then transitions to state 470, where the patient's heart rate is read. Next, in the determination state 471, it is determined whether or not the heart rate has changed since the last reading.

When the heart rate has changed since the last reading, it is determined in the determination state 473 whether the heart rate is increasing or decreasing. If the heart rate is decreasing, process 460 transitions to state 474, where it moves left along the X axis of heart rate indicator heart pump object 400. However, if the decision state 473 determines that the heart rate is increasing, then the process 460 transitions to a state 475 where the heart rate indicator 430 is right along the X axis of the heart pump object 400. Move to. As can be considered in reviewing FIG. 7, as the heart rate indicator 430 moves horizontally along the X axis, the width of the shaded rectangle 410 increases and decreases accordingly.

Process 460 then transitions to state 477, where the central venous pressure (CVP) value is read. At decision state 478, a determination is made whether the CVP has changed since the last read. If the CVP is changing, a determination is made at decision state 479 as to whether the CVP has increased or decreased. If CVP is decreasing, process 460 is in state 480
, Where the analog CVP gauge 452 moves along the planned arc. As described above, as the CVP analog gauge 452 moves to the right along the arc, the right ventricular metaphor 440 changes to indicate a less dilated ventricle.

If the decision state 479 determines that CVP is increasing, then the process 460 transitions to state 482, where the CVP analog gauge 452 moves left along its arc, and the right ventricular metaphor 440. The left side 456 begins to bulge outwards to show the inflated ventricle. Process 460 then transitions to state 483 where the wedge pressure (WP) value is read.

Process 460 then transitions to decision state 485 to determine if the wedge pressure has not changed since the last read. If the wedge entry pressure is changing, a determination is made at decision state 486 as to whether the wedge entry pressure is increasing or decreasing. If the wedge pressure is decreasing, the process 460 transitions to state 488 where the wedge pressure analog gauge 45
4 moves left along the planned arc. As analog gauge 454 moves to the left, side 458 of left ventricular metaphor 450 becomes more recessed, indicating a less dilated ventricle. In addition, as the patient's heart rate (HR) changes, the WP analog gauge slides left along the X axis. When heart rate increases, the WP analog gauge slides to the right, but when HR decreases, the WP analog gauge slides to the left.

However, if a determination is made at decision state 486 that the wedge pressure is increasing, then process 460 transitions to state 490 where wedge pressure gauge 454 moves to the right along the predetermined arc. . As the wedge pressure analog gauge 454 moves to the right, as can be considered in the consideration of the heart pump object 400, the end 458 of the left ventricular metaphor 450 bends outward to indicate an inflated or expanded ventricle. The process 460 then ends at end 492.

C. Vascular Resistance Object This graphical display object contains information about Ohm's law of flow. Perfusion pressure is displayed on the pressure scale on the left and is defined by mean arterial pressure (MAP) and central venous pressure (CVP). Blood flow is displayed on the pressure scale on the right and is defined by the cardiac output pointer (CO). Perfusion pressure and heart rate output are centralized, indicating systemic vascular resistance (SVR), such that when SVR is low, it is "dilated", and when SVR is high, the tube is "contracted". Coupled together using a meter.

According to FIG. 9, the vascular resistance object 500 is used to display the blood flow corresponding to Ohm's law. This display is used by medical personnel during surgery to optimize the patient's hemodynamic physiology. The vascular resistance object 500 is represented by the following formula, mean arterial pressure / central venous pressure = heartbeat output × systemic vascular resistance. This data is used by the object 50 so that the shape of the "pipe" appears with a flow from left to right.
Displayed at 0. Two linear scales related to the blood pressure gradient and the actual heart rate output (l / min) are such that the systemic vascular resistance (S
VR) shown as a function.

The set of two Y-axes is used to generate the vascular resistance object 500.
The left Y-axis includes mean arterial pressure (MAP) indicator 510 and central venous pressure (CVP) indicator 515. The blood input area 520 between the MAP indicator 510 and the CVP indicator 515 indicates the "inflow" of blood into the pipe. In contrast, the blood output area 521 shows the "outflow" from the pipe to the blood. The right Y-axis includes a cardiac output (CO) indicator 524 that reflects the calculated cardiac output of the patient. This is the outflow section of the pipe. The SVR analog gauge 528 is placed on the X axis connecting the left and right Y axes. When a normal SVR is set at the 3 o'clock position on the SVR analog gauge 528, the gauge moves down and the pipe opens when the reading is low. In contrast to this
If the SVR reading is high, the gauge moves up and the pipe closes as shown in FIG.

In physiologic terms, increased SVP results in decreased blood flow, as indicated by a contracted pipe. Blood flow increases as SVP decreases, as shown by the open pipe. As MAP increases, the inflow increases and the overall blood flow also increases.
AP indicator 510 can affect the model. As can be imagined, the vascular resistance object 500 closely reflects the actual physiology of the patient. Thus, the vascular resistance object 500 is an intuitive object for deciphering a complicated situation of a patient.

With reference to FIG. 10, a process 53 for updating the vascular resistance object 500.
Explain 5. The process 535 starts at start 537 and then moves to 539 where the mean arterial pressure (MAP) is read. Next, in decision state 541, a determination is made whether the MAP has changed since the last reading. If the MAP is changing, process 535 moves to decision state 544 to determine if the MAP has risen or fallen. If the MAP drops, the process 535 moves to 544 and the MAP indicator 510 moves down along the Y axis of the vessel resistance object 500. However, if the decision state 542 determines that the MAP has risen, then the process 535 moves to 546 and the MAP indicator 510 moves upward along the X axis. As you can see from a review of Figure 9, the MAP indicator 5
As 10 moves up and down along the X axis, the area 520 also grows and shrinks.

Next, process 535 proceeds to 548 where the patient's central venous pressure is read. Then 550
At, it is determined whether the CVP has changed since the last reading. If the CVP has changed, process 535 moves to 552 and a determination is made as to whether the CVP has increased or decreased. If CVP drops. Process 535 moves to 554 and CVP indicator 515 moves down. If the decision state 552 determines that the CVP has risen, the process 535 moves to 556 and the CVP indicator 515 moves upward. Then the process
The 535 moves to 558 and the heart rate output (CO) is read.

Next, in decision state 560, a determination is made whether the heartbeat output has changed since the last reading. If the cardiac output has changed, the process 535 moves to a decision state 562 to make a determination as to whether the cardiac output has increased or decreased. If the cardiac output has decreased, the process 535 moves to 564 and the cardiac output indicator 524 moves down along the Y-axis. However, if in decision state 562 it is determined that the cardiac output has increased, then the process 535 moves to 568 and the cardiac output indicator 524 moves upward along the Y axis. The process 535 then moves to 570 and the systemic vascular resistance is read.

Next, in decision state 572, a determination is made as to whether the systemic vascular resistance (SVR) has changed since the last reading. If the SVR has changed, then at decision state 574 a determination is made as to whether the SVR has increased or decreased since the last reading. If SVR has decreased, process 535 transfers to 578 and SVR analog gauge 528 moves to the right along a predetermined arc. Thus, as the patient's vascular resistance decreases, the vascular resistance object 500 represents a larger area of outward flow. If it is determined at decision state 574 that the SVR has increased, then process 535 moves to 580 and SVR analog gauge 528 moves left along a predetermined arc. As shown in FIG. 9, when the SVR analog gauge 528 moves to the left, the output area 521 of the blood vessel resistance object 500 decreases. The process 535 then ends at end 582.

D. Metabolism Objects Graphical display objects for metabolic factories include oxygen delivery (DO ₂ ) (total), aerobic (oxygen burning) metabolic activity (oxygen consumption or VO ₂ ) and no oxygen to cell factories. Includes information about oxygenate metabolic activity (with a relationship suggesting lactate production, in this case base deficiency). The data scale is arranged so that the oxygen supply can be compared to indicators of oxygen utilization and good condition of the cells.

The metabolism object 600 will be described with reference to FIG. Metabolism object 600
Displays the relationship of oxygen delivery (DO ₂ ) by showing the following equation: oxygen delivery = heart rate output × arterial oxygen content.

Further, the metabolism object 600 can also indicate the oxygen utilization amount (VO2) by the following formula: oxygen utilization amount = arterial blood oxygen content−venous blood oxygen content.

In normal patients, oxygen supply far exceeds oxygen consumption. Thus, the fulcrum or pivot 610 is used to illustrate the balance of oxygen supply (DO ₂ ) indicator 620 and oxygen demand (VO 2) indicator 630. The lever or balance line 640 moves between the DO ₂ indicator 620 and the VO ₂ indicator 630 and is balanced on the pivot 640. The inclination of the DO ₂ for VO ₂ is used to indicate the "balance" or association of more easy to understand DO ₂ and VO ₂ for the physician. In addition, anoxic metabolism and its associated acidosis negatively scale the scale, indicating that oxygen is supplied but cells are not utilizing it.

With reference to FIG. 12, a process 650 for updating the metabolic object 600 will be described. The process 650 begins at start 652 and then moves to 654 where the patient's blood oxygenation is read. The process 650 then moves to decision state 656 where the oxygen supply value (DO ₂ ) is reached.
A determination is made as to whether has changed since the last reading. If the oxygen supply value changes, process 650 moves to decision state 658 to determine if the patient's blood oxygen supply has increased or decreased. If the oxygen supply value decreases, the process 650 moves to 650 and the oxygen supply indicator 620 (FIG. 11) moves down along the Y axis. However, if the oxygen supply value increases, the process 650 moves to 662 and the oxygen supply indicator 620 moves upward along the Y axis. The process 650 then moves to 664 and the patient's oxygen demand value (VO ₂ ) is read.

Once the oxygen demand value is read at 664, the process 650 moves to 666 to determine if the oxygen demand value has changed since the last reading. If the oxygen demand has changed, the process 650 transitions to a decision state 668 to determine if the oxygen demand has risen or dropped. If the oxygen demand value drops, process 650 moves to 670 and oxygen demand indicator 630 (FIG. 11) moves downward along the Y-axis. However, if at decision state 668 it is determined that the oxygen demand has increased, the process 650 proceeds to 67
Moving to 2, the oxygen demand indicator 630 moves upward. The process 650 then ends at end 674.

E. Alveolar Artery Partial Oxygen Gradient Object As shown in FIG. 17A, this graphical data display object 800 has an outline 802 showing lung units located on the left side, an outline 804 showing arteries located on the right side, and It includes a scale 806 that represents a barrier to oxygen diffusion from the lungs to the blood located in the middle. The pointer 808 on the left inside the "lung" indicates the partial pressure of alveolar oxygen using the ideal alveolar gas equation. Right pointer inside the "artery"
Reference numeral 810 represents the arterial oxygen partial pressure. The tendency is displayed on the left. The normal slope, represented as a green area on the scale, is based on the accepted equation (normal arterial oxygen content as a function of fractional oxygen inspiration). The line connecting the pointers indicates the slope.

F. Data Box Graphic Element An example data box graphic element 900 is shown in FIG. 17B. As shown in this example, the data box may have three sub-boxes: a number box 902, an alarm box 906 and a propensity box 904. Number boxes contain data values, data labels and data units. The alarm box contains a reference scale, a value pointer, and a normal zone encoded in a color (here 34 and 15) indicating the upper and lower limits of the alarm (usually green over green). Warning zones that can be set by the clinician are indicated by triangular areas. The pointer and number box change color in steps when the value falls into the alarm zone (eg, change to red).
Confidence intervals for the data are shown combining the thickness of the pointer tip with the accuracy of the measured variable. The propensity box shows the parameter values recorded during a particular time period. 1
It will be appreciated that some relevant parameters are displayed using multiple data boxes on one display.

G. Acid Base Graph Object FIG. 17C shows an exemplary acid base object 950. One of ordinary skill in the art will appreciate that the acid-base objects represent the relevant metabolic and respiratory components of Henderson-Hasselback on the x, y graph 952. PH diagonal 954 on the reference grid
Is shown. The colored markings are used to encode normal zones 958, 956 and 960 for bicarbonate, carbon dioxide partial pressure and pH, respectively. The use of bicarbonate and carbon dioxide allows clinicians to understand the two major components of the acid-base system that can be treated with IV sodium bicarbonate and ventilation exchange.

H. Aggregation of Data Objects into an Integrated Display FIG. 13 illustrates one embodiment of a display having data objects 300, 400, 500 and 600, respectively. The data object is that oxygen is transported from the left ventricle of the heart pump object 400 through the vascular resistance 500 (eg, capillary cells) to the arterial blood cells 310a, and oxygen is delivered by the tissue cells (object 600) to the venous blood cells 310b. Are arranged in the pattern shown to create a circuit that indicates returning to the right ventricle 440 through. Thus, a complete illustration of the oxygenation cycle is provided in a very intuitive way by the object associations in FIG.

I. Boundary Information All scales used to map values to indicators and gauges preferably have normal and abnormal zones (preferably tintable or tinted zones). Thus, the indicator can change color when the patient is in the danger zone. The alert zones are selectable so that the physician can make the alert more or less severe based on the physiology of the particular patient. In this way, the user sets a value above or below the critical threshold at the point where he wants the alert to be issued. When falling into the warning zone, the indicator begins to change color in steps and begins to flash, the clearer the red color of the indicator, the closer the value is to that threshold. Of course, the indicator can be changed in various ways to alert the physician that an abnormal zone has been encountered. The present invention should not be configured to be limited by any particular notification method.

J. Information on Confidence Intervals When the accuracy and bias of the measured data channel is revealed,
The pointer tip is assembled on the appropriate value, but preferably has a thickness that contacts the scale and covers the known errors associated with that data. This creates a pointer that changes color and falls into a danger zone based on less favorable scenes.

K. Information on Propensity Information on propensity includes, for example, a set of “cards” on a time scale on the z-axis or the X-axis. Values exceeding the time interval selected by the user are displayed and the resolution (sampling rate) of the data becomes visible.

L. Normalization of Information Since the variability between patients is remarkable and the physiological state of the patient changes in settings such as surgery (definition of what is regarded as normal change, etc.), the reference frame is set. The indicated value can be resized or scaled with a command. For example, the "normal" SVR setting for the SVR object 550 of FIG. 9 can default to 1000 at the 3 o'clock position. However, if the patient's SVR is typically 2000, this feature allows the normal 3 o'clock position of the SVR analog gauge to be reset to 2000.

M. Artifact Detection and Signal Quality Information Viewing analog signals on a given data channel provides a great deal of information on signal quality. Therefore, like the propensity window, the pop-up window next to the data pointer can be used to detect information about noise or artifacts. For example, a popup window can be launched by clicking on the data pointer.

N. Information About Patient's Disease If necessary, data about disease status can be saved and the defaults for boundaries can be reset. For example, hypertension shifts the automatic control curve to the right so that many physicians can maintain blood pressure in a higher than normal range.

O. Examples of Disease States FIG. 14 shows an example of a circuit display in anaphylaxis or sepsis. FIG. 15 shows an example of a circuit display in cellular acidosis. FIG. 16 shows an example of a circuit display in a pulmonary embolism.

Pilot Study A pilot study was conducted to test the hypothesis that the developed set of object displays would improve the anesthesiologist's ability to solve problems such as acute hypotension.

Subjects: All subjects were anesthesiologists (N = 10) in the final year of training or attending levels. Each physician had over 3 months of experience in providing cardiac anesthesia.

Test parameters: 5 patterns of shock (anaphylactic shock, bradycardic shock, hypovolemic shock, cardiogenic shock and shock secondary to pulmonary embolism) and near 5 patterns of shock (MAP-CVP A dataset was generated for 60-70 mmHg, but five other shock states were shown).
Twenty "flash cards" (one set of standard display card and one set of graphic display card) were generated using the data set. FIG. 14 is an example of one flash card from a test showing anaphylaxis.

The hardware consisted of a computer workstation with a 21 inch touch screen monitor. The analyte test was a software application written in LabView. The application "shuffles" the cards and randomizes the order in which they are presented to subjects. When the application is started (comprising the test), the next display is hidden on the screen with the button "Next". When the subject touches this button, the image on the first display appears and the subject must choose from five buttons (no problem, anaphylaxis, bradycardia, reduced blood flow, ischemia and pulmonary embolism). Next, a screen appears with a "Next" button, and touching the button advances to the next card.
This is done for all 20 cards. A computer's internal clock is used to measure problem (shock) recognition speed and accuracy and pattern recognition (pathogenesis) speed and accuracy. Subjects were surveyed before and after the study.

We found that the resident was able to recognize the problem 30% faster than the conventional display. In addition, the resident was able to identify patient patterns 25% faster than with traditional displays. We have found that there is no difference in accuracy. The total training time was about 30 minutes.

CONCLUSIONS Conventional displays presenting physiological data to physicians engaged in critical care require physicians to perform significant cognitive work to interpret that data. The display system disclosed herein provides visual memory cues to graphically map complex data to a display that matches the mental model used by physicians to interpret the physiology of oxygen transport.

The system receives the analog signal and activates the display in real time. Alarm conditions can be set by the doctor and can be viewed with the naked eye at any time. The danger zone, which creates a red shade on the data pointer, is easy for doctors to understand (doctors are used to using fuzzy theory to interpret data). Moreover, the way the data elements are constructed and displayed yields a perceptual diagram. The shape itself provides the physician with a very high level of information regarding the physiology of oxygen delivery.

[Brief description of drawings]

FIG. 1 is a schematic diagram illustrating one system for oxygen transport physiology collection, processing, and display configured in accordance with an embodiment of the present invention.

[Fig. 2]   1 is a schematic diagram of a computer system used to operate the present invention.

FIG. 3 is a flowchart detailing a preferred software scheme used to operate the present invention.

FIG. 4 is a schematic diagram of data entry and operations performed in selected embodiments of the present invention.

[Figure 5]   1 illustrates an example of a red blood cell object.

6 is a flow chart illustrating one method of updating the display of the red blood cell object of FIG.

[Figure 7]   1 illustrates an example of a heart pump object.

[Figure 8]   8 illustrates one method of updating the display of the cardiac pump object of FIG.

[Figure 9]   3 illustrates an example of a vascular resistance object.

[Figure 10]   10 illustrates one method of updating the display of the vascular resistance object of FIG.

FIG. 11   1 shows an example of a metabolic object.

[Fig. 12]   12 illustrates one method of updating the display of the metabolic object of FIG.

FIG. 13 shows a display representing a circuit for displaying physiological data. In one example, the display includes a heart pump object, a vascular resistance object, a red blood cell object and a metabolic object.

FIG. 14   1 shows an example of a circuit in anaphylaxis or sepsis.

FIG. 15   An example of a circuit in cellular acidosis is shown.

FIG. 16   1 shows an example of a circuit in a pulmonary embolism.

FIG. 17 shows selected object displays and elements compatible with the present invention. More specifically, FIG. 17A shows an alveolar arterial blood pressure oxygen gradient target, FIG. 17B shows a graphic element of a data box, and FIG. 17C shows an acid-base graph object.

[Procedure for Amendment] Submission for translation of Article 34 Amendment of Patent Cooperation Treaty

[Submission date] September 7, 1999 (1999.9.7)

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be amended] Detailed explanation of the invention

[Correction method] Change

[Contents of correction]

Description: TECHNICAL FIELD The present invention relates to a display system. More specifically, especially in medical settings
It relates to a system for displaying graphical information. Background Art Medical display systems provide information to physicians in a clinical setting.
A typical display system presents data as numbers and a unitary signal waveform.
However, the attending physician must evaluate them in real time. like this
In some systems, unsafe conditions, such as when the value exceeds the recommended value,
May include an alarm to alert you. In the field of anesthesiology, for example
For example, the anesthesiologist can monitor the patient's condition while anesthetizing and
And (ii) identify the cause of the problem and (iii) take coordinative measures.
Yes. Misjudgments can be fatal. There are more than 2000 deaths related to anesthesia per year, about 50% of which are manual.
It is known that the cause is improper choice during surgery. Generally, for anesthesia
Human error in the anesthesiologist does not recognize the problem (abnormal physiology)
By not specifying and not taking appropriate regulatory measures when anesthetizing the patient
It is shown that. Anesthesia performance model, ie causality with mistakes, incidents and accidents
The model showing the affairs and the model showing the development of accidents in anesthesia are all
It shows the fact that it is a complicated situation that tends to occur. The display of physiological data about the patient's condition allows anesthesiologists to
In observing the condition and inferring the likely cause of the problem during surgery
Play a mental role. As you can predict, the Australian Incident Monitoring Stu
63% of reported accidents in the dy (AIMS) database are standard data monitors
It was considered more detectable. Some have tried to solve these problems
However, the results were limited. For example, Cote et al. Call a patient who has been ventilated in an intensive care unit (ICU).
We have developed a set of objects for displaying tractor physiology. This one
A set of displays provides information from the patient and ventilator, respiratory rate, volume and inspiration.
Integrate information on air oxygen content (%). ICU doctor from object display
The information used in the data is faster and more accurate than when using an alphanumeric display.
I was able to interpret the data. Cole printed as if doctor used tabular data
Comparison of how data was interpreted when graphic data was used
Published a paper on. However, Cole's research was on analog data channels
Receive and drive a real-time graphic display on the medical monitor
It was not related to the system. In addition, Ohmeda, a company that manufactures anesthesia related equipment, has a graphic
Manufactures modular CD machines with the option to display data
There is. This display has been called a glyph. Physiologic data above hexagon
Is mapped with. The six data channels make up six sides of the hexagon. This device
Although the display is graphical, alphanumeric information dominates. Na
There is no clear logic to assign physiological data to one side of a hexagon. Furthermore
To identify symmetric changes to the various signs of this geometric shape.
Is very difficult. In the surgical and post-operative setting, decisions regarding the need for blood transfusion are usually hemoglobin.
(Hb) or hematocrit level (Hct). Hematocrit
Percentage by volume of concentrated red blood cells after centrifugation of a blood sample
Is defined as If the patient's hemoglobin level per dl of blood is high,
The practitioner can infer that the patient has sufficient capacity to deliver oxygen to the tissue. during surgery
, This value is often used as a trigger, i.e. the value is
If the blood pressure falls below the normal value, blood is further administered to the patient. These parameters
Indicates the arterial oxygen content, but the total acid delivered (or supplied) to the tissue.
No information is provided regarding elemental or tissue oxygen content. For example, in patients with systemic atherosclerosis, if the postoperative hematocrit is low, the
It has been shown to be associated with later ischemia. Many researchers limit the critical Hc level.
However, most authoritative parties are wondering if they are based on Hb or Hct.
Empirical and automatic transfusion triggers should be avoided and red blood cell transfusions tailored to individual patients
You will agree that it should be done. Therefore, it is more than the specified value.
The transfusion trigger should be activated based on the patient's response to anemia. That is, part of this is how well the patient's tissue is actually oxygenated.
Due to the fact that many parameters are important in determining whether or not. This
Heart rate output also correlates hemoglobin level with tissue oxygenation in terms of
It is an important factor to attach. Heart rate output or CO is the time unit (ml / m
in), which is defined as the volume of blood ejected from the left ventricle of the heart into the aorta.
It can be measured by the water-repellent technique. For example, if the patient has internal bleeding, blood hemoglobin
Although the bottle concentration is normal, total blood volume may be low. Therefore, the heartbeat output
Simply measure the amount of hemoglobin in the blood without measuring other parameters such as
Is not always sufficient to infer the patient's actual oxygenation status. More specifically, the oxygenation status of a tissue depends on the tissue's oxygen supply / demand relationship, ie
Total oxygen consumption (VO ₂ ) To the total oxygen delivery (DO ₂ ) Relationship
. Hemoglobin is oxygenated to oxyhemoglobin in the pulmonary capillaries and then to the heart.
The pulse output carries it to the tissue where it consumes oxygen. Oxyhemoglobin
Release oxygen into the tissue, the oxygen partial pressure (PO ₂ ) Is sufficient oxygen is released and oxygen consumption
Amount (VO ₂ ) Is satisfied. How to measure the oxygenation status of a specific organ bed (
Intestinal pressure measurement; near infrared spectroscopy, etc.)
It is difficult to apply to the settings. Therefore, the organization from The oxygenation status of the blood
A parameter that reflects the oxygen partial pressure of mixed venous blood (PvO ₂ ; Oxygen in mixed venous blood
(Also known as tension) or mixed venous blood oxyhemoglobin saturation (SvO ₂ ), Is generally accepted for assessing the overall oxygenation status of tissues.
Has become a way of doing. Unfortunately, a more invasive technique for more accurate measurement of tissue oxygenation levels.
I need surgery. From this point, directly measure the oxygenation status of mixed venous blood during surgery
Pulmonary artery catheterization is used for. Complete overall oxygen transport and delivery
One catheter (Directional Pulmonary Artery (PA) Catheter) is used to evaluate the pulmonary artery
Then, place another catheter in the peripheral artery. Next, a blood sample is taken from each
Pulmonary arteries and arterial blood oxygen levels are measured. I considered it earlier
As such, a PA catheter can also be used to measure heart rate output. Then the doctor measures
How well a patient's tissue is oxygenated from the oxygen content of a blood sample
Presume. Although these methods have proven to be relatively accurate, these methods
Is also extremely invasive. For example, the Swan-Ganz thermodilution catheter (Baxter Internat
Use of devices such as ional, Santa Ana, CA) causes infections, pulmonary hemorrhage, pneumothorax and
Leading to an increased risk of other complications. In addition, the risks associated with PA catheters and
Due to the cost, use in surgery may put patients at high risk or with significant blood loss.
Limited to surgery (eg heart surgery, liver transplantation, curative treatment of malignant lesions), and
Limited to patients who are vulnerable (eg elderly patients, diabetics, atherosclerotic patients)
Is determined. Among other variables, measuring the oxygenation state of a tissue is the amount of blood released to the tissue.
(CO) and its blood (arterial blood) oxygen content (CaO ₂ ) Should be included
. The product of these variables is the total oxygen delivery (DO ₂ ) Can also be used to measure
It Currently DO ₂ Evaluation requires the use of the invasive monitoring devices mentioned above
. Therefore, DO ₂ Is not possible in most surgical cases. Shi
However, in the intensive care unit (ICU), invasive monitoring is routine for patients.
Tend to be part of management and therefore DO in this patient group ₂ Is more acceptable
Easy to get. Mixed venous oxygen tension or mixed venous oxygen tension (PvO ₂ ) For PA catheter
It is another important parameter that can be measured. Venous blood and braid
Oxygen partial pressure (PO) ₂ The equilibrium that exists between
The oxygenation status can be estimated. More specifically, arterial blood flows through tissues
And PO in the arterial blood flowing through the tissue and the blood of the tissue itself. ₂ There is a partial pressure gradient between
To do. Because of this oxygen partial pressure gradient, hemoglobin in red blood cells and solution in plasma?
Oxygen is released from the ₂ Spread to the organization. Capillary end of vein
Blood PO from the edge ₂ (PvO ₂ ) Is the distal (venous) end of the tissue through which the capillaries pass
Edge PO ₂ Closely reflects Mixed venous oxygen tension (PvO ₂ ) Is closely related to available oxygen bonds
Mixed venous blood oxyhemoglobin satiety expressed as a percentage of hemoglobin
The degree of harmony (SvO2). Generally, the oxyhemoglobin dissociation curve is SO ₂ Value and PO ₂ The value
Is plotted using. Oxygen partial pressure in blood (PO ₂ ) Decreases (ie blood
As they pass through the capillaries), hemoglobin oxygen saturation (SO ₂ ) Correspondingly decreases
To do. PO in arterial blood ₂ And SO ₂ Values around 95 mmHg and 97%, respectively.
Oxygen concentration of mixed venous blood (PvO ₂ , SvO ₂ ) Is about 45 mmHg and 75% respectively
It Like this SvO ₂ Is PvO ₂ As well as suggesting an overall tissue oxygenation status. Unfortunate
In particular, PvO ₂ Similar to SvO ₂ Can only be measured using relatively invasive measurements. Another parameter that can provide information about the patient's oxygenation status is deliverable
Oxygen (dDO ₂ ). dDO ₂ Is transported to the tissue, PvO ₂ (Implicitly the overall set
The amount of oxygen that can be delivered to the tissue before the tissue oxygen tension drops below a certain value (ie
That is, the amount of oxygen consumed by the tissue). For example, dDO ₂ (40) is PvO ₂ Is 40
The amount of oxygen that can be delivered to the tissue before it reaches mmHg, dDO ₂ (35) is PvO ₂ Is 35 mmHg
It shows the amount of oxygen consumed before dropping to. In addition, some relevant parameters can be measured non-invasively. An example
For example, the total body oxygen consumption can be calculated from the difference between the inspiratory volume of oxygen, the mixed expiratory volume of oxygen, and the minute volume of artificial respiration.
Amount (VO ₂ ) Can be calculated. Also, the heart rate output depends on the thermodilution catheter
Instead, it can be presumed to be non-invasive by measuring arterial blood pressure. For example,
Kraiden et al. (US Pat. No. 5,183,051 and described here as a precedent) show continuous arterial blood
Using a blood pressure monitor to measure pressure. These data are pulse contour
Converted to curved waveform. From this waveform, Kraiden and colleagues calculated the patient's heart rate output.
It No matter how the individual parameters are obtained, the person skilled in the art is well established.
Understand that new parameters can be derived from various relationships
Will do. For example, Fick's formula (Fick, A. Wurzburg, Physikalisch edizinis
che Gesellschaft Sitzungsbericht 16 (1870)) is an arterial oxygen concentration, venous acid
It correlates elementary concentration and heart rate output with the patient's total oxygen consumption and is expressed as follows:
(CaO ₂ ・ CvO ₂ ) × CO = VO ₂ Where CaO ₂ Is arterial oxygen content, CvO ₂ Is venous oxygen content, CO is heart rate output, VO ₂ Represents total body oxygen consumption. Non-invasive extraction of such parameters is useful in clinical settings
But a more definitive “transfusion trigger” would clearly be useful. PvO ₂ Or DO ₂ Suffers from
If accepted as a valid indicator of worker safety, the “safety” of these parameters
The question arises as to what constitutes the "all" level. Criticality in animal models
Despite data on oxygen delivery levels, critical PvO in clinical settings ₂ There is little to say what is. The available data is extreme in level.
It shows that it is variable. For example, trying to undergo cardiopulmonary bypass surgery
Critical patients with critical PvO ₂ Varied between 30 and 45 mmHg, the latter value being normal and healthy.
It is well within the range of values found in poor patients. Safe do ₂ Is the same as
Shows variability. For implementation purposes, PvO ₂ If the value is 35 mmHg or more,
Considered to indicate that the overall oxygen supply is sufficient, this is due to the vasomotor system.
Implies that it is normal and working. Similarly,
DO ₂ The accurate measurement of is dependent on normal cardiovascular system. Wide during surgery
A safe margin and when the patient is clearly in good condition as far as oxygen dynamics
Blood transfusion trigger (DO ₂ , PvO ₂ , SvO2 or their derivatives)
Is the best. In practice, only certain patients are monitored with pulmonary artery catheters
To be done. Therefore, the above parameters are not available for all patients.
However, the majority of patients are incomplete and sometimes dangerous triggers of Hb concentration are monitored.
And Efforts have been made in the past to resolve these problems with little success
It was For example, Faithfull et al ( Oxygen Transport to Tissue XVI , Ed. M. Hogan, P
lenum Press, 1994, pp. 41-49) show the oxygenation state of tissues under various conditions.
It describes the model to be pulled out. However, this model is just static
Simulation, which allows operators to perform various cardiovascular or physical
The effect of changes in various parameters on tissue oxygenation
it can. Continuous to provide a dynamic display of what may actually happen
There are no specific data acquisition and evaluation regulations. Therefore, this model is
Used to measure the patient's tissue oxygenation status in real time under clinical conditions
I can't. Thus, what is needed in this technology is to provide the physician with physiological information.
It is a means for visually displaying. From this point, the method described below
The system provides a novel approach to physician patient data. Starting
Other aspects of clarity will be apparent from the description below. DISCLOSURE OF THE INVENTION One or more embodiments of the present invention accurately reflect the physiological condition of a patient.
Provide a measurement and display of the value of. A good value is the patient's overall oxygen
Includes inflammatory and cardiovascular conditions. Each value allows the physician to understand the patient's medical condition
Displayed as an intuitive medical process diagram to help
It In addition, the majority of the displayed values are present in the patient without invasive means.
It can be measured in profit. Thus, the display system considered here
Systems and methods provide safe and intuitive monitoring and display of the patient's physiological condition.
It can be used to adjust the therapeutic parameter based on the determined value. By using the display system of the present invention with various medical devices
It will be appreciated that the desired physiological information can be obtained. More specifically
, The disclosed display is used to monitor or treat a patient
It can be effectively and effectively associated with any medical device or device. this
From the point of view, such devices include anesthesia machines, ventilators, heart-lung machines and those described here.
These include, but are not limited to, various types of oxygenation monitors.
Exemplary values displayed include anesthesia machines, heart-lung machines, ventilators, oxygenators.
In the niter is the oxygenation parameter oxidation parameter or analog information, or artificial
Cardiopulmonary information is cardiomechanical information. In either case, the disclosed display
B. Effectively present quantitative data in a way that medical personnel can quickly understand
To do. In a preferred embodiment, the present invention is a physiologically important indicator of tissue oxygenation status in a patient.
Oxygenation parameters, such as total oxygen delivery (DO ₂ ), Deliverable oxygen delivery (dDO ₂ ), Mixed venous blood oxyhemoglobin saturation (SvO2) and mixed venous oxygen tension
(PvO ₂ ) Etc. and provide real time display. Also,
Ming is another oxygenation parameter, supply / demand ratio (dDO ₂ / VO2) to get
Used by physicians to accurately monitor and adjust patient oxygen status using a single number
To be able to. Using the obtained oxygenation parameters alone or more preferably in combination
It will be appreciated that it can be inferred to indicate overall tissue oxygenation level.
Thus, the present invention carries the risks associated with conventional invasive monitoring devices.
Can be used as a simple, real-time intervention trigger in clinical settings without
Wear. More specifically, acceptable PvO for each patient ₂ , SvO2 or dDO ₂ The minimum of
Establishing gives the attending physician a simple trigger point to indicate when an intervention is taking place.
For example, based on clinical experience, the attending physician may need to provide the patient with sufficient oxygenation to provide adequate oxygenation.
PvO ₂ Is not less than 35mmHg or DO ₂ Must be above 600ml / min
And so on. Preferably, the clinician has access to each oxygenation parameter.
The desired one or more values can be displayed. In particular
In the preferred embodiment, the system uses selected PvO ₂ Supply / demand ratio (dDO ₂ / V
O2) to enable physicians to address patient needs based on a single value
To do. In the present embodiment, PvO is set according to one or more values. ₂ (Overall tissue oxygenation
) Is higher than the established trigger point. In a particularly preferred embodiment, input from an indwelling catheter placed in the peripheral artery is used.
Used to provide continuous (beat interval) measurement of heart rate output (CO). In this regard, Mo
Equipment such as the delflow system (TNO-Biomedical Instrumentation, Amsterdam)
Optionally used in conjunction with the present invention to provide continuous CO measurements in real time. Cardiac output
Force Aortic Input Impedance Through Human Three-dimensional Nonlinear Model
It can be calculated using an algorithm that simulates the behavior of the system. This model
The heart rate output calculated using is compared with the heart rate output measured by the thermodilution method.
To be done. In addition to the heartbeat output, the following hemodynamic information based on beat intervals
low, ie, systolic, diastolic and average, which can be obtained from systems such as
Blood pressure, pulse rate, stroke volume and peripheral vascular resistance. An embodiment of the present invention is used to derive the desired value for the patient's arterial oxygen content.
Amount (CaO ₂ ) Is also measured. Specifically, the oxygen content of arterial blood (CaO ₂ ) To measure
The patient's hemoglobin concentration, arterial blood oxygen tension (PaO2), arterial blood carbon dioxide tension
Use one or more numerical values corresponding to force (PaCO2), arterial blood pH and body temperature
can do. These numbers can be obtained from a blood chemistry monitor or manually.
You can enter with. In a particularly preferred embodiment, the heart rate output value is measured at the same time.
Use a blood chemistry monitor to obtain the desired value. In addition, the patient's oxygen consumption (VO
2) is preferably measured by gas analysis or metabolic rate measurement. As noted above, embodiments of the present invention further use the supply / demand ratio to analyze patient tissue.
Methods and apparatus that can be used to monitor oxygenation status are provided. further,
One embodiment of the present invention uses a supply / demand ratio (dDO ₂ / VO2), including patient tissue oxygen
Intended for relatively non-invasive methods of real-time condition monitoring
. Similarly, other embodiments also provide real-time measurements of patient tissue oxygenation status.
Intended for relatively non-invasive devices. Such equipment can be supplied / demand (dDO ₂ / V
It contains instructions for measuring O2). Calculations and values required to obtain the desired ratio
And the device is as described herein throughout. In all cases, the preferred embodiment of the present invention is a blood chemistry monitor and / or
Or pressure transducers (ie pressure transducers for CO, etc.) are included, but they are
It is not an essential component of the invention and is necessary to carry out the disclosed method.
It has to be emphasized that not. For example, a doctor can manually
, Body temperature and Hg concentration can be measured and this information can be entered into the system from the keyboard.
You can Other methods of measuring heart rate output, namely ultrasound, thorax impeder
Or CO2 partial pressure repeat breathing method can be used. Those skilled in the art will further appreciate that the oxygenation constant is dependent on the physical properties of the oxygen carrier or the physiological characteristics of the patient.
It will be understood that it is a number mainly related to sex. Such an oxygenation constant is
Blood volume, oxygen solubility in plasma, desired units of saturated oxyhemoglobin acid
Including, but not limited to, elementary content. Preferably, in the present invention
The oxygenation parameters selected using one or more oxygenation constants.
The present invention obtains the value (CaO ₂ , VO ₂ And CO) of the patient
Mixed venous oxygen content (CvO ₂ ), The Fick equation VO2 = (CaO ₂ ・ CvO ₂ ) ×
Solve CO. Once CvO ₂ Is decided, SvO ₂ Can be calculated, and Kelman's formula (Kelm
an, J.Appl.Physiol, 1966, 21 (4): 1375-1376; described here as a prior example).
Using an algorithm to calculate the position of the oxyhemoglobin dissociation curve
PvO ₂ Can be pulled out easily. Similarly, DO ₂ , DDO ₂ And dDO ₂ / VO ₂ Such as
Other parameters can also be derived from the values obtained. Anesthesiologists may use the methods disclosed herein to provide real-time data (ie, previously discussed).
Continuously monitored oxygenation parameters) to determine the patient's overall oxygenation status.
The full picture is revealed. Trigger port with one of the selected parameters established
If you reach the point, take enough time to stabilize the target,
Appropriate measures such as pharmacological interventions, infusions, blood transfusions, and adjustment of mechanical ventilation profiles
Can take Thus, the continuous flow of this data is
Diseases (including but not limited to anemia, decreased cardiac output, hypoxia)
It is possible to more easily determine the cause and adapt the correspondence appropriately. In terms of the present invention, a high risk environment (medical, etc.) to reduce human error
Is focused on graphically displaying data to users in
It In particular, the system and display of the present invention is an operator's cognitive requirement.
Helps map needs to graphical elements of the display. Therefore
In certain aspects, the present invention provides display data for patient data and physical function.
Imitates the physiology of the body to better represent In one aspect, the present invention utilizes task analysis methodologies to transform data into information.
Display physiological data of elementary delivery. Doctor is information (not raw data)
Interpret this data to diagnose pathological conditions and take appropriate regulatory measures
Which is less error-prone than interpreting data obtained by other systems
. In one particular aspect, the invention provides one or more data collections from a patient.
To create an object display that provides a set of information from the sensors in. this
These object displays are, for example, (1)
Relationship, (2) data in context, (3) reference frame for data, (4) information for data
The information change rate and / or (5) event information is shown. Constructed according to the invention
The system is thus particularly useful in presenting physicians with oxygen transport physiology.
It is for. In another aspect of the invention, the system comprises data acquisition hardware (eg,
Patient probe), computer, object display algorithm and
Use software. In one preferred aspect, software and algorithms
Is an analog data channel (eg, a patient monitoring signal or probe).
(Obtained from the digital camera) to represent the physiology of oxygen transport using a digital representation of
Configure the eject display. However, an intuitive medical process die
Aspects of the invention relating to Agram do not require special monitoring equipment
It should be noted. Display as an intuitive medical process diagram
Any known patient monitoring device can be used to collect data for
. The present invention offers several advantages over the prior art. As an example,
The data display maps patient information to meaningful mental models. Therefore
, Physicians using mental models such as this are complicated by the physiology of oxygen delivery.
Better understanding of physiology. On the one hand, mental models are complex
Use analogical form to describe the process. Thus, the oxygen transport physiology of the present invention
A suitable model is (1) filling the lungs with fuel in the form of oxygen, (2) oxygen
Sending out the converted blood from the heart to the organs and tissues, (3) oxygen from red blood cells
Including delivery to tissue, and (4) oxygen and oxygen utilization by tissue. By analogy, this model can be used as a covered wagon in the form of (1) coal in the coal yard.
Loading, (2) Separate the covered wagon with fuel loaded by the locomotive to some extent.
To the furnace, (3) dropping coal from the covered wagon into the furnace, (4) coal in the furnace
Can be contrasted with burning. In this analogy, the coal yard is oxygen
Represents an inflated lung. Boxed wagons represent red blood cells filled with oxygen. Locomotive with lungs
Represents the heart pumping oxygen-carrying red blood cells around the circulation between tissues. In the furnace
The percentage of each boxcar coal unloading is the fractional extraction of oxygen by cells in the tissue.
Represents the out. Finally, the burning coal in the furnace represents the oxygen utilization by cells and tissues.
You As mentioned above, the present invention is compatible with many different types of medical devices. As well
In addition, aspects of the invention can be used in several settings. First, the system is different
Can be used with sensor sets that drive data displays from other manufacturers
Is. For object displays, the display may be partial or
Can be used globally. For example, all or part of the physiology of oxygen delivery can be monitored.
Examples of medical areas that are affected include intensive care units, operating rooms, emergency rooms and all treatment rooms.
including. The display system of the present invention allows a patient to undergo cardiopulmonary bypass surgery.
It can also be used to provide medical teams with information on the physiology of oxygen transport during
is there. This system is a surgical instrument for the education and training of persons involved in oxygen transport physiology.
It can also be attached to medical simulation devices such as The software of the present invention is used for medical devices currently used for data acquisition, especially for oxygen transport.
May be installed on medical devices used in connection with physiology or cardiac mechanics.
You can The present invention is directed to the physiology of oxygen delivery in veterinary medicine or to animal laboratories.
It can also be used to monitor the physiology of oxygen delivery. In one aspect, the present invention interacts with displays of other physiology, such as respiratory physiology.
It is also possible to make it a module for use. Implement research protocols and implement complex controls
It can also be used to perform your task better. Further use acid
Can also include interfaces for large dataset analysis of elementary transport information
Is. One embodiment of the present invention is a method of displaying physiological data from a patient.
It In this example, data from a patient's organ is acquired via a probe or other device.
taking measurement. The measured data is then used to determine the patient's blood oxygenation level and cardiac dynamics.
To measure physiological quantities of data such as statistical values. The physiological amount is an object
The shape of the displayed object is
Reflect the structure. Another embodiment of the invention is a method of displaying patient physiological data.
In this example, the patient's blood oxygenation level is first measured by conventional means. Circular
A shape is displayed to show the percentage of oxygenated patient blood
Is shaded. Another aspect of the invention is to display physiological data obtained from a patient.
The patient's blood oxygenation level is first measured by conventional methods to
The shapes are displayed on the monitor, and each of the shapes is the structure of an organ in the human body.
Represents structure. A further embodiment of the present invention is a method of displaying physiological data from a patient.
Method, using analog gauges such as dials and needles to represent physiological data
There is. Another aspect of the invention is a display system that represents physiological data from a patient.
is there. The display system includes a set of display objects,
Each object represents a different but related measurement taken from the patient
. The integrated display is formed by a set of four objects. First object
Is the patient's heart rate output, the second object is the patient's arterial oxygenation level, the third
The fourth object is the patient's venous oxygenation level
10 shows arterial, capillary and venous tension in the. The present invention will now be further described with reference to the preferred embodiments, which are understood by those skilled in the art.
Various additions, deletions and changes can be made without departing from the scope of
Will become clear. <Best Mode for Carrying Out the Invention> The present invention obtains medical information from a patient and displays the information in an intuitive format to a doctor.
A method and system for spraying. This intuitive format
Physician reading the played information quickly perceives the importance of changing values for the patient
Therefore, it can be called a medical process diagram. Medical
Process diagrams take advantage of advances in research on cognition for non-anesthetic components
Developed by others in the field. Research in applied human factors has aimed to reduce human error
Same as high-risk environments such as operating rooms (eg nuclear control rooms and flight decks)
Focus on the use of graphic displays in high risk environments such as
Has been. The success of a medical process diagram depends on the cognitive needs of the operator.
How well the semantics are mapped to the graphic elements of the display
It is thought to be a function. Use accepted task analysis methods to
How the teacher interprets the physiological data of oxygen transport to diagnose pathological conditions,
A system was developed to explain to patients how to take appropriate regulatory measures.
More information will be provided in an effort to produce more data that the physician needs to interpret.
A set of object displays to serve has been developed. A set of display objects are: 1) the relationship of data to other data, 2
) Data in context, 3) Reference frame of data, 4) Ratio of information change to data
, And 5) Developed to illustrate information about events. Specifically, cis
The system was developed to present physicians with the physiology of oxygen delivery. This system is
Data acquisition hardware, computer, oxygen transport calculation software and objects
Use the Vect Display software. One example is detailed below.
As you can see, the object display software is an oxygen transport calculator.
A set of four objects that describe the physiology of oxygen transport using data provided by ware.
Build a project. Unfortunately, the current practice of presenting physiological data to physicians in critical care
The display system is highly cognitive to the physician to interpret the data.
I have to work hard. In contrast, the display system described below
Grab complex data using alumistic cues and perceptual diagrams.
Map to Fick formula. Next, these data maps solve the physiology of oxygen transport.
Displayed to match the mental model used by the doctor to release
It The system receives an analog signal from the patient and then some physiological
The patient data is used to drive the display in real time as the volume is calculated.
It is used for As noted above, the present invention is directed to ventilators, anesthesia machines, partial or total fluid replacement.
This along with various medical devices such as the Qi system, cardiac mechanics monitor and cardiopulmonary bypass
It can be used in association with the above. More generally, the present invention relates to operating rooms and intensive care units.
It can be used in conjunction with the computerized laboratory information system found in.
In the preferred embodiment, there are one or two displayed parameters or values.
One centralized display (ie video monitor), obtained from one or more devices
Transmitted. In another embodiment, the device is a stand-alone system with a self-contained display.
And work. Either way, the operator optimizes the presentation of the desired data
It is preferable to be able to manipulate the display parameters as follows. Operator
It will be appreciated that the appropriate device can be adjusted based on the data played. As for ventilators, this display is compatible with several systems currently in use.
Compatible. Volume-controlled timed ventilator or pressure-controlled timed ventilator
The gap is appropriate. As suggested above, conventional ventilators like these
Can be used in conjunction with the present invention and traditional gas or partial liquid ventilators
. Similarly, the present invention provides a variety of commercially available cardiopulmonary bypass devices or blood oxygen and
And hemoglobin monitoring devices (ie lung catheters, EKG).
It can be used. In another preferred embodiment, the display of the invention is a commercial integrated hemp.
Driven by drunk delivery and monitoring equipment. In yet another embodiment,
Closed circuit fluid such as the system described in WO 97/19719 described herein.
Can be used in conjunction with a body ventilation system. The selected medical system
Regardless of the type, those skilled in the art will appreciate the intuitive display of the parameters with which the present invention is relevant.
You will understand that it enables b. The book, as evidenced by the above
The inventive display is compatible with several types of medical devices. However
, And for the purpose of explanation, a new real-time oxygenation
Consider the display of oxygenation parameters in conjunction with the narizer. Related to the present invention
In the following description of the present invention, which is disclosed below, since only exemplary embodiments are disclosed, the scope of the present invention is
It should be understood that other variations within the enclosure are possible. Therefore,
The description is not limited to the particular embodiments described in detail below. I. Hardware System FIG. 1 is constructed in accordance with an embodiment of the present invention directed to measuring oxygenation parameters.
1 illustrates a system 10 that has been installed. The set of probes 12 includes various types of probes associated with the patient 14.
Connected to a monitoring activity, such as a heart rate probe 12a
It These probes are well-known and commonly monitor activity.
Generate a representative analog signal 16. The signal 16 is a well-known signal from the data conversion module 20.
Generates a digital signal corresponding to the analog signal 16 through the A / D device 18
To be converted. This data is available on the data bus 22. The processing module 24 produces usable quantitative measurements of patient activity.
Not only the target display, but (1) specific data for other data
Data; (2) present data in context; (3) data in the reference frame
(4) measuring the conversion rate of data information; and / or (5)
The data is processed on bus 22 for sending and comparing presentations of elephant information. One embodiment of module 24 therefore analyzes and analyzes the data input from probe 12.
And / or a plurality of data processing sections 26 for quantifying. For example, 1 sex
26a is connected to the probe 12a by a data chain and is in the form of a digital word.
Process the data on bus 22 to give an indication of the heart rate at. The patient's heart rate has changed
When converted, the digital word changes. Memory module 28, module 24
A device that supports heart rate activity, including a record of the patient's heart rate and
Used to store selection data, such as digital words. Memory 28
In addition, the nominal value of the data that compares the data with the reference frame and the extreme value that represents the threshold of the desired patient
It also stores such information. Display driver section 30 is in section 26
Connected and, therefore, display heart rate data in the context of the display.
Command to display on spray 32 and / or reference data in memory 28
Make it relative to the frame. The data from section 26 is also compared to other data within the evaluation module 34.
, Or can be associated with a recorded threshold. As an example, for probe 12a
Corresponding data is probed through the digital part process in module 34.
Can be compared against 12b. Continue to the driver 30 this related data
Can be commanded to be displayed on display 32. Another example is the rating module
34 can compare other data with the data stored in memory 28;
Also, if the comparison exceeds the set threshold, a warning event may be displayed on the display 32.
You can One of ordinary skill in the relevant arts will appreciate that a probe 12 may provide self-contained A / D conversion capability and data manipulation.
You should recognize that you may have a work. Moreover, such a probe is
It can easily be directly connected to the evaluation module 34 and the memory 28 by a known technique. The system 10 uses input from the user interface 36, such as a keyboard.
Display driver 30, and the display driver 30 displays the data on the display 32.
Format to seed purpose format 40. Therefore, − other data and specific data
Data-instructing the selected process within the evaluation module 34.
Will automatically display such data in the desired destination format.
It is displayed on i32. The special purpose format according to the present invention is described below.
It is as if it were. Preferably, these destination formats are comprehensive data files.
Displayed simultaneously on the same display to give the operator a lofi
Is preferred. 2 is a representative computer system that may be used with the system 10 of FIG.
Shows 155. System 155 is a network of stand-alone configurations or computer systems.
It can be operated as part of a network. System 155 collects data from the patient.
An integrated system that collects and displays processed data on a display for observation by a physician.
It is. The computer system 155 is a computer 160, such as Microsoft
Run in conjunction with an operating system, such as Windows 95, available from Corporation
Included blood-monitoring software. Other embodiments have different operating environments.
Alternatively, different computers or both may be used. In another embodiment of the invention, computer 160 is a wide area network (WAN).
) Through the connection, it is possible to connect to other doctors or hospitals. Another doctor
A WAN connection to a healthcare facility will provide a realistic view of the patient's progress during surgery or in the intensive care unit.
Im possible to consider. Referring again to FIG. 2, one embodiment of computer 160 is 300 MHz and 32 megabytes.
Intel Pentium or similar memory running on Mb RAM memory (not shown).
Including a black processor. System 155 is a hard disk connected to processor 170.
It includes a storage device 165, such as a disk drive. Hard drive 165 is a network
Option in the network configuration, that is, the workstation is a file server
Use a hard disk or other storage device. Computer 160 has a stand-alone configuration
The hard drive 165, if used, is preferably 100 Mb or higher.
Good However, the system is limited to a particular type of computer equipment
Not a thing. Which can operate the display system described here
Such computer equipment is also expected to work within the scope of the present invention. The computer 160 is configured integrally with the computer peripheral device group, and
VGA (Video Graphic Array) display that provides display output for the System 155
Ray standard, or better, connected to a color video monitor. Disp
The Ray 175 may be a 17 inch monitor operated at 1024 x 768 pixels with 65,536 colors.
Keyboard 180 compatible with IBM AT type computers connected to computer 160
You may. A pointing device 185, such as a 2- or 3-button mouse, is also
It may be connected to the computer 160. The mouse usage description is a different type of pointing
It does not mean the elimination of the use of a gag device. The printer 190 is a hardcopy output, such as a printout for recording files.
Connected to give a way out. In one configuration, Colorado Memory
Jumbo 250Mb cartridge tape backup unit available from System
Such a backup device 195 is preferably connected to the computer 160. Stand-alone configuration, that is, as one of the workstations of network configuration
In another embodiment, system 155 is a laptop or notebook computer.
, Premium Executive 386SX / 20 available from AST Research and various sales
Portable computer, such as other computers available from vendors
May be included. A computer 160 for a portable computer (not shown)
Are equipped with components similar to those described in connection with. Programmed computer also runs with full or partial custom circuitry
It will be understood by one of ordinary skill in the art that what can be done. therefore,
The set of instruments selected should be considered as limiting in any way.
There is no. II. Software Many different ways of implementing the software of the present invention will be appreciated by those skilled in the art.
Will For example, Labview, C ++, Basic, Cobol, Fortran or Modula-2.
Uh, the programming language is one of the features of the present invention, one software package
Can be used to integrate into. Another way to describe the software of the present invention is to
Patient PvO in real time ₂ Spreadsheet program to collect and measure
Is to use. This method is described in detail below. A. Blood Gas Level Measurements As mentioned above, the system and method of the present invention collects data from a patient and provides
Time measures various tissue oxygenation parameters of the patient. The software is
Used to indicate process. Those skilled in the art will find that the desired parameter is
Obtained using various software structures written in any one of
Will make sure you can lay. FIG. 3 discloses the disclosed method and system.
5 illustrates a software scheme that can be used with the. As shown in FIG. 3, when the start signal is in the start state 200, the system is operated by the user.
The process is started when it is sent to the mobile phone. Start signal opens the collection of data
Can be a keystroke of a mouse command that launches the software to initiate
You can After receiving the start command in state 200, the arterial pressure data is in state 202
Collected from patients at. As is well known, the arterial pressure data can
It can be collected by connecting. Once the data is collected from the patient in state 202, “in range data”
Is determined in the determination state 204. At this stage, the software has been collected in state 202.
The data collected is compared to a known and suitable range of arterial pressure values. Suitable for arterial pressure data
The range is, for example, between 70/40 and 250/140. The data collected in process state 200 is within the range programmed in decision state 204
If not, or if the arterial pressure undulation is abnormal, the error / exception process
The process routine begins at state 206. The error process routine in state 206
Software loops back to process state 202 to recollect pulse pressure data
To do. In this way, incorrect arterial data readings are
Is not passed. If the data collected in process state 202 is relevant in decision state 204.
When in the critical range, the software pointer will direct you to collect arterial pressure.
To process state 208, which includes Preferably, the data collected is the body of the patient.
Temperature, arterial blood pH, hemoglobin level, PaO ₂ And PaCO ₂ Is included. In addition,
Can provide information about the patient's blood gas levels, acid-base status and hematology status.
Preferably, it is produced by an attached blood chemistry monitor. Such an example
In, the data receives the data stream through the series connection from the blood chemistry monitor
By being collected in the computer. Alternatively, the associated value is the key
It can be obtained from access data manually entered from the board. As mentioned above, blood chemistry monitors continuously sample arterial blood from a patient.
However, it is preferred to measure some characteristics of the patient's blood from each sample. Professional
The data corresponding to each characteristic collected from the blood chemistry monitor in process state 208 is judged.
It is checked in the state 210 whether it is within the range. A suitable range of pH is 7.15 to 7.65
Is. A suitable range of hemoglobin levels is 0 to 16 g / dl. PCO ₂ Suitable for
Range is from 15mmHg to 75mmHg, while PaO ₂ Suitable range for is 50mmHg to 650mmH
It is g. If at decision state 210 the data is not within the proper range for each particular variable, then at state 212
The error / exception process routine is started. Error / Exception process in state 212
The routine collects the variables collected in state 208 to determine if they are in range.
Analyze each. Error if the selected variables collected in state 208 are not in the proper range
/ The exception process routine 212 uses software to ensure accurate data is collected.
Loop back the pointer to state 208. Range of the selected data in judgment box 210
If yes, then the software has previously
To heart rate output (CO) together with CaO ₂ Get the value. As mentioned above, heart rate output can also be obtained from arterial pressure measurements by several methods.
It For example, TNO Biochemical's Model flow system uses arterial pressure signals for real-time
Im can obtain heartbeat output. Other methods mentioned above measure heart rate output
It is also used in process step 214. Once the heart rate output value is
Patient's total oxygen delivery (DO ₂ ) In process step 215
can get. As mentioned above, the patient's total oxygen delivery depends on heart rate output and arterial oxygen content.
Is the product of This parameter is displayed arbitrarily and is also determined by the decision state 217.
As shown, the software terminates the program when it receives a stop command.
Can be completed. However, in decision state 217, data collection may be stopped.
In case the software does not receive keyboard or mouse input,
Then point the program to process state 216 to get further parameters.
It In particular, process state 216 is the patient's VO ₂ Related to the measurement or input of. Patient VO ₂ Should be measured by attaching a suitable ventilator to the patient and
Measuring oxygen uptake through a system like the Physioflex described above or Sensormedi
Numerous other devices, such as the system manufactured by cs and Puritan Bennett
Can be calculated using Ventilator by measuring oxygen inspiration and expiration
Can also be used to calculate the total amount of oxygen absorbed by the patient.
Patient step VO in process step 216 ₂ After the values have been measured, set these variables to state 218
Apply to Fick's formula in real-time CVO ₂ To get Fick's formula is given above. Once CvO ₂ , The mixed venous blood oxyhemoglobin saturation (SvO ₂ ) Mixed with
Pulse oxygen tension (PvO ₂ ) Is obtained in state 220. Mixed veins as described above
Blood pH and PCO ₂ Value of Kelma for limiting the position of the oxyhemoglobin dissociation curve.
Arterial blood pH and PaCO used with other variables in the n formula ₂ Related to each
Inferred to have a constant (but mutable). Alternatively, these values
An algorithm is obtained for the calculation of. If you know the Hb concentration, PvO ₂ Is obtained, and
Then CvO determined by Fick's formula ₂ Total CvO equal to ₂ (From Hb, plasma and PFC
(Including the contribution of). CvO ₂ If the value “does not fit” Fick's formula, then another Pv
O ₂ Select a value. This process is balanced by Fick's formula and is a true PvO. ₂ Until you understand
Is repeated. Those skilled in the art will use the same formula and algorithm to mix venous blood oxyhemoglobin saturation SvO ₂ Recognize that it can be used to obtain and optionally display
Will That is, SvO ₂ Is PvO ₂ Is closely related to
This means that it can be easily obtained from the moglobin dissociation curve. This is
, And even PvO ₂ Similarly SvO ₂ Monitor the patient's oxygenation status if desired by the clinician.
It can be used as a trigger and as an intervention trigger.
Will be recognized. As mentioned above, the mixed venous blood oxyhemoglobin saturation is
Volume alone or, more preferably, in combination with other derived parameters.
Can be used. PvO ₂ , SvO ₂ Or, after you have obtained the values for both, enter that value or both values in Step 22.
2 can be displayed on the computer. Software collects data in state 224
If you do not receive keyboard or mouse input to stop the
The interface loops the program back to process state 202 and starts the arterial pressure data again.
Data collection is started. This way the real-time data loop will continue
The patient's mixed venous oxygen tension (PvO ₂ ) Or saturation (SvO ₂ ) Has a status of 222
Updated and displayed on the computer. If the software is in decision state 224,
If a stop command is received from the keyboard or mouse input,
The post-termination routine 228 is started. B. Calculation of oxygen delivery values The following systems collect information from patients and ₂ , SvO ₂ , And DO ₂ Places containing
Large Microsoft EXCEL® Spread to display desired parameters
I'm using a do seat. Receive real-time input of cardiovascular and oxygenation variables
Previously, a number of oxygenation constants were entered into the system. These constants are preferably
, Estimated patient blood volume, oxygen solubility in plasma and acid in 1 g of saturated oxyhemoglobin
Including elementary content. At that time, store the oxygenation constant in the memory of the computer, and later
Used to calculate. Table 1 collects patient data and also obtains values for desired oxygenation parameters from Microso
ft EXCEL® Shows commands from a portion of the spreadsheet. Program
Assigns names to various oxygenation constants used throughout the software.
It will be initialized. In the example shown here, blood volume (BV), perf
Oxygen solubility (O2SOL) of Luorocarbon emulsion, either perfluoro
Specific gravity of carbon emulsion (SGPFOB) in perfluorocarbon emulsion
Intravascular half-life (HL) of perfluorocarbon emulsion weight / volume (CONC),
Atmospheric pressure (BARO) at sea level, oxygen ml / saturated hemoglobin g (HbO), and oxygen ml / 100 ml blood
All oxygenation constants corresponding to plasma / 100 mm mercury (PIO) are entered. Perfluoroca
Carbon-related blood is associated with perfluorocarbons when administered to patients
A constant is entered. An example of starting values for the Kelman constant for a subset of oxygenation constants is also shown in Table 1.
It These starting values are based on the patient's mixed venous oxygenation status or mixed venous blood oxygenation.
For later calculations to obtain other desired parameters such as saturation
Can be The Kelman constant, like the other oxygenation constants, is also as shown in Table 1.
Be assigned.

[Table 1]                                 table 1 ┌──────────────────────┬───────────┐ │Assumption                                        │Starting value:      │ │ ├───────────┤ │Blood volume (ml / kg) ・ BV │70 │ │ O in PFB₂Solubility (ml / dl @ 37 ℃) −O2SOL │52.7 │ │ Specific gravity of PFDB − SGPFOB │ 1.92 │ │Intravascular half-life (hours) of Oxygent HT −HL │ = 1/2 life of Oxygent │PFOB emulsion weight / volume / 100− │0.6 │ │CONC │760 │ │ Barometric pressure @ Sea level − BARO │ 1.34 │ │ ml O₂Per g saturated Hb-HbO │0.3 │ │ ml O₂Every 100 ml Plasma 100 mm Hg Saturated Hb-HlO │ │ │ ├──────────────────────┼───────────┤ │ ├───────────┤ └──────────────────────┴───────────┘ KELMAN constant:                                 Starting value:                                               ┌───────────┐  Ka1 │ = -8.5322289 * 1000 │  Ka2 │ = 2.121401 * 1000 │  Ka3 │ = -6.7073989 * 10 │  Ka4 │ = 9.3596087 * 100000 │  Ka5 │ = -3.1346258 * 10000 │  Ka6 │ = 2.3961674 * 1000 │  Ka7 │-67.104406 │                                               └───────────┘   After the oxygenation constants, including Kelman's constant, assign a name, arterial pressure line and blood
The real-time input from the liquid chemistry monitor is initialized and begins supplying data. Table 2
The system described in this example, as shown in FIG.
Sum percentage (SaO₂) Induces or receives data related to Special
In addition, the saturation percentage is the oxygen tension (PaO₂), PH (pHa), carbon dioxide tension (PaCO ₂ ), And body temperature (TEMP) arterial blood data. The invention, if desired by the clinician
SvO for use in monitoring tissue oxygenation status in patients.₂Value (calculated Pv
O₂, PHv, PvCO₂And a real-time display of values obtained from body temperature). The above
Street, PvCO₂The values of pH and pHv are determined by the algorithm, respectively, by a fixed amount.
PaCO₂And is related to the value of pHa. Heart rate output (CO) is also VO₂Entered to be
Be done. FIG. 4 provides a schematic representation of this procedure and the resulting data.   When Hb concentration, arterial blood gas and acid / base parameters are entered into the program (
O, both automatically and manually) in both erythrocyte and plasma phases containing Hb₂Supply and consumption
It is possible to measure variables. Variables for PFC (for blood substitutes),
It is also possible to measure variables related to Hb-based oxygen carriers.   Again referring to Figure 4, CaO₂Useful values for calculating Hb concentration, arterial oxygen tension (PaO ₂ ), Arterial blood carbon dioxide tension (PaCO₂), Arterial blood pH (pHa) and body temperature. oxygen
-The position of the hemoglobin dissociation curve is the Ke entered in the program as the oxygenation constant.
It is calculated using the lman formula. These calculations are described here as a precedent
Comprehensive Severinghaus (J. Appl. Physiol. 1966, 21: 11088-1116)
Indistinguishable from the proposed parent curve, O₂Produces a curve that spans the physiological range of tension
. As shown in the schematic diagram in Fig. 4, Hb, plasma, and fluorocarbon must meet Fick's equation.
PvO, resulting in the required mixed venous oxygen content in Bonn₂ (SvO₂Through
Iterative methods can be used to calculate).

[Table 2]

[Table 3]

[Table 4] Based on the numbers supplied, the program can
Calculate oxygenation parameters like vO ₂ and SvO ₂ . These values are then fed into the display system described below to generate the perceptual diagram. These diagrams are used by physicians, for example, to determine when to transfuse a patient or to change clinical management of a patient. The displayed values can also be used to monitor the physiological effects of blood transfusions that deliver hemoglobin or perfluorinated chemicals. Tables 3 and 4 are additional information demonstrating the utility and applicability provided by the present invention. In particular, Table 3 provides various oxygenation values calculated using the methods disclosed herein and Table 4 provides indicators of oxygen consumption and oxygen delivery that are useful in optimal patient treatment. A closer examination of Table 3 shows that the system of the present invention can be used to provide the individual oxygen content of different components in a mixed oxygen delivery system. In particular, Table 3 provides calculations to give the oxygen content of arterial blood or venous blood which calculates hemoglobin, plasma and fluorinated drugs respectively. Such values may be particularly useful when intravenously transfusing a fluorinated drug emulsion blood substitute associated with a surgical procedure. Table 4 illustrates that the present invention may be used to provide real-time information on oxygen consumption and delivery. As mentioned above, Hb or Hct measurements are
Not a proper reflection of tissue oxygenation. This is the total oxygen delivery to the tissues used (
It does not provide information on DO ₂ ) but only indicates the potential arterial O ₂ content (CaO ₂ ). However, as shown in Table 4, the present invention solves this problem by providing oxygen delivery information online based on CaO ₂ and cardiac output (CO). Heart rate output is currently calculated using thermodilution and CaO ₂ is calculated by calculating arterial blood oxyhemoglobin saturation (SaO ₂ ) and hemoglobin levels and inserting these values into the following equation: : CaO ₂ = ([Hb] × 1.34 × SaO ₂ ) + (PaO ₂ × 0.003),
Here, [Hb] = hemoglobin concentration (g / dl unit); 1.34 = 1 g of fully saturated hemoglobin
Oxygen delivery in the medium; PaO ₂ = arterial pressure; and 0.003 is the oxygen delivery by plasma (per deciliter per oxygen pressure mmHg). The present invention combines the continuous heart rate output algorithm with Kelman's equation which gives the position of the oxygen hemoglobin dissociation curve. With on-line and off-line inputs of body temperature, hemoglobin and venous blood gas, the present invention can trend DO ₂ on a continuous basis. The factors used to measure DO ₂ are displayed along with their product; thus, the etiology of decreased DO ₂ (insufficient cardiac output, anemia, or hypoxia) is It is readily apparent, the decision on the appropriate intervention can be made quickly, and the outcome of the procedure is clear and easy to follow. More specifically, the preferred embodiment of the invention provides real-time DO ₂ , arterial blood gas,
Using to provide and display hemoglobin concentration and CO (also other hemodynamic data already discussed such as BP, heart rate, systemic vascular resistance, velocity pressure product and heart work) You can As shown in Table 3, this example also shows that Hb
, Can give individual readouts of the contribution of plasma and PFC (if in circulation) to DO ₂ . That is, the oxygen contribution of each component can be accurately monitored and adjusted throughout some therapeutic diet. Such data would be particularly useful in both OR and ICU to provide a safe cushion for patient oxygenation. The importance of maximizing DO ₂ for a particular patient in the ICU has been highlighted by recent studies. The present invention can also be used to determine when such interventions are indicated and provide the necessary data to achieve the desired outcome. Once DO ₂ is known, the maximum O ₂ consumption (VO ₂ ) that can be the basis for a particular (and also arterial blood) PvO ₂ can be calculated. As mentioned above, this value can be referred to as the deliverable oxygen amount (dDO ₂ ). For example, 36 mmHg of PvO ₂ is selected for a healthy 25-year-old patient, but 42 mmHg or More PvO ₂ will be needed. Oxygen consumption varies under anesthesia, but in most cases it is in the range of 1.5 to 2.5 ml / kg / min. If the VO ₂ sustainable in the chosen PvO ₂ was well above this range, then everything would be healthy and no intervention would be needed. The more deliverable VO ₂ approaches to a range of normal VO _2, intervention is more quickly taken into account. This relationship is used to give a single value based on deliverable oxygen (dDO ₂ ) versus oxygen consumption (VO ₂ ). As mentioned above, dDO ₂ is the amount of oxygen delivered to the tissue, which can be delivered before the venous oxygen partial pressure (PvO ₂ ) and the tissue oxygenation tension drops below a defined level. Thus, the PvO ₂ value is 40 (this number is
DO ₂ (and dDO ₂ ) should be kept at sufficient levels if desired not to drop below (depending on the general medical condition of the patient). The supply / demand ratio (dDO ₂ / VO ₂ ) for the selected PvO ₂ is given to give only one value indicating that the amount of oxygen applied is sufficient to maintain the desired oxygenation state. Can be used. For example, the dD required to hold 40 PvO ₂
Assuming that O ₂ is 300 ml / min and the actual measurement (VO ₂ ) is 200 ml / min, it can be seen that the patient is supplied with sufficient oxygen required. That is, the supply / demand ratio is 300 ml / min / 200 ml / min or 1.5. A supply / demand ratio of 1 means that PvO ₂ (or other particular parameter, eg SvO ₂ ) is at the selected trigger value (here 40 mmHg). Conversely, when dDO ₂ (deliverable oxygen amount) is 200 ml / min and VO ₂ (oxygen consumption amount) is 300 ml / min, the ratio is 0.66, and the patient cannot obtain sufficient oxygen ( That is, PvO ₂ is 40 or less). By continuously monitoring and displaying this ratio, the clinician will be able to observe values approaching 1 and intervene appropriately. III. Display of Objects for Physiological Numerical Values As mentioned above, the computer system 155 of FIG. 2 includes software and system for displaying a medical process diagram for the calculated values. The display system collects oxygen delivery values and creates a display object that is presented to the physician. Some data are derived from reading raw analog or digital data from the patient's monitor, but many numbers can be read from the calculated data, as shown in Tables 1-4. The system samples the data 200 times per second and updates the display every 2 seconds. However, the system allows for faster sampling and display updates to present the doctor with the latest data. As mentioned above, the perceptual diagram constitutes a series of data objects that represent the physiological processes of the body. Examples of these data objects include red blood cell objects, heart pump objects, vascular resistance objects, alveolar-arterial blood objects, acid-base objects, and metabolic objects. These objects are displayed alone or together to provide a physiological diagram of the patient's oxygen delivery system, as described below. C. Red Blood Cell Object This graphical display object contains information on the amount of red blood cells (as hemoglobin), the oxygen loading of red blood cells (as percent oxygen saturation), and the oxygen content (using the accepted formula). The size of the circle correlates with hemoglobin. The black circles from the bottom correlate with oxygen saturation. The product of hemoglobin and oxygen saturation correlates with the oxygen content (CaO ₂ ) pointer on the left. Specifically, in FIG. 5, the red blood cell object 300 displays information regarding the amount of hemoglobin in the patient's blood, the amount of oxygen loaded on the red blood cells, the temperature effect of blood viscosity, and the oxygen content of blood. In some circumstances, this relationship is defined by the following formula: arterial oxygen content = (arterial oxygen saturation) × (hemoglobin) × 1.
34. In FIG. 5, the arterial blood saturation is classified as “SaO ₂ ” and the hemoglobin is “HB”.
And the arterial oxygen content is classified as “CaO ₂ ”. These red blood cell related values are then paired into a perceptual diagram (eg, computer display 32 of FIG. 1). 5, the arterial blood part 314 and the venous blood part 316 of the red blood cell object 300 are present, as shown in Fig. 5. In the arterial blood part 314, the CaO ₂ value of the patient is a rhombus. Indicated by 320, Y
Maps to the axis. The patient's hemoglobin level, the volume percentage of red blood cells in whole blood, is mapped on the X-axis. In the venous section 316, the patient's CvO ₂ is indicated by the diamond 330 and is mapped to the Y axis. Hemoglobin levels are mapped on the X axis. The non-coaxial circles 310a, b are made using the Y-axis to define the tangents along the left endpoints 340a, b of the non-coaxial circles 310a, b. Each non-coaxial circle has a similar left end point 340a along the Y axis.
, B are included. As the level of arterial oxygen increases, CaO ₂ diamonds 320 move up along the Y-axis. The horizontal oxygen extraction line 350 defines the upper boundary of the shaded area 360 formed on the arterial red blood cell type object 310a and indicates the level of arterial oxygenation. Red blood cell type objects 310a, b, as illustrated in FIG. 5 which illustrates the percentage of patients' red blood cells filled with oxygen (eg, half shaded, cells are half filled with oxygen). Can be partially or totally shaded. As the patient's hemoglobin (Hb) level increases, the shadows also increase with respect to the circumference of the red blood cell type objects 310a, b. Similarly, for the venous red blood cell type object 310b, as the venous oxygenation level in the patient rises and falls, the CvO ₂ diamond 330 moves up and down along the Y axis. When the CvO ₂ rhombus 330 moves upward and downward, the amount of the shaded area 370 changes within the formation of the venous blood red blood cell type object 310b. Thus, venous oxygenation of the annulus of the blood vessel is quickly shown to the physician. Relatively shaded areas 360 (arterial blood side) and 362 (
The venous blood side) reveals a rapid perceptual understanding of oxygen extraction when the oxygen content of arterial blood and venous blood are compared. As is well known, oxygen extraction = (arterial blood oxygen content) · (venous blood oxygen content). Thus, by comparing the opposing shaded areas of the red blood cells that form the red blood cell type object 310a and 310b, the physician can perceptually understand the patient's oxygen extraction. The oxygen extraction line 350 extends from the arterial blood cell 310a to the oxygen extraction slide scale 364. The oxygen extraction slide scale 364 holds the CvO ₂ diamond 330 at the lower border. As the CaO ₂ level increases, the oxygen extraction slide scale 364 increases. Similarly, as the level of CvO ₂ falls, the oxygen extraction slide scale 364 also rises. This makes sense, as it is expected that the oxygen extraction will increase due to increased arterial oxygen tension or decreased venous oxygen tension. The physician may therefore refer to the Oxygen Extraction Slide Scale 364 to quickly measure oxygen extraction on behalf of the patient. The method by which the red blood cell object 300 mimics the actual in-vivo action of red blood cells makes the red blood cell object 300 extremely intuitive for a physician. In FIG. 6, the process 370 of updating the red blood cell object 300 begins at 372.
Begins with. The process 370 then transitions to a state 374 where the patient's CaO ₂ value is read. As mentioned above, this value can be read from some form of data table or memory storage of the computer system. When the CaO ₂ value is read in state 374, process 370 determines if the CaO ₂ value has changed from the last sampling,
Go to decision state 376 to make a decision. When the CaO ₂ value is changing, process 370 determines whether the CaO ₂ value is increasing or decreasing to determine state 378.
Move to. When the CaO ₂ value is increasing, the CaO ₂ indicator 320 and the oxygen extraction line 350 move vertically up along the Y axis in state 382. However, when the CaO ₂ value is decreasing, the process 370 causes the CaO ₂ indicator 320 and the oxygen extraction line 35.
0 transitions to state 380, which is a downward movement along the Y axis in state 382. Process 370 then transitions to state 384, which reads the CvO ₂ value. Next, determine whether the CvO ₂ value has changed since the last data sampling.
Judge with 6. If the value has changed, process 370 transitions to decision state 387 to determine if the CvO ₂ value is increasing or decreasing. If it is determined that the CvO ₂ value is increasing, the process 370 transitions to a state 390 where the CvO ₂ indicator 330 moves upward along the Y axis. Similarly, if the determination is at decision state 387 that the CvO ₂ value is decreasing, then process 370 transitions to state 389 where CvO ₂ indicator 330 transitions downward along the Y axis. Process 370 then transitions to state 391 where the patient's hemoglobin value is read. Process 370 then transitions to decision state 392 to determine if the hemoglobin value has changed since the last sampling. If it is determined that the hemoglobin level is changing, the process 370 transitions to a decision state 394, which determines if the hemoglobin value has increased or decreased. If the hemoglobin level is increasing, the process 370 transitions to state 397 where the shaded area 360 increases in size to indicate a large amount of red blood cells in the patient's blood. However, if the decision state 394 is a decision that the hemoglobin level is decreasing, then the process 370 transitions to the state 395 where the shaded areas 360-362 are circumferentially reduced. The process 370 ends at end 399. Cardiac Pump Object A graphical display object contains information about blood flow (as a cardiac output), pulse rate (generated from an arterial blood transducer) and stroke volume (using an acceptable equation). The resulting rectangle (defined by pulse rate and stroke volume) is filled black during diastole of the cardiac cycle. During systole of the cardiac cycle, the rectangle empties from top to bottom at a rate determined by its correlation with myocardial contractility (such as dP / dt). In particular, in FIG. 7, the heart pump object 400 shows the following relationship: Heart rate output = (stroke volume) × (heart rate). In one situation, the heart pump object 400 is shown as a rectangle 410, the extent of the rectangle 410 of which represents the patient's cardiac output. The volume of blood pumped with each stroke of the heart, the stroke volume (SV), is indicated by the diamond 420 on the X-axis. Heart rate (HR) is shown as a diamond 430 along the X axis. At each heart beat, heart rate and stroke volume were calculated and plotted in this diagram. The rectangle 410 is divided into a right ventricle (RV) metaphor 440 and a left ventricle (LV) metaphor 450 by dividing the size of the rectangle 410 in half along the X axis. The shape of the ventricle with low stroke volume will be represented by the short, wide rectangle 410, while the bradycardia shape of a normal SV is shown by the long, thin rectangle 410. Filling pressure or volume information, or (left and right) ventricular contractility, is presented in the form of a central venous pressure (CVP) analog gauge 452 and a pulmonary artery capillary wedge pressure (WP) analog gauge 454 located on the X-axis. For both analog meters 452, 454, the 12 o'clock position is defined as normal. Therefore, when CVP and WP are read as normal, the rectangle becomes a square. However, because the CVP analog meter 452 draws an arc along the X axis, the left side 456 of the rectangle 410 will bow outward or inward if the CVP read is not normal. If the left side 456 bows outward due to high CVP, it indicates a left ventricle that has inflated and filled. Similarly, when the left side 456 bows inward due to low CVP, it represents an empty, deflated left ventricle. As can be seen, the bulging shape of the left side 456 of the rectangle 410 quickly reminds us of the image of the in-vivo heart filled with blood. When the WP is not normal, the WP analog meter 454 draws an arc along the right side of the rectangle 410. As WP increases, it shows the patient's inflated and filled right ventricle and bulges outward.
In addition, as WP decreases, the WP analog meter 454 follows a corrugated arc along the right side 458, so that the right ventricle is depicted as an empty, deflated ventricle. Right side 458 and left side 456
Is in agreement with the image of the heart seen in the four longitudinal chambers using transesophageal echocardiography. Thus, noting the relative outside dimensions of rectangle 410 as well as the shape of its sides, it will be immediately apparent to the anesthesiologist if the right or left ventricle is deflated or swollen during surgery. FIG. 8 describes a process 460 of adjusting the heart pump object 400. The process 460 begins at start 462 and then transitions to state 463 where the stroke volume (SV) is read. As can be inferred, the stroke volume can be read by a computer system from a table or buffer. Process 460 then transitions to decision state 465 to determine if stroke volume has changed since the last read. If the stroke volume has changed, transition to decision state 466 to determine if the stroke volume has increased or decreased. If the stroke volume is decreasing, the process 460 transitions to state 468 where the stroke volume indicator 420 moves down along the Y axis. As the stroke volume indicator 420 moves downwards along the Y-axis, the shaded rectangle 410 contracts in height, as illustrated in FIG. If at decision state 466 a determination is made that stroke volume is increasing, then process 460 transitions to state 469 where:
The stroke volume indicator 420 moves upward along the Y-axis. Subsequently, this reduces the height of the shaded rectangle 410. Process 460 then transitions to state 470, where the patient's heart rate is read. Next, in the determination state 471, it is determined whether or not the heart rate has changed since the last reading. If the heart rate has changed since the last read, a determination is made at decision state 473 as to whether the heart rate is increasing or decreasing. If the heart rate is decreasing, process 460 transitions to state 474, where it moves left along the X axis of heart rate indicator heart pump object 400. However, if the decision state 473 determines that the heart rate is increasing, then the process 460 transitions to a state 475 where the heart rate indicator 430 is right along the X axis of the heart pump object 400. Move to. As can be considered in reviewing FIG. 7, as the heart rate indicator 430 moves horizontally along the X axis, the width of the shaded rectangle 410 increases and decreases accordingly. Process 460 then transitions to state 477, where the central venous pressure (CVP) value is read. At decision state 478, a determination is made whether the CVP has changed since the last read. If the CVP is changing, a determination is made at decision state 479 as to whether the CVP has increased or decreased. If CVP is decreasing, process 460 is in state 480
, Where the analog CVP gauge 452 moves along the planned arc. As described above, as the CVP analog gauge 452 moves to the right along the arc, the right ventricular metaphor 440 changes to indicate a less dilated ventricle. If decision state 479 determines that CVP is increasing, then process 460 transitions to state 482, where CVP analog gauge 452 moves to the left along its arc, to the left 456 of right ventricular metaphor 440. Begin to bulge outwards to show the inflated ventricle. Process 460 then transitions to state 483 where the wedge pressure (WP) value is read. Process 460 then transitions to decision state 485 to determine if the wedge pressure has not changed since the last read. If the wedge entry pressure is changing, a determination is made at decision state 486 as to whether the wedge entry pressure is increasing or decreasing. If the wedge pressure is decreasing, the process 460 transitions to state 488 where the wedge pressure analog gauge 45
4 moves left along the planned arc. As analog gauge 454 moves to the left, side 458 of left ventricular metaphor 450 becomes more recessed, indicating a less dilated ventricle. In addition, as the patient's heart rate (HR) changes, the WP analog gauge slides left along the X axis. When heart rate increases, the WP analog gauge slides to the right, but when HR decreases, the WP analog gauge slides to the left. However, if a determination is made at decision state 486 that the wedge pressure is increasing, then process 460 transitions to state 490 where wedge pressure gauge 454 moves to the right along the predetermined arc. As the wedge pressure analog gauge 454 moves to the right, as can be considered in the consideration of the heart pump object 400, the end 458 of the left ventricular metaphor 450 bends outward to indicate an inflated or expanded ventricle. The process 460 then ends at end 492. C. Vascular Resistance Object This graphical display object contains information about Ohm's law of flow. Perfusion pressure is displayed on the pressure scale on the left and is defined by mean arterial pressure (MAP) and central venous pressure (CVP). Blood flow is displayed on the pressure scale on the right and is defined by the cardiac output pointer (CO). Perfusion pressure and heart rate output are centralized, indicating systemic vascular resistance (SVR), such that when SVR is low, it is "dilated", and when SVR is high, the tube is "contracted". Coupled together using a meter. According to FIG. 9, the vascular resistance object 500 is used to display the blood flow corresponding to Ohm's law. This display is used by medical personnel during surgery to optimize the patient's hemodynamic physiology. The vascular resistance object 500 is represented by the following formula, mean arterial pressure / central venous pressure = heartbeat output × systemic vascular resistance. This data is used by the object 50 so that the shape of the "pipe" appears with a flow from left to right.
Displayed at 0. Two linear scales related to the blood pressure gradient and the actual heart rate output (l / min) are such that the systemic vascular resistance (S
VR) shown as a function. The set of two Y-axes is used to generate the vascular resistance object 500.
The left Y-axis includes mean arterial pressure (MAP) indicator 510 and central venous pressure (CVP) indicator 515. The blood input area 520 between the MAP indicator 510 and the CVP indicator 515 indicates the "inflow" of blood into the pipe. In contrast, the blood output area 521 shows the "outflow" from the pipe to the blood. The right Y-axis includes a cardiac output (CO) indicator 524 that reflects the calculated cardiac output of the patient. This is the outflow section of the pipe. The SVR analog gauge 528 is placed on the X axis connecting the left and right Y axes. When a normal SVR is set at the 3 o'clock position on the SVR analog gauge 528, the gauge moves down and the pipe opens when the reading is low. In contrast to this
If the SVR reading is high, the gauge moves up and the pipe closes as shown in FIG. In physiologic terms, increasing SVP decreases blood flow, as shown by a contracted pipe. Blood flow increases as SVP decreases, as shown by the open pipe. As MAP increases, the inflow increases and the overall blood flow also increases.
AP indicator 510 can affect the model. As can be imagined, the vascular resistance object 500 closely reflects the actual physiology of the patient. Thus, the vascular resistance object 500 is an intuitive object for deciphering a complicated situation of a patient. A process 53 for updating the vessel resistance object 500 with reference to FIG.
Explain 5. The process 535 starts at start 537 and then moves to 539 where the mean arterial pressure (MAP) is read. Next, in decision state 541, a determination is made whether the MAP has changed since the last reading. If the MAP is changing, process 535 moves to decision state 544 to determine if the MAP has risen or fallen. If the MAP drops, the process 535 moves to 544 and the MAP indicator 510 moves down along the Y axis of the vessel resistance object 500. However, if the decision state 542 determines that the MAP has risen, then the process 535 moves to 546 and the MAP indicator 510 moves upward along the X axis. As you can see from a review of Figure 9, the MAP indicator 5
As 10 moves up and down along the X axis, the area 520 also grows and shrinks. The process 535 then moves to 548 and the patient's central venous pressure is read. Then 550
At, it is determined whether the CVP has changed since the last reading. If the CVP has changed, process 535 moves to 552 and a determination is made as to whether the CVP has increased or decreased. If CVP drops. Process 535 moves to 554 and CVP indicator 515 moves down. If the decision state 552 determines that the CVP has risen, the process 535 moves to 556 and the CVP indicator 515 moves upward. Then the process
The 535 moves to 558 and the heart rate output (CO) is read. Next, in decision state 560, a determination is made whether the heart rate output has changed since the last reading. If the cardiac output has changed, the process 535 moves to a decision state 562 to make a determination as to whether the cardiac output has increased or decreased. If the cardiac output has decreased, the process 535 moves to 564 and the cardiac output indicator 524 moves down along the Y-axis. However, if in decision state 562 it is determined that the cardiac output has increased, then the process 535 moves to 568 and the cardiac output indicator 524 moves upward along the Y axis. The process 535 then moves to 570 and the systemic vascular resistance is read. Next, in decision state 572, a determination is made whether the systemic vascular resistance (SVR) has changed since the last reading. If the SVR has changed, then at decision state 574 a determination is made as to whether the SVR has increased or decreased since the last reading. If SVR has decreased, process 535 transfers to 578 and SVR analog gauge 528 moves to the right along a predetermined arc. Thus, as the patient's vascular resistance decreases, the vascular resistance object 500 represents a larger area of outward flow. If it is determined at decision state 574 that the SVR has increased, then process 535 moves to 580 and SVR analog gauge 528 moves left along a predetermined arc. As shown in FIG. 9, when the SVR analog gauge 528 moves to the left, the output area 521 of the blood vessel resistance object 500 decreases. The process 535 then ends at end 582. D. Metabolism Objects Graphical display objects for metabolic factories include oxygen delivery (DO ₂ ) (total), aerobic (oxygen burning) metabolic activity (oxygen consumption or VO ₂ ) and anoxic to cell factories. Includes information about metabolic activity (using relationships that suggest lactate production, in this case base deficiency). The data scale is arranged so that the oxygen supply can be compared to indicators of oxygen utilization and good condition of the cells. The metabolism object 600 will be described with reference to FIG. 11. Metabolism object 600
Displays the relationship of oxygen delivery (DO ₂ ) by showing the following equation: oxygen delivery = heart rate output × arterial oxygen content. Further, the metabolism object 600 can also indicate the oxygen utilization amount (VO2) by the following formula: oxygen utilization amount = arterial blood oxygen content-venous blood oxygen content. In normal patients, oxygen supply far exceeds oxygen consumption. Thus, the fulcrum or pivot 610 is used to illustrate the balance of oxygen supply (DO ₂ ) indicator 620 and oxygen demand (VO 2) indicator 630. The lever or balance line 640 moves between the DO ₂ indicator 620 and the VO ₂ indicator 630 and is balanced on the pivot 640. The inclination of the DO ₂ for VO ₂ is used to indicate the "balance" or association of more easy to understand DO ₂ and VO ₂ for the physician. In addition, anoxic metabolism and its associated acidosis negatively scale the scale, indicating that oxygen is supplied but cells are not utilizing it. A process 650 for updating the Metabolism object 600 will be described with reference to FIG. The process 650 begins at start 652 and then moves to 654 where the patient's blood oxygenation is read. The process 650 then moves to decision state 656 where the oxygen supply value (DO ₂ ) is reached.
A determination is made as to whether has changed since the last reading. If the oxygen supply value changes, process 650 moves to decision state 658 to determine if the patient's blood oxygen supply has increased or decreased. If the oxygen supply value decreases, the process 650 moves to 650 and the oxygen supply indicator 620 (FIG. 11) moves down along the Y axis. However, if the oxygen supply value increases, the process 650 moves to 662 and the oxygen supply indicator 620 moves upward along the Y axis. The process 650 then moves to 664 and the patient's oxygen demand value (VO ₂ ) is read. Once the oxygen demand value is read at 664, process 650 moves to 666 to determine if the oxygen demand value has changed since the last reading. If the oxygen demand has changed, the process 650 transitions to a decision state 668 to determine if the oxygen demand has risen or dropped. If the oxygen demand value drops, process 650 moves to 670 and oxygen demand indicator 630 (FIG. 11) moves downward along the Y-axis. However, if at decision state 668 it is determined that the oxygen demand has increased, the process 650 proceeds to 67
Moving to 2, the oxygen demand indicator 630 moves upward. The process 650 then ends at end 674. E. Alveolar Artery Partial Oxygen Gradient Object As shown in FIG. 14A, this graphical data display object 800 has an outline 802 showing lung units located on the left side, an outline 804 showing arteries located on the right side and an intermediate position Includes a scale 806 that represents a barrier to oxygen diffusion from the living lungs to blood. The pointer 808 on the left inside the "lung" indicates the partial pressure of alveolar oxygen using the ideal alveolar gas equation. Right pointer inside the "artery"
Reference numeral 810 represents the arterial oxygen partial pressure. The tendency is displayed on the left. The normal slope, represented as a green area on the scale, is based on the accepted equation (normal arterial oxygen content as a function of fractional oxygen inspiration). The line connecting the pointers indicates the slope. F. Data Box Graphic Element An exemplary data box graphic element 900 is shown in FIG. 14B. As shown in this example, the data box may have three sub-boxes: a number box 902, an alarm box 906 and a propensity box 904. Number boxes contain data values, data labels and data units. The alarm box contains a reference scale, a value pointer, and a normal zone encoded in a color (here 34 and 15) indicating the upper and lower limits of the alarm (usually green over green). Warning zones that can be set by the clinician are indicated by triangular areas. The pointer and number box change color in steps when the value falls into the alarm zone (eg, change to red).
Confidence intervals for the data are shown combining the thickness of the pointer tip with the accuracy of the measured variable. The propensity box shows the parameter values recorded during a particular time period. 1
It will be appreciated that some relevant parameters are displayed using multiple data boxes on one display. G. Acid Base Graph Object FIG. 14C illustrates an exemplary acid base object 950. One of ordinary skill in the art will appreciate that the acid-base objects represent the relevant metabolic and respiratory components of Henderson-Hasselback on the x, y graph 952. PH diagonal 954 on the reference grid
Is shown. The colored markings are used to encode normal zones 958, 956 and 960 for bicarbonate, carbon dioxide partial pressure and pH, respectively. The use of bicarbonate and carbon dioxide allows clinicians to understand the two major components of the acid-base system that can be treated with IV sodium bicarbonate and ventilation exchange. H. Aggregation of Data Objects into an Integrated Display Figure 13 illustrates one embodiment of a display having data objects 300, 400, 500 and 600, respectively. The data object is that oxygen is transported from the left ventricle of the heart pump object 400 through the vascular resistance 500 (eg, capillary cells) to the arterial blood cells 310a, and oxygen is delivered by the tissue cells (object 600) to the venous blood cells 310b. Are arranged in the pattern shown to create a circuit that indicates returning to the right ventricle 440 through. Thus, a complete illustration of the oxygenation cycle is provided in a very intuitive way by the object associations in FIG. I. Boundary Information All scales used to map values to indicators and gauges preferably have normal and abnormal zones (preferably tintable or tinted zones). Thus, the indicator can change color when the patient is in the danger zone. The alert zones are selectable so that the physician can make the alert more or less severe based on the physiology of the particular patient. In this way, the user sets a value above or below the critical threshold at the point where he wants the alert to be issued. When falling into the warning zone, the indicator begins to change color in steps and begins to flash, the clearer the red color of the indicator, the closer the value is to that threshold. Of course, the indicator can be changed in various ways to alert the physician that an abnormal zone has been encountered. The present invention should not be configured to be limited by any particular notification method. J. Information on Confidence Intervals When the accuracy and bias of the measured data channel is revealed,
The pointer tip is assembled on the appropriate value, but preferably has a thickness that contacts the scale and covers the known errors associated with that data. This creates a pointer that changes color and falls into a danger zone based on less favorable scenes. K. Trend Information Trend information includes, for example, a set of "cards" on a time scale on the z-axis or the X-axis. Values exceeding the time interval selected by the user are displayed and the resolution (sampling rate) of the data becomes visible. L. Normalization of information Since the variability between patients is significant and the physiological state of patients changes in settings such as surgery (definition of what should be normal changes, etc.), the value indicating the reference frame is You can change the size or scale with the command. For example, the "normal" SVR setting for the SVR object 550 of FIG. 9 can default to 1000 at the 3 o'clock position. However, if the patient's SVR is typically 2000, this feature allows the normal 3 o'clock position of the SVR analog gauge to be reset to 2000. M. Artifact Detection and Signal Quality Information Viewing analog signals on a given data channel provides a great deal of information on signal quality. Therefore, like the propensity window, the pop-up window next to the data pointer can be used to detect information about noise or artifacts. For example, a popup window can be launched by clicking on the data pointer. N. Information about the patient's illness If necessary, you can save the data about the condition of the illness and reset the defaults for boundaries. For example, hypertension shifts the automatic control curve to the right so that many physicians can maintain blood pressure in a higher than normal range. Pilot Studies A pilot study was conducted to test the hypothesis that a set of developed object displays would improve the anesthesiologist's ability to solve problems such as acute hypotension. Subjects: All subjects were anesthesiologists (N = 10) in the final year of training or attending level. Each physician had over 3 months of experience in providing cardiac anesthesia. Test parameters: 5 patterns of shock (anaphylactic shock, bradycardic shock, hypovolemic shock, cardiogenic shock and shock secondary to pulmonary embolism) and near 5 patterns of shock (MAP-CVP 60-70 mmHg , But the other five were shown to be in shock).
Twenty "flash cards" (one set of standard display card and one set of graphic display card) were generated using the data set. FIG. 14 is an example of one flash card from a test showing anaphylaxis. The hardware consisted of a computer workstation with a 21-inch touch screen monitor. The analyte test was a software application written in LabView. The application "shuffles" the cards and randomizes the order in which they are presented to subjects. When the application is started (comprising the test), the next display is hidden on the screen with the button "Next". When the subject touches this button, the image on the first display appears and the subject must choose from five buttons (no problem, anaphylaxis, bradycardia, reduced blood flow, ischemia and pulmonary embolism). Next, a screen appears with a "Next" button, and touching the button advances to the next card.
This is done for all 20 cards. A computer's internal clock is used to measure problem (shock) recognition speed and accuracy and pattern recognition (pathogenesis) speed and accuracy. Subjects were surveyed before and after the study. We found that the resident could recognize the problem 30% faster than the traditional display. In addition, the resident was able to identify patient patterns 25% faster than with traditional displays. We have found that there is no difference in accuracy. The total training time was about 30 minutes. Conclusion Traditional displays presenting physiological data to physicians engaged in critical care require physicians to perform significant cognitive work to interpret that data. The display system disclosed herein provides visual memory cues to graphically map complex data to a display that matches the mental model used by physicians to interpret the physiology of oxygen transport. The system receives the analog signal and activates the display in real time. Alarm conditions can be set by the doctor and can be viewed with the naked eye at any time. The danger zone, which creates a red shade on the data pointer, is easy for doctors to understand (doctors are used to using fuzzy theory to interpret data). Moreover, the way the data elements are constructed and displayed yields a perceptual diagram. The shape itself provides the physician with a very high level of information regarding the physiology of oxygen delivery.

[Procedure Amendment 2]

[Document name to be amended] Statement

[Name of item to be corrected] Brief description of the drawing

[Correction method] Change

[Contents of correction]

[Brief description of drawings]

FIG. 1 is a schematic diagram illustrating one system for oxygen transport physiology collection, processing, and display configured in accordance with an embodiment of the present invention.

[Fig. 2]   1 is a schematic diagram of a computer system used to operate the present invention.

FIG. 3 is a flowchart detailing a preferred software scheme used to operate the present invention.

FIG. 4 is a schematic diagram of data entry and operations performed in selected embodiments of the present invention.

[Figure 5]   1 illustrates an example of a red blood cell object.

6 is a flow chart illustrating one method of updating the display of the red blood cell object of FIG.

[Figure 7]   1 illustrates an example of a heart pump object.

[Figure 8]   8 illustrates one method of updating the display of the cardiac pump object of FIG.

[Figure 9]   3 illustrates an example of a vascular resistance object.

[Figure 10]   10 illustrates one method of updating the display of the vascular resistance object of FIG.

FIG. 11   1 shows an example of a metabolic object.

[Fig. 12]   12 illustrates one method of updating the display of the metabolic object of FIG.

FIG. 13 shows a display representing a circuit for displaying physiological data.
In one example, the display includes a heart pump object, a vascular resistance object, a red blood cell object and a metabolic object.

FIG. 14 shows selected object displays and elements compatible with the present invention. More specifically, FIG. 14A shows an alveolar blood pressure oxygen gradient object, FIG.
4B shows a graphic element of the data box, and FIG. 14C shows an acid-base graph object.

[Procedure 3]

[Document name to be corrected] Drawing

[Correction target item name] All drawings

[Correction method] Change

[Contents of correction]

[Fig. 2]

[Figure 3]

[Figure 6]

[Figure 8]

[Figure 10]

[Fig. 12]

[Procedure for Amendment] Submission for translation of Article 34 Amendment of Patent Cooperation Treaty

[Submission date] March 23, 2000 (2000.3.23)

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be amended] Claims

[Correction method] Change

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[Claims]

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, SD, SZ, UG, ZW), EA (AM , AZ, BY, KG, KZ, MD, RU, TJ, TM) , AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, D K, EE, ES, FI, GB, GD, GE, GH, GM , HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, L T, LU, LV, MD, MG, MK, MN, MW, MX , NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, U A, UG, US, UZ, VN, YU, ZW (72) Inventor Brik, George, Tee.             United States Vermont 05055 No             -Witch Hawk Pine Hills             340 (72) Inventor Faisful, Nicholas, Simon             United States 92037 California               La Jolla Coast Boulevard             220 apartment 3 a (72) Inventor Rhodes, Glenn             United States 92129 California               San Diego Davenport Aveni             View 14071 F-term (reference) 4C017 AA08 AA10 AA12 AA16 BD01                       FF05                 4C038 KK01 KL05 KL09 KX01 KY01

Claims (40)

[Claims] 1. A computer having a sensor for monitoring a physiological value of a patient and a display for receiving and processing the information of the sensor, providing physiological data using a multidimensional schematic view of anatomical components. An oxygen-carrying object, each axis of the component corresponds to a measured value obtained from information of a processed sensor, a coordinate space specified by the axis specifies an important physiological relevance, and the computer The object is generated and displayed by a program executed by a tissue oxygen analyzer. 2. The tissue oxygen analyzer of claim 1, wherein the oxygen carrying object is selected from the group consisting of a heart pump object, a vascular resistance object, a metabolic object and a red blood cell object. 3. The tissue oxygen analyzer according to claim 1, wherein the coordinate space specified by the axis has a triangular shape. 4. The tissue oxygen analyzer of claim 1, comprising an analog gauge, wherein the measurement indicated by the analog gauge changes the coordinate space specified by the axis. 5. The tissue oxygen analyzer of claim 1, wherein the sensor is a non-invasive arterial pressure transducer. 6. The tissue oxygen analyzer of claim 1, wherein the sensor is a manual input. 7. The tissue oxygen analyzer of claim 1, wherein the computer includes instructions for utilizing the Fick equation. 8. The tissue oxygen analyzer of claim 1, wherein the computer includes instructions for utilizing the Kelman equation. 9. A non-invasive arterial pressure transducer, a blood gas monitor,
A computer with a display that receives and processes data from transducers and blood gas monitors, and multiple multidimensional objects showing the oxygenation cycle including metaphors for heart pumps, arterial blood cells, vascular resistance, and venous blood cells. A tissue oxygen sensor, which is an object that is provided and that indicates a physiological oxygen relationship derived from the received data, the object being generated and displayed by a program executed by a computer. 10. The tissue oxygen analyzer of claim 9, comprising an analog gauge, wherein the measurement indicated by the analog gauge comprises an analog gauge that changes the shape of the metaphor. 11. The patient's stroke volume on one axis of the cardiac pump metaphor (
10. The tissue oxygen analyzer of claim 9, comprising a substantially quadrilateral region defined by the patient's heart rate (HR) on the SV) and the other axis. 12. The tissue oxygen analyzer of claim 11 wherein the sides of the substantially quadrilateral region are movable by rotation of an analog gauge. 13. The arterial blood cell metaphor is represented by a first circle that identifies a substantially circular area, the first circular area representing the arterial oxygen content (DO ₂ ) in the patient's blood. 10. The tissue oxygen analyzer of claim 9, shown to reflect. 14. The venous blood cell metaphor is represented by a first circle identifying a substantially circular region, the first circular region being the venous oxygen content (VO ₂ ) in the blood of the patient. 10. The tissue oxygen analyzer of claim 9, which is shown to reflect 15. The vascular resistance metaphor comprises a first substantially quadrilateral region exhibiting mean arterial pressure (MAP) and central venous pressure (CVP), wherein the higher MAP value is due to the larger first region. The tissue oxygen analyzer according to claim 9, which is reflected. 16. The second of the vascular resistance metaphors is indicative of a patient's cardiac output (CO).
10. The tissue oxygen analyzer of claim 9, comprising a substantially quadrilateral region of, wherein the greater cardiac output is reflected by the greater second region. 17. The vascular resistance metaphor comprises an analog gauge indicating the systemic vascular resistance (SVR) of the patient, the analog gauge controlling the area of cardiac output so that the larger SVR increases the second area. Item 15. The tissue oxygen analyzer according to Item 15. 18. The tissue oxygen analyzer of claim 9, wherein the computer includes instructions for utilizing the Fick equation. 19. The tissue oxygen analyzer of claim 9, wherein the computer includes instructions for utilizing the Kelman equation. 20. A first circle, which identifies a substantially circular region, wherein the percentage of the first circular region is shown to reflect the arterial oxygen content (DO ₂ ) of the patient. A circle and a second circle that substantially identifies the area of the circle, wherein the percentage of the area of the second circle is shown to reflect venous blood oxygen content (VO ₂ ).
And an oxygen extraction indicator indicating the amount of oxygen extracted from the patient's blood corresponding to the content data indicated by the first and second circles. 21. The data object of claim 20, wherein the first circle is shown shaded. 22. The data object of claim 20, wherein the second circle is shaded. 23. The data object of claim 20, wherein the oxygen extraction indicator changes color to indicate that the patient is in an abnormal oxygenation state. 24. The hemoglobin (Hb) of the patient, wherein the first circle changes in diameter.
The data object according to claim 20, which indicates a change in level. 25. The hemoglobin (Hb) of the patient, wherein the second circle changes in diameter.
The data object according to claim 20, which indicates a change in level. 26. A substantially quadrilateral region specified by the patient's stroke volume (SV) on one axis and the patient's heart rate (HR) on the other axis; A data object showing an amount of blood flowing through the heart, comprising an analog gauge located along an edge, the analog gauge describing an arc that defines a side of the quadrilateral. 27. The data object of claim 26, wherein the quadrilateral region is a triangle. 28. The analog gauge value is related to wedge pressure.
Described data object. 29. The data object of claim 26, wherein the analog gauge value is related to central venous pressure (CVP). 30. A first substantially quadrilateral region, in which a higher MAP value is reflected by a larger region, indicating mean arterial pressure (MAP) and central arterial pressure (CVP) in the blood of the patient, A second substantially quadrilateral region showing a patient's heart rate output (CO) and a region increasing to a larger heart rate output, and a patient's systemic vascular resistance (SVR), showing the second as the SVR increases. A data object showing blood vessel vascular resistance in a patient, including an analog gauge that controls the cardiac output area so that the area of the blood vessel increases. 31. The data object of claim 30, comprising a CVP indicator that changes color to indicate an abnormal oxygenation status of the patient. 32. The data object of claim 30, comprising a MAP indicator that changes color to indicate an abnormal oxygenation state of the patient. 33. The data object of claim 30, comprising a CO indicator that changes color to indicate an abnormal oxygenation status of the patient. 34. An oxygen-carrying object that senses multiple physiological values of a patient, processes the sensed physiological values, and provides physiological data using a multidimensional schematic view of anatomical components. The tissue oxygen status of the patient, where each axis of the component corresponds to a measurement obtained from the processed sensor information, and the coordinate space specified by the axis identifies important physiological relevance. How to measure. 35. The method of claim 34, wherein the method of displaying the oxygen carrying object comprises the step of displaying a heart pump object. 36. The method of claim 34, wherein the method of displaying the oxygen carrying object comprises the step of displaying a vascular resistance object. 37. The method of claim 34, wherein the method of displaying an oxygen carrying object comprises the step of displaying a metabolic object. 38. The method of claim 34, wherein the method of displaying the oxygen carrying object comprises the step of displaying a red blood cell pump object. 39. The method of claim 34, wherein the coordinate space specified by the axes is triangular in shape. 40. The method of claim 34, wherein the method of displaying an oxygen-carrying object further comprises the step of displaying an analog gauge, wherein the measurement indicated by the analog gauge changes the coordinate space specified for the axis.