Patent Application
20210228794
The present invention relates broadly to the field of patient monitoring systems and process control tools in healthcare, such as for example, a process control tool that will seek to optimize oxygen delivery during cardiopulmonary bypass, and the like. It can be appreciated that an effective process control tool may require real time data from multiple sources to collect data required to perform advanced calculations automatically, comparing the calculated results to defined process control limits. Unfortunately, there is no current way to write, deploy and evaluate process controls in real time. The present invention can be appreciated in the context of open-heart surgery as an example, but has, as is noted, a broader applicability.
Open heart surgery may be regarded as one of the most important medical advances in the 20th century, and cardiopulmonary bypass has been key to the development of open-heart surgery. The term cardiopulmonary bypass describes technology in which the circumvention of native heart and lungs is achieved with the use of extracorporeal devices. Examples of extracorporeal devices that may be used to circumvent a patient's native heart and/or lungs to provide mechanical means for pumping and oxygenating blood include cardiopulmonary bypass machines and extracorporeal membrane oxygenation (ECMO) machines.
Employing a cardiopulmonary bypass machine to replace the function of a patient's heart and lungs requires constant monitoring of the patient's perfusion, oxygen delivery, and physiological parameters to ensure that the patient's oxygen consumption needs are met by the oxygen delivery provided by the cardiopulmonary bypass machine. If the cardiopulmonary bypass machine is not operated optimally to provide the patient with adequate mechanical perfusion, and/or to provide an oxygen delivery that surpasses the patient's oxygen consumption needs, then increased morbidity and mortality may result from tissue hypoxia due to inadequate oxygen delivery to the patient's tissues and anaerobic metabolism. Insufficient oxygen delivery during cardiopulmonary bypass, due either to excessive anemia, or to low flow (i.e., inadequate perfusion), or both, is associated with postoperative complications or increased post-operative surgical mortality, often due to multi-organ failure including renal and gastrointestinal organ systems. While certain patient parameter's may be measured during cardiopulmonary bypass, such as hematocrit % (HCT), hemoglobin (g/dL), arterial oxygen saturation (%), arterial oxygen tension (mm Hg), etc., despite intraoperative measures taken to maintain adequate oxygen delivery based on these parameters, inadequate oxygen delivery and tissue hypoxia may still occur during cardiopulmonary bypass procedures as evident from postoperative elevated levels of blood lactate levels.
One predictor of elevated lactate levels resulting from tissue hypoxia is the ratio of indexed oxygen delivery (DO2i) to indexed carbon dioxide elimination (VCO2i). However, this ratio is a complicated calculation derived from a number of measured variables, from multiple data sources, so its use has been limited to a retrospective clinical outcomes research. Furthermore, there are no systems available that would allow a user to monitor such a complicated clinical predictor in real time and, at the same time, facilitate in the operating room, optimization of one or more complicated clinical predictors to improve patient care. These calculations may require data from multiple sources, making real time calculation impractical in the OR. The collection of data is further complicated due to the various machine languages used for data transmission from the electronic devices.
Monitoring systems for cardiac surgical operations with cardiopulmonary bypass are known. For example, U.S. Pat. No. 10,039,490 to Ranucci, the disclosure of which is incorporated herein by reference, teaches a monitoring system for cardiac operations with cardiopulmonary bypass comprising: a processor operatively connected to a heart-lung machine; a pump flow detecting device connected to a pump of the heart-lung machine to continuously measure the pump flow value and send it to the processor; a hematocrit reading device to continuously measure the blood hematocrit value and to send it to the processor; a data input device to allow the operator to manually input data regarding the arterial oxygen saturation and the arterial oxygen tension; computing means integrated in the processor to compute the oxygen delivery value on the basis of the measured pump flow, the measured hematocrit value, the preset value of arterial oxygen saturation, and the preset value of arterial oxygen tension; and a display connected to the processor to display in real time the computed oxygen delivery value.
There is a need in the field of cardiopulmonary bypass operations, and other similar operations and/or medical-surgical intensive care settings, for a system and method that can be used to operationalize any process control including to collect data from multiple sources, calculate, simulate, and monitor complicated calculated indicators of adequate oxygen delivery and oxygen consumption in real time to prospectively make better clinical decisions. More generally, there is a need in the field of medicine and surgery for a system and method that can be used to calculate, simulate, and monitor complicated indicators of medical interventions, patient outcome and survival, namely, clinically relevant parameters for a patient, in real time, wherein each of these medical interventions and clinical parameters constitute complicated functions of multiple data input parameters and are useful in helping clinicians prospectively make better clinical decisions and operationalize any process control in the most compliant manner.
Broadly, the present invention is directed to a monitoring system that will allow clinicians to generate, operationalize and get feedback on any process control in real time. The system can include a clinical parameter calculation-simulation-monitoring system, such as may be used to calculate, simulate and/or monitor complicated clinical parameters, such as those that are functions of multiple measured variables. The present invention may be used, for example, for an oxygen delivery and consumption monitoring system that facilitates the calculation, simulation, and/or monitoring of oxygen delivery and oxygen consumption for a patient during cardiac bypass surgeries, and like surgical and/or medical situations in which the calculation, simulation, and/or monitoring of oxygen delivery and oxygen consumption is desired. Specifically, the present invention can apply to a perfusion monitoring system that facilitates the calculation, simulation and/or monitoring of a patient's hematocrit or hemoglobin values during cardiac bypass surgeries, and like surgical and/or medical situations in which the calculation, simulation and/or monitoring of a patient's perfusion status is required.
The invention is directed to a monitoring system for care protocols, wherein the system comprises a plurality of sensors operably connected to electronic devices to input data from a patient to an interface, said sensors being disposed to measure critical values from a patient; an interface for receiving input data and allowing users to define process control limits and when appropriate change these limits of a process control in real time, as appropriate for the care of the specific patient; a means for authorized practitioners to formally document the decision to deviate from a medical facility defined protocol or the specific patient care plan; a processor operably connected to the interface to date stamp and receive, agnostically, data signals corresponding to received data input pertaining to one or more input parameters, wherein specific data values collected from the multiple data sources may be used in more than one output calculation formula, the processor calculates one or more output values based on the one or more input parameters and compares said output values to said critical values to determine in real time whether said output values are outside an acceptable range; and input means for setting critical values for a patient, ranges of critical value, and alarm points when the critical values are outside of the ranges by providing appropriate defined notifications/prompts and/or recommended actions in real time; said interface configured to receive data input pertaining to one or more input parameters selected from the group consisting of patient input parameters, perfusion input parameters, oxygen delivery input parameters, oxygen consumption input parameters, carbon dioxide production input parameters, narcotic input parameters, blood pressure input parameters, and other critical patient input parameters, and combinations thereof; wherein the interface includes a manual input for at least one or more input parameters by a user and a machine input configured to receive sensor-derived input from one or more sensors; and wherein the system is operable to perform one or more functions directed to calculating and monitoring critical steps or values for a patient and enables the output values for monitoring or for display, in real time, including the output values calculated by the processor, and the range of critical values.
In other examples of the use of the system in accordance with the present invention, clinicians will be able to define groups of patients, define interventions to be applied to groups at various phases of care, define who should be alerted and how, and see performance in real time. For example, process control to reduce narcotic use during surgery and identify which patients process control should apply to, identify specific interventions for pre/intra/post op phases, define changes to case flow (documentation), alerts, notifications and verifications as applicable, define escalation pathways, define reporting requirements. Once operationalized, supervising clinicians will have full visibility to entire process including deficiencies and deviations from expected course in real time. Different alerts based on different clinical roles
Another use of the system in accordance with the present invention would be in blood pressure management. The system would define which patients should be in blood pressure management process control, define specific interventions that should apply to different phases of care (such as, early labor, post-partum, and the like), and see compliance and be alerted to exceptions and deviations from expected course in real time. Different alerts based on different clinical roles.
Another use of the present system would be for control, such as when a ventilator is in use and in the ventilator weaning, the system will define which patients should be weaned from ventilator support, define step wise weaning approach, and define when patients are ready for next step in weaning or identify those who are failing and should be replaced on original support in real time. There can be different alerts based on different clinical roles.
Thus, the present invention has the ability to define, operationalize, and get feedback in real time in any care area or patient population, which is clinician defined.
The foregoing and other features and advantages of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which:
The present invention is directed to a monitoring system for medical patient care protocols, such as surgical operations, that is capable of writing, operationalizing and providing feedback on any process control, in real time. To accomplish this the system is capable of collecting information from any number of electronic devices including medical devices and manual entries. The data is collected, time stamped at time of data collection, stored, translated to the appropriate machine language, transmitted to the data storage repository, using applicable calculation algorithm, and providing the required notification and/or prompt to the medical practitioner(s) requiring notification. The system performance allows this series of activities to be accomplished in milliseconds.
The monitoring system of the present invention comprises a plurality of sensors operably connected to electronic devices to input data from a patient to an interface for receiving input data and allowing users to write process controls and change elements of a process control in real time; a processor operably connected to the interface to receive data signals corresponding to the received data input pertaining to the one or more input parameters, wherein specific data values collected from the multiple data sources may be used in more than one output calculation formula.
The interface is configured to receive data input pertaining to one or more input parameters, including patient input parameters, perfusion input parameters, oxygen delivery input parameters, oxygen consumption input parameters, carbon dioxide production input parameters, narcotic input parameters, blood pressure input parameters, and other critical patient input parameters and the interface includes a manual input of at least one or more input parameters by a user and a machine input configured to receive sensor-derived input from one or more sensors; and wherein the system is operable to perform one or more functions directed to calculating and monitoring critical steps or values for a patient and enables the output values for monitoring or for display, in real time, including the output values calculated by the processor, and the range of critical values. The sensors are disposed to measure critical values from a patient
The system of the present invention includes means to connect to all medical devices to facilitate collection of data as fast as the devices can output data, means to integrate to any available health information system, including electronic health records, means to document and facilitate manual user input, means to leverage published simple computations to calculate clinician required values as needed, a processor operably connected to receive and process the collected data in real time, to execute clinician generated process controls, means to dynamically change documentation requirement to simplify and execute process control as needed, means for providing notifications, verifications, and guidance alerts, and monitor display means to allow users to see which process controls are operational, exceptions, alerts etc. and provide full visibility of what is going on in patient populations at all times and means for real time reporting.
The present invention is focused on the care giver defining the patient care plan (prescription) with or without the formulas. This is true regardless of the specific care plan or area. With the present invention the use of closed loop interoperability, which is known in the industry, is not required. With the present invention interoperability as defined by the industry and FDA is never required. The tool provides a means to control the processes and compliance with practitioner directed care without the limitations of medical device interoperability.
The processor calculates one or more output values based on the one or more input parameters and compares said output values to said critical value to determine in real time whether the output values are outside the acceptable range. The input means allows for setting critical values for a patient, ranges of critical value, and alarm points when the critical values are outside of the range by providing appropriate defined notifications and prompts and/or recommended actions in real time. These calculations are known in the industry and are made using formulas known in the industry and can be done using the processor. By comparison of the input and output values, it is determined that the output values are outside of the acceptable range.
The present invention provides a way to write, deploy and evaluate process controls in real time. The process controls will be clinician defined and can be editable on the fly. The process can include any interventions including medications or procedures and can also indicate clinical guidance that can be used to mitigate negative patient events. The present invention can span care areas and phases of care, can include multiple care teams, can provide clinical role specificity and manage hand-offs, such as transitions of care. The present invention will provide for exceptions/deviations from expected care and patient course to be viewable in real time. Thus, compliance reports available at defined times (e.g. case end) to “close loop”. The present invention incorporates mobile tools, such as smart phones, tables, etc., that augment clinical workflows.
The present invention is achieved by connecting disparate data sources (devices, electronic health records (EHR) etc.) so that process controls can be implemented and visualized in real time, providing a simple user interface (UI) for clinicians to write their own process controls, allowing clinicians to change elements of a process control in real time, allowing clinicians to indicate whether is process control is relevant in real time, sorting patients into risk groups or other categories in real time, matching groups of patients at risk/or patient categories with risk or group specific interventions, and incorporating decision support elements and documentation tools to dynamically indicate when specific interventions are due based on patient risk/categories to make it easy for clinicians who are executing the process control to understand when something is due proactively, and when something is past due. Thus, the present invention exposes compliance with a process control or deviation from expected course in real time by closing the loop in real time so that process improvement can occur.
The programed computer will receive data from various sources, such as medical devices for monitoring and/or treating a patient. Monitored data can comprise physiological data elements, video data elements, and audio data elements. Once the data is received, it is date stamped, and stored. The present invention allows the data to be collected agnostically. By agnostically, it is meant that the data is collected from various sources, equipment, instruments, and/or sensors without regard to the language in which it is transmitted, and/or is generalized so that it is interoperable among various systems. So, the system of the present invention does not require a match with the data source to be functional and can accommodate various data sources.
The data which may need to be translated or converted to the machine-language of the programed computer is translated. This means translating data received from any electronic source to the data storage language of the computer, and, in turn, translating from the data storage to the language of the receiving electronic source. This allows the hospital to utilize any number of suppliers and/or device models within the interoperability environment. This eliminates the need to buy new equipment just to achieve interoperability. The system will allow access to all relevant patient data from all applicable sources as discussed above and a means to store accurately, timely and completely all relevant data regarding patient care and patient response/outcome. If translation is unnecessary, the data is stored, preferably in a cloud storage, which provides remote access to the data. The data is then evaluated for the accuracy of the data and that is verified. In response to a request for data transfer to a target device, the applicable data is collected per the data mapping requirements. If data translation is needed for the target device, evaluation and translation are done. Then, the data is transmitted to the target device and the accuracy is verified.
As an example, data can be expressed in many machine-language instructions. Since there are many machine-languages, as is known in the art, each device and operating system functions in its chosen machine-language. The present invention senses the machine-language in which the data is presented and translates it into the machine-language employed by the present invention. The machine -language employed by the present invention is not critical and is one known in the art. So, it is only a matter of translating the machine-language of the data received to that which will function in the method and system of the present invention. In turn, when data is transmitted to an electronic source, it is translated into the machine-language of that source.
The present invention allows for the acquisition of data from multiple disparate sources, consolidation of all information within a unified view with all data time synchronized at time of collection, running process controls and workflows, and delivering actionable insights to specific users in real time, i.e., the actual time during which an event occurs. Since data is being acquired in real time, the time synchronization is required to accurately align the data from the various sources of information. The internal clocks of the various sources are not in agreement and may not be provided as part of the data provided by the device. Therefore, the need to synchronize the data to the time collected rather than use the various electronic source times, if available. This allows the data from multiple sources to be presented on the same screen. This allows for an accurate representation and display of the alignment of patient interaction with the patient's response, which is required for an informed assessment of patient response to patient care activities.
Data from various sources, including monitored data elements from any electronic device, such as medical devices for monitoring and/or treating a patient, can comprise physiological data elements, video data elements, and audio data elements. Once the data is received, it is date stamped, and stored. Data which is received may need to be translated or converted from the machine-language in which it is sent to the machine-language of the processor of the present invention. If the data which needs to be translated or converted to the machine-language of the processor of the present invention, is translated. If translation is unnecessary, the data is stored, preferably in a cloud storage, which provides remote access to the data. The data is then evaluated for the accuracy of the data and that is verified. In response to a request for data transfer to a target device, the applicable data is collected per the data mapping requirements. If data translation is needed for the target device, evaluation and translation are done. Then, the data is transmitted to the target device and the accuracy is verified.
The present invention provides an effective process control tool by requiring that real time data from multiple sources be collected so that the calculations can be done automatically and the calculated results can be compared to defined process control limits. When calculated values indicate that the value is not within specified ranges, the notification and prompt rules are activated, and appropriate individuals are made aware of the condition.
Converting a pre-incision brief during cardiac surgery into a process control that is dynamically executed in real time, with full transparency.
Traditionally, elements of patient's care during CPB are verbally discussed by Surgeon and Perfusionist during pre-incision brief. E.g. Surgeon instructs Perfusionist to maintain perfusion within certain settings including pump flow, hemoglobin and oxygen delivery/SV02. Surgeon has no ability to see perfusion course compared to desired goals while case in progress. Surgeon has no ability to evaluate perfusion course compared to goal in summary at case end.
With the present invention, the Perfusionist will enter all surgeon instructions into a mobile pre-incision briefing tool. The instructions will be converted to an advanced clinical guidance prescription in real time. The surgeon will have full visibility into compliance with the advanced clinical guidance prescription in real time while case in process. Surgeon will also be able to view compliance summary at the cases end in any format, including mobile.
The following equations are applied to implement the monitoring system according to the invention:
VO2=Qc×(CaO2—CvO2) in a normal circulation (1)
VO2=Qp×(Ca O2—CvO2) during CPB (2)
DO2=Qc×CaO2 in a normal circulation (3)
DO2=Qp×CaO2 during CPB (4)
O2 ER=VO2/DO2(%) (5)
Hb=HCT/3 (6)
CaO2=Hb×1.36×Sat(a)+PaO2×0.003 (7)
CvO2=Hb×1.36×Sat(v)+PvO2×0.003 (8)
VCO2=Ve×eCO2×1.15 (9)
The present system can be employed, for example, with a heart-lung machine, or as a cardiac bypass system, or as a cardiopulmonary bypass system, and which includes cardiopulmonary bypass (CPB) systems, minimal extracorporeal circulation (MECC) systems, extracorporeal membrane oxygenation (ECMO) systems (respiratory and cardiac), and pump assisted lung protection (PALP) systems) includes an oxygen delivery and consumption calculation-simulation-monitoring system, as well as a venous reservoir, a blood pump and an oxygenator. Such systems are well known and therefore have not been illustrated.
Such systems have blood sensors which measure blood oxygenation parameters SaO2, PaO2, etc., pertaining to the amount of oxygen carried by the blood. A flow meter may be provided to measure the flow rate of blood exiting the blood pump and to input blood flow rate data Qp to the calculation-simulation-monitoring system. A CO2 sensor or capnograph may capture exhaled carbon dioxide (expCO2) data which is continuously measured and input into the calculation-simulation-monitoring system. A hematocrit (HCT) sensor may be placed on the venous or arterial side of the blood flow circuit to measure deoxygenated blood flowing from the cavoatrial cannula. Alternatively, the HCT sensor may be a non-invasive hemoglobin (Hb) sensor. Either HCT data or Hb data can be continuously input to the monitoring system.
The monitoring system includes an interface comprising a manual interface portion and a machine interface portion. The interface is operably connected to provide data input to a programed processor, which employs the data in calculations of output values indicative of the patient's condition, or of output values simulating outcomes of hypothetical or planned clinical intervention. The processor is connected to a display assembly, which is used to display output values calculated by the processor, and to a memory assembly that is used to store output values and non-outputted values calculated by the processor. The memory assembly includes both RAM and ROM components, and/or other devices suitable for data storage. In accordance with an embodiment of this disclosure, processor is a general computer, but the processor may be an embedded system with particular dedicated functions (i.e., such as those described herein) within the larger electrical system of the calculation-simulation-monitoring system.
The manual interface portion is configured so that a user manually inputs data into user interface to populate the calculation-simulation-monitoring system. For example, certain data pertaining to a patient are substantially static data with respect to the cardiopulmonary bypass procedure to be performed. Examples of such static patient data includes patient morphological data such as height and weight, which will not substantially change during the cardiopulmonary bypass procedure. Such static data pertaining to the patient at the start of the cardiopulmonary bypass procedure may be referred to as patient input parameters. Thus, in accordance with this disclosure, static data constitutes data collected before, or at the beginning of a medical and/or surgical procedure and constitutes data that does not change appreciably during the course of the medical and/or surgical procedure.
Other static data that a user may input via the manual interface portion of the interface include perfusion input parameters such as the patient's pre-cardiac bypass blood volume per unit weight, and the patient's pre-cardiac bypass hematocrit. These perfusion input parameters pertain to the patient's starting condition at the beginning of the cardiopulmonary bypass procedure. While hematocrit, for instance, may change during the cardiopulmonary bypass procedure, its starting value at the beginning of the procedure does not. Consequently, it constitutes data that a user may input manually into the system via the manual interface portion.
As illustrated in the drawings, in
In
Although the invention has been presented by the example of the drawings, it is much broader. It is a tool that allows users to write, deploy and get feedback on process controls in real time. Targeted oxygen delivery for perfusion is just one example.
Although the invention has been described in detail with reference to particular examples and embodiments, the examples and embodiments contained herein are merely illustrative and are not an exhaustive list. Variations and modifications of the present invention will readily occur to those skilled in the art. The present invention includes all such modifications and equivalents. The claims alone are intended to set forth the limits of the present invention.
| Number | Date | Country | |
|---|---|---|---|
| 62966273 | Jan 2020 | US |
