US-12616787-B2 - Monitoring system for care protocols

US12616787B2US 12616787 B2US12616787 B2US 12616787B2US-12616787-B2

Abstract

A monitoring system for care protocols, comprising sensors connected to electronic devices to input data from a patient, where sensors measure critical values from a patient; an interface for receiving data and allowing users to write and change process control in real time; a processor connected to the interface to receive input parameters, wherein the processor calculates output values based on the input parameters compared to the critical value to determine whether the output values are outside acceptable range; means for setting critical values, ranges of critical value, and alarm points when the critical values are outside of the range; where the interface receives critical patient parameters and the interface includes a manual input and a machine input from one or more sensors; and wherein the system calculates and monitors critical steps or values for a patient and enables the output values for monitoring or display, in real time.

Inventors

Harish Lecamwasam
Giuseppe Saracino
William Murphy
Gary COLISTER

Assignees

Talis Clinical LLC

Dates

Publication Date: 20260505
Application Date: 20210127

Claims (16)

1 . A monitoring system, comprising: a plurality of sensors configured to sense sensors input data from a patient, each of the sensors being operably connected to a corresponding electronic device; a sensor interface coupled to the sensors and configured to receive from the sensors input data and to allow users to define process control limits and, when appropriate, to change these process control limits in real time; an authorized user interface permitting authorized practitioners to input patient care parameters corresponding to a patient care plan; and a processor operably connected to the plurality of sensors, wherein the processor is configured to: first, sense a machine language of each of the input data; after sensing the machine language of each of the input data, determine, based on the sensed machine language of each of the input data, whether each sensed machine language differs from a first machine language of the processor; in response to determining that the machine language of a given input datum differs from the first machine language of the processor, translate the machine language of the given input datum to the first machine language; and in response to determining that the machine language of the given input datum is the same as the first machine language, not translate the given input data and store the given input data in the first machine language, wherein the processor is operably connected to the sensor interface to date stamp data signals corresponding to the sensors input data, the processor calculating at least one output value including at least one of a hematocrit and a hemoglobin level based on the sensors input data and comparing the at least one output value to the patient care parameters to determine in real time whether the at least one output value is acceptable based on the patient care plan.
2 . A system for real time calculation of patient care parameters of a patient, comprising: a plurality of sensors detecting data corresponding to patient care decisions, the sensors including a first sensor receiving first data of the data and a second sensor receiving second data of the data, wherein a first form of the first data is incompatible with a second form of the second data; a patient care device; a memory storing parameters relevant to a course of treatment for the patient along with a desired range for at least a first parameter of the parameters based on the course of treatment; and a processor coupled to the sensors and configured to: first, receive the data from the sensors; second, sense the first and second forms of the first and second data, respectively; third, compare each of the sensed first and second forms to a form used by the processor; and fourth, (a) in response to determining that the first form differs from the form used by the processor, translate the first data into one of (i) the second form and (ii) the form used by the processor into which the second data has also been translated; and, (b) in response to determining that the first form is the form used by the processor, not translate the first form, the processor being configured to combine the first and second data to determine whether the first parameter of the parameters stored in the memory that is based on the data represented by the first and second data is in the desired range.
3 . The system of claim 2 , wherein the first data is one of a hematocrit or hemoglobin value, and the second data is a pump flow rate value and third data of the data from a third sensor of the sensors is an arterial oxygen saturation value, the processor translating at least one of the first, second and third data so that the processor can combine at least one of the first, second, and third data to calculate an indexed oxygen delivery value.
4 . The system of claim 3 , wherein the memory includes a stored range for the indexed oxygen delivery value and wherein the processor is configured to compare the calculated indexed oxygen delivery value to the stored range for the indexed oxygen delivery value.
5 . The system of claim 4 , further comprising an alarm triggered by the processor when the calculated indexed oxygen delivery value is outside of the stored range of delivery value stored in the memory.
6 . The system of claim 4 , further comprising a display operably coupled to the processor, the display configured to display, in a first window, the calculated indexed oxygen delivery value, and in a second window values of physiological parameters of the patient in real time during a care episode, wherein the processor is further configured to display on the display a compliance report at an end of the care episode.
7 . The system of claim 2 , further comprising an interface configured to receive input provided by a user relating to the course of treatment or the desired range for the first parameter.
8 . The system of claim 2 , wherein the first data includes physiological data, the second data includes video data and third data of the data from a third sensor of the sensors includes audio data, and wherein the processor is configured to not translate the first form of the physiological data in response to detection that the first form of the physiological data is the form used by the processor, translate the form of the video data into the form used by the processor in response to detection that the second form is different from the form used by the processor, and translate the audio data into the form of the processor in response to detection that the a third form of the audio data is different form the form used by the processor.
9 . The system of claim 2 , wherein the first data is time stamped by the processor upon receipt.
10 . The system of claim 2 , wherein the processor is coupled to the device providing treatment to the patient, the processor being configured to translate instructions for the device into a language compatible with the device.
11 . The system of claim 10 , wherein the processor is configured, when connected to the device, to identify a machine language compatible with the device.
12 . The system of claim 9 , wherein the processor is configured to interface with internal clocks of the first and second sensors to synchronize the first and second data in a consistent common time frame.
13 . The system of claim 6 , wherein the compliance report displays additional information that quantifies non-compliance of indexed oxygen delivery.
14 . The system of claim 1 , wherein, in response to determining that the machine language of the given input datum is the same as the first machine language, the processing is configured to store the given input data in cloud storage.
15 . The system of claim 2 , wherein, when the first form is not translated when the first form is the form used by the processor, the first data is stored in cloud storage.
16 . The system of claim 2 , wherein, in response to a request for data transfer to a target device, the processor is configured to perform machine language evaluation and selective translation of the data relative to a machine language of the target device.

Description

BACKGROUND OF THE INVENTION 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 ca