Invented by Steven R. Wehba, Timothy L. Ruchti, ICU Medical Inc
The ICU Medical Inc invention works as followsA system and method for configuring a rule-set used in connection with an electronic medical monitoring system to monitor patients and patient care devices, including medication delivery pumps, on the basis of a variety conditions and parameters related to monitored biometric data and equipment information, and for providing user defined responses to these conditions and parameter.
Background for System and Method for Configuring a Rule Set for Medical Event Management and Responses
Modern medical care involves the use medication management systems that include devices for medication delivery and patient monitoring, such as medication pumps and/or monitors of patient parameters. The disclosures include medication management systems that control, monitor, and configure the delivery of medications. As an example, the U.S. Patent application Ser. No. No. 10/930/358, which was published on June 30, 2005 as US20050144043A1. Patent application No. 30/2005 and U.S. Patent Ser. No. The 10/783/573, which was published on December 15, 2005 as US20050278194A1, discloses a system for medication management wherein customized drug library or configuration information of medical devices is created using a module and program of a MMU. The MMU receives information about the status of the pump as well as the customized drug library. Patent application No. No. No. The invention disclosed in this patent application, dated June 2, 2005, relates to the creation, editing, storage, and communication of the configuration information for a medical device or drug library to a device that delivers fluids, fluid medications, and/or fluid medications to patients.
According to the patents mentioned above, a typical system for medication management includes a MMU and/or a point-of-care computer (such as a pharmacy computer or barcode point of service computer) in communication with at least one medication delivery device. The MMU and/or point of care computers, along with their associated memory, can store information such as prescription information, personalized drug library, or other information for managing medication deliveries to patients. This includes performing five-rights checks, configuring medication delivery devices, as well as receiving and storing information from the devices.
Caregivers make decisions about patient care based on the outputs of equipment and patient monitoring devices. The receiver can be used to receive the output signals of the patient monitoring and equipment monitoring devices. The receivers can display or record information from patient monitoring devices and patient care equipment. Other devices include a recording or monitoring medium. The receivers and devices can also include preset or adjustable alerts that are activated when one of the outputs generated by the monitoring device for patient or equipment deviates from an established limit.
False positive alarms are a drawback to conventional monitoring systems. False positive alarms can occur when a monitored condition temporarily deviates beyond the preset limits but quickly returns to normal. One application of a conventional alarm system is to monitor a patient’s response to controlled analgesia. Current technologies in such systems are prone to false alarms caused by erroneous blood gas or respiratory readings, which are often due to motion artifacts and poor sensor placement. This alarm can be triggered if, for instance, a patient monitor has been briefly disconnected from the monitoring device. False alarms are a waste of time for hospital staff who have to respond to these alarms. False positive alarms can also make medical responders less sensitive to the alarm. A false positive alarm can also cause a medical responder to act inappropriately, believing that it is a real alarm.
Another drawback to such systems is their inability to trigger a response when multiple parameters are changed, for example, a drop in blood oxygen level and a shift in breathing. For monitoring analgesics via a pump alarms are usually associated with univariate parameter, such as end tidal carbon dioxide (ETCO2) or SpO2 alone. This is to detect changes in these parameters that are consistent with respiratory depression. Due to the complex body response to analgesia, and the inadequacy of a single parameter to reflect the wide range of clinical situations and patient parameters which may result from administration, these systems can have a number of problems. An example of an adverse event that can occur with the administration of analgesics or sedatives is a depression of a patient’s central nervous system and/or respiratory system. The profound differences in drug efficacy among patients and over time can increase the risk for patients. The healthcare professions are concerned about avoiding drug overdoses, which can lead to the administration of too little narcotics. This problem can cause unnecessary discomfort, and it is also associated with prolonged hospital stays and longer recovery times.
Another disadvantage of these systems is that it’s difficult to create a rule set easily customized for monitoring, alarming, and requiring response. These systems also lacked the capability to automatically react to changes in multiple monitored conditions. These traditional systems are often incapable of automatically switching from one rule set to another based on changes in monitored parameters.
The system described herein allows hospital staff to create a set of rules by entering, via an interface, a variety of monitored equipment or patient parameters and conditions that are associated with these parameters. When the inputs from medical equipment or patient monitoring devices satisfy those conditions, they trigger a response defined by or selected by the user. The rule set may include Boolean combination of these parameters with their respective conditions in order to create a multi-variable set of inputs before a response can be triggered. The authorized hospital personnel can customize each rule set by customizing the type of parameter and the conditions that must be met to meet the parameter. “The software used to implement this invention can use context-free grammar, specifically Backus Naur form metasyntax to build rule sets that include parameters, conditions, and responses.
All patents and applications referred to in this Background of Invention section are hereby included by reference and become a part this specification. The present invention also provides advantages and aspects that are not available in medical systems and achieves other objectives not stated explicitly above. The following detailed description will provide a fuller discussion of the advantages, features and objects of this invention. It is done with the help of the accompanying drawings.
The following specifications taken together with the drawings will reveal other features and benefits of the invention.
The drawings show preferred embodiments and the detailed description will be given here. It is understood that this disclosure is intended as a demonstration of the principles and not to limit the invention’s broad aspects to the illustrated embodiments.
FIG. “FIG. As shown in FIG. A medication management system 100 contains a patient monitor (120) for monitoring biometric or physiological data of different types. The monitored information may include, for example, but not be limited to, ETCO2, SPO2, respiratory rates, heart rate and blood pressure, as well as other biometric or physiological information. As is well known, the patient monitor can include biometric sensors that are able to sense the desired information. Biometric sensors can include EKG systems, respiratory monitors (blood gas monitors), glucose monitors (blood analyte monitoring), blood analyte monitoring, and/or any other measurement system that monitors physiological variables or analytes. “For example, a system of patient controlled analgesia can use a NELLCOR monitor or MASSIMO with an ORIDION respiratory monitor board to generate data, waves, and alarms related to heart rates, SpO2 values, respiratory rates, and ETCO2 level.
The patient monitor can include an optional processor and patient monitoring software to monitor the information that is received by the biometric sensors. The patient monitor 120 can include an interface to allow input from the patient or caregiver. The processor of the patient monitor compares the data received from the sensors to generate an alarm signal. Alarm signals are generated when an alarm limit has been reached, or if the limit is exceeded. Alarm limits may include an upper limit or a lower one, or a combination of both. These limits define if there are any acceptable ranges. “Patient monitor 120 is connected to a rule set processor and interface 125, which allows it to transmit monitored information or alarms.
As shown in FIG. 1. A patient care device shown as a medicine delivery pump 130 may be connected or in communication with a patient. The medication delivery device 130 can be configured to deliver a controlled dose of medication to a patient. The medical pump may be used in conjunction with PCA (patient-controlled analgesia), request devices that allow a patient to’self-deliver. Analgesics or analgesics are examples of medication. U.S. Pat. No. The patent 4,551.133 to Zeggers De Beyl and others, published Nov. 5, 1986, is incorporated herein in its entirety by reference. It discloses a system of patient-controlled analgesia for the introduction of medication into a peripheral vein. A microprocessor-based system controls the delivery of analgesics in response to a patient’s request. The microprocessor can be connected to a PCA or remote patient control device that sends an actuation command to the microprocessor whenever the patient requests medication delivery.
The system 100 can further include a plurality medication delivery pumps 130 to administer a variety of medications. The medication pump may also include an interface that allows a caregiver inputs into the medication pump 130. These inputs can include a patient’s pain score, which is used to determine how much and how often a patient controlled analgesic should be administered. In one embodiment, a medication delivery pump includes a user interface that allows a caregiver select a set of rules, sometimes referred as an algorithm, to monitor the patient, patient care equipment, and respond to inputs received from the patient, patient care equipment. This is described in more detail below. The user interface of the medication delivery pumps 130 also provides caregivers with a way to respond to alarms or infusion events (for example an infusion pause) by using a push-button or touch screen interface.
The medication pump 130 is connected to the patient monitor and rule processor 125. This allows information to be communicated between the medication pump 130, patient monitor 120 and other components in the system 100. The medication delivery pump 130 can communicate medical pump information to other components in the system 100. This medical pump information can include medical pump status and medical event data. Medical pump information may include, but not be limited to, whether medication is being delivered, at what rate, how much is left to deliver, and when the delivery started. Medical pump information includes but is not restricted to information such as whether or not an alert was issued since the previous communication, if the pump has lost power, and if there have been any alarms. Status information or medication delivery status is used to refer to medical pump information, medical event information, or other status and/or events information. Medical delivery status information can be transmitted in the form of historical logs or real-time communication or information.
The medication pump 130 can also transmit the rule set that was selected by the caregiver on the medication pump 130 to the interface and rule processor 125. The central memory 135 has a library or portions of rule sets stored in it. The library of rules sets can be part of a customized drug library or any other library that can be downloaded onto medical devices. In one embodiment the patient interface rule set processor 125 uses the information from the patient monitor 130 (such as ETCO2, SpO2, heart rate, respiratory rate, blood pressure and temperature) and/or information from the medication pump 130 to apply the selected rule to the rule. The patient interface and rules set processor 125 can generate an output signal that tells the medication pump 130 to adjust medication delivery based on whether or not the parameters and conditions of the rule are met.
In another embodiment, the rule set processor and patient monitor interface 125 can send information directly from the patient monitoring system 120 to the medication pump 130. This is done without a rule-set. A caregiver can configure the medication delivery pump 120 or patient monitor to accept alarm limits. Alarm limits can be matched to patient information at the medication pump 130. Alarm limits can also be related to information about the medication delivery device 130. The pump processor compares selected alarm limits with the relevant information and generates an alert signal if it meets, exceeds or falls between the alarm limits. The pump’s alarm signal can be sent to the rule set processor and patient monitor 125, as well as to other components in the system 100.
The medication delivery pumps 130 can display patient information in a display of the pump. The display screen can also show a variety medical pump status data, including but not restricted to: a patient’s identifier, a room number, a delivery mode, a delivery rate, if a delivery is active, the time since delivery started, a basal rate amount, a PCA-bolus amount and a lockout period or volume for a PCA-bolus.
In an alternative embodiment, which will be readily understood by those skilled in the art based on the figures and descriptions herein the patient monitor interface 125 can be part of the medication delivery pump 120 or the patient monitoring system 120 rather than as a separate component. The processing capacity and functions of the system 100 can be distributed between the various components as shown in the figures and descriptions or can be rearranged within the processors of the system.
The central memory 135, which is a personal computer, has a rule set configuration process 140. The rule set configuration process 140, which can be a PC, PDA or similar device, includes a user interface that allows an administrator to configure and create a rule set. The rule set will then be sent to the central memory 135, where it is stored.
The central Memory 135 may also receive certain information from both the rule set processor and patient monitor interface 125. The central memory 135 can receive logs containing patient information from the patient monitor 120, and medication pump information from the medication pump 130. The central memory 135 may receive this information in real-time from the rule set processor and patient monitor interface 125.
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