Surgery – Diagnostic testing
Reexamination Certificate
1999-11-03
2002-06-18
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
C128S920000, C128S903000, C128S104100
Reexamination Certificate
active
06406426
ABSTRACT:
The present invention relates generally to medical monitoring and alert systems, and more specifically to a medical monitoring and alert system for monitoring the status of therapeutic devices such as intravenous infusion pumps, ventilators, and patient warming devices and providing alert status information to remote caregivers via bi-directional wireless communications. The medical monitoring and alert system can also be used to control the operation of the therapeutic devices through wireless communications from a central monitoring system, monitor physiological parameters and provide bi-directional communications with an alert system.
BACKGROUND
Electronic devices for delivering a medical therapy are well known in the art. Among these devices are intravenous infusions pumps (IV Pumps), ventilator support devices (ventilators), hemodialysis machines, and patient warming/cooling systems.
Electronic therapeutic devices frequently include an audio or visual alarm or alert system to provide an indication to a caregiver when attention is required. In some cases, these devices also include an analog output port that can be connected to a simple “Nurse Call” system, such as a remote audio alarm or a lamp illuminated outside the patients' room. More recently, therapeutic devices have included an RS-232 serial port for communicating various therapy status data and alarm data to an external system. The data is often transmitted to an existing computer network in a clinical setting, and frequently to computerized patient record devices to collect status information. While these known therapeutic devices are very effective in some applications, they also suffer from some notable disadvantages.
One problem associated with prior art patient monitor/therapeutic device combinations is that the devices are not sufficiently mobile for many clinical settings. In many cases, the patient monitors are large, non-mobile, fixed units. Those which are sufficiently small to allow for mobile applications are generally connected through an RS-232 port or other hard-wired communications port to an external network or other system. Whenever a patient must be moved, therefore, the monitor must be disconnected and reconnected at the new location. Furthermore, a patient cannot move throughout a care facility while being monitored. These units, therefore, are problematic in many clinical settings.
Another problem associated with prior art therapeutic devices is that they often include audio or visual alarms or alert signals that require the caregiver to be near the device when an emergency occurs. Visual and audio alert signals are generally sufficient when used in an intensive care unit or other closely watched hospital setting. In these environments, the caregiver is always within range of any alarms that the therapeutic device generates. These devices, however, are not sufficient for use in general clinical settings where a small number of nurses or other caregivers are monitoring a large number of patients, because visual and audio alert signals do not provide a means for notifying a remote caregiver of an alert situation.
Additionally, the alert or alarm signals coupled to prior art devices generally require a manual confirmation that an alert or alarm signal has been received. The confirmation may require the activation of a switch, a telephone call, or other manual input. In other cases, the alert or alarm signal is unidirectional. In these cases, the alarm or alert signal can continue indefinitely without receiving the response of a caregiver.
Furthermore, existing patient monitor/therapeutic device combinations generally cannot control the therapy delivered to a patient from a remote location. Therefore, when a change in a patient's condition is detected, a caregiver must physically move to the patient's bedside. This system is inefficient in many clinical settings where a limited number of personnel are monitoring and providing medical care to a number of patients.
There remains a need, therefore, for an integrated medical monitoring and alert system capable of optionally monitoring both the therapy delivered to and the physiological parameters of a mobile or ambulatory patient while providing an alarm or alert signal to remote caregivers. Therapy delivery, monitoring, and alert signal devices would preferably be coupled to the monitoring system via hardwired or wireless communications links, depending on the required application. Monitoring information would preferably be transmitted via a wireless communication link to allow for monitoring of mobile patients. The communications link would preferably also be bi-directional to provide a means for acknowledging the receipt of an alert or alarm signal, and therefore a means of determining that an alert condition has been attended to or resolved. Furthermore, bi-directional communications allow for remote control of therapy delivery and physiological monitoring parameters from an external device. Preferably, the medical monitoring system would include a patient monitor for monitoring and transmitting patient vital sign data, and a central monitoring system located at a nurse's station or other centralized location to provide a remote monitor of patient therapy status and alert conditions. The central monitoring system would preferably also provide a storage location for maintaining a database of patient therapy status data, alert conditions, vital sign parameters, and therapy applied data to provide a total record of patient care. The central monitoring system would also preferably be linked to an overall hospital information system for maintaining overall patient records, which could include clinical data in addition to insurance data, physician data, pharmaceutical data, and other medical information.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the invention to provide an integrated medical monitoring and alert system which can be used to monitor a medical therapy delivered to a patient and provide therapy status data, physiological data, and alert data to a remote caregiver via bi-directional communications.
It can be another object of the invention to provide a medical monitoring system optionally comprising physiological monitoring, therapy delivery, and alert devices which can be selectively configured to provide a customized system for a given medical monitoring situation.
It can be another object of the invention to provide a medical therapy delivery system linked bi-directionally to both monitoring and alert condition devices.
It can be another object of the invention to provide a medical monitoring system comprising a communications network which can include both wireless bi-directional links and hardwired links between therapy delivery, monitoring, storage and alert components such that each of the components of the system can selectively communicate with each of the other components of the system.
It can be another object of the invention to provide a medical monitoring system capable of monitoring a medical therapy delivered to mobile patients and capable of providing alert condition data to remote caregivers.
It can be another object of the invention to provide a bi-directional alert and monitoring system coupled to a therapy delivery system.
It will be understood by those skilled in the art that one or more aspects of this invention can meet certain objectives, while one or more other aspects meet certain other objectives. Each objective may not apply equally, in all instances, to every aspect of the invention. As such, the objects can be viewed in the alternative with respect to any one aspect of the present invention.
The medical monitoring system of the present invention preferably comprises a central monitoring system for monitoring the therapy and physiological status of a number of patients from a nurse's station or other centralized monitoring location and at least one of a therapeutic delivery device, a local patient monitor for monitoring therapy and physiological parameters, and an integr
Henry Michael J.
Reuss James L.
Astorino Michael
Criticare Systems
Reinhart Boerner Van Deuren S.C.
Shaver Kevin
LandOfFree
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