Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
1999-04-14
2001-10-23
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S588000
Reexamination Certificate
active
06308089
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical sensor devices and methods for measuring clinical physiological parameters including vital signs. More particularly, the invention is concerned with a medical monitoring system that limits the duration and/or number of uses of an associated sensor device to prevent overuse and potential failure.
BACKGROUND
Medical sensor devices, such as internal probes that are inserted into a body cavity or under the skin of a patient in order to monitor biological parameters, are well known in the art. Typically, such devices comprise a housing including at least one monitoring element such as a pressure sensor, a light emitting device and associated detector, an ECG sensor, or other vital sign monitoring device. One particular example of a medical sensor device is fetal sensor, such as that described in U.S. Pat. No. 5,425,362. Fetal sensors are inserted into the uterine wall of a mother to noninvasively monitor the condition of a fetus, a mother, and a placenta.
One problem associated with known medical sensor devices is that they have a limited life span. Sensor devices are prone to wear through repeated use or through extended use over a period of time. Problems associated with such overuse include spurious readings as internal wires and connectors become loose. More importantly, sensor devices that are used repeatedly or over an extended period of time are prone to break. Once such an incident occurs, it is often difficult to determine when the sensor failed, or to track the cause of such an occurrence.
To prevent these problems, medical clinicians may limit the number and duration of uses of a given medical sensing device through an equipment log or other manual system. While such systems may be effective in certain circumstances, they rely heavily on manual records, which are time-consuming and difficult to maintain, particularly since the cooperation of a number of clinical personnel is required. In busy hospital settings, and especially in emergency situations, such systems are difficult to manage and are easily overlooked or ignored.
There remains, therefore, a need for a medical monitoring system that can automatically limit the usage of medical sensor devices. Such a system would preferably limit the duration or number of uses of a given medical sensing device to a predetermined limit value. Preferably, the medical monitoring system would also provides additional functions, such as error checking, time and date stamping, and security checking.
It is therefore an object of the invention to provide a medical monitoring system that can limit the number of times a medical sensor device is used.
It is another object of the invention to provide a medical monitoring system that can limit the duration of the use of a medical sensor device.
It is still another object of the invention to provide a medical monitoring system that provides a time and date stamp to identify monitoring processes performed by monitoring equipment.
It is a still further object of the invention to provide a medical sensor device that can store information regarding the duration of use of the device.
It is another object of the invention to provide a medical monitoring device that can store information regarding the number of times the device has been used.
It is a yet further object of the invention to provide a medical monitoring system that can provide product identity of an associated medical sensor device.
It is still another object of the invention to provide a medical monitoring system that includes a security function for verifying the identity of attached sensors.
It is yet another object of the invention to provide a medical monitoring system that includes a security function to prevent tampering with stored data.
SUMMARY OF THE INVENTION
In one aspect, the present invention is a medical probe that includes at least one sensor device and a memory storage component capable of communicating with external devices for maintaining data about usage of the probe. The memory storage component can include information regarding the number of times the medical probe has been used, the duration of each use, the total duration of use, and other information regarding the duty cycle of usage of the medical probe. Other parameters, including the date and time of a given use of the sensor, the date and time when a given condition occurred, product identity, clinical information such as patient or doctor data, and other medical information can also be stored in the memory storage location of the sensor device. The medical probe is preferably identified by a unique serial number that can be used in a security function to identify the device and prevent tampering with the use data.
The medical probe is coupled to a monitoring device to provide a medical monitoring system. The monitoring device, through communications with the medical probe, determines usage of the medical probe and limits the total use of each medical probe to a limit value by preventing use beyond a predetermined limit. The limit, as noted above, can be based on either total number of uses, total duration of use, or a combination of both. The monitoring device, in conjunction with the medical probe, provides a security function for verifying the identity of the sensor device. Preferably, the security function operates on internal serial numbers and encryption keys to ensure that the proper probes are coupled to the monitoring system, that the internal use data has not been tampered with, and to verify communications between the medical probe and monitoring device.
The monitoring system can also provide a series of product identity functions, as well as stored data for identifying the equipment used in a given monitoring procedure. The stored data can include serial numbers of the equipment used, a date and time stamp, information regarding the medical personnel involved in a monitoring procedure, patient data, and other information.
In one highly preferred embodiment of the invention, the medical monitoring system comprises a fetal sensor for monitoring oxygen saturation in the blood of a fetus while in the womb. Preferably the memory storage component comprises a token counter chip that is coupled directly to the fetal sensor connector. The token counter chip preferably includes memory storage, a counter that can store a use value, and a built-in security function to prevent tampering.
Other advantages and features of the invention, together with the organization and manner of operation thereof, will become apparent from the following detailed description when taken in conjunction with the accompanying drawings wherein like elements have like numerals throughout the drawings.
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patent: WO 00/53082 (2000-09-01), None
Bahr Dennis E.
Larsen Michael T.
von der Ruhr Gerhard
O'Connor Cary
O.B. Scientific, Inc.
Reinhart, Boerner, Van Deuren, Norris & Rieselbach, s.c.
Wingood Pamela
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