Surgery – Diagnostic testing
Reexamination Certificate
1998-04-20
2001-02-20
O'Connor, Cary (Department: 2765)
Surgery
Diagnostic testing
C705S002000, C128S903000, C600S301000, C600S529000
Reexamination Certificate
active
06190313
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a system and method for monitoring the health status of a patient at the site of the patient and providing the patient with an evaluation of such health status to allow the patient to take an interactive role in his/her own health care.
BACKGROUND OF THE INVENTION
With the advances in instrumentation it is possible to monitor patients from remote locations, allowing more frequent measurements of one or more physiological parameters related to the patient's health condition. This remote monitoring brings two benefits to the patients. First, remote monitoring is less disruptive to the patient's life style and, second, remote monitoring can provide more representative values of the patient's state of health, since the values are being measured in a familiar environment.
Monitoring patients is frequently done for patients being treated for a chronic health condition. For patients being treated for a chronic health condition, monitoring allows the patient's health care provider to monitor the health status of the patient and adjust the treatment of the patient accordingly. Similarly, monitoring is helpful in treating an acute health condition which may be temporary or intermittent. Monitoring can also be helpful to individuals who are on a health care maintenance program rather than a treatment program. In this case, monitoring is useful in evaluating the effectiveness of the health care maintenance program.
U.S. Pat. No. 5,410,471 is directed to a passive patient monitoring system which provides various sensors which operate in non-medical environments. These sensors also record personal identification information and encode it with the measurement data so that the source of the data can be identified. The sensors can be provided with memory and linked together with other sensors and instruments to provide a network which can utilize the data to track the state of health of the patient. The encoded data is transmitted to a central location for processing and evaluation, and can optionally be displayed on a monitor at the patient's site. While the '471 patent does teach sharing the information collected, it does not provide a method for evaluating the data or making such evaluation available to the patient.
U.S. Pat. No. 5,626,144 teaches another system which employs remote sensors to monitor the state of health of a patient. This system differs in part from the system of the '471 patent in that the patient is not only aware of the testing, but actively participates in the testing. The system taught in the '144 patent is commercially provided by ENACT Health Management Systems, Inc., under the trademark AirWatch™. The '144 patent discloses a remote patient-operated air flow meter which has a memory for recording, tagging, and storing a limited number of test results. The patient-operated air flow meter also has a display to allow the patient to view a series of normalized values, and provides a warning when the value falls below a prescribed percentage of a “personal best number” value previously set by the patient. The patient-operated air flow meter also includes a modem for transmission of the tagged data over the telephone to a remote computer for downloading and storing in a relational database. The '144 patent also teaches that the remote computer can be employed to analyze the data. This analysis can then be provided as a report to the health care provider and/or to the patient.
While the '144 patent does offer some rudimentary indication of the patient's state of health, and in particular for asthma, it does so based on an individual reading which is compared to a preset “personal best number”. The “personal best number” is defined in the user guide for the AirWatch™ device as “the Peak Flow reading that you can usually measure with your AirWatch monitor when your airway is clear and your breathing is good.” Thus, this preset “personal best number” is a subjective value which may or may not provide an adequate index of the patient's health status. If the patient wishes a more objective indication of his/her state of health, such can only be obtained based on an analysis done at a remote location, and this information is historically based, providing little information which could help the patient take actions prior to the occurrence of a health crisis to avoid the same.
Thus, there is a need for a patient orientated system which allows the patient to take greater responsibility for his/her state of health. Such a system should provide a method of analyzing the patient's health measurement data which provides advance warning of a potential health crisis. The system should also use the analysis to provide guidance to the patient as to a course of action to be pursued to prevent the potential health crisis. Preferably, such a patient oriented system provides for automatic updating of the health care provider as to the status of the patient and as to whether intervention is required on the part of the health care provider.
SUMMARY OF THE INVENTION
The present invention provides a method of evaluation of the state of health of a patient under the supervision of a health care provider, where the patient measures a physiological parameter which is indicative of his/her health. The invention also provides a system for monitoring the state of health of the patient which utilizes the method and does not require interaction with the health care provider to inform the patient as to his/her state of health.
The method collects and records data on one or more physiological parameters of a patient and analyze the data on an ongoing basis as the data becomes available. This data is preferably supplied to the patient's health care provider so that it is available for review and analysis by the health care provider.
In the case that a larger health care community interest such as a health maintenance organization (HMO) is involved, such should also be provided the data for its analysis. This gives the HMO the ability to conduct various analyses of the data to determine the statistical effectiveness of a certain treatment program which is used for a number of patients, comparing the relative effectiveness of different health care providers, discovering seasonal or locational factors which effect health status, etc. The results of such analyses by the HMO can then be provided to the health care providers and individual patients to assist them in developing more effective treatment programs for maintaining the health of the patients.
To evaluate the state of health of the patient, the data is analyzed using the principles of statistical process control (SPC) analysis. The principles of SPC in detecting special cause variations in industrial processes to indicate when the industrial process is not stable within its control limits is further discussed in
Economic Control of Quality of Manufactured Product
by Walter A. Shewhart (Van Nostrand, 1931; repr. ed., American Society for Quality Control, 1980.) Over the years, these principles have been distilled into Shewhart's rules of detection. The present invention applies the principles of Shewhart's rules, which have classically been used for industrial quality control, for monitoring health status. Preferably, control charts are used to assist the patient and the health care provider in identifying when the conditions for one of Shewhart's rules of detection is met.
When one of Shewhart's rules is met, notice is provided to the patient that a special cause variation has occurred. Depending on the health condition being monitored and the control limit which the data are approaching or exceeding, such special cause variation may indicate a significant change in the health status of the patient. These changes may result in improvement or deterioration of the health of the patient. When improvement is indicated, the patient is notified that the health maintenance program of the patient may need to be
Astorino Michael
O'Connor Cary
Semprebor Jeffrey E.
Weins Michael J.
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