Imaging safety device

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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Details

C600S407000, C600S411000, C600S439000

Reexamination Certificate

active

06438405

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to methods and apparatus which, connect and integrate an imaging system with patient monitoring devices to inform the user of the imaging system about detected irregularities. The present invention is particularly useful in integrating an ultrasound imaging system and an ECG monitor with known heart function abnormality detectors.
Ultrasound imaging is usually performed at the highest power level setting provided by an ultrasound system. Recent advances in ultrasound imaging include the use of contrast agents to enhance ultrasound returns. Contrast agents are substances which strongly interact with ultrasound waves and return echoes which may be clearly distinguished from those returned by blood and tissue. With the use of contrast agents, lower power levels can be utilized for normal scanning procedures. However, the use of contrast agent lead to imaging methods involving repeated high power scans to disrupt contrast agent. This is useful for two reasons: first, the high power scans bust (or disrupt) contrast agent creating an easily detectable disturbance; and second, once the contrast agent has been disrupted, subsequent viewing will show the re-population of contrast agent, allowing an extrapolation of flow rates, including perfusion.
Presently, new higher power modes of imaging with and without contrast agent are being explored. Indications are that future methods may require ever increasing power level to obtain some measurement or image. Such high power scanning is causing increasing unease in the medical industry, which is questioning possible side-effects produced by such ultrasound procedures.
Such safety concerns have lead to advances in ultrasound technology, for example the use of modified waveforms to gently increase the applied acoustic energy. However, the present inventors have recognized a need for additional monitoring of a patient's condition, and that such additional monitoring must be integrated with an ultrasound system. The main reason for such integration is that many sonographers are not trained to operate or interpret the output of other patient monitoring devices. The present inventors have also realized that such integration should be expanded to allow automated control of the ultrasound system in the event of an emergency.
SUMMARY OF THE INVENTION
The present invention integrates an abnormality detection function with an imaging system. A method is described in which an imaging system receives signals from a patient monitoring device, during an imaging procedure, and performs abnormality detection thereon. When an abnormality is discovered, an action database is consulted and appropriate actions, i.e. issuance of an alert or an alarm, and modification of the operation of the imaging system, are implemented.
The present invention also provides a medical device, including an imaging system, in which a patient monitoring device monitors physiological parameters of a patient and outputs a signal, indicating values for the parameters, to an imaging system. The imaging system includes an imaging probe that directs energy into and receives energy from a patient, and a signal analyzer, in communication with the patient monitoring device, that analyzes the signal from the patient monitoring device and outputs a signal indicating irregularities in parameters monitored. A control unit, in the imaging system, monitors the signal from the signal analyzer and, when a predetermined signal is output, issues an alarm to the operator of the patient imaging system. The control unit can also be programed to issue an alarm, reduce the output power of the imaging probe and/or alert a central monitoring facility in response to the output of the signal analyzer.


REFERENCES:
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patent: 5871446 (1999-02-01), Wilk
patent: 5876349 (1999-03-01), Wang et al.
patent: 5967994 (1999-10-01), Wang
patent: 6246897 (2001-06-01), Foo et al.

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