Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2000-05-11
2001-06-26
Kamm, William E. (Department: 3762)
Surgery
Diagnostic testing
Cardiovascular
Reexamination Certificate
active
06253102
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to medical devices and in particular to a system for organizing, displaying and interacting with cardiac arrhythmia data
BACKGROUND OF INVENTION
Implantable cardiac defibrillators (ICDs) are well established therapeutic devices for treating patients who have experienced one or more documented episodes of hemodynamically significant ventricular tachycardia or ventricular fibrillation. Since their clinical inception more than two decades ago, ICDs have evolved from basic to sophisticated electronic devices that provide physicians with a variety of clinically useful functions with which to treat patients.
Presently, even the most basic of ICDs typically has more than one tachycardia detection criterion, tiered therapy which combines bradycardia support pacing with various antitachycardia pacing modes, low-energy cardioversion, defibrillation, and data logging capabilities. The data logging capabilities within ICDs have become increasingly important, since the amount of data required for the ICDs operation increases proportionally with the increase in ICD functions. Efficiently processing this large amount of data has become possible with the incorporation of microprocessors and memory within the ICD.
Even with the advances in ICD data logging and processing capabilities, arrhythmia event recording capabilities have been limited, making it difficult to verify the adequacy and efficacy of arrhythmia detection and therapy settings. Furthermore, ICDs have been designed to record electrocardiogram and diagnostic channel data which can indicate to the physician the ICDs behavior during multiple tachyarrhythmia episodes. These ICDs also include arrhythmic event counters which log the number of episodes detected and the success or failure of each programmed therapy. Moreover, monitoring capability in some ICDs allow for recording of electrocardiogram waveforms, which can assist the physician in assessing the efficacy of the implanted ICD.
Once an ICD has been implanted, the physician interacts with the ICD through a clinical programmer. The clinical programmer is used to establish a telemetric link with the implanted ICD. The telemetric link allows for instructions to be sent to the electronic circuitry of the ICD and clinical data regarding the occurrence and treatment of a patient's cardiac arrhythmias and the ICD's operation to be sent from the electronic circuitry of the ICD to the clinical programmer. The typical programmer is a microprocessor-based unit that has a wand for creating the telemetric link between the implanted ICD and the programmer, and a graphics display screen that presents a patient's recorded cardiac data and ICD system information to the physician.
As the amount of cardiac data recorded by ICDs increases with each new generation of ICD, manufacturers and clinicians alike are becoming more sensitive to the role that time-efficient programming and data interpretation plays in the physician's clinical visit with the patient. As ICDs become increasingly complex, the interpretation of recorded arrhythmic episodes and the programming of the ICD can be challenging and time-consuming tasks for some users. Therefore, a need exists for improved ICD and programmer technology that will provide efficient classification and presentation of ICD recorded arrhythmic data to assist a physician in programming and interpreting an implanted ICD's functions.
SUMMARY OF THE INVENTION
The present disclosure describes a medical device system for organizing, displaying and interacting with a patient's recorded arrhythmia episodes. In one embodiment, the medical device system graphically displaying symbols representing one or more arrhythmic episodes on an interactive display screen based on at least one arrhythmia analysis criteria. The symbols representing the one or more arrhythmic episodes are displayed on an interactive display screen or interface, on which a physician reviews not only the cumulative number of arrhythmic episodes that the patient has experienced, but also the morphological similarities of the episodes. Additionally, the physician is also able to review the recorded electrocardiogram and therapy regimens delivered in order to treat a given arrhythmia. By displaying the patient's recorded cardiac arrhythmic episodes on an interactive display screen, the physician can more quickly assess and interpret the nature of the patient's cardiac arrhythmias and provide for more effective and efficient programming of the patient's ICD.
In one embodiment, the medical device system comprises a cardiac defibrillator and a medical device programmer unit for the cardiac defibrillator. The cardiac defibrillator includes electronic control circuitry for determining and recording the occurrence of arrhythmic episodes of a heart. The programmer unit has programmer electronic circuitry coupled to an interactive display screen. In one embodiment, the programmer electronic circuitry is coupled to the electronic control circuitry of the cardiac defibrillator through a telemetric link. This allows for cardiac data to be received from, and programming signals to be sent to, the cardiac defibrillator.
After receiving the stored cardiac data, the programmer displays a therapy history of the plurality of arrhythmic episodes detected and treated by the cardiac defibrillator on the interactive display screen. One or more of the stored plurality of arrhythmic episodes is selected through the interactive display screen, along with at least one arrhythmia analysis criteria. In one embodiment, the arrhythmia analysis criteria include a similarity/dissimilarity determination, a chronological occurrence of arrhythmias, a circadian occurrence of arrhythmia, morphological similarities, arrhythmia rate, therapy outcome, therapy type, and/or sensor reading. The programmer then graphically displays symbols representing the selected arrhythmic episodes on the interactive display screen based on the at least one arrhythmia analysis criteria.
In one embodiment, the programmer graphically displays distinct symbols representing each of the selected one or more arrhythmic episodes as a function of time. In an alternative embodiment, the programmer plots the selected arrhythmic episodes using a similarity/dissimilarity determination. The programmer electronic circuitry determines an arrhythmic vector for each of the plurality of arrhythmic complexes based on received cardiac QRS waves. Each arrhythmic vector is then compared with a normal rhythm vector representing a patient's QRS complex during normal sinus rhythm to calculate a similarity value and a dissimilarity value for each of the arrhythmic complexes. A symbol representing each of the plurality of complexes of the selected arrhythmic episodes is then generated by the programmer. The programmer then plots, or maps, one or more of the symbols representing the arrhythmia complexes as a function of the calculated similarity values and the dissimilarity values on an interactive display screen. In one embodiment, the symbols are plotted on a discrimination plane having a similarity coordinate axis and a dissimilarity coordinate axis which are orthogonal to the similarity coordinate axis.
In an additional embodiment, symbols representing the arrhythmia complexes of one or more arrhythmic episodes are grouped together within a defined boundary created on the interactive display screen. In one embodiment, the defined boundary is drawn by the user on the interactive display screen. In an alternative embodiment, the defined boundary is created by the electronic control circuitry programmed to distinguish discrete regions of plotted, or mapped, symbols. The position of the defined boundaries encircling the symbols is then retrievably stored.
The stored boundary positions are retrieved at the request of the user. In one embodiment, the user selectively designates one or more boundaries as a notice boundary. The medical device programmer plots the retrieved notice boun
Hsu William
Lang Douglas J.
Cardiac Pacemakers Inc.
Kamm William E.
Schwegman Lundberg Woessner & Kluth P.A.
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