Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-08-20
2001-11-20
Evanisko, George R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S030000
Reexamination Certificate
active
06321117
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to the field of medical devices, and more particularly to implantable medical devices.
BACKGROUND
Cardiac rhythm management devices such as pacemakers, cardioverter/defibrillators, and combination devices typically include numerous program parameters that affect device function, including arrhythmia detection and therapy delivery. Device function can be adjusted to meet the needs of a patient by changing the program parameters. Some examples of program parameters include tachy mode (for detecting and providing therapy for tachycardia) and brady mode (for detecting and providing therapy for bradycardia). Changing program parameters such as tachy mode and/or brady mode activates or deactivates major cardiac analysis and therapy functions of the device.
Most program parameters are adjusted using an external programmer recorder/monitor that communicates with the implanted device via wireless telemetry through the skin. Program parameters may be turned on or off through the use of the external programmer. Other mechanisms may also modify parameter programming. For example, the device may, upon detection of an exhausted battery condition, disable some device functions rather than delivery compromised therapy that may be erratic or potentially dangerous. Some devices respond to the presence of a magnet by inhibiting therapy momentarily, or permanently via magnet maneuvers. Robust device designs perform periodic system integrity validation including program parameters. The device may alter programming to correct integrity errors. These types of changes to the program parameters may have a profound effect on the overall operation of the implanted device.
When a patient visits their physician for routine periodic device follow-ups, the device is interrogated using the external programmer recorder/monitor. During this interrogation, a review is made of parameter programming to assure that the device settings are appropriate for the patient cardiac condition. When parameters are not as expected (e.g., a program parameter has been turned off, or there is an alteration in programmable values the program parameter is using), the clinician must investigate to discover how and why this occurred and take corrective action. Knowing why and when the parameter programming changed is important information to assess the situation. When this information is limited or incomplete, it places doubt on the assessment and the reliability of the device. Therefore, a need exists for understanding how and why parameter programs have been affected during the operation of a cardiac rhythm management device.
SUMMARY OF THE INVENTION
As explained in detail below, the present subject matter is directed to a method and system for providing a log maintained within an implantable medical device that records changes to the operation of the implantable medical device. The log includes entries made by the implantable medical device when operating parameters for executable programs within the medical device and/or the operating state of the implantable medical device change. Logging these types of changes are important in diagnosing how and why changes occurred in the operation of the implantable medical device.
In one embodiment of the present subject matter, an executable program is stored in an implantable pulse generator. The executable program includes one or more programmable parameters that have a first state. The implantable pulse generator further includes a parameter log. The parameter log is used to record changes to the state of the programmable parameters for the executable program. Changes to the state can include turning the executable program on or off, or making alterations to programmable values used by the executable program. When these types of changes are detected, the first state of the one or more programmable parameters changes to a second state. The first state of the one or more programmable parameters changed to the second state is then stored in the parameter log. Then, when it is discovered that changes have occurred to the programmable parameters, the log of these changes can be reviewed by the physician to more easily discover how and why the changes occurred.
Changes recorded in the log include changes to the execution (e.g., turned on or turned off) of the programs for the programmable parameters. Additionally, recorded changes can include those relating the use of a programmable parameter to deliver a “STAT” shock to a patient. Also, events in which the implantable pulse generator initiates an electronic circuitry reset program to test its circuitry and program settings is also recorded in the log. Additional events logged include when the implantable pulse generator is partially or totally disabled with use of a magnet or when the implantable pulse generator terminated an executable program due to a battery malfunction or expiration. In addition to storing why changes occurred to the programmable parameters, the time and the date of the change to the parameters is also recorded in the log.
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Koshiol Allan T.
Mackey LeAnne Marie
Cardiac Pacemakers Inc.
Evanisko George R.
Schwegman Lundberg Woessner & Kluth P.A.
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