Cardiac pacemaker with bidirectional communication
First Claim
1. A cardiac pacemaker constructed and adapted to be implanted in the body of a patient to sense cardiac activity including dysrhythmias and to respond to the sensing of a dysrhythmia with an appropriate therapy selected to return the heart to normal sinus rhythm, said pacemaker comprising a therapy generator including a biocompatible housing, electrical sensing and pacing/defibrillating therapy-generating circuitry within the housing, an electrically insulative header atop the housing, at least one female electrical connector coupled to the circuitry within the housing and having an exposed opening in the header adapted to receive a mating proximal end of a pacemaker endocardial lead for at least supplying intracardiac ECG signal information from the patient'"'"'s heart to the therapy generator, said header having an outer surface for exposure to tissue and fluid of the patient when the pacemaker is implanted, and at least two electrodes incorporated into the header and exposed by mounting at said outer surface thereof, said at least two electrodes being connected to the circuitry within the housing for detecting within the patient'"'"'s body electrical signals emanating from the patient'"'"'s heart as additional ECG signal information independent of the lead-based intracardiac ECG signal information for confirming or distinguishing the intracardiac ECG signal information.
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Accused Products
Abstract
An interventional medical device has a capability to sense cardiac dysrhythmias and to selectively respond with one among a hierarchy of therapies appropriate to terminate the sensed dysrhythmia and return the heart of the patient in whom the device is adapted to be implanted to normal sinus rhythm. The device includes a therapy generator having a housing and electronics for conducting bidirectional communication with the patient. The bidirectional communication is carried out by detecting the occurrence of a predetermined dysrhythmia, such as atrial fibrillation, to alert the patient of such occurrence, and by responding to instructions from the patient following such alert for addressing the detected predetermined dysrhythmia. The detection is performed by electrodes mounted directly on the header of the device housing to both detect occurrence of the atrial fibrillation and for alerting the patient thereof by stimulating body tissue such as pectoral muscle in the vicinity of the header electrodes. Response to patient-initiated instructions is implemented by triggering certain device functions such as storage of ECG events detected by the header electrodes, or deliver of a therapy appropriate to terminate the atrial defibrillation, or delay of delivery of the appropriate therapy, according to the nature of the patient-initiated instructions.
205 Citations
23 Claims
- 1. A cardiac pacemaker constructed and adapted to be implanted in the body of a patient to sense cardiac activity including dysrhythmias and to respond to the sensing of a dysrhythmia with an appropriate therapy selected to return the heart to normal sinus rhythm, said pacemaker comprising a therapy generator including a biocompatible housing, electrical sensing and pacing/defibrillating therapy-generating circuitry within the housing, an electrically insulative header atop the housing, at least one female electrical connector coupled to the circuitry within the housing and having an exposed opening in the header adapted to receive a mating proximal end of a pacemaker endocardial lead for at least supplying intracardiac ECG signal information from the patient'"'"'s heart to the therapy generator, said header having an outer surface for exposure to tissue and fluid of the patient when the pacemaker is implanted, and at least two electrodes incorporated into the header and exposed by mounting at said outer surface thereof, said at least two electrodes being connected to the circuitry within the housing for detecting within the patient'"'"'s body electrical signals emanating from the patient'"'"'s heart as additional ECG signal information independent of the lead-based intracardiac ECG signal information for confirming or distinguishing the intracardiac ECG signal information.
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15. An implantable interventional medical device for treating cardiac dysrhythmias, comprising a case housing electronic components and circuitry for said device;
- a header on said case for mounting an electrical connector adapted to connect to a lead for signal communication between said electronic components and circuitry in the case and the heart of a patient in whom the device is adapted to be implanted;
at least two electrodes surface-mounted directly on one of the case and the header for direct exposure to tissue and fluid when said device is implanted in the patient, and means including said electronic components and circuitry cooperatively associated with said electrodes in both collecting cardiac signals indicative of dysrhythmias and stimulating muscle tissue in the vicinity of the implant site to alert the patient of occurrence of one of (I) a fault in the circuitry or the lead and (ii) a predetermined dysrhythmia.
- a header on said case for mounting an electrical connector adapted to connect to a lead for signal communication between said electronic components and circuitry in the case and the heart of a patient in whom the device is adapted to be implanted;
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16. A device-implemented method of detecting and treating cardiac dysrhythmias in a patient employing a cardiac pacemaker implanted in the patient to sense and respond to abnormal cardiac activity with a therapy appropriate for relieving the abnormal cardiac activity;
- wherein the pacemaker includes a therapy generator having a biocompatible housing, electrical sensing and pacing/defibrillating therapy-generating circuitry within the housing, an electrically insulative header atop the housing having an electrical connector mounted therein coupled to the circuitry within the housing, an electrical lead implanted proximate the patient'"'"'s heart and connected to the electrical connector to supply intracardiac ECG signal information from the patient'"'"'s heart to the therapy generator;
said method including the steps of detecting signals propagating in an electrical field from the heart through the patient'"'"'s body with at least two electrodes surface-mounted on and incorporated into the header and connected to the circuitry within the housing, as additional ECG signal information independent of the lead-based intracardiac ECG signal information for confirming or distinguishing the intracardiac ECG signal information, and responding to a dysrhythmia detected from the intracardiac ECG signal information and confirmed by said additional independent ECG signal information detected with the surface-mounted electrodes by delivering said appropiate therapy from the therapy generator to the patient'"'"'s heart. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23)
- wherein the pacemaker includes a therapy generator having a biocompatible housing, electrical sensing and pacing/defibrillating therapy-generating circuitry within the housing, an electrically insulative header atop the housing having an electrical connector mounted therein coupled to the circuitry within the housing, an electrical lead implanted proximate the patient'"'"'s heart and connected to the electrical connector to supply intracardiac ECG signal information from the patient'"'"'s heart to the therapy generator;
Specification