Upgradable implantable medical device with post-shock pacing and redraw functions

• US 6,157,859 A
• Filed: 03/09/1998
• Issued: 12/05/2000
• Est. Priority Date: 05/16/1996
• Status: Expired due to Term

• Current Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: Sulzer Intermedics, Inc. (Sulzer AG)
• Inventors: Alt, Eckhard
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/037,168
• Time in Patent Office: 1,002 Days
• Field of Search: 607/4, 607/5, 607/14, 607/15
• US Class Current: 607/4
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: G06F 8/64 Retargetable
• CPC Class Codes: G06F 8/65 Updates security arrangements therefor G06F21/57

Abstract

An implantable medical interventional device is adapted to provide therapy to a patient in whom the device is implanted to treat cardiac dysrhythmias including tachyarrhythmia. The device performs a plurality of functions corresponding to different levels of therapy for treatment of sensed dysrhythmias, including an electric shock waveform of predetermined energy content for delivery to the patient'"'"'s heart to terminate at least one type of tachyarrhythmia. In response to cessation of the tachyarrhythmia after delivery of the electric shock waveform, the device promptly thereafter applies post-shock pacing pulses to the heart for a period of time sufficient to allow the heart to recover from the shock and to resume substantially normal sinus rhythm. The device may be upgraded by programming to select among the various functions as necessary to provide designated therapy by suppressing some functions and activating others. The functions include, among others, simulating different conditions of interaction between activity of the heart and the therapies offered by the device, based on stored intrinsic heart beat signals over a respective time period with modified settings of parameters associated with the therapies. The results of the simulated different conditions of interaction can be displayed to show the effectiveness of treatment by the device if the dysrhythmia were actually encountered while the device is programmed with the respective time period and parameter settings.

Claims

1. An implantable medical interventional device adapted to provide therapy to a patient in whom the device is implanted to treat cardiac dysrhythmias including tachyarrhythmia, said device comprising a therapy function generator for providing a plurality of functions corresponding to different levels of therapy for treatment of sensed dysrhythmias, said functions including an electric shock waveform of predetermined energy content for delivery to the patient'"'"'s heart to terminate at least one type of sensed tachyarrhythmia;

said function generator being responsive to cessation of the tachyarrhythmia following delivery of the electric shock waveform for promptly thereafter applying post-shock pacing pulses to the heart with a magnitude exceeding a predetermined threshold greater than the threshold for normal pacing of the patient'"'"'s heart by the device, for the duration of a period of time sufficient to allow the heart to recover from the shock and to commence sinus rhythm.

2. The device of claim 1, wherein said period of time of application of post-shock pacing pulses exceeds approximately 30 seconds.

3. The device of claim 1, wherein said period of time of application of post-shock pacing pulses is from approximately 30 seconds to about five minutes.

4. The device of claim 1, further including means for sensing dysrhythmias to be treated, a first lead electrically coupled to said function generator and said sensing means and having an electrode exposed thereon and adapted to be positioned in the right atrium of the patient'"'"'s heart for sensing and pacing cardiac activity of the atrium;

a second lead electrically coupled to said function generator and said sensing means and having an electrode exposed thereon and adapted to be positioned in the right ventricle of the patient'"'"'s heart for sensing and pacing cardiac activity of the ventricle.

5. The device of claim 4, wherein said device includes an electrically conductive case for housing components of the device including said function generator and said sensing means, and further includes a third lead electrically coupled to said function generator and having an electrical coil thereon for delivering defibrillation shocks to the ventricle relative to said conductive case as an electrode positioned external to the heart, said coil adapted to be positioned in the right ventricle.

6. The device of claim 4, further including:

means for detecting atrial signals indicative over time of the atrial ECG morphology, and

memory means for storing said atrial signals, and thereby, the atrial ECG morphology, for diagnosis of cardiac activity before, during and after a tachyarrhythmia.

7. The device of claim 6, further including:

telemetry means for selective retrieval of the stored atrial signals representing the patient'"'"'s atrial ECG morphology to facilitate interpretation of cardiac activity leading to and during the tachyarrhythmia, and in response to therapy delivered by the device subsequent to detection of such event.

8. An implantable medical interventional device adapted to provide therapy to a patient in whom the device is implanted to treat cardiac dysrhythmias including tachyarrhythmia, said device comprising a therapy function generator for providing a plurality of functions corresponding to different levels of therapy for treatment of sensed dysrhythmias, said functions including an electric shock waveform of predetermined energy content for delivery to the patient'"'"'s heart to terminate at least one type of sensed tachyarrhythmia;

said function generator being responsive to cessation of the tachyarrhythmia following delivery of the electric shock waveform for promptly thereafter applying post-shock pacing pulses to the heart for a period of time sufficient to allow the heart to recover from the shock and to commence sinus rhythm;

said function generator further including means for selectively curtailing or restoring at least some of said functions;

an extended memory, and means for selectively retrieving from said extended memory a stored therapy function having parameters used for successful treatment of a simulated dysrhythmia suffered by the patient, whereby to provide a redraw function by which said successful therapy function is reusable upon sensing an actual occurrence of said simulated dysrhythmia.

9. Advice-implemented method of treating cardiac dysrhythmias, including tachyarrhythmia, with an implantable medical interventional device adapted to deliver therapy to an implant patient, wherein the device possesses the capability to provide a plurality of functions corresponding to different levels of therapy for treatment of dysrhythmias, said method including the steps of:

sensing any of a plurality of different types of dysrhythmias of the patient'"'"'s heart;

responding to each different type of sensed dysrhythmia by delivering to the patient'"'"'s heart a programmed level of therapy appropriate thereto, including, when at least one type of tachyarrhythmia is sensed, delivering an electric shock waveform of predetermined energy content to a selected chamber of the patient'"'"'s heart to terminate said sensed tachyarrhythmia; and

promptly upon cessation of said sensed tachyarrhythmia, ceasing further delivery of the electric shock waveform and instead applying post-shock pacing pulses to the patient'"'"'s heart with a magnitude exceeding a predetermined threshold greater than the threshold for normal pacing of the patient'"'"'s heart by the device, for the duration of a period of time sufficient for the heart to recover from the shock and to commence sinus rhythm.

10. The device-implemented method of claim 9, including applying said post-shock pacing pulses to the heart for a period exceeding approximately 30 seconds.

11. The device-implemented method of claim 9, including applying said post-shock pacing pulses to the heart for a period of up to about five minutes.

12. A device-implemented method of treating cardiac dysrhythmias, including tachyarrhythmia, with an implantable medical interventional device adapted to deliver therapy to an implant patient, wherein the device possesses the capability to provide a plurality of functions corresponding to different levels of therapy for treatment of dysrhythmias, said method including the steps of:

sensing any of a plurality of different types of dysrhythmias of the patient'"'"'s heart;

responding to each different type of sensed dysrhythmia by delivering to the patient'"'"'s heart a programmed level of therapy appropriate thereto, including, when at least one type of tachyarrhythmia is sensed, delivering an electric shock waveform of predetermined energy content to a selected chamber of the patient'"'"'s heart to terminate said sensed tachyarrhythmia;

promptly upon cessation of said sensed tachyarrhythmia, ceasing further delivery of the electric shock waveform and instead applying post-shock pacing pulses to the patient'"'"'s heart for a period of time sufficient for the heart to recover from the shock and to commence sinus rhythm,

sensing and, when required, pacing cardiac activity of the atrium via a first lead from the device inserted in the patient'"'"'s heart with a bipolar electrode of said first lead positioned in the right atrium;

when required, pacing cardiac activity of the ventricle and sensing the underlying ECG via a second lead from the device inserted in the patient'"'"'s heart with an electrode of said second lead positioned in the right ventricle; and

when required, delivering defibrillation shocks to the ventricle via a third lead from the device with an electrical coil of said third lead positioned in the right ventricle relative to an electrode positioned external to the ventricle.

13. The device-implemented method of claim 12, including the step of:

with a therapy function generator of the device implanted in the left pectoral region of the patient'"'"'s chest, using an electrically conductive case that houses said function generator as said electrode positioned external to the ventricle for delivery of said defibrillation shocks relative to said electrical coil.

14. The device-implemented method of claim 12, including the steps of:

detecting the atrial ECG morphology from said electrode of said first lead when positioned in the right atrial appendage, and

storing atrial signals indicative of the detected atrial ECG morphology for diagnosis of cardiac activity before, during and after a tachyarrhythmic event.

15. The device-implemented method of claim 14, including the step of:

selectively retrieving the stored atrial signals representing the patient'"'"'s atrial ECG morphology by telemetry from the device, to facilitate interpretation of cardiac activity leading to and during a tachyarrhythmic event, and response of the heart to therapy delivered by the device subsequent to detection of such event.

16. A device-implemented method of treating cardiac dysrhythmias, including tachyarrhythmia, with an implantable medical interventional device adapted to deliver therapy to an implant patient, wherein the device possesses the capability to provide a plurality of functions corresponding to different levels of therapy for treatment of dysrhythmias, said method including the steps of:

sensing any of a plurality of different types of dysrhythmias of the patient'"'"'s heart;

responding to each different type of sensed dysrhythmia by delivering to the patient'"'"'s heart a programmed level of therapy appropriate thereto, including, when at least one type of tachyarrhythmia is sensed, delivering an electric shock waveform of predetermined energy content to a selected chamber of the patient'"'"'s heart to terminate said sensed tachyarrhythmia;

promptly upon cessation of said sensed tachyarrhythmia, ceasing further delivery of the electric shock waveform and instead applying post-shock pacing pulses to the patient'"'"'s heart for a period of time sufficient for the heart to recover from the shock and to commence sinus rhythm, and

selectively retrieving from an extended memory of the device a stored therapy function having parameters used for successful treatment of a simulated dysrhythmia suffered by the patient, whereby to provide a redraw function by which said successful therapy function is reusable upon sensing an actual occurrence of said simulated dysrhythmia.

17. An implantable medical interventional device for delivering an appropriate therapy to an implant patient suffering from one or more cardiac dysrhythmias, said device comprising a therapy generator for providing said appropriate therapy from among a plurality of therapies available from said generator in response to a respective sensed dysrhythmia, one said appropriate therapy being an electric shock waveform of relatively high energy content for delivery to a selected chamber of the patient'"'"'s heart to terminate a tachyarrhythmia thereof;

said therapy generator including a portion responsive to cessation of further delivery of said electric shock waveform to the selected chamber upon termination of said tachyarrhythmia for promptly thereupon applying post-shock pacing pulses to said selected chamber for a period of time sufficient to allow the patient'"'"'s heart to recover from said shock waveform and to commence a sinus rhythm;

said device further including a programmable portion for selectively temporarily disabling the availability of any one or more, including said electric shock waveform, but less than all, of said plurality of therapies from said generator.

18. The device of claim 17, further including apparatus for ascertaining that an available one of said plurality of therapies is particularly effective for treating a particular dysrhythmia of the patient'"'"'s heart, and for initiating said particularly effective therapy whenever said particular dysrhythmia is sensed.

19. The device of claim 17, wherein said programmable portion includes apparatus for selectively restoring the availability of at least one temporarily disabled therapy through a security code.

20. An implantable pacemaker/cardioverter/defibrillator device adapted to be upgraded from time to time to enable the device to provide additional therapy for treatment of dysrhythmias in a patient in whom the device is implanted, as the needs of the patient for such treatment undergo change, said device comprising a therapy function generator for providing a plurality of functions corresponding to different levels of therapy for treatment of dysrhythmias;

means for sensing any of a plurality of different types of dysrhythmias;

means responsive to each different type of dysrhythmia sensed by said sensing means for enabling said function generator to provide a level of therapy appropriate to the respective sensed dysrhythmia, said plurality of functions including an electric shock waveform of predetermined energy content for delivery to a selected chamber of the patient'"'"'s heart to terminate a sensed tachyarrhythmia and a waveform containing a plurality of post-shock pacing pulses to be delivered to the heart promptly following termination of said tachyarrhythmia for a period of time sufficient to allow the heart to recover from the shock waveform and to resume substantially normal sinus rhythm; and

means for programmably curtailing the availability of at least some of said plurality of functions from said function generator and for selectively restoring the curtailed functions when needed upon access through a security code.