Cardiac pacemaker with bidirectional communication

• US 6,080,187 A
• Filed: 04/06/1998
• Issued: 06/27/2000
• Est. Priority Date: 10/21/1996
• Status: Expired due to Fees

• Current Assignee: Eckhard Alt
• Original Assignee: Intermedics Incorporated
• Inventors: Alt, Eckhard, Stotts, Lawrence J.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/055,212
• Time in Patent Office: 813 Days
• Field of Search: 607/30, 607/32, 607/60, 607/4, 607/5, 607/36, 128/903
• US Class Current: 607/32
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37258 Alerting the patient

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 dysrhytlnia, 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.

Claims

1. A body implantable interventional medical device having a capability to sense cardiac dysrhythrias 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, said device comprising:

a therapy generator including a housing and means for conducting bidirectional communication with the patient, said bidirectional communication means including;

detection means responsive to occurrence of a predetermined dysrhythmia for alerting the patient of such occurrence, said detection means including electrode means mounted on the device housing for both detecting occurrence of said predetermined dysrhythima and for alerting the patient thereof, and

initiation means responsive to instructions from the patient following such alert for addressing the detected predetermined dysrhythmia.

2. The device of claim 1, wherein said device housing includes a case and a header, and said electrode means includes first and second electrodes mounted on opposite sides of the header to detect cardiac signals that spread through the patient'"'"'s body tissue and to stimulate the body tissue when cardiac signals indicative of said predetermined dysrhythmia are detected.

3. The device of claim 1, wherein said initiation means includes sensing means for sensing patient-initiated coded signals and for responding thereto by at least one of (i) storing cardiac signals indicative of said predetermined dysrhythima, (ii) deliver a therapy appropriate to terminate said predetermined dysrhythmia, or delaying delivery of said therapy, according to the nature of the patient-initiated coded signals.

4. The device of claim 3, wherein said sensing means comprises means responsive to a predetermined sequence of taps delivered to the device housing.

5. The device of claim 3, wherein said sensing means comprises means responsive to application of a magnetic field adjacent to the device housing.

6. The device of claim 4, wherein said sensing means comprises means responsive separately to first, second, and third predetermined distinct and different coded sequences of taps for storing said cardiac signals, for delivering said appropriate therapy, and for delaying delivery of said appropriate therapy, respectively.

7. The device of claim 1, detection means further comprises an acoustic source within said housing activated by said electrode means for sounding an audible alert to the patient.

8. The device of claim 1, wherein said initiation means comprises means for triggering diagnostic functions of the device.

9. The device of claim 1, wherein said initiation means comprises means for triggering therapeutic functions of the device.

10. A body implantable interventional medical device having 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, said device comprising:

a therapy generator including a housing and means for conducting bidirectional communication with the patient, said bidirectional communication means including;

detection means responsive to occurrence of a predetermined dysrhythmia for alerting the patient of such occurrence, and

initiation means responsive to instructions from the patient following such alert for addressing the detected predetermined dysrhythmia; and

means responsive to detection of said predetermined dysrhythmia to open a preset time window, and mews responsive during the time window to patient-initiated signals for triggering a therapeutic function of the device and to closing of the time window for reversion to automatic therapy delivery by the device.

11. An implantable interventional medical device for treating cardiac dysrhythmias, comprising electronic components and circuitry for performing diagnostic and therapeutic functions with respect to said cardiac dyshythmias, a case housing said electronic components and circuitry an electrical connector attached to the case and connected to said circuitry for conducting electrical signals to and from said circuitry representing detected cardiac signals for diagnosing dysrhythmias and electrical stimuli for delivery of therapy in response to such diagnosis respectively, an accelerometer mounted in said case for both (i) detecting physical activity of the patient in whom the device is to be implanted to control cardiac pacing functions of said device and (ii) responding to coded taps on said case representing instructions to said circuitry to initiate at least some of said diagnostic and therapeutic functions of said device, and means for overriding an instruction represented by said coded taps to delay delivery of a therapeutic function of said device when the delay exceeds a predetermined time interval.

12. In a body implantable interventional medical device having a capability to sense cardiac dysrhythmias and to selectively respond with any 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, a device-implemented method of bidirectional communication with the patient comprising the steps of detecting the occurrence of any one among a set of predetermined dysrhythmias, responding to the detection of a non-life threating dysrhythmia among set by alerting the patient thereof, responding to patient-initiated coded signals applied as instructions to said device following such alert for mandating one among a plurality of patient directives in response to said detected dysrhythmia wherein said plurality includes directing a delay in delivery of therapy which would otherwise be a response by said device to said detected dysrhythmia and overriding a patient directive to delay delivery of therapy after said delay exceeds a predetermined time interval while said detected dysrhythmia is still occurring.

13. The device-implemented method of claim 12, including sensing said patient-initiated coded signals, and wherein said patient directives in response thereto include at least one of (i) storing cardiac signals indicative of the detected dysrhythmia or (ii) delivering a therapy appropriate to terminate said detected dysrhythmia or (iii) postponing delivery of said therapy, according to the nature of the patient-initiated coded signals.

14. The device-implemented method of claim 13, including sensing patient-initiated coded signals in the form of a predetermined sequence of taps delivered to the device housing.

15. The device-implemented method of claim 13, including sensing patient-initiated coded signals in the form of magnet induce d-actuation imposed on the device housing.

16. The device-implemented method of claim 12, including energizing electrodes surface-mounted on a housing for the device to alert the patient of said detected dysrhythmia.

17. The device-implemented method of claim 12, including energizing an acoustic source within a housing for the device to sound an audible alert to the patient.

18. The device-implemented method of claim 12, including responding to said patient-initiated coded signals by triggering diagnostic functions of the device.

19. The device-implemented method of claim 12, including responding to said patient-initiated coded signals by triggering therapeutic functions of the device.

20. In a body implantable interventional medical device having a capability to sense cardiac dysrhythmias and to selectively respond with any 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, a device-implemented method of bidirectional communication with the patient comprising detecting the occurrence of a predetermined dysrhythmia alerting the patient of said occurrence responding to instructions initiated by the patient following such alert for addressing the detected predetermined dysrhythmia responding to detection of said predetermined dysrhythmia by opening a preset time window, responding during the time window to patient-initiated signals for triggering a therapeutic function of the device, and responding to closing of the time window by reverting to automatic therapy delivery by the device.