SEMI-AUTOMATIC ATRIAL DEFIBRILLATION SYSTEM, IMPLANTABLE ATRIAL DEFIBRILLATOR AND PORTABLE COMMUNICATION DEVICE

• US 20070265667A1
• Filed: 05/15/2006
• Published: 11/15/2007
• Est. Priority Date: 05/15/2006
• Status: Abandoned Application

• Current Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Lian, Jie, Muessig, Dirk
• Application Number:
  US11/383,235
• Publication Number:
  US 20070265667A1
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A semi-automatic atrial defibrillation system monitors activity of a heart, detects atrial fibrillation (AF), and cardioverts detected AF. The system includes an implantable atrial defibrillator capable of communicating with an external portable device that can further communicate with a remote service center. The implantable atrial defibrillator is capable of detecting AF, automatically sending warning signal and diagnostic data to an external portable device after detection of AF, receiving commands from the external portable device, and cardioverting AF. The external portable device is capable of sending commands to the implantable atrial defibrillator, receiving data from the implantable atrial defibrillator, providing patient discernable warning signal and brief diagnostic information after detection of AF, and transmitting diagnostic information to the remote service center. The external portable device is operable by the patient, who may self-control the delivery of atrial cardioversion therapy after receiving the AF warning message, or may contact the remote service center for physician'"'"'s advice before taking any action.

Claims

1. Atrial defibrillation system comprising:

an implantable atrial defibrillator having

an implant'"'"'s control unit

an implant'"'"'s bidirectional data transceiver connected to the control unit

an automatic atrial fibrillation detector, connected to the control unit and being adapted to receive data from and send data to an external patient device

an atrial cardioversion/defibrillation unit connected to and being responsive to the control unit

said implantable atrial defibrillator being adapted to operate in at least one of;

a patient-activation mode wherein AF therapy is manually initiated by a patient via an external portable device

 

or

an automatic-activation mode wherein AF therapy is automatically initiated by the implant'"'"'s control unit

an external portable device having

a human interface including

an output unit and

an input unit,

a first external bidirectional data transceiver adapted to bidirectionally communicate with the implant'"'"'s bidirectional data transceiver of the implantable atrial defibrillator and being connected to the human interface

a second external bidirectional data transceiver adapted to bidirectionally communicate with a central service center

wherein

the automatic atrial fibrillation detector is adapted to automatically determine the presence or absence of an atrial fibrillation and to notify the control unit accordingly

the implant'"'"'s control unit is adapted

to trigger sending of a warning trigger signal via the implant'"'"'s bidirectional data transceiver after the automatic fibrillation detector has notified the implant'"'"'s control unit of an ongoing atrial fibrillation, the warning trigger signal being adapted to cause the external patient device to cause it'"'"'s output unit to put out a patient discernable warning signal, and

to trigger the atrial cardioversion/defibrillation unit

a) after a warning trigger signal was send out

 

and

b) if a defibrillation trigger signal is received by the implant'"'"'s data transceiver after sending out of said warning trigger signal

 

or

 

if the implantable atrial defibrillator is in its automatic-activation mode and automatic triggering of the atrial cardioversion/defibrillation unit is not switched off by a patient'"'"'s command

 

and

c) if the automatic fibrillation detector determines that the atrial fibrillation is still going on.

2. An atrial defibrillation system according to claim 1, wherein

the implantable atrial defibrillator is adapted to send out a clearing signal if the automatic fibrillation detector determines that the atrial fibrillation has terminated after the warning trigger signal was send out,

and

the external portable device is adapted to clear the warning signal upon receipt of the clearing signal.

3. An atrial defibrillation system according to claim 1, further including a remote service center having means to bidirectionally communicate with the external portable device.

4. An implantable atrial defibrillator forming an implant comprising:

a control unit,

an implant'"'"'s bidirectional data transceiver connected to the control unit,

an automatic atrial fibrillation detector, connected to the control unit and being adapted to receive data from and to send data to an external patient device, and

an atrial cardioversion/defibrillation unit connected to and being responsive to the control unit

wherein

the automatic atrial fibrillation detector is adapted to automatically determine the presence or absence of an atrial fibrillation and to notify the implant'"'"'s control unit accordingly

the implant'"'"'s control unit is adapted

to trigger sending of warning trigger signal via the implant'"'"'s bidirectional data transceiver after the automatic fibrillation detector has notified the implant'"'"'s control unit of an ongoing atrial fibrillation, the warning trigger signal being adapted to cause the external patient device to cause the external device'"'"'s output unit to put out a patient discernable warning signal, and

to trigger the atrial cardioversion/defibrillation unit

a) after said warning trigger signal was send out

 

and

b) if a defibrillation trigger signal is received by the implant'"'"'s data transceiver after the warning trigger signal was send out

 

or

 

if the implantable atrial defibrillator is in its automatic-activation mode and automatic triggering of the atrial cardioversion/defibrillation unit is not switched off by a patient'"'"'s command

 

and

c) if the automatic fibrillation detector determines that the atrial fibrillation is still present.

5. An atrial defibrillator system according to claim 4, wherein

the implantable atrial defibrillator is adapted to send out a clearing signal if the automatic fibrillation detector determines that the atrial fibrillation has terminated after a notification of an ongoing atrial fibrillation was send out.

6. An implantable atrial defibrillator according to claim 4, wherein the automatic atrial fibrillation detector is connected to an atrial sensing unit and adapted to process signals derived by the atrial sensing unit.

7. An implantable atrial defibrillator according to claim 6, wherein the atrial sensing unit is adapted to derive and record an intracardiac electrogram and the automatic atrial fibrillation detector is adapted to process said recorded intracardiac electrogram.

8. An implantable atrial defibrillator according to claim 7, wherein the automatic atrial fibrillation detector is adapted to determine an absence or presence of an atrial fibrillation by way of an analysis of rate, rhythm, morphology, and/or other features of the recorded atrial intracardiac electrogram.

9. An implantable atrial defibrillator according to claim 4, wherein the atrial cardioversion/defibrillation unit is adapted to interrogate the automatic atrial fibrillation detector and to thereby check the presence of atrial fibrillation prior to atrial cardioversion and abandon the atrial cardioversion if atrial fibrillation is not confirmed.

10. An implantable atrial defibrillator according to claim 4, wherein the implantable atrial defibrillator comprises a ventricular sensing unit adapted to sense ventricular signals and wherein the atrial cardioversion/defibrillation unit is adapted to deliver the cardioverting electrical energy in synchronous with a shockable R wave based on analysis of the ventricular sensed signals.

11. An implantable atrial defibrillator according to claim 4, wherein the implant'"'"'s control unit is adapted to delay triggering of the atrial cardioversion/defibrillation unit upon receipt of a patient triggered delay command.

12. An implantable atrial defibrillator according to claim 4, wherein the implantable atrial defibrillator comprises an atrial stimulation unit adapted to generate atrial stimulation pulses having a strength sufficient to excitation of atrial myocardium and wherein the implant'"'"'s control unit is adapted to trigger the atrial stimulation unit do deliver an anti-tachycardia pacing (ATP) after the automatic fibrillation detector has notified the implant'"'"'s control unit of an ongoing atrial fibrillation.

13. An implantable atrial defibrillator according to claim 4, wherein the implantable atrial defibrillator comprises means to retrieve and store diagnostic information and is adapted to transmit said diagnostic information upon receipt of a data request command received via the implant'"'"'s bidirectional data transceiver.

14. An implantable atrial defibrillator according to claim 13, wherein the implantable atrial defibrillator is adapted to retrieve and store device-recorded atrial intracardiac electrogram (IEGM) as diagnostic information to be transmitted to the external device upon demand.

15. An external portable device comprising

a human interface including

an output unit

an input unit (command entering unit)

a first external bidirectional data transceiver adapted to bidirectionally communicate with the implant'"'"'s bidirectional data transceiver of the implantable atrial defibrillator and being connected to the human interface

a second external bidirectional data transceiver adapted to bidirectionally communicate with a central service center

16. The external portable device according to claim 15, wherein the output unit is adapted to generate at least one of:

a light-up or blinking of one or more light emitting diodes;

a text message displayed in a liquid crystal display;

an audible message played by a speaker;

or

a mechanical vibration generated by a vibrator.

17. The external portable device according to claim 16, wherein the output unit is adapted to generate a warning message upon receipt of a warning trigger signal transmitted by the implantable atrial defibrillator.

18. The external portable device according to claim 15, wherein the input unit is adapted to allow for entering of a control command.

19. The external portable device according to claim 18, wherein the control command is one of

a therapy trigger command,

a therapy delay command

a therapy enable/disable command or

a data request command.

20. The external portable device according to claim 18 or 19, wherein the input unit is adapted activate or deactivate the possibility to enter one or more of the control commands depending upon signals received from the implantable atrial defibrillator via the first external bidirectional data transceiver, thus providing a situation adaptive human interface.