Implantable medical device and method for detecting cardiac events without using of refractory or blanking periods

• US 6,925,330 B2
• Filed: 07/10/2002
• Issued: 08/02/2005
• Est. Priority Date: 07/10/2002
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kleine, Bruce
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/193,040
• Publication Number:
  US 20040010294A1
• Time in Patent Office: 1,119 Days
• Field of Search: 600508-509, 600/512, 607/9, 607/26
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

Cardiac electrical events are detected by comparing signal vectors with pre-determined classification zones representative of different cardiac events. The signal vector is generated by sensing the voltages between various combinations of electrodes, such as A-tip to V-tip, A-tip to A-ring, and A-ring to V-ring. The signal vector is compared with a set of classification zones corresponding to different events, such as P-waves, R-waves, T-waves, A-pulses, and V-pulses, to determine whether the vector lies within any of the classification zones. In this manner, cardiac events are detected using only the voltages received from the electrodes and no refractory periods or blanking periods are required to distinguish one event from another. The classification zones vary from patient to patient and a technique is provided herein for generating a set of vector classification zones for a particular patient. Signal vectors corresponding to various unknown cardiac events are generated by the implanted device and are transmitted to an external device programmer. ECG signals, generated by a surface ECG detector, are simultaneously received by the external programmer. The external programmer identifies the cardiac electrical event corresponding to each signal vector based on the ECG signals and then generates classification zones for each event type using only the signal vectors corresponding to the event.

Claims

1. In an implantable cardiac stimulation device for implant within a patient wherein the device has multiple electrodes, a method for detecting cardiac electrical events comprising:

inputting a data packet representative of a set of vector classification zones pertinent to a particular implantable cardiac stimulation device;

sensing electrical signals from selected combinations of the electrodes;

calculating a vector representative of the electrical signals; and

comparing the vector with the set of vector classification zones, each representative of a different electrical event within the heart of the patient, to classify the electrical event.

2. The method of claim 1 wherein the electrical events include one or more of P-waves, R-waves, T-waves, A-waves, V-waves, premature ventricular contraction (PVCs), premature atrial contraction (PACs), atrial fibrillation (A-fib) events and ventricular fibrillation (V-fib) events and wherein the step of comparing the vector with a set of predetermined vector classification zones includes the step of comparing the vector with zones representative of one or more of P-waves, R-waves, T-waves, A-waves, V-waves, PVCs and PACs to classify the event as either a P-wave, R-wave, T-wave, A-wave, V-wave, PVC, PACs, an A-fib event or a V-fib event.

3. The method of claim 1 wherein the electrodes include one or more of an atrial tip electrode (A-tip), an atrial ring electrode (A-ring), a ventricular tip electrode (V-tip), a ventricular ring electrode (V-ring), a coil, and a device can and the step of sensing electrical signals from various combinations of the electrodes includes the step of sensing voltage signals between two or more of the electrodes.

4. The method of claim 3 wherein the step of sensing voltage signals between two or more of the electrodes includes the step of sensing one or more of an A-tip to device can voltage, an A-tip to coil voltage, an A-tip to V-ring voltage, an A-tip to V-tip voltage, an A-tip to A-ring voltage, an A-ring to device can voltage, an A-ring to coil voltage, an A-ring to V-ring voltage, an A-ring to V-tip voltage, a V-tip to device can voltage, a V-tip to coil voltage, a V-tip to V-ring voltage, a V-ring to can voltage, a V-ring to coil voltage, and coil to device can voltage.

5. The method of claim 4 wherein the step of calculating a vector representative of the electrical signals includes the step of calculating one or more components of a vector A=[a₁, . . . , a₁₅] wherein a₁, . . . , a₁₅ represent, respectively, the A-tip to device can voltage, the A-tip to coil voltage, the A-tip to V-ring voltage, the A-tip to V-tip voltage, the A-tip to A-ring voltage, the A-ring to device can voltage, the A-ring to coil voltage, the A-ring to V-ring voltage, the A-ring to V-tip voltage, the V-tip to device can voltage, the V-tip to coil voltage, the V-tip to V-ring voltage, the V-ring to can voltage, the V-ring to coil voltage, and the coil to device can voltage.

6. The method of claim 1 further including the step of controlling the delivery of therapy based on the classification of the event.

7. The method of claim 1 further including the steps of:

identifying events that do not correspond to any of the predetermined vector classification zones; and

storing diagnostic information representative of the events that do not correspond to any of the predetermined vector classification zones.

8. The method of claim 7 wherein the step of storing diagnostic information includes the step of storing values representative of the vectors of the events that do not match any of the vector classification zones.

9. The method of claim 1 wherein the data packet comprises vector classification zones corresponding to one or more of P-waves, R-waves, A-waves, V-waves, and T-waves.

10. The method of claim 1 wherein the step of comparing the vector with a set of predetermined vector classification zones includes the step of:

comparing a sequence of vectors with a sequence of vector classification zones, each representative of a different sequence of electrical events within the heart of the patient, to classify the electrical event.

11. The method of claim 10 wherein the data packet comprises vector classification zones corresponding to one or more of sinus beats, premature ventricular contractions (PVCs), premature atrial contraction (PACs), atrial fibrillation events and ventricular fibrillation events.

12. The method of claim 1 wherein the predetermined vector classification zone is a multidimensional truncated cone.

13. The method of claim 1 wherein the predetermined vector classification zone is represented by a direction vector, a maximum angle from the vector, a minimum vector length and a maximum vector length.

14. The method of claim 1 further including the initial steps of:

determining the vector classification zones for the particular patient in which the device is implanted; and

storing the vector classification zones within the implantable device for subsequent use with the patient.

15. In an implantable cardiac stimulation device for implant within a patient wherein the device has multiple electrodes, a method for detecting cardiac electrical events comprising:

determining vector classification zones, each representative of a different electrical event within the heart of a particular patient in which the device is implanted;

storing the vector classification zones within the implantable device for subsequent use with the particular patient;

sensing electrical signals from selected combinations of the electrodes;

calculating a vector representative of the electrical signals; and

comparing the vector with the stored set of vector classification zones to classify the electrical event, wherein determining the vector classification zones comprises

sensing electrical signals from the selected combination of electrodes corresponding to electrical events and calculating signal vectors for the electrical events;

identifying the electrical events based on ECG signals; and

correlating the signal vectors with the corresponding electrical events and, for each type of electrical event, calculating the characteristics of the classification zone for the event based on all signal vectors correlated with the event.

16. The method of claim 15:

wherein the vector classification zones are each represented by a direction vector and geometric range; and

wherein the step of calculating the characteristics of the classification zone includes the step of calculating the direction vector and the geometric range for the classification zone based on the vectors correlated with the event.

17. The method of claim 16 wherein the step of calculating the geometric range includes the step of adding a safety margin to the geometric range.

18. The method of claim 16:

wherein each geometric range is represented by a maximum angle relative to the direction vector, a minimum vector length and a maximum vector length; and

wherein the step of calculating the geometric range includes the step of calculating the maximum angle, minimum length and maximum length for the classification zone based on the vectors correlated with the event.

19. The method of claim 15 wherein the step of calculating the characteristics of the classification zone includes the step of averaging the vectors correlated with the event.

20. The method of claim 19 wherein, if (a_1,1, a_1,2, . . . , a_1,m), (a_2,1, a_2,2, . . . , a_2,m), . . . , (a_n,1, a_n,2, . . . , a_n,m) represent n signal vectors generated from m electrode pairs, then the step of averaging the signal vectors includes the step of calculating:

$\begin{array}{c}\stackrel{.}{\mathrm{\alpha <br><br>}}=<br><br>\left({\mathrm{\alpha <br><br>}}_1,{\mathrm{\alpha <br><br>}}_2,\mathrm{\dots <br><br>}<br><br>\text{\hspace{1em}<br><br>},{\mathrm{\alpha <br><br>}}_m\right)\\ =<br><br>[\left(a_{1,1}+a_{2,1}+\mathrm{\dots <br><br>}+a_{n,1}\right)/n,\\ <br><br>\left(a_{1,2}+a_{2,2}+\mathrm{\dots <br><br>}+a_{n,2}\right)/n,\mathrm{\dots <br><br>}<br><br>\text{\hspace{1em}<br><br>},\left(a_{1,m}+a_{2,m}+\mathrm{\dots <br><br>}+a_{n,m}\right)/n].\end{array}$

21. The method of claim 18 wherein the steps of calculating the minimum and maximum lengths include the steps of calculating the length of individual signal vectors and selecting the signal vectors having, respectively, the shortest and longest lengths.

22. The method of claim 18 wherein the step of calculating the maximum angle include the steps of calculating the angles between each of the individual signal vectors and the direction vector and selecting the largest angle.

23. The method of claim 18 wherein the step of calculating the angles between each of the individual signal vectors and the direction vector angle includes the step of calculating

⊖

=cos<sup>−

1</sup>[(a_i·

{dot over (α

)})/(∥

a_i∥

∥

{dot over (α

)}∥

)]

wherein a_i represents the sensed vector and {dot over (α

)}represents the direction vector.

24. The method of claim 23 wherein the predetermined vector classification zone is represented by

Z_i={{dot over (α

)}_i, ⊖

_i, I_i, L_i}

where Z_i is a classification zone and {dot over (α

)}_i, ⊖

_i, I_i, and L_i represent the direction vector, maximum angle, minimum length, and maximum length, respectively.

25. The method of claim 24 wherein the step of comparing a vector with a set of predetermined vector classification zones to classify the electrical event includes the step of determining whether the vector is within the vector classification zone.

26. The method of claim 25 wherein the step of determining whether the vector is within the vector classification zone includes the steps of:

determining whether I_i<

=∥

A∥

<

=L_i; and

determining whether (A·

{dot over (α

)})/(∥

A∥

∥

{dot over (α

)}∥

)<

=cos ⊖

_i;

wherein Z_i={{dot over (α

)}_i, ⊖

_i, I_i, L_i} represents the classification zone and a represents the vector.

27. In an implantable cardiac stimulation device having multiple electrodes for implant within a patient, a system for detecting cardiac electrical events comprising:

a set of sense amplifiers operative to sense voltages between selected combinations of the electrodes;

memory operative to store a data packet representative of a set of vector classification zones pertinent to a particular implantable cardiac stimulation device; and

a vector-based cardiac event detection unit operative to identify cardiac electrical events based on the voltages sensed between the selected combinations of electrodes by calculating a vector representative of the electrical signals and comparing the vector with the stored vector classification zones, wherein each vector classification zone is representative of a different electrical event.

28. In an implantable cardiac stimulation device for implant within a patient wherein the device has multiple electrodes, a system for detecting cardiac electrical events comprising:

means for inputting a data packet representative of a set of vector classification zones pertinent to a particular implantable cardiac stimulation device;

means for sensing electrical signals from selected combinations of the electrodes; and

means for identifying cardiac electrical events based on the voltages sensed between the selected combinations of electrodes by calculating a vector representative of the electrical signals and comparing the vector with the set of vector classification zones, each representative of a different electrical event within the heart of the patient.