Medical device for automatic diagnosis of undersensing by timing

• US 6,129,745 A
• Filed: 10/23/1998
• Issued: 10/10/2000
• Est. Priority Date: 10/23/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rueter, John C., Olson, Eric, Hess, Michael F., Sun, Weimin
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/178,390
• Time in Patent Office: 718 Days
• Field of Search: 607/4, 607/9, 607/27, 607/28, 600/509, 600/510
• US Class Current: 607/27
• CPC Class Codes: A61N 1/37 Monitoring; Protecting

Abstract

There is provided a system and method applicable for use with a dual chamber pacemaker for determining whether long atrial intervals are due to atrial undersensing or to sick sinus syndrome. The determination of undersensing is based upon an algorithm which statistically analyzes a long atrial interval in terms of the patient'"'"'s prior atrial rate history, and compares a calculated statistical probability measure with an empirically determined undersense threshold factor. The pacemaker can respond to a determination of undersensing by correcting already collected diagnostic data, adjusting one or more pacemaker operating parameters, adjusting synchronous tracking and/or providing an annotated marker channel for indicating undersense events.

Claims

1. An implantable medical device having atrial sensing means for sensing physiologic atrial signals and for producing an atrial sensed event signal responsive thereto, comprising:

atrial interval means for determining atrial interval values between said atrial sensed event;

storage means for storing values of successive said atrial interval values;

data means for obtaining statistical data representative of a variance of a mean value of said atrial intervals;

detecting means for detecting an occurrence of a statistically long one of said atrial interval values within said stored values; and

evaluating means for assigning, based on said statistical data, a probability value indicative of whether said long one of said atrial intervals was due to undersensing, and for producing a signal representing said assigned probability value for said long one of said atrial intervals.

2. The implantable medical device as set forth in claim 1, wherein said evaluating means comprises means for performing sequential hypothesis testing based on a series of said atrial interval values.

3. The implantable medical device as set forth in claim 1, wherein said data means comprises determining means for determining said mean value of said atrial interval values.

4. The implantable medical device as set forth in claim 1, wherein said storage means stores ventricular escape intervals, and further comprising:

an implantable pulse generator housed within said device;

a medical electrical lead for providing timed electrical stimulation pulses to ventricular cardiac tissue from said implantable pulse generator, said timed electrical stimulation pulses based on said ventricular escape intervals stored by said storage means; and

synchronizing means enabled if said probability value is indicative of undersensing, said synchronizing means for synchronizing delivery of said timed electrical stimulation pulses with an atrial sinus beat which is not sensed due to undersensing by controlling said ventricular escape intervals.

5. The implantable medical device as set forth in claim 1, wherein said evaluating means further comprises means for assigning a probability value indicative of whether said long one of said atrial intervals was caused by an occurrence of sick sinus syndrome.

6. The implantable medical device as set forth in claim 1, wherein said evaluating means comprises means for initiating a test for determination of undersensing, said means for initiating a test comprising means for placing said implantable medical device in a VDD mode.

7. The implantable medical device of claim 6, and further comprising a flag to indicate whether to test for undersensing, and wherein said means for initiating a test additionally comprises means for determining whether said flag is in a predetermined state.

8. A testing system, for use in an implantable medical device, said implantable medical device having sensing means for sensing a patient'"'"'s atrial heartbeat signals, said testing system to determine whether said sensing means is missing atrial senses due to undersensing, said testing system comprising:

atrial interval means for continually determining an interval time values between atrial senses;

data means for obtaining a mean value for said interval time values, and for determining from said mean value a nsr variance value for a normal sinus atrial rate and a sss variance value for a sick sinus atrial rate;

determining means for determining a statistically long atrial interval and for determining from said nsr variance value and said sss variance value and said mean value a measure of probability that said long interval was due to undersensing; and

comparison means for comparing said measure with a predetermined undersense threshold to determine whether said long interval was due to undersensing.

9. The system as described in claim 8, comprising means for continuing said determination by said testing system when said comparing does not determine whether said long interval was due to undersensing.

10. A method carried out by a dual chamber pacemaker for determining when atrial undersensing is occurring, comprising:

sensing atrial signals and determining from said sensed atrial signals atrial intervals between said sensed atrial signals;

storing values of said atrial intervals;

obtaining statistical data representative of said stored atrial intervals, said statistical data including variance values for a normal sinus rate and a sick sinus rate;

detecting an occurrence of a statistically long atrial interval;

determining, based on said long atrial interval, said stored atrial intervals and said statistical data, whether said long interval was due to atrial undersensing.

11. A method as set forth in claim 10 further comprising coordinating delivery of a ventricular pacing stimulation based on the determining step.

12. An implantable medical device, comprising:

atrial sense means for sensing atrial signals from a patient;

long interval means for determining when there is a long interval between two successive atrial signals;

undersense means for determining when a said long interval is to be classified as an undersense, said undersense determining means comprising;

first probability means for determining a first probability that said long interval was due to undersensing by said atrial sense means;

second probability means for determining a second probability that said long interval was due to patient sick sinus syndrome; and

classifying means for classifying said long interval as an undersense based on a function of said first and second probabilities.

13. An implantable medical device as set forth in claim 12, further comprising means for assuming that one of said atrial signals occurred within said long interval that is classified as an undersense.

14. An implantable medical device as set forth in claim 13 and further comprising means for providing ventricular stimulation to a patient'"'"'s heart in timed relation to an undersense.

16. The method of claim 14, wherein step b.) includes the step of dividing said long atrial interval into portions and selecting a predetermined one of said portions for use as said long atrial interval in step d.).

17. The method of claim 16, and further including the step of modifying said average time interval based on the length of said predetermined one of said portions obtained in step b.).

15. A method for use in an implantable device for determining whether long atrial intervals included between atrial beats of a sensed atrial signal are a result of one of undersensing a absence of atrial beats, the method comprising the steps of:

a.) calculating an average time interval between said atrial beats of said sensed atrial signal;

b.) a long atrial interval between two successive ones of said atrial beats that is longer than said average time interval by a predetermined value;

c.) calculating probability data descriptive of sick sinus syndrome rates and probability data indicative of undersensing rates based on said average time interval; and

d.) determining, based on said probability a whether said long atrial interval is due to one of sick sinus syndrome, undersensed normal sinus rate, and a cause that can not be determined.

18. The method of claim 15, wherein the implantable device further delivers cardiac pacing pulses, and further including the step of adjusting the rate of said cardiac pacing pulses based on the determination made in step d.).

19. An implantable medical device, comprising:

an atrial signal sensor to sense atrial signals;

a processor coupled to said atrial sensor to a.) calculate a mean value for intervals between successive ones of said atrial signals, to b.) determine whether any said interval between successive ones of said atrial signals is indicative of a long atrial interval, and to c.) calculate a variance from said mean value for each said long atrial interval; and

a storage device coupled to said processor to store probability distribution signals descriptive of the rate of said atrial signals, wherein said processor utilizes said probability distribution signals for determine whether said variance is indicative of one of an undersensed normal atrial rate and sick sinus syndrome.

20. The implantable medical device of claim 19, and further including:

an output amplifier circuit to deliver a pacing signal; and

a timer circuit coupled to said output amplifier circuit and to said processor, said timer circuit to adjust said pacing signal based on whether said processor makes a determination that said variance is indicative of one of an undersensed normal atrial rate and sick sinus syndrome.

21. The implantable medical device of claim 19, and further including processing means for dividing each said long atrial interval into portions and using a predetermined one of said portions to re-calculate said mean value.

22. The implantable medical device of claim 21, and further including means for adjusting said probability distribution signals stored in said storage device based on a re-calculated mean value.