CA2196430C - Atrial and ventricular capture detection and threshold-seeking pacemaker - Google Patents

Abstract

Capture detection and stimulation threshold-measurement methods and apparatu s for deriving atrial and ventricular pace pulse (A-pace and V-pace) stimulati on energy strength-duration data. In a first atrial and ventricular threshold test regimen for use with patients having intact A-V conduction of first degree AV block, A-pace pulses are delivered at a test escape interval and A -V delay. Atrial loss of capture (ALOC) in response to an A-pace test stimulus is declared by the absence of a detected ventricular depolarization (V-event) i n the latter portion of the paced A-V delay interval following the delivery of the A-pace test stimulus. In the ventricular threshold test regimen, a V-pac e test stimulus is delivered after a shortened A-V delay. Ventricular loss of capture (VLOC) is declared by the detection of a V-event in the ventricular refractory period of the V-pace test stimulus. In a second algorithm for use in the atrium or ventricle in patients having regular measured sinus rhythm, premature A-pace or V-pace test stimuli are delivered, and the presence of a n A-event or V-event at the end of the measured sinus escape interval is declared to be ALOC or VLOC, respectively. A-pace and V-pace test stimuli ar e repeated to confirm capture declarations at an energy exceeding the LOC test energy. The atrial and ventricular stimulation threshold data derived by varying both pulse amplitude (strength) and width (duration) is stored in memory for telemetry out and analysis and for use in setting the V-pace and A- pace normal pulse width and amplitude used between successive auto-capture tests in order to conserve battery energy.

Description

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EI~LD OE THE l1h'V>rNTION
The present invention generally relates to implantable pacemakers and more particularly to a method and apparatus for testing and detecting capture of the heart in both chambers of the heart, deriving and storing stimulat~;on signal threshold data, and adjusting stimulation signal energy for energy efficiency.
~C'rROUND OF THE INVENTION
As described in comrnonly assigned U.S. Patent No. 5,32U,643, a cardiac pacemaker is an electrical device used to supplant some or all of an abnormal heart's natural pacing function by delivering appropriately timed electrical stimulation signals designed to cause the myocardium of the s ' heart to contract or "beat", i.e. to "capture" the heart. Stimulation pulses provided by implanted 2 0 pacemakers usually have wel l-defined amplitude and pulse width characteristics which can be adjusted by remote programming and telemetry equipment to meet physiologic and device power conservation needs of the particular patient.
The strength (amplttt,~de} and duration (pulse width) of the pacing pulses must be of such an energy magnitude above the ~timulatirn~ threshold that capture is maintained to prevent serious 2 5 complications and even death. Yet, it is desirable for these energy magnitudes not to be higher than the stimulation threshold than is needed for a reasonable "safety margin" in order to prolong battery life.
The patient's stimulation thre;4holds in tire atrium and ventricle often fluctuate in the short term, and gradually change in the long term. It has been clinically observed that the lowest stimulation threshold is observed immediately after implantation of the pacemaker (the acute threshold). Inflammation in the 3 0 cardiac tissue around the tip of the pacing lead electrode drives the stimulation threshold up sharply during the ftrst two to six weeks after icnplant to its highest level (the peak threshold), and greater pacing pulse energy is required to et~'ect captum. Some of the inflammation reduces over the long-term, to tower the threshold below the peak leve:l--the chronic threshold, However, the chronic threshold does not reduce to the acate level, .since some permanent fibrous tissue, requiring greater energy than non-3 5 fibrous tissue for signal propagation, remains around the electrode tip.
In the short-term, thresholds may decrease with exercise, for example, and may increase with various activities, including sleep.
Consequently, the safety margin is typically set by the physician on implantation of the pacemaker to account for projected maximaa stimulation thresholds.
Alv9ENDED SHEET

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=. _J. .-~J .~JV~.a n.w..:,;u.v ..~:..,.~.v As descn'bed in commonly assigned U.S. Patent No. 5,324,310, the post-operative determination of the Stimulation thresholds by the ph~rsician typically requires the patiient to be connected to surface ECG equipment while a threshold routine is conducted using the pacemaker programmer, The pacemaker programmer remotely effects the successive temponsry reprogramming of the pulse width and/or amplitude to ascertain the points at which capture is lost, and a suet~th-duration curve may be 2 0 plotted from the resulting thrEahold da>:a. In this process, pacing pulses are delivered to either heart chamber at a test pacing rate ~~bove the patient's own underlying rate, and the pace pulse energy is decreased from pulse to pulse in a presE;t pattern. The pacing pulses are observed on a display yr paper tracing as spikes, and capture or loss of capture is observed by the presence or absence of the evoked cardiac response waveshape (a P-wave or an R-wave) that follows each spike. At loss of capture, the .
pacing pulse energy may be immediately restored so that the patient does not experience syncope. The resulting threshold data may tic used to permanently reprogram the pulse energy. Naturally, such periodic patient studies are tune consuming and expensive to conduct.
Moreover, they do not provide an indication of stimulation thre:;hold fluctuation over the course of a patient's day and levels of activity.
The life of the implantablc pulse generator (/PG) is shortened as the battery is depleted at a rate higher 2 0 than necessary to meet the pal;ient's needs.
As a result of these considerations, a great deal of effort has been expended over many years to develop /PGs having the capability of automatically testing the stimulation threshold, i.e. providing an "auto-capture" detection functdon, and resetting the pacing pulse energy to exceed the threshold by the safety margin without the need for clinical or patient intervention. A wide variety of approaches have 2 5 been taken as reflected by the extensive listing of earlier patents described in the commonly assigned ' 310 and '643 patents and in further U.S. Patent Nos. 5,165,404, 5,165,405, 5,172,690, 5,222,493 and 5,285,780.
In such /PGs, the capture det:ect:ion approaches have taken a variety of fornts Ly~pically in the attempt to overcome the difficulty in detecting the evoked cardiac response wave shape from the pacing 3 0 electrodes employed to deliver the pacing pulse. The high stimulation energy pacinE pulse and the ensuing after-potentials and electrode-tissue polarization artifacts mask the evoked response, and also saturate the sense amplifiers coupled to the electrodes, until they dissipate.
AN1E~:DED SHEET

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Iy.rt~:J" LS;j _lij~ J~EQfv7~ H 7 By the time that the sense arnplifier is no longer blinded, the evoked response, if any, has typically passed the electrodes. ManS~ of the approaches that have been taken include blanking intervals for the sense amplifiers combined vrith effort~t to suppress or attenuate or compensate electronically for the composite post-delivery signal levels at the sense amplifier input during the blanking intetvals to shorten the saturation period (and the blanking interval) as much as possible.
Alternatively, the use of separate "far field" EGM amplifiers and electrode systems from those "near field" electrode systems used in delivering the pacing pulse have been proposed in a variety of configurations, as ea.emplifie:d by the e~bove referenced '3I0 patent.
In a further approacl'~, one or more physiologic sensors that show a response to the mechanical action of the heart, e.g. a piezoelectric or impedance sensor, or that show changes in physical properties of the blood when the heart is captured, e.g. blood pH, temperature, impedance or blood pressure sensors on the pacing lead have also beers suggested as exemplified by the above referenced '643 patent.
The function and accuracy of the these approaches have been adversely affected by one or more of factors including, but not limited to: myopotentials (electrical signals which are the product of muscle movement). in the case of EGMs; stray electromagnetic interference (EMn; problems with the 2 0 sensor sensitivity (either too sensitive or not sensitive enough}; and, in the case of pressure sensors, variations of the sensed electrical signals as a result of changes in thoracic pressure (for example, due to respiration, coughing or sneezing).
In virtually all of the approaches, it is necessary to rely on additional components and circuitry which consume more energy and add t~o the bulk and cost of the system and raise reliabiliiy issues. The 2 5 additional components and ciircuitry are increased further in dual chamber pacemakers, where the difficulty of detecting the evoked p-wave is further complicated by its relatively low amplitude. Very few of the numerous approaches of the prior art have been attempted in an implantable pacemaker system and fewer yet have been proven clinically useful and commercially successful.
Perhaps the closest r~;ferences ~to approach these problems are international publication WO -A-3 0 94!12237 and U.S. Patent No. 4,729,376, neither of which solve the problems.
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P-3338 PC?

In view of the foregoing, it is a. first object of the present invention to provide a cardiac pacemaker having a capture detection feature in which atrial and ventricular capture may be detected and distinguished without the' use of any additional components, e.g. special leads, electrodes or sensors or additional circuitry to that normally present in a micro-processor based dual chamber IPG, 1t is a further object of the invention, in a dual chamber pacemaker, to measure atrial stimulation thresholds by applying a test stimulus in the atrium and detecting loss of capture of the atrium in the ventricle from the absence of a conducted ventricular depolarization occurring within a certain atrial-ventricular time interval following delivery of the atrial stimulus.
It is a still further object of the invention, in a dual chamber pacemaker, to measure ventricular stimulation thresholds by applying a te:rt stimulus in the ventricle following delivery of an atrial pace t pulse and detecting loss of capture from the presence of a conducted ventricular depolarization in an atrial-ventricular time window following delivery of the ventricular stimulus.
It is yet another object of the invention to measure either atrial or ventricular stimulation thresholds in the atrium or the; ventricle:, respectively, by applying a test stimulus prematurely timed with 2 0 respect to a previous atrial or ventriculs~r beat and detecting loss of capture from the presence of an airial or ventricular beat following the earlier beat at the end of the expected sinus escape interval.
It is yet a further object of th.e present invention to provide a regimen for periodic atrial and ventricular threshold testing andl derivation of atrial end ventricular strength-duration data, adjusting the atrial and ventril~ular pacing pulse amplitude and width in relation tn the atrial and 2 5 ventricular threshold data, storing the data and reading out the data and current pacing pulse amplitudes and widths on command of art external programmer.
These and other objects of the invention are realized in automatic capture detection and stimulation threshold-seeking deterministic operating steps employing or requiring apparatus for use with a dual ehamber or a single chembe;r cardiac pacemaker IPG operating to perform the above stated 3 0 objects to derive attial and/or ventricular pace pulse (A-pace and V-pace) stimulation energy strength-duration data.
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In a ~rgt aspect of the invention particularly for use with patients having intact and regular A-V
conduction or first degree bloclS an atrial and ventricular threshold test regimen, A-pace pulses are delivered at a test escape interval and A-V delay. Atrial loss of capture (ALOC) in response to a triggered A-pace test Stimulus is declac~ed by the absence of a detected ventricular depolarization (V-event) in the latter portion of the paned A-V delay interval following the delivery of the A-pace test stimulus. In the ventricular threshold test regimen, a V-pace test stimulus is delivered after a shortened A-V delay ftom the precedin~~ A-pace. Ventricular loss of capture (VLOC) is declared by the detection of a V-event in the ventricular refractory period of the V-pace test stimulus.
In a second aspect of the invention, for use in the atrium or ventricle in patients having regular measured sinus rhythm, premature A-pace or V-pace test stimuli are delivered at a test escape interval set as a fraction of the average measured escape interval. The presence of a following A-event or V-event, respectively, outside a not reset window set to be somewhat longer than the test escape interval is declared to be ALOC or VLC~C, respectively. Preferably, in this embodiment, the test stimuli energy in pulse width and amplitude is increased until CAPTURE is declared so that the patient's normal rythm is riot disturbed frequently during the test.
2 0 A-pace and V-pace test stimuli are repeated to confirm capture declarations at an energy exceeding the LpC test ener8y. The atrial and ventricular stimulation threshold data derived by varying both pulse amplitude (strength) and width (duration) at both LOC and capture test values is stored in memory for telemetry out and analysis and also for use in setting the V-pace and A-pace normal pulse width and amplitude used between successive threshold measurement tests 2 5 The resulting A-pace and V-pa~~e stimulation threshold pulse amplitudes and pulse widths may be stored in existing memory for retrieval using existing telemetry and external programmers. )<n the ~:- IPG, the normal A-pace and/crr V-pace pulse widths and amplitudes may be changed, if appropriate, from the programmed or previously set values tnlcing the appropriate safety margin into account in order to conserve battery energy.
3 0 Advantageously, the ;present invention may be applied to a programmable single chamber iPG
or a mufti-programmable DDD(R) IPG by simply storing the operating algorithm in memory to periodically perfozm the threshold measurement steps. No additional circuitry, H(v~cPJDED SHEET

sensors or other components are necessary to practice the invention. The pacemaker pulse generator is effectively re-configured to establish threshold test A-pace and/or V-pace escape intervals, A-V delay intervals, and other timing intervals, to operate the atrial and/or ventricular pulse generators to deliver the A-pace and/or V-pace test stimuli at varying pulse widths and amplitudes, to process the V-event signals of the ventricular sense amplifier and to declare ALOC and VLOC at the stimulation threshold for A-pace and V-pace pulse width and amplitude.
The invention may be summarized according to a first aspect as a dual chamber pacemaker pulse generator for attachment with atrial and ventricular pacing and sensing electrodes for pacing a patient's heart in the atrium and the ventricle at adjustable atrial and ventricular pacing pulse energies comprising: variable escape interval timing means for establishing an atrial normal pacing rate escape interval; atrial pace pulse generator means for generating an atrial pace pulse at said atrial electrodes at the end of said atrial normal rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;
ventricular sensing means coupled to said ventricular electrodes for generating a ventricular sensed event signal in response to a depolarization of ventricular tissue;
atrial stimulation threshold test means for operating said escape interval timing means at an atrial pace test escape interval and for initiating the delivery of an atrial pace test stimulus by said atrial pace pulse generator means at the end of an atrial pace test escape interval at an atrial pace test pulse energy varying from said normal atrial pace pulse energy in an atrial pace test cycle; atrial capture 6a detection means responsive to said ventricular sensing means for declaring atrial capture following the delivery of an atrial pace test stimulus by the detection of a ventricular sensed event signal in at least a portion of an A-V delay interval following the delivery of the atrial pace test stimulus; and atrial loss of capture detection means responsive to said ventricular sensing means for declaring atrial loss of capture following the delivery of an atrial pace test stimulus by the absence of a ventricular sensed event signal detected in the A-V delay interval.
The invention may be summarized according to a second aspect as a dual chamber pacemaker pulse generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarizations of a patient's heart in the atrium and the ventricle, respectively, said pacing being at adjustable atrial and ventricular pacing pulse energies and wherein said generator comprises: variable escape interval timing means for establishing an atrial normal rate escape interval and an atrial test escape interval; atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said atrial normal rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy; atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said atrial normal rate escape interval; atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse; ventricular sensing means adapted to be coupled 6b through said ventricular sense electrodes for generating a ventricular sensed event signal ventricular pace pulse generator means for generating a ventricular pace pulse through said ventricular pacing electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval;
means for establishing a ventricular refractory period time interval following delivery of a ventricular pace pulse;
ventricular stimulation threshold test means periodically operable for initiating a ventricular stimulation threshold test further comprising: means for operating said escape interval timing means at atrial pace test escape intervals and said atrial-ventricular delay timing means at a test A-V
delay interval commencing in timed relation to the delivery of an atrial pace pulse; means for operating said atrial pace pulse generator means to generate an atrial pace pulse at the end of the atrial pace test escape interval at an atrial pace pulse energy sufficient to ensure that atrial capture is achieved and that a conducted ventricular depolarization follows outside said test A-V delay interval;
and means for initiating the delivery of a ventricular pace test stimulus by said ventricular pace pulse generator means at the end of said test A-V delay interval which is timed to render the patient's ventricle refractory to potential subsequent intrinsically conducted depolarization stimulus captures and depolarizes the ventricle; and ventricular capture detection means responsive to said ventricular sensing means for declaring ventricular capture by the absence of a ventricular sensed event signal in the ventricular refractory period following delivery of the ventricular pace test stimulus.
The invention may be summarized according to a third aspect as a dual chamber pacemaker implantable pulse 6c generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarization of a patient's heart in the atrium and the ventricle respectively, said being at adjustable atrial and ventricular pacing pulse energies, said generator characterized by: variable escape interval timing means for establishing a normal atrial rate escape interval; atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said normal atrial rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;
atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said normal atrial rate escape interval; atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse and where in relation to a pace pulse said A-V
delay interval comprises a first and second temporal portion; ventricular sensing means adapted to be coupled to said ventricular electrodes for generating a ventricular sensed event signal in response to a depolarization of ventricular tissue; ventricular pace pulse generator means for generating a ventricular pace pulse at said ventricular electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval; means for establishing a ventricular refractory period time interval following delivery of a ventricular pace pulse; pace test stimulus by the presence of a ventricular sensed event signal detected within the ventricular refractory period; ventricular 6d capture detection means responsive to said ventricular sensing means for declaring ventricular capture by the absence of a ventricular sensed event signal in the ventricular refractory period following delivery of the ventricular pace test stimulus; and means for periodically triggering the operation of said atrial and ventricular stimulation threshold test means in a predetermined sequence of successive test pacing cycles to derive atrial and ventricular stimulation threshold test data related to the declarations of atrial and ventricular capture and loss of capture.
The invention may be summarized according to a fourth aspect as in a pacemaker pulse generator having atrial and ventricular pulse generators for generating and applying atrial and ventricular pacing pulses to the atrium and ventricle of the heart separated by an A-V delay interval to evoke stimulated atrial and ventricular depolarizations and capture the atrium and ventricle and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, a method of testing for the stimulation threshold energy of the ventricle characterized by the steps of: determining the patient's atrial escape interval; operating said atrial pulse generator to deliver an atrial pace pulse at an energy sufficient to capture the atrium when said atrial escape interval times out; setting a test pace A-V delay interval;
operating said ventricular pulse generator to deliver a ventricular test stimulus at the end of said test pace A-V
delay interval; setting a ventricular sense time window;
operating said ventricular sense amplifier during said ventricular sense time window to sense a depolarization of the ventricle; declaring capture of the ventricle by the ventricular test stimulus if a depolarization of the 6e ventricle is not sensed in the ventricular sense time window; and declaring loss of capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is sensed in the ventricular sense time window.
The invention may be summarized according to a fifth aspect as in a pacemaker pulse generator having an atrial pulse generator for generating and applying atrial pacing pulses to the atrium of the heart to evoke a stimulated depolarization and capture the atrium and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, apparatus for testing for the stimulation threshold energy of the atrium characterized by: means for determining the patient's atrial escape interval; means for operating said atrial pulse generator to deliver an atrial test pulse at a test energy to the atrium in the atrial escape interval timed to capture the atrium if the test energy is sufficient to capture the atrium after said atrial escape interval times out; means for setting a paced A-V delay interval beginning after a PVC blanking period following said atrial test pulse; means for operating the ventricular sense amplifier during at least the paced A-V delay interval to sense a depolarization of the ventricle;
means for declaring capture of the atrium by the atrial test pacing pulse if a depolarization of the ventricle is sensed in the paced A-V delay interval; and means for declaring loss of capture of the atrium by the atrial test pacing pulse if a depolarization of the ventricle is not sensed in the paced A-V delay interval.
The invention may be summarized according to a sixth aspect as in a pacemaker pulse generator having atrial and ventricular pulse generators for generating and applying atrial and ventricular pacing pulses to the atrium and 6f ventricle of the heart separated by an A-V delay interval to evoke stimulated atrial and ventricular depolarizations and capture the atrium and ventricle and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, apparatus for testing for the stimulation threshold energy of the ventricle characterized by: means for determining the patient's atrial escape interval; means for operating said atrial pulse generator to deliver an atrial pace pulse at an energy sufficient to capture the atrium after said atrial escape interval times out; means for setting a test pace A-V delay interval; means for operating said ventricular pulse generator to deliver a ventricular test stimulus at the end of said test pace A-V
delay interval; means for setting a ventricular sense time window; means for operating said ventricular sense amplifier during said ventricular sense time window to sense a depolarization of the ventricle; means for declaring capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is not sensed in the ventricular sense time window; and means for declaring loss of capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is sensed in the ventricular sense time window.
The invention may be summarized according to a seventh aspect an apparatus comprising a dual chamber pacemaker pulse generator for attachment with atrial and ventricular sensing and pacing electrodes to an atrial and ventricular chamber of a patient's heart, respectively and having means for detecting capture during that refractory period which follows the delivery of a pacing pulse in one of said chambers by sensing depolarizations of tissue in the other of said chambers and having timing means for excluding 6g sensed depolarizations too close in time to the delivery of a pacing pulse in said one chamber.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other advantages, objects and features of the invention will be further understood when reference is made to the following description, taken in conjunction with the accompanying drawings, in which:
Figure 1 is an illustration of a dual chamber pacemaker according to the present invention in conjunction with an associated set of cardiac pacing leads, illustrated as located in a cutaway view of a human heart;
Figure 2 is a functional block diagram of the dual chamber pacemaker illustrated in Figure 1 in conjunction with an external programmer/monitoring unit, for use in performing the atrial and ventricular capture detection and auto threshold setting functions of the present invention;
Figure 3 is a block diagram of the dual chamber pacemaker illustrated in Figures 1 and 2, illustrating the functional components of the device in more detail;
Figure 4 is a flow chart of the overall operation of the pacemaker of Figures 1-3;

'66742-594 Figure 5 is a typical strength-duration curve for cardiac stimulation signals;
Figure 6 is a simplified timing diagram illustrating operations of the algorithm for testing atrial stimulation threshold levels and discriminating capture from loss of capture;
Figure 7 is a simplified timing diagram illustrating operations of the algorithm for testing ventricular stimulation threshold levels and discriminating capture from loss of capture;
Figures 8a, 8b and 9a and 9b taken together depict the algorithm of one embodiment of the present invention for automatically conducting atrial and ventricular threshold tests and deriving atrial and ventricular strength-duration stimulation threshold data therefrom; and Figures 10a, lOb depict the algorithm of a further embodiment of the present invention for automatically conducting atrial or ventricular threshold tests in the same heart chamber and deriving atrial and ventricular strength-duration stimulation threshold data therefrom.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
In accordance with a first aspect of the invention, the inventive processes is enabled by incorporation into a dual chamber IPG as described in the following Figures 1-9 particularly for use with patient's having intact and regular AV conduction or first degree AV
block. In a further aspect of the invention, an algorithm is set forth in Figure 10 for making threshold measurements ;i ~66742-594 7a in a single chamber pacemaker or in a single chamber of a dual chamber pacemaker, particularly for patients only needing single chamber pacing or lacking intact, regular AV
conduction. The following detailed description of a multi-programmable, rate responsive, dual chamber IPG and remote programmer provides a preferred mode in which either or both aspects of the invention may be incorporated. It will be understood that the single chamber pacemaker or pacing modes would selectively incorporate features of the particularly described IPG and programmer architecture as necessary.
PART I, DESCRIPTION OF THE IPG AND LEADS
Figure 1 illustrates the external configuration of a dual chamber IPG 26, which is provided with a hermetically sealed enclosure 18, typically fabricated of biocompatible metal such as titanium. Mounted to the top of the enclosure 18 is a connector block assembly 12, which receives electrical connectors located on the proximal ends of leads 14 and 16. The combination of the leads 14 and 16 and the IPG 26 constitute an implantable pacemaker. Figures 1-3 and related Figure 4 are described in U.S. Patent Application Serial No. 08/214,933, filed March 17, 1994, entitled METHOD
AND APPARATUS FOR DUAL CHAMBER CARDIAC PACING which has now issued as U.S. Patent No. 5,507,782.
Lead 16 is an atrial bipolar pacing lead, carrying two electrodes 20 and 22. Electrodes 20 and 22 are used both to sense atrial depolarizations (P-waves) and to deliver atrial pacing pulses. Atrial pacing pulses may be delivered between electrodes 20 and 22 in a bipolar pacing mode or between electrode 22 and the housing 18 of the IPG
26 in a unipolar pacing mode. Sensing of P-waves may occur between electrode 20 and electrode 22 in a bipolar sensing '66742-594 7b mode or between either of electrode 20 and 22 and the housing 18 of the IPG 26 in a unipolar sensing mode.
Similarly, lead 14 represents a ventricular bipolar pacing lead, carrying two electrodes 28 and 30. As discussed above in conjunction with atrial lead 16, electrodes 28 and 30 are used to sense and pace the ventricle. Bipolar ventricular pacing may be accomplished between electrodes 30 and 28 or unipolar ventricular pacing may be accomplished between electrode 30 and the conductive housing 18 of IPG 26. Sensing of ventricular depolarizations or R-waves may be accomplished between electrodes 30 and 28 in a bipolar sensing mode or between either of electrodes 30 and 28 and the housing 18 of the IPG
26 in a unipolar sensing mode.

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P-3338 PCT ' 219b430 As discussed below, the speci~6c embodiment of the IPG 26 disclosed preferably operates in a DDD or DDDR pacing mode;, wherein pacing pulses are delivered to both atrium and ventricle and wherein sensed atria( and ventricular drpolarizations are both effective to inhibit delivery of the next scheduled pacing pulse in the: chamber in which they are detected. The atria( and ventricular capture detection from the vencriculax electrodes afforded by the present invernion is believed optimally practiced in a pacemaker operating in ~the DDD, DDI, DVI, DDDR, DVFR and DDIR
pacing modes.
Figure 2 illustrates the IpG 26 in block diagram form, coupled to a human heart 10 through the leads 14, 16, in conjunction with an external programmer 40 corresponding to those typically employed to program modern, mufti-programmalble implantable pacemakers. Within the housing of the IPG 26 are located the pacing circuitry 320, which includes circuitry performing all of the basic timing, stimulation and sensing functions of a D:DD or DDDR cardiac pacemaker, and a microcomputer circuit 302, which r controls the timing iz;tervals provided'by the pacing circuitry 320. Pacing circuitry 320 also includes a bi-directional telemetry circuit coupled to an antenna 334, allowing transmission of information from e~.tcrnal programmer 40 into the IPG 2;6 to modify its parameters and allowing transmission of information from the IPG 26 to the external programmer 40, again generally corresponding to telemetry 2 0 and programming systems pt~esontly e7cisting in commercially marketed mufti-programmable implantable pacemakers.
'fhe programmer 40 also includes a telemetry antcona 100 coupled to a telemetry/antenna driver circuit 102 which serves to demodulans telemetry signals received from antenna 334 of the IPG 26, and to apply them in parallel or serial digital format to inputloutput (U0) unit 108. The telemetry signals in turn may be applied to a video monitor 1 l2, via graphic interface 110, and/or provided to central processing unit 114 andlor painter 118.. Microprocessor I 14 controls the operation of the programmer 40 and is responsive to physician entered commands via keyboard 116, for controlling programming signals sent to the IPG 26 anld operation of the video display 112 and primer 118. Alsa illustrated in Figure 2 is an ECG interface 104 coupled to three ECG clecbrodes l06 which are intended to be placed 3 0 upon the patient's body. ECG interface 104 pravides sensed electrograms to input/output device 108, where they in torn may be provided to the video display 112, the central processing unit 114 or the printer 118.
Figure 3 is a mare detailed functional block diagram ofthe pacemaker illustrated in Figure l and 2, as connected to a human heart 10. 7."he combined IPG circuit 300 illustrated is all located within the 3 5 conductive housing 18 of the; IPG 26 as illustrated in Figure 1. The bipolar leads 14 and 16 are illustrated schematically as coupled directly to the input/output circuit 320.
However, in the actual implantable device they would, of course, be coupled by means of removable electrical connectors inserted in the connector blo~ak 12 illustrated in Figure 1.
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The IPG circuit 300 is divided generally into a microcomputer circuit 302 and a pacing circuit 320. An output amplifier circuit 340 includes a ventricular pulse generator circuit coupled to the ventricle of the heart 10 by nteaas of electrodes 30 and 28 on lead 14 as well as an atrial pulse generator circuit coupled to the atrium of heart 10 by means of atrial etecuodes 20 and 22, located on lead I6.
Similarly, sense amplifier eir~cuit 360 i~ncludas atrial and ventricular sense amplifiers coupled to the atrium and ventricle, respectively, by nneans of leads 14 and 16. The output circuit 340 and sense amplifier circuit 360 may contain pulse: generators and sense amplifters corresponding to any of those presently employed in coznmcrcially m~arketcd cardiac pacemakers. For purposes of explaining the present invention, it will be assumed trial tht atrial eltctrodes 20, 22 and the ventricular electrodes 28, 30 are coupled to the arrial at~d ventricular sense amplifiers and pulse generators, respectively, for pacing and sensing in the bipolar mode:.
Sensed atrial depolarizations or P-waves that are confirmed by the atrial sense ampli$er (A-event) in response to an A-sense arc communicated to the digital controller/timer circuit 330 on A-event line 352. Similarly, ventricular depolarizazions or R-waves that are confirmed by the ventricular sense amplifier (V-event) in response to a V-sense arc cornrnunicated to the digital controllcr/timcr circuit 330 Z 0 on V-event line 3 54. In order to trigger generation of a ventricular pacing or V-pace pulse, digital controller/timer circuit 330 generates a trigger signal on V-trig line 342.
Similarly, in order to trigger an atrial pacing or A-pace pulse;, digital controllerltimer circuit 330 generates a trigger pulse on A-trig line 344.
Control of timing and other functions within the pacing circuit 320 is provided by digital 2 5 controller/ti.mcr circuit 330, which includes a set of timers and associated logic. Digital controller/tima circuit 330 defines the basic pacing or escape interval, which may take the form of an A-A escape interval initiated on atrial sensing (A-event) or pacing (A-pace) and triggering atrial pacing (A-pace) at the expiration thereof or may take the form of a V-V escape interval, initiated on ventricular sensing (V-event) or pacing (V-pace) an~i triggering ventricular pulse pacing (V-pace) at the expiration thereof, 3 0 Digital controllerltiraer circuit 330 similarly defines the A-V delay intervals SAV and PAV that commence following a sense~3 A-event and a delivered A-pace, respectively. The specific values of the intervals defined are cantrolll~d by the microcomputer circuit 302 by means o;f data and control bus 306 from programmed in parameter values and operating modes.
AMENDED SHEET

9a Digital controllerltimer circuit 330 also defines tint intervals for controlling operation of the atria! and ventricular sense amplif ers in sense amplifier circuit 360.
Typically, digital controller/timer circuit 330 defines an atria! blanking; intcnral following delivery of an A-pace pulse, during which atria!
sensing is disabled, as welli as ventricular blanking intervals following atria! and ventricular pacing pulse delivery, during which ventricular sensing is disabled. Digital controllerltimer circuit 330 also defines an atria! refractory period I;ARP) during which atria! sensing is disabled or the A-event is iglnored for the purpose of resetting the es~;ape interval. The ARP extends from the beginning of the SAV or PAV
interval following either an A-event or an A-trig and until a predetermined time following sensing of a ventricular depolarization ~or triggering the delivery of a V-pact pulse.
Digital controller/timer circuit 330 similarly defines a ventricular n:fractory period (VRP), Which is typically shorter than the portion of the ARP following ventricular sensing or pacing, following either a V-event or V-trig. In the case of an octopic V-event, both a VItP and a post-ventricular atria! refractory period (pVAI~) defined by the digital controller/timer circuit 330 separately from the ARP may be generated.
'I7~e durations of the ARP, PVARf and V1ZP may also be selected as a programmable parameter stored in the microcomputer 302. Digital controller/tirzcer circuit 330 also controls sensitivity settings of the sense amplifiers 360 by 2 0 means of sensitivity control 350.
In the embodiment illustrated in Figure 3, the IPG 26 is provided with a piezo electric sensor 316 which is intended to monitor patient activity, in order to allow provision of DDDR rate responsive pacing, such that the defined pacing rate {A-A escape interval or V-V escape interval) increases with increased demand for oxygenated blood. Sensor 316 generates electrical signals in response to sensed 2 S physical activity which arE: processed by activity circuit 322 and provided to digital controller/timer circuit 330. Activity circuit 332 and associated sensor 316 may correspond to the eir cuitry disclosed in U.S. Patent No. 5,052,388, issued to Betzold et al., and U.S. Patent No.
4,428,378, issued to Anderson ct al. which provide understanding of prior art. 5imiiarly, the present invention may be practiced in conjunction with alternate types of :censors such as oxygenation sensors, pressure sensors, pH sensors 3 0 and respiration sensors, al l well known for use in providing rate responsive pacing capabilities. As stated above, the present invention may also be practiced in non-rate responsive pacemakers.
Data VanSI111S510J1 to and from the external programmer 40 illustrated in Fig_ 2 is accomplished by means of the telemetry antenna 334 and an associated RF' transmitter and receiver 322, which serves both to demodulate received downlink telemetr~r and to transmit uplink 3s AMENDED SHEET

21 '9 6430 WO 96/04956 ~ ~I PCT/tTS95/09610 telemetry. For example, circuitry for deu~c~uf,~g3 ~d decoding downlink telemetry may correspond to that disclosed in U.S. Patent No.
4,556,063 issued to Thompson et al. and U.S. Patent No. 4,257,423 issued to McDonald et al., while uplink telemetry functions may be provided according to U.S. Patent No. 5,127,404 issued to Wyborny et al. and U.S. Patent No. 4,374,382 issued to Markowitz. Uplink telemetry capabilities will typically include the ability to transmit stored digital information as well as real time or stored EGMs of atrial and/or ventricular electrical activity (according to the teaching of the above-cited Wyborny patent), as well as transmission of Marker Channel pulses indicating the occurrence of sensed and paced depolarizations in the atrium and ventricle, as disclosed in the cited Markowitz patent.
In addition, in the context of the present invention, stimulation threshold data from a series of auto-capture test stimulation pace events may be stored in the RAM 310 or the RAM/ROM unit 314 of microcomputer 302 for later telemetry out on command of the programmer 40. This data may be encoded in digital form and transmitted via RF
transmitter 332 and antenna 334 to the external programmer 40 for display and/or analysis in the form of atrial and ventricular strength-duration curves described below with reference to Figure 5.
Crystal oscillator circuit 338 provides the basic timing clock for the pacing circuit 320, while battery 318 provides power. Power-on-reset circuit 336 responds to initial connection of the circuit to the battery for defining an initial operating condition and similarly, resets the operative state of the device in response to detection of a low battery condition. Reference mode circuit 326 generates stable voltage reference and currents for the analog circuits within the pacing circuit 320, while analog to digital converter ADC and multiplexor circuit 328 digitizes analog signals and voltage to provide real time telemetry if a cardiac signals from sense amplifiers 360, for uplink transmission via RF transmitter and receiver circuit 332.
Voltage reference and bias circuit 326, ADC and multiplexor 328, power-on-reset circuit 336 and crystal oscillator circuit 338 may correspond to any of those presently used in current marketed implantable cardiac pacemakers.
Microcomputer 302 controls the operational functions of digital controller/timer 324, specifying which timing intervals are employed, and controlling the duration of the various timing intervals, via data and control bus 306. Microcomputer 302 contains a microprocessor 304 and associated system clock 308 and on-processor RAM and ROM chips 310 and 312, respectively. Ln addition, microcomputer circuit 302 includes a separate RAM/ROM; chip 3.14 to provide additional memory capacity.
Microprocessor 304 is interrupt driven, operating in a reduced power consumption mode normally, and awakened in response to defined interrupt events, which away include the A-trig, V-trig, A-event and V-event signals.

WO 96/04956 2 i 9 6 4 3 0 pCT~S95/09610 As described abcwe, if the IPG is programmed to a rate responsive mode, the patient's activity level is monitored periodically and the escape interval ie adjusted proportionally. A timed interrupt, e.g., every two seconds, may be provided in order to allow the microprocessor 304 to analyze the output of the activity circuit 322 and update the basic escape interval (A-p, or V-V) of the IPG. The microprocessor 304 may also define variable A,-V intervals and variable ARPs and VRPs which vary with the escape interval established in response to patient activity. For example, th,e microprocessor 304 may specify a variable rate adaptive decrement interval (RAD) to be subtracted from the defined A-V delay intervals when the heart rate (paced or sensed) is above a defined resting or' "start" rate. Similarly microprocessor 304 may define ARPs and/or VRP~s which decrease in duration in relation to an increase in sensed or paced heart rate above the start rate.
The illustrated IPG block diagram of Figure 3 is merely exemplary, and corresponds to the general functional organization of most multi-programmable microprocessor controlled DDD(R) cardiac pacemakers presently commercially available. It is believed that the present invention is moat readily practiced in the context of such a device, and that the present invention can therefore readily be practiced using the basic hardware of existing microprocessor controlled dual chamber pacemakers, as presently available, with the invention implemented primarily by means of modifications to the software stored in the ROM
312 of the microcomputer circuit 302. However, the present invention may also be usefully practiced by means of a full custom integrated circuit, for example, a circuit taking the form of a state machine as set forth in the above-cited Betzold et al. patent, in which a state counter serves to control an arithmetic logic unit to perform calculations according to a prescribed sequence of counter controlled steps. As such, the present invention should not be understood to be limited to a pacemaker having an architecture as illustrated in Figure 3, and a circuit architecture as illustrated in Figure 3 is not believed to be a prerequisite to enjoying the benefits of the present invention.
Figure 4 is a functional flow chart of the normal operation of the pacemaker illustrated in Figures 1, 2 and 3 in DDD pacing mode. For the sake of simplicity, functional steps corresponding to the provision of refractory and blanking periods have been omitted, to allow for easier understanding of the overall operational mode. In the flow chart of Figure 4, it is assumed that the basic timing of the device is based around of the definition of an atrial escape interval (A-A
interval) which may be fixed or may vary as a result of the output of the physiologic sensor, e.g. the activity sensor 316 of Figure 3 in a manner described ab~we. This A-A interval is reset at block 400, along with the current A=V delay intervals SAV and PAV. During the A-V delay interval the device awaits either time out of the current A-V delay interval (PAV or SA'V) at block 402 or ventricular sensing at block 406.

~, i 9~43iJ
WO 96/04956 1 ~ PCTIUS95/09610 If ventricular sensing (V-event) does not occur prior to A-V delay interval time out, a ventricular pacing pulse is generated at block 404 at the end of the A-V interval, and the values of the A-V intervals are updated, if necessary, at block 410.
If a ventricular depolarization or V-event is sensed at block 406, prior to expiration of the current A-V delay interval, the pacemaker's timing may optionally be reset at block 408 to deliver an atrial pacing pulse at a V-A escape interval (thereafter equal to the A-A escape interval minus the current A-V delay interval), or the device may proceed directly to updating the A-V delay intervals at block 410, and not alter the timing of the next scheduled atrial pacing pulse at the expiration of the A-A escape interval.
Following update of the base A-V delay interval at block 410, the device awaits expiration of the A-A (or optionally the V-A) escape interval at block 416, sensing of a ventricular depolarization at block 420 outside of the VRP, or sensing of an A-event at block 422, outside of the ARP. If the A-A (or V-A) escape interval expires at block 416 without any intervening A-event or V-event sensing, an A-pace pulse is generated at block 414, and the next succeeding A-V delay interval is defined to be equal to PAV at block 412, followed by reset of the A-A
escape interval and the A-V delay interval at block 400.
In the event that a V-event is sensed at block 420 prior to expiration of the A-A escape interval, the timing is reset to trigger A-pace at the expiration of the V-A interval (A-A escape interval minus PAV). A V-event sensed at this point is not effective to trigger an update of the SAV and PAV intervals.
If an A-event is sensed at block 422, prior to expiration of the A-A
(or V-A) interval, the subsequent A-V interval is defined to be equal to SAV at block 424, and the A-A escape and A-V delay intervals are reset at block 400.
In the normal, everyday operation of the IPG, the A-pace and V-pace pulse energy in each case may be established initially by programming the pulse widths and amplitudes post-operatively or at a later patient examination. The programmed values are later, in the practice of the present invention, periodically adjusted automatically eo that the normal values may fluctuate from the programmed values.
The other time interval values, including the A-A escape interval, the PAV delay interval, the ARP, vRP and any other time intervals defined by operating algorithms at any particular time are stored in either ROM or RAM and are fetched and used as described above. Thus, in the operations of the IPG in either the general algorithm of Figure 4 or in the strength-duration (SD) algorithms described below, the specified time intervals may be fetched and employed in each designated step in response to the trigger or event signals designated in any of the algorithms. PART II. CAPTURE DETECTION AND THRESHOLD MEASUREMENT.
Details of the stimulation threshold measurement and capture restoration features of the first aspect of the present invention WO 96/04956 .2-19 6 4 3 0 PCT/LTS95/09610 ~) incorporated into a dual .chamber pacemaker of the type described above and of the second ~ispect of the invention incorporated into a single chamber pacemaker or the single chamber of a dual chamber pacemaker follow below. First the .S-D characteristics taken into account in the operation of the invention are described in reference to Figure 5.
Figure 5 shows a typical S-D curve for electrical stimulation of myocardial tissue allotted as pulse amplitude in volts versus pulse width in milliseconds corresponding generally to Figure 2 of the above-referenced '643 pai:ent. ',the graph shows, inter alia, that the stimulation threshold increases with a decreasing pulse width, and thus decreases with an increas:Lng pulse width, except that beyond the Rheobase 200, no further reductions in the amplitude threshold can be achieved. Thus, increasing the pulse width beyond about one millisecond (in thE: examp:Le shown) still requires a threshold of 0.5 volts. Also included on i:he graph for illustrative purposes ie the Chronaxie 202, a ms:asure of myocardial excitability, which is the point representing the lowest pulse width needed to have an amplitude threshold equal to twice i:he Rheobase threshold.
It is well known: in then art to provide a safety margin between the actual delivered pacing pulse width and amplitude and the stimulation thresholds appearing in the strength-duration curve. However, as previously stated, the amount of the safety margin may change over time and must be balance:d against the need to maximize battery life, as increased amplitude: and pulse width will cause a greater battery energy consumption. Physiological changes in the patient may alter the thresholds from the: initial programmed value or values, and can lead to loss of capture, with inadequate amplitude or pulse width.
Dual Chamber Embodiment In accordance with the first aspect of the present invention, this normal pacing operation is departed from on a periodic schedule to operate under the control of the SD algorithms of Figures 8 and 9 for deriving both atria~l and ventricular stimulation threshold data for storage in memory for telE:metry out and analysis and also for use in setting the V-pace and A-pace normal pulse width and amplitude used between successive auto-capture tests in order to conserve battery energy. The pacemaker circuit 300 operating in accordance with this first aspect of they present invention is capable of detecting ALOC and VLOC in patients having a regular and predictable A-V conduction or first degree A-V block. The pacemaker circuit 300 following the ASD
algorithm of Figures 8 looha for a V-event response to a premature A-pace test stimulus during the latter portion of the PAV delay interval and declares ALOC when no V-event is detected in that interval.
Following the VSD a.lgoritr:m of Figure 9, the pacemaker circuit 300 looks for a V-event in the: VRP following a V-pace test stimulus delivered at the en,d of a test PAV interval started by an A-pace and declares VLOC when a V-eve:nt is detected in the VRP.

WO 96104956 ,~ ~ PCT/US95/09610 The microcomputer 302 may be programmed with these algorithms to periodically, e.g. every night at a certain time when the patient would be sleeping, to automatically adjust the A-pace and V-pace output amplitude and pulse width to test for atrial and ventricular stimulation thresholds. The process followed derives and stores in RAM
the Rheobase and Chronaxie stimulation threshold values resulting from the tests for later telemetry out and uses the values to automatically reset the normal pacing pulse Width and amplitude, reflecting a safety margin, until the next test is conducted. In the process of testing for the thresholds, capture is restored on detection of ALOC and VLOC
by applied backup A-pace or V-pace pulses at programmed pulse width and amplitude energy.
The automatically adjusted parameter (amplitude or pulse width) is referred to herein as the test stimulus "test value", and the other parameter is referred to herein as the test stimulus "fixed value".
The test value is adjusted throughout the stimulation threshold determination and recovery procedure described below (applicable to either ALOC or VLOC). The fixed value remains constant until the derivation of the LOC threshold values of the test value as described below.
The present invention provides a method of automatically determining atrial and ventricular pacing thresholds in patients that have normal A-V conduction or first degree A-V block. The ASD and VSD algorithm does not require any special hardware or additional circuits to detect whether an A-pace or V-pace at a test value captures the atrium or the ventricle, respectively. It simply uses the measured A-V conduction of a patient within certain time windows to determine CAPTURE or LOC. The algorithm measures at least two values for each heart chamber and records them in the IPG RAM unit 310 or RAM/ROM unit 314 of Figure 3.
The stored values may be read out by the programmer 40 of Figure 2 and characterized as Rheobase (amplitude threshold at a pulse width of 1.0 ms) and Chronaxie (pulse width threshold at twice Rheobase) as described above with respect to Figure 5.
The stored values for both atrial and ventricular pulse width and pulse amplitude will be the actual measured values at CAPTURE or LOC or both as determined in the course of conducting the atrial and ventricular pacing threshold tests. The actual stimulation threshold data that are stored and later characterized as Rheobase and Chronaxie may therefore be selected as either the measured value declared as LOC
' or CAPTURE as described below.
It is intended that the SD algorithm operate only during periods of sleep, and that, if possible, it be initiated about the same time every night by a programmed start time. The SD algorithm establishes a test pacing rate for the selected heart chamber that is clinically acceptable and not arrythmogenic but is fast enough to prevent a patient from breaking through with a sinus escape mechanism which thereby causes inhibition of the pacemaker or leads to multiple fusion 2~ 9b43i~
WO 96/04956 1 ~ PCT/US95/09610 events. In this regard, the pacing rate during the test should not exceed 100 bpm to avoid intolerable patient symptoms from pacing rapidly in patients who may have coronary artery disease or may be sensitive to rapid. stimulation. A rate of 60 to 100 bpm is fast enough to prevent intolerable eyTnptoms when a beat is dropped due to LOC.
Ventricular rate pauses during the recovery from LOC described below should be no longer than two seconds.
The following description of the algorithms is divided into sections including the determination of ALOC and VLOC and the Atrial SD (ASD) Test and Ventricular SD (VSD) Tests. The ASD and VSD algorithms depicted in Figures 8 and, 9 will operate only in DDI(R), DVI(R) and DDD(R) modes, i.e. with dual chamber pacing and sensing enabled with rate response to activity optionally enabled.
Atrial Loss Of Capture AL~
It is important to note that the algorithm that determines ALOC
depends on several things including the expected characteristics of the A-V conduction consistency and delay. For example, the simplest algorithm may assume that every A-pace that results in a V-event during the A-V interval captures the atrium and every A-pace that does not result in a V-event during the A-V interval does not capture the atrium. This definition of ALOC would work if in every patient the A-V
interval was very consistent in duration, if there was conduction after every A-pace that captures the atrium, and if premature ventricular contractions (PVC's) would not occur during the A-V interval. In practice, these conditions do not always prevail.
Consequently, the algorithm for determining atrial capture and ALOC
is based on the assumption that A-V conduction will be quite consistent in a given patient, if the atrial pacing rate is consistent, and the following rules are followed in order.
First, if there is no ventricular sense V-event during the entire Pace A-V (PAV) interval following an A-pace test stimulus, then ALOC is declared. It is assumed that the A-pace test stimulus was below the atrial stimulation threshold.
Second, if there is a ventricular sense V-event during the PAV
following a first .A-pace test stimulus, then it must be determined whether the V-event resulted via the patient's A-V conduction from the capture of the atrium by the A-pace test stimulus or the V-event reflects a PVC. If the ventricular sense V-event is within the first 110 ms of the PAV, the current cycle is ignored, and ventricular safety pacing (VSP), if enabled, ie allowed to pace the ventricle at the backup, programmed, V-pace values. The detection of a V-event within the 110 ms window signifies the occurrence of a PVC, because the normal, conducted, ventricular depolarization, triggered by a preceding atrial depolarization, at the maximum A-pace rate of 100 bpm employed in the threshold Mast regimen in humane exceeds 110 ms. If this occurs, the atrial stimulation threshold test at the same A-pace test Z'' i6r.~~i WO 96/04956 ~ C PCT/ITS95/09610 stimulus values is repeated following the lapse of the programmed number of A-A interval Cycles Between Beats (defined below).
If the ventricular sense V-event is within the PAV and after the first 110 ms, the A-CAPTURE condition is declared or defined. Then, the A-pace test value is decremented, and the lower energy A-pace teat stimulus is delivered after the requisite Cycles Between Beats.
Figure 6 is a highly simplified timing diagram of a series of pacing cycles illustrating these principles with regard to the ALOC
determining algorithm. The symbols 'a' and 'b' each represent the test and fixed values of each A-pace test stimulus (pulse width and amplitude test values and fixed values defined below) delivered at a test A-A interval along a time line. The symbol 'C' appearing above the time line means that a ventricular sense V-event occurred during the PAV after the immediately preceding A-pace test value indicated as the adjacent vertical line below the time line. The symbol 'NC' above the time line means that the pacemaker paced the ventricle at the end of the PAV interval with the programmed V-pace output settings. In the illustrated example, 'SEN' appearing above the time line means that a ventricular sense V-event occurred during the first 110 ms of the PAV
initiated by the A-pace test stimulus of test value 'a' or was detected in the immediately preceding V-A interval. The symbol 'BAR' denotes delivery of an A-pace pulse that uses the programmed A-pace output energy settings following the NC beat. Figure 6 thus depicts associated events illustrating the principles of ALOC and A-CAPTURE
discrimination.
In Figure 6, the first test A-pace pulse delivered at test value 'a' results in A-V conduction outside the 110 ms window. Therefore, A-CAPTURE at the test value 'a' is assumed and declared, and the test value of the next A-pace test stimulus is decreased to 'b'. For first teat value 'b', the first A-pace test stimulus results in no detected V-event over the entire PAV interval. This result indicates that the A-pace test stimulus did not capture the atrium, causing the algorithm to declare ALOC, and the pacemaker to deliver the programmed V-pace at the end of the PAV interval. This pacing cycle is followed by at least one backup pacing cycle that uses the programmed atrial and ventricular pace pulse output settings at BAR.
Continuing with a further example in Figure 6, the test value 'a' of the A-pace test stimulus is repeated after the backup pacing cycle or at another time and results in a V-event within the 110 ms window that is classified as a SEN. This beat is ignored. The next A-pace test stimuli at test value 'a' results in a V-event sensed outside the 110 ms window indicating capture and A-V conduction. Therefore, A-CAPTURE
is declared, and the A-pace test value is decreased to 'b'. At the reduced energy level 'b', the first A-pace test stimulus results in no V-event detection in the PAV interval indicating a lack of atrial capture and/or A-V conduction, causing the algorithm to declare ALOC.

WO 96/04956 ~ 19 6 4 3 0 pCT~S95/09610 Again, this pacing cycle is followed by at least one backup cycle that uses the programmed atrial and ventricular output settings.
In accordance with an embodiment of the present invention described below, the stimulation thrershold is confirmed by next providing a series of three Insurance Eteats at the previous energy level at 'a' to confirm A-CAPTURE at that synergy. Alternatively, the confirmation of the threshold may be~ deteru~ined by repeating the delivery of the A-pace test stimulus at the energy level 'b'. Alternatively, each time an energy level results in A-CAPTURE, the same energy level may be repeated before the energy level is decreased.
Thus, ALOC is declared ~rhen it is unambiguous that the test value of the A-pace test etimuluev is reduced to a point where conducted ventricular events a.re not present because the atrium was not captured.
The setting of the A-A and PAV test intervals is set forth below in relation to the algorithms of Figures 8 and 9.
Ventricular Loss Of Captures (VLOC1 As with ALOC, Ven.tricula~r Loss Of Capture (VLOC) depends on several things including the expected characteristics of the A-V conduction consistency and delay. For example, the simplest VLOC and V-CAPTURE
algorithm may assume: (1) that every suprathreshold V-pace delivered early in the A-V interval after an A-event or A-pace will prevent V-event detection for a period equal to the Ventricular Refractory Period (VRP)f and (2) every subthreshc~ld V-pace delivered early in the A-V interval will be followed at the e~xpirati.on of the A-V interval by a conducted V-event (referred to a.s a "VFt eense") that also falls in the VRP of that delivered test V-pace, becaiuse the failure of the subthreshold V-pace to capture does not block t:he A-V conduction of the preceding atrial depolarization. This definition of VLOC would work fine if PVC's did not occur during the VRP, t:he A-V interval was very consistent in duration, and T-Waves of the QRST complex would not be sensed, triggering a false V'-event. Since these conditions axe not likely, the following algorithm has besrn devised to determine VLOC. This VLOC (and V-CAPTURE distinguishing) algorithm is based on the assumption that PAV
conduction will be qpite consistent in a heart that is paced at a fixed A-A test pacing escape inte:rval/rate.
First, if there i.s no verntricular sense or V-event during the VRP
following a V-pace test stimulus applied at the end of the test PAV
interval, then V-CAF~TURE is declared. Second, if there is a V-event sensed during the VP:P following such a V-pace test stimulus, then VLOC
is declared. Following each declared VLOC, at least one A-pace and V-pace cycle is delivered using the programmed output settings in the next pacing cycle. Then, t:he V-CAPTURE threshold is confirmed by applying a series of Insurance Beats at the immediately preceding, greater V-pace test value end looking for V-CAPTURE.
Figure 7 illustrates thss operation of the VLOC algorithm in a series of situations wherein the symbols 'a' and 'b' each represent a V-pace 2 ~ y64 ~~~
WO 96/04956 ~ PCT/US95/09610 teat value. The symbol 'C' means no V-event is detected in the VRP
after the V-pace test stimulus (no VR sense) indicated below the line.
The symbol 'NC' means that a V-event is detected in the VRP after the associated V-pace test stimulus. In these illustrations, the symbol 'SEN' means that a PVC occurred in the absence of a preceding V-pace test stimulus. The symbol 'BAR' denotes delivery of a V-pace pulse at the programmed output energy pulse width and amplitude settings.
In Figure 7, the first V-pace at the teat value 'a' delivered into a PAV is not followed by a VR sense. Therefore, V-CAPTURE is assumed and declared, and the V-pace test stimulus test value is decreased to 'b'. At test value 'b', the first V-pace test pulse is followed by a VR sense, causing the algorithm to declare VLOC. This A-A escape interval pacing cycle is followed by a backup A-A escape interval cycle that uses the programmed atrial and ventricular output settings at BAR.
Continuing with a second example in Figure 7, the V-pace test stimulus at teat value 'a' pulse is classified as a SEN, because a PVC
occurred and was detected as a V-event (not shown) during the V-A
interval immediately before this V-pace test stimulus. It is unlikely that the PVC occurring in the V-A interval will be detected as a V-event in the PAV interval, but the timing sequence could cause errors.
Consequently, this beat is ignored. The next V-pace test stimulus at teat energy 'a' is not followed by V-event in the VRP. Therefore, V-CAPTURE is assumed and declared, and the V-pace teat stimulus test value is decreased to test value 'b'. At test value 'b', the first V-pace test stimulus is followed by a V-event during VRP, causing the algorithm to declare VLOC. Again a backup pace cycle follows.
The above described ALOC and VLOC algorithms are embodied in the ASD
and VSD algorithms of Figures 8 and 9 which are intended to be read together in the following descriptions of the ASD Test and the VSD
Test. The ASD and VSD Test algorithms are intended to derive S-D curve threshold data based on ALOC and VLOC at both amplitude and pulse width test values for storage in the microcomputer RAM for later telemetry out on command and for automatically adjusting the stimulation thresholds upward and downward for the period between successive invocation of the ASD and VSD algorithm. A number of the sets of ASD
and VSD data values may be stored in RAM to telemeter out to show threshold trends over time.
In the ASD Test, as well as the VSD Test described below, the underlying time out of the specified intervals and the delivery of the A-pace and V-pace pulses described hereafter is governed by the operating program of the IPG generally depicted in Figure 4 and described above. The ASD and VSD algorithms of Figures 8 and 9 provide the operating time intervals and teat and fixed pace pulse and stimulus values to the general operating program and monitors events derived from the operation of the IPG as described above.

~~ 96430 ~q Atrial Strength-Duration IASD) Test The combined ASD and V'SD algorithm is preferably invoked as described above during a patient's sleep, when the heart is normally at its rest rate and activity induced rate variation is minimal.
Immediately after being triggered, e.g. by a built-in clock providing the time of day, the ASD Test commences at block 500 in Figure 8 and measures eight, consecutive, intrinsic A-A intervals in block 502 to determine what A-A pacing escape interval, called the Test Rate Interval, to use during the ASD and VSD Test. Atrial refractory senses are ignored during this measurement. The intrinsic intervals measured exclude atrial ref:cactory sense events.
The minimum of 'these eight consecutive A-A intervals is called the Measured Interval. At blocks 504 and 506, the ASD Test will be terminated if the lMeaeured Interval is less than 800 ms (heart rate is measured to be abo~~e 75 b;pm) to aid in accurate measurement of pacing thresholds by reducing the chance of timing conflicts between the pacemaker and the :Lntrins,ic atrial rate. In block 508, the Teat Rate A-A Escape Interva:L for tine ASD Test is set equal to the Measured Interval minus 200 ms, and the initial PAV ie set at 250 ms. In DDD
and DDDR modes, Non-Competitive Atrial Pacing (NCAP) is enabled and Post Ventricular At:rial Riafractory Period (PVARP) is forced to 400 ms during the ASD Test:. In 1)DI and DDIR modes, PVARP is forced to 400 ms during the ASD Test:.
After the Test Hate A-A Escape Interval is set, eight beats are delivered using them initial PAV interval of 250 ms to allow for measurement of the intrinsic A-V conduction time interval in block 508.
During these eight beats, all A-V intervals must end in a V-event as determined in block: 510. If this doesn't happen, the ASD Test is terminated in blocl~: 512, and the Escape Interval, PAV, NCAP and PVARP
are returned to ths~ programmed settings. If all PAV intervals do end in a V-event, the maximum measured A-V interval is used to set the Max PAV interval equal to the maximum measured PAV plus 30 ms in block 514.
Each ASD Test will begin with an A-pace test stimulus set to the current programmed or operating pulse output amplitude and a 1.0 ms pulse width as set in block 516. A-pace test stimuli will be delivered once every Cycles H~etween Beats, where the Cycles Between Beats is an adjustable value (range 0-~7). Cycles Between Beats thus represents the number of pacing cycles of A-pace and P-pace stimuli to be delivered at the initial programmed or operating pulse amplitude and width values between test cycles that contain A-pace test stimuli. It should be noted that the illustrations of Figures 6 and 7 have Cycles Between Beats set at zero for simplicity of illustration.
The teat value parameter being changed initially during the ASD Test is pulse amplitude which will decrease as A-pace test stimuli are delivered until a test value results in the declaration of ALOC. The next set of three A-pace test stimuli uses the amplitude value from the immediately preceding set of A-pace test values that previously 2~9643Q
WO 96104956 ~ Q PCT/US95/09610 resulted in the declaration of A-CAPTURE. These three test stimuli are called Insurance Beats and they may be separated by the programmed Cycles Between Beats. In block 516, an Insurance Beat counter is initially set to zero. The Insurance Beats are employed and counted in steps 546 - 552 described below.
The Number of Senses refers to the count of Sensed events that occur inappropriately during the SD test regimen. If an A-event or a V-event (PAC, PVC, refractory ventricular sense or ventricular sense after an atrial refractory sense) occurs during the V-A interval before an A-pace test stimulus or if a V-event occurs during the first 110 ms of the PAV interval, then the A-pace test stimulus is aborted for the current test cycle and continued on the next test cycle with the same test value. This restriction includes A-event senses during PVARP.
If, during the course of the ASD test, more than 25 cycles contain Senses as described above, the ASD Test will abort. At block 516, the Number of Senses counter is also initialized by setting the Number of Senses to zero. It is expected that a maximum number of aberrant A-event and V-event senses to be allowed would be on the order of 25 to allow for an infrequent PAC or PVC while avoiding pacing at the increased fixed rate in the presence of over sensing or a relatively constant tachyarrythmia.
After all counts and the starting test value is established in block 516, the ASD algorithm continues to await the completion of the programmed Cycles Between Beats in block 518. When the A-pace test cycle occurs, the A-pace test stimuli is generated, starting the A-A
test cycle period, and the steps of blocks 518 - 560 of Figure 8 are initiated. At decision block 520, the Number of Senses count is checked, as is the current state of the test value and the activity counter. An ongoing calculation of the activity level of the patient is conducted in parallel in the rate determination algorithm in response to the signal on line 324 of Figure 3. If the sensor derived escape interval/pacing rate is greater than a resting rate (defined as a programmed or calculated value between the lower rate and the upper rate), then the patient is considered to be active, the ASD test is terminated, and the VSD Test algorithm is initiated in block 522.
Similarly, if the Number of Senses equals 25 or if the maximum pulse Width or amplitude is reached in the respective threshold tests of each energy variable, then the VSD Test algorithm is commenced in block 522.
As indicated below, if these conditions persist, then the VSD Test algorithm will also be terminated.
Assuming that the ASD Test continues, a further invalid V-event may occur if a PVC V-event is sensed in the V-A interval. If this is the case, as determined in block 524, then each such instance is also counted in Increment Number of Senses block 526. If the A-A test escape interval times out instead, the A-pace test stimulus ie generated and the algorithm moves to block 530 to examine the response during the PAV interval.

ze~6~~
WO 96/04956 ~ 1I PCT/US95/09610 At block 530, the occurrence of a V-event due to a ventricular depolarization during the PAV interval is looked for. If the V-event does not occur during the PAV interval, then ALOC is assumed and declared in block 532. In block 532, the test value is incremented so that the Insurance Beats may be delivered at the incremented value, and the backup A-pace pulse at the programmed pulse width and amplitude ie forced to be delivered at the next pacing cycle, if the Cycles Between Beats is set to zero. When Cycles Between Beats is programmed other than zero, the next A-pace pulse would be at the programmed or the previously determined pulse energy in any case.
If there is a V-event sensed, then it is determined in block 534 whether or not it fell within the 110 ms window from the start of the PAV interval. If it did, then the Number of Sense count is again incremented in block 536. If not, then it is presumed that A-CAPTURE
has occurred, and in it is determined whether the capture was the result of one of the Insurance Beats previously generated due to an earlier ALOC in block 546. The Insurance Beats count is examined in block 546, and if it is not greater than zero, then the test value is decremented, and t:he wait for Cycles Between Beats is commenced in block 518.
If the count of Insurance Beats is greater than zero (as set on ALOC
in block 532) but less than three, as determined in block 550, then the Insurance Beats aria being delivered. On each delivery, the count of the number of Insu:cance Beats is incremented in block 552. Again, the wait for Cycles Between Beats is commenced in block 518 between the delivery of each Insurance Beat.
If ALOC is again encountered during the delivery of any of the Insurance Beats, then in .block 532, the test value is again incremented, and the delivery of the three Insurance Beats at the new test value is repeated.
After three Insurance Beats are delivered at the same test value and A-CAPTURE is decla:ced for all of them, se determined in block 550, then the test value output parameter being varied as the current test value is examined in block 554. If it is still the pulse amplitude, then in block 558 a number of conditions are set to record the pulse amplitude test value at ALOC, switch the test value to pulse width and the fixed value to pulse amplitude, and repeat the testing as width is reduced to ALOC. Ae depicted, the Rheobase value 1e set at the last test value of pulse amplitude and stored in the IPG RAM. The teat values for both pulse amplitude ALOC and 'the A-CAPTURE value of the Insurance Beats may be stored in IPG RAM, and either one may be characterized as Rheobase.
The pulse amplitudia initial setting for pulse width ALOC determination is then set to twice the ;Rheobase value. Then the algorithm loops back, and the wait for Cycles Between Beats to elapse is commenced in block 518.
Thus, after the ASD pulse amplitude test is finished and Rheobase has been found, th~a ASD pulse width test is started. The steps 518 -~ ~ ~~4JiJ
WO 96104956 ~ ~ PCTIUS95/09610 554 are repeated as pulse width is decreased by one step for each set of test values. When an atrial pulse width test value results in ALOC, the next set of three atrial test stimuli Insurance Beats use the pulse width value from the last set of test values that resulted in A-CAPTURE.
If all of the Insurance Beats result in A-CAPTURE, the pulse width test value at ALOC or last A-CAPTURE is recorded as Chronaxie in block 556 and stored in IPG RAM. The atrial pulse width test values of both the Insurance Beats and at ALOC may be stored in IPG RAM. The ASD
threshold test is completed, and atrial pulse amplitude and width are returned to their programmed values for the duration of the VSD test.
As noted above with respect to block 520, if the amplitude reaches maximum voltage (e. g. 6 V) during the amplitude test, or the pulse width reaches maximum width (e. g. 1.5 ms) during the pulse width teat, or if the sensor rate exceeds the resting rate while the ASD test is in progress, the atrial stimulation threshold test is aborted in block 522, and zero Rheobase and Chronaxie values are recorded to indicate a search failure.
Ventricular Strength-Duration (VSD) Test The VSD Test algorithm is similar to the Atrial SD Test and commences at block 566. The parameter being changed during the VSD
Test, either pulse width or amplitude is likewise called the test value, and the fixed parameter is the fixed value. For the first part of the VSD Test, the amplitude will decrease until a test value results in the declaration of VLOC. The next set of three Insurance Beat ventricular test stimuli uses the amplitude value from the preceding set of test values that resulted in the declaration of V-CAPTURE.
If all of the Insurance Seats result in V-CAPTURE, the amplitude value is recorded as rheobase, the output amplitude is doubled and the pulse width is reduced by one step. If any of the Insurance Beats result in VLOC, the algorithm assumes that capture was lost and attempts the next greater amplitude step, repeating Insurance Beats at the new test value.
These cases are identical to those of the ASD Test, and the description in that section with respect to blocks 518 - 560 is largely applicable to blocks 572 - 598 of Figure 9. The principle of VLOC and V-CAPTURE declaration is different in that the absence or presence of a V-event in the VRP following the delivery of the V-pace test stimuli at the end of the short PAV interval is declared to be V-CAPTURE or VLOC, respectively. The V-event during the VRP following the V-pace test stimulus is examined in block 580.
The VSD Test will be initiated following the ASD Test in blocks 566, and the PAV (and SAV in DDD[R]) is set to 30 ms during the VSD Test in block 568. Each VSD Teat will begin with pulse amplitude designated as the test value, and the initial V-pace test stimulus set to the current output amplitude and a 1.0 ms pulse width in block 570. The counts of the Number of Senses and the number of Insurance Beats are also set to WO 96/04956 ~ ~ PCT/US95/09610 zero in block 570. Test stimuli will be delivered once ev~ry Cyclve Between Beats, where Cycles Between Beats is again the adjustable value (range 0-7). As ir,~ the A:~D Test, the Cycles Between Beats represents the number of pacing cycles to be delivered between cycles that contain teat stimuli.
After block 572 is satisfied, the count of the Number of Senses is examined in block f.74, and if the count is 25, then the VSD Test ie terminated in blocH: 578. If the amplitude reaches 6 V during the amplitude search oz' the pulse width reaches 1.5 ms during the pulse width search While the Ventricular SD test is in progress, the VSD Test is aborted, and zero rheobase and chronaxie values are recorded to indicate a search failure.
At block 576, the decie~ion block acts on the occurrence of a PVC or PAC Sense or the er.~d of the A-A test escape interval. If a PVC or PAC
Sense occurred, ths:n the count of the Number of Senses ie incremented in block 578, the cycle containing the V-pace teat stimulus is ignored, and ventricular threshold test continues on the next cycle in block 572.
If the A-A escape interval ended with delivery of an A-pace, then the algorithm waited in block 580 for the delivery of the V-pace test stimulus after the 30 ms. PAV delay interval and for the occurrence of a V-event during tree VRP started at delivery of the V-pace teat stimulus. If a V-event is detected in the VRP, then VLOC is declared, and the test value is incremented for the Insurance Beat value, the backup pacing cycls~ is forced, if necessary, and the Insurance Beats count is set to one in block 582.
If a V-event is not detected in the VRP at block 580, then V-CAPTURE
is declared, and the Number of Insurance Beats is examined in block 584. If the number is zera, then the test value is decremented in block 586 and the algorithm loops back to block 572 to test at the lower amplitude V-Face test stimuli. The pace test cycles repeat through blocks 572 - 586 until VLOC is declared, and the Insurance Beats are delivered three tunes per blocks 588 and 590.
The operation of' delivE:ring the Insurance Beats, recording the Rheobase value, setaing the pulse amplitud~ fixed value and starting the VSD test with F>ulse w3.dth as the test value through blocks 584 -592 is the same as described above with reference to blocks 546 - 554.
As described above, both t:he VLOC and Insurance Beat pulse amplitude test values may also be et:ored in IPG RAM and one may be recorded or used as the Rheobas~e value. Then the VSD Test repeats for ventricular pulse width as the test value.
When the pulse width VI:OC value is arrived at and the Insurance Beats are delivered, the 7Cnsurance Beat V-CAPTURE test value is recorded as the VSD Chronaxie value in block 596. The Insurance Beat and VLOC pulse width teat values may also both be stored in IPG RAM.
The V-pace pulse width and amplitude values are restored to the WO 96/04956 ~ ~ ~ 'r1 PCT/US95/09610 programmed value in block 596, and the VSD Test is terminated in block 598.
Thus, as the stimulation threshold data is derived in the ASD and VSD algorithms, the ALOC and VLOC pulse width and amplitude test values as well as the A-CAPTURE and V-CAPTURE test values confirmed as Insurance Beats are stored in RAM 312 or RAM\ROM unit 314 for telemetry out on command of the external programmer 40. The data may be depicted in ASD and VSD curves on the programmer display 112 or printed out on the printer 114 in a manner well known in the art using either or both sets of CAPTURE and LOC data.
Within the IPG circuit 300, the data may be used to establish or confirm the prior V-pace and A-pace pulse width and amplitude settings.
The general operating program of the IPG in Figure 4 may also invoke a resetting of the A-pace and V-pace pulse widths and amplitudes as a function of the stored values.
Simplified Single Chamber ALOC and VLOC Determination In a further embodiment of the present invention, the general inventive concept (embodied above in the VSD algorithm) of injecting a teat stimulus prematurely within a pacing cycle, monitoring for a sensed event in a time window when a natural or conducted depolarization would be expected to follow a preceding natural or conducted depolarization, and declaring the absence of the sensed event as CAPTURE by the injected test stimulus and the presence of the sensed event as LOC may also be applied in a single chamber pacemaker context or operating mode for testing either atrial or ventricular stimulation thresholds or in a dual chamber pacemaker context or operating mode for sequentially testing for ALOC and VLOC and deriving ASD and VSD
threshold data. The algorithm of Figure 10 provides an alternative threshold testing mode in dual chamber IPGs implanted in patients who do not enjoy normal A-V conduction and have second or third degree block. The selection of the particular algorithm to be used in a given patient may be a programmable option in that context.
Specifically, in patient's having regular, intrinsic atrial and/or ventricular sinus rates but not necessarily having intact A-V
conduction or first degree block, the alternative ASD and/or VSD
algorithm as shown in Figure 10 may be invoked periodically to teat for pulse amplitude and width stimulation thresholds. In Figure 10, the ASD test is particularized for the example of testing the atrial threshold and is initiated at block 600. The patient's intrinsic atrial sinus rate is monitored for a number of consecutive cycles in block 602. In block 604, the A-A interval lengths (or the average value thereof) are compared to the minimum interval, and the test is abandoned in block 606 if the intrinsic rate is too great, as in blocks 500 - 506 of Figure 8. If the instantaneous or average rate is slow enough, then it is checked for regularity in block 608. If the measured A-A intervals are irregular beyond a certain range of regularity, then the teat is also abandoned in block 606.

219b430 WO 96104956 ,~, ~ PCT/LTS95/09610 If the sinus rate is evlow and regular enough to proceed, then the test escape interval for the test stimuli to be injected prematurely in the sinus A-A escape interval is set in block 610 to be, for example, 50$ of the average measured interval. During an appropriate Not Reset Window (NRW) interval or sense test window following the delivery of the test stimulus to the heart chamber, the sense amplifier for sensing depolarizations of that same chamber is operated (after an appropriate blanking interval less than about 100 ms) to detect the following natural depolarization of the heart. The interval from the delivered test stimulus to the occurrence of the next sensed A-event is timed and the timeout is compared to the NRW. This insures that an A-event detected during the NRW will more likely than not be a natural depolarization occurring at about the average measured escape interval from the preceding A-event that signifies that the test stimulus was insufficient to capture, and ALOC is declared. If the A-event is sensed after the NRW, A-CAPTURE is assumed and declared. In block 612, NRW is set to the test escape interval (50~ of the average measured A-A
interval) plus 100 ms, for example.
In block 614, the test value is selected as pulse amplitude, the pulse width is set to 1.0 ms, and the Insurance Beats are set to zero.
In this SD test, the Number of Senses previously employed is not considered relevant. At this point, the algorithm of Figure 10 moves to block 616 to wait for the programmed Cycles Between Beats to count down to zero (it may be set at zero). Then in blocks 618 - 640 the pulse amplitude and pulse width LOC and Insurance Beat CAPTURE test values are determined in a manner analogous to that method described above with reference to blocks 572 - 598 of Figure 9 with certain differences.
The first principal difference is that the test stimuli are commenced at a test pulse energy level in pulse amplitude or width that is certain to result in L~OC, and the pulse amplitude or width is increased stepwise until CAPTURE is declared for the pulse width or amplitude test value. A second difference is that the Insurance Beats are set to be repeated after the delivery of a backup cycle, if necessary, at the ~rAPTURE threshold to verify the stimulation threshold. Since CAPTURE results in an elevated heart rate, it ie desirable to avoid unnecessary repetition of the high rate pacing of the heart chamber.
In blocks 618 and 620, the ASD algorithm is abandoned at maximum pulse width or amplitude, and a VSD test may be started at block 600, if the algorithm is enabled for both chambers in a dual chamber pacemaker. At this point, the delivery of the next A-pulse at the test value and the test escape interval (i.e., the atria! test stimulus) is enabled to be deli~~rered following the next A-event in the general operating algorithm of the IPG. At block 622, the A-sense time interval after delivery of the test stimulus is compared to the NRW, and if it is less than the NRW, ALOC is declared for that test value.

WO 96/04956 ~ ~ PCT/US95/09610 In block 626, the Insurance Beat count is compared to zero, and if it is still zero (signifying that A-CAPTURE was not previously declared), then the atrial pulse amplitude test value is incremented. The next higher pulse amplitude atrial test stimulus is then delivered after satisfying blocks 616 - 620.
If the test stitaulus energy is sufficient to capture the atrium, then the test A-pace to A-sense interval will exceed NRW in block 622, and the Insurance Beats count is incremented and a backup cycle is forced in block 624, if the Cycles Between Beats is programmed at zero.
The next two A-pace test stimuli are delivered at the same pulse amplitude test value energy until block 630 is satisfied. When the delivered number is three, then, since the test value is pulse amplitude, A-CAPTURE for pulse width is declared, the Rheobase is set to the A-CAPTURE pulse width test value, and the conditions for commencing the threshold test for A-pace pulse width are all set in block 636.
The starting A-pace test stimulus pulse width is set to the minimum in block 636, and the steps 616 - 634 are repeated as the pulse width is increased until A-CAPTURE is again declared at the threshold pulse width. The Chronaxie test value is recorded, and normal A-pace pulse amplitude and width are re-confirmed in block 638. If programmed, then the VSD test is conducted in block 640. In this example, the VSD test is identical to the ASD teat of blocks 600 - 640, with appropriate test values pre-selected. Although the SD algorithm of Figure 10 is particularly characterized for ASD testing, it will be understood that the algorithm may be used for VSD testing alone in the same fashion, using the ventricular pulse generator and sense amplifier.
Other AT~Dlications and Embodiments of the Invention Although the above described ASD and VSD algorithms of Figures 8-10 contemplate being invoked at a particular time of day when a patient is at rest, it will be understood that the principles of the invention may be invoked at other times to test for LOC. In blocks 516, 570 and 614, the Cycles Between Beats are set so that the delivery of the test stimuli may be either sequential or separated by normal pacing cycles up to a programmable maximum number. It will also be understood that the inventive stimulation and detection concepts may be employed to periodically test either ventricular or atrial capture in a shortened test escape interval by delivering a test A-pace or V-pace stimuli at a selected reduced energy so that a record of each declared A-CAPTURE/V-CAPTURE or ALOC/VLOC can be stored in IPG RAM with the associated time of day and/or other operating conditions for later telemetry out and diagnostic study. For example, such a record may be compiled correlated to the patient's activity level or current pacing rate as determined contemporaneously by the activity sensor.
The algorithms presented in Figures 8-10 and the above variations may also be simplified and performed with simple reductions in pace pulse energy, e.g. pulse amplitude or width or preset combinations of r..~.~s~ Yc: i 2 ~ 9 X430 both, without deriving S-D threshold data in the manner described. In addition, the threshold tests following the princi~ales of the present invention ntay be invoked by remote triggering employing the programmer or a simplified triggering device.
Other applications of the inventive method of delivering the test stimuli from the conventional atrial and vE;ntricular pulse generators and detecting the responses from the conventional sense amplifiers and pacc/sensc electrodes in the manner described above will be apparent to those of skill in the a.~t.
Although the present invention is described in conjunction with a microprocessor-based architecture, it will be un~3erstood that it could be implemented in other technology such as digital logic-based, custom integrated circuit (Ifs architecture, if desired.
It will also be understood that the present invention may bt implemented in dual-chamber pacemakers, cardioverters, defibrillators and the like, ._~_ . ._ y~.. m~. . . _ A AA, ~;: ~!.flFt1_.5,~1.F~.T _7 ~.-._.._ .

Claims (37)

CLAIMS:

1. A dual chamber pacemaker pulse generator for attachment with atrial and ventricular pacing and sensing electrodes for pacing a patient's heart in the atrium and the ventricle at adjustable atrial and ventricular pacing pulse energies comprising:
variable escape interval timing means for establishing an atrial normal pacing rate escape interval;
atrial pace pulse generator means for generating an atrial pace pulse at said atrial electrodes at the end of said atrial normal rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;
ventricular sensing means coupled to said ventricular electrodes for generating a ventricular sensed event signal in response to a depolarization of ventricular tissue;
atrial stimulation threshold test means for operating said escape interval timing means at an atrial pace test escape interval and for initiating the delivery of an atrial pace test stimulus by said atrial pace pulse generator means at the end of an atrial pace test escape interval at an atrial pace test pulse energy varying from said normal atrial pace pulse energy in an atrial pace test cycle;
atrial capture detection means responsive to said ventricular sensing means for declaring atrial capture following the delivery of an atrial pace test stimulus by the detection of a ventricular sensed event signal in at least a portion of an A-V delay interval following the delivery of the atrial pace test stimulus; and atrial loss of capture detection means responsive to said ventricular sensing means for declaring atrial loss of capture following the delivery of an atrial pace test stimulus by the absence of a ventricular sensed event signal detected in the A-V delay interval.

2. A dual chamber pacemaker pulse generator as set forth in claim 1 and further characterized by:
atrial sensing means coupled to said atrial electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said atrial normal pacing rate escape interval;
atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse; and ventricular pace pulse generator means for generating a ventricular pace pulse at said ventricular electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval.

3. A pacemaker pulse generator of claims 1 or 2 wherein said atrial stimulation threshold test means further comprises:
means for setting the atrial test escape interval to correspond to an atrial pace test rate exceeding the natural atrial depolarization rate of the patient's atrium;
and means for determining a starting atrial pace test pulse energy that consistently results in capture of the patient's atrium at said atrial test rate.

4. A pacemaker pulse generator of claims 1, 2 or 3 wherein said atrial capture detection means further comprises:
means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before the conducted ventricular depolarization resulting from the capture of the atrium would be expected to appear at the site of the ventricular electrodes; and means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient's atrium by the preceding atrial pace test stimulus and not indicative of atrial capture or loss of capture by the preceding atrial pace test stimulus.

5. A pacemaker pulse generator of claims 1 - 4 wherein said atrial stimulation threshold test means further comprises:
means for reducing the atrial test pulse energy of the succeeding atrial pace test stimuli and repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

6. A pacemaker pulse generator of claim 5 wherein said pulse energy reducing means further comprises means for reducing the atrial pace test stimulus pulse width until atrial loss of capture is declared at a reduced pulse width indicative of the atrial stimulation pulse width threshold and for thereafter reducing the atrial pace test stimulus pulse amplitude until atrial loss of capture is declared at a reduced pulse amplitude indicative of the atrial stimulation pulse amplitude threshold.

7. A pacemaker pulse generator of claims 1 - 6 further comprising:
means for setting the normal atrial pace pulse energy at a normal pace pulse width and pulse amplitude exceeding the atrial loss of capture stimulation threshold pulse width and pulse amplitude by a safety margin.

8. A pacemaker pulse generator of claims 1 - 7 wherein said atrial pace pulse generator means further comprises:
means responsive to the atrial loss of capture declared by said atrial loss of capture detection means for generating an atrial backup pace pulse at a greater pace pulse energy at the end of the following atrial pace normal rate escape interval.

9. A pacemaker pulse generator of claims 1-8 further comprising:
means for storing the atrial test pulse energy at atrial loss of capture and/or atrial capture as atrial stimulation threshold data; and means operable on command of a remote programmer located outside the patient's body for telemetering said stored atrial stimulation threshold data to said remote programmer.

10. A pacemaker pulse generator of claims 1 - 9 wherein said atrial capture detection means further comprises:
means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before the conducted ventricular depolarization resulting from the capture of the atrium would be expected to appear at the site of the ventricular electrodes; and means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient's atrium by the preceding atrial pace test stimulus and not indicative of atrial capture or loss of capture by the preceding atrial test stimulus.

11. A pacemaker pulse generator of claim 10 wherein said atrial stimulation threshold test means further comprises:
means for reducing the atrial test pulse energy of the succeeding atrial pace test stimuli and repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

12. A pacemaker pulse generator of claim 1 wherein said atrial capture detection means further comprises:
means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before the conducted ventricular depolarization resulting from the capture of the atrium would be expected to appear at the site of the ventricular electrodes; and means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient's atrium by the preceding atrial pace test stimulus and not indicative of atrial capture or loss of capture by the preceding atrial test simulus.

13. A pacemaker pulse generator of claim 12 wherein said atrial stimulation threshold test means further comprises:

means for reducing the atrial test pulse energy of the succeeding atrial pace test stimuli and repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

14. A dual chamber pacemaker pulse generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarizations of a patient's heart in the atrium and the ventricle, respectively, said pacing being at adjustable atrial and ventricular pacing pulse energies and wherein said generator comprises:
variable escape interval timing means for establishing an atrial normal rate escape interval and an atrial test escape interval;
atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said atrial normal rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;

atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said atrial normal rate escape interval;
atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse;
ventricular sensing means adapted to be coupled through said ventricular sense electrodes for generating a ventricular sensed event signal ventricular pace pulse generator means for generating a ventricular pace pulse through said ventricular pacing electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval;
means for establishing a ventricular refractory period time interval following delivery of a ventricular pace pulse;
ventricular stimulation threshold test means periodically operable for initiating a ventricular stimulation threshold test further comprising:
means for operating said escape interval timing means at atrial pace test escape intervals and said atrial-ventricular delay timing means at a test A-V delay interval commencing in timed relation to the delivery of an atrial pace pulse;
means for operating said atrial pace pulse generator means to generate an atrial pace pulse at the end of the atrial pace test escape interval at an atrial pace pulse energy sufficient to ensure that atrial capture is achieved and that a conducted ventricular depolarization follows outside said test A-V delay interval; and means for initiating the delivery of a ventricular pace test stimulus by said ventricular pace pulse generator means at the end of said test A-V delay interval which is timed to render the patient's ventricle refractory to potential subsequent intrinsically conducted depolarization stimulus captures and depolarizes the ventricle; and ventricular capture detection means responsive to said ventricular sensing means for declaring ventricular capture by the absence of a ventricular sensed event signal in the ventricular refractory period following delivery of the ventricular pace test stimulus.

15. A pacemaker pulse generator of claim 14 wherein said ventricular stimulation threshold test means further comprises:
means for setting the atrial test escape interval to correspond to an atrial test rate exceeding the natural atrial depolarization rate of the patient's atrium; and means for determining a starting atrial pace and ventricular pace test pulse energy that consistently results in capture of the patient's atrium and ventricle, respectively, at said atrial test rate.

16. A pacemaker pulse generator of claim 14 further including ventricular loss of capture detection means responsive to said ventricular sensing means for declaring ventricular loss of capture following the delivery of a ventricular pace test stimulus by the presence of a ventricular sensed event signal detected within the ventricular refractory period.

17. A pacemaker pulse generator of claim 16 wherein said ventricular loss of capture detection means further includes means operable in response to a declaration of ventricular loss of capture for repeating the delivery of ventricular pace test stimuli by said ventricular pace pulse generator means during a next test pacing cycle at the ventricular test pace pulse energy previously declared as ventricular capture to confirm the threshold capture energy over at least two test pacing cycles.

18. A pacemaker pulse generator of claim 17 further comprising a test pacing cycle repeating means for reducing the ventricular pace test stimulus pulse width through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse width indicative of the ventricular stimulation pulse width threshold and for thereafter reducing the ventricular pace test stimulus pulse amplitude through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse amplitude indicative of the ventricular stimulation pulse amplitude threshold.

19. A pacemaker pulse generator of claim 18 further comprising:
means for storing values representing the ventricular test pulse width and pulse amplitude at ventricular loss of capture and/or ventricular capture as ventricular threshold test data; and means operable on command of a remote programmer located outside the patient's body for telemetering said stored ventricular threshold test data to said remote programmer.

20. A pacemaker pulse generator of claim 19 further including means for setting a normal ventricular pace pulse energy value at a normal pace pulse width and pulse amplitude exceeding at least one of the ventricular loss of capture stimulation threshold pulse width and pulse amplitude values by a safety margin.

21. A pacemaker pulse generator of claim 20 wherein said ventricular loss of capture detection means further includes means responsive to the ventricular loss of capture declared by said ventricular loss of capture detection means for providing a backup pacing pulse to capture the ventricle at the end of the following normal escape interval.

22. A pacemaker pulse generator of claim 16 wherein said ventricular loss of capture detection means further comprises:
means responsive to the ventricular loss of capture declared by said ventricular loss of capture detection means for providing a backup pacing pulse to capture the ventricle at the end of the following normal escape interval.

23. The pacemaker pulse generator of claim 16 further comprising:
means for storing the ventricular test pulse width and pulse amplitude values at ventricular loss of capture and/or ventricular capture as ventricular threshold test data; and means operable on command of a remote programmer located outside the patient's body for telemetering said stored ventricular threshold test data to said remote programmer.

24. The pacemaker pulse generator of claim 16 further comprising:
means for setting a normal ventricular pace pulse energy at a normal pace pulse energy exceeding the ventricular loss of capture stimulation threshold pulse energy by a safety margin.

25. The pacemaker pulse generator of claim 14 further comprising a test pacing cycle repeating means for reducing the ventricular pace test stimulus pulse energy through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse energy level indicative of the ventricular stimulation pulse energy threshold.

26. A dual chamber pacemaker implantable pulse generator for attachment with atrial and ventricular pacing and sensing electrodes said electrodes being for delivering electrical pulses from said generator for pacing and sensing depolarization of a patient's heart in the atrium and the ventricle respectively, said being at adjustable atrial and ventricular pacing pulse energies, said generator characterized by:
variable escape interval timing means for establishing a normal atrial rate escape interval;
atrial pace pulse generator means for generating an atrial pace pulse through said atrial pacing electrodes at the end of said normal atrial rate escape interval in the absence of an atrial sensed event signal at a normal pace pulse energy;
atrial sensing means adapted to be coupled through said atrial sense electrodes for generating an atrial sensed event signal in response to a natural depolarization of atrial tissue during at least a major portion of said normal atrial rate escape interval;
atrial-ventricular delay timing means for establishing an A-V delay interval commencing in timed relation to an atrial sensed event signal or an atrial pace pulse and where in relation to a pace pulse said A-V delay interval comprises a first and second temporal portion;
ventricular sensing means adapted to be coupled to said ventricular electrodes for generating a ventricular sensed event signal in response to a depolarization of ventricular tissue;
ventricular pace pulse generator means for generating a ventricular pace pulse at said ventricular electrodes at the end of said A-V delay interval in the absence of a ventricular sensed event signal detected within said A-V delay interval;
means for establishing a ventricular refractory period time interval following delivery of a ventricular pace pulse;
pace test stimulus by the presence of a ventricular sensed event signal detected within the ventricular refractory period;
ventricular capture detection means responsive to said ventricular sensing means for declaring ventricular capture by the absence of a ventricular sensed event signal in the ventricular refractory period following delivery of the ventricular pace test stimulus; and means for periodically triggering the operation of said atrial and ventricular stimulation threshold test means in a predetermined sequence of successive test pacing cycles to derive atrial and ventricular stimulation threshold test data related to the declarations of atrial and ventricular capture and loss of capture.

27. A pacemaker pulse generator according to claim 26 further including:
means for storing said atrial and ventricular stimulation threshold test data; and means for retrieving and transmitting said stored atrial and ventricular stimulation threshold test data on command to a remote receiver for review and analysis.

28. A pacemaker pulse generator of claim 26 further including:
means for storing said atrial and ventricular stimulation threshold test data; and means for adjusting the atrial and ventricular pace pulse energies of the atrial and ventricular pace pulses generated by said atrial and ventricular pace pulse generator means to energy values in excess of said stored atrial and ventricular stimulation threshold test data.

29. A pacemaker pulse generator of claim 26 wherein said atrial capture detection means further comprises:
means for defining a time window interval commencing with said A-V delay interval and timing out at a time within said A-V delay interval before the conducted ventricular depolarization resulting from the capture of the atrium would be expected to appear at the site of the ventricular electrodes; and means for declaring a ventricular sensed event occurring during said time window interval as a natural ventricular depolarization not resulting from capture of the patient's atrium by the preceding atrial pace test stimulus and not indicative of atrial capture or loss of capture by the preceding atrial pace test stimulus.

30. The pacemaker pulse generator of claim 26 wherein said ventricular loss of capture detection means further includes means responsive to the ventricular loss of capture declared by said ventricular loss of capture detection means for providing a backup pacing cycle employing backup atrial and ventricular pace pulse energies at the end of the following normal escape interval.

31. The pacemaker pulse generator of claim 26 wherein said test pacing cycle repeating means further includes means for reducing the ventricular pace test stimulus pulse width through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse width indicative of the ventricular stimulation pulse width threshold and for thereafter reducing the ventricular pace test stimulus pulse amplitude through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse amplitude indicative of the ventricular stimulation pulse amplitude threshold.

32. The pacemaker pulse generator of claim 26 wherein said test pacing cycle repeating means further comprises:
means for reducing the atrial test pulse energy of the succeeding atrial pace test pulse and repeating delivery of atrial pace test pulse by said atrial pace pulse generator means at the end of successive test escape intervals at successively reduced atrial test pace pulse energies until atrial loss of capture is declared at a reduced atrial test pulse energy; and means responsive to declaration of atrial loss of capture for repeating the delivery of atrial pace test stimuli by said atrial pace pulse generator means at the end of successive atrial test escape intervals at the atrial pace test pulse energy of a preceding declared atrial capture until such atrial capture is declared at least twice.

33. The pacemaker pulse generator of claim 32 wherein said test pacing cycle repeating means further includes means for reducing a ventricular pace test pulse width through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse width indicative of the ventricular stimulation pulse width threshold and for thereafter reducing the ventricular pace test stimulus pulse amplitude through a series of test pacing cycles until ventricular loss of capture is declared at a reduced pulse amplitude indicative of the ventricular stimulation pulse amplitude threshold.

34. In a pacemaker pulse generator having atrial and ventricular pulse generators for generating and applying atrial and ventricular pacing pulses to the atrium and ventricle of the heart separated by an A-V delay interval to evoke stimulated atrial and ventricular depolarizations and capture the atrium and ventricle and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, a method of testing for the stimulation threshold energy of the ventricle characterized by the steps of:
determining the patient's atrial escape interval;
operating said atrial pulse generator to deliver an atrial pace pulse at an energy sufficient to capture the atrium when said atrial escape interval times out;
setting a test pace A-V delay interval;
operating said ventricular pulse generator to deliver a ventricular test stimulus at the end of said test pace A-V delay interval;
setting a ventricular sense time window;
operating said ventricular sense amplifier during said ventricular sense time window to sense a depolarization of the ventricle;
declaring capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is not sensed in the ventricular sense time window; and declaring loss of capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is sensed in the ventricular sense time window.

35. In a pacemaker pulse generator having an atrial pulse generator for generating and applying atrial pacing pulses to the atrium of the heart to evoke a stimulated depolarization and capture the atrium and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, apparatus for testing for the stimulation threshold energy of the atrium characterized by:
means for determining the patient's atrial escape interval;
means for operating said atrial pulse generator to deliver an atrial test pulse at a test energy to the atrium in the atrial escape interval timed to capture the atrium if the test energy is sufficient to capture the atrium after said atrial escape interval times out;
means for setting a paced A-V delay interval beginning after a PVC blanking period following said atrial test pulse;
means for operating the ventricular sense amplifier during at least the paced A-V delay interval to sense a depolarization of the ventricle;
means for declaring capture of the atrium by the atrial test pacing pulse if a depolarization of the ventricle is sensed in the paced A-V delay interval; and means for declaring loss of capture of the atrium by the atrial test pacing pulse if a depolarization of the ventricle is not sensed in the paced A-V delay interval.

36. In a pacemaker pulse generator having atrial and ventricular pulse generators for generating and applying atrial and ventricular pacing pulses to the atrium and ventricle of the heart separated by an A-V delay interval to evoke stimulated atrial and ventricular depolarizations and capture the atrium and ventricle and a ventricular sense amplifier for sensing natural depolarizations of the ventricle, apparatus for testing for the stimulation threshold energy of the ventricle characterized by:
means for determining the patient's atrial escape interval;
means for operating said atrial pulse generator to deliver an atrial pace pulse at an energy sufficient to capture the atrium after said atrial escape interval times out;
means for setting a test pace A-V delay interval;
means for operating said ventricular pulse generator to deliver a ventricular test stimulus at the end of said test pace A-V delay interval;
means for setting a ventricular sense time window;
means for operating said ventricular sense amplifier during said ventricular sense time window to sense a depolarization of the ventricle;
means for declaring capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is not sensed in the ventricular sense time window; and means for declaring loss of capture of the ventricle by the ventricular test stimulus if a depolarization of the ventricle is sensed in the ventricular sense time window.

37. An apparatus comprising a dual chamber pacemaker pulse generator for attachment with atrial and ventricular sensing and pacing electrodes to an atrial and ventricular chamber of a patient's heart, respectively and having means for detecting capture during that refractory period which follows the delivery of a pacing pulse in one of said chambers by sensing depolarizations of tissue in the other of said chambers and having timing means for excluding sensed depolarizations too close in time to the delivery of a pacing pulse in said one chamber.