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1. (WO1993016756) PACEMAKER A CARACTERISTIQUE D'HYSTERESIS ADAPTABLE
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CARDIAC PACEMAKER WITH HYSTERESIS BEHAVIOR

BACKGROUND OF THE INVENTION

The present invention relates to cardiac pacemakers, and more specifically to a pacemaker having a selectable hysteresis feature which compensates for sinus node
malfunction.
It is well known that natural heart activity, including the depolarization of the sinus node provides optimum hemodynamic performance. Atrial or ventricular stimulations induced by such devices as cardiac pacemakers, generally delay or inhibit natural heart activity by preventing the depolarization of the sinus node.
The hysteresis feature was developed to address this concern, by allowing the pacemaker to follow the sensed sinus node depolarization to a certain predetermined rate below the programmed lower rate of the pacemaker. As such, the escape interval in conventional demand pacemakers equipped with hysteresis feature, is longer than the lower rate interval, for enabling the patient's intrinsic rhythm to control the heart as long as the intrinsic rate is maintained above a predetermined minimum rate. However, in selected patients, these conventional pacemakers do not generally allow the natural heart activity to resume
normally after pacing.
The following patents provide a brief historical background for the development and use of the hysteresis feature as it relates to cardiac pacing technology. U.S. Patent No. 4,856,523, entitled "RATE-RESPONSIVE PACEMAKER WITH AUTOMATIC MODE SWITCHING AND/OR VARIABLE HYSTERESIS RATE," issued to Sholder et al, on August 15, 1989,
describes the inclusion of the hysteresis feature in a rate-responsive pacemaker, in an attempt to prevent competition between the pacemaker and the heart's SA node, when the anterograde conduction path is restored. The Sholder patent proposes to vary the hysteresis rate as a function of the pacemaker sensor rate, to a predetermined level upon sensing of the natural heart contraction during the escape interval, as illustrated in Figure 3B and 4.
U.S. Patent No. 4,363,325 entitled "MODE ADAPTIVE
PACER," issued to Roline et al, on December 14, 1982, and assigned to Medtronic, Inc., discloses a multiple-mode pacer which automatically switches from an atrial synchronous mode to a ventricular inhibited mode when the intrinsic atrial rate drops below a preset hysteresis rate. The Roline patent is incorporated herein by reference.
While the above cited patents and other publications and studies relating to the hysteresis feature have
attempted with varying degrees of success to allow the patient's intrinsic rhythm to control, none was completely successful in causing the natural heart activity to resume optimally after pacing.

SUMMARY OF THE INVENTION

Briefly, the above and further objects and features of the present invention are realized by providing a new and improved pacemaker having a hysteresis feature which permits intrinsic heart activity, controlled by the sinus node to resume optimally after pacing.
The pacemaker has a programmable lower rate and upper rate, a programmable lower hysteresis rate (LRH)
corresponding to a lower rate hysteresis interval (LRHI), and a programmable rate (IR) intermediate an upper pacing rate (UR) and a lower pacing rate (LR). A microprocessor measures the average rate of change in the intervals between consecutive ventricular depolarizations MAVG, and compares the last intrinsic escape (RRN) interval to the lower rate hysteresis interval (LRHI).

If the last intrinsic ventricular interval (RRN) will be longer than the lower rate hysteresis interval (LRHI), and if the value of MAVG is greater than a first preselected value SL1 but less than a second preselected value SL2, the pacemaker stimulates at the lower rate hysteresis (LRH) and thereafter gradually increases the pacing rate up to the intermediate rate (IR) while the pulse generator is in the demand mode. A time counter maintains a continuous pacing at the intermediate rate (IR) for a predefined period of time, and the pacing rate is gradually decreased down to the lower pacing rate (LR).
The accompanying Table I summarizes the features offered by the present invention, and correlates these features to Figures 2A through 6.


BRIEF DESCRIPTION OF THE DRAWINGS

The above and other options, features and advantages of the present invention will be more apparent from the
following more particular description thereof, presented in conjunction with accompanying drawings, wherein:
Figure 1 is a block diagram showing the primary
functional blocks of the pacemaker according to the present invention;
Figures 2A and 2B are flow charts of a simplified software program suitable for use in the pacemaker of Figure

1;
Figure 3 is an illustration of two exemplary generally increasing limit functions SL1 and SL2 which determine the behavior of the pacemaker according to the software program of Figures 2A and 2B;
Figure 4 is a response curve illustrating the variation of the pacing rate according to the present invention;
Figure 5 is another response curve illustrating pacing rate variation according to the present invention; and
Figure 6 is yet another response curve illustrating pacing rate variation according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings and more particularly to Figure 1 thereof, there is illustrated a block diagram of the components of the pacemaker 100 of the present
invention. Block 150 illustrates a microprocessor chip, such as the CDP 1802 microprocessor made by RCA. The microprocessor 150 is connected to a ROM memory 151 and to a RAM memory 152 via a data bus 156. An address bus 154 interconnects the ROM memory 151, the RAM memory 152, and a controller circuit 158. The controller circuit 158, in turn, controls a pacer circuit 161 and a pacemaker output stage 160 for stimulating the heart. The pacemaker 100 could be used for single chamber or dual chamber pacing.
Figures 2A and 2B together illustrate the flow diagram of a program 200 which is stored in the ROM memory 151, and which is run once each cycle in the pacemaker 100.
Alternatively, the program 200 could, be stored in the RAM memory 152. The program 200 does not contain all the steps which are carried out by the microprocessor 150, but it includes those steps that illustrate the operation of the pacemaker 100 according to the present invention. Several variables of the software-controlled operations can be reprogrammed through the RAM memory 152.
Before proceeding with a more detailed explanation of the present invention, it would be helpful to review the following definitions:
"Intrinsic rhythm" or "intrinsic rate" of the heart is the rate at which the heart naturally beats on its own, without being stimulated by a pacemaker-provided stimulus.
"Hysteresis" means extension of the range of rates at which inhibition of the pacemaker pulses will occur. The base pacing interval is increased by the hysteresis
interval. Thus, hysteresis provides a longer escape
interval, thereby giving the heart an opportunity to beat on its own before the pacer provides stimulation pulses.
"Pacing Rate" is the rate at which the stimulation pulses are provided from the heart from the pacemaker.
Starting at step 201, the program 200 is initiated, and the intrinsic ventricular depolarizations are sensed at 202. While the program 200 uses ventricular events for carrying out the invention, it should be understood that atrial events can alternatively be used.
The program 200 measures, at step 204, the intrinsic escape interval, such as the RR interval between two successive sensed ventricular events, and calculates, at step 206, a parameter "D" , as follows:
D = RRi - RRi-1, (1) where RRi is the RR interval which has been recently
measured at step 204; and RRi-1 is the RR interval preceding

RR;. It therefore follows that the parameter D is
indicative of the rate of change of the RR interval.
In this respect, if D were found to have a positive value, it is an indication that the RR interval is
increasing with time, and consequently the intrinsic rate of the heart is dropping. The reverse holds true where D has a negative value, indicating that the RR interval is
decreasing and that the intrinsic rate is increasing.
Additionally, the absolute value of D represents the rate of change of the intervals of the intrinsic ventricular
depolarizations, which is also illustrated by the slope the curve AB in Figures 5 and 6, as it will be described later in greater detail.
If at step 208 the value of D is found to be negative, this value will not be used since it represents an increase in the intrinsic ventricular depolarization rate, and the above subroutine, including steps 202, 204, 206 and step 208, is repeated until a positive value of D is found. The dashed line 207 indicates that if the value of D is found to be negative, then the attending physician will have the option to either cause the software to set n=O, at step 203, or to restart at step 202. The preferred embodiment of the present invention relates principally to precipitous drops in heart rates, and consequently only positive values of D are added and stored at 212 by the random access memory RAM 152.
While the preferred embodiment includes adding only those positive values of D, it will become apparent to those skilled in the art that consecutive D values could
alternatively be added. The feature of selecting between consecutive and positive D values is a programmable feature, and is selectable by the attending physician.
In order to detect and ascertain the occurrence of precipitous heart rate drops, the software 200 calculates the average rate of increase MAVG of a preselected number

"N" of RR intervals. Preferably, MAVG is calculated over a predetermined period of time "T". If during that period T, the value of MAVG is less than a first limit function SL1, then this is an indication that the intrinsic heart rate has not dropped rapidly enough to warrant the use of corrective measures, such as the activation of the hysteresis feature. If on the other hand, the value of MAVG reaches or exceeds the first limit SL1, but is less than a second limit SL2, the pacemaker is instructed to take appropriate measures, as will be described later in greater detail.
To achieve this function, the program 200 stores the calculated positive values of D, at step 212, and counts the number of events "n" indicative of a positive D value. When the count reaches a preprogrammed number "N" of stored beats or reaches the time period T, the program 200 calculates the sum "M" of the N stored values D, as follows:



where j is an integer that varies between 1 and N; and where N is the number of stored beats.
The value of M is then averaged at step 217 over the number of stored beats N, as follows:



In the preferred mode of the present invention the above parameters are assigned the following values:

N = 6 beats.
T = 15 seconds.
It should, however, be understood that different values or ranges of values can alternatively be employed within the scope of the invention.
Digressing from the flow chart of Figure 2A, and turning to Figure 3, there is a shown lower limit function SL1 and an upper limit function SL2 which are identified by the numeral references 10 and 12, and which divide the quadrant into six regions: I, II, III, IV, V and VI. Each one of these regions will now be described in greater detail in relation to Figures 2A through 5. The horizontal
coordinate axis represents time "t", and the vertical coordinate axis represents RR intervals "RRI".
As used in this specification, the LRI and LRHI parameters in the following context:
"LRI" means the Lower Rate Interval which corresponds to the lower pacing rate "LR" of the pacemaker. LR is typically programmed to 70 beats per minute.
"LRHI" means the Lower Rate Hysteresis Interval that corresponds to the lower rate hysteresis "LRH" which is typically programmed to 50 beats per minute.
By comparing the average rate of change MAVG to the programmable limit functions SL1 and SL2, it would be
possible to identify the region which corresponds to the mode of operation of the pacemaker 100. For clarity
purposes, the six regions are defined as follows:
"Region I" is the portion of the quadrant defined by the lower limit function SL1 and by the RRI and time axes. The pacemaker 100 operates in Region I whenever the value of

MAVG is less than SL1; and the last intrinsic ventricular escape interval RRN is shorter than the lower rate
hysteresis interval LRHI. Pacing is inhibited in Region I, as illustrated by the curve KL in Figure 4, and by step 222 of Figure 2A. The curve KL shows the heart rate decreasing at a slow rate.
"Region II" is the portion of the quadrant defined by the limit functions SL1 and SL2, and by the lower rate hysteresis interval LRHI axis. The pacemaker 100 operates in Region II whenever the value of MAVG is greater than SL1, but less than SL2; and the last intrinsic ventricular escape interval RRN is shorter than LRHI. Pacing is inhibited in Region II, as illustrated by the curve AB in Figures 5 and 6, and by step 236 of Figure 2B. The curve AB shows the heart rate decreasing at an intermediate rate.
"Region III" is the portion of the quadrant defined by the upper limit function SL2, by the RRI axis and by the lower rate hysteresis interval LRHI axis. The pacemaker 100 operates in Region III whenever the value of MAVG is greater than SL2; and the last intrinsic escape interval RRN is shorter than LRHI. Pacing is inhibited in Region III, as illustrated by the curve K'L in Figure 4, and by the step

232 of Figure 2B. The curve K'L shows the heart rate decreasing precipitously.
"Region IV" is the portion of the quadrant above the lower rate hysteresis interval LRHI axis, and defined by the

RRI axis and by the upper limit function SL2. The pacemaker

100 operates in Region IV whenever the value of MAVG is greater than SL2; and the last intrinsic escape interval RRN will be longer than LRHI. As illustrated by the curve LPQ in Figure 4, and by the step 230 of figure 2B, pacing is carried out at the lower rate LR. It should however be understood that pacing could alternatively occur at LRH.
"Region V" will be the portion of the quadrant above the lower rate hysteresis interval LRHI axis, between the two limit functions SL1 and SL2. The pacemaker 100 operates in Region V whenever the value of MAVG is less than SL2 but greater than SL1, and the last intrinsic escape interval RRN is longer than LRHI. As illustrated by the curves BCDEF and BB'CDE'R in Figures 5 and 6 respectively, and by steps 238 through 254 of Figure 2B, pacing starts at the lower rate hysteresis rate LRH and gradually increases until the pacing rate reaches an intermediate pacing rate IR. Pacing at IR is maintained for a predetermined period of time, and is thereafter gradually reduced until it reaches the lower rate LR. Pacing is maintained at the lower rate until the intrinsic rate exceeds the pacemaker lower rate, as illustrated by the curve FGH in Figure 5, and the curve RS in Figure 5. The pacemaker operation in Region V is
triggered by an intermediate rate of decrease in the
intrinsic heart rate.
"Region VI" is the portion of the quadrant defined by the lower limit function and by the lower limit function

SL1. The pacemaker 100 operates in Region VI whenever the value of MAVG is less than SL1; and the last intrinsic ventricular escape interval RRN will be longer than the lower rate hysteresis interval LRHI. As illustrated by the curve LPQ in Figure 4, and by the step 224 of Figure 2A, pacing is carried out at the lower rate LR. It should however be understood that pacing could alternatively occur at LRH.
Returning now to Figure 2A, the program 200 compares MAVG to SL1 and step 218. If MAVG is less than SL1, then a further determination is made at step 220 whether the last ventricular intrinsic escape interval RRN is less than or equal to LRHI. If it is, the pacemaker 100 operates in Region I, and pacing is inhibited, as indicated by step 222 in Figure 2A and by the response curve KL in Figure 4.
If the intrinsic escape interval (RRN) is determined at step 220, to be equal to or tend to exceed LRHI, and if there is no sensed event at a shorter interval, while the pacemaker is still in the demand mode, the pacemaker 100 will operate in Region IV, and stimulation is carried out at the lower pacing rate LR, as illustrated by the curve LPQ in

Figure 4. The curves in Figures 4, 5 and 6 which are drawn in dashed lines indicate that pacing is inhibited, while the curves drawn in solid lines indicate that pacing is
occurring.
Returning now to step 218 in the flow chart of Figure

2A, if the program 200 determines that MAVG is greater than or equal to SL1 then a further determination is made at step

226 whether MAVG is less than or equal to SL2. If MAVG is found to be greater than SL2 then the pacemaker 100 will operate in either Region III or Region IV. A further decision is made at step 228 whether the last intrinsic escape interval RRN is less than or equal to the lower rate hysteresis interval (LRHI).
If the program 200 determines that RRN is less than or equal to LRHI then the pacemaker 100 will operate in Region III, and as indicated by step 232 of Figure 2B, and by the curve K'L in Figure 4, pacing will be inhibited. If. on the other hand, it is determined at step 228, that RRN is greater than LRHI, then the pacemaker 100 will operate in

Region IV and as indicated by step 230 of Figure 2B, and by the curve LPQ in Figure 4, pacing is carried out at the lower pacing rate (LR).
The pacemaker 100 identifies and reacts to intermediat drops in the intrinsic heart rate, whenever MAVG is found to be intermediate the limit functions SL1 and SL2, as follows:
SL1 ≤ MAVG ≤ SL2 (4)
In the above condition, the pacemaker is caused to pace at a gradually increasing pacing rate until it reaches a predetermined intermediate pacing rate (IR) which is lower than, or in certain circumstances, equal to, the upper pacing rate (UR). Demand pacing is maintained at the intermediate pacing rate (IR) for a predetermined period of time, and is thereafter reduced gradually.
With reference to Figure 2B, the program 200 determines at step 234 whether the last intrinsic escape interval RRN is less than or equal to LRHI. If it is, then the pacemaker

100 will operate in Region II, and as indicated by step 236, and by the curve AB in Figures 5 and 6, pacing is inhibited.

If however, it is determined at step 234 that RRN will tend to be longer than LRHI, then the condition set forth in equation (6) above is satisfied, and the pacemaker 100 will operate in Region V, and will respond by pacing at the lower rate hysteresis (LRH) for a predetermined period of time or a preset number of beats, as illustrated by the dashed line

BB' in Figure 6, and by step 238 in Figure 2B.
It should however be understood that the pacemaker 100 could alternatively bypass step 238 and start pacing along curve BC (Figure 5), with one paced beat at the lower rate hysteresis (LRH). In this respect, pacing is started at point B (Figure 5) and the pacing rate is incrementally increased until it reaches the intermediate rate (IR). The intermediate rate IR is programmable, and could be changed by the attending physician. The incremental increase in the pacing rate is illustrated by the curves BC in Figures 5 and

6. During this period, the pacemaker 100 is in the
inhibited mode for single chamber pacemakers, or in the DDD mode for dual chamber pacemakers.
The incremental increase of the pacing rate is achieved by steps 240 through 244, whereby the value of the pacing rate is incrementally increased by a value X (step 240), and a determination is made at step 242 whether the pacing rate is less than or equal to IR. Once IR is reached, then, as indicated by step 244, a time counter is set to maintain the continuous pacing at that intermediate rate (IR) for a preselected programmable period of time, such as for five minutes. This continuous pacing at the intermediate rate is illustrated by curve CD in Figures 5 and 6. If during the execution of the subroutine 244 through 248, an intrinsic rhythm is sensed at 245, then the intrinsic rate prevails, and pacing is inhibited.
Once the counter time lapses, then, as illustrated by the curves DE and DE' in Figure 5 and 6 respectively, the pacing rate is gradually decreased from the intermediate pacing rate (IR), toward the lower pacing rate (LR). This decrement is achieved by the subroutine 250 - 252, where the pacing rate is decreased by an incremental value Y until the pacing rate reaches the lower rate LR.
If decremental pacing is maintained until it reaches the lower rate LR, the pacemaker 100 starts pacing at that lower rate, as illustrated by the curve EF in Figure 5, and the routine 200 is repeated. If an intrinsic rhythm is sensed at any time during the decremental change (curve DE') in the pacing rate, then the intrinsic rate prevails, and pacing is inhibited, as illustrated by the curve E'RS in Figure 6. The subroutine 200 is thereafter repeated.
It is therefore clear that the new approach described in the present invention teaches away from the conventional hysteresis response feature. In the present invention, whenever an intermediate drop in the heart rate occurs and the hysteresis feature is activated, the natural heart rate resumes and is tracked until it reaches the hysteresis rate. Thereafter, the pacing rate is increased until the
intermediate rate (IR) is reached. Pacing at that
intermediate rate is maintained for a predetermined period of time, and thereafter allowed to gradually decay toward the lower rate.
It should become apparent to those skilled in the art after reviewing the present description, that the present invention can be made an integral part of single chamber and dual chamber pacemakers which operate in one or more of the programmed modes: SSI, SSIR, DDD, DDDR, DVI, DVIR, DDI and/or DDIR. The present hysteresis feature can be applied to the atrial and/or ventricular channels of a dual chamber pacemaker.
While the following ranges reflect exemplary values of

IR, LR, UR, LRH, SL1 and SL2, it should be understood to those skilled in the art that other values and ranges can also be employed and/or programmed.

100 bpm ≤ UR ≤ 150 bpm.
80 bpm ≤ IR ≤ 100 bpm.
60 bpm ≤ LR ≤ 80 bpm.
40 bpm ≤ LRH ≤ 60 bpm.
2 % ≤ SL1 ≤ 10 %.
5 % ≤ SL2 ≤ 20 %.
4 beats ≤ N ≤ 16 beats

While particular embodiments of the present invention have been disclosed, it is to be understood that various different modifications are possible and are contemplated within the scope and spirit of the specification, drawings, abstract, and appended claims.