# US 5,702,424 A · Method and apparatus for controlling the change of an escape interval in an active implantable medical device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,702,424 A - Document ID: US5702424A - Status: Granted - Kind: A - Application number: 08/657,802 - Filed: 1996-05-31 - Granted: 1997-12-30 - Earliest claimed: 1995-05-31 - Assignees: ELA Medical S.A. - Inventors: Thierry Legay; Jean-Luc Bonnet; Laurence Geroux - Web page: https://patentgrep.com/patent/US5702424A ## CPC - A61N 1/365: controlled by a physiological parameter, e.g. heart potential {(evoked response A61N1/371)} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract An active implantable medical device, notably a cardiac pacemaker or fibrillator, which detects the instantaneous cardiac rhythm, spontaneous or stimulated, of the bearer of the device, and delivers stimulation pulses with a variable escape interval and which increases gradually this escape interval. The gradual increase of the escape interval is obtained by memorizing information corresponding to the evolution of the cardiac rhythm sensed by a conventional detection circuit over a first time period, wherein the escape interval to be adjusted is later in time to the memorized information, notably by determining a variable rate of increase of the escape interval, which variable rate is essentially determined as a function of the memorized information, and/or by operating an integration of the previously detected cardiac rhythm. ## Claims ### Claim 1 An active implantable medical device to be borne by a patient comprising: means for detecting an instantaneous cardiac rhythm of the patient, means for delivering stimulation pulses having an escape interval (EIn) between successive delivered stimulation pulses, and means for gradually increasing said escape interval comprising means for memorizing information corresponding to a plurality of successive detected instantaneous cardiac rhythms, wherein the gradually increasing means is operated to increase a given escape interval by a variable amount that is a first function of previously memorized information of the detected cardiac rhythm. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the gradually increasing means further comprises means for determining a rate of increase of the escape interval (RATEdec) as a second function of said memorized information, wherein the first function further operates on said determined rate of increase RATEdec. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the first function of the gradually increasing means is an integration of the previously memorized information of the detected cardiac rhythm. ### Claim 4 (depends on 1) The apparatus of claim 1, further comprising means for determining a state (Ind) of increase or decrease of the escape interval, and means for determining a rate of increase of said gradually increasing means, wherein the gradually increasing means, in response to a detected decrease state, is operated to apply the determined rate of increase to increase said escape interval and, in response to a detected increase state, is maintained at the value previously applied. ### Claim 5 An active implantable medical device to be borne by a patient comprising: means for detecting an instantaneous cardiac rhythm of the patient, means for delivering stimulation pulses having an escape interval (EIn) between successive delivered stimulation pulses, means for gradually increasing said escape interval comprising means for memorizing information corresponding to an evolution of said cardiac rhythm detected by said detecting means, wherein the gradually increasing means is operated to increase a given escape interval by a variable amount that is a first function of previously memorized information of the detected cardiac rhythm, and means for determining a rate of increase of the escape interval (RATEdec) as a second function of said memorized information, wherein the first function further operates on said determined rate of increase RATEdec. ### Claim 6 An active implantable medical device to be borne by a patient comprising: means for detecting an instantaneous cardiac rhythm of the patient, means for delivering stimulation pulses having an escape interval (EIn) between successive delivered stimulation pulses, and means for gradually increasing said escape interval comprising means for memorizing information corresponding to an evolution of said cardiac rhythm detected by said detecting means, wherein the gradually increasing means is operated to increase a given escape interval as by a variable amount that is an integration of the previously memorized information of the detected cardiac rhythm. ### Claim 7 (depends on 6) The apparatus of claim 6, further comprising a counter having a count value (CTR) and a means for determining a rate of increase of the escape interval (RATEdec), wherein the gradually increasing means operates to increase or decrease the count value CTR in response to the detected cardiac rhythm, and wherein the rate determining means determines the rate of increase (RATEdec) according to the count value (CTR), and wherein the first function further operates on said determined rate of increase RATEdec. ### Claim 8 (depends on 7) The apparatus of claim 7, wherein the rate of increase RATEdec varies inversely to the count value CTR. ### Claim 9 (depends on 7) The apparatus of claim 7, wherein the rate determining means further comprises a plurality of ranges of values, each range corresponding to a preselected rate of increase, and means for comparing the counter count value to said plurality of ranges to select a rate of increase corresponding to the count value CTR. ### Claim 10 (depends on 7) The apparatus of claim 7 further comprising a means for calculating a final escape interval value (EIf), wherein the counter count values range between a minimal limit and a maximal limit, and wherein the maximal limit is a variable that is a function of said calculated final escape interval value (EIf). ### Claim 11 (depends on 7) The apparatus of claim 7 further comprising a means for calculating a final escape interval value (EIf), further comprising means for the counter in which of incrementing the counter in which the speed of incrementing varies according to the calculated final escape interval value (EIf). ### Claim 12 (depends on 8) The apparatus of claim 8, wherein the speed determining means further compromises a multiplier factor variable (Macc) having a value according to the calculated final interval escape value (EIf). ### Claim 13 (depends on 7) The apparatus of claim 7, further comprising means for determining a speed of incrementing the counter in which the speed of incrementing varies according to the value of the escape interval determined for the preceding cardiac cycle. ### Claim 14 (depends on 13) The apparatus of claim 13, further comprising means for calculating a final escape interval value (EIf), wherein the speed determining means further comprises a multiplier factor variable (Mdec) having a value according to the calculated final escape interval value (EIf). ### Claim 15 An active implantable medical device to be borne by a patient comprising: means for detecting an instantaneous cardiac rhythm of the patient, means for delivering stimulation pulses having an escape interval (EIn) between successive delivered stimulation, pulses, and means for gradually increasing said escape interval comprising means for memorizing information corresponding to an evolution of said cardiac rhythm detected by said detecting means, wherein the gradually increasing means is operated to increase a given escape interval as a first function of previously memorized information of the detected cardiac rhythm, means for determining a state (Ind) of increase or decrease of the escape interval, and means for determining a rate of increase of said gradually increasing means, wherein the gradually increasing means, in response to a detected decrease state, is operated to apply the determined rate of increase to increase said escape interval and, in response to a detected increase state, is maintained at the value previously applied. ### Claim 16 A method of controlling the escape interval of a cardiac stimulation device comprising: (a) providing a base escape interval for stimulating a heart at a basic cardiac rhythm; (b) monitoring cardiac electrical activity including spontaneous and stimulated cardiac events; (c) determining an escape interval for a cardiac stimulation in the absence of a spontaneous cardiac event; (d) determining whether the determined escape interval corresponds to an increasing cardiac rhythm or a decreasing cardiac rhythm; and (e) in response to a determined increasing cardiac rhythm: (i) recording a history of the increase of the cardiac rhythm, and (ii) determining a rate of increase of an escape interval as a function of the recorded history; and (f) in response to a determined decreasing cardiac rhythm: (i) applying the rate of increase determined during a determined increasing cardiac rhythm preceding said determined decreasing cardiac rhythm to increase gradually the determined escape interval to the base escape interval, and (ii) using the increased escape interval in said device. ### Claim 17 (depends on 16) The method of claim 16 wherein step (e) further comprises using said determined escape interval in the device during said determined increasing cardiac rhythm. ### Claim 18 (depends on 16) The method of claim 16 wherein step (c) further comprises determining said escape interval in response to the detected cardiac electrical activity. ### Claim 19 (depends on 18) The method of claim 18 wherein step (c) further comprises monitoring a physiological parameter indicative of a patient's cardiac output requirements, determining a rate responsive escape interval as a function of said monitored physiological parameter, and determining the escape interval as a function of the determined rate responsive escape interval and the detected cardiac electrical activity. ### Claim 20 (depends on 19) The method of claim 19 wherein step (c) further comprises smoothing the determined escape interval according to a predetermined slope. ### Claim 21 (depends on 16) The method of claim 16 wherein step (c) further comprises monitoring a physiological parameter indicative of a patient's cardiac output requirements, and determining said escape interval as a function of said monitored physiological parameter. ### Claim 22 (depends on 16) The method of claim 16 wherein step (c) further comprises selecting an escape interval according to one of a plurality of algorithms for determining an escape interval. ### Claim 23 (depends on 16) The method of claim 16 wherein step (d) further comprises: comparing a last determined escape interval and a previously determined escape interval; declaring that the cardiac rhythm is increasing in response to the previously determined escape interval being larger than the last determined escape interval; and declaring that the cardiac rhythm is decreasing in response to the last determined escape interval bing larger than the preceding determined escape interval. ### Claim 24 (depends on 23) The method of claim 23 further comprising performing step (d) every n cardiac cycles, wherein n is an integer selected from between 2 and 16. ### Claim 25 (depends on 16) The method of claim 16 wherein step (d) further comprises: (i) comparing a last determined escape interval to a previously determined escape interval and the base escape interval; (ii) suspecting an increasing cardiac rhythm in response to one of the last determined escape interval being less than or equal to the preceding determined escape interval and the last determined escape interval being less than the base escape interval; (iii) in response to a suspected increasing cardiac rhythm, confirming that the suspected increasing cardiac rhythm is increasing; (iv) suspecting a decreasing cardiac rhythm in response to one of the last determined escape interval being greater than the preceding determined escape interval and the last determined escape interval being greater than or equal to the base escape interval; and (v) in response to a suspected decreasing cardiac rhythm, confirming that the suspected decreasing cardiac rhythm is decreasing. ### Claim 26 (depends on 25) The method of claim 25 wherein step (e) does not respond to the suspected increasing cardiac rhythm that is not confirmed, and wherein step (f) does not respond to the suspected decreasing cardiac rhythm that is not confirmed. ### Claim 27 (depends on 25) The method of claim 25, wherein step (d) further comprises: providing a first hysteresis amount and a second hysteresis amount; (g) maintaining an indicator having a first state corresponding to a confirmed increasing cardiac rhythm and a second state corresponding to a confirmed decreasing cardiac rhythm; wherein step (d) (iii) further comprises determining one of the indicator being in the first state, a difference between the last determined escape interval and the preceding determined escape interval decreased by the first hysteresis amount being greater than the first hysteresis amount, and the occurrence of at least a preselected number of successive attempts to confirm a suspected increasing cardiac rhythm; and wherein step (d) (v) further comprises determining one of the indicator being in the second state, a difference between the last determined escape interval and the preceding determined escape interval increased by the second hysteresis amount being greater than the second hysteresis amount, and the occurrence of at least a preselected number of successive attempts to confirm a suspected decreasing cardiac rhythm. ### Claim 28 (depends on 27) The method of claim 27 wherein step (g) (iii) further comprises setting the indicator to the first state in response to a confirmed increasing cardiac rhythm and wherein step (g) (v) further comprises setting the indicator to the second state in response to a confirmed decreasing cardiac rhythm. ### Claim 29 (depends on 16) The method of claim 16 wherein: step (e) (i) further comprises providing a counter having a count value and incrementing the counter value in response to a determined escape interval corresponding to a determined increasing cardiac rhythm; and step (e)(ii) further comprises selecting the rate of increase as a function of the incremented counter count. ### Claim 30 (depends on 29) The method of claim 29 wherein step (f) further comprises (iii) decreasing the counter count value in response to a determined escape interval corresponding to a determined decreasing cardiac rhythm. ### Claim 31 (depends on 16) The method of claim 16 wherein step (e)(i) further comprises: providing a counter having a count value, a lower count limit, an upper count limit, and a count threshold between the upper and lower count limits, and incrementing the counter count by a first value in response to a determined escape interval corresponding to an increasing cardiac rhythm and the count value being less than said count threshold; incrementing the counter count by a second value in response to a determined escape interval corresponding to an increasing cardiac rhythm and the count value being greater than said count threshold, the count value being limited to a maximum of the upper count limit, the second value being greater than the first value; and step (e) (ii) further comprises selecting the rate of increase as a function of the incremented counter count. ### Claim 32 (depends on 31) The method of claim 31 wherein step (f) further comprises (iii) decreasing the counter count value by a third value in response to a determined escape interval corresponding to a determined decreasing cardiac rhythm and the count value being greater than the count threshold, and decreasing the counter count value by a fourth value in response to a determined escape interval corresponding to the base cardiac interval, the count value be limited to a minimum of the lower count limit, the fourth value being greater than the third value. ### Claim 33 (depends on 32) The method of claim 32 wherein step (e) (ii) further comprises: providing a plurality of ranges of count values between said upper and lower limits; associating with each one of said plurality of ranges a rate of increase; determining the one range of count values including the incremented count value; and selecting the one rate of decrease associated with the one range. ### Claim 34 (depends on 31) The method of claim 31 wherein step (e) (ii) further comprises: providing a plurality of ranges of count values between said upper and lower limits; associating with each one of said plurality of ranges a preselected rate of increase; determining the one range of count values including the incremented count value; and selecting the one preselected rate of increase associated with the one determined range. ### Claim 35 (depends on 34) The method of claim 34 further comprising selected each preselected rate of increase to have a magnitude in a range of from between a maximum rate and a minimum rate, the magnitude range of the selected preselected rates being inversely related to the magnitude of the counter count. ### Claim 36 (depends on 31) The method of claim 31 further comprising providing the second value as a multiple of the first value, and providing the fourth value and a multiple of the third value. ### Claim 37 (depends on 31) The method of claim 31 further comprising: determining a multiplier as a function of the determined escape interval; and providing the second value as a function of the first value and the determined multiplier. ### Claim 38 (depends on 31) The method of claim 31 further comprising: determining a multiplier as a function of the determined escape interval; and providing the fourth value as a function of the third value and the determined multiplier. ### Claim 39 (depends on 31) The method of claim 31 further comprising providing the counter upper limit as a variable function of the determined escape interval. ### Claim 40 (depends on 16) The method of claim 16 wherein step (e) (i) further comprises integrating the detected cardiac rhythm corresponding to the detected escape interval.