US5372607A — Method and apparatus for monitoring pacemaker int…

Claim 1

Independent Claim 292 words

A rate-responsive pacemaker system, comprising an implantable pulse generator unit and an external programming unit, wherein said implantable pulse generator unit comprises: pulse generator means for generating pacing pulses; sensing circuitry means for detecting electrical cardiac signals; sensor means for producing a sensor output signal reflecting a patient's metabolic demand for oxygenated blood; control means for controlling the rate of delivery of pacing pulses by said pulse generator means in accordance with said sensor output signal and further comprising means for inhibiting delivery of pacing pulses in the presence of normal electrical cardiac signals; memory means for storing numeric data; processing means coupled to said control means and to said memory means, for computing and storing in said memory means, data reflecting percentages of paced cardiac events occurring during each one of a succession of predefined intervals, and further comprising means for storing in said memory means, data reflecting said sensor output signal during each one of said succession of predefined intervals, data reflecting heart rate during each one of said succession of predefined intervals, and data reflecting AV interval durations of each one of a succession of cardiac cycles; first telemetry circuit means, coupled to said memory means and to said control means, responsive to an interrogate signal from said external programming unit for transmitting said percentage of paced events data, said sensor output signal data, said heart rate data, and said AV interval data to said external programming unit; and wherein said external programming unit comprises: a second telemetry circuit means for sending said interrogate signal and for receiving said data transmitted by said first telemetry circuit means and; means for displaying said percentage of paced events data, said heart rate data, sensor signal data, and said AV interval data.

Claim 2

Dependent Claim 292 words

A rate-responsive pacemaker system, comprising an implantable pulse generator unit and an external programming unit, wherein said implantable pulse generator unit comprises: pulse generator means for generating pacing pulses; sensing circuitry means for detecting electrical cardiac signals; sensor means for producing a sensor output signal reflecting a patient's metabolic demand for oxygenated blood; control means for controlling the rate of delivery of pacing pulses by said pulse generator means in accordance with said sensor output signal and further comprising means for inhibiting delivery of pacing pulses in the presence of normal electrical cardiac signals; memory means for storing numeric data; processing means coupled to said control means and to said memory means, for computing and storing in said memory means, data reflecting percentages of paced cardiac events occurring during each one of a succession of predefined intervals, and further comprising means for storing in said memory means, data reflecting said sensor output signal during each one of said succession of predefined intervals, data reflecting heart rate during each one of said succession of predefined intervals, and data reflecting AV interval durations of each one of a succession of cardiac cycles; first telemetry circuit means, coupled to said memory means and to said control means, responsive to an interrogate signal from said external programming unit for transmitting said percentage of paced events data, said sensor output signal data, said heart rate data, and said AV interval data to said external programming unit; and wherein said external programming unit comprises: a second telemetry circuit means for sending said interrogate signal and for receiving said data transmitted by said first telemetry circuit means and; means for displaying said percentage of paced events data, said heart rate data, sensor signal data, and said AV interval data.

Claim 3

Dependent Claim 69 words

A pacemaker system in accordance with claim 1, wherein said sensing circuitry means comprises means for sensing atrial electrical signals, and wherein said pulse generator means comprises means for generating ventricular pacing pulses, and wherein said control means comprises means responsive to a sensed atrial signal for triggering generation of a ventricular pacing pulse after a defined AV interval which varies as a function of said sensor output signal.

Claim 4

Dependent Claim 32 words

A pacemaker system in accordance with claim 1, wherein said control means comprises means for selecting from among a plurality of predefined functions relating said sensor output signal to said pacing rate.

Claim 5

Dependent Claim 26 words

A pacemaker system in accordance with claim 1, wherein said processing means comprises means for storing a bin number corresponding to a range of heart rates.

Claim 6

Dependent Claim 26 words

A pacemaker system in accordance with claim 4, wherein said processing means comprises means for storing a percent paced value corresponding to a range of percentages.

Claim 7

Dependent Claim 94 words

A pacemaker system in accordance with claim 5, wherein said display means comprises means for displaying said percentage of paced events data and said heart rate data in the form of a horizontal succession of boxes, where each box corresponds to a separate one of said succession of predefined time intervals and where each box's vertical position on said display screen corresponds to said bin number for the predefined interval corresponding to said box, and where each box is shaded according to said percent paced value for the predefined interval corresponding to said box.

Claim 8

Dependent Claim 97 words

A pacemaker system in accordance with claim 1, wherein said display means comprises means for displaying said percentage of paced events data and said heart rate data in the form of a horizontal succession of boxes, where each box corresponds to a separate one of said succession of predefined time intervals and where each box's vertical position on said display screen corresponds to said heart rate data for the predefined interval corresponding to said box, and where each box is shaded according to said percentage of paced events data for the predefined interval corresponding to said box.

Claim 9

Dependent Claim 40 words

A pacemaker system in accordance with claim 1, said processing means further comprises means for storing in conjunction with said AV interval data for each cardiac cycle an identification of whether an atrial pacing pulse was delivered for said cycle.

Claim 10

Dependent Claim 75 words

A pacemaker system in accordance with claim 1, wherein said sensing means comprises means for detecting atrial signals, and wherein said pulse generator means comprises means for generating ventricular pacing pulses, and wherein said control means further comprises means for triggering generation of ventricular pacing pulses after a defined AV interval has elapsed following detection of an atrial signal, means responsive to said sensor output signal for varying said defined AV interval in accordance therewith.

Claim 11

Independent Claim 263 words

A method of monitoring and pacing a patient's heart comprising the steps of: (a) sensing electrical cardiac signals of said patient's heart; (b) producing an activity signal reflecting said patient's metabolic demand for oxygenated blood; (c) delivering pacing pulses to said patient's heart at a base pacing rate when no electrical cardiac signals are sensed in step (a) above; (d) determining said base pacing rate in accordance with a first function of said activity signal; (e) inhibiting delivery of pacing pulses when normal electrical cardiac signals are sensed; (f) defining a succession of intervals during a brief patient exercise; (g) after each one of said succession of intervals, storing data reflecting percentages of paced cardiac events occurring during each said one of said succession of intervals; (h) after each one of said succession of intervals, storing data reflecting said activity signal during each said one of said succession of intervals; (i) during each one of said succession of intervals, measuring the duration of at least one cardiac cycle during said each one interval; (j) after each one of said succession of intervals, storing heart rate data reflecting said duration of at least one cardiac cycle measured in step (i) above; (k) during said succession of intervals, timing the duration of an AV interval of each cardiac cycle; (l) after each cardiac cycle during said succession of intervals, storing data reflecting said AV interval duration of said cardiac cycle; (m) after said succession of intervals displaying said percentage of paced events data, said heart rate data, sensor signal data, and said AV interval data.

Claim 12

Independent Claim 263 words

A method of monitoring and pacing a patient's heart comprising the steps of: (a) sensing electrical cardiac signals of said patient's heart; (b) producing an activity signal reflecting said patient's metabolic demand for oxygenated blood; (c) delivering pacing pulses to said patient's heart at a base pacing rate when no electrical cardiac signals are sensed in step (a) above; (d) determining said base pacing rate in accordance with a first function of said activity signal; (e) inhibiting delivery of pacing pulses when normal electrical cardiac signals are sensed; (f) defining a succession of intervals during a brief patient exercise; (g) after each one of said succession of intervals, storing data reflecting percentages of paced cardiac events occurring during each said one of said succession of intervals; (h) after each one of said succession of intervals, storing data reflecting said activity signal during each said one of said succession of intervals; (i) during each one of said succession of intervals, measuring the duration of at least one cardiac cycle during said each one interval; (j) after each one of said succession of intervals, storing heart rate data reflecting said duration of at least one cardiac cycle measured in step (i) above; (k) during said succession of intervals, timing the duration of an AV interval of each cardiac cycle; (l) after each cardiac cycle during said succession of intervals, storing data reflecting said AV interval duration of said cardiac cycle; (m) after said succession of intervals displaying said percentage of paced events data, said heart rate data, sensor signal data, and said AV interval data.

Claim 13

Dependent Claim 66 words

A method in accordance with claim 10, wherein said step (a) of sensing electrical cardiac signals comprises sensing atrial electrical signals and wherein said method further comprises the steps of: (o) delivering a ventricular pacing pulse following a defined AV interval initiated after sensing an atrial signal; and (p) varying said defined AV interval of step (o) above as a second function of said activity signal.

Claim 14

Dependent Claim 110 words

A method in accordance with claim 11, further comprising the steps of: (r) periodically increasing said defined AV interval to a high value; (s) detecting whether an ventricular signal occurs following a sensed atrial signal; (t) when ventricular signal is found to occur in step (s), storing AV interval data reflecting time between said sensed atrial signal and said ventricular signal; (u) storing, along with said AV interval data in step (t), data reflecting said patient's current activity level; (v) repeating steps (r) through (u) above for different current activity levels; (w) programming said second function in accordance with said stored activity level data and said stored AV interval data.

Claim 15

Dependent Claim 28 words

A method in accordance with claim 10, further comprising the step of: (q) selecting said first function of said activity signal from among a plurality of predefined functions.

Claim 16

Dependent Claim 45 words

A method in accordance with claim 10, wherein said step (j) of storing heart rate data comprises the steps of selecting a bin number corresponding to a range of heart rates, as a function of said measured cardiac cycle duration, and storing said bin number.

Claim 17

Dependent Claim 33 words

A method in accordance with claim 14, wherein said step (g) of storing percentage of paced events data comprises the sub-step of computing a percent paced value corresponding to a range of percentages.

Claim 18

Dependent Claim 39 words

A method in accordance with claim 10, wherein said step (l) of storing AV interval data for each cardiac cycle includes the step of storing an identification of whether an atrial pacing pulse was delivered for each said cycle.

Claim 19

Dependent Claim 24 words

A method in accordance with claim 10, wherein said step (e) of defining a succession of intervals comprises defining a succession of two-second intervals.

Claim 20

Dependent Claim 24 words

A method in accordance with claim 10, wherein said step (e) of defining a succession of intervals comprises defining a succession of four-second intervals.

Claim 21

Independent Claim 189 words

A method of monitoring and pacing a patient's heart, comprising the steps of: (a) causing said patient to engage in an exercise during an exercise period; (b) defining a plurality of successive time intervals during said exercise period; (c) after each one of said plurality of time intervals, recording heart rate data reflecting said patient's heart rate during said time interval; (d) after each one of said plurality of time intervals, recording percent paced data reflecting a percentage of paced events during said time interval; (e) after each one of said plurality of time intervals, recording activity data reflecting a level of patient activity during said time interval; (f) after each cardiac cycle during said exercise period, recording AV interval data reflecting a duration of an AV interval of said cardiac cycle; (g) after each cardiac cycle during said exercise period, recording pace/sense data reflecting whether an atrial stimulating pulse was delivered during said cardiac cycle; (h) after said exercise period, simultaneously displaying said heart rate data, said percent paced data, and activity data; and (i) after said exercise period, displaying said AV interval data and said pace/sense data.

Claim 22

Independent Claim 189 words

A method of monitoring and pacing a patient's heart, comprising the steps of: (a) causing said patient to engage in an exercise during an exercise period; (b) defining a plurality of successive time intervals during said exercise period; (c) after each one of said plurality of time intervals, recording heart rate data reflecting said patient's heart rate during said time interval; (d) after each one of said plurality of time intervals, recording percent paced data reflecting a percentage of paced events during said time interval; (e) after each one of said plurality of time intervals, recording activity data reflecting a level of patient activity during said time interval; (f) after each cardiac cycle during said exercise period, recording AV interval data reflecting a duration of an AV interval of said cardiac cycle; (g) after each cardiac cycle during said exercise period, recording pace/sense data reflecting whether an atrial stimulating pulse was delivered during said cardiac cycle; (h) after said exercise period, simultaneously displaying said heart rate data, said percent paced data, and activity data; and (i) after said exercise period, displaying said AV interval data and said pace/sense data.

Claim 23

Dependent Claim 191 words

A pacemaker system, comprising an implantable pacemaker and an external monitoring unit; wherein said implantable pacemaker comprises: pulse generator means for generating pacing pulses at a pacing rate; sensing means for sensing atrial and ventricular signals; control means, coupled to said pulse generator means, for controlling said pacing rate; memory means for storing numeric data; computing means coupled to said sensing means, said control means and to said memory means, for simultaneously computing and storing in said memory means, data reflecting a patient's heart rate and data reflecting AV interval durations of each one of a succession of cardiac cycles; and a first telemetry circuit, coupled to said memory means and to said control circuit, said first telemetry circuit comprising means responsive to an interrogate signal from said external programming unit, for transmitting said heart rate data and said AV interval data to said external programming unit; and wherein said external monitoring unit comprises: a second telemetry circuit comprising means for sending said interrogate signal and means for receiving said data transmitted by said first telemetry transmitter circuit; and means for displaying said heart rate data versus said AV interval data.

Claim 24

Dependent Claim 191 words

A pacemaker system, comprising an implantable pacemaker and an external monitoring unit; wherein said implantable pacemaker comprises: pulse generator means for generating pacing pulses at a pacing rate; sensing means for sensing atrial and ventricular signals; control means, coupled to said pulse generator means, for controlling said pacing rate; memory means for storing numeric data; computing means coupled to said sensing means, said control means and to said memory means, for simultaneously computing and storing in said memory means, data reflecting a patient's heart rate and data reflecting AV interval durations of each one of a succession of cardiac cycles; and a first telemetry circuit, coupled to said memory means and to said control circuit, said first telemetry circuit comprising means responsive to an interrogate signal from said external programming unit, for transmitting said heart rate data and said AV interval data to said external programming unit; and wherein said external monitoring unit comprises: a second telemetry circuit comprising means for sending said interrogate signal and means for receiving said data transmitted by said first telemetry transmitter circuit; and means for displaying said heart rate data versus said AV interval data.

Claim 25

Dependent Claim 49 words

A pacemaker system in accordance with claim 20, further comprising: sensor means, coupled to said control means, for producing an output signal reflecting a patient's metabolic demand for oxygenated blood; and wherein said control means comprises means for varying said pacing rate as a function of said output signal.

Claim 26

Dependent Claim 40 words

A pacemaker system in accordance with claim 21, wherein said control means comprises means responsive to a sensed atrial signal for delivering a ventricular pacing pulse after a defined AV interval which varies as a function of said output signal.

Claim 27

Dependent Claim 37 words

A pacemaker system in accordance with claim 20, wherein said computing means comprises means for selecting a bin number corresponding to a range of heart rates and means for storing said bin number in said memory means.

Claim 28

Dependent Claim 48 words

A pacemaker system in accordance with claim 20, wherein said pulse generator means comprises means for generating atrial pacing pulses and wherein said computing means comprises means for storing in said memory means an indication of whether an atrial pacing pulse was delivered, in each said cardiac cycle.

Claim 29

Dependent Claim 48 words

A pacemaker system in accordance with claim 20, wherein said pulse generator means comprises means for generating ventricular pacing pulses and wherein said computing means comprises means for storing in said memory means an indication of whether a ventricular pacing pulse was delivered, in each said cardiac cycle.

Claim 30

Dependent Claim 34 words

A pacemaker system in accordance with claim 20, wherein said computing means comprises means for storing in said memory means an indication of whether an atrial signal was sensed, in each said cardiac cycle.

Claim 31

Dependent Claim 34 words

A pacemaker system in accordance with claim 20, wherein said computing means comprises means for storing in said memory means an indication of whether a ventricular signal was sensed, in each said cardiac cycle.

Claim 32

Independent Claim 144 words

A method of monitoring and pacing a patient's heart, said method comprising the steps of: implanting a pacemaker having the capability to sense atrial and ventricular signals and to deliver pacing pulses, in said patient; causing said patient to engage in an exercise during an exercise period; defining a plurality of successive time intervals during said exercise period; after each one of said plurality of time intervals, recording activity data reflecting a level of patient activity during said time interval; after each cardiac cycle during said exercise period, recording AV interval data reflecting a duration of an AV interval of each said cardiac cycle; after each cardiac cycle during said exercise period, recording pace/sense data reflecting whether a stimulating pulse was delivered during said cardiac cycle; and after said exercise period, simultaneously displaying said activity data, said AV interval data and said pace/sense data.

Claim 33

Independent Claim 144 words

A method of monitoring and pacing a patient's heart, said method comprising the steps of: implanting a pacemaker having the capability to sense atrial and ventricular signals and to deliver pacing pulses, in said patient; causing said patient to engage in an exercise during an exercise period; defining a plurality of successive time intervals during said exercise period; after each one of said plurality of time intervals, recording activity data reflecting a level of patient activity during said time interval; after each cardiac cycle during said exercise period, recording AV interval data reflecting a duration of an AV interval of each said cardiac cycle; after each cardiac cycle during said exercise period, recording pace/sense data reflecting whether a stimulating pulse was delivered during said cardiac cycle; and after said exercise period, simultaneously displaying said activity data, said AV interval data and said pace/sense data.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1997-12-12	1998-06-13	1998-12-13	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2001-12-12	2002-06-13	2002-12-13	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2005-12-12	2006-06-13	2006-12-13	$7700.00	Window Closed / Lapsed

Method and apparatus for monitoring pacemaker intervals

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