Method and system for determining and automatically adjusting the sensor parameters of a rate-responsive pacemaker
First Claim
1. A rate-responsive pacing system comprising:
- (1) an implantable rate-responsive pacemaker including;
(a) sensing means for sensing natural contractions of a heart,(b) stimulation means for generating stimulation pulses for delivery to the heart at a prescribed pacing rate in the absence of sensed natural contractions,(c) physiological sensor means for sensing a physiological parameter and generating a sensor indicated rate (SIR) signal as a function thereof,(d) control means for defining said prescribed pacing rate as a selected one of either a programmed pacing rate value or said SIR signal, and(e) counting means for counting and storing each occurrence of said SIR signal that falls within one of a plurality of rate ranges, whereby SIR histogram data is collected within said rate-responsive pacemaker; and
(2) an external programming device having;
(a) telemetry means for establishing an RF telemetry link with said implantable pacemaker through which said SIR histogram data may be retrieved,(b) distinguishing means for identifying which of a plurality of different pacemaker models said implantable pacemaker is,(c) programming means for selected control data into said rate-responsive pacemaker through said RF telemetry link, said control data including said programmed value of said pacing rate, an indication of whether the programmed value or the SIR signal is to be used to define said pacing rate, and a set of SIR control parameters that define the manner in which said SIR signal is generated from the physiological parameter sensed by said physiological sensor means, and(d) processing means for processing said SIR histogram data so as to produce a recommended set of SIR control parameters for programming into said rate-responsive pacemaker.
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Accused Products
Abstract
A rate-responsive pacing system and method allows the inter-related sensor operating parameters associated with the physiological sensor of a rate-responsive pacemaker to be automatically and/or optimally set for a particular patient. The system includes both a pacemaker and an external programming device. The pacemaker includes appropriate memory circuits for recording a sensor indicated rate (SIR) signal in a histogram. The external programming device retrieves the SIR histogram data, as well as other data associated with the operation of the pacemaker, and selectively processes and displays such data in a prescribed manner. An Auto-Set sequence or routine, carried out by the external programming device, sets all of the rate-responsive operating parameters to a known initial value and places the pacemaker in a passive mode. In the passive mode the SIR signal does not control the pacing rate. The Auto-Set routine then displays instructions for the physician that cause diagnostic data to be collected. Such instructions effectively cause the pacemaker to be subjected to a known or predictable load. The Auto-Set routine then computes appropriate rate-responsive operating parameters that may be displayed for consideration by the physician, and/or that are automatically programmed into the pacemaker. The Auto-Set routine thus provides a method for automatically setting the programmable sensor parameters of the rate-responsive pacemaker based on a simple programming sequence performed by a physician.
245 Citations
22 Claims
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1. A rate-responsive pacing system comprising:
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(1) an implantable rate-responsive pacemaker including; (a) sensing means for sensing natural contractions of a heart, (b) stimulation means for generating stimulation pulses for delivery to the heart at a prescribed pacing rate in the absence of sensed natural contractions, (c) physiological sensor means for sensing a physiological parameter and generating a sensor indicated rate (SIR) signal as a function thereof, (d) control means for defining said prescribed pacing rate as a selected one of either a programmed pacing rate value or said SIR signal, and (e) counting means for counting and storing each occurrence of said SIR signal that falls within one of a plurality of rate ranges, whereby SIR histogram data is collected within said rate-responsive pacemaker; and (2) an external programming device having; (a) telemetry means for establishing an RF telemetry link with said implantable pacemaker through which said SIR histogram data may be retrieved, (b) distinguishing means for identifying which of a plurality of different pacemaker models said implantable pacemaker is, (c) programming means for selected control data into said rate-responsive pacemaker through said RF telemetry link, said control data including said programmed value of said pacing rate, an indication of whether the programmed value or the SIR signal is to be used to define said pacing rate, and a set of SIR control parameters that define the manner in which said SIR signal is generated from the physiological parameter sensed by said physiological sensor means, and (d) processing means for processing said SIR histogram data so as to produce a recommended set of SIR control parameters for programming into said rate-responsive pacemaker. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. An Auto-Set system for use within an external programming device in contact with an implantable rate-responsive pacemaker through an RF telemetry link,
said rate-responsive pacemaker having: -
means for sensing natural cardiac activity, means for generating stimulation pulses in the absence of sensed natural cardiac activity, a sensor from which a sensor indicated rate (SIR) signal is derived in accordance with a prescribed relationship, said SIR signal being selectively utilized within said rate-responsive pacemaker to define the rate at which said rate-responsive pacemaker generates stimulation pulses in the absence of sensed natural cardiac activity, and means for detecting and storing selected pacing events associated with the operation of said pacemaker, including a count of said SIR signals classified by rate; said external programming device having; means for establishing said RF telemetry link with said rate-responsive pacemaker, mans for distinguishing means for identifying which of a plurality of different pacemaker models said rate-responsive pacemaker is; and means for programming said rate-responsive pacemaker with a set of control parameters, said set of control parameters including SIR control parameters that define the manner in which said SIR signal is derived from said sensor; said Auto-Set system comprising; (a) means for setting said set of control parameters, including said SIR control parameters, to known initial values, said control parameters causing said rate-responsive pacemaker to assume a PASSIVE mode wherein said SIR signal is generated but does not define the rate at which stimulation pulses are generated; (b) means for gathering diagnostic data using said rate-responsive pacemaker under known conditions, said diagnostic data including a count of said SIR signals as a function of rate during the time that said control parameters have assumed said known initial values; and (c) means for processing the diagnostic data in order to define a multiplicity of SIR control parameters that optimally define the manner in which said SIR signal is derived from said sensor for the particular environment under which said diagnostic data was gathered. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. A method for determining a proposed set of programmable sensor parameters for use within a rate-responsive pacemaker implanted within a patient comprising:
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(a) setting the programmable sensor parameters within said pacemaker to a set of specified initial values, said specified initial values including a prescribed slope that relates a given sensor indicated rat (SIR) index signal to a specific SIR signal, said SIR index signal varying as a function of a sensed physiological parameter, the SIR signals accumulated over time as said SIR index signal varies comprising SIR data, said specified initial values further causing said pacemaker to assume a PASSIVE mode wherein the SIR data does not influence the operation of said rate-responsive pacemaker; (b) instructing the patient within whom the rate-responsive pacemaker has been implanted to perform a specified task; (c) storing said SIR data in said rate-responsive pacemaker during the time that the task specified in step (b) is being performed; (d) estimating a desired sensor indicated rate for the rate-responsive pacemaker for the specified task performed in step (b); and (e) processing the SIR data stored in step (c) and the desired sensor indicated rate estimated in step (d) to determine a proposed set of programmable parameters for use within said rate-responsive pacemaker. - View Dependent Claims (18, 19, 20, 21, 22)
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Specification