Diagnostic function data storage and telemetry out for rate responsive cardiac pacemaker

• US 5,330,513 A
• Filed: 05/01/1992
• Issued: 07/19/1994
• Est. Priority Date: 05/01/1992
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L., Nichols, Lucy M., Bennett, Tom D., Roline, Glenn M.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Parker, Marianne
• Application Number:
  US07/881,996
• Time in Patent Office: 809 Days
• Field of Search: 128/419 PG, 128/419 DT, 607/14, 607/15, 607/17-26
• US Class Current: 607/32
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

An implantable physiologic device, e.g., a multi-programmable, microprocessor based cardiac pacemaker, is provided with data storage and transmission capabilities for transmitting out certain current operating parameters and sensed events and for storing counted events for transmission of counts, histograms and real-time clock data out on command. The device preferably comprises a rate responsive cardiac pacemaker for providing an optimized pacing rate of stimulation pulses as a function of at least one selected rate control parameter. Each rate control parameter has a value which varies as a function of changes in a patient'"'"'s physiologic demand and includes a sensor system for sensing the rate control parameter value and for providing a sensor output representative thereof. The cardiac pacemaker also includes control circuitry which includes a rate response defining means for deriving desired pacing rates as a function of the sensor output signal(s) modified by sensor gain and selective weighting coefficient values. An achievement monitoring means that has a predetermined achievement criterion monitors the relationship between the derived pacing rates and the achievement criterion over an optimization period. Output circuitry providing optimized pacing rates as a function of optimization is accomplished by adjusting the rate response gain for each sensor as a function of the monitored achievement relationship. Another optimization function is provided by adjusting a sensor weighting coefficient value which weights or regulates the relative contribution each sensor'"'"'s derived desired pacing rates will contribute toward the pacemaker-derived optimized pacing rate.

Claims

1. An implantable, rate responsive cardiac pacemaker comprising:

means for determining an occurrence of selected cardiac events;

means for detecting and processing a physiologic parameter;

means for delivering pacing pulses at a selected pacing rate;

means for varying the pacing rate as a function of a stored algorithm having at least one programmed-in rate responsive modifier value for setting the pacing rate in dependence upon the measured physiologic parameter and the occurrence of selected cardiac events;

means for establishing at least one rate response algorithm modifier value;

means for periodically optimizing the rate response algorithm modifier value to achieve a predetermined rate achievement criteria;

means for transmitting signals representative of the optimized rate responsive modifier value and the programmed-in rate responsive modifier value to a remote location external of said implantable pacemaker;

means for storing n periodic changes of the first rate response algorithm modifier value and a time of change of the response algorithm modifier value in n memory locations;

means for transmitting the n periodic changes to said remote location and their corresponding times;

means for sampling the varying pacing rate and storing rate trend data in memory over a predetermined time duration, said rate trend data indicative of a trend in said pacing rate;

means for transmitting the rate trend data in conjunction with the algorithm modifier value to said remote location;

means for deriving beat-by-beat averages of the pacing rate and percentage of paced values in a total of the spaced and sensed event intervals value over programmable time segments; and

means for accumulating the derived rate averages and percentage paced values in memory over a predetermined duration in conjunction with storing the n periodic changes for subsequent transmission to said remote location.

2. An implantable, rate responsive cardiac pacemaker comprising:

means for determining an occurrence of selected cardiac events;

means for detecting and processing a physiologic parameter;

means for delivering pacing pulses at a selected pacing rate;

means for varying the pacing rate as a function of a stored algorithm having at least one programmed-in rate responsive modifier value for setting the pacing rate in dependence upon the measured physiologic parameter and the occurrence of selected cardiac events;

means for establishing at least one rate response algorithm modifier value;

means for periodically optimizing the rate response algorithm modifier value to achieve a predetermined rate achievement criteria;

means for transmitting signals representative of the optimized rate responsive modifier value and the programmed-in rate responsive modifier value to a remote location external of said implantable pacemaker;

means for storing n periodic changes of the first rate response algorithm modifier value and a time of change of the response algorithm modifier value in n memory locations;

means for transmitting the n periodic changes to said remote location and their corresponding times;

means for selectively disabling said means for varying the pacing rate, and for operating said pacemaker at a further defined fixed or varying pacing rate;

means for deriving a projected pacing rate as a function of said stored algorithm and storing projected rate trend data in memory over a predetermined time duration, said rate trend data indicative of a trend in said pacing rate; and

means for transmitting the projected rate trend data in conjunction with the algorithm modifier value to said remote location.

3. The pacemaker of claim 2 further comprising:

means for deriving beat-by-beat averages of the pacing rate and percentage of paced values in a total of the paced and sensed event intervals over programmable time segments; and

means for accumulating the derived rate averages and percentage paced values in memory over a predetermined duration in conjunction with storing the n periodic changes for subsequent transmission to said remote location.

4. An implantable, rate responsive cardiac pacemaker comprising:

means for determining an occurrence of selected cardiac events;

means for detecting and processing a physiologic parameter;

means for delivering pacing pulses at a selected pacing rate;

means for varying the pacing rate as a function of a stored algorithm having at least one programmed-in algorithm modifiers rate responsive modifier value for setting the pacing rate in dependence upon the measured physiologic parameter and the occurrence of selected cardiac events;

modifier value establishing means for establishing at least one rate response algorithm modifier value;

means for periodically optimizing the rate response algorithm modifier value to achieve a predetermined rate achievement criteria; and

,

means for transmitting signals representative of the optimized rate responsive modifier value and the programmed-in rate responsive modifier value to a remote location external of said implantable pacemaker;

wherein said means for detecting and processing a physiologic parameter further comprises;

first sensor and signal processing means for deriving a first physiologic signal representative of a cardiac function; and

second sensor and signal processing means for deriving a second physiologic signal representative of a metabolic demand for cardiac output;

and wherein said means for varying the pacing rate further comprises means for selectively employing either or both of the first and second physiologic signals to derive a pacing rate;

and wherein said modifier value establishing means further comprises means for establishing first and second gain control values and a relative weighting coefficient for said first and second physiologic signals; and

further comprising;

means for deriving a pacing rate as a function of the first and/or second physiologic signals modified by said gain control values and weighting coefficient;

and wherein said optimizing means periodically optimizes the gain control values and weighting coefficient.

5. The pacemaker of claim 4 further comprising:

means for storing n periodic changes, achieved by said optimizing means, of the first and second gain control values and the weighting coefficient, and a corresponding rate of said n changes in n memory locations; and

means for transmitting data representing the n periodic changes to said remote location along with the dates that the changes were made.

6. The pacemaker of claim 5 further comprising:

means for sampling the varying pacing rate and storing rate trend data in memory over a predetermined time duration, said rate trend data indicative of a trend in said pacing rate; and

means for transmitting the rate trend data in conjunction with the n periodic changes data to said remote location.

7. The pacemaker of claim 6 further comprising:

means for deriving beat-by-beat averages of the pacing rate and percentage of paced to total paced and sensed event intervals value over programmable time segments; and

means for accumulating the derived rate averages and percentage paced values in memory over a predetermined duration in conjunction with storing the n periodic changes data for subsequent transmission to said remote location.

8. The pacemaker of claim 5 further comprising:

means for selectively disabling said means for varying the pacing rate and operating said pacemaker at a further defined fixed or varying pacing rate;

means for deriving the projected pacing rate as a function of said stored algorithm and storing projected rate trend data in memory over a predetermined time duration; and

means for transmitting the projected rate trend data in conjunction with the n periodic changes data to said remote location.

9. The pacemaker of claim 8 further comprising:

means for deriving beat-by-beat averages of the projected pacing rate over programmable time segments; and

means for accumulating the derived rate averages in memory over a predetermined duration in conjunction with storing the n periodic changes data for subsequent transmission to said remote location.

10. An implantable, programmable cardiac pacemaker comprising:

means for determining an occurrence of selected cardiac paced and sensed events;

means for delivering pacing pulses at a predetermined pacing rate corresponding to an interval elapsed from a preceding paced or sensed event;

means for measuring a predetermined parameter associated with each one of said selected cardiac events;

means for registering occurrences of said selected cardiac events;

means for classifying each said registered event into respective classes of said parameter associated with said event in accordance with a measured value of said parameter;

means for accumulating counts of said registered events for each said class thereby providing data of a distribution of said registered events;

means for halting accumulating of said counts of said registered events upon achievement of a predetermined count of said registered events for at least one of said classes and registering a time corresponding to the achievement of the maximum count in association with the specific register; and

means for outputting signals representative of said accumulated counts and said time to a location external of said implantable pacemaker.

11. The cardiac pacemaker of claim 10 further comprising:

means for varying the pacing rate as a function of a physiologic parameter of the patient;

means for classifying each of said pacing rates into respective rate classes between a maximum and a minimum allowable rate, whereby histograms of the rate data are accumulated in said accumulating means until the count in one of said respective rate classes achieves a predetermined maximum count;

means for registering a time of achievement of the maximum count; and

means for outputting signal representative of the histograms and said time to said external location.

12. The cardiac pacemaker of claim 10 further comprising:

means for counting selected sensed events and for classifying each of said sensed events into respective interval classes between a maximum and a minimum allowable interval whereby histograms of the sensed event interval data are accumulated in said accumulating means until the count in one of said respective interval classes achieves a predetermined maximum count;

means for registering a time corresponding to the achievement of the maximum count; and

means for outputting signal representative of the histograms and said time to said external location.

13. A method for providing an optimized pacing rate of stimulation pulses in a rate responsive cardiac pacemaker, as a function of at least one selected rate control parameter, each of said rate control parameters having a value which varies as a function of changes in a patient'"'"'s physiologic demand for cardiac output, the method comprising the steps of:

sensing each of said rate control parameter values and for providing a sensor output representative thereof;

deriving desired pacing rates for each of said sensor means as a function of said sensor output signals corresponding thereto, modified by a predetermined rate response algorithm modifier function for each of said sensor means, such that for a predetermined change in sensor output signal a corresponding change in said desired pacing rate is provided;

periodically monitoring a relationship between each of said derived desired pacing rates and a defined achievement criterion corresponding thereto over a predetermined optimization period, for providing an achievement output indicative of each of said monitored relationships, wherein each of said achievement criterion is reflective of expected levels of exercise of said patient during said optimization period;

providing optimized pacing rates as a function of each of said derived desired pacing rates;

adjusting each of said rate response algorithm modifier functions as a function of said achievement output corresponding thereto, such that each of said adjusted rate response functions provides an increased or decreased change in desired pacing rate corresponding to said predetermined change in sensor output;

storing in memory, said rate response algorithm modifier functions adjusted during the optimization periods; and

upon receipt of an interrogation command, transmitting the stored functions to a remote location.