Medtronic, Inc.

Lucy M Nichols

David L Thompson

Glenn M Roline

Tommy Dean Bennett

Paul B Wyborny

Karen J Kleckner

Eduardo N Warman

Xiaohong Zhou

Lilian Kornet

Paul D Ziegler

Richard N M Cornelussen

Alberto Della Scala

Robert W Stadler

Tom Dean Bennett

Yong Kyun Cho

Catherine R Condie

William G Howard

Luc Roland Mongeon

John J Grevious

Donald R Merritt

James W Busacker

Paul M Skarstad

Douglas J Weiss

Gerald A Portzline

John S Brandstetter

David E Dalluge

Steve R Hornberger

Jean M Holschbach

Christine M Blanchette

The disclosure herein relates generally to methods for treating heart conditions using vagal stimulation, and further to systems and devices for performing such treatment. Such methods may include monitoring physiological parameters of a patient, detecting cardiac conditions, and delivering vagal stimulation (e.g., electrical stimulation to the vagus nerve or neurons having parasympathetic function) to the patient to treat the detected cardiac conditions.

Use of preventative vagal stimulation in treatment of acute myocardial infarction or ischemia

Vagal stimulation

Preventative vagal stimulation

A method and an apparatus for performing implementing external data into an implantable medical device. A first stress test is performed using an external sensor. External data resulting from the initial stress test is acquired. An external data injection process is performed. The external data injection process includes providing the external data to the implantable medical device. A second stress test is performed, the second stress test being substantially similar to the first stress test. Internal data resulting from the second stress test is acquired. Internal data resulting from the second stress test along with the external data resulting from the first stress test, are processed.

Method and apparatus for injection of external data within an implantable medical device

A pacemaker capable of automatically adjusting the sensitivity of its sense amplifier to electrical cardiac signals is disclosed. In one embodiment, a pacemaker having a pressure sensor disposed on the distal end of its pacing/sensing lead counts the number of pressure events and electrical events which occur during an autosensitivity timing period. If the number of electrical events exceeds the number of pressure events by more than a predetermined margin, the sense amplifier's sensitivity threshold is decreased. If the number of electrical events does not exceed the number of pressure events by more than the predetermined margin, the sense amplifier's sensitivity threshold is increased. In another embodiment, the pacemaker maintains a running average of the peak voltages of sensed electrical events over a predetermined history period. Periodically, the pacemaker computes the ratio of the running average of peak voltages to a preprogrammed sense margin value, and adjusts the sensitivity threshold of the sense amplifier according to this computation. By basing the adjustment of the sense amplifier's sensitivity threshold on a long-term average of peak sense values, the effects of cycle-to-cycle variation in sensed values are minimized. In still another embodiment of the invention, a pressure sensor alone is employed to detect natural cardiac events.

Automatic sensitivity adjust for cardiac pacemakers

A method of and apparatus for telemetering analog and digital data transcutaneously between an implantable medical device and an external receiver, such as between an external programmer and an implantable cardiac pacer. A damped carrier at 175 kilohertz is pulse position modulated by digital data. The data, along with synchronization and identification codes, are positioned into predefined ranges within predefined frames as measured by individual time periods. The data is uniquely identified by the position of one or more bursts of the carrier within the predefined range. An automatically initiated hand shake protocol maintains the link over slight variations in programmer head position with an indicator notifying the operator when repositioning is required. Analog data may be transferred in digital form or alternatively transferred using phase modulation of the carrier bursts. A cyclic redundancy code is used for link error detection. The digital data may be encoded/decoded in bit or byte format using hardware and/or software elements.

Telemetry system for an implantable medical device

A method and apparatus for determination of battery end-of-service in a medical device in which the medical device comprises a cathode limited electrochemical cell having an active metal anode and a manganese dioxide cathode and means for digital telemetry of cell voltage. The sloped, well defined voltage curve of such a cell during cell discharge combined with precise information available through digital telemetry allows for improved determination of battery end-of-service for the medical device.

Method and apparatus for determination of end-of-service for implantable

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.

Diagnostic function data storage and telemetry out for rate responsive

An automatic capture restoration and threshold-seeking method and apparatus for use with a cardiac pacemaker derives control signals for restoring cardiac capture from a cardiac pressure sensor. The pressure sensor also provides input control signals for a threshold-seeking apparatus. Both pulse width and amplitude thresholds can be changed contemporaneously during both capture restoration and threshold seeking.

Automatic cardiac capture restoration and threshold-seeking method and

An implantable medical device for human implant. The device includes a telemetry transmitter and receiver for communicating information from the implanted device to an external programmer or monitor and for receiving commands or other information from an external programmer. The device is provided with one or more sensors and means for monitoring, recording and storing the recordings of physiologic signals after implant. The device is provided with a waveform compression and storage system which stores monitored signals in the form of defined analog voltages maintained within the device, rather than employing more traditional digital storage techniques.

Compressed storage of data in cardiac pacemakers

A method of and apparatus for telemetering both analog and digital data transcutaneously between an implantable medical device and an external receiver, such as between an external programmer and an implantable cardiac pacer. A damped carrier at 175 kilohertz is pulse position modulated by digital data. The data, along with synchronization and identification codes, are positioned into predefined ranges within predefined frames as measured by individual time periods. The data is uniquely identified by the position of a burst of the carrier within the predefined range. An automatically initiated hand shake protocol maintains the link over slight variations in programmer head position with an indicator notifying the operator when repositioning is required. Analog data may be transferred in digital form or alternatively transferred using phase modulation of the carrier bursts. A cyclic redundancy code is used for link error detection.

Hand shake for implanted medical device telemetry

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 a rate response defining means for deriving desired pacing rates as a function of the sensor output, an achievement monitoring means that has a predetermined achievement criterion (primary criterion), for monitoring the relationship between the derived pacing rates and the achievement criterion over an optimization period, and either one of Average Activity level or Average Activity Difference level monitoring means that has a corresponding predetermined minimum and a predetermined maximum Average Activity level or Average Activity Difference level (secondary criterion), for monitoring the relationship between the derived pacing rates and the secondary criterion over an optimization period. Another optimization function is provided by adjusting a sensor weighting value which weights or regulates the relative contribution each sensor's derived desired pacing rates will contribute toward the pacemaker-derived optimized pacing rates.

Rate responsive cardiac pacemaker and method for providing an optimized

A pacemaker system includes a dual sensor implantable pacemaker and an external programmer for automatically and simultaneously optimizing and initializing a plurality of pacing parameters. The pacemaker includes means for automatically initializing a sensitivity threshold, pacing pulse width, pacing pulse amplitude, activity threshold, and pressure rate response gain setting.

Rate responsive pacemaker and method for automatically initializing the

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 an 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 and an achievement monitoring means that has a predetermined achievement criterion, for monitoring the relationship between the derived pacing rates and the achievement criterion over an achievement output. An output circuitry provides optimized pacing rates as a function of the desired pacing rates; and a rate response control means adjusts the rate response defining means accordingly.

Rate responsive pacemaker and methods for optimizing its operation

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 and an achievement monitoring means that has a predetermined achievement criterion, for monitoring the relationship between the derived pacing rates and the achievement criterion over an optimization period. An output circuitry provides optimized pacing rates as a function of the desired pacing rates, such optimization being accomplished by adjusting the rate response function for each sensor as a function of of the monitored achievement relationship. Another optimization function is provided by adjusting a sensor weighting value which weights or regulates the relative contribution each sensor's derived desired pacing rates will contribute toward the pacemaker-derived optimized pacing rates, such sensor weighting value being adjusted as a function of the monitored achievement relationshp, or as a function of the sensor gain optimization activity, as desired.

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Maple Grove, MN, United States of America

Lucy M Nichols