Medtronic, Inc.

Bradley C Peck

Michael T Hemming

Brian A Blow

Scott M Morrison

Robert John Schuelke

John D Wahlstrand

Rick D McVenes

Ross O Starkson

David J Jorgenson

Charles D Trautmann

Christopher M Manrodt

Todd Jon Sheldon

H Toby Markowitz

Ajinkya M Joglekar

A device for programming an implantable fluid delivery device receives a therapeutic agent concentration, wherein the therapeutic agent concentration comprises a mass of the therapeutic agent per unit of volume. The device further determines a reference rate value based on the received therapeutic agent concentration, wherein the reference rate value comprises a mass per unit of time. The device additionally displays a graphical user interface comprising a horizontal axis and a vertical axis, wherein the horizontal axis represents time and the vertical axis represents rates of delivery of the fluid by the implantable fluid delivery device. The maximum value of the vertical axis displayed in the graphical user interface is determined based on the determined reference rate value and is determined to be less than a maximum therapeutic agent infusion rate.

Determining vertical axis scale for implantable fluid delivery system

A system for monitoring trends in lead impedance includes collecting data from various sources in an implantable medical device system. Lead impedance, non-physiologic sensed events percentage of time in mode switch, results of capture management operation, sensed events, adversion pace counts, refractory sense counts and similar data are used to determine the status of a lead. A set of weighted sum rules are implemented by a software system to process the data and provide displayable information to health care professionals via a programmer. The lead monitoring system includes a patient alert system for patients to seek help in the event a serious lead condition is identified.

Implantable lead functional status monitor and method

An implantable medical device (IMD) includes a lead status monitoring system. The lead status monitoring system employs a method including the steps of: collecting data sets from a lead impedance source, a stimulation threshold source, and at least one additional source included in the IMD; and processing the data sets to determine if a lead status event has occurred.

Undersensing of an evoked response during an automatically initiated search of the stimulation threshold in a stimulation channel of an IMD, e.g., the pacing threshold in a pacing channel of a pacing system, is minimized by repeating the search using the sense amplifier of the stimulation channel configured in bipolar and unipolar sensing configurations. A failure to sense an evoked response in the search in one sensing configuration can be confirmed, and stimulation energy set to a high output, if an evoked response is not sensed in an alternate sensing configuration or refuted if an evoked response is sensed in the alternate sensing configuration. If the failure is refuted, the alternate sensing configuration is employed until the next search.

Method and apparatus for performing stimulation threshold searches

An apparatus and method for detecting micro-dislodgment at a heart tissue/pacing lead electrode interface involves measuring a first pacing threshold parameter at a first time in a patient's cardiac cycle and measuring a second pacing threshold parameter at a second time in the patient's cardiac cycle. Micro-dislodgment occurring at the heart tissue/pacing lead electrode interface is detected using the first and second pacing threshold parameters. Micro-dislodgment may be detected by comparing a difference between, or a ratio of, the first and second pacing threshold parameters to a preestablished maximum allowable deviation value. A difference between the first and second pacing threshold parameters or a ratio in excess of the preestablished maximum allowable deviation value indicates a problem at the heart tissue/pacing lead interface. The first and second pacing threshold parameters are preferably pacing threshold voltages, and the preestablished maximum allowable deviation value is either a voltage ranging from about 0.2 volts to about 2 volts or a percentage ranging from about 5% to about 100%. The micro-dislodgment procedure may be performed in-situ an implantable pulse generator (IPG), with data indicative of a detected change at the heart tissue/pacing electrode interface being stored in a memory coupled to the IPG and subsequently read out of memory for evaluation. Alternatively, the micro-dislodgment procedure may be performed using an external programmer and may further be performed during implantation of a pacing lead electrode at the heart tissue/pacing lead electrode interface to assure a physician of proper lead attachment.

Apparatus and method for detecting micro-dislodgment of a pacing lead

An implantable medical device (IMD) coupled with leads extending to body tissue providing storage of lead related data, monitoring of lead functional status, and indication of lead integrity to the clinician. A lead status monitor (LSM) processes lead related data in a system self test mode and provides a lead status report that identifies and declares conductor/connector issues, insulation issues, and electrode/tissue interface issues indicative of suspected lead related condition mechanisms for each lead employed in the IMD. The LSM operates employing a set of LSM rules that process measured lead impedance values and loss of capture (LOC) values. In a pacing system, particular LSM rules are defined that process periodically determined, pacing pulse characteristic at LOC and bipolar and unipolar lead impedance values that are measured periodically. The lead impedance values are compared to upper and lower limits or trip points of a normal impedance range. Simultaneously, significant changes in lead impedance are detected, and the unipolar impedance value is compared to the bipolar lead impedance value of each lead. Counts of deviations in lead impedances satisfying each LSM rule are maintained. Certain of the lead related condition mechanisms are declared if a count of lead impedance deviations meets a programmed threshold number of such lead impedance deviations within a further programmed number of sequential impedance measurements. Preferably, the pacing pulse strength or voltage at LOC (characterized as LOC_RHEOBASE herein) is periodically determined and compared to a reference LOC_RHEOBASE.

A software programmable device means such as a microprocessor discriminates between evoked response signals and post-pace polarization signals sensed by an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. It has been discovered that the post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and that the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window . The sign of the post-pace polarization polarity, either positive or negative, is determined by the design of the specific output circuitry. The evoked response signal may reverse the polarity of the sensed signal in either case, from positive to negative or from negative to positive, during the time window of interest. In another embodiment of the present invention, and when the magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response is achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform.

Microprocessor capture detection circuit and method

A method and apparatus for discriminating between evoked response signals and post-pace polarization signals sensed by a sense amplifier of an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. The post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window. The sign of the post-pace polarization polarity, either positive or negative, is determined. The evoked response signal may reverse the polarity of the sensed signal from positive to negative or from negative to positive, during the time window of interest. When the magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response is achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform. In one embodiment, sensing of the evoked response is based upon a relationship between a maximum magnitude of a derivative of a sensed signal and a predetermined threshold reference value. The evoked response is declared when the maximum amplitude of the a derivative of the sensed signal equals or exceeds the threshold reference value.

Capture detection circuit for pulses and physiologic signals

A software programmable microprocessor discriminates between evoked response signals and post-pace polarization signals sensed by an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. It has been discovered that the post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and that the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window. The sign of the post-pace polarization polarity, either positive or negative, is determined by the design of the specific output circuitry. The evoked response signal may reverse the polarity of the sensed signal in either case, from positive to negative or from negative to positive, during the time window of interest. In another embodiment, when the magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response is achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform.

The present invention employs software programmable device means such as a microprocessor to discriminate between evoked response signals and post-pace polarization signals sensed by an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. It has been discovered that the post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and that the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window. The sign of the post-pace polarization polarity, either positive or negative, is determined by the design of the specific output circuitry. The evoked response signal may reverse the polarity of the sensed signal in either case, from positive to negative or from negative to positive, during the time window of interest. In another embodiment of the present invention, and when the magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response is achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform.

The programmable device means such as a microprocessor are employed to discriminate between evoked response signals and post-pace polarization signals sensed by an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. It has been discovered that the post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and that the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window . The sign of the post-pace polarization polarity, either positive or negative, is determined by the design of the specific output circuitry. The evoked response signal may reverse the polarity of the sensed signal in either case, from positive to negative or from negative to positive, during the time window of interest. When magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response may be achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform.

Software programmable device means such as a microprocessor are employed to discriminate between evoked response signals and post-pace polarization signals sensed by an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. It has been discovered that the post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and that the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window. The sign of the post-pace polarization polarity, either positive or negative, is determined by the design of the specific output circuitry. The evoked response signal may reverse the polarity of the sensed signal in either case, from positive to negative or from negative to positive, during the time window of interest. When the magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response may be achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform.

The present invention permits discrimination between evoked response signals and post-pace polarization signals sensed by an implantable medical device by noting the polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes during a short period of time immediately following a paced event. It has been discovered that the post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and that the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window. The sign of the post-pace polarization polarity, either positive or negative, is determined by the design of the specific output circuitry. The evoked response signal may reverse the polarity of the sensed signal in either case, from positive to negative or from negative to positive, during the time window of interest. In another embodiment of the present invention, and when the magnitude of the post-pace polarization is so great that the evoked response does not reverse the polarity of the waveform, discrimination of the evoked response is achieved by noting an acceleration (or increasing magnitude of dv/dt) in the sensed signal or waveform.

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Ham Lake, MN, United States of America

Bradley C Peck