Leadless pacemaker using pressure measurements for pacing capture verification
First Claim
1. An implantable medical device in the form of a cardiac pacemaker, comprising:
- at least first and second electrodes for at least one of delivering therapy or sensing electrical signals;
a pressure sensor for sensing intracardiac pressure;
operational circuitry coupled to the electrodes and the pressure sensor; and
a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry;
wherein the operational circuitry is configured to perform a pressure based capture verification process including the following;
deliver an electrical pacing stimulus to the heart of a patient using the at least first and second electrodes;
obtaining a pressure signal received with the pressure sensor over a period of time following delivery of the electrical pacing stimulus;
monitor for an evoked capture response indicating the electrical pacing stimulus was captured using the pressure sensor by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and
if the evoked capture response is detected, conclude that the electrical pacing stimulus captured at least a portion of the patient'"'"'s heart; and
if the evoked capture response is not detected, conclude that the electrical pacing stimulus did not capture the patient'"'"'s heart.
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Accused Products
Abstract
Methods, devices, and systems for performing pacing capture verification in implantable medical devices such as a leadless cardiac pacemakers using a pressure signal. An example medical device includes a pressure sensor and is configured to monitor for an evoked capture response using the pressure sensor following pace delivery. Various factors of the pressure waveform may be used including the use of threshold, templating, and slope, as well as comparing cross-domain sensed events including using a fiducial point from the pressure signal for comparison to an acoustic, electrical, or motion event, or the use of data obtained from a second device which may be implanted, wearable, or external to the patient.
1212 Citations
20 Claims
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1. An implantable medical device in the form of a cardiac pacemaker, comprising:
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at least first and second electrodes for at least one of delivering therapy or sensing electrical signals; a pressure sensor for sensing intracardiac pressure; operational circuitry coupled to the electrodes and the pressure sensor; and a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry; wherein the operational circuitry is configured to perform a pressure based capture verification process including the following; deliver an electrical pacing stimulus to the heart of a patient using the at least first and second electrodes; obtaining a pressure signal received with the pressure sensor over a period of time following delivery of the electrical pacing stimulus; monitor for an evoked capture response indicating the electrical pacing stimulus was captured using the pressure sensor by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and if the evoked capture response is detected, conclude that the electrical pacing stimulus captured at least a portion of the patient'"'"'s heart; and if the evoked capture response is not detected, conclude that the electrical pacing stimulus did not capture the patient'"'"'s heart. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. An implantable medical device in the form of a cardiac pacemaker, comprising:
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at least first and second electrodes for at least one of delivering therapy or sensing electrical signals; a pressure sensor for sensing intracardiac pressure; operational circuitry coupled to the electrodes and the pressure sensor; and a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry; wherein the operational circuitry is configured to obtain a pressure signal received with the pressure sensor over a period of time following delivery of the electrical signals; wherein the operational circuitry is configured to perform a pressure based capture verification process by using the pressure sensor to determine whether a delivered pacing therapy to the heart of a patient has generated an evoked response by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and wherein the operational circuitry is configured to perform an electrical pacing capture verification process by using an electrical signal captured via the at least first and second electrodes to determine whether a delivered pacing therapy to the heart of a patient has generated an evoked response; wherein the operational circuitry is configured to use one, the other, or both of the pressure based capture verification process and the electrical pacing capture verification process to assess efficacy of pacing stimuli.
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20. A method of verifying pacing capture in an implantable cardiac pacemaker comprising at least first and second electrodes for at least one of delivering therapy or sensing electrical signals, a pressure sensor for sensing intracardiac pressure, operational circuitry coupled to the electrodes and the pressure sensor configured to obtain a pressure signal received with the pressure sensor over a period of time following delivery of the electrical signals, and a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry;
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wherein the method comprises; delivering an electrical pacing stimulus to the heart of a patient using the at least first and second electrodes; monitoring for an evoked capture response indicating the electrical pacing stimulus was captured using the pressure sensor by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and if the evoked capture response is detected, concluding that the electrical pacing stimulus captured at least a portion of the patient'"'"'s heart; and if the evoked capture response is not detected, concluding that the electrical pacing stimulus did not capture the patient'"'"'s heart.
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Specification