Implantable cardiac stimulation device having automatic capture/threshold capability using a dynamically adjustable safety margin
First Claim
1. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the stimulation device comprising:
- a pulse generator configured for electrical coupling to the electrode and configured to generate stimulation pulses at a controlled energy level to thereby stimulate the patient'"'"'s heart, wherein the controlled energy level has an amplitude component and a duration component;
a detection circuit configured for electrical coupling to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response to each of the stimulation pulses;
a controller coupled to the pulse generator and the detection circuit for determining the controlled energy level by adding a safety margin value to a threshold controlled energy level at which capture is detected; and
wherein the safety margin value varies according to a safety margin adjustment criteria related to the absence of evoked responses.
1 Assignment
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Accused Products
Abstract
An improved system and method for performing automatic capture/threshold detection in an implantable cardiac stimulation device or any device capable of stimulating some organ or tissue in the body. In existing systems a threshold stimulation energy level is periodically determined and a working stimulation energy level is then set by increasing the threshold stimulation energy level by a fixed or preprogrammed safety margin, e.g., a fixed voltage level or a percentage safety margin. However, in certain circumstances this safety margin may not be sufficient, resulting in either frequent threshold level determinations or losses-of-capture. To avoid these situations which may be wasteful of battery energy or dangerous for the patient, embodiments of the present invention periodically increase and/or decrease the safety margin according to the performance of the stimulation device, i.e., based upon the frequency of capture.
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Citations
31 Claims
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1. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the stimulation device comprising:
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a pulse generator configured for electrical coupling to the electrode and configured to generate stimulation pulses at a controlled energy level to thereby stimulate the patient'"'"'s heart, wherein the controlled energy level has an amplitude component and a duration component;
a detection circuit configured for electrical coupling to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response to each of the stimulation pulses;
a controller coupled to the pulse generator and the detection circuit for determining the controlled energy level by adding a safety margin value to a threshold controlled energy level at which capture is detected; and
whereinthe safety margin value varies according to a safety margin adjustment criteria related to the absence of evoked responses. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the method comprising the steps of:
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periodically delivering a stimulation pulse to the selected cardiac tissue, the stimulation pulse having a controlled energy level wherein the controlled energy level is defined by a set of characteristics including an amplitude component and a duration component;
detecting the presence or absence of an evoked response generated by the selected cardiac tissue in response to the stimulation pulse during a detection window;
determining whether a safety margin adjustment criteria is satisfied according to the number of cardiac cycles in which an absence of capture has been detected;
adjusting a safety margin value according to the safety margin adjustment criteria;
periodically determining a threshold stimulation energy level at which capture is detected; and
determining the controlled energy level by increasing the threshold energy level by the adjusted safety margin value. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue, the method comprising the steps of:
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periodically delivering a stimulation pulse to the selected cardiac tissue, the stimulation pulse having a controlled energy level wherein the controlled energy level is defined by a set of characteristics including an amplitude component and a duration component;
detecting the presence or absence of an evoked response generated by the selected cardiac tissue in response to the stimulation pulse during a detection window;
determining whether a safety margin adjustment criteria is satisfied according to the number of cardiac cycles in which an absence of capture has been detected;
adjusting the safety margin value according to the safety margin adjustment criteria; and
periodically adjusting the controlled energy level according to the safety margin adjustment criteria.
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25. A method for stimulating muscle tissue through at least one electrode implanted in electrical contact with the muscle tissue, the method comprising the steps of:
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periodically delivering a stimulation pulse to the muscle tissue, the stimulation pulse having a controlled energy level wherein the controlled energy level is defined by a set of characteristics including an amplitude component and a duration component;
detecting the presence or absence of an evoked response generated by the muscle tissue in response to the stimulation pulse during a detection window;
determining whether a safety margin adjustment criteria is satisfied according to the number of times in which an absence of capture has been detected;
adjusting the safety margin value according to the safety margin adjustment criteria; and
periodically adjusting the controlled energy level according to the safety margin adjustment criteria.
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26. An implantable cardiac stimulation device for stimulating a patient'"'"'s heart during a cardiac cycle through at least one electrode implanted in electrical contact with selected cardiac tissue the stimulation device comprising:
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means for periodically delivering a stimulation pulse to the patient'"'"'s heart, the stimulation pulse having a controlled energy level, wherein the controlled energy level is defined by an amplitude component and a duration component;
means for detecting the presence or absence of an evoked response to each of the stimulation pulses;
means for determining a threshold controlled energy level at which capture is detected, means for adding a safety margin value to the determined threshold controlled energy level; and
whereinthe safety margin value varies according to a safety margin adjustment criteria related to the absence of evoked responses. - View Dependent Claims (27, 28, 29, 30)
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31. A system for stimulating a patient'"'"'s heart during a cardiac cycle, the system comprising:
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an electrode implanted in electrical contact with selected cardiac tissue of the patient'"'"'s heart;
a pulse generator configured for electrical coupling to the electrode and configured to generate stimulation pulses at a controlled energy level to thereby stimulate the patient'"'"'s heart, wherein the controlled energy level has an amplitude component and a duration component;
a detection circuit configured for electrical coupling to the electrode and configured to receive cardiac signals for determining the presence or absence of an evoked response to each of the stimulation pulses;
a controller coupled to the pulse generator and the detection circuit for determining the controlled energy level by adding a safety margin value to a threshold controlled energy level at which capture is detected; and
whereinthe safety margin value varies according to a safety margin adjustment criteria related to the absence of evoked responses.
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Specification