Implantable cardiac stimulation system with high threshold response and patient notification method
First Claim
1. A method of responding to an increase in a capture threshold, for use in a cardiac stimulation device having an automatic capture verification feature, comprising:
- detecting a significant increase in the capture threshold;
in response to the detecting step, adjusting a stimulation output to a level above the capture threshold;
in further response to the detecting step, adjusting a stimulation electrode configuration during high output stimulation; and
delivering a notification to the patient regarding the adjustment of the stimulation output.
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Abstract
An implantable cardiac stimulation device and associated method provide automatic capture verification and threshold testing capabilities with an added high-threshold response algorithm and patient notification process. The stimulation device responds to higher than normal capture thresholds by permitting the stimulation pulse energy to be set above the fixed maximum pulse energy normally allowed by automatic capture verification techniques. In order to maintain comfortable yet effective stimulation, the high-energy stimulation is delivered in a bipolar configuration. The stimulation device alerts the patient of the change to high-energy output when it occurs. After the high-energy output is automatically set, one or more high-energy stimulation pulses are delivered in a unipolar configuration on a scheduled or event-triggered basis. A unipolar high-energy stimulation pulse is typically perceptible by the patient due to stimulation of excitable tissue surrounding the device housing. Sensation of a periodic high-energy pulse alerts the patient that stimulation conditions have changed and medical attention should be sought.
65 Citations
49 Claims
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1. A method of responding to an increase in a capture threshold, for use in a cardiac stimulation device having an automatic capture verification feature, comprising:
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detecting a significant increase in the capture threshold;
in response to the detecting step, adjusting a stimulation output to a level above the capture threshold;
in further response to the detecting step, adjusting a stimulation electrode configuration during high output stimulation; and
delivering a notification to the patient regarding the adjustment of the stimulation output. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of responding to an increase in a capture threshold, for use in a cardiac stimulation device having an automatic capture verification feature, comprising the steps of:
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storing a plurality of capture threshold ranges;
storing a working margin associated with each capture threshold range;
measuring a capture threshold;
categorizing a measured capture threshold in one of the plurality of capture threshold ranges;
automatically adjusting a stimulation output to the measured capture threshold plus a safety margin associated with the capture threshold range;
switching to bipolar stimulation if an adjusted stimulation output exceeds a predefined maximum automatic capture output; and
delivering a notification when the adjusted stimulation output exceeds a predefined alarm level. - View Dependent Claims (22, 23, 24)
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25. A method of responding to an increase in a capture threshold, for use in a cardiac stimulation device having an automatic capture verification feature, comprising:
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detecting a significant increase in the capture threshold;
adjusting a stimulation output to a level above the capture threshold;
v us adjusting a stimulation electrode configuration during high output stimulation;
delivering a notification to the patient about a change in the stimulation output;
checking one or more stimulation leads for evidence of lead failure; and
adjusting the stimulation electrode configuration if lead failure is detected. - View Dependent Claims (26, 27)
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28. A cardiac stimulation device capable of implementing automatic capture verification, for responding to an increase in a capture threshold, comprising:
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a pulse generator that selectively generates stimulation pulses;
a lead connected to the pulse generator, that delivers the stimulation pulses to one or more cardiac chambers;
a sensing circuit connected to the lead that detects the occurrence of a significant increase in the capture threshold;
a control circuit that responds to the significant increase in the capture threshold by adjusting a stimulation output to a level above the capture threshold and by further adjusting a stimulation electrode configuration during high output stimulation; and
notification circuit that delivers a notification to the patient regarding the adjustment of the stimulation output. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35)
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36. A cardiac stimulation device capable of implementing automatic capture verification, for responding to an increase in a capture threshold, comprising:
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a pulse generator that selectively generates stimulation pulses;
a lead connected to the pulse generator, that delivers the stimulation pulses to one or more cardiac chambers;
a sensing circuit connected to the lead that detects the occurrence of a significant increase in the capture threshold, and that measures a capture threshold;
memory for storing a plurality of capture threshold ranges and a working margin associated with each capture threshold range;
a control circuit connected to the sensing circuit and the memory, that categorizes a measured capture threshold in one of the plurality of capture threshold ranges and that automatically adjusts a stimulation output to the measured capture threshold plus a safety margin associated with the capture threshold range; and
a switch connected to the control circuit that switches to bipolar stimulation if an adjusted stimulation output exceeds a predefined maximum automatic capture output. - View Dependent Claims (37, 38, 39, 40)
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41. A cardiac stimulation device capable of implementing automatic capture verification, for responding to an increase In a capture threshold, comprising:
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means for detecting a significant increase in the capture threshold;
means for adjusting a stimulation output to a level above the capture threshold in response to the significant increase in the capture threshold;
means for adjusting a stimulation electrode configuration during a high stimulation output in further response to the significant increase in the capture threshold; and
means for notifying the patient regarding the adjustment of the stimulation output. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49)
a highest pulse amplitude available;
ora highest pulse width available.
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46. The device of claim 41, wherein the stimulation electrode configuration is switched to a bipolar configuration during high output stimulation.
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47. The device of claim 41, wherein the stimulation output is set to a highest level available and, when applicable, stimulation is switched to, and is maintained in a unipolar output configuration.
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48. The device of claim 41, wherein the stimulation output is set to a highest level available;
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when applicable, stimulation is switched to, and is maintained in a unipolar output configuration, wherein the stimulation output is insufficient to evoke local muscle stimulation and wherein the means for delivering the notification is programmable to an output level that is greater than the highest level.
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49. The device in claim 48, further including means for delivering periodic notification signals.
Specification