Periodic electrical lead intergrity testing system and method for implantable cardiac stimulating devices
First Claim
1. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue, said cardiac tissue having periods of refractoriness through at least one electrical lead to interrupt cardiac arrhythmias, the implantable cardiac stimulating device comprising:
- high voltage shock delivery circuitry, electrically connected to said at least one electrical lead, for generating a high energy shock and for delivering said shock to cardiac tissue through said at least one electrical lead in response to a shock delivery control signal;
low voltage control circuitry for detecting the onset of a cardiac arrhythmia, for generating said shock delivery control signal to cause said high voltage shock delivery circuitry to generate and deliver said high energy shock, and for generating a lead integrity test control signal to initiate a lead integrity test on said at least one lead, said low voltage control circuitry comprising means for delivering said shock delivery control signal to said high voltage shock delivery control circuitry and further comprising means for detecting refractory periods of said cardiac tissue, wherein said low voltage control circuitry initiates lead integrity tests only during said refractory periods; and
a lead integrity testing circuit, coupled to said at least one electrical lead via said high voltage shock delivery circuitry and to said low voltage control circuitry, for performing said lead integrity test by evaluating the impedance of said at least one electrical lead in response to said lead integrity test control signal and for providing results of said lead integrity test to said low voltage control circuitry.
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Accused Products
Abstract
A periodic electrical lead integrity testing system is provided which periodically tests electrical leads used with an implantable cardiac stimulating device. The system is especially advantageous in multi-functional implantable cardiac stimulating devices. Lead integrity is evaluated by periodically comparing the impedance of the electrical leads to a reference impedance. A pass/fail algorithm is used to determine if electrical lead integrity has been compromised. The system improves the efficacy and safety of implantable cardiac stimulating devices by detecting electrical failures independent of the delivery of therapeutic shocks. The required circuitry adds only minimal complexity and cost to the implantable cardiac stimulating device.
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Citations
79 Claims
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1. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue, said cardiac tissue having periods of refractoriness through at least one electrical lead to interrupt cardiac arrhythmias, the implantable cardiac stimulating device comprising:
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high voltage shock delivery circuitry, electrically connected to said at least one electrical lead, for generating a high energy shock and for delivering said shock to cardiac tissue through said at least one electrical lead in response to a shock delivery control signal; low voltage control circuitry for detecting the onset of a cardiac arrhythmia, for generating said shock delivery control signal to cause said high voltage shock delivery circuitry to generate and deliver said high energy shock, and for generating a lead integrity test control signal to initiate a lead integrity test on said at least one lead, said low voltage control circuitry comprising means for delivering said shock delivery control signal to said high voltage shock delivery control circuitry and further comprising means for detecting refractory periods of said cardiac tissue, wherein said low voltage control circuitry initiates lead integrity tests only during said refractory periods; and a lead integrity testing circuit, coupled to said at least one electrical lead via said high voltage shock delivery circuitry and to said low voltage control circuitry, for performing said lead integrity test by evaluating the impedance of said at least one electrical lead in response to said lead integrity test control signal and for providing results of said lead integrity test to said low voltage control circuitry. - 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. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue through a plurality of electrical leads to interrupt cardiac arrhythmias, the implantable cardiac stimulating device comprising:
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high voltage shock delivery circuitry, electrically connected to said plurality of electrical leads, for generating a high energy shock and for delivering said shock to cardiac tissue through said plurality of electrical leads in response to a shock delivery control signal; low voltage control circuitry for detecting the onset of a cardiac arrhythmia, for generating said shock delivery control signal to cause said high voltage shock delivery circuitry to generate and deliver said high energy shock, and for generating a lead integrity test control signal to initiate a lead integrity test on at least one of said plurality of electrical leads, said low voltage control circuitry comprising means for delivering said shock delivery control signal and said lead selection control signal to said high voltage shock delivery control circuitry and said low voltage control circuitry generates a lead selection control signal that identifies said at least one of said plurality of electrical leads to be tested; and a lead integrity testing circuit, coupled to said plurality of electrical leads via said high voltage shock delivery circuitry and to said low voltage control circuitry, for performing said lead integrity test by evaluating the impedance of said at least one of said plurality of electrical leads in response to said lead integrity test control signal and for providing results of said lead integrity test to said low voltage control circuitry, wherein said high voltage shock delivery circuitry, in response to said lead selection control signal, couples said identified at least one of said plurality of electrical leads to said lead integrity testing circuit for lead integrity testing, and further wherein to evaluate the impedances of said plurality of electrical leads, said lead integrity testing circuit applies a low energy test pulse through each of said identified at least one of said plurality of electrical leads in response to said lead integrity test control signal and further wherein said lead integrity testing circuit applies a different low energy test pulse through each of said identified at least one of said plurality of electrical leads in response to said lead integrity test control signal. - View Dependent Claims (22, 23, 24)
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25. An implantable cardiac stimulating device coupled to a pacing lead system for delivering pacing pulses to cardiac tissue and for sensing signals representative of natural cardiac activity, and coupled to a plurality of high energy shocking leads for delivering high energy shocks to cardiac tissue, comprising:
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a pacing and device control circuit comprising; pacing pulse regulation and delivery circuitry for generating, in response to pacing pulse control signals, pacing pulses which are delivered to said cardiac tissue through said pacing lead system, means for sensing signal representative of natural cardiac activity, processing circuitry for amplifying and digitizing said sensed signals, and microprocessor and logic control circuitry for analyzing said amplified and digitized signals to detect cardiac arrhythmias, for providing pacing pulse control signals and high energy shock control signals in accordance with said detected arrhythmias, and for providing lead integrity test control signals to initiate lead integrity tests on said plurality of high energy shocking leads; and a high energy shock delivery and control circuit comprising; a communication interface coupled to said microprocessor and logic control circuitry of said pacing and device control circuit, high voltage shock delivery circuitry, electrically connected to said plurality of high energy shocking leads, for generating, in response to high energy shock generation control signals, high energy shocks which are delivered to cardiac tissue through said plurality of high energy shocking leads; high energy shock control circuitry, coupled to said communication interface, for providing said high energy shock generation control signals in response to said high energy shock control signals provided by said microprocessor and logic control circuitry, isolation circuitry for providing a communication path between said high voltage shock delivery circuitry and said high energy shock control circuitry and for providing a communication path to said communication interface while protecting said high energy shock control circuitry, said communication interface, and said pacing and device control circuit from high voltage operations of said high voltage shock delivery circuitry, and impedance comparison circuitry, directly coupled to said high voltage shock delivery circuitry and coupled to said microprocessor and logic control circuitry through said isolation circuitry and said communication interface, for performing lead integrity tests on said plurality of high energy shocking leads in response to said lead integrity test control signals and for providing results of said lead integrity tests to said microprocessor and logic control circuitry, wherein, to evaluate the impedance of said lead, said impedance comparison circuitry applies at least one low energy test pulse through said plurality of high energy shocking leads in response to said lead integrity test control signals. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. In an implantable cardiac stimulating device detachably coupled to a lead in contact with cardiac tissue, the implantable cardiac stimulating device including:
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high voltage shock delivery circuitry, electrically coupled to said lead, for generating high energy shocks and for delivering said high energy shocks to cardiac tissue through said lead, low voltage control circuitry for detecting the onset of cardiac arrhythmias and for causing said high voltage shock delivery circuitry to generate and deliver said high energy shocks in response to a detected cardiac arrhythmias, means for evaluating the integrity of said lead and for generating test results, and means for passing signals between said high voltage shock delivery circuit and said low voltage control circuitry, a method for evaluating the integrity of said lead comprising the steps of; generating a low energy test pulse with said high voltage shock delivery circuitry; applying said low energy test pulse to said lead in response to a lead integrity test control signal provided by said low voltage control circuitry; evaluating the integrity of said lead while said test pulse is being applied; generating test results indicative of whether lead integrity has been compromised; and providing said test results to said low voltage control circuitry. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42)
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43. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue, said cardiac tissue having periods of refractoriness, through at least one lead to interrupt cardiac arrhythmias, the implantable cardiac stimulating device comprising:
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shock delivery circuitry, electrically coupled to said at least one lead, for generating a high energy shock and for delivering said high energy shock to cardiac tissue through said at least one lead in response to a shock delivery control signal; control circuitry for detecting the onset of a cardiac arrhythmia, for generating said shock delivery control signal to cause said shock delivery circuitry to generate and deliver said high energy shock, and for generating a lead integrity test control signal to initiate a lead integrity test on said at least one lead; a lead integrity testing circuit, coupled to said at least one lead, for performing said lead integrity test in response to said lead integrity test control signal and for providing results of said lead integrity test to said control circuitry, wherein said lead integrity testing circuit performs said lead integrity test by applying a low energy test pulse to said at least one lead and further wherein the result of said lead integrity test comprises a pass/fail indication of the integrity of said at least one lead; a means for passing signals between said lead integrity testing circuit and said control circuitry; and a means for passing signals between said shock delivery circuit and said control circuitry. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67)
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68. In an implantable cardiac stimulating device detachably coupled to a lead in contact with cardiac tissue, the implantable cardiac stimulating device including:
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high voltage shock delivery circuitry, electrically coupled to said lead, for generating high energy shocks and for delivering said high energy shocks to cardiac tissue through said lead, control circuitry for detecting the onset of cardiac arrhythmias and for causing said high voltage shock delivery circuitry to generate and deliver said high energy shocks in response to a detected cardiac arrhythmias, means for detecting refractory periods of said cardiac tissue, means for evaluating the integrity of said lead and for generating test results, and a means for passing signals between said high voltage shock delivery circuit and said control circuitry, a method for evaluating the integrity of said lead comprising the steps of; generating a lead integrity test control signal, said lead integrity test control signal being generated only when a refractory period of said cardiac tissue is detected by said means for detecting refractory periods; generating a test pulse with said high voltage shock delivery circuitry; applying said test pulse to said lead in response to said lead integrity test control signal provided by said low voltage control circuitry; evaluating the integrity of said lead while said test pulse is being applied; generating test results indicative of whether lead integrity has been compromised; and providing said test results to said control circuitry.
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69. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue, said cardiac tissue having periods of refractoriness, through at least one lead to interrupt cardiac arrhythmias, the implantable cardiac stimulating device comprising:
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shock delivery circuitry, electrically coupled to said at least one lead, for generating a high energy shock and for delivering said high energy shock to cardiac tissue through said at least one lead in response to a shock delivery control signal; control circuitry for detecting the onset of a cardiac arrhythmia, for detecting refractory periods of said cardiac tissue, for generating said shock delivery control signal to cause said shock delivery circuitry to generate and deliver said high energy shock, and for generating a lead integrity test control signal to initiate a lead integrity test on said at least one lead, wherein said control circuitry initiates lead integrity tests only during said refractory periods; a lead integrity testing circuit, coupled to said at least one lead, for performing said lead integrity test in response to said lead integrity test control signal and for providing results of said lead integrity test to said control circuitry, wherein the result of said lead integrity test comprises a pass/fail indication of the integrity of said at least one lead; a means for passing signals between said lead integrity testing circuit and said control circuitry; and a means for passing signals between said shock delivery circuit and said control circuitry.
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70. In an implantable cardiac stimulating device detachably coupled to a lead in contact with cardiac tissue, the implantable cardiac stimulating device including:
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high voltage shock delivery circuitry, electrically coupled to said lead, for generating high energy shocks and for delivering said high energy shocks to cardiac tissue through said lead, said high voltage shock delivery circuitry coupled to at least one high voltage capacitor for generating said high energy shocks, control circuitry for detecting the onset of cardiac arrhythmias and for causing said high voltage shock delivery circuitry to generate and deliver said high energy shocks in response to a detected cardiac arrhythmias, means for evaluating the integrity of said lead and for generating test results, and a means for passing signals between said high voltage shock delivery circuit and said control circuitry, a method for evaluating the integrity of said lead comprising the steps of; generating a lead integrity test control signal; generating a test pulse with said high voltage shock delivery circuitry, said test pulse generated independently of said at least one high voltage capacitor; applying said test pulse to said lead in response to said lead integrity test control signal provided by said low voltage control circuitry; evaluating the integrity of said lead while said test pulse is being applied; generating test results indicative of whether lead integrity has been compromised; and providing said test results to said control circuitry.
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71. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue, said cardiac tissue having periods of refractoriness, through at least one lead to interrupt cardiac arrhythmias, the implantable cardiac stimulating device comprising:
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shock delivery circuitry, electrically coupled to said at least one lead, for generating a high energy shock and for delivering said high energy shock to cardiac tissue through said at least one lead in response to a shock delivery control signal, wherein said shock delivery circuitry comprises at least one high voltage capacitor for generating said high energy shock; control circuitry for detecting the onset of a cardiac arrhythmia, for generating said shock delivery control signal to cause said shock delivery circuitry to generate and deliver said high energy shock, and for generating a lead integrity test control signal to initiate a lead integrity test on said at least one lead; a lead integrity testing circuit, coupled to said at least one lead, for performing said lead integrity test in response to said lead integrity test control signal and for providing results of said lead integrity test to said control circuitry, wherein the result of said lead integrity test comprises a pass/fail indication of the integrity of said at least one lead and wherein said lead integrity test is performed independently of said at least one high voltage capacitor; a means for passing signals between said lead integrity testing circuit and said control circuitry; and a means for passing signals between said shock delivery circuit and said control circuitry.
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72. An implantable cardiac stimulating device for administering electrical stimulation to cardiac tissue through at least one lead, the implantable cardiac stimulating device comprising:
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means for detecting refractory periods of said cardiac tissue; and means for performing a lead integrity test on said at least one lead, wherein said lead integrity test is initiated only during detected refractory periods of said cardiac tissue. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79)
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Specification