Source: http://www.google.com/patents/US6882883?ie=ISO-8859-1&dq=6,163,776
Timestamp: 2014-03-08 21:22:08
Document Index: 661405018

Matched Legal Cases: ['art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110']

Patent US6882883 - Implantable medical device (IMD) system configurable to subject a patient to ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsVarious implantable medical devices (IMDs) are disclosed for implantation in a patient. The IMD includes pacing circuitry configured to selectively produce pacing pulses at a programmable pacing rate. In one embodiment, the IMD is configurable to subject a patient to a stress test. The IMD may be configurable...http://www.google.com/patents/US6882883?utm_source=gb-gplus-sharePatent US6882883 - Implantable medical device (IMD) system configurable to subject a patient to a stress test and to detect myocardial ischemia within the patientAdvanced Patent SearchPublication numberUS6882883 B2Publication typeGrantApplication numberUS 09/945,195Publication dateApr 19, 2005Filing dateAug 31, 2001Priority dateAug 31, 2001Fee statusPaidAlso published asUS20030045908Publication number09945195, 945195, US 6882883 B2, US 6882883B2, US-B2-6882883, US6882883 B2, US6882883B2InventorsCatherine R. Condie, Robert W. Stadler, Lee StylosOriginal AssigneeMedtronic, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (13), Non-Patent Citations (1), Referenced by (18), Classifications (9), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetImplantable medical device (IMD) system configurable to subject a patient to a stress test and to detect myocardial ischemia within the patientUS 6882883 B2Abstract Various implantable medical devices (IMDs) are disclosed for implantation in a patient. The IMD includes pacing circuitry configured to selectively produce pacing pulses at a programmable pacing rate. In one embodiment, the IMD is configurable to subject a patient to a stress test. The IMD may be configurable to subject the patient to the stress test at the time specified by stored timing information, or in response to a signal (e.g., from a patient activator). Another embodiment of the implantable medical device (IMD) includes sensor circuitry, a memory for storing data, and a control unit. The sensor circuitry produces sensor data relating to cardiac condition. The control unit is configurable to store the sensor data in the memory until a trigger signal is received. Methods are described for performing a stress test in a patient with an IMD, and for subsequently reproducing cardiac operational states.
Myocardial ischemia can be symptomatic or silent. Symptomatic myocardial ischemia is characterized by chest pain (i.e., �angina pectoris� or simply �angina�), especially during physical exertion. People with angina are at risk of having a heart attack. Those suffering silent myocardial ischemia have no signs, and are typically at greater risk of having a heart attack with no warning than those with symptomatic myocardial ischemia.
Transesophageal atrial pacing has also been used to elevate heart rates and test for myocardial ischemia. Transesophageal atrial pacing takes advantage of the anatomical proximity of the esophagus to the left atrium of the heart for minimally invasive heart stimulation. In preparation for transesophageal atrial pacing, a patient swallows an electrode connected to one end of a lead. While in the esophagus, the electrode is positioned near the left atrium of the patient's heart by adjusting the lead length. A stimulator is coupled to the other end of the lead, and produces electrical pulses which electrically stimulate (i.e., �pace�) the left atrium of the heart. In addition to providing a method for temporary atrial pacing in patients whose heart rates are too slow or irregular to meet the demands of their bodies (i.e., patients with bradycardia), transesophageal pacing also offers an alternative method for elevating heart rates for diagnosis of myocardial ischemia and other types of heart disease.
SUMMARY OF THE INVENTION Several different embodiments of an implantable medical device (IMD) are disclosed for implantation in a patient. The IMD includes pacing circuitry configured to selectively produce pacing pulses at a programmable pacing rate for delivery to muscle tissue of a heart (i.e., myocardium) of the patient. In one embodiment, the IMD is configurable to subject the patient to a stress test. During the stress test, the pacing rate is increased from a start rate to a stop rate, wherein the stop rate is greater than the start rate, and stress test data is acquired and stored within the IMD. The IMD may be configurable to store timing information specifying a time the IMD is to subject the patient to the stress test, and to subject the patient to the stress test at the time specified by the timing information. Alternately, the IMD may be configurable to subject the patient to the stress test in response to a signal (e.g., a radio frequency signal generated by a patient activator when the patient activates a pushbutton of the patient activator). The IMD may also be configurable to provide the stress test data stored within the IMD.
FIG. 4 is a diagram of one embodiment of the memory of FIG. 3, wherein the memory stores several values associated with a �rate response� operating mode of the pacemaker;
FIG. 5 is a diagram of one embodiment of the timing/pacing control circuitry of FIG. 3, wherein the timing/pacing control circuitry includes means for storing several values associated with a �demand� operating mode of the pacemaker;
FIGS. 11A and 11B in combination form a flow chart illustrating one embodiment of a method for subjecting the patient of FIG. 1 to a stress test (e.g., an �in-office� stress test) using the implantable medical device (IMD) system of FIG. 1;
FIGS. 13A-13C in combination form a flow chart illustrating one embodiment of a second method for subjecting the patient of FIG. 1 to a stress test (e.g., an �ambulatory� stress test) using the implantable medical device (IMD) system of FIG. 1;
FIG. 16 shows data and instructions stored in the memory of the pacemaker of FIGS. 1-3 and associated with �record ischemic episode� mode and a �recreate ischemic episode� mode of the pacemaker;
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will, of course, be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with health-related, system-related, and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.
Adapted for connecting to the atrial lead 104 and the ventricular lead 106 and capable of delivering pacing pulses to the right atrium and the right ventricle of the heart 110 (FIG. 1), the pacemaker 102 of FIGS. 1 and 2 may be termed a dual-chamber pacemaker. The pacemaker 102 may be programmable to operate in one or more of several different predefined operating modes, including a �demand� mode. In the demand mode, the pacemaker 102 senses intrinsic electrical signals present within the heart 110 of the patient 108 (FIG. 1), and produces pacing pulses only when the pacing pulses are needed. For example, the pacemaker 102 may be programmed with a value indicating whether or not the demand mode is enabled, a �low rate limit� value indicating a low limit of an intrinsic beat rate of the heart 110 of the patient 108 (FIG. 1), and an atrial-ventricular (A-V) interval value indicating a maximum length of time between an atrial contraction or �atrial beat� and a subsequent ventricular contraction or �ventricular beat.�
The timing/pacing control circuitry 304 includes sensing circuitry that receives and detects intrinsic electrical signals present within the heart 110 of the patient 108 (FIG. 1). Specifically, the sensing circuitry of the timing/pacing control circuitry 304 receives a first electrical signal indicative of an intrinsic contraction of the right atrium via the atrial lead 104. In response to the first electrical signal, the sensing circuitry may generate an �atrial beat� signal within the timing/pacing control circuitry 304.
The sensing circuitry of the timing/pacing control circuitry 304 also receives a second electrical signal indicative of an intrinsic contraction of the right ventricle via the ventricular lead 106. In response to the second electrical signal, the sensing circuitry may generate a ventricular beat signal within the timing/pacing control circuitry 304. The A-V interval value 504 indicates a desired A-V interval. In the demand mode, if the ventricular beat signal is not generated within the desired A-V interval indicated by the A-V interval value 504 following an atrial beat signal, the timing/pacing control circuitry 304 may provide a �ventricular trigger� signal to the pacing output circuitry 302. In response to the ventricular trigger signal, the pacing output circuitry 302 may produce a ventricular pacing pulse, and provide the ventricular pacing pulse to the right ventricle of the heart 110 (FIG. 1) via the ventricular lead 106. The ventricular pacing pulse typically causes the right and left ventricles of the heart 110 to contract in unison.
The activity sensing circuit 322 senses movement or physical activity of the patient 108 (FIG. 1), and produces an �activity output� indicative of a magnitude of the movement or physical activity of the patient 108. In one embodiment, the �activity output� constitutes digital �activity values� produced at regular time intervals. In other embodiments, the activity output may be a continuous analog signal.
In the rate response operating mode, the CPU 306 (FIG. 3) may execute software instructions of the rate response software 406 (FIG. 4) as described above. In the rate response operating mode, the CPU 306 may vary the low rate limit value 502 and/or the A-V interval value 504 stored in the timing/pacing control circuitry 304, dependent upon the minute ventilation output produced by the MV sensing circuit 308 and/or the activity output produced by the activity sensing circuit 322. The transfer function value(s) 404 (FIG. 4) indicates a desired transfer function. The CPU 306 may vary the low rate limit value 502 and/or the A-V interval value 504 according to the desired transfer function indicated by the transfer function value(s) 404 to achieve a desired rate response. The desired rate response is defined by the low rate limit value 502, the high rate limit value 402, and the transfer function value(s) 404. The rate at which the pacing output circuitry 302 produces the atrial pacing pulses is varied between the low rate limit, indicated by the low rate limit value 502, and the high rate limit, indicated by the high rate limit value 402, dependent upon the minute ventilation output produced by the MV sensing circuit 308 and/or the activity output produced by the activity sensing circuit 322. For example, a �target� pacing rate at which pacing output circuitry 302 produces the atrial pacing pulses may be expressed as:
target pacing rate=low rate limit+�(sensing circuit output)
where � is a linear or monotonic function of the minute ventilation output produced by the MV sensing circuit 308 and/or the activity output produced by the activity sensing circuit 322.
The rate response function � is preferably selected such that the target pacing rate is based on a combination of the outputs of the activity sensing circuit 322 and the minute ventilation sensing circuit 308. For example, the rate response function � may be selected such that the target pacing rate is based substantially on the activity output produced by the activity sensing circuit 322 when the patient is relatively inactive, and based substantially on the minute ventilation output produced by the minute ventilation sensing circuit 308 when the patient is relatively active. Any one of several known methods for combining or �blending� outputs of activity sensors and minute ventilation sensors may be employed in generating the target pacing rate.
FIGS. 10 and 11A-B will now be used to describe an �in-office stress test� operating mode of the pacemaker 102 of FIGS. 1-3. The in-office stress test operating mode subjects the patient 108 (FIG. 1) to a stress test, during which the pacemaker 102 is used to gradually increase the rate at which the heart 110 (FIG. 1) of the patient 108 beats from a start rate to a stop rate, wherein the stop rate is greater than the start rate. During an initial portion of the stress test, the heart rate of the patient 108 is increased in a linear or monotonic fashion from the start rate to the stop rate. During a final portion of the stress test, the heart rate of the patient 108 is decreased in a linear or monotonic fashion from the stop rate to the start rate. The stress test is intended to be accomplished while the patient 108 is in a physician's office, and will therefore be referred to as an �in-office stress test� herein below. During the in-office stress test, the programming head 116 (FIG. 1 ) may be positioned in proximity of the pacemaker 102, and the pacemaker 102 may transmit lead/sensor data to the programming unit 114 (FIG. 1) for display and/or analysis.
The rate-of-change value 1004 specifies a rate at which the pacemaker 102 increases the heart rate of the patient 108 during the in-office stress test. The rate-of change value 1004 reflects a �linear acceleration� embodiment of the invention. For example, the rate-of-change value 1004 may correspond to �5 beats per minute (bpm)/30 sec.�, and may specify that the pacemaker 102 is to increase the heart rate of the patient 108 by 5 beats per minute (bpm) every 30 seconds during the in-office stress test.
FIGS. 11A and 11B in combination form a flow chart illustrating one embodiment of a method 1100 for subjecting the patient 108 (FIG. 1) to a stress test using the implantable medical device (IMD) system 100 of FIG. 1. Intended to be accomplished while the patient 108 is in a physician's office, the stress test is referred to as an �in-office stress test.�
As described above, the rate-of-change value 1004 (FIG. 10) specifies a rate at which the pacemaker 102 increases the heart rate of the patient 108 during the in-office stress test. The rate-of-change value 1004 conveys both a number of beats per minute (bpm) the heart rate of the patient 108 is to be increased, and a �rate-of-change interval� between heart rate increases. For example, the rate-of-change value 1004 may correspond to �5 beats per minute (bpm)/30 sec.�, and thus specify that the pacemaker 102 is to increase the heart rate of the patient 108 by 5 beats per minute (bpm) every 30 seconds during the in-office stress test. In this situation, the number of beats per minute (bpm) the heart rate of the patient 108 is to be increased is 5 bpm, and the rate-of-change interval conveyed by the rate-of-change value 1004 is 30 seconds.
After the heart 110 of the patient 108 has been paced by the pacemaker 102 at the maximum rate indicated by the stop rate value 1002 for an entire rate-of-change interval, the pacing rate is decreased linearly or monotonically over a period of time from the maximum rate indicated by the stop rate value 1002 to the rate indicated by the start rate value 1000. For example, a second rate-of-change value (not shown) stored within the memory 310 (FIG. 3) may specify a rate at which the pacemaker 102 is to decrease the heart rate of the patient 108 during a final portion of the in-office stress test. The second rate-of-change value may convey both a number of beats per minute (bpm) the heart rate of the patient 108 is to be decreased, and a �rate-of-change interval� between heart beats increases. For example, the second rate-of-change value may correspond to �30 beats per minute (bpm)/60 sec.�, and thus specify that the pacemaker 102 is to decrease the heart rate of the patient 108 by 30 beats per minute (bpm) every 60 seconds during the final portion of the in-office stress test.
Further, the pacemaker 102 may be configured to respond to a trigger signal, produced within the pacemaker 102 and indicating detected myocardial ischemia within the patient 108 during the in-office stress test, by aborting the stress test. For example, the pacemaker 102 may include myocardial ischemia detection software stored in the memory 310 (described below). The myocardial ischemia detection software may be executed by the CPU 306 (FIG. 3) during the in-office test, and the myocardial ischemia detection software may produce a trigger signal when myocardial ischemia is detected in the patient 108 during the in-office stress test. In response to the trigger signal, the pacemaker 102 may abort the in-office stress test. FIGS. 12 and 13A-C will now be used to describe an �ambulatory stress test� operating mode of the pacemaker 102 of FIGS. 1-3. The ambulatory stress test operating mode subjects the patient 108 (FIG. 1) to a stress test, during which the pacemaker 102 is used to gradually increase the rate at which the heart 110 (FIG. 1) of the patient 108 beats from a start rate to a stop rate, wherein the stop rate is greater than the start rate. The stress test is intended to be accomplished while the patient 108 is not in a physician's office, and will therefore be referred to as an �ambulatory stress test� herein below.
The start rate value 1204 specifies a starting pacing rate used by the pacemaker 102 at a beginning of the ambulatory stress test. The stop rate value 1206 specifies a stopping pacing rate used by the pacemaker 102 at an end of the ambulatory stress test. The rate-of-change value 1208 specifies a rate at which the pacemaker 102 increases the heart rate of the patient 108 during the ambulatory stress test. For example, the rate-of-change value 1208 may correspond to �5 beats per minute (bpm)/30 sec.�, and may specify that the pacemaker 102 is to increase the heart rate of the patient 108 by 5 beats per minute (bpm) every 30 seconds during the ambulatory stress test.
FIGS. 13A-13C in combination form a flow chart illustrating one embodiment of a second method 1300 for subjecting the patient 108 (FIG. 1) to a stress test using the implantable medical device (IMD) system 100 of FIG. 1. Intended to be accomplished while the patient 108 is not in a physician's office, the stress test is referred to as an �ambulatory stress test.�
As described above, the rate-of-change value 1208 (FIG. 12) specifies a rate at which the pacemaker 102 increases the heart rate of the patient 108 during the ambulatory stress test. The rate-of-change value 1208 conveys both a number of beats per minute (bpm) the heart rate of the patient 108 is to be increased, and a �rate-of-change interval� between heart rate increases. For example, the rate-of-change value 1208 may correspond to �5 beats per minute (bpm)/30 sec.�, and thus specify that the pacemaker 102 is to increase the heart rate of the patient 108 by 5 beats per minute (bpm) every 30 seconds during the ambulatory stress test. In this situation, the number of beats per minute (bpm) the heart rate of the patient 108 is to be increased is 5 bpm, and the rate-of-change interval conveyed by the rate-of-change value 1208 is 30 seconds.
When an ambulatory stress test is aborted for any reason, a �disable� flag (not shown) may be set in a memory location of the memory 310 (FIG. 3). Subsequent ambulatory stress tests may be blocked until the disable flag is cleared (e.g., by a physician) via the programming unit 114.
After the heart 110 of the patient 108 has been paced by the pacemaker 102 at the maximum rate indicated by the stop rate value 1206 for an entire rate-of-change interval, the pacing rate is decreased linearly or monotonically over a period of time from the maximum rate indicated by the stop rate value 1206 to the rate indicated by the start rate value 1204. For example, a second rate-of-change value (not shown) stored within the memory 310 (FIG. 3) may specify a rate at which the pacemaker 102 is to decrease the heart rate of the patient 108 during a final portion of the ambulatory stress test. The second rate-of-change value may convey both a number of beats per minute (bpm) the heart rate of the patient 108 is to be decreased, and a �rate-of-change interval� between heart rate decreases. For example, the second rate-of-change value may correspond to �30 beats per minute (bpm)/60 sec.�, and thus specify that the pacemaker 102 is to decrease the heart rate of the patient 108 by 30 beats per minute (bpm) every 60 seconds during the final portion of the ambulatory stress test.
FIG. 15 illustrates an exemplary graph of data obtained from the pacemaker 102 of FIGS. 1-3 and displayed on a display screen 1500 of the programming unit 114 of FIG. 1. The graph includes an �activity level� vertical axis, wherein the plotted activity level values represent activity levels of the patient 108 (FIG. 1) during the ambulatory stress tests. The graph also includes a �minute ventilation (MV) level during ischemia� vertical axis, wherein the plotted minute ventilation (MV) level during ischemia values represent minute ventilation (MV) levels of the patient 108 when myocardial ischemia was detected within the patient 108 during the ambulatory stress tests. The graph also includes a �heart rate (bpm) during ischemia� vertical axis, wherein the plotted heart rate (bpm) during ischemia values represent heart rates of the patient 108 in beats per minute (bpm) when myocardial ischemia was detected within the patient 108 during the ambulatory stress tests. The graph also includes an �ST deviation� vertical axis, wherein the plotted ST deviation values represent deviations of ST segments of electrogram (EGM) waveforms of the patient 108 during the ambulatory stress tests.
FIGS. 16 and 17 will now be used to describe a �record ischemic episode� operating mode and a �recreate ischemic episode� operating mode of the pacemaker 102 of FIGS. 1-3. While in the record ischemic episode operating mode, the pacemaker 102 continuously acquires lead/sensor data and stores the lead/sensor data in a buffer (e.g., a circular buffer). The pacemaker 102 also monitors the lead/sensor data for signs of myocardial ischemia within the patient 108. When the pacemaker 102 detects myocardial ischemia within the patient 108, the pacemaker 102 stops storing lead/sensor data in the circular buffer. The pacemaker 102 may then be programmed (e.g., while the patient 108 is in a physician's office) to use the stored ischemic episode data to recreate the cardiac conditions associated with the ischemic episode.
During the second portion 1710 of the method 1700, the rate at which the pacemaker 102 paces the heart 110 of the patient 108 may be increased and/or decreased linearly or monotonically over periods of time to prevent abrupt changes in heart rate. For example, the lead/sensor data stored in the lead/sensor data buffer 1602 may indicate an �ischemic� heart rate of the patient 108, occurring during the recorded ischemic episode, was substantially greater than a current heart rate of the patient 108. In this situation, a first rate-of-change value (not shown) stored within the memory 310 (FIG. 3) may specify a rate at which the pacemaker 102 is to increase the heart rate of the patient 108 from the current heart rate to the ischemic heart rate when the pacemaker 102 initially enters the recreate ischemic episode mode. A second rate-of-change value (not shown) stored within the memory 310 (FIG. 3) may specify a rate at which the pacemaker 102 is to decrease the heart rate of the patient 108 from the ischemic heart rate to the current heart rate after the ischemic episode has been recreated. The first and second rate-of-change values may convey both a number of beats per minute (bpm) the heart rate of the patient 108 is to be increased and decreased, respectively, and �rate-of-change intervals� between heart rate increases and decreases as described above.
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M.S. LC 340 710 MEDTRONIC PARKWAYMFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CONDIE, CATHERINE R. /AR;REEL/FRAME:012374/0102;SIGNING DATES FROM 20010926 TO 20010927RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google