Source: http://www.google.com/patents/US20030055461?dq=7,441,219
Timestamp: 2016-02-14 09:10:03
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Patent US20030055461 - Cardiac rhythm management systems and methods predicting congestive heart ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsThis document describes, among other things, systems, devices, and methods for predicting how the status of the patient's congestive heart failure (CHF) condition will progress in the future. In one example, a therapy is provided or adjusted at least in part in response to the prediction....http://www.google.com/patents/US20030055461?utm_source=gb-gplus-sharePatent US20030055461 - Cardiac rhythm management systems and methods predicting congestive heart failure statusAdvanced Patent SearchPublication numberUS20030055461 A1Publication typeApplicationApplication numberUS 10/213,268Publication dateMar 20, 2003Filing dateAug 6, 2002Priority dateOct 1, 1999Also published asEP1539296A1, US7127290, WO2004012815A1Publication number10213268, 213268, US 2003/0055461 A1, US 2003/055461 A1, US 20030055461 A1, US 20030055461A1, US 2003055461 A1, US 2003055461A1, US-A1-20030055461, US-A1-2003055461, US2003/0055461A1, US2003/055461A1, US20030055461 A1, US20030055461A1, US2003055461 A1, US2003055461A1InventorsSteven Girouard, Jeffrey Stahmann, Robert Sweeney, Bruce KenKnightOriginal AssigneeGirouard Steven D., Stahmann Jeffrey E., Sweeney Robert J., Kenknight Bruce H.Export CitationBiBTeX, EndNote, RefManPatent Citations (98), Referenced by (303), Classifications (7), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetCardiac rhythm management systems and methods predicting congestive heart failure status
DETAILED DESCRIPTION [0015] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents. [0016] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this documents and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls. [0017] This document discusses, among other things; systems, device., and methods that will be described in applications involving implantable medical devices including, but not limited to, implantable cardiac rhythm management systems such as pacemakers, cardioverter/defibrillators, pacer/defibrillators, biventricular or other multi-site resynchronization or coordination devices, and drug delivery systems. However, these systems, devices, and methods may be employed in unimplanted devices, including, but not limited to, external pacemakers, cardioverter/defibrillators, pacer/defibrillators, biventricular or other multi-site resynchronization or coordination devices, monitors, programmers and recorders, whether such devices are used for providing a diagnostic, a therapy, or both a diagnostic and a therapy. [0018] [0018]FIG. 1 is a schematic diagram illustrating generally, by way of example, but not by way of limitation, portions of a cardiac rhythm management system 100 capable of predicting future congestive heart failure (CHF) status. In this example, system 100 includes a hermetically sealed implantable cardiac rhythm management device 105 and a programmer or other external user interface 110. In this example, intracardiac leads 115A-B are catheters connected to device 105, with respective distal portions intravascularly introduced into heart 120. In the illustrative example of FIG. 1, a distal portion of lead 115A is introduced into a right ventricle of heart 120, and a distal portion of lead 115B is introduced through coronary sinus 125 (which, in this document, includes the great cardiac vein) into proximity with a wall of a left ventricle of heart 120. In this example, leads 115A-B each include one or more pacing and/or defibrillation electrodes, e.g., 117A-B, such as for providing pacing, resynchronization (e.g., for a CHF subject), cardioversion, and/or defibrillation therapy to heart 120. [0019] In the example of FIG. 1, device 105 carries various electrical components, such as a communication circuit 130, which is capable of wirelessly communicating with a communication circuit of nearby remote external user interface 110. In another example, communication circuit 130 is capable of wirelessly communicating with a communication circuit of a distant remote external user interface 199, such as by using a nearby external communication repeater 196. In one example, repeater 196 is coupled to user interface 199 via internet connection 197. In another example, repeater 196 also communicatively couples device 105 to an electronic medical database 198, such as via internet connection 197. In a further example, communication circuit 130 of device 105 is communicatively coupled to a communication circuit of a weight scale or other external sensor 135. In one example, device 105 additionally or alternatively includes an implantable sensor 140 therewithin or implanted nearby and coupled thereto. For predicting a future change in a subject's CHF status, system 100 includes a CHF physiological parameter input device 145 and a processor 150 for performing the prediction by computing a weighted probability using at least two CHF physiological parameters obtained from CHF parameter input device 145, thereby increasing the accuracy of the future CHF status change prediction. CHF parameter input device 145 includes one or more of external sensor(s) 135, nearby external user interface 110, distant external user interface 199, computerized patient information medical database 198, and/or implantable sensor(s) 140. In one example, device 105 also includes a therapy control module 155, which uses an indication of the predicted probability of a CHF status change occurring within a predetermined future time period as at least one factor for adjusting a therapy provided by pulse generator circuit 160 through electrodes 117A-B to heart 120. In another example, device 105 communicates an indication of the predicted probability of a CHF status (or derived therefrom) to nearby external user interface 110 and/or more distant external user interface 199 to be provided to a physician, caregiver, patient, or other user. [0020] In the example of FIG. 1, processor 150 is capable of sequencing through various control states such as, for example, by using a digital microprocessor having executable instructions stored in an associated instruction memory circuit, a microscquencer, or a state machine. However, processor 150 is capable of using many other hardware/firmware/software implementations. In the example of FIG. 1, processor 150 includes an on-board or off-board memory circuit 165, which is capable of storing data associated with at least two CHF physiologic parameters (e.g., CHF Parameter 1, CHF Parameter 2, . . . , CHF Parameter N) and corresponding conditional probabilities or other weights associated with each such parameter (e.g., Weight 1, Weight 2, . . . , Weight N). In general, each weight is computed using historical data relating the corresponding CHF physiologic parameter to CHF status. In one example, the historical data is obtained from the same subject from which the CHF physiologic information is obtained. In another example, the historical data is obtained from at least one different subject (for example, by accessing data in medical database 198). In a further example, the historical data is obtained from a population of subjects. Processor 150 also includes a CHF status change module 170, which may be implemented either in dedicated hardware or as a sequence of instructions executed by processor 150. [0021] In another example, a weight is computed using not only its corresponding CHF physiologic parameter, but also using information about which other CHF physiologic parameter (and/or how many other CHF physiologic parameters) are also being used to predict the likelihood of a change in the subject's CHF status. In an illustrative example, suppose parameters A and B each have weights of 0.1, leading to a combined prediction weight of 0.2. In another example, however, parameters A and B each have weights of 0.1, when these parameters are individually used in the CHF status change prediction, but have a different (e.g., greater or lesser) weight when both are present (e.g., a stronger weight of 0.5 when both A and B are sufficiently present and used in the CHF status change prediction. Therefore, the weight values may depend on cross-correlation between two or more different CHF physiologic parameters. In one example, a matrix is used to store the weights, and the matrix index is used to access the particular weights that are appropriate for a particular combination of CHF physiologic parameters. In another example, the weight values depend on how many CHF physiologic parameters are being used to compute the likelihood of a subject's CHF status change. As an illustrative example, suppose CHF physiologic parameter A has a weight of 0.5 when it is used alone for predicting a subject's CHF status change. In another example, however, CHF physiologic parameter has a weight of 0.25 when used in combination with one other different CHF physiologic parameter (e.g., parameter B or parameter C, etc.). [0022] In the example of FIG. 1, CHF status change module 170 includes a probability computation module 172 that computes a probability of the subject undergoing a change in CHF status using the weighted probability of the at least two CHF physiologic parameters. An indication of the computed probability is output at node 175 and input to comparator 180, which compares it to a predetermined threshold that is also input to comparator 180. The resulting comparison, which is stored at prediction storage location 185, provides a binary indication of whether the predicted change in CHF status is deemed significant. In one example, either this binary indication at node 190 of whether the predicted CHF status change is significant, or the underlying probability of a change in CHF status at 195 is provided to therapy control module 155, which responsively adjusts one or more therapy parameters controlling how pulse generator circuit 160 delivers therapy to heart 120. Either or both of the status indicators at 175 and/or 190 can also be communicated via nearby user interface 110 and/or more distant user interface 199. [0023] [0023]FIG. 2 is a graph illustrating generally, by way of example, but not by way of limitation, various CHF physiological parameters 200A-S, at least two of which are used in the probability computation 205 to provide a weighted probability at 210 of a CHF status change occurring during a predetermined future time period. The probability at 210 is computed by normalizing an indication of each of the two or more CHF physiological parameters 200A-S (to obtain Pi) and scaling each such normalized CHF physiological parameter 200A-S by its corresponding weight, Wi, and summing the resulting products. [0024] In one example, fluid in the subject's lungs (i.e., acute pulmonary edema) is used as a CHF physiologic parameter 200A. In one example, acute pulmonary edema is measured by an implantable sensor 140 that senses transthoracic impedance, a low frequency component of which changes with edema status. In another example, acute pulmonary edema is measured on an X-ray by a user, and an indication of the degree of edema is input to CHF parameter input device 145 by the user at external user interface 110. An increase in pulmonary edema correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0025] In another example, the subject's weight is used as a CHF physiologic parameter 200B. In one example, the subject's weight is measured by an external sensor 135 having a scale coupled to a wireless communication circuit that is capable of communicating with communication circuit 130 in implantable device 105. In another example, the subject's weight is measured on an external scale, and manually input by the subject, caregiver, or another user to nearby external user interface 110, and wirelessly communicated to communication circuit 130 of implantable device 105. An increase in weight correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0026] In another example, the subject's shortness of breath while sleeping (i.e., paroxysmal nocturnal dyspnea) is used as a CHF physiologic parameter 200C. In one example, paroxysmal nocturnal dyspnea is measured by implantable sensors 140 including a respiration sensor (e.g., an impedance sensor) to detect the shortness of breath and a sleep detector. One example of a sleep detector is described in Carlson et al. U.S. patent application Ser. No. 09/802,316, entitled “CARDIAC RHYTHM MANAGEMENT SYSTEM USING TIME-DOMAIN HEART RATE VARIABILITY INDICIA,” which is assigned to Cardiac Pacemakers, inc., and which is incorporated herein by reference in its entirety, including its description of a sleep detector. In another example, the subject, caregiver, or another user enters an indication of the degree of paroxysmal nocturnal dyspnea into nearby external user interface 110 of CHF parameter input device 145. An increase in paroxysmal nocturnal dyspnea correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0027] In another example, the subject's shortness of breath while lying down, i.e., orthopnea, is used as a CHF physiologic parameter 200D. In one example, orthopnea is measured by implantable sensors 140 including a respiration sensor (e.g., an impedance sensor) to detect the shortness of breath and a posture sensor (e.g., an accelerometer). In another example, the subject, caregiver, or another user enters an indication of the degree of orthopnea into external user interface 110 of CHF parameter input device 145. An increase in orthopnea correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0028] In another example, the subject's changed respiration sounds (e.g., increased rales) is used as a CHF physiologic parameter 200E. In one example, the changed respiration sounds are measured by implantable sensor 140 including a microphone, accelerometer, or other like sound detector. In another example, the subject, caregiver, or another user enters an indication of the degree of increased rales into external user interface 110 of CHF parameter input device 145. An increase in rales correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0029] In another example, the subject's heart sounds (for example, heart sounds referred to in the art as S1, S2, and particularly the heart sound referred to in the art as S3) are used as a CHF physiologic parameter 200F. In one example, the heart sounds are measured by implantable accelerometer or other sensor 140, such as by using the systems and methods described in Lincoln et al. U.S. patent application Ser. No. 09/862,763, entitled “CARDIAC RHYTHM MANAGEMENT SYSTEM SELECTING A-V DELAY BASED ON INTERVAL BETWEEN ATRIAL DEPOLARIZATION AND MITRAL VALVE CLOSURE,” and/or the systems and methods described in Lincoln et al. U.S. Patent Application Serial Number 10/099,865, entitled “CARDIAC RHYTHM MANAGEMENT SYSTEM AND METHOD USING TIME BETWEEN MITRAL VALVE CLOSURE AND AORTIC EJECTION,” each of which is assigned to Cardiac Pacemakers, Inc., and the disclosure of each of which is incorporated herein by reference in its entirety, including its description of heart sound detection. An increase in certain heart sounds (e.g., S3) correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0030] In another example, the subject's neck vein distension (e.g., bulging neck vein) is used as a CHF physiologic parameter 200G. In one example, the subject, caregiver, or another user enters an indication of the degree of neck vein distension into external user interface 110 of CHF parameter input device 145. An increase in neck vein distension correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0031] In another example, the subject's abdominojugular reflex (e.g., bulging of neck vein upon applying compression to the subject's thorax) is used as a CHF physiologic parameter 200H. In one example, the subject, caregiver, or other user enters an indication of the degree of abdominojugular reflex into external user interface 110 of CHF parameter input device 145. An increase in abdominojugular reflex correlates to a future worsening of the subject's CHF status during the predetermined time period. [0032] In another example, the subject's cardiomegaly (i.e., enlargement of heart) is used as a CHF physiologic parameter 200I. In one example, the subject's heart size is measured by implantable sensor 140 (e.g., a transthoracic impedance sensor). For example, a reduced cardiac stroke component of a transthoracic impedance signal correlates to an increase in heart size. In another example, the subject, caregiver, or another user enters an indication of the subject's heart size, based on an echocardiogram or other imaging measurement, into external user interface 110 of CHF parameter input device 145. An increase in heart size correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0033] In another example, the subject's intravascular blood pressure is used as a CHF physiologic parameter 200J. In one example, the subject's intravascular blood pressure is measured by implantable sensor 140 (e.g., a vena cava or right atrial pressure transducer). In another example, the subject, caregiver, or another user enters an indication of the subject's intravascular blood pressure (e.g., based on an external measurement) into external user interface 110 of CHF parameter input device 145. An increase in intravascular blood pressure correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0034] In another example, the subject's dyspnea on exertion is used as a CHF physiologic parameter 200K. In one example, the rapid shallow breathing associated with dyspnea is measured by implantable sensors 140 including a respiration sensor (e.g., an impedance sensor) and an activity sensor (e.g., an accelerometer) to detect exertion. For example, an increase in respiratory rate together with an increase in activity, if accompanied by a decrease in tidal volume of the respiration, is indicative of dyspnea on exertion. In another example, the subject, caregiver, or another user enters an indication of the subject's dyspnea on exertion into external user interface 110 of CHF parameter input device 145. An increase in dyspnea on exertion correlates to a future worsening of the subject's CHF status during the future predetermined time period. [0035] In another example, the subject's night cough (or cough while lying down) is used as a CHF physiologic parameter 200L. In one example, the night cough is measured by an implantable sensor(s) 140 (e.g., a transthoracic impedance sensor) to detect the cough and a clock, a sleep detector, or a posture detector to respectively detect a time period during the night, the subject's sleep, and/or the subject's lying down. In another example, the subject, caregiver, or another user enters an indication of the subject's night cough into external user interface 110 of CHF parameter input device 145. An increase in night cough (or cough while lying down) correlates to a future worsening of the subject's CHF status during the future predetermined time period. [0036] In another example, the subject's heart rate is used as a CHF physiologic parameter 200M. In one example, heart rate is measured using an implantable sensor 140 (e.g., a cardiac signal sense amplifier coupled to an electrode 117A and/or 117B). In another example, the subject, caregiver, or another user enters an indication of the subject's heart rate (e.g., based on an external measurement) into external user interface 110 of CHF parameter input device 145. An increase in heart rate (e.g., average resting heart rate) correlates to a future worsening of the subject's CHF status during the future predetermined time period. [0037] In another example, the subject's pleural effusion (i.e., fluid in the subject's chest, but outside the subject's lungs) is used as a CHF physiologic parameter 200N. In one example, pleural effusion is measured by an implantable sensor 140 that senses transthoracic impedance, a low frequency component of which changes with pleural effusion status. In another example, pleural effusion is measured on an X-ray or other image by a user, and an indication of the degree of pleural effusion is input to CHF parameter input device 145 by the user at external user interface 110. An increase in pleural effusion correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0038] In another example, the subject's hepatomegaly (i.e., liver enlargement) is used as a CHF physiologic parameter 2000. In one example, hepatomegaly is measured on an X-ray or other image by a user, and an indication of the degree of hepatomegaly is input to CHF parameter input device 145 by the user at external user interface 110. An increase in hepatomegaly correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0039] In another example, the subject's peripheral edema (i.e., fluid retention in the extremities) is used as a CHF physiologic parameter 200P. In one example, a user, physician, or caregiver measures a swollen arm or leg (e.g., using a tape measure) and inputs an indication of the degree of peripheral edema to CHF parameter input device 145 at external user interface 110. An increase in peripheral edema correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0040] In another example, the subject's left ventricular end diastolic pressure (LVEDP) is used as CHF physiologic parameter 200Q. In one example, LVEDP is measured using an implantable pressure sensor 140 disposed within in the subject's left ventricle. An increase in LVEDP correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0041] In another example, the subject's left atrial pressure (“LA pressure”) is used as CHF physiologic parameter 200R. In one example, LA pressure is measured using an implantable pressure sensor 140 disposed within in the subject's left atrium. An increase in LA pressure correlates to a future worsening of the subject's CHF status during the predetermined future time period. [0042] In another example, the subject's brain natriaetic peptide (BNP) level is used as CHF physiologic parameter 200S. BNP is released by the subject's body in response to left ventricular stress. An increase in BNP correlates to a future worsening of the subject's CHF status during the predetermined future time period. In one example, the subject's BNP level is measured by an external blood test, and an indication of the BNP level is input to CHF parameter input device 145 by the user at external user interface 110. In another example, the subject's BNP level is measured by an implantable sensor 140 or an external (e.g., transdermal) sensor 135. [0043] In a further example, therapy control module 155 adjusts a therapy being provided by pulse generator 160 to heart 120 based on at least one of the binary indication predicting whether a significant change in CHF status is expected to occur within a predetermined future time period or on the multivalued underlying probability of the change in CHF status. In one example, such therapy adjustment includes changing which electrodes are being used to deliver cardiac resynchronization therapy for spatially coordinating heart contractions. [0044] In another example, such therapy adjustment includes initiating or adjusting paired pacing. Paired pacing involves delivering a premature electrical energy pulse to a portion of the heart during a time period that excites heart tissue, but does not cause a corresponding heart contraction. The energy thus delivered increases an intracellular calcium concentration, and is followed by delivery of a second energy pulse during an immediately subsequent time period that does trigger a resulting heart contraction. Thus, in this example, pacing a particular heart chamber of a subject at 75 beats per minute includes delivering pairs of pacing pulses at the 75 beats per minute rate, the first pacing pulse in the pair increasing intracellular calcium concentration, but not triggering a resulting heart chamber contraction, and the second pacing pulse in the pair using the increased calcium concentration in triggering a resulting heart chamber contraction. [0045] In an alternative example, the probability computation 205 takes the form of a conditional probability computation, such as described in Sweeney et al. U.S. Pat. No. 6,272,377, which is assigned to Cardiac Pacemakers, Inc., and which is incorporated by reference herein in its entirety, including its description of using conditional probabilities to predict the likelihood of occurrence of a future event. In the present context, the future event is a CHF status change, and the CHF physiologic parameters serve as triggers/markers or, more generally, conditioning events. The weights correlating each CHF physiologic parameter to a future CHF status change are conditional probabilities that may alternatively be expressed as rates, as described in the above-incorporated Sweeney et al. reference. [0046] One such example includes detecting a conditioning event (e.g., one of CHF physiologic parameters 200A-S) statistically associated with the occurrence of a CHF status change in a subject. In this example, device 105 predicts the occurrence of a CHF status change within a specified prediction time period if an estimated CHF status change probability exceeds a specified threshold value. The estimated CHF status change probability is computed from a conditional CHF status change probability, associated with the conditioning event, that is derived from past observations of instances in which the conditioning event occurs alone or together with a CHF status change within a specified time period. [0047] In a further example, the conditional CHF status change probability CP is a ratio of the number of observed instances in which the conditioning event is followed by a CHF status change within a specified basic time period to the total number of observed instances of the conditioning event. In a further example, this involves estimating a rate C at which the conditioning event occurs. The estimated CHF status change probability is then calculated by the expression: [0048] estimated CHF status change probability=CP�(1−e−CT), where T is a measure of the specified prediction time period. In one example, the conditional CHF status change probability is calculated by the expression: CP=1−e −RT, [0049] where T is a measure of the specified prediction time period, and R is an estimate of the rate at which the CHF status changes occur while the conditioning event is present. In a further example, a plurality of conditioning events statistically associated with the occurrence of a CHF status change are detected, and a composite estimated CHF status change probability is compared with a threshold value in order to predict the occurrence of a CHF status change. The composite CHF status change probability is associated with a combination of the estimated CHF status change probabilities associated with each detected conditioning event, such as described in the above-incorporated Sweeney et al. reference. [0050] It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-discussed examples may be used in combination with each other. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. 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EventsDateCodeEventDescriptionNov 18, 2002ASAssignmentOwner name: CARDIAC PACEMAKERS, INC., MINNESOTAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GIROUARD, STEVEN D.;STAHMANN, JEFFREY E.;SWEENEY, ROBERTJ.;AND OTHERS;REEL/FRAME:013492/0131;SIGNING DATES FROM 20021015 TO 20021029Dec 11, 2007CCCertificate of correctionApr 14, 2010FPAYFee paymentYear of fee payment: 4Mar 26, 2014FPAYFee paymentYear of fee payment: 8RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services