Source: http://www.google.com/patents/US20050102002?dq=5,912,661
Timestamp: 2016-02-10 03:20:57
Document Index: 55446064

Matched Legal Cases: ['art 101', 'art 101', 'art 101', 'art 101', 'art 101', 'art 101', 'art 101', 'art 101']

Patent US20050102002 - Electrical therapy for diastolic dysfunction - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsPacing pulses are delivered to one or more cardiac regions to improve diastolic performance in patients having diastolic dysfunction and/or heart failure. A cardiac pacing system executes a pacing algorithm using a parameter indicative of the diastolic performance as an input. The pacing pulses excite...http://www.google.com/patents/US20050102002?utm_source=gb-gplus-sharePatent US20050102002 - Electrical therapy for diastolic dysfunctionAdvanced Patent SearchPublication numberUS20050102002 A1Publication typeApplicationApplication numberUS 10/703,398Publication dateMay 12, 2005Filing dateNov 7, 2003Priority dateNov 7, 2003Also published asEP1680179A2, EP1680179B1, EP2314347A1, EP2314347B1, US9002452, WO2005046788A2, WO2005046788A3Publication number10703398, 703398, US 2005/0102002 A1, US 2005/102002 A1, US 20050102002 A1, US 20050102002A1, US 2005102002 A1, US 2005102002A1, US-A1-20050102002, US-A1-2005102002, US2005/0102002A1, US2005/102002A1, US20050102002 A1, US20050102002A1, US2005102002 A1, US2005102002A1InventorsRodney Salo, Matthew SaloOriginal AssigneeSalo Rodney W., Matthew SaloExport CitationBiBTeX, EndNote, RefManPatent Citations (36), Referenced by (103), Classifications (7), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetElectrical therapy for diastolic dysfunction
DETAILED DESCRIPTION [0019] 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 spirit and scope of the present invention. The following detailed description provides examples, and the scope of the present invention is defined by the appended claims and their equivalents. [0020] It should be noted that references to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. [0021] This document discusses, among other things, a cardiac pacing method and apparatus for improving diastolic performance in patients suffering diastolic dysfunction and/or heart failure. Such patients generally have an ejection fraction of greater than 50%, an absence of significant mitral regurgitation, and symptoms of heart failure resulted from problems in the relaxation of the heart. [0022] Left ventricular (LV) mechanical dyssynchrony (also referred to as asynchrony) due to delayed electrical activation has been shown to impact LV systolic function. Cardiac resynchronization therapy (CRT) improves hemodynamic performance by delivering pacing pulses to one or more regions in lateral ventricular walls such that the ventricles contract in synchrony to result in a more efficient ejection of blood during systole. A study indicates that most patients with diastolic dysfunction also have significant LV dyssynchrony, with abnormally heavy loading on the septal wall. Thus, a treatment for these patient includes delivering pacing pulses to pre-excite the septal wall, thereby reducing the loading on the septal wall and providing a more uniform distribution of loading across the LV wall. More generally, pacing pulses are delivered to one or more most heavily loaded cardiac regions, i.e., the regions that contribute the most to the contraction or the ejection of blood, to restore LV mechanical synchrony during diastole. [0023] FIG. 1A is a schematic/block diagram illustrating one embodiment of a cardiac pacing system 100 for improving diastolic performance and portions of the environment in which system 100 is used. In one embodiment, cardiac pacing system 100 includes leads 110A-B, a sensing circuit 112, a pacing circuit 114, a diastolic performance sensor 116, a signal processor 130, and a pacing controller 120. [0024] Leads 110A-B are intracardiac pacing leads each including one or more electrodes for sensing electrogram from and delivering pacing pulses to a predetermined region within a heart 101. Leads 110A-B provide for electrical connections between sensing circuit 112 and heart 101 and between pacing circuit 114 and heart 101. In one embodiment, diastolic performance sensor 116 is also incorporated into one of leads 110A-B for intracardiac placement. In the embodiment illustrated in FIG. 1, lead 110A is an atrial pacing lead with one or more electrodes for placement in the RA of heart 101, lead 110B is an transeptal pacing lead with at least one electrode fixable onto the septum of heart 101. One example of the transeptal pacing lead providing for access to the septum through the RV for LV septal excitation by pacing is discussed in U.S. Pat. No. 5,728,140, “METHOD FOR EVOKING CAPTURE OF LEFT VENTRICLE USING TRANSEPTAL PACING LEAD,” assigned to Cardiac Pacemakers, Inc., which is hereby incorporated by reference in its entirety. In other embodiments, cardiac pacing system 100 includes one or more pacing leads in additional to leads 110A-B to provide access to additional intracardiac regions, such as regions within the RV and/or LV including additional septal regions. [0025] In the embodiment illustrated in FIG. 1A, sensing circuit 112 senses RA and septal electrograms through leads 110A-B, and pacing circuit 114 delivers pacing pulses to at least the septum through lead 10B. In one embodiment, pacing circuit 114 delivers pacing pulses to RA and the septum through leads 110A-B. In other embodiments, where additional leads are included, sensing circuit 112 senses additional electrograms and, when necessary, pacing circuit 114 delivers pacing pulses to additional sites through the additional leads. [0026] Pacing controller 120 controls whether, where, and when to deliver the pacing pulses using the electrograms and a diastolic performance parameter as inputs. Diastolic performance sensor 116 senses a signal indicative of a diastolic function. Signal processor 130 process the signal. In one embodiment, signal processor 130 includes a diastolic performance parameter generator 132 to produce the diastolic performance parameter based on the signal indicative of the diastolic function. [0027] In one embodiment, diastolic performance sensor 116 includes a pressure sensor to sense a signal indicative of an LV pressure. In one specific embodiment, diastolic performance sensor 116 is placed in the LV to directly sense the LV pressure. In other embodiments, diastolic performance sensor 116 indirectly senses the LV pressure, by sensing another pressure having a known or predictable relationship with the LV pressure. Examples of pressures having known or predictable relationships with the LV pressure during all or a portion of the cardiac cycle include an LA pressure and a coronary vein pressure. One specific example of measuring the LV pressure using a coronary vein pressure sensor is discussed in U.S. patent application Ser. No. 10/038,936, “METHOD AND APPARATUS FOR MEASURING LEFT VENTRICULAR PRESSURE,” filed on Jan. 4, 2002, assigned to Cardiac Pacemakers, Inc., which is hereby incorporated by reference in its entirety. In one embodiment, diastolic performance parameter generator 132 includes a diastolic pressure detector to detect a left ventricular end diastolic pressure (LVEDP) from the signal indicative of the LV pressure. The diastolic performance parameter is the LVEDP. In another embodiment, diastolic performance parameter generator 132 includes a diastolic pressure timer to measure a time constant (tau) related to a decrease in the left ventricular pressure. The diastolic performance parameter is that time constant. [0028] In another embodiment, diastolic performance sensor 116 includes a pulmonary flow sensor to sense a signal indicative of a pulmonary venous blood flow. In one specific embodiment, the pulmonary flow sensor includes a pulmonary impedance sensing circuit to sense the pulmonary impedance, indicative of the pulmonary blood volume. Diastolic performance parameter generator 132 includes a velocity detector to calculate an antegrade pulmonary venous blood velocity based on the signal indicative of the pulmonary venous blood flow. The diastolic performance parameter is the pulmonary venous blood velocity. [0029] In another embodiment, diastolic performance sensor 116 includes a mitral flow sensor to sense a signal indicative of blood flow through the mitral valve. In one specific embodiment, the mitral flow sensor includes an impedance sensor to a measure an LV volume. The LV volume is derived from an impedance measured between electrodes in the right ventricle and in a left ventricular coronary vein. One example of such an impedance sensor and measurement is discussed in U.S. Pat. No. 6,278,894, “MULTI-SITE IMPEDANCE SENSOR USING CORONARY SINUS/VEIN ELECTRODES,” assigned to Cardiac Pacemakers, Inc., which is hereby incorporated by reference in its entirety. The time-derivative of this LV volume signal during diastole (after the opening of the mitral valve at the end of ejection) is a measure of the blood flow through the mitral valve. The peak blood flow during diastole, the duration of the rapid initial blood flow during diastole, and the time constant of the decrease in the blood flow during diastole are all useful measures of diastolic performance. Diastolic performance parameter generator 132 includes one or more of a peak detector to detect the peak blood flow, a timer to measure the duration of the rapid initial blood flow, and another timer to measure the time constant of the decrease in the blood flow. The diastolic performance parameter includes one of the peak blood flow, the duration of the rapid initial blood flow, and the time constant of the decrease in the blood flow during diastole. [0030] In another embodiment, diastolic performance sensor 116 includes an acoustic sensor to sense a signal indicative of heart sounds. In one specific embodiment, the acoustic sensor includes an accelerometer. In another specific embodiment, the acoustic sensor includes a microphone. Diastolic performance parameter generator 132 includes a heart sound analyzer to detect a diastolic acoustic noise from the signal indicative of heart sounds. The diastolic performance parameter is the diastolic acoustic noise. The diastolic acoustic noise is the total acoustic noise measured over the diastolic phase of one cardiac cycles. Examples of methods for calculating the total acoustic noise measured over a predetermined time period are discussed in U.S. Pat. No. 6,044,298, “OPTIMIZATION OF PACING PARAMETERS BASED ON MEASUREMENT OF INTEGRATED ACOUSTIC NOISE,” and U.S. Pat. No. 6,058,329, “OPTIMIZATION OF PACING PARAMETERS BASED ON MEASUREMENT OF ACOUSTIC NOISE,” both assigned to Cardiac Pacemakers, Inc., which are hereby incorporated by reference in their entirety. [0031] FIG. 1B is a schematic/block diagram illustrating one embodiment of pacing controller 120. Pacing controller 120 receives the diastolic performance parameter and uses it to determine and/or adjust one or more pacing parameters. Pacing controller 120 includes a pacing parameter optimization module 124 and a pacing algorithm execution module 122. Pacing parameter optimization module 124 receives the diastolic performance parameter and calculates one or more approximately optimal pacing parameters based on at least the diastolic performance parameter. In one embodiment, the approximately optimal pacing parameter is a pacing parameter predicted to provide a target value (including a maximum or minimum value) for the diastolic performance parameter. In another embodiment, the approximately optimal pacing parameter is a pacing parameter predicted to maintain a threshold value for the diastolic performance parameter. In one specific embodiment, the target or threshold value for the diastolic performance parameter is determined based on systemic considerations including both systolic and diastolic performance of heart 101. In one embodiment, pacing parameter optimization module 124 includes a pacing site selector to select one or more pacing sites and a pacing timing calculator to calculate one or more pacing timing parameters such as atrioventricular and interventricular pacing delays. Pacing algorithm execution module 122 controls the delivery of the pacing pulses by executing a predetermined pacing algorithm using the one or more approximately optimal pacing parameters. In one embodiment, the predetermined pacing algorithm defines an atrial tracking pacing mode such as a DDD or a VDD mode. The one or more approximately optimal pacing parameters include an atrioventricular pacing delay. In one embodiment, wherein multiple ventricular leads are applied to provide sensing and pacing of multiple ventricular sites, the one or more approximately optimal pacing parameters include one or more atrioventricular pacing delays, one or more interventricular pacing delays, and/or one or more pacing sites to which pacing pulses are actually delivered. [0032] FIG. 2 is a schematic/block diagram illustrating one embodiment of portions of a cardiac rhythm management (CRM) system 200 and portions of the environment in which system 200 is used. CRM system 200 incorporates cardiac pacing system 100 to provide a pacing therapy to heart 101. In one embodiment, CRM system 200 includes an implantable system 235, an external system 255, and a telemetry link 245 providing for bidirectional communication between implantable system 235 and external system 255. Implantable system 235 includes an implantable device 240 and a lead system 210. Implantable device 240 is implanted within a body 202 and coupled to heart 101 via lead system 210. Examples of implantable device 240 include pacemakers, pacemaker/defibrillators, cardiac resynchronization devices, cardiac remodeling control devices, and any other implantable medical devices with a pacing function. In one embodiment, lead system 210 includes leads 110A-B and additional pacing leads, if any. In another embodiment, diastolic performance sensor 116 is incorporated in a lead of lead system 210. In one embodiment, external system 255 is a patient management system including an external device 250 in proximity of implantable device 240, a remote device 270 in a relatively distant location, and a telecommunication network 260 linking external device 250 and remote device 270. An example of such a patient management system is discussed in U.S. patent application Ser. No. 10/323,604, “ADVANCED PATIENT MANAGEMENT FOR DEFINING, IDENTIFYING AND USING PREDETERMINED HEALTH-RELATED EVENTS,” filed on Dec. 18, 2002, assigned to Cardiac Pacemakers, Inc., which is incorporated herein by reference in its entirety. The patient management system allows access to implantable system 235 from a remote location, for purposes such as monitoring patient status and adjusting therapies. In another embodiment, external system 255 includes a programmer. In one embodiment, telemetry link 245 is an inductive telemetry link. In an alternative embodiment, telemetry link 245 is a far-field radio-frequency telemetry link. In one embodiment, telemetry link 245 provides for data transmission from implantable device 240 to external system 255. This may include, for example, transmitting real-time physiological data acquired by implantable device 240, extracting physiological data acquired by and stored in implantable device 240, extracting therapy history data stored in implantable device 240, and extracting data indicating an operational status of implantable device 240 (e.g., battery status and lead impedance). In a further embodiment, telemetry link 245 provides for data transmission from external system 255 to implantable device 240. This may include, for example, programming implantable device 240 to acquire physiological data, programming implantable device 240 to perform at least one self-diagnostic test (such as for a device operational status), and programming implantable device 240 to deliver at least one therapy. [0033] The physical distribution of cardiac pacing system 100 in CRM system 200 depends on practical factors such as the size and power constraints for an implantable device, computational power of the implantable device, and convenience of implementation and use. In one embodiment, cardiac pacing system 100 is included in implantable system 235. This embodiment allows for a diastolic performance based feedback loop (including diastolic performance sensor 116, signal processor 130, pacing controller 120, and pacing circuit 114) to operate continuously, without the need to communicate with external system 255. In another embodiment, portions of cardiac pacing system 100 are included in implantable system 235, and the remaining portions are included in external system 255. In one specific embodiment, external system 255 includes diastolic performance parameter generator 132 and pacing parameter optimization module 124. The signal sensed by diastolic performance sensor 116 is transmitted to external system 255 via telemetry link 245. One or more approximately optimal pacing parameters are transmitted to implantable device 240 via telemetry 245. Including portions of cardiac pacing system 100 in external system reduces size, power, and/or computational demands on implantable device 240. [0034] FIG. 3 is a flow chart illustrating one embodiment of a method for improving diastolic performance by cardiac pacing. The method determines and adjusts one or more pacing parameters based on a sensed signal indicative of a diastolic function. In one embodiment, the method is performed by cardiac pacing system 100. [0035] The signal indicative of the diastolic function is sensed at 300. A diastolic performance parameter is derived from that signal at 310. In one embodiment, the signal indicative of the diastolic function is a signal indicative of an LV pressure, and the diastolic performance parameter is an LVEDP measured from the signal indicative of the LV pressure. In another embodiment, the signal indicative of the diastolic function is a signal indicative of an LV pressure, and the diastolic performance parameter is a time constant (tau) related to a decrease in the LV pressure. In another embodiment, the signal indicative of the diastolic function is a signal indicative of a pulmonary venous blood flow, and the diastolic performance parameter is an antegrade pulmonary venous blood velocity calculated based on the signal indicative of the pulmonary venous blood flow. In another embodiment, the signal indicative of the diastolic function is a signal indicative of blood flow through the mitral valve, and the diastolic performance parameter is the peak blood flow, the duration of the initial blood flow peak, or time constant related to the decrease in the blood flow during diastole. In another embodiment, the signal indicative of the diastolic function is a signal indicative of heart sounds, and the diastolic performance parameter is a diastolic acoustic noise detected from the signal indicative of heart sounds. [0036] One or more approximately optimal pacing parameters are calculated based on at least the diastolic performance parameter at 320. In one embodiment, the one or more approximately optimal pacing parameters include one or more pacing timing parameters such as atrioventricular pacing delays and interventricular pacing delays. In another embodiment, the one or more approximately optimal pacing parameters include one or more pacing sites. The one or more pacing sites includes one or more ventricular regions doing most of the work in ventricular contraction and blood ejection. In one embodiment, the one or more pacing sites includes at least one site in the ventricular septum. In one specific embodiment, the one or more pacing sites includes at least one site in the LV septum. [0037] A predetermined pacing algorithm is executed at 330. The pacing algorithm execution includes generating commands to control a delivery of pacing pulses. As the predetermined pacing algorithm is being executed, cardiac signals are sensed at 340, and pacing pulses are delivered at 350. The pacing algorithm applies a set of predetermined pacing logic rules and parameters to determine the timing and/or site for each pacing pulse delivery using the one or more approximately optimal pacing parameters and the sensed cardiac signals as inputs. [0038] FIG. 4 is an exemplary LV regional displacement diagram used for determining sties for placement of one or more ventricular pacing electrodes. To deliver the pacing pulses to improve diastolic performance, implantable device 240 and lead system 210 are implanted in body 202. The implantation of lead system 210 includes placement of electrodes on each lead in predetermined cardiac sites. [0039] In one embodiment, an LV echocardiogram is recorded and analyzed using an echocardiographic analysis system such as Echo-CMS (Echocardiographic Measurement System) by Medis, Leiden, Netherlands (Medis Echo-CMS). The Medis Echo-CMS automatically detects LV wall motion contours in sequential echocardiographic image frames over several (e.g., two to five) cardiac cycles, and calculates average LV regional endocardial displacement over one cardiac cycle for 100 equally spaced segments on the LV wall motion contours, as illustrated in FIG. 4. An example of such an embodiment is discussed in U.S. patent application Ser. No. 10/402,324, “METHOD AND APPARATUS FOR QUANTIFICATION OF CARDIAC WALL MOTION ASYNCHRONY,” filed on Mar. 28, 2003, assigned to Cardiac Pacemakers, Inc., which is incorporated herein by reference in its entirety. [0040] In FIG. 4, the magnitudes of the LV regional endocardial displacement are shown by lines 490 for the 100 equally spaced segments on the LV wall motion contours. Contours 492 and 494 show the overall LV endocardial displacement range over one cardiac cycle. The distance between contours 492 and 494 at any region shows the wall displacement over one cardiac cycle for that region. As illustrated in FIG. 4, twenty contiguous segments of the 100 equally spaced segments on the LV wall motion contours are combined into five regions labeled 1 through 5. The LV septal wall is on the left and approximately includes regions 1 and 2. In one embodiment, diastolic performance is improved by delivering pacing pulses to pre-excite the region showing the largest LV regional displacement covariant with the overall LV area or volume change, i.e., the region contributing the most to LV contraction or ejection of the blood from the LV. In the example of FIG. 4, pacing pulses are to be delivered to at least region 2. [0041] FIG. 5 is a flow chart illustrating one embodiment of a procedure for determining and delivering a pacing therapy to improve diastolic performance. The effectiveness of delivering pacing pulses to improve a measure of diastolic performance is being predicted at 500. The effectiveness is predicted when a patient is diagnosed to have conditions meeting a set of criteria and accepts the therapy. The criteria include, by way of example, but not by way of limitation, an ejection fraction greater than 50%, absence of significant mitral regurgitation, and manifestation of symptoms of heart failure due to high filling LA pressures. In one embodiment, the effectiveness prediction further includes an echocardiographic analysis providing an LV regional displacement diagram such as the one shown in FIG. 4. The effectiveness of delivering pacing pulses to improve the diastolic performance is predicted when the LV regional endocardial displacements are significantly non-uniform across the LV wall. In one embodiment, the LV endocardial wall is divided into multiple regions. An average LV regional endocardial displacement is calculated for each of the regions. In one specific embodiment, the effectiveness of delivering pacing pulses is predicted when the average LV regional endocardial displacement of at least one of the regions exceeds a predetermined threshold. In another specific embodiment, the effectiveness of delivering pacing pulses is predicted or when the largest difference between the average LV regional endocardial displacements for any two of the regions exceeds a predetermined threshold. [0042] If delivering pacing pulses is predicted to be effective and accepted by the patient, the pacing pulses are delivered to one or more cardiac regions to treat the diastolic dysfunction at 510. Delivering the pacing pulses includes determining one or more electrode sites at 512, determining a pacing mode at 514, determining one or more pacing parameters at 516, and adjusting the one or more pacing parameters at 518. [0043] In one embodiment, one or more ventricular regions showing the most contribution to the LV contraction are selected as the one or more electrode sites at 512. An electrode site is the site for the placement of an electrode during lead implantation as discussed above with reference to FIG. 4. A study has shown that the one or more pacing sites likely include at least one site in an LV septal region. In one specific embodiment, the LV septal region is paced using an insulated electrode fixed into the septum through the right ventricle, as discussed above (U.S. Pat. No. 5,728,140). One specific example of a method for determining the one or more electrode sites is discussed above with reference to FIG. 4. [0044] In one embodiment, an atrial tracking mode is selected at 514. If the patient retains a normal sinus rhythm, a VDD pacing mode is selected. Otherwise, a DDD pacing mode is selected. The VDD and DDD pacing modes each include a multi-ventricular-site version when more than one ventricular pacing sites are selected. [0045] In one embodiment, one or more pacing parameters are determined based on a diastolic performance parameter at 516. This includes sensing a signal indicative of a diastolic function and deriving the one or more pacing parameters from the sensed signal. Specific examples of a method for determining one or more approximately optimal pacing parameters are discussed above with reference to FIG. 3. In one specific embodiment, after the one or more electrode sites are selected at 512, they are individually activated using a pacing parameter specifying one or more actual pacing sites. In one specific embodiment, the one or more actual pacing sites are determined by selecting from the one or more electrode sites on a beat-by-beat basis. [0046] In one embodiment, after an initial determination, the one or more pacing parameters are adjusted at 518. This includes sensing the signal indicative of the diastolic function and updating the one or more pacing parameters based on the sensed signal. In one specific embodiment, the one or more pacing parameters are dynamically and continuously adjusted. In another specific embodiment, the one or more pacing parameters are periodically adjusted. In another specific embodiment, the one or more pacing parameters are adjusted when a need develops, such as when the patient's physiological or pathological condition changes. [0047] In one embodiment, the pacing pulses are delivered to treat diastolic dysfunction as well as other pathological conditions such as systolic dysfunction. In one embodiment, steps 512, 514, 516, and 518 are each performed as part of a systemic approach optimizing a therapy for improving an overall hemodynamic performance. In one specific embodiment, the one or more pacing parameters are determined and adjusted to improve both systolic and diastolic performances. In one specific embodiment, the one or more pacing parameters are determined and adjusted to maintain predetermined minimum systolic and minimum diastolic performance. In another specific embodiment, the one or more pacing parameters are determined and adjusted to maintain a minimum systolic performance while maximizing the diastolic performance, or to maintain a minimum diastolic performance while maximizing the systolic performance. Examples of determining approximately optimal pacing parameters for improving systolic performance are discussed in U.S. patent application Ser. No. 10/314,910, “METHOD AND APPARATUS FOR OPTIMIZING VENTRICULAR SYNCHRONY DURING DDD RESYNCHRONIZATION THERAPY USING ADJUSTABLE ATRIO-VENTRICULAR DELAYS,” and U.S. patent application Ser. No. 10/314,899, “METHOD AND APPARATUS FOR OPTIMIZING STROKE VOLUME DURING DDD RESYNCHRONIZATION THERAPY USING ADJUSTABLE ATRIO-VENTRICULAR DELAYS,” both filed on Dec. 9, 2002, assigned to Cardiac Pacemakers, Inc., which are hereby incorporated by reference in their entirety. [0048] It is to be understood that the above detailed description is intended to be illustrative, and not restrictive. Other embodiments, including any possible combinations of the elements of the apparatus and methods discussed in this document, will be apparent to those of skill in the art upon reading and understanding the above description. For example, the electrical therapy for diastolic dysfunction can be applied in conjunction with a chemical therapy and/or a biological therapy. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. 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