WO2006124636A2 - Method and apparatus for cardiac protection pacing - Google Patents

Method and apparatus for cardiac protection pacing Download PDF

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Publication number
WO2006124636A2
WO2006124636A2 PCT/US2006/018497 US2006018497W WO2006124636A2 WO 2006124636 A2 WO2006124636 A2 WO 2006124636A2 US 2006018497 W US2006018497 W US 2006018497W WO 2006124636 A2 WO2006124636 A2 WO 2006124636A2
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WO
WIPO (PCT)
Prior art keywords
pacing
cardiac
ischemic event
signals
sequences
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PCT/US2006/018497
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English (en)
French (fr)
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WO2006124636A3 (en
Inventor
Tamara Colette Baynham
Yi Zhang
Joseph M. Pastore
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Cardiac Pacemakers Inc
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Cardiac Pacemakers Inc
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Priority to AT06752527T priority Critical patent/ATE508767T1/de
Priority to JP2008511421A priority patent/JP4995191B2/ja
Priority to EP06752527A priority patent/EP1904164B1/en
Publication of WO2006124636A2 publication Critical patent/WO2006124636A2/en
Publication of WO2006124636A3 publication Critical patent/WO2006124636A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36557—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by chemical substances in blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36521—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure the parameter being derived from measurement of an electrical impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36564—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36578—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36585—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by two or more physical parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate

Definitions

  • TECHNICAL FIELD This document relates generally to cardiac pacing systems and particularly to a system for delivering pacing pulses to protect the heart from injuries associated with ischemic events.
  • the heart is the center of a person's circulatory system. It includes an electro-mechanical system performing two major pumping functions. The left portions of the heart draw oxygenated blood from the lungs and pump it to the organs of the body to provide the organs with their metabolic needs for oxygen. The right portions of the heart draw deoxygenated blood from the body organs and pump it to the lungs where the blood gets oxygenated. These pumping functions are resulted from contractions of the myocardium. In a normal heart, the sinoatrial node, the heart's natural pacemaker, generates electrical impulses that propagate through an electrical conduction system to various regions of the heart to excite the myocardial tissues of these regions.
  • MI Myocardial infarction
  • myocardial infarction is the necrosis of portions of the myocardial tissue resulted from cardiac ischemia, a condition in which the myocardium is deprived of adequate oxygen and metabolite removal due to an interruption in blood supply caused by an occlusion of a blood vessel such as a coronary artery.
  • the necrotic tissue known as infarcted tissue, loses the contractile properties of the normal, healthy myocardial tissue. Consequently, the overall contractility of the myocardium is weakened, resulting in an impaired hemodynamic performance.
  • cardiac remodeling starts with expansion of the region of infarcted tissue and progresses to a chronic, global expansion in the size and change in the shape of the entire left ventricle. The consequences include a further impaired hemodynamic performance and a significantly increased risk of developing heart failure, as well as a risk of suffering recurrent MI.
  • a pacing system delivers cardiac protection pacing to protect the heart from injuries associated with ischemic events.
  • the pacing system detects an ischemic event and, in response, initiates one or more cardiac protection pacing sequences each including alternative pacing and non-pacing periods.
  • a cardiac pacing system includes a sensing circuit, an ischemia detector, a pulse output circuit, and a control circuit.
  • the sensing circuit senses one or more signals indicative of an ischemic event.
  • the ischemia detector detects the ischemic event from the one or more signals.
  • the pulse output circuit delivers pacing pulses.
  • the control circuit controls the delivery of the pacing pulses and includes a cardiac protection pacing sequence initiator and a cardiac protection pacing timer.
  • the cardiac protection pacing sequence initiator initiates one or more cardiac protection pacing sequences in response to the detection of the ischemic event.
  • the one or more cardiac protection pacing sequences each include alternating pacing and non-pacing periods.
  • the pacing periods each have a pacing duration during which a plurality of the pacing pulses is delivered.
  • the non-pacing periods each have a non-pacing duration during which none of the pacing pulses is delivered.
  • the cardiac protection pacing timer times the one or more cardiac protection pacing sequences.
  • a method for delivering the cardiac protection pacing is provided.
  • One or more signals indicative of an ischemic event are sensed.
  • the ischemic event is detected from the one or more signals.
  • One or more cardiac protection pacing sequences are initiated in response to the detection of the ischemic event.
  • the one or more cardiac protection pacing sequences each include alternating pacing and non-pacing periods.
  • the pacing periods each have a pacing duration during which a plurality of pacing pulses is delivered.
  • the non-pacing periods each have a non-pacing duration during which no pacing pulse is delivered.
  • the plurality of pacing pulses is delivered during each of the pacing periods.
  • FIG. 1 is an illustration of an embodiment of a cardiac rhythm management (CRM) system including an implantable system and an external system and portions of an environment in which the CRM system is used.
  • CRM cardiac rhythm management
  • FIG. 2 is a block diagram illustrating an embodiment of portions of the circuit of a cardiac pacing system of the implantable system.
  • FIG. 3 is a block diagram illustrating a specific embodiment of portions of the circuit of the cardiac pacing system.
  • FIG. 4 is a block diagram illustrating an embodiment of portions of circuits of the implantable system and the external system.
  • FIG. 5 is a block diagram illustrating an embodiment of the external system.
  • FIG. 6 is a flow chart illustrating an embodiment of a method for delivering pacing pulses for cardiac protection.
  • FIG. 7 is a flow chart illustrating a specific embodiment of the method for delivering pacing pulses for cardiac protection.
  • a pacing system including an implantable medical device that delivers pacing pulses to protect the heart from injuries associated with ischemic events, including MI.
  • the pacing pulses are delivered to the heart to change the distribution of stress in the myocardium, thereby triggering the intrinsic myocardial protective mechanism against ischemic damage to the myocardial tissue.
  • the implantable medical device detects ischemic events.
  • a cardiac protection pacing sequence is initiated to protect the heart from ischemic damage caused by the detected ischemic event by delivering a pacing postconditioning therapy.
  • the pacing postconditioning therapy and the prophylactic pacing preconditioning therapy each include delivery of one or more cardiac protection pacing sequences each including alternating pacing and non-pacing periods.
  • the pacing periods each have a pacing duration during which a plurality of pacing pulses is delivered.
  • the non-pacing periods each have a non-pacing duration during which no pacing pulses is delivered, hi other words, the pacing postconditioning therapy and the prophylactic pacing preconditioning therapy each include intermittent delivery of pacing pulses over a predetermined duration.
  • FIG. 1 is an illustration of an embodiment of a cardiac rhythm management (CRM) system 100 and portions of an environment in which system 100 is used.
  • System 100 includes an implantable system 105, an external system 115, and a telemetry link 112 providing for communication between implantable system 105 and external system 115.
  • CRM cardiac rhythm management
  • Implantable system 105 includes, among other things, implantable medical device 110 and lead system 108.
  • implantable medical device 110 is an implantable CRM device including one or more of a pacemaker, a cardioverter/defibrillator, a cardiac resynchronization therapy (CRT) device, a cardiac remodeling control therapy (RCT) device, a neruostimulator, a drug delivery device or a drug delivery controller, and a biological therapy device.
  • CTR cardiac resynchronization therapy
  • RCT cardiac remodeling control therapy
  • neruostimulator a drug delivery device or a drug delivery controller
  • biological therapy device As illustrated in FIG. 1, implantable medical device 110 is implanted in a body 102.
  • lead system 108 includes leads for sensing physiological signals and delivering pacing pulses, cardioversion/defibrillation shocks, neurostimulation pulses, pharmaceutical agents, biological agents, and/or other types of energy or substance for treating cardiac disorders.
  • lead system 108 includes one or more pacing-sensing leads each including at least one electrode placed in or on a heart 101 for sensing electrogram and/or delivering pacing pulses.
  • electrodes placed in body 102 but away from heart 101 are used to sense physiological signals and deliver pacing pulses, cardioversion/defibrillation shocks, neurostimulation pulses, pharmaceutical agents, biological agents, and/or other types of energy or substance for treating cardiac disorders.
  • one or more electrodes are incorporated onto implantable medical device 110 for subcutaneous placement.
  • Implantable medical device 110 includes a cardiac pacing system 120.
  • Cardiac pacing system 120 is capable of delivering cardiac protection pacing therapies through lead system 108.
  • the delivery of a cardiac protection pacing therapy is timed as a cardiac protection pacing sequence including alternating pacing and non-pacing periods.
  • cardiac pacing system 120 in addition to the cardiac protection pacing therapy, cardiac pacing system 120 also delivers one or more other cardiac pacing therapies, such a bradycardia pacing therapy, CRT, and RCT. If another pacing therapy is being delivered when a cardiac protection pacing sequence is to be initiated, that pacing therapy is temporarily suspended to allow the delivery of the cardiac protection pacing therapy and resumed upon completion of the cardiac protection pacing sequence.
  • External system 115 allows a user such as a physician or other caregiver or a patient to control the operation of implantable medical device 110 and obtain information acquired by implantable medical device 110.
  • external system 115 includes a programmer communicating with implantable medical device 110 bi-directionally via telemetry link 112.
  • external system 115 is a patient management system including an external device communicating with a remote device through a telecommunication network. The external device is within the vicinity of implantable medical device 110 and communicates with implantable medical device 110 bi-directionally via telemetry link 112. The remote device allows the user to monitor and treat a patient from a distant location. The patient monitoring system is further discussed below, with reference to FIG. 5.
  • Telemetry link 112 provides for data transmission from implantable medical device 110 to external system 115. This includes, for example, transmitting real-time physiological data acquired by implantable medical device 110, extracting physiological data acquired by and stored in implantable medical device 110, extracting therapy history data stored in implantable medical device 110, and extracting data indicating an operational status of implantable medical device 110 (e.g., battery status and lead impedance). Telemetry link 112 also provides for data transmission from external system 115 to implantable medical device 110. This includes, for example, programming implantable medical device 110 to acquire physiological data, programming implantable medical device 110 to perform at least one self-diagnostic test (such as for a device operational status), and programming implantable medical device 110 to deliver at least one therapy.
  • Cardiac pacing system 220 is a specific embodiment of cardiac pacing system 120 and includes a sensing circuit 222, an ischemia detector 224, a pulse output circuit 226, and a control circuit 228.
  • Sensing circuit 222 senses one or more signals using a plurality of electrodes and/or one or more sensors. The one or more signals are indicative of ischemic events.
  • Ischemia detector 224 detects the ischemic events from the one or more signals.
  • Pulse output circuit 226 delivers pacing pulses to heart 101.
  • Control circuit 228 controls the delivery of the pacing pulses based on the one or more sensed signals and/or in response to the detection of each ischemic event.
  • cardiac pacing system 220 is substantially contained in an implantable housing of implantable medical device 110.
  • Control circuit 228 includes a cardiac protection pacing sequence initiator 230 and a cardiac protection pacing timer 232.
  • Cardiac protection pacing sequence initiator 230 initiates one or more cardiac protection pacing sequences in response to the detection of each ischemic event.
  • the one or more cardiac protection pacing sequences each include alternating pacing and non- pacing periods.
  • the pacing periods each have a pacing duration during which a plurality of pacing pulse is delivered.
  • the non-pacing periods each have a non- pacing duration during which no pacing pulse is delivered.
  • the one or more cardiac protection pacing sequences each have a sequence duration in a range of approximately 30 seconds to 1 hour.
  • the pacing duration is in a range of approximately 5 seconds to 10 minutes.
  • the non-pacing duration is in a range of approximately 5 seconds to 10 minutes.
  • FIG. 3 is a block diagram illustrating an embodiment of portions of the circuit of a cardiac pacing system 320.
  • Cardiac pacing system 320 is a specific embodiment of cardiac pacing system 220 and includes sensing circuit 222, ischemia detector 224, pulse output circuit 226, and a control circuit 328.
  • Sensing circuit 222 senses the one or more signals indicative of the ischemic events.
  • Ischemia detector 224 detects the ischemic events from the one or more signals.
  • Pulse output circuit 226 delivers the pacing pulses to heart 101.
  • Control circuit 328 controls the delivery of the pacing pulses based on the one or more sensed signals and/or in response to the detection of each ischemic event.
  • cardiac pacing system 320 is substantially contained in an implantable housing of implantable medical device 110.
  • Ischemia detector 224 includes an ischemia analyzer running an automatic ischemia detection algorithm to detect the ischemic event from the one or more signals. In one embodiment, ischemia detector 224 produces an ischemia alert signal indicative of the detection of each ischemic event. The ischemia signal is transmitted to external system 115 for producing an alarm signal and/or a warning message for the patient and/or a physician or other caregiver.
  • ischemia detector 224 detects the ischemic events from one or more cardiac signals.
  • Sensing circuit 222 includes a cardiac sensing circuit.
  • cardiac signals are sensed using a wearable vest including embedded electrodes configured to sense surface biopotential signals indicative of cardiac activities. The sensed surface biopotential signals are transmitted to implantable medical device 110 via telemetry.
  • ischemia detector 224 detects the ischemic events from one or more wireless electrocardiogram (ECG) signals.
  • ECG wireless electrocardiogram
  • Sensing circuit 222 includes a wireless ECG sensing circuit.
  • a wireless ECG is a signal approximating the surface ECG and is acquired without using surface (skin contact) electrodes. An example of a circuit for sensing the wireless ECG is discussed in U.S. Patent Application Serial No. 10/795, 126, entitled "WIRELESS ECG IN
  • ischemia detector 224 detects the ischemic events from one or more electrogram signals.
  • Sensing circuit 222 includes an electrogram sensing circuit. Examples of an electrogram-based ischemia detector are discussed in U.S. Patent No.
  • ischemia detector 224 detects the ischemic events from one or more impedance signals.
  • Sensing circuit 222 includes an impedance sensing circuit to sense one or more impedance signals each indicative of a cardiac impedance or a transthoracic impedance.
  • Ischemia detector 224 includes an electrical impedance based sensor using a low carrier frequency to detect the ischemic events from an electrical impedance signal. Tissue electrical impedance has been shown to increase significantly during ischemia and decrease significantly after ischemia, as discussed in Dzwonczyk, et al. IEEE Trans. Biomed. Eng., 51(12): 2206-09 (2004).
  • the ischemia detector senses low frequency electrical impedance signal between electrodes interposed in the heart, and detects the ischemia as abrupt changes in impedance (such as abrupt increases in value).
  • ischemia detector 224 detects the ischemic events from one or more signals indicative of heart sounds.
  • Sensing circuit 222 includes a heart sound sensing circuit.
  • the heart sound sensing circuit senses the one or more signals indicative of heart sounds using one or more sensors such as accelerometers and/or microphones. Such sensors are included in implantable medical device 110 or incorporated into lead system 108.
  • Ischemia detector 224 detects the ischemic event by detecting predetermined type heart sounds, predetermined type heart sound components, predetermined type morphological characteristics of heart sounds, or other characteristics of heart sounds indicative of ischemia.
  • ischemia detector 224 detects the ischemic events from one or more pressure signals.
  • Sensing circuit 222 includes a pressure sensing circuit coupled to one or more pressure sensors.
  • the pressure sensor is an implantable pressure sensor sensing a signal indicative of an intracardiac or intravascular pressure whose characteristics are indicative of ischemia.
  • ischemia detector 224 detects the ischemic event from one or more acceleration signals each indicative of regional cardiac wall motion.
  • Sensing circuit 222 includes a cardiac motion sensing circuit coupled to one or more accelerometers each incorporated into a portion of a lead positioned on or in the heart. The ischemia detector detects ischemia as an abrupt decrease in the amplitude of local cardiac accelerations.
  • ischemia detector 224 detects the ischemic event from a heart rate variability (HRV) signal indicative of HRV.
  • Sensing circuit 222 includes an HRV sensing circuit 760 to sense the HRV and produce the HRV.
  • HRV signal which is representative of an HRV parameter.
  • HRV is the beat-to- beat variance in cardiac cycle length over a period of time.
  • the HRV parameter includes any parameter being a measure of the HRV, including any qualitative expression of the beat-to-beat variance in cardiac cycle length over a period of time.
  • the HRV parameter includes the ratio of Low- Frequency (LF) HRV to High-Frequency (HF) HRV (LF/HF ratio).
  • the LF HRV includes components of the HRV having frequencies between about 0.04 Hz and 0.15 Hz.
  • the HF HRV includes components of the HRV having frequencies between about 0.15 Hz and 0.40 Hz.
  • the ischemia detector detects ischemia when the LF/HF ratio exceeds a predetermined threshold.
  • Control circuit 328 is a specific embodiment of control circuit 228 and includes a pacing mode switch 334, a pacing mode controller 336, a cardiac protection pacing sequence initiator 330, and a cardiac protection pacing timer 332.
  • Control circuit 328 allows cardiac pacing system 320 to control the delivery of the cardiac protection pacing therapy as well as other pacing therapies. This allows the function of cardiac protection pacing to be included in an implantable medical device that delivers pacing therapies on a long-term basis, such as for treatment of bradycardia and heart failure.
  • cardiac protection pacing therapy includes a temporary pacing therapy delivered for one or more brief periods in response to the detection of each ischemia event, and the implantable medical device also delivers a chronic pacing therapy such as a bradycardia pacing therapy, CRT, or RCT.
  • a chronic pacing therapy such as a bradycardia pacing therapy, CRT, or RCT.
  • the cardiac protection pacing therapy is the only pacing therapy delivered, or the cardiac protection pacing therapy is the only pacing therapy programmed to be delivered for at least a certain period of time.
  • Pacing mode switch 334 switches the pacing mode from a chronic pacing mode to a temporary pacing mode when a cardiac protection pacing sequence is initiated and to switch the pacing mode from the temporary pacing mode to the chronic pacing mode when the cardiac protection pacing sequence is completed.
  • Pacing mode controller 336 controls the delivery of the pacing pulses from pulse output circuit 226 according to the pacing mode as selected by pacing mode switch 334.
  • the temporary pacing mode refers to the pacing mode used in a cardiac protection pacing therapy, which is a temporary pacing therapy.
  • the chronic pacing mode refers to the pacing mode used in a chronic pacing therapy such as a bradycardia pacing therapy, CRT, or RCT.
  • the temporary pacing mode is substantially different from the chronic pacing mode, such that the cardiac protection pacing therapy changes the distribution of stress in the myocardium, thereby triggering the intrinsic myocardial protective mechanism against ischemic damage to the myocardial tissue.
  • Examples of the temporary pacing mode include VOO, VVI, VDD, and DDD modes, including their rate- responsive versions if applicable.
  • the pacing rate is set to be about 20 pulses per minute higher than the patient's intrinsic heart rate during the temporary pacing mode.
  • the temporary pacing mode is an atrial tracking pacing mode such as the VDD or DDD mode, including their rate- responsive and multi- ventricular site versions.
  • the chronic pacing mode is an atrial tracking pacing mode such as the VDD or DDD mode
  • the temporary pacing mode is a VOO or VVI mode at with a pacing rate higher than the patient's intrinsic heart rate or a VDD or DDD mode with substantially different pacing parameter such as a pacing rate, pacing sites, and/or atrioventricular pacing delays.
  • Cardiac protection pacing sequence initiator 330 is a specific embodiment of cardiac protection pacing sequence initiator 230 and initiates one or more cardiac protection pacing sequences in response to the detection of each ischemic event. In one embodiment, cardiac protection pacing sequence initiator 330 also initiates one or more cardiac protection pacing sequences in response to one or more commands issued by the user through external system 115. For example, following a diagnosis of vulnerable plaque indicative of a high risk for MI, a physician applies a pacing preconditioning therapy by starting a cardiac protection pacing sequence by issuing such a command. Cardiac protection pacing timer 332 times the one or more cardiac protection pacing sequences including the alternating pacing and non-pacing periods.
  • the one or more cardiac protection pacing sequences initiated in response to the detection of each ischemic event include at least one postconditioning sequence and a plurality of prophylactic preconditioning sequences.
  • cardiac protection pacing sequence initiator 330 includes a postconditioning sequence initiator 338 and a preconditioning sequence initiator 340
  • cardiac protection pacing timer 332 includes a postconditioning timer 342 and a preconditioning timer 344.
  • Postconditioning sequence initiator 338 initiates the postconditioning sequence in response to the detection of an ischemic event. In one embodiment, postconditioning sequence initiator 338 initiates the postconditioning sequence when the end of the ischemic event is detected.
  • the end of the ischemic event is detected when the ischemic event is no longer detected by ischemia detector 224.
  • postconditioning sequence initiator 338 initiates the postconditioning pacing sequence when a post-ischemia time interval expires.
  • the post-ischemia time interval starts when the end of the ischemic event is detected and is up to approximately 10 minutes, with approximately 30 seconds being a specific example.
  • the post-ischemia time interval is chosen such that the postconditioning pacing sequence is initiated after the reperfusion phase following the ischemic event has started.
  • postconditioning sequence initiator 338 initiates the postconditioning pacing sequence in response to one or more postconditioning commands issued by the user.
  • Preconditioning sequence initiator 340 initiates the prophylactic preconditioning sequences, one at a time, after the end of the ischemic event is detected and the postconditioning sequence is completed. In one embodiment, preconditioning sequence initiator 340 initiates the prophylactic preconditioning pacing sequences on a periodic basis using a predetermined period. The predetermined period is in a range of approximately 24 hours to 72 hours, with approximately 48 hours being a specific example. In another embodiment, preconditioning sequence initiator 340 initiates the prophylactic preconditioning pacing sequences according to a programmed preconditioning schedule, hi another embodiment, preconditioning sequence initiator 340 initiates the prophylactic preconditioning pacing sequences in response to one or more preconditioning commands issued by the user.
  • Postconditioning timer 342 times the postconditioning sequence including alternating postconditioning pacing and non-pacing periods.
  • the postconditioning pacing periods each have a postconditioning pacing duration during which a plurality of pacing pulses is delivered.
  • the postconditioning non-pacing periods each have a postconditioning non-pacing duration during which no pacing pulse is delivered.
  • the postconditioning sequence has a postconditioning sequence duration in a range of approximately 30 seconds to 1 hour, with approximately 10 minutes being a specific example.
  • the postconditioning pacing duration is in a range of approximately 5 seconds to 10 minutes, with approximately 30 seconds being a specific example.
  • the postconditioning non-pacing duration is in a range of approximately 5 seconds to 10 minutes, with approximately 30 seconds being a specific example.
  • Preconditioning timer 344 times the prophylactic preconditioning pacing sequences including alternating preconditioning pacing and non-pacing periods.
  • the preconditioning pacing periods each have a preconditioning pacing duration during which a plurality of pacing pulse is delivered.
  • the preconditioning non- pacing periods each have a preconditioning non-pacing duration during which no pacing pulse is delivered.
  • the prophylactic preconditioning pacing sequences each have a preconditioning sequence duration in a range of approximately 10 minutes to 1 hour, with approximately 40 minutes being a specific example.
  • the preconditioning pacing duration is in a range of approximately 1 minute to 30 minutes, with approximately 5 minutes being a specific example.
  • the preconditioning non-pacing duration is in a range of approximately 1 minute to 30 minutes, with approximately 5 minutes being a specific example.
  • control circuit 328 detects an arrhythmia and suspends the one or more cardiac protection pacing sequences in response to the detection of the arrhythmia.
  • Control circuit 328 includes an arrhythmia detector to detect one or more predetermined types of arrhythmia.
  • cardiac protection pacing sequence initiator 330 cancels, holds, or otherwise adjusts the timing of the initiation of a cardiac protection pacing sequence in response to a detection of arrhythmia.
  • cardiac protection pacing timer 332 terminates or suspends a cardiac protection pacing sequence in response to the detection of an arrhythmia that occurs during the cardiac protection pacing sequence.
  • postconditioning sequence initiator 338 cancels the initiation of a postconditioning sequence in response to the detection of arrhythmia.
  • preconditioning sequence initiator 340 holds the initiation of a prophylactic preconditioning pacing sequence in response to the detection of arrhythmia unit the arrhythmia is no longer detected.
  • cardiac protection pacing timer 332 terminates or suspends a cardiac protection pacing sequence in response to the detection of an arrhythmia that occurs during the cardiac protection pacing sequence.
  • FIG. 4 is a block diagram illustrating an embodiment of portions of circuits of an implantable system 405 and an external system 415.
  • Implantable system 405 is a specific embodiment of implantable system 105.
  • External system 415 is a specific embodiment of external system 115.
  • Implantable system 405 includes lead system 108, one or more sensors
  • Sensor(s) 409 includes electrodes, accelerometer(s), pressure sensor(s), and/or other sensors for sensing one or more signals required for the operation of implantable medical device 410, including detection of ischemic events.
  • sensor(s) 409 are included in an implantable housing of implantable medical device 410, attached to implantable medical device 410, coupled to implantable medical device 410 through wired or wireless connections, and/or incorporated into lead system 108.
  • Implantable medical device 410 is a specific embodiment of implantable medical device 110 and includes cardiac pacing system 120 (including its various embodiments) and an implant telemetry circuit 450.
  • External system 415 includes an external telemetry circuit 452, an ischemia alert signal receiver 454, and a user interface 456.
  • External telemetry circuit 452 and implant telemetry circuit 450 supports telemetry link 112, through which directional communication is performed between external system 415 and implantable system 405.
  • User interface 456 includes a presentation device 458 and a user input device 460.
  • Presentation device 458 includes a display screen. In one embodiment, presentation device 458 further includes a printer and a speaker.
  • User input device 460 allows programming of implantable medical device 410, including the entry of commands for initiating one or more cardiac protection pacing sequences and/or parameters controlling the delivery of the cardiac protection pacing therapy. In one embodiment, portions of presentation device 458 and user input device 460 are integrated as an interactive screen.
  • Ischemia alert signal receiver 454 receives the ischemia alert signal produced by ischemia detector 224 and transmitted to external system 415 via telemetry link 112 and, in response, causes presentation device 458 to produce an alarm signal and/or a warning message for the patient and/or a physician or caregiver.
  • external system 415 includes a programmer. In another embodiment, external system 415 includes a patient management system as discussed below with reference to FIG. 5.
  • FIG. 5 is a block diagram illustrating an embodiment of an external system 515, which is a specific embodiment of external system 415.
  • external system 415 is a patient management system including an external device 562, a telecommunication network 564, and a remote device 570.
  • External device 562 is placed within the vicinity of an implantable medical device and includes external telemetry system 452 to communicate with the implantable medical device via telemetry link 112.
  • Remote device 570 is in one or more remote locations and communicates with external device 562 through network 564, thus allowing a physician or other caregiver to monitor and treat a patient from a distant location and/or allowing access to various treatment resources from the one or more remote locations.
  • remote device 570 includes user interface 456. This allows the user to initiate and/or adjust the cardiac protection pacing therapy in response to the alarm signal and/or warning message associated with the ischemia alert signal.
  • FIG. 6 is a flow chart illustrating an embodiment of a method for delivering pacing pulses for cardiac protection against tissue damage associated with ischemic events. In one embodiment, the method is performed by system 100.
  • One or more signals indicative of an ischemic event are sensed at 600.
  • the ischemic event is detected from the one or more signals at 610.
  • one or more cardiac protection pacing sequences are initiated at 620.
  • the one or more cardiac protection pacing sequences each include alternating pacing and non-pacing periods.
  • the pacing periods each have a pacing duration during which a plurality of pacing pulses is delivered.
  • the non-pacing periods each having a non-pacing duration during which no pacing pulse is delivered.
  • the plurality of pacing pulses is delivered during each of the pacing periods at 630.
  • FIG. 7 is a flow chart illustrating a specific embodiment of the method for delivering pacing pulses for cardiac protection that is discussed with reference to FIG. 6.
  • the method is performed by system 100.
  • One or more signals indicative of an ischemic event are sensed at 700.
  • the one or more signals are selected from surface ECG signals or other surface biopotential signals indicative of cardiac activities, wireless ECG signals, electrogram signals, impedance signals, heart sound signals, pressure signals, acceleration signals, signals representative of HRV parameters, and/or any other signals having characteristics allowing detection of ischemic events.
  • the ischemic event is detected from the one or more signals at 710, by running an automatic ischemia detection algorithm.
  • an ischemia alert signal is produced to indicate the detection of the ischemic event to the patient and/or a physician or other caregiver.
  • cardiac protection pacing sequences are initiated and timed at 720.
  • a pacing mode is switched from a chronic pacing mode to a temporary pacing mode when a cardiac protection pacing sequence is initiated and switched back from the temporary pacing mode to the chronic pacing mode when the cardiac protection pacing sequence is completed.
  • the pacing mode determines whether and how pacing pulses are delivered before, during, and after the cardiac protection pacing sequence.
  • the temporary pacing mode is substantially different from the chronic pacing mode.
  • one or more cardiac protection pacing sequences are also initiated in response to user commands.
  • the cardiac protection pacing sequences include at least one postconditioning sequence and a plurality of prophylactic preconditioning sequences.
  • postconditioning sequence is initiated at 722.
  • the postconditioning sequence is initiated when the end of the ischemic event is detected.
  • the end of the ischemic event is detected when the ischemic event is no longer detected.
  • the postconditioning pacing sequence is initiated when a post-ischemia time interval expires.
  • the post-ischemia time interval starts at the end of the ischemic event and ends after a predicted reperfusion period following the ischemic event has started, hi another embodiment, the postconditioning sequence is initiated in response to a postconditioning command issued by a user.
  • the postconditioning sequence including alternating postconditioning pacing and non-pacing periods is timed at 724.
  • the postconditioning pacing periods each have a postconditioning pacing duration during which a plurality of pacing pulses is delivered.
  • the postconditioning non-pacing periods each have a postconditioning non-pacing duration during which no pacing pulse is delivered.
  • the prophylactic preconditioning sequences are initiated, one at a time, at 726.
  • the prophylactic preconditioning pacing sequences are initiated on a periodic basis with a predetermined period. In another embodiment, the prophylactic preconditioning pacing sequences are initiated according to a preconditioning schedule programmed by the user. In another embodiment, the prophylactic preconditioning pacing sequences are initiated in response to one or more preconditioning commands issued by the user. After being initiated, each of the prophylactic preconditioning pacing sequences including alternating preconditioning pacing and non-pacing periods is timed at 728. The preconditioning pacing periods each have a preconditioning pacing duration during which a plurality of pacing pulses is delivered.
  • the preconditioning non-pacing periods each have a preconditioning non-pacing duration during which no pacing pulse is delivered.
  • predetermined type arrhythmias are detected.
  • the one or more cardiac protection pacing sequences are suspended in response to the detection of the arrhythmia.
  • the plurality of pacing pulses is delivered during each of the pacing periods of the cardiac protection pacing sequences at 730. That includes the delivery of pacing pulses during the postconditioning pacing periods of the postconditioning sequence and the delivery of pacing pulses during the preconditioing pacing periods of each of the preconditioning sequences.

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US7917210B2 (en) 2011-03-29
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US8855762B2 (en) 2014-10-07

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