WO2006078519A2 - Control of electrical stimulation using heart rate variability - Google Patents

Control of electrical stimulation using heart rate variability Download PDF

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Publication number
WO2006078519A2
WO2006078519A2 PCT/US2006/000963 US2006000963W WO2006078519A2 WO 2006078519 A2 WO2006078519 A2 WO 2006078519A2 US 2006000963 W US2006000963 W US 2006000963W WO 2006078519 A2 WO2006078519 A2 WO 2006078519A2
Authority
WO
WIPO (PCT)
Prior art keywords
hrv
parameter
stimulation
pacing
algorithm
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2006/000963
Other languages
English (en)
French (fr)
Other versions
WO2006078519A3 (en
Inventor
Joseph M. Pastore
Rodney W. Salo
Gerrard M. Carlson
Andrew P. Kramer
Jiang Ding
Yinghong Yu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiac Pacemakers Inc
Original Assignee
Cardiac Pacemakers Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/037,309 external-priority patent/US7672725B2/en
Priority claimed from US11/037,723 external-priority patent/US7580745B2/en
Application filed by Cardiac Pacemakers Inc filed Critical Cardiac Pacemakers Inc
Priority to EP20060718078 priority Critical patent/EP1846098B1/en
Priority to JP2007552170A priority patent/JP5036561B2/ja
Publication of WO2006078519A2 publication Critical patent/WO2006078519A2/en
Publication of WO2006078519A3 publication Critical patent/WO2006078519A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61N1/36592—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by the heart rate variability
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02405—Determining heart rate variability
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
    • A61B5/4035—Evaluating the autonomic nervous system
    • 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36114—Cardiac control, e.g. by vagal stimulation
    • 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
    • A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions

Definitions

  • an HRV-based safety assurance method for electrical stimulation is provided.
  • a cardiac signal is sensed.
  • a variance in cardiac cycle lengths is measured over a predetermined period of time to produce an HRV parameter based on the sensed cardiac signal.
  • Electrical stimulation pulses are delivered by executing at least one stimulation algorithm. The execution of the stimulation algorithm is stopped when the HRV parameter falls out of a safety window.
  • FIG. 12 is a flow chart illustrating one embodiment of a method for starting and stopping a therapy using an HRV parameter.
  • Root-Mean-Square of Successive Differences (RMSSD). Root-mean- square values are computed, each for time differences between successive R-R intervals determined for a period of time.
  • 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.
  • lead system 108 includes one or more neurostimulation-sensing leads each including at least one electrode placed on a nerve of the autonomic nervous system for sensing neural signals and delivering neurostimulation pulses
  • lead system 108 includes one or more pacing-sensing leads and one or more neurostimulation-sensing leads to synchronize neurostimulation with intrinsic activities of heart 101 and/or pacing.
  • external system 185 is a patient management system including an external device 190, a network 192, and a remote device 194.
  • implantable medical device 110 includes a neurostimulator that delivers neurostimulation pulses to the autonomic nervous system to maximize the HRV.
  • implantable medical device includes a pacemaker and a neurostimulator to deliver combined cardiac pacing and autonomic neurostimulation to maximize the HRV.
  • the distribution of stimulation system 115 in system 100 depends on design and patient management considerations, such as the size and power consumption of each system component and the ability of monitoring the patient in various settings from various locations.
  • implantable medical device 110 includes the entire system 115. This allows implantable system 105 to adjust stimulation parameters in response to changes in an HRV parameter without communicating to external system 185.
  • implantable medical device 110 and external system 185 each include portions of system 115. Stimulation parameters are adjusted based on an HRV parameter when implantable medical device 110 and external system 185 are communicatively coupled via telemetry link 180.
  • HRV measurement circuit 220 includes, but is not limited to, one or more of an SDNN generator to produce an SDNN, an SDANN generator to produce an SDANN, an LF/HF ratio generator to produce an LF/HF ratio, an HRV footprint generator to produce an HRV footprint, and an RMSSD generator to produce an RMSSD.
  • HRV measurement circuit 220 includes an autonomic balance monitor to monitor an HRV parameter indicative of a balance between sympathetic and parasympathetic activities.
  • the autonomic balance monitor includes the LF/HF ratio generator to produce the LF/HF ratio as the HRV parameter indicative of the balance between sympathetic and parasympathetic activities.
  • the MTR is adjusted based on the HRV parameter at 630.
  • the MTR is set to one of a plurality of predetermined values based on the HRV parameter.
  • the HRV parameter is compared to a threshold HRV level. The MTR is set to a first value if the HRV parameter exceeds the predetermined threshold HRV level and a second value if the HRV parameter does not exceed the threshold HRV level. The first value is substantially higher than the second value to allow for a higher exercise intensity when the HRV is higher.
  • the threshold HRV level is dynamically adjusted based on an indication, estimation, or prediction of the patient's activity level.
  • the threshold HRV level is adjusted based on the patient's heart rate, hi another embodiment, the threshold HRV level is adjusted based the patient's anticipated activity level during specific times of each day.
  • FIG. 7 is a block diagram illustrating one embodiment of a stimulation system 715 that includes an HRV-based stimulation parameter optimization module.
  • Stimulation system 715 is a specific embodiment of stimulation system 115 and includes sensing circuit 212, pulse output circuit 214, HRV measurement circuit 220, and a stimulation control circuit 730.
  • Stimulation control circuit 730 includes a stimulation parameter optimization module 731 that adjusts at least one stimulation parameter to an approximately optimal value based on at least one HRV parameter produced by HRV measurement circuit 220.
  • stimulation control circuit 730 includes a pacing control circuit that includes a pacing parameter optimization module to adjust at least one pacing parameter to an approximately optimal value based on the HRV parameter.
  • the neurostimulation parameter optimization module includes, but is not limited to, one or more of a stimulation pulse frequency optimization module to optimize a stimulation frequency and a stimulation sites optimization module to optimize a selection of one or more sites to which the neurostimulation pulses are delivered, hi general, the neurostimulation parameter optimization module allows optimization of any neurostimulation parameter whose value affects the HRV by adjusting that parameter for a maximum HRV indicated by the HRV parameter, hi one embodiment, HRV measurement circuit 220 continuously updates the HRV parameter to reflect changes in the patient's cardiac condition, and stimulation parameter optimization module 731 adjusts the stimulation parameter to the approximately optimal value based on the HRV parameter on a continuous basis.
  • the approximately optimal value is the value corresponding to a maximum value of the HRV parameter produced for the stimulation parameter optimization period.
  • stimulation parameter generator 838 produces a plurality of values for each stimulation parameter.
  • Pulse output controller 840 controls the delivery of a plurality of series of stimulation pulses. Each series of stimulation pulses is delivered using a combination of values produced for all the stimulation parameters to be optimized.
  • Stimulation parameter selector 842 selects an approximately optimal combination of values for all the stimulation parameters to be optimized.
  • the approximately optimal combination of values is the combination of values corresponding to a maximum value of the HRV parameter produced for the stimulation parameter optimization period.
  • FIG. 9 is a block diagram illustrating another embodiment of a stimulation parameter optimization module 931, which is another embodiment of stimulation parameter optimization module 731.
  • Stimulation parameter generator 938 dynamically produces the values for the dynamic stimulation parameter.
  • stimulation parameter generator 938 includes a physiologic parameter measurement module 944 and a dynamic stimulation parameter generator 948.
  • Physiologic parameter measurement module 944 measures at least one physiologic parameter related to the patient's cardiac condition.
  • Dynamic stimulation parameter generator 948 dynamically produce values of the dynamic stimulation parameter based on the physiologic parameter.
  • the pacing lowers the degree of ventricular synchrony and the cardiac output, which are measures of hemodynamic performance.
  • One consequent problem is that when a post MI patient becomes active, the pacing with the short AVD may limit the cardiac output and hence, prevent the heart from pumping sufficient blood to meet the patient's metabolic need.
  • One solution is to deliver the CRT and RCT on an alternating basis, depending on the instantaneous metabolic need of the post MI patient, such that the pacing provides for optimal hemodynamic performance when the metabolic need is high, and post MI remodeling control when the metabolic need is low.
  • Safety check module 1152 stops the execution of the stimulation algorithm based on the HRV parameter produced by HRV measurement circuit 220.
  • safety check module 1152 includes a comparator 1154 and a switch circuit 1156.
  • Comparator 1154 receives the HRV parameter from HRV measurement circuit 220 and compares the HRV parameter to a safety threshold.
  • Switch circuit 1156 stops the execution of the stimulation algorithm when the HRV parameter falls below the safety threshold.
  • switch circuit 1156 resumes the execution of the stimulation algorithm when the HRV parameter exceeds another safety threshold.
  • the values of the two safety thresholds are determined based on specific considerations in cardiac condition management and can be equal or different.
  • the stimulation algorithm is the RCT pacing algorithm.
  • safety check module 1152 includes a safety threshold generator to dynamically adjust the safety threshold(s) based on an indication, estimation, or prediction of the patient's activity level.
  • the safety threshold generator adjusts one or more safety thresholds based on the patient's heart rate.
  • the safety threshold generator adjusts one or more safety thresholds based the patient's anticipated activity level during specific times of each day.
  • the safety window is dynamically adjusted based on an indication, estimation, or prediction of the patient's activity level. In one specific embodiment, the safety window is adjusted based on the patient's heart rate. In another embodiment, the safety window is adjusted based the patient's anticipated activity level during specific times of each day.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Electrotherapy Devices (AREA)
PCT/US2006/000963 2005-01-18 2006-01-12 Control of electrical stimulation using heart rate variability Ceased WO2006078519A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP20060718078 EP1846098B1 (en) 2005-01-18 2006-01-12 Control of electrical stimulation using heart rate variability
JP2007552170A JP5036561B2 (ja) 2005-01-18 2006-01-12 心拍変動を使用する電気的刺激の制御

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US11/037,308 US7672724B2 (en) 2005-01-18 2005-01-18 Method and apparatus for optimizing electrical stimulation parameters using heart rate variability
US11/037,309 2005-01-18
US11/037,309 US7672725B2 (en) 2005-01-18 2005-01-18 Method and apparatus for using heart rate variability as a safety check in electrical therapies
US11/037,308 2005-01-18
US11/037,723 US7580745B2 (en) 2005-01-18 2005-01-18 Method and apparatus for using heart rate variability to control maximum tracking rate in pacing therapy
US11/037,723 2005-01-18

Publications (2)

Publication Number Publication Date
WO2006078519A2 true WO2006078519A2 (en) 2006-07-27
WO2006078519A3 WO2006078519A3 (en) 2007-04-19

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PCT/US2006/000963 Ceased WO2006078519A2 (en) 2005-01-18 2006-01-12 Control of electrical stimulation using heart rate variability

Country Status (4)

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US (2) US7672724B2 (enExample)
EP (2) EP2554216B1 (enExample)
JP (2) JP5036561B2 (enExample)
WO (1) WO2006078519A2 (enExample)

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US7580745B2 (en) 2005-01-18 2009-08-25 Cardiac Pacemakers, Inc. Method and apparatus for using heart rate variability to control maximum tracking rate in pacing therapy
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US7672724B2 (en) 2005-01-18 2010-03-02 Cardiac Pacemakers, Inc. Method and apparatus for optimizing electrical stimulation parameters using heart rate variability
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US7580745B2 (en) 2005-01-18 2009-08-25 Cardiac Pacemakers, Inc. Method and apparatus for using heart rate variability to control maximum tracking rate in pacing therapy
US7672725B2 (en) 2005-01-18 2010-03-02 Cardiac Pacemakers, Inc. Method and apparatus for using heart rate variability as a safety check in electrical therapies
US7672724B2 (en) 2005-01-18 2010-03-02 Cardiac Pacemakers, Inc. Method and apparatus for optimizing electrical stimulation parameters using heart rate variability
US8805503B2 (en) 2005-01-18 2014-08-12 Cardiac Pacemakers, Inc. Method and apparatus for optimizing electrical stimulation parameters using heart rate variability
US8831724B2 (en) 2005-01-18 2014-09-09 Cardiac Pacemakers, Inc. Method and apparatus for using heart rate variability as a safety check in electrical therapies
JP2011513027A (ja) * 2008-03-13 2011-04-28 カーディアック ペースメイカーズ， インコーポレイテッド 断続的な治療を制御するための自律神経平衡監視

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US20100137932A1 (en) 2010-06-03
US20060161208A1 (en) 2006-07-20
JP5036561B2 (ja) 2012-09-26
US7672724B2 (en) 2010-03-02
EP1846098B1 (en) 2015-04-22
EP1846098A2 (en) 2007-10-24
EP2554216A1 (en) 2013-02-06
JP2008526456A (ja) 2008-07-24
JP2012071206A (ja) 2012-04-12
WO2006078519A3 (en) 2007-04-19

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