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WO2025068782A1 - Medical device programming - Google Patents

Medical device programming Download PDF

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Publication number
WO2025068782A1
WO2025068782A1 PCT/IB2024/057102 IB2024057102W WO2025068782A1 WO 2025068782 A1 WO2025068782 A1 WO 2025068782A1 IB 2024057102 W IB2024057102 W IB 2024057102W WO 2025068782 A1 WO2025068782 A1 WO 2025068782A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
control parameter
pending value
status
communication
Prior art date
Application number
PCT/IB2024/057102
Other languages
French (fr)
Inventor
Eric A. Schilling
Kristen J. Cattin
Eric R. Williams
Yanina GRINBERG
Original Assignee
Medtronic, 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
Application filed by Medtronic, Inc. filed Critical Medtronic, Inc.
Publication of WO2025068782A1 publication Critical patent/WO2025068782A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37264Changing the program; Upgrading firmware
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37288Communication to several implantable medical devices within one patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37235Aspects of the external programmer
    • A61N1/37247User interfaces, e.g. input or presentation means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3756Casings with electrodes thereon, e.g. leadless stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3956Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A61N1/3962Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • A61N1/39622Pacing therapy

Definitions

  • the disclosure relates generally to medical devices, systems and methods for programming control parameter values in a medical device that is operating in a patient having at least one other medical device.
  • IMDs implantable medical devices
  • Examples include IMDs that deliver therapy to and/or monitor conditions associated with the heart, muscle, nerve, brain, stomach or other tissue.
  • Some therapies include the delivery of electrical stimulation to such tissues.
  • Some IMDs may employ electrodes for the delivery of therapeutic electrical signals to such organs or tissues, electrodes for sensing intrinsic physiological electrical signals within the patient, which may be propagated by such organs or tissue, and/or other sensors for sensing physiological signals of a patient.
  • two or more medical devices can be implanted within and/or worn by a single patient. Each of the two or more medical devices may operate individually to perform a monitoring function and/or deliver a therapy to the patient.
  • Implantable cardioverter defibrillators may be used to deliver high energy cardioversion or defibrillation (CV/DF) shocks to a patient's heart when ventricular tachyarrhythmia, e.g., tachycardia or fibrillation, is detected.
  • An ICD may detect a tachyarrhythmia based on an analysis of a cardiac electrogram (EGM) or electrocardiogram (ECG) sensed via electrodes, and may deliver anti-tachyarrhythmia shocks, e.g., defibrillation shocks and/or cardioversion shocks, via electrodes.
  • EGM cardiac electrogram
  • ECG electrocardiogram
  • An ICD or an implantable cardiac pacemaker may provide cardiac pacing therapy to the heart when the natural pacemaker and/or conduction system of the heart fails to provide synchronized atrial and ventricular contractions at rates and intervals sufficient to sustain healthy patient function.
  • ICDs and cardiac pacemakers may also provide overdrive cardiac pacing, referred to as anti-tachycardia pacing (ATP), to suppress or convert detected tachyarrhythmias in an effort to avoid cardioversion/defibrillation shocks.
  • ATP anti-tachycardia pacing
  • the techniques of this disclosure generally relate to techniques performed by a medical device system during a programming session for avoiding programming a control parameter of a medical device that results in conflicting operations or undesired interactions between two medical devices operating in or on a patient.
  • a first medical device operating according to the techniques disclosed herein may receive a programming instruction from an external programming device to set a value of a programmable control parameter used by the first medical device to control a medical device function.
  • the first medical device may determine whether the control parameter is a dependent parameter that may be associated with conflicting or undesired interactions with functions performed by a second medical device operating in or on the patient.
  • the first medical device may request the status of one or more control parameters from the second medical device via inter-device, intrabody communication.
  • the first medical device may perform one or more actions in response to receiving the requested status of the control parameter(s) from the second medical device.
  • the first medical device may determine compatibility of the pending value of the programmable control parameter with the status of the control parameter(s) received from the second medical device.
  • the first medical device may implement the pending value of the control parameter when compatibility with the status of the control parameter of the second medical device is determined. Additionally or alternatively, the first medical device may transmit a notification or warning to the external programming device based on the control parameter status information received from the second medical device.
  • the disclosure provides a medical device comprising circuitry configured to operate according to a control parameter for performing a medical device function and communication circuitry for receiving a pending value of a first control parameter transmitted from an external programming device.
  • the communication circuitry may be further configured to receive information on a second medical device control parameter status.
  • the control circuit may be configured to, based on at least the received information on the second medical device control parameter status, perform one of: cancel the pending value of the first control parameter or implement the pending value of the first control parameter for performing the medical device function.
  • the disclosure provides a method comprising receiving by a medical device a pending value of a first control parameter transmitted from an external programming device and receiving information on a second medical device control parameter status.
  • the method may further include, based on at least the received information on the second medical device control parameter status, performing one of: cancelling the pending value of the first control parameter or implementing the pending value of the first control parameter for performing the medical device function according to the pending value of the first control parameter.
  • the disclosure provides a non-transitory computer-readable medium comprising a set of instructions that, when executed by processing circuitry of a medical device system cause the medical device system to perform a medical device function according to a control parameter, receive a transmitted pending value of the control parameter and receive information on a second medical device control parameter status.
  • the instructions may further cause the medical device system to, based on at least the received information on the second medical device control parameter status, perform one of: cancel the pending value of the control parameter; or implement the pending value of the control parameter for performing the medical device function.
  • the disclosure provides a medical device system comprising an external programming device comprising external communication circuitry, a first medical device configured to control a medical device function according to a programmable control parameter and a second medical device.
  • the first medical device is configured to receive a pending value of the programmable control parameter from the external programming device and, in response to receiving the pending value of the programmable control parameter, transmit a first communication signal requesting a second device control parameter status.
  • the second medical device is configured to receive the first communication signal and transmit a second communication signal in response to receiving the first communication signal.
  • the first medical device is further configured to, based on at least the received second communication signal, perform one of: cancel the pending value of the programmable control parameter or implement the pending value of the programmable control parameter for performing the medical device function.
  • FIG. 1 is a conceptual diagram of a method for controlling programming of a medical device according to some examples.
  • FIG. 2 is a conceptual diagram of an implantable medical device (IMD) system including multiple medical devices in operative contact with a patient and capable of intrabody communication for managing medical device programming according to one example.
  • IMD implantable medical device
  • FIG. 3 is a conceptual diagram of a pacemaker that may be included in the IMD system of FIG. 2 according to some examples.
  • FIG. 4 is a conceptual diagram of a programmable medical device capable of performing intrabody communication according to some examples.
  • FIG. 5 is a flow chart of a method that may be performed by a programmable medical device according to some examples.
  • FIG. 6 is a flow chart of a medical device programming method according to another example.
  • FIG. 1 is a conceptual diagram 1 of a method for controlling programming of a medical device that includes intrabody medical device communication according to some examples.
  • an external programming device 50 is configured to communicate with two or more medical devices 4, 6.
  • Medical devices 4, 6 can be operatively positioned for delivering a therapy to a patient and/or monitoring a physiological function of the patient.
  • Medical devices 4, 6 may be IMDs that can be co-implanted in a patient.
  • Illustrative examples presented herein generally relate to medical device systems in which two or more IMDs are co-implanted in a patient and an external programming device 50 can be used to program at least one of the IMDs, and at least two of the co-implanted IMDS are configured to communicate via an intrabody communication method.
  • medical devices 4 and/or 6 may be external devices, which may or may not be wearable devices but can be operatively coupled to the patient, e.g., using one or more cutaneous or transcutaneous sensors, electrodes, catheters, patches or the like, for performing one or more patient monitoring and/or therapy delivery functions.
  • medical devices 4, 6 that may be included in a medical device system configured to operate according to the techniques disclosed herein include, but are not limited to, cardiac monitoring devices, blood pressure monitors, electroencephalogram monitoring devices, glucose monitoring devices, fall detectors, pacemakers, ICDs, drug delivery devices, neurostimulators for delivering electrical stimulation to the brain, spinal cord, nerves or muscles, or other IMDs or external medical devices.
  • the medical devices 4 and 6 can be configured to communicate with each other to exchange data relating to control parameter programming of each individual device. Medical devices 4 and 6 may perform independent functions, e.g., physiological signal monitoring and/or therapy delivery functions, but may communicate via an intrabody communication method to manage programming of control parameters in at least one of the medical devices 4 or 6 that may lead to undesirable device interactions or functional redundances.
  • intrabody communication refers to the transmitting and receiving of signals through at least a portion of the patient’s body.
  • the term “intrabody communication” may refer to the transmission and reception of communication signals wholly or entirely within a patient’s body, e.g., when both medical devices are IMDs, but is not necessarily limited to being wholly within the patient’s body.
  • the intrabody communication includes transmitting and receiving communication signals via electrodes, antennas, light emitting diodes (LED), microphones, or other transmitting/receiving members of the intrabody communication system that are implanted in the patient’s body and/or positioned cutaneously on the patient’s skin.
  • intrabody communication could include transmission and/or reception of signals at the surface of the patient’s skin.
  • External programming device 50 may be configured to communicate with at least one of the medical devices 4, 6 for retrieving data from the medical device 4 and/or 6 and for transmitting values or settings of one or more programmable control parameters to the medical device 4 and/or 6, e.g., in the form of a programming command.
  • External programming device 50 may communicate with medical device 4 or medical device 6, e.g., one at a time, during an individual programming session.
  • the programmable control parameters that may be programmed by external programming device 50 may be used by the respective medical device 4 or 6 for controlling the medical device functions, such as sensing a physiological signal, detecting a physiological condition or event, responding to a physiological event detection (e.g., by recording data and/or generating a notification or alert) and/or delivering a therapy (e.g., an electrical stimulation therapy, a prescribed medication or biological therapy).
  • a physiological event detection e.g., by recording data and/or generating a notification or alert
  • a therapy e.g., an electrical stimulation therapy, a prescribed medication or biological therapy.
  • External programming device 50 may include a processor 52, memory 53, display unit 54, user interface 56 and communication unit 58.
  • Processor 52 controls external programming device operations and processes data and signals received from medical devices 4 and 6.
  • Display unit 54 which may include a graphical user interface (GUI), displays data and other information to a user for reviewing medical device operation and programmed parameters as well as physiological signals retrieved from medical device 4 or 6, for example.
  • GUI graphical user interface
  • processor 52 may receive data from medical device 4 or 6 relating to sensed physiological signals or detected physiological events.
  • processor 52 may receive programmed control parameter values from the medical device 4 or 6. Data received from the medical device 4 or 6 during the interrogation session may be displayed by display unit 54 for review by a clinician.
  • various windows or menus of programmable control parameters and selectable values of the control parameters may be displayed by display unit 54 for selection by a user, e.g., the patient, a clinician or other caregiver, or a medical device expert.
  • the user may select a pending value of a programmable control parameter for producing a programming command that can be transmitted by communication unit 58 to the respective medical device 4 or 6 via a communication link.
  • Processor 52 may execute instructions stored in memory 53.
  • Processor 52 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry.
  • processor 52 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry.
  • the functions attributed to processor 52 herein may be embodied as software, firmware, hardware or any combination thereof.
  • Memory 53 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital or analog media.
  • Memory 53 may be configured to store various medical device control parameters, e.g., physiological signal sensing control parameters, physiological event detection control parameters, and/or therapy delivery control parameters, and associated programmable settings for each of medical device 4 and medical device 6.
  • memory 53 may store tables of programmable control parameters of each medical device 4 and 6, which can include an identification of which control parameters are dependent control parameters in some examples, as further described below.
  • User interface 56 may include a mouse, touch screen, keypad or the like to enable a user to interact with external device 50 to initiate a communication session with medical device 4 or medical device 6 for retrieving data from and/or transmitting data to the respective medical device.
  • a user interacting with user interface 56 may cause communication unit 58 to send and receive data to and from medical device 4 or medical device 6 during the communication session.
  • User interface 56 may include one or more input devices and one or more output devices, which may include display unit 54.
  • the input devices of user interface 56 may include a communication device such as a network interface, keyboard, pointing device, voice responsive system, video camera, biometric detection/response system, button, sensor, mobile device, control pad, microphone, presence- sensitive screen, touch-sensitive screen (which may be included in display unit 54), or any other type of device for detecting input from a human or machine.
  • a communication device such as a network interface, keyboard, pointing device, voice responsive system, video camera, biometric detection/response system, button, sensor, mobile device, control pad, microphone, presence- sensitive screen, touch-sensitive screen (which may be included in display unit 54), or any other type of device for detecting input from a human or machine.
  • the one or more output devices of user interface 56 may include a network interface, display, sound card, video graphics adapter card, speaker, presence-sensitive screen, one or more USB interfaces, video and/or audio output interfaces, or any other type of device capable of generating tactile, audio, video, or other output.
  • Display unit 54 may function as an input and/or output device using technologies including liquid crystal displays (LCD), quantum dot display, dot matrix displays, light emitting diode (LED) displays, organic light-emitting diode (OLED) displays, cathode ray tube (CRT) displays, e-ink, or monochrome, color, or any other type of display capable of generating tactile, audio, and/or visual output.
  • LCD liquid crystal displays
  • LED light emitting diode
  • OLED organic light-emitting diode
  • CRT cathode ray tube
  • user interface 56 may produce an output to a user in another fashion, such as via a sound card, video graphics adapter card, speaker, presence- sensitive screen, touch-sensitive screen, one or more USB interfaces, video and/or audio output interfaces, or any other type of device capable of generating tactile, audio, video, or other output.
  • display unit 54 is a presence- sensitive display that may serve as a user interface device that operates both as one or more input devices and one or more output devices.
  • Communication unit 58 may include a transceiver and antenna configured for bidirectional communication with a communication circuit included in medical device 4 and/or medical device 6. Communication unit 58 is configured to operate in conjunction with processor 52 for sending and receiving data to and from a medical devices 4 or 6 during a communication session.
  • a bidirectional communication link e.g., represented by arrows 2, 7 with medical device 4 and arrows 9,11 with medical device 6, may be established between external programming device 50 and the respective medical device 4 or medical device 6 using a radio frequency (RF) link such as BLUETOOTH®, Wi-Fi, Zigbee or other IEEE specification based communication protocol, Global System for Mobile Communication (GSM) or other mobile communication protocol, Medical Implant Communication Service (MICS) or other RF, cellular or infrared communication protocols as examples.
  • RF radio frequency
  • external programming device 50 may be configured to communicate via a communication protocol performed by communication unit 58 under the control of external device processor 52 with at least one medical device, e.g., medical device 4, but not necessarily all medical devices operating in or on the patient.
  • external programming device 50 may communicate with medical device 4 but not necessarily with medical device 6.
  • the two medical devices 4 and 6 may be configured to communicate directly with each other, however.
  • the two medical devices 4 and 6 may communicate with each other according to a different communication protocol and/or using different communication circuitry than that used for executing communication between external programming device 50 and medical device 4. As such, even though bidirectional communication is represented in FIG.
  • external programming device 50 may be configured for bidirectional communication with medical device 4 but not necessarily medical device 6.
  • the communication sessions between external programming device 50 and medical device 4 may occur at discrete times different than the times of communication sessions between external programming device 50 and medical device 6.
  • External programming device 50 may not be configured to perform simultaneous communication with medical device 4 and medical device 6, for example.
  • External programming device 50 may be configured for wireless communication to enable programming of medical devices 4 and/or 6 when implanted inside a patient’s body.
  • external device 50 may include a programming head that can be placed proximate a medical device 4 or 6 to establish and maintain a communication link with the respective medical device.
  • external programming device 50 may be configured to communicate with a respective medical device 4 or 6 using a distance telemetry algorithm and circuitry that does not require the use of a programming head and does not require user intervention to maintain a communication link, allowing for ambulatory and/or remote programming of medical device 4 and/or 6.
  • external programming device 50 may include connection ports 55 for connecting communication wires or cables extending between external programming device 50 and another medical device 4 or 6 for wired communication with the respective medical device if the medical device 4 or 6 is an external, e.g., wearable, device.
  • Data stored or acquired by medical devices 4 and/or 6, including physiological signals or associated data derived therefrom, results of device diagnostics, and histories of detected physiological events or episodes and/or delivered therapies, may be retrieved from medical device 4 and/or medical device 6 by external programming device 50 following an interrogation command transmitted to the respective medical device 4 or 6.
  • External programming device 50 may be embodied as a programmer used in a hospital, clinic or physician’s office to retrieve data from medical devices 4 and 6 and to program operating parameters and algorithms in medical devices 4 and 6 for controlling medical device functions.
  • External device 50 may alternatively be embodied as a home monitor or hand-held device, such as a smart phone, tablet or other hand-held device.
  • aspects of external programming device 50 may generally correspond to the external programming/monitoring unit disclosed in U.S. Pat. No. 5,507,782 (Kieval, et al.), hereby incorporated herein by reference in its entirety.
  • An example programmer that may be configured to perform the techniques disclosed herein is the CARELINK® Programmer, commercially available from Medtronic, Inc., Dublin, Ireland.
  • a medical device system including two or more medical devices, e.g., medical devices 4 and 6, operatively coupled to a patient to monitor and/or deliver therapy to the patient, is configured to perform intrabody communication between the two or more medical devices 4 and 6 in at least some instances when a programming instruction is received by one of the medical devices.
  • the programming instruction may include a programmable value of a control parameter used by the medical device for controlling a function of the medical device, e.g., related to patient monitoring or delivering a therapy.
  • the medical device may determine when the control parameter is a dependent parameter.
  • dependent parameter refers to a programmable control parameter that is used by the medical device to control a device function that can result in an interaction with a function performed by another medical device that is implanted in or otherwise operatively coupled to the same patient.
  • performing a medical device function that results in an interaction with another medical device may include, but is not limited to, performing a function that is in conflict with a function performed by the other medical device, performing a function that results in an undesired outcome when performed in combination with a function of the other medical device, performing a function that is a redundant to a function performed by the other medical device when redundancy is not intended or desired, and/or performing a function that interferes with or prevents the other medical device from performing a programmed function.
  • An appropriate value of a dependent parameter in a first medical device for avoiding an undesired interaction with a second medical device may be dependent on the value of a control parameter in the second medical device.
  • the control parameter in the second medical device may or may not be the same control parameter as the dependent parameter in the first device.
  • a therapy delivery control parameter in the first medical device may be a dependent parameter that can be programmed to a value that could cause an undesired interaction with the second medical device depending on a sensing or monitoring control parameter in the second medical device.
  • a therapy delivery control parameter in the first medical device may be in conflict with the same therapy delivery control parameter programmed in the second medical device.
  • independent parameter refers to a control parameter that is used by a medical device to control a device function that generally will not interact or conflict with a function of another medical device that is implanted in or otherwise operatively coupled to the same patient.
  • the independent parameter may be a control parameter used to control a medical device function that may or may not be redundant to a function of another medical device that is implanted in or otherwise operatively coupled to the same patient.
  • redundant functions of two or more medical devices is not desired in order to avoid unnecessary power drain of a medical device battery if another device is performing the same or equivalent function.
  • a control parameter used by medical device 4 for performing a common monitoring function of medical device 6 may be defined as a dependent parameter if redundant monitoring is undesired in order to conserve the longevity of the power source of medical device 4, free up processing circuitry of medical device 4 to perform other device functions, and/or avoid accumulating duplicate or conflicting data for review by a clinician.
  • a control parameter used by medical device 4 for performing a monitoring function that is also performed by medical device 6 may be defined as an independent parameter if redundant monitoring is desired in order to provide redundant detection of physiological events for confirming or verifying detection of the physiological events by both medical devices 4 and 6.
  • Medical devices 4 and 6 may be configured to perform intrabody communication via radiofrequency (RF) signals, infrared (IR) signals, acoustical signals, tissue conductance communication (TCC) signals or other communication protocol signals.
  • RF radiofrequency
  • IR infrared
  • TCC tissue conductance communication
  • the methods disclosed herein for managing programming of a control parameter of a medical device are not limited to practice in conjunction with a particular form or type of intrabody communication. Rather, the intrabody communication performed for transmitting second medical device control parameter information to a first medical device, which may be in response to the first medical device receiving a programming instruction for setting a value of a dependent parameter or other triggering event, can conform to any communication method that the medical devices, e.g., medical devices 4 and 6, are configured to perform.
  • external programming device 50 may transmit a pending value of a programmable control parameter to medical device 4 (as shown by arrow 2).
  • Medical device 4 may determine whether the programmable control parameter is a dependent control parameter. If the programmable control parameter is not dependent (e.g., independent), medical device 4 may implement the pending value of the control parameter and transmit a confirmation of the programmed value back to external programming device 50, e.g., as notification 7. However, when medical device 4 determines that the programmable control parameter for which a pending value has been received is a dependent control parameter, medical device 4 may transmit an intrabody communication to medical device 6 (as shown by arrow 3).
  • the intrabody communication may include a request for the status of a control parameter of medical device 6.
  • the control parameter of medical device 6 may be a fixed or programmable control parameter in medical device 6. However, the control parameter of medical device 6 may be used to control a function of medical device 6 that could interact with, conflict with or be redundant to the function of medical device 4 that is controlled at least in part by the dependent control parameter being programmed in medical device 4.
  • Medical device 6 may transmit an intrabody communication signal back to medical device 4 (as indicated by arrow 5) in response to receiving the control parameter status request.
  • the intrabody communication signal 5 may include the status of the control parameter of medical device 6.
  • the status may be communicated as a value of the control parameter, which may be a quantitative (e.g., numerical) value or a qualitative value (e.g., on/off or enabled/disabled).
  • the first intrabody communication signal 3 requesting the second medical device control parameter status may not be required.
  • Medical device 6 may transmit information on the status of one or more control parameters to medical device 4 (as indicated by arrow 5) in response to any of a number of triggering events.
  • a triggering event may be detecting the presence of medical device 4, a command from external programming device 50, or detecting the presence of a magnet applied to the patient’s body to trigger a communication session, as non-limiting examples.
  • medical device 4 may determine if the pending value of the programmable control parameter received from external programming device 50 is compatible with the control parameter status received from the second medical device 6. In other examples, medical device 4 may receive an indication of compatibility from medical device 6 as the parameter status response signal 5. If compatible, medical device 4 may implement the pending value of the dependent control parameter and transmit a programming confirmation notification (arrow 7) back to external programming device 50. If medical device 4 determines that the pending value of the programmable control parameter is not compatible with the control parameter status of medical device 6, e.g., may result in undesired device interactions, and/or undesired redundant function, medical device 4 may transmit a notification to external programmer 50 that a potential programming conflict is detected.
  • the processor 52 of the external programming device 50 may generate data for display on display unit 54 for review by the user.
  • the user may resend the pending value as a programming instruction or otherwise confirm programming of the pending value, select a different value of the programmable control parameter to transmit as a programming instruction to medical device 4, or cancel the programming of the programmable control parameter in medical device 4.
  • the user may use external programming device 50 to transmit a new parameter value (arrow 9) as a programming instruction to medical device 6 to alter the function of the second medical device 6 to avoid any potential conflict, undesired device interaction, or undesired redundancy when the pending value of the dependent parameter transmitted to the first medical device 4 (arrow 2) is implemented.
  • the second medical device 6 may return a confirmation signal to external device 50 in response to receiving and implementing the programmed parameter value of medical device 6.
  • medical device 4 may transmit the parameter status received from medical device 6 (arrow 5) to external programming device 50 as a notification (arrow 7) to enable the user to determine if the parameter status of the second medical device 6 and the pending value of the programmable control parameter of the first medical device 4 are compatible.
  • medical device 4 may transmit the parameter status received from medical device 6 (arrow 5) to external programming device 50 as a notification (arrow 7), and processor 52 of external programming device 50 may determine if the parameter status of the second medical device 6 and the pending value of the programmable control parameter of the first medical device 4 are compatible.
  • the external programming device may be configured to determine and display one or more recommended settings to the user as alternative control parameter values that are compatible with the parameter status of the second medical device.
  • a programming confirmation of the pending value of the programmable control parameter or a different value of the programmable control parameter may be transmitted as a programming instruction to medical device 4 from communication unit 58 based on the compatibility determination.
  • medical device 4 is shown as initiating the intrabody communication by transmitting the parameter status request (arrow 3) to medical device 6, in response to receiving a pending value for a control parameter that is identified as a dependent parameter, and subsequently receiving a parameter status signal (arrow 5) from medical device 6.
  • analogous intrabody communication signals may be transmitted between medical device 6 and medical device 4 when medical device 6 receives a pending value of a programmable control parameter from external programming device 50.
  • the analogous intrabody communication signals are not shown in FIG. 1 for the sake of clarity. It is to be understood, however, from the general diagram of FIG.
  • medical device 6 may initiate an intrabody communication by transmitting a parameter status request to medical device 4 in response to receiving a pending value of a programmable control parameter from external programming device 50 that is identified as a dependent parameter.
  • medical device 6 may be programmed independently of medical device 4 without performing intrabody communication whereas medical device 4 may be programmed in a manner that is dependent on the status of control parameters of medical device 6 such that intrabody communication methods for controlling and managing the implementation of pending values of dependent control parameters are utilized.
  • FIG. 2 is a conceptual diagram of an IMD system 10 including multiple medical devices in operative contact with a patient and capable of intrabody communication for managing medical device programming according to one example.
  • IMD system 10 is provided as an illustrative example of two medical devices 14 and 114 that may be coimplanted in a patient and operate in a medical device system including external programming device 50 for managing programming of at least one of the two medical devices 14 and 114 in a manner that utilizes intrabody communication between medical devices 14 and 114.
  • IMD system 10 includes an ICD 14 and a pacemaker 114.
  • ICD 14 and pacemaker 114 are configured to communicate wirelessly in this example although in some instances two or more devices may be coupled via communication cables or wires for conducting communication signals between medical devices.
  • ICD 14 and pacemaker 114 are configured to communicate via TCC to exchange the status of a programmable value of a control parameter. Examples of medical devices and methods for performing TCC that may be adapted for performing the techniques disclosed herein are generally disclosed in U.S. Patent No. 9,636,511 (Carney, et al., filed January 23, 2015) and U.S. Patent No.
  • ICD 14 and pacemaker 114 may be configured to communicate via an RF communication protocol, e.g., BLUETOOTH® Low Energy (BLE), Wi-Fi, an IEEE standard, Medical Implant Communication Service (MICS) or other communication protocol.
  • IMD system 10 including ICD 14 and pacemaker 114 may be capable of sensing cardiac electrical signals produced by the patient’s heart 8 and delivering CV/DF shocks and/or cardiac pacing pulses to the patient’s heart 8.
  • the cardiac signal sensing functions and the delivery of cardiac electrical stimulation pulses by ICD 14 and pacemaker 114 can be controlled by the control circuitry included in the respective individual device 14 or 114 according to various operating control parameters. At least some of the operating control parameters utilized by ICD 14 and pacemaker 14 can be programmable by external programming device 50.
  • ICD 14 includes a housing 15 that forms a hermetic seal that protects internal components of ICD 14.
  • the housing 15 of ICD 14 may be formed of a conductive material, such as titanium or titanium alloy.
  • the housing 15 may function as an electrode (sometimes referred to as a “can” electrode).
  • the housing 15 of ICD 14 may include a plurality of electrodes on an outer portion of the housing.
  • the outer portion(s) of the housing 15 functioning as an electrode(s) may be coated with a material, such as titanium nitride for reducing post-stimulation polarization artifact.
  • Housing 15 may be used as an active can electrode for use in delivering CV/DF shocks or other high voltage pulses delivered using a high voltage therapy circuit.
  • housing 15 may be available for use in delivering relatively lower voltage cardiac pacing pulses and/or for sensing cardiac electrical signals in combination with electrodes carried by lead 16. In any of these examples, housing 15 may sometimes be used in a transmitting and/or receiving electrode vector for transmitting and/or receiving TCC signals according to the intrabody communication techniques performed for programming of ICD 14 or pacemaker 114 as disclosed herein.
  • ICD 14 is shown coupled to a medical electrical lead 16 (referred to hereafter as “lead” 16) carrying one or more electrodes positioned in operative proximity to the patient’s heart 8.
  • ICD 14 includes a connector assembly 17 (also referred to as a connector block or header) that includes electrical feedthroughs crossing housing 15 to provide electrical connections between conductors extending within the lead body 18 of lead 16 and electronic components included within the housing 15 of ICD 14.
  • housing 15 may house one or more processors, memories, transceivers, cardiac electrical signal sensing circuitry, therapy delivery circuitry, communication circuitry, power sources, other optional sensors and/or other components for sensing cardiac electrical signals, detecting a heart rhythm, and controlling and delivering electrical stimulation pulses to treat an abnormal heart rhythm.
  • lead 16 includes an elongated lead body 18 having a proximal end 27 that includes a lead connector (not shown) configured to be connected to ICD connector assembly 17 and a distal portion 25 that includes one or more electrodes.
  • the distal portion 25 of lead body 18 may include defibrillation electrodes 24 and 26 and pace/sense electrodes 28 and 30.
  • defibrillation electrodes 24 and 26 may together form a defibrillation electrode in that they may be configured to be activated concurrently.
  • defibrillation electrodes 24 and 26 may form separate defibrillation electrodes in which case each of the electrodes 24 and 26 may be selectively activated independently.
  • Electrodes 24 and 26 are referred to herein as defibrillation electrodes because they can be utilized, individually or collectively, for delivering high voltage stimulation therapy (e.g., cardioversion or defibrillation shocks). Electrodes 24 and 26 may be elongated coil electrodes and generally have a relatively high surface area for delivering high voltage electrical stimulation pulses compared to pacing and sensing electrodes 28 and 30. However, electrodes 24 and 26 and housing 15 may also be utilized to provide pacing functionality, sensing functionality, and/or TCC signal transmitting and receiving in addition to or instead of high voltage stimulation therapy.
  • high voltage stimulation therapy e.g., cardioversion or defibrillation shocks.
  • Electrodes 24 and 26 may be elongated coil electrodes and generally have a relatively high surface area for delivering high voltage electrical stimulation pulses compared to pacing and sensing electrodes 28 and 30. However, electrodes 24 and 26 and housing 15 may also be utilized to provide pacing functionality, sensing functionality, and/or TCC signal transmit
  • electrodes 24 and 26 may be used in a sensing vector used to sense cardiac electrical signals and detect and discriminate tachyarrhythmias. Electrodes 24 and 26 may be used in a TCC signal transmitting electrode vector in combination with each other, collectively with housing 15, or individually with housing 15. When ICD 14 operates in a receiving mode for receiving TCC signals from pacemaker 114, electrodes 24, 26 and/or housing 15 may be used in a TCC receiving electrode vector.
  • the TCC transmitting and receiving electrode vectors may be the same or different vectors.
  • Electrodes 28 and 30 are relatively smaller surface area electrodes which can be available for use in sensing electrode vectors for sensing cardiac electrical signals and may be used for delivering relatively low voltage pacing pulses in some configurations. Electrodes 28 and 30 are referred to as pace/sense electrodes because they are generally configured for use in low voltage applications, e.g., delivery of relatively low voltage pacing pulses and/or sensing of cardiac electrical signals, as opposed to delivering high voltage CV/DF shocks. In some instances, electrodes 28 and 30 may provide only pacing functionality, only sensing functionality or both. Furthermore, one or both of electrodes 28 and 30 may be used for TCC signal transmission and/or receiving in some examples, together or in combination with any of electrodes 24, 26 and/or housing 15.
  • electrode 28 is located proximal to defibrillation electrode 24, and electrode 30 is located between defibrillation electrodes 24 and 26. Electrodes 28 and 30 may be ring electrodes, short coil electrodes, hemispherical electrodes, or the like. Electrodes 28 and 30 may be positioned at other locations along lead body 18 and are not limited to the positions shown. In other examples, lead 16 may include none, one or more pace/sense electrodes and/or one or more defibrillation electrodes.
  • ICD 14 may obtain cardiac electrical signals corresponding to electrical activity of heart 8 via a combination of sensing electrode vectors that include combinations of electrodes 24, 26, 28, 30 and/or housing 15. Various sensing electrode vectors utilizing combinations of electrodes 24, 26, 28, and 30 may be selected by sensing circuitry included in ICD 14 for receiving a cardiac electrical signal via one or more sensing electrode vectors.
  • a TCC transmitting/receiving electrode vector may be selected from the available electrodes, e.g., defibrillation electrodes 24, 26, 28, 30 and housing 15 of ICD 14.
  • the TCC transmitting/receiving electrode vector may be used for transmitting TCC signals produced by a TCC transmitter included in ICD 14 and for receiving TCC signals from another device, e.g., pacemaker 114.
  • ICD 14 may include an RF antenna in connector assembly 17 for receiving and transmitting RF communication signals with an RF transceiver enclosed within housing 15.
  • RF communication signals may be received from and transmitted to pacemaker 114 in response to receiving a programming command from external programming device 50. For example, when a pending value of a programmable control parameter is received from external programming device 50 and ICD 14 determines that the programmable control parameter is a dependent parameter, ICD 14 may transmit a communication signal to pacemaker 114 for requesting the status of a corresponding dependent parameter that is used by pacemaker 114 for controlling pacemaker functions.
  • communication circuitry included in ICD 14 may include an RF antenna and transceiver for bidirectional communication with external programming device 50 and TCC circuitry for transmitting and receiving intrabody TCC signals, e.g., via transmitting and receiving pairs of electrodes carried by lead 16.
  • TCC may be used for intrabody communication with pacemaker 114 and RF communication may be used for communication with external programming device 50.
  • ICD 14 may include communication circuitry for communicating according to two different methods such that during a programming session with external programming device 50, ICD 14 may conduct intrabody communication as needed with pacemaker 114.
  • lead 16 extends subcutaneously or submuscularly over the ribcage 32 medially from the connector assembly 27 of ICD 14 toward a center of the torso of patient 12, e.g., toward xiphoid process 20 of patient 12.
  • lead 16 bends or turns and extends superiorly, e.g., subcutaneously or submuscularly over the ribcage and/or sternum or substernally under the ribcage and/or sternum 22.
  • the distal portion 25 of lead 16 may be implanted at other locations, such as over sternum 22, offset to the right or left of sternum 22, angled laterally from sternum 22 toward the left or the right, or the like.
  • lead 16 may be placed along other subcutaneous, submuscular or substernal paths. The path of extra-cardiovascular lead 16 may depend on the location of ICD 14, the arrangement and position of electrodes carried by the lead body 18, and/or other factors.
  • ICD 14 is shown implanted subcutaneously on the left side of patient 12 along the ribcage 32. ICD 14 may, in some instances, be implanted between the left posterior axillary line and the left anterior axillary line of patient 12. ICD 14 may, however, be implanted at other subcutaneous or submuscular locations in patient 12. For example, ICD 14 may be implanted in a subcutaneous pocket in the pectoral region. In this case, lead 16 may extend subcutaneously or submuscularly from ICD 14 toward the manubrium of sternum 22 and bend or turn and extend inferiorly from the manubrium to the desired location subcutaneously or submuscularly. In yet another example, ICD 14 may be placed abdominally.
  • the lead body 18 of lead 16 may be formed from a non-conductive material and shaped to form one or more lumens within which the one or more conductors extend.
  • Lead body 18 may be a flexible lead body that conforms to an implant pathway. In other examples, lead body 18 may include one or more preformed curves.
  • Electrical conductors (not illustrated) extend through one or more lumens of the elongated lead body 18 of lead 16 from the lead connector at the proximal lead end 27 to electrodes 24, 26, 28, and 30 located along the distal portion 25 of the lead body 18.
  • the elongated electrical conductors contained within the lead body 18 are each electrically coupled with respective defibrillation electrodes 24 and 26 and pace/sense electrodes 28 and 30, which may be separate respective insulated conductors within the lead body 18.
  • the respective conductors electrically couple the electrodes 24, 26, 28, and 30 to circuitry of ICD 14, such as a signal generator for therapy delivery and TCC signal transmission, when intrabody communication is performed via TCC, and/or a sensing circuit for sensing cardiac electrical signals and/or receiving TCC signals in some examples, via connections in the connector assembly 17, including associated electrical feedthroughs crossing housing 15.
  • the electrical conductors may transmit therapy from a therapy delivery circuit within ICD 14 to one or more of defibrillation electrodes 24 and 26 and/or pace/sense electrodes 28 and 30 and transmit sensed electrical signals from one or more of defibrillation electrodes 24 and 26 and/or pace/sense electrodes 28 and 30 to the sensing circuit within ICD 14.
  • the electrical conductors also transmit TCC signals from a TCC transmitter to electrodes selected for transmitting the TCC signals.
  • ICD 14 may receive TCC signals from pacemaker 114 conducted from a receiving pair of electrodes of ICD 14 to a TCC signal receiver enclosed by housing 15.
  • ICD 14 analyzes the cardiac electrical signals received from one or more sensing electrode vectors to monitor for abnormal rhythms, such as bradycardia, tachycardia or fibrillation. ICD 14 may analyze the heart rate and morphology of the cardiac electrical signals to monitor for tachyarrhythmia in accordance with any of a number of tachyarrhythmia detection techniques. ICD 14 generates and delivers electrical stimulation therapy in response to detecting a tachyarrhythmia, e.g., ventricular tachycardia (VT) or ventricular fibrillation (VF), using a therapy delivery electrode vector which may be selected from any of the available electrodes 24, 26, 28 30 and/or housing 15.
  • VT ventricular tachycardia
  • VF ventricular fibrillation
  • ICD 14 may deliver ATP in response to VT detection, and in some cases may deliver ATP prior to a CV/DF shock or during high voltage capacitor charging in an attempt to avert the need for delivering a CV/DF shock. If ATP does not successfully terminate VT or when VF is detected, ICD 14 may deliver one or more CV/DF shocks via one or both of defibrillation electrodes 24 and 26 and/or housing 15. ICD 14 may generate and deliver other types of electrical stimulation pulses such as post-shock pacing pulses or bradycardia pacing pulses using a pacing electrode vector that includes any of electrodes 24, 26, 28, and 30 and/or the housing 15 of ICD 14.
  • electrical stimulation pulses such as post-shock pacing pulses or bradycardia pacing pulses using a pacing electrode vector that includes any of electrodes 24, 26, 28, and 30 and/or the housing 15 of ICD 14.
  • Bradycardia or post-shock pacing pulses may be delivered by ICD 14 to pace the ventricles of the patient’s heart when an R-wave is not sensed by ICD 14 before a pacing escape interval expires.
  • the pacing escape interval may be a lower pacing rate interval corresponding to a programmed lower rate.
  • the programmed lower rate may be used by ICD 14 for controlling the rate of delivered cardiac pacing pulses for maintaining a minimum heart rate of the patient.
  • Pacemaker 114 is shown as a leadless intracardiac pacemaker configured to communicate with ICD 14.
  • Pacemaker 114 may include one or more housing-based electrodes as described below in conjunction with FIG. 3 for sensing cardiac electrical signals and delivering cardiac pacing pulses.
  • Pacemaker 114 may be delivered transvenously and anchored by a fixation member at an intracardiac pacing and sensing site.
  • pacemaker 114 may be implanted in an atrial or ventricular chamber of the patient’s heart.
  • pacemaker 114 may be attached to an external surface of heart 8 (e.g., in contact with the pericardium and/or epicardium) such that pacemaker 114 is disposed outside of heart 8.
  • Pacemaker 114 is configured to deliver cardiac pacing pulses via a pair of housingbased electrodes and may be configured to sense cardiac signals for determining the need and delivery time of a pacing pulse.
  • pacemaker 114 may deliver bradycardia pacing pulses, rate responsive pacing pulses, ATP, post-shock pacing pulses and/or other pacing therapies based on sensed cardiac signals.
  • pacemaker 114 may include an accelerometer or other motion sensor for sensing acceleration signals associated with mechanical activity of heart 8.
  • pacemaker 114 may be configured to sense atrial event signals corresponding to atrial mechanical systole for triggering atrial synchronous ventricular pacing pulses delivered by pacemaker 114.
  • Pacemaker 114 may be implanted in the right atrium or the right ventricle of heart 8 to sense cardiac signals and deliver pacing therapy. Pacemaker 114 may be implanted in the ventricle for sensing a ventricular electrogram (EGM) signal and deliver ventricular pacing pulses. Pacemaker 114 may be implanted at or near the ventricular apex in the right ventricle to pace the ventricular myocardium. In other examples, pacemaker 114 may be implanted along the interventricular septum to provide pacing of the cardiac conduction system (e.g., via the left and/or right bundle branches) and/or septal myocardium.
  • EVM ventricular electrogram
  • Pacemaker 114 may operate in an atrial synchronous ventricular pacing mode, e.g., denoted as a VDD or DDD pacing mode. Ventricular pacing pulses may be delivered by pacemaker 114 at an atrioventricular pacing interval from a sensed P-wave or delivered atrial pacing pulse. At other times, pacemaker 114 may operate in a single chamber atrial pacing mode or a single chamber, asynchronous ventricular pacing mode, e.g., a VVI or VOO pacing mode.
  • External programming device 50 is configured for wireless telemetric communication with ICD 14, e.g., via a wireless communication link 42, and for wireless telemetric communication with pacemaker 114, e.g., via a wireless communication link 44.
  • Communication link 42 or 44 may be established between ICD 14 or pacemaker 114, respectively, and external device 50 using any of the example communication techniques described above in conjunction with FIG. 1.
  • ICD 14 and/or pacemaker 114 may communicate with external device 50 using TCC, e.g., using TCC transmitting/receiving electrodes coupled to external device 50 and placed externally on patient 12.
  • external programming device 50 may be used to program operating parameters and algorithms in ICD 14 for controlling ICD functions and/or to program operating parameters and algorithms in pacemaker 114 for controlling pacemaker functions.
  • External device 50 may be used to program cardiac signal sensing control parameters, cardiac rhythm detection control parameters and therapy delivery control parameters used by ICD 14 and by pacemaker 114 in respective programming sessions with the individual devices 14 and 114.
  • Data stored or acquired by ICD 14 and/or pacemaker 114, including physiological signals or associated data derived therefrom, results of device diagnostics, and histories of detected rhythm episodes and delivered therapies, may be retrieved from ICD 14 and/or pacemaker 114 by external device 50 following an interrogation command.
  • FIG. 3 is a conceptual diagram of pacemaker 114 that may be included in the medical device system of FIG. 2 according to some examples.
  • Pacemaker 114 may be a leadless pacemaker configured to communicate with another medical device in operative contact with a patient, e.g., ICD 14 as shown in FIG. 2.
  • Pacemaker 114 may be implanted in a ventricular heart chamber for sensing cardiac signals and delivering ventricular pacing pulses.
  • pacemaker 114 may be configured for implantation in the right atrium for providing atrial pacing and/or ventricular pacing from a right atrial location.
  • Pacemaker 114 may include a housing 150 carrying housing-based electrodes 162, 164 and 165.
  • the type, number and location of housing based electrodes provided on pacemaker 114 may be adapted for a particular implant location and sensing/pacing application.
  • Other features of a leadless pacemaker such as fixation members, size, etc. may be adapted as necessary for a particular pacing and sensing application.
  • pacemaker 114 shown in FIG. 3 is illustrative in nature of a leadless pacemaker that can be one type of device that may be included in a medical device system that performs intrabody communication for coordinating programming of medical device control parameters according to the techniques disclosed herein.
  • pacemaker 114 is not intended to be a limiting example of a pacemaker or more generally an IMD that may be included in a medical device system configured to operate according to the disclosed techniques, particularly with regard to a specific implant location or features adapted for that implant location.
  • pacemaker 114 may be configured to receive one or more leads, each carrying one or more electrodes, which may be advanced transvenously into the patient’s heart for sensing and/or cardiac electrical stimulation therapy delivery in one or more heart chambers.
  • pacemaker 114 includes a housing 150 having a distal end face 102 and a proximal end face 104.
  • the lateral sidewall 170 of housing 150 extending from distal end face 102 to proximal end face 104 may be generally cylindrical to facilitate transvenous delivery, e.g., via a catheter, of pacemaker 114 to an implant site.
  • Distal end face 102 is referred to as “distal” in that it is expected to be the leading end as pacemaker 114 is advanced through a delivery tool, such as a catheter, and placed against a targeted implant site.
  • housing 150 may have a generally prismatic shape.
  • the housing 150 encloses the electronics and a power supply for sensing cardiac signals, producing pacing pulses and controlling therapy delivery and other functions of pacemaker 114 as described herein.
  • Pacemaker 114 is shown including electrodes 162, 164 and 165 spaced apart along the housing 150 of pacemaker 114 for sensing cardiac electrical signals and delivering pacing pulses. Pacemaker 114 may have more than or fewer than three electrodes, however. In another example, pacemaker 114 may only include electrodes 162 and 165 or only electrodes 162 and 164 for instance. Electrodes 162, 164 and 165 may be, without limitation, titanium, platinum, iridium or alloys thereof and may include a low polarizing coating, such as titanium nitride, iridium oxide, ruthenium oxide, platinum black, among others.
  • Electrode 164 also referred to herein as “tip electrode” 164, is shown extending from distal end face 102 of housing 150.
  • Tip electrode 164 is shown as a screw-in helical electrode which may provide fixation of pacemaker 114 at an implant site as well as serving as a pacing and sensing electrode.
  • pacemaker 114 may be implanted in the right atrium so that electrode 164 can be advanced from within the right atrial chamber to a ventricular pacing site, e.g., toward or into the interventricular septum, for delivering pacing to the His-Purkinje conduction system and/or for pacing of ventricular septal myocardial tissue.
  • a proximal portion of tip electrode 164, nearest housing distal end face 102, may be provided with an electrically insulative coating.
  • the more distal portion of tip electrode 164, positioned at a target pacing site, may be uninsulated to function as the electrically conductive portion of tip electrode 164 for pacing pulse delivery and for sensing cardiac electrical signals, e.g., a ventricular EGM signal.
  • Examples of insulating coatings that may be provided on the proximal portion of tip electrode 164 include parylene, urethane, poly ether ether ketone (PEEK), or polyimide, among others.
  • tip electrode 164 is not necessarily a tissue piercing electrode as shown in this example. Electrode 164 may be a dot, button, ring, hemispherical, segmented, fishhook, helical, or other type of electrode positioned on the distal end face 102 for positioning in operative proximity to or within tissue at a targeted pacing site. When implemented as a non-tissue piercing electrode, tip electrode 164 may be implanted in intimate proximity to myocardial tissue and held in a stable position via other fixation means, e.g., anchored in the atrium or the ventricle via fixation tines, for pacing atrial myocardium or ventricular myocardium respectively.
  • fixation means e.g., anchored in the atrium or the ventricle via fixation tines
  • Electrode 165 is shown as a ring electrode along the lateral side wall 170 of housing 150.
  • electrode 165 may be a dot, button, ring, hemispherical, segmented or other type of electrode positioned on the distal end face 102 of housing 150 and/or along the lateral sidewall 170.
  • Electrode 162 is shown as a ring electrode along the lateral sidewall 170 of housing 150 spaced proximally from electrode 165, toward proximal end face 104 of housing 150.
  • electrode 162 may be a dot, button, ring, hemispherical, segmented or other type of electrode positioned on the proximal end face 104 of housing 150 and/or along the lateral sidewall 170, spaced proximally and/or laterally from electrode 165. Electrodes 162 and 165 may both be ring electrodes circumscribing the lateral sidewall 170 in some examples, e.g., adjacent proximal end face 104 and adjacent distal end face 102, respectively. Other portions of housing 150 may be electrically insulated by an insulating coating.
  • Tip electrode 164 may serve as a cathode electrode with ring electrode 162 serving as a return anode for delivering ventricular pacing pulses, which may be delivered to capture of at least a portion of the His-Purkinje system and/or ventricular myocardium.
  • Tip electrode 164 and ring electrode 162 may be used as a bipolar pair for ventricular pacing and for receiving a ventricular electrical signal from which R-waves can be sensed by sensing circuitry enclosed by housing 150.
  • Electrodes 162, 164 and 165 may form a second cathode and return anode pair for bipolar atrial pacing and sensing an atrial electrical signal from which P-waves can be sensed by the sensing circuitry enclosed by housing 150.
  • any combination of electrodes 162, 164 and 165 may be used in an electrode sensing vector for sensing one or more cardiac electrical signals from which P-waves and/or R-waves may be sensed.
  • Electrodes 162, 164 and 165 may be positioned at locations along pacemaker 114 other than the locations shown.
  • pacemaker 114 includes a distal tip electrode 164 and one proximal electrode 162 or 165.
  • a TCC transmitting electrode pair and a TCC receiving electrode pair may be selected from the available electrodes 162, 164 and 165 when pacemaker 114 is configured to perform intrabody communication via TCC signals.
  • a sensing/pacing electrode pair and the TCC electrode pair carried by housing 150 may include no shared electrodes, one shared electrode or two shared electrodes in various examples. In some examples, at least one electrode pair may be carried by housing 150 for sensing cardiac signals and delivering cardiac pacing and another electrode pair may be carried by housing 150 as a TCC electrode pair. The sensing/pacing electrode pair and the TCC electrode pair may be dedicated electrode pairs or selectable from available electrodes carried by housing 150.
  • pacemaker 114 may be coimplanted with another leadless pacemaker (e.g., implanted in a different heart chamber), another pacemaker coupled to transvenous lead(s) carrying electrodes positioned for pacing and sensing at a different location than pacemaker 114, an ICD coupled to transvenous leads, a cardiac monitor such as the REVEAE LINQTM Insertable Cardiac Monitor (available from Medtronic, Inc., Dublin, Ireland), a blood pressure monitor, a fluid status monitor, an oxygen saturation monitor, or other monitor including one or more sensors, a drug pump, a neurostimulator, or other medical device configured to perform intrabody communication with pacemaker 114 during a device programming session.
  • another leadless pacemaker e.g., implanted in a different heart chamber
  • an ICD coupled to transvenous leads
  • a cardiac monitor such as the REVEAE LIN
  • Housing 150 is formed from a biocompatible material, such as a stainless steel or titanium alloy.
  • the housing 150 may include an insulating coating. Examples of insulating coatings include parylene, urethane, PEEK, or polyimide, among others.
  • the entirety of the housing 150 may be insulated, but only electrodes 162, 164 and 165 uninsulated. Electrodes 162, 164 and 165 are electrically coupled to internal circuitry, e.g., a pacing pulse generator and cardiac electrical signal sensing circuitry, enclosed by housing 150. Electrodes 162 and 165 may be formed as a conductive portion of housing 150 defining respective electrodes that are electrically isolated from each other and from the other portions of the housing 150 as generally shown in FIG. 3.
  • Pacemaker 114 may include features for facilitating deployment to and fixation at an implant site.
  • pacemaker 114 may optionally include a delivery tool interface 158.
  • Delivery tool interface 158 may be located at the proximal end 104 of pacemaker 114 and is configured to connect to a delivery device, such as a catheter, guidewire or other tool used to position pacemaker 114 at an implant location during an implantation procedure.
  • the delivery tool interface 158 may enable a clinician to advance, retract and steer pacemaker 114 to an implant site and rotate pacemaker 114 to advance the helical tip electrode 164 into the cardiac tissue.
  • Helical tip electrode 164 in this example provides fixation of pacemaker 114 at the implant site.
  • pacemaker 114 may include a set of fixation tines, hooks or other fixation members at or near distal end face 102 to secure pacemaker 114 to cardiac tissue. Numerous types of fixation members may be employed for anchoring or stabilizing pacemaker 114 in an implant position.
  • a medical device such as pacemaker 114
  • a medical device such as pacemaker 114
  • a pulse generator of pacemaker 114 used to generate cardiac pacing pulses may be controlled for generating TCC signals transmitted via electrodes 162, 164 and/or 165.
  • Pacemaker 114 may be configured for sensing cardiac electrical signals, e.g., R- waves or P-waves, attendant to intrinsic depolarizations of the myocardial tissue.
  • Pacemaker 114 may include a TCC receiver for receiving and detecting a TCC signal transmitted by another medical device, e.g., ICD 14 or any of the other examples described herein.
  • a voltage potential develops across an electrode pair, e.g., tip electrode 164 and ring electrode 162 or between ring electrodes 162 and 165, in response to current conducted via a tissue pathway during TCC signal transmission from another medical device.
  • FIG. 4 is a conceptual diagram of a programmable medical device 214 capable of performing intrabody communication according to some examples.
  • the medical device 214 is referred to herein as an “implantable medical device” or IMD 214.
  • two medical devices configured to perform intrabody communication may be IMDs.
  • a medical device performing intrabody communication may be an external device configured to perform intrabody communication with another medical device by receiving and passing communication signals through a patient’s body via electrodes, an antenna or other transmitting/receiving device that is positioned on the patient’s skin or positioned transcutaneously.
  • the device housing 215 may serve as one of the at least two electrodes and is represented conceptually as an electrode in FIG. 4, available for sensing, electrical stimulation pulse delivery and, in some examples, as a receiving and/or transmitting electrode during TCC.
  • a device configured to perform intrabody communication in association with programming of a control parameter value as disclosed herein may have more or fewer electrodes than the four electrodes 224, 226, 228 and 230 shown in FIG. 4 and may not include any electrodes at all when configured to perform functions that do not require an electrode for sensing electrophysiological signals, delivering electrical stimulation pulses, or performing intrabody communication.
  • IMD 214 may include a control circuit 80, memory 82, therapy delivery circuit 84, sensing circuit 86, sensors 87, communication circuit 88, TCC circuit 90 and power source 89.
  • Power source 89 provides power to the circuitry of IMD 214, including each of the circuits 80, 82, 84, 86, 87, 88 and 90 as needed.
  • Power source 89 may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries.
  • power source 89 may be coupled to charging circuits included in therapy delivery circuit 84 for charging capacitors or other charge storage devices and activating output switching circuitry included in therapy delivery circuit 84 for producing electrical stimulation pulses such as cardiac electrical stimulation pulses (e.g., CV/DF shock pulses or pacing pulses) or neurostimulation pulses.
  • Power source 89 may be coupled to an optional TCC circuit 90 for providing power for generating TCC signals by transmitter 91 and powering TCC receiver 92.
  • Power source 89 provides power to processors and other components of control circuit 80, memory 82, amplifiers, analog-to-digital converters and other components of sensing circuit 86, any additional sensors 87 optionally included in IMD 214 and a transceiver of communication circuit 88, when included, as examples.
  • Memory 82 may store computer-readable instructions that, when executed by a processor included in control circuit 80, cause IMD 214 to perform various functions attributed to IMD 214 (e.g., sensing physiological signals, communication with another device, and/or delivery of an electrical stimulation therapy).
  • Memory 82 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other digital or analog media.
  • RAM random access memory
  • ROM read-only memory
  • NVRAM non-volatile RAM
  • EEPROM electrically erasable programmable ROM
  • flash memory or any other digital or analog media.
  • Sensing circuit 86 may be selectively coupled to electrodes 224, 226, 228, 230 and/or housing 215 in order to monitor electrical activity of the patient’s heart. Sensing circuit 86 may include switching circuitry for selecting which electrodes 224, 226, 228, 230 and housing 215 are coupled to sense amplifiers or other cardiac event detection circuitry included in event detector 85. Switching circuitry may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple sense amplifiers to selected electrodes.
  • the event detector 85 within sensing circuit 86 may include one or more sense amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), or other analog or digital components configured to detect a feature from a sensed physiological signal to enable processing circuitry of control circuit 80 to monitor cardiac electrical signals for detecting a heart rhythm.
  • cardiac electrical event signals attendant to myocardial depolarizations e.g., P-waves attendant to atrial depolarizations and/or R- waves attendant to ventricular depolarizations, may be sensed by event detector 85 from a cardiac electrical signal received via a sensing electrode vector.
  • sensing circuit 86 includes multiple sensing channels for acquiring cardiac electrical signals from multiple sensing electrode vectors selected from electrodes 224, 226, 228, 230 and housing 215.
  • Each sensing channel may be configured to amplify, filter, digitize and rectify the cardiac electrical signal received from selected electrodes coupled to the respective sensing channel to improve the signal quality for sensing cardiac event signals, e.g., P-waves and/or R-waves.
  • each sensing channel in sensing circuit 86 may include an input or pre-filter and amplifier for receiving a cardiac electrical signal developed across a selected sensing electrode vector, an analog- to-digital converter, a post- amplifier and filter, and a rectifier to produce a filtered, digitized, rectified and amplified cardiac electrical signal.
  • the event detector 85 may include a sense amplifier, comparator or other circuitry for comparing the rectified, filtered and amplified cardiac electrical signal to a cardiac event sensing threshold, such as a P- wave sensing threshold amplitude or an R-wave sensing threshold amplitude, which may be an auto-adjusting threshold.
  • Event detector 85 may produce a sensed cardiac event signal in response to a sensing threshold crossing that is passed to control circuit 80.
  • the sensed cardiac event signals corresponding to detected R-waves and/or P-waves can be used by control circuit 80 for determining a heart rate, detecting cardiac rhythms and determining a need for a pacing and/or CV/DF therapy.
  • Control circuit 80 may include interval timers or counters, which may be reset upon receipt of a cardiac sensed event signal from sensing circuit 86.
  • the value of the interval timer or counter when reset by a cardiac sensed event signal may be used by control circuit 80 to measure the cardiac cycle length or other cardiac event intervals, e.g., durations of R-R intervals, or P-P intervals, which are measurements that may be stored in memory 82.
  • Control circuit 80 may use the cardiac event intervals to detect an arrhythmia, e.g., bradycardia or tachyarrhythmias such as fibrillation or tachycardia.
  • the therapy delivery circuit 84 may include a pulse generator configured to generate cardiac electrical stimulation pulses, e.g., CV/DF shock pulses and cardiac pacing pulses for delivery to the patient’s heart via selected electrodes 224, 226, 228, 230 and/or 215.
  • Therapy delivery circuit 84 may include one or more energy storage elements, such as one or more capacitors, configured to store the energy required for a therapeutic CV/DF shock or pacing pulse.
  • control circuit 80 controls therapy delivery circuit 84 to charge the energy storage element(s) to prepare for delivering a CV/DF shock.
  • Therapy delivery circuit 84 may include other pulse generating circuitry, such as a transformer, charge pump, charge storage capacitors and switches to couple the charge storage capacitors to electrode terminals via an output capacitor or other output circuitry such as an H-bridge to discharge and deliver the electrical stimulation pulses.
  • Therapy delivery circuit 84 may include voltage levelshifting circuitry, switches, transistors, diodes, or other circuitry as needed for generating and delivering electrical stimulation pulses.
  • therapy delivery circuit 84 may include both a low voltage therapy circuit for generating and delivering relatively low voltage therapy pulses, such as cardiac pacing or neurostimulation pulses, and a high voltage therapy circuit for generating and delivering CV/DF shocks or other relatively higher voltage stimulation pulses which may include cardiac pacing pulses delivered via extra-cardiac electrodes as described in conjunction with FIG. 2.
  • IMD 214 can be configured to monitor the impedance of an electrode vector.
  • therapy delivery circuit 84 may apply a current (or voltage) drive signal to a pair of electrodes coupled to IMD 214.
  • Sensing circuit 86 may detect the resulting voltage (or current) developed across a pair of recording electrodes.
  • Impedance monitoring may be performed to monitor bioimpedance in a tissue volume, e.g., thoracic impedance or cardiac impedance, for monitoring a patient condition.
  • impedance monitoring may be performed for tracking a fluid status of the patient, e.g., correlated to lung wetness in patients with symptoms of congestive heart failure.
  • a fluid status metric may be determined from impedance measurements by control circuit 80 and stored in memory 82 over time for detecting when the fluid status metric meets a threshold for detecting a pulmonary edema condition for example.
  • TCC circuit 90 may include a TCC transmitter 91 configured to generate TCC signals for transmission from a transmitting electrode vector selected from the electrodes 224, 226, 228, 230 and housing 215 via a conductive tissue pathway.
  • TCC transmitter 91 is configured to generate and transmit a TCC signal to communicate with another IMD (or in some cases an external device coupled to the patient via skin electrodes or transcutaneous electrodes).
  • TCC circuit 90 may include a pulse generator for generating TCC signals and switching circuitry for selectively coupling TCC transmitter 91 to a selected transmitting electrode vector, e.g., using any two or more of electrodes 224, 226, 228, 230 and housing 215.
  • the TCC signal may be transmitted by TCC circuit 90 having a carrier signal, which may be an oscillating signal having a peak-to-peak amplitude and carrier frequency selected to avoid stimulation of excitable tissue, e.g., nerve, smooth muscle, skeletal muscle or cardiac tissue, of the patient.
  • the carrier frequency of the TCC signal may be 100 kilohertz (kHz) or higher.
  • a TCC signal emitted or received, for example by a TCC electrode pair, at a frequency of at least approximately 100 kHz may be less likely to stimulate nearby tissue, e.g., muscles or nerves, or cause pain or other sensation than lower frequency waveforms.
  • a TCC signal having a frequency of at least approximately 100 kHz can have a higher amplitude than a lower frequency signal without causing extraneous nerve or muscle stimulation.
  • a relatively higher amplitude signal may increase the likelihood that another medical device successfully receives the TCC signal from IMD 214.
  • the peak-to-peak amplitude of the TCC signal may be within a range from approximately 100 microamps to 10 milliamps (mA) or more, such as within a range from approximately 1 mA to approximately 10 mA. In some examples, the amplitude of the TCC signal may be approximately 3 mA.
  • a TCC signal having a frequency of at least approximately 100 kHz and an amplitude no greater than approximately 10 mA may be unlikely to stimulate nearby tissue, e.g., muscles or nerves, or cause pain or other sensation.
  • the voltage signal at the transmitting electrode vector may be 2 Volts peak-to-peak.
  • the voltage developed at the receiving electrode vector may be in the range of 0.1 to 100 millivolts peak-to-peak, as illustrative examples. However, it is contemplated that other frequencies and amplitudes of TCC signals may be used in conjunction with the techniques disclosed herein.
  • the TCC circuit 90 may transmit a TCC signal as a modulated signal in some examples.
  • Amplitude modulation (AM), frequency modulation (FM), or digital modulation (DM), such as frequency- shift keying (FSK) or phase-shift keying (PSK) may be performed by TCC circuit 90.
  • the modulation can be FM toggling between two frequencies, e.g., toggling between approximately 100-150 kHz and approximately 200-250 kHz.
  • the TCC signal has a frequency of 150- 200 kHz and is modulated using FSK modulation at 12.5 kbps.
  • a TCC signal having a carrier frequency of 100 kHz is modulated to encode data using binary phase shift keying (BPSK).
  • BPSK binary phase shift keying
  • Balanced pulses of opposite polarity may be used to shift the phase of the TCC signal, e.g., by 180 degrees positively or negatively, and balance the charge injected into the body tissue during the phase shift to minimize the likelihood of interfering with cardiac event sensing operations of sensing circuit 86.
  • Techniques for BPSK modulation of the TCC carrier signal using charge balanced phase shifts are disclosed in U.S. Patent No. 11,110,279 (Roberts, et al.), incorporated herein by reference in its entirety.
  • the data carried by modulated or unmodulated TCC signals may include wake up signals, a request to receive the status of one or more control parameters of the second medical device, a confirmation signal following receipt of a control parameter status signal from the second medical device, acknowledgment of a wake up signal transmitted from the second medical device, and the status of a programmed control parameter of ICD 214 transmitted in response to a request from the second medical device, as examples.
  • TCC circuit 90 includes TCC receiver 92 to facilitate “two-way” TCC between IMD 214 and a second medical device.
  • a voltage signal that develops on a TCC receiving electrode pair when a TCC signal is transmitted by a second medical device may be received and demodulated by the TCC receiver 92 and decoded by processing circuitry included in control circuit 80.
  • the TCC receiver 92 may include amplifiers, filters, analog- to-digital converters, rectifiers, comparators, counters, a phase locked loop and/or other circuitry configured to detect a signal from a transmitting device and detect and demodulate a modulated carrier signal, which may be transmitted in data packets including encoded data.
  • TCC receiver 92 may include a pre-amplifier and a high-Q filter tuned to the carrier frequency of a carrier signal that is used to transmit wake up signals and/or data signals during a TCC session between two medical devices implanted in or otherwise operatively coupled to the patient.
  • the filter may be followed by another amplifier and a demodulator that converts the received signals to a binary signal representing coded data.
  • the circuitry of TCC receiver 92 may include circuitry shared with electrical signal sensing circuitry of sensing circuit 86 in some examples.
  • the filters included in a TCC receiver and cardiac electrical signal sensing circuitry are expected to operate at different passbands, for example, for detecting different signal frequencies.
  • the TCC signals may be transmitted with a carrier frequency in the range of 33 to 250 kHz, in the range of 60 to 200 kHz, or at 100 kHz as examples.
  • Cardiac electrical signals generated by heart 8 are generally less than 100 Hz.
  • IMD 214 may transmit a parameter status request from TCC transmitter 91 to another medical device when IMD 214 receives a programming command from external programming device 40 for programming a dependent parameter. IMD 214 may receive the requested status signal from the other medical device via TCC receiver 92. A modulated or non-modulated carrier signal may be received by TCC receiver 92 via TCC receiving electrodes (e.g., any of electrodes 224, 226, 228, 230 and/or housing 215) selectively coupled to TCC circuit 90. TCC receiver 92 may include an amplifier, filter and demodulator to pass the demodulated signal, e.g., as a stream of digital values, to control circuit 80 for decoding of the received signal and further processing as needed.
  • TCC receiving electrodes e.g., any of electrodes 224, 226, 228, 230 and/or housing 215
  • TCC receiver 92 may include an amplifier, filter and demodulator to pass the demodulated signal, e.g., as a stream of digital values, to control circuit 80
  • TCC receiver 92 may be included in or share sensing circuitry with sensing circuit 86.
  • TCC transmitter 91 may be included in or share signal generating circuitry with therapy delivery circuit 84.
  • TCC circuit 90 or the functionality for performing TCC implemented in therapy delivery circuit 84 and sensing circuit 86 may be omitted if IMD 214 is configured to communicate with other medical devices by other means, e.g., using RF communication which may be conducted by communication circuit 88.
  • Memory 82 may be configured to store a variety of operational control parameters, therapy control parameters, sensing control parameters, sensed and detected data, and any other information related to the monitoring of and therapy delivered to the patient.
  • Memory 82 may store, for example, thresholds and control parameters used in determining a need for therapy from a sensed physiological signal and control parameters used in controlling therapy delivery. Memory 82 may store communications transmitted to and/or received from another medical device. Memory 82 may store a list of dependent parameters that require IMD 214 to determine a parameter status from another medical device coupled to or implanted in the patient before implementing a pending value of a dependent parameter received from external programming device 50.
  • IMD 214 may be equipped with one or more other physiological sensors 87 for sensing physiological signals, such as an accelerometer, pressure sensor, temperature sensor, oxygen saturation sensor, gyroscope, heart sound sensor or the like.
  • IMD 214 includes a single axis or multi-axis, e.g., three dimensional, accelerometer that may be used for sensing patient posture, sensing patient physical activity level, and/or sensing cardiac mechanical events, e.g., associated ventricular systole, ventricular diastole and/or atrial systole.
  • Control circuit 80 may monitor one or more physiological signals received from sensors 87 for detecting a patient condition or physiological event.
  • Control circuit 80 may generate a notification or alert, record data in memory 82 and/or control therapy delivery circuit 84 based on events or conditions detected from one or more physiological signals.
  • IMD 214 may be provided with a communication circuit 88 including an antenna and transceiver for RF telemetry communication with another implanted or external device, e.g., with external programming device 50 shown in FIGs. 1 and 2.
  • IMD 214 may perform intrabody communication with another medical device, which may be coimplanted with IMD 214, for exchanging data relating to the status of a dependent parameter during or before a programming session between IMD 214 and external programming device 50.
  • Communication circuit 88 may include an oscillator and/or other circuitry configured to generate a carrier signal at the desired frequency.
  • Communication circuit 88 further includes circuitry configured to modulate data, e.g., stored physiological data, therapy delivery data, and programmable control parameter values or status on the carrier signal.
  • the modulation of RF communication signals may be, as examples, AM, FM, or DM, such as FSK or PSK.
  • communication circuit 88 is configured to modulate the TCC signal for transmission by TCC transmitter 91.
  • communication circuit 88 may be configured to modulate and/or demodulate both RF telemetry signals and TCC signals within the same frequency band, e.g., within a range from approximately 150 kHz to approximately 200 kHz, the modulation techniques for the two signals may be different.
  • TCC transmitter 91 may include a modulator for modulating TCC signals.
  • communication circuit 88 may include communication circuitry for communicating with external programming device 50 according to a first communication protocol, e.g., BLUETOOTH® Low Energy, and communication circuitry for communicating with a second medical device according to a second communication protocol, e.g., via MICS or another RF communication protocol operating at a different frequency than the first communication protocol.
  • IMD 214 may communicate with external programming device 50 via first communication circuitry included in communication circuit 88 configured to operate according to an RF communication protocol.
  • IMD 214 may communicate with a second IMD via second communication circuitry included in communication circuit 88 and configured to operate according to a different mode of communication than RF communication, e.g., using TCC, LEDs, acoustical communication, IR, modulated electrical stimulation pulses (e.g., modulated rate of pacing pulses), or other communication means. It is to be understood that transmission of data between IMD 214 and a second IMD may occur only non- concurrently with the transmission of data between IMD 214 and external programming device 50 in some examples. Depending on the communication protocol(s) and communication circuitry used by IMD 214, in some examples, data transmission to and/or data reception from external programming device 50 may occur concurrently with data transmission to and/or data reception from the second medical device.
  • second communication circuitry included in communication circuit 88 and configured to operate according to a different mode of communication than RF communication, e.g., using TCC, LEDs, acoustical communication, IR, modulated electrical stimulation pulses (e
  • Communication circuit 88 may be configured to receive, e.g., from external programmed device 50, a pending value of a control parameter used by IMD 214 for controlling a medical device function. Communication circuit 88 is further configured to receive information on a second medical device control parameter status. In some examples, communication circuit 88 may receive the second medical device control parameter status during a communication session with the second medical device that is initiated upon implantation of IMD 214, upon implantation of the second medical device, at the time of reprogramming of the second medical device, or when IMD 214 receives a pending value of a dependent parameter and transmits a request to the second medical device.
  • IMD 214 initiates communication with the second medical device by transmitting a first communication signal as a request for second medical device control parameter status.
  • IMD 214 may receive the information on the second medical device control parameter status in a second communication signal that is a response to the first communication signal. It is to be understood however, that receiving information on the second medical device control parameter status may not necessarily require transmission of a first communication signal by IMD 214 for requesting the status.
  • Transmission of information on the status of one or more second medical device control parameters may be initiated by the second medical device, e.g., upon detecting the presence of IMD 214, in response to a command from external programming device 50, upon a programming change received from external programming device 50, upon automatic adjustment of a second medical device control parameter by the second medical device, upon application of a magnet to the patient to initiate an exchange of control parameter status, or other triggering event.
  • FIG. 5 is a flow chart 300 of a method that may be performed by a programmable medical device included in a medical device system according to some examples.
  • the process of flow chart 300 is described with reference to the IMD 214 of FIG. 4, which may correspond to ICD 14 or pacemaker 114 in some examples but may correspond to other types of medical devices as listed herein.
  • control circuit 80 may receive a programming request via communication circuit 88 from external device 50.
  • the programming request may be transmitted from external device 50 after establishing a communication link between external device 50 and IMD 214.
  • the programming request may include a pending value of a programmable control parameter value as indicated at block 304.
  • the pending parameter value is a value of a control parameter that can be used by control circuit 80 to control a device function which may be any of delivery of a therapy by therapy delivery circuit 84, sensing of a physiological signal by sensing circuit 86 or sensors 87, or detecting tachyarrhythmias or other physiological conditions, e.g., cooperatively by circuitry included in sensing circuit 86 and control circuit 80.
  • control circuit 80 may determine if the programmable control parameter for which the pending value is received is a dependent parameter.
  • external programming device 50 may store classifications or labels of programmable control parameters as being dependent parameters according to a particular combination of IMDs implanted in the patient (or otherwise operatively coupled to the patient).
  • External programming device memory 53 may store multiple look up tables of control parameters for different possible device combinations. For example, when ICD 14 is implanted with pacemaker 114, a table of programmable control parameters for each device 14 and 114 may be stored in external programmer memory 53 indicating which programmable control parameters are dependent parameters for each device. The pending parameter value transmitted to IMD 214 may be flagged as a dependent parameter.
  • Control circuit 80 may determine that the associated control parameter is a dependent parameter based on whether the pending parameter value received at block 304 is flagged as being a dependent parameter.
  • each programmable control parameter may be labeled as either dependent or independent for a given medical device based on a second device that is co-implanted with the first device.
  • Patient related data may be stored in external programming device 50 indicating all co-implanted IMDs so that dependent parameters can be flagged or identified in a look up table in external programming device memory 53, for example.
  • IMD 214 may store flags or labels in IMD memory 82 indicating which programmable control parameters are dependent based on the identification of a co-implanted second medical device.
  • IMD 214 When IMD 214 is implanted in a patient, IMD 214 may be enabled to communicate with another, previously implanted IMD to detect the presence of the second IMD. When IMD 214 is already present in a patient when a second IMD is implanted, a communication session may be established between the two IMDs so that each IMD can recognize each other and store, in a respective memory, labels or flags of dependent parameters identified based on the other IMD type. In other examples, IMD 214 may transmit a communication signal to ping other devices that may be implanted or otherwise operatively coupled to the patient. A second medical device may respond to the ping so that IMD 214 can identify the second medical device.
  • IMD 214 may determine if the pending value of the control parameter received at block 304 is a dependent parameter or not. In some examples, IMD 214 may transmit the identity of the second medical device to external programming device 50 with a query requesting whether the control parameter for which a pending value has been received is a dependent parameter or not.
  • Dependent parameters may, in some cases, include device-related control parameters that may generally relate to the overall operation of the medical device, such as date/time settings, temporary operating modes during clinical procedures, etc. Additional examples of dependent parameters are described below. [0103] When IMD 214 determines that the control parameter for which a pending value has been received is not a dependent parameter, IMD 214 may update the control parameter to the pending value at block 314 and control the associated medical device function according to the updated control parameter. When IMD 214 receives the pending parameter value at block 304 identified as a dependent parameter at block 306, control circuit 80 may initiate intrabody communication with a second, co-implanted device at block 308.
  • control circuit 80 may request the status of one or more related control parameters from the second device. For example, if a dependent parameter that is a cardiac pacing control parameter is received at block 306, control circuit 80 may request the pacing mode, pacing rate, and/or other pacing control parameters from the second device. At block 312, control circuit 80 may determine if the pending value received at block 304 is compatible with the control parameter status received from the second device. A pending value can be compatible with the status of a control parameter of the second device when the pending value is to program a device function off when the device function is redundant to a second device function having a status of being on or enabled.
  • the dependent parameter may be determined to be compatible at block 312.
  • the dependent parameter may be determined to be compatible if fluid status monitoring, fall detection, or other monitoring for a physiological event or condition is being programmed off when the status of monitoring for the same physiological event or condition is turned on in the second device.
  • the dependent parameter may be determined to be compatible if fluid status monitoring, fall detection, or other monitoring for a physiological event or condition is being programmed off when the status of monitoring for the same physiological event or condition is turned on in the second device.
  • Other examples of determining that a pending value of a dependent parameter is compatible with the status of the second device are described below.
  • control circuit 80 of IMD 214 may implement the pending value of the control parameter at block 314, e.g., by updating the parameter value stored in memory 82 to the pending value received at block 304.
  • IMD 214 may operate, e.g., perform the associated medical device function, in accordance with the updated programmed control parameter.
  • control circuit 80 may transmit a notification to external programming device 50 at block 315.
  • the notification transmitted at block 315 may indicate that programming of the pending value is not allowed based on the status of a control parameter of the second device.
  • a user may reprogram the second device to different control parameter values that would not conflict and then resend the programming command with the same pending value to IMD 214.
  • the user may select a different control parameter value for the dependent parameter that will not conflict with the current control parameter status of the second device.
  • the notification transmitted at block 315 may be a warning indicating that device interactions or conflicts could occur. The user may select a different control parameter value for programming in IMD 214, reprogram the second medical device to avoid any undesired device interactions, or override the warning and continue with programming the pending value.
  • therapy delivery control parameters that may be identified as dependent parameters may include bradycardia pacing control parameters, ATP control parameters, and CV/DF shock control parameters, e.g., when IMD 214 is a pacemaker or ICD and is co-implanted with another pacemaker or ICD capable of delivering cardiac pacing therapies and/or CV/DF shocks.
  • programmable therapy delivery control parameters that can be dependent parameters may be used to control neurostimulation, drug delivery, or other types of therapy delivery.
  • examples of dependent parameters may include the cardiac pacing mode, pacing rate, enabling or disabling ATP therapies, pacing pulse amplitude and/or other cardiac pacing control parameters.
  • ICD 14 shown in FIG. 2 is programmed to deliver ventricular pacing according to one pacing mode and pacing rate and pacemaker 114 is programmed to deliver ventricular pacing according to a different pacing mode and/or different pacing rate
  • competitive cardiac pacing or other pacing interactions could occur between ICD 14 and pacemaker 114.
  • the device programmed to pace at a higher rate may dominate, depending on the programmed pacing mode, which may or may not be desired.
  • both devices are programmed to pace at the same rate, and one device is not sensing pacing pulses or pacing evoked responses caused by the other device
  • the combined pacing pulses delivered by both devices may be delivered at a rate that is faster than the programmed rate of either device, at variable rates, or at improper pace delivery times, e.g., relative to atrial activity or during the vulnerable period associated with the repolarization phase of the ventricular cycle.
  • two co-implanted devices may be programmed in a VOO pacing mode.
  • a VOO pacing mode ventricular pacing pulses are delivered at a fixed rate without sensing for ventricular event signals, e.g., R-waves, that would normally inhibit ventricular pacing pulse delivery in other pacing modes, e.g., in a VVI pacing mode that includes ventricular pacing and ventricular sensing.
  • the two devices could each be pacing at the same or different rates resulting in a higher than expected pacing rate. For example, two devices pacing in a VOO pacing mode at 60 beats per minute could result in an effective pacing rate of 120 beats per minute if the pacing pulses are delivered out of phase from each other.
  • two co-implanted devices are programmed to deliver pacing according to two different pacing modes, e.g., one in an atrial synchronous ventricular pacing mode (such as a VDD or DDD pacing mode) and the other in an asynchronous ventricular pacing mode (such as a VVI or VOO pacing mode), competitive pacing may occur. If the programmed pacing rate in the device operating in the asynchronous ventricular pacing mode is faster than the intrinsic atrial rate, asynchronous ventricular pacing may dominate when atrial synchronous pacing may be desired.
  • an atrial synchronous ventricular pacing mode such as a VDD or DDD pacing mode
  • asynchronous ventricular pacing mode such as a VVI or VOO pacing mode
  • IMD 214 may identify the pending value as being associated with a dependent parameter at block 306 and transmit an intrabody communication signal to a second device at block 310 requesting the status of the pacing mode and pacing rate programmed in the second device. IMD 214 may receive the pacing mode and pacing rate status from the second medical device at block 312 and compare the pacing mode and pacing rate to its own pacing mode and pacing rate if the pending parameter value received at block 304 is implemented.
  • the pending parameter value may be determined to be incompatible at block 312. If the pending parameter value is to turn pacing off or program the rate to a value less than the programmed pacing rate of the second device, the pending parameter value may be determined to be compatible at block 312 in that the other device may be programmed to be the primary pacing device. In other instances, if pacing is turned off or the second device pacing rate is set to a value less than the pacing rate of IMD 214 after implementing the pending parameter value, IMD 214 may be the primary pacing device.
  • the pending parameter value may be determined to be compatible at block 312 by control circuit 80 of IMD 214.
  • IMD 214 may update the programmed parameter value at block 314 and transmit a programming confirmation to external programming device 50.
  • IMD 214 may operate to control delivery of cardiac pacing in accordance with the programmed parameter value.
  • IMD 214 may still transmit a notification to the external programming device 50 at block 315 to alert the user to the combination of programmed dependent parameters that will result if the pending parameter value is implemented.
  • the user may have the opportunity to transmit a confirmation or acceptance signal using external programming device 50 back to IMD 214 (received at block 316) to proceed with updating dependent parameter to the pending value. In this way, the user may confirm that the desired pacing therapy delivery configuration is implemented between the two co-implanted devices according to the programmed control parameter values.
  • the pending value received at block 304 may be a control parameter for controlling ATP therapy delivery. If ATP therapy is enabled in one device it may be desirable to program ATP therapy off or disabled in a second device to avoid delivering ATP from two devices in response to detecting ventricular tachyarrhythmia. Accordingly, when a pending parameter value for controlling ATP therapy is received at block 304, IMD 214 may request the status of ATP therapy control parameter values from the second medical device at block 310 to determine if the programmed status of ATP therapies in the second medical device is compatible with the pending value received at block 304.
  • control circuit 80 of IMD 214 may verify at block 312 that ATP therapies are turned off in the second medical device if ATP therapies are being turned on or enabled in response to the pending parameter value.
  • Control circuit 80 of IMD 214 may verify that ATP therapies are turned off in the second medical device if a sequence or programmed menu of ATP therapies, ATP pulse amplitude, ATP pulse intervals or other control parameter used by IMD 214 is being programmed to a new value based on the pending value received at block 304. If ATP therapies are programmed off in the second medical device, IMD 214 may determine a compatible pending parameter value at block 312 and implement the programmed pending parameter value at block 314 for controlling ATP therapies.
  • IMD 214 may transmit a notification at block 315 to notify the user that ATP therapies will be off in all devices if the pending value is implemented.
  • the user may confirm the pending value to program ATP therapy off in IMD 214 or choose not to confirm programming ATP therapy off.
  • Control circuit 80 of IMD 214 may either confirm and implement the pending programmed value or return to block 302 to wait for another programming request based on an instruction from external programming device 50 received at block 316.
  • control circuit 80 may determine that the pending parameter value is compatible at block 312.
  • the second medical device may be the primary device for delivering ATP.
  • Control circuit 80 may update the pending value for disabling ATP therapy in IMD 214 at block 314.
  • a cardiac pacing control parameter may be a pending pacing pulse amplitude that could cause other types of device interactions, even when the second device is not programmed to or capable of delivering cardiac pacing.
  • other device interactions could include interference with cardiac signal sensing or other electrical signal sensing by the second device when the pacing pulse amplitude is increased and/or a pacing rate is increased.
  • a cardiac pacing rate programmed to a high rate or to a rate response pacing mode in IMD 214 could prevent certain features in a second medical device from operating correctly. For example, a detected heart rate greater than a threshold rate, e.g., greater than 85 beats per minute may prevent the second medical device from performing a capture management test.
  • the first device e.g., IMD 214
  • the second medical device is programmed to deliver other pacing therapies, such as ATP or post-shock pacing.
  • the second medical device cancels a pending capture threshold test due to the detected heart rate being greater than a threshold rate
  • the second medical device may deliver ATP or post-shock pacing using a pacing pulse amplitude that has not been confirmed to successfully capture the heart based on capture threshold testing.
  • IMD 214 may obtain, at block 310, the status of pacing therapies that are enabled in the second medical device, the status of sensing control parameters (e.g., the programmed sensitivity) and/or the status of capture management testing (e.g., if enabled or disable and scheduled time of day for testing) in the second medical device.
  • the status of pacing therapies that are enabled in the second medical device
  • the status of sensing control parameters e.g., the programmed sensitivity
  • capture management testing e.g., if enabled or disable and scheduled time of day for testing
  • feedback to the user can be provided at block 315 by transmitting a notification indicating “programming not allowed” based on the second medical device settings, or transmitting an informational or warning message to consider the implications of the programming attempt given how the second medical device is programmed.
  • the user may transmit an override or confirmation instruction to IMD 214 via external programming device 50 at block 316 to cause IMD 214 to update the dependent parameter to the pending value received at block 304.
  • IMD 214 may receive a cancellation instruction to cancel the pending value (or may not receive a confirmation message within a time out limit) and return to block 302 to wait for another programming request without implementing the pending value of the dependent parameter.
  • requesting a second device parameter status at block 310 may be a request for currently programmed value of the same dependent parameter (e.g., pacing mode or pacing rate) and/or a request for programmed value(s) of other control parameters of the second medical device that may control functions that can be affected by a change in the dependent parameter value.
  • the same dependent parameter e.g., pacing mode or pacing rate
  • a request for programmed value(s) of other control parameters of the second medical device may control functions that can be affected by a change in the dependent parameter value.
  • Examples of programmable control parameters that can be identified as dependent control parameters at block 306 can include sensing control parameters, e.g., used by sensing circuit 86 for sensing event signals.
  • sensing control parameters e.g., used by sensing circuit 86 for sensing event signals.
  • one or more sensing control parameters such as a sensing electrode vector, a blanking period, refractory period, and parameters used to control the cardiac event sensing threshold amplitude, such as a starting cardiac event sensing threshold amplitude and the sensitivity, which is sometimes referred to as the “sensing floor” because it is the minimum signal amplitude that may be sensed as a cardiac event signal.
  • Changes to a sensing control parameter may result in interactions with the second medical device, e.g., due to oversensing of electrical stimulation pulses delivered by the second medical device. Accordingly, before implementing a pending value of a sensing control parameter, IMD 214 may determine if the pending value is compatible with the control parameter status of the second medical device.
  • a high pacing pulse amplitude in the second medical device may be incompatible with increasing the sensitivity (lowering the sensitivity setting to a lower voltage) in IMD 214.
  • a different sensing electrode vector used for sensing a cardiac electrical signal by IMD 214 may be incompatible with a pacing pulse amplitude or pacing electrode vector of the second medical device, e.g., if the pending sensing electrode vector is more proximate to the pacing electrode vector than the currently implemented sensing electrode vector.
  • IMD 214 may determine that the pending value may not be compatible at block 312 or that compatibility is indeterminate at block 312. IMD 214 may transmit a notification to external programming device 50 to alert the user to possible sensing issues before implementing the pending value.
  • examples of dependent parameters may include enabling or disabling detection of the physiological condition or event, enabling or disabling storage of a physiological signal episode or other related data in memory 82, and/or enabling or disabling transmission of an alert or notification to external programming device 50. For instance, transmitting redundant alerts to external programming device 50 from multiple medical devices configured to detect the same condition or event in the patient may be undesirable. As such, a control parameter that enables transmission of an alert or notification may be a dependent parameter. However, control parameters related to storage of a physiological signal or other related data may or may not be dependent.
  • a clinician may want to interrogate a second medical device configured to monitor for the same physiological condition or event to retrieve stored physiological signal episodes and/or related data to confirm or further review the detected condition or event.
  • Tachyarrhythmia episodes, fluid status (e.g., related to edema or lung wetness), or a patient fall are a few examples among a wide variety of physiological conditions or events that may be detected by two medical devices implanted in or otherwise operatively coupled to a patient.
  • control parameters that may be dependent parameters may include one or more thresholds or other criteria applied to a monitored signal or data derived therefrom for detecting a physiological condition or event.
  • a detection control parameter e.g., a tachycardia detection interval, fibrillation detection interval, and/or number of intervals to detect (NID)
  • NID number of intervals to detect
  • Detection control parameters may be identified as dependent parameters to avoid conflicting detection information (e.g., time of detection, time of termination, duration of detected episode(s), etc.). Detection control parameters may be identified as dependent parameters to provide a single source of truth, e.g., one medical device enabled to detect and the other medical device disabled for detecting the same physiological condition or event, or for promoting detection according to a common set of detection criteria as defined by one or more programmed values of detection control parameter(s) to reduce the likelihood of conflicting detection data acquired by the two medical devices.
  • IMD 214 may include processing circuitry, e.g., included in sensing circuit 86 and/or control circuit 80, for detecting a physiological condition from one or more sensed physiological signals according to one or more control parameters.
  • the detection control parameters may be dependent control parameters, such as a detection threshold (e.g., threshold number of tachyarrhythmia intervals, threshold acceleration for detecting a patient fall, or threshold cumulative impedance change for detecting edema.
  • Other control parameters that may be dependent parameters relating to physiological condition detection may include an alert control parameter, a data storage control parameter and/or an enable or disable command for turning on or off detection of the physiological condition.
  • a device-related dependent parameter may be the date and time of day stored in the medical device.
  • IMD 214 may request the date and/or time status from a second medical device to ensure that the date and time match before accepting the pending value.
  • Another devicerelated dependent parameter may be enabling or disabling a temporary operating mode of the medical device that may enable other clinical testing or monitoring to be performed.
  • One example is a temporary magnetic resonance imaging (MRI) operating mode.
  • the dependent control parameter may be enabling or disabling the temporary MRI mode.
  • IMD 214 may verify that an MRI mode of a co-implanted, second medical device is also enabled or disabled. If the MRI mode status of the second medical device conflicts, IMD 214 may transmit a notification to external programming device 50 to notify the user that the MRI mode status of the second medical device may need to be programmed to the same status.
  • a clinician may perform an in-office underlying cardiac rhythm test or other clinical evaluations that require a temporary operating mode, e.g., suspending cardiac pacing of IMD 214.
  • the external programming device 50 may be used to place IMD 214 in a temporary operating mode that suspends pacing pulse delivery.
  • the temporary operating mode may be a dependent parameter.
  • IMD 214 may request the status of one or more control parameters of the second medical device to verify that the second medical device is not operating in a conflicting pacing mode (e.g., delivering cardiac pacing) when IMD 214 receives a suspend pacing mode command from external programming device 50.
  • a conflicting pacing mode e.g., delivering cardiac pacing
  • IMD 214 may request the status of a control parameter of the second medical device relating to detecting and storing a cardiac signal episode, e.g., when a long pause or asystole is detected. Storage of an episode by the second medical device when cardiac pacing is temporarily suspended during an in-office clinician visit may create a data record that is confusing to a clinician at a later follow-up.
  • IMD 214 may transmit a notification to the external programming device 50 to indicate that the second medical device may require programming to a temporary operating mode before or in conjunction with implementing a temporary operating mode programming command received by IMD 214 at block 304.
  • Yet another device-related dependent parameter may be a command to perform an automatic test by the IMD 214.
  • IMD 214 may be configured to perform automatic test algorithms upon receiving a command from external programming device 50, such as a pacing capture threshold test or a defibrillation threshold test.
  • the automatic test may interfere with functions of the second medical device or the functions of the second medical device may interfere with the automatic test performed by IMD 214.
  • IMD 214 when IMD 214 is embodied as an ICD capable of performing an automatic defibrillation threshold (DFT) test, IMD 214 may request an operating status of a second medical device and/or transmit a notification to the external programming device 50 that prior to initiating the defibrillation threshold test, reprogramming of the second medical device may be required to reduce the likelihood of any interference in the DFT test by the second medical device or potential damage to the second medical device. For example, cardiac pacing by the second medical device may need to be disabled to avoid pacing interference with fibrillation induction.
  • DFT automatic defibrillation threshold
  • Cardiac pacing by the second medical device may interfere with detection of the induced fibrillation and synchronizing or scheduling a CV/DF shock delivery by IMD 214 with intrinsic R-waves. Some sensing operations of the second medical device may need to be disabled or adjusted to avoid high voltage signals from interfering with sensing operations and/or damaging the second medical device. As such, IMD 214 may request the status of pacing control parameters and/or sensing control parameters from the second medical device. If pacing is turned off, IMD 214 may determine that the DFT test request is compatible with the status of the second medical device at block 312 and perform the DFT test according to the programmed request at block 314.
  • Methods described herein for performing intrabody communication for determining whether to implement a pending value of a programmable control parameter based on the status of a second, e.g., co-implanted, medical device provide improvements in medical device systems for managing medical device programming for avoiding conflicts or undesired interactions between two medical devices functioning in/on the same patient.
  • the techniques disclosed herein therefore provide improvements in the computer-related field of medical device programming.
  • the clinical benefit of two or more medical devices operating in/on the patient can be improved by the disclosed techniques by simplifying the process of programming the medical devices and avoiding undesired consequences or device interactions.
  • the techniques disclosed herein may enable selection and programming of medical devices with a high degree of confidence in a manner that is simplified, flexible, and patientspecific while avoiding human error.
  • IMD 214 may transmit a notification at block 315.
  • the notification may indicate that the programming is not allowed, include a warning that the programming could result in an undesired interaction or that the programmed parameters of the second medical device should be reviewed or reprogrammed prior to programming the pending value in IMD 214.
  • the notification may include an acceptable or alternative setting of the dependent parameter that would be compatible with the status of the second medical device.
  • IMD 214 may be configured to reject or cancel the pending parameter value that is determined not to be compatible with the second device control parameter status.
  • Control circuit 80 of IMD 214 may be configured to identify an alternative setting of the dependent parameter that is compatible with the second device control parameter status.
  • IMD 214 may transmit the compatible alternative setting of the dependent parameter to the external programming device at block 315 to receive a confirmation of the alternative setting as a new pending value at block 316.
  • IMD 214 may implement the alternative setting automatically and transmit a notification of the implemented alternative setting at block 315.
  • the alternative setting may be a pacing rate, pacing mode, or other therapy delivery control parameter that is compatible with the second device parameter status.
  • the alternative setting may be a sensing control parameter that is compatible with the second device control parameter status.
  • the alternative setting may be a detection control parameter that is compatible with the second device control parameter status.
  • the alternative setting may be disabling or enabling a device function to be compatible with the second device control parameter status.
  • the data transmitted at block 315 can include the status information received from the second medical device by IMD 214.
  • external programming device 50 may display control parameter values or the status of a device function of a second medical device without establishing a communication link directly with the second medical device during the existing communication session with the first medical device, e.g., with IMD 214.
  • the clinician or other user may confirm or cancel the pending value of the dependent parameter based on the displayed status information retrieved by IMD 214 from the second device.
  • the clinician or other user may terminate the communication session with the first medical device, IMD 214, and start a communication session with the second medical device to alter the status of a control parameter or device function based on the information received via IMD 214.
  • the user may select a different pending value or confirm the programming of the existing pending value based on the review of the second medical device control parameter status.
  • FIG. 6 is a flow chart 400 of a medical device programming method according to another example.
  • a first medical device e.g., IMD 214
  • receives a programming request from external programming device 50 e.g., via IMD communication circuit 88 (shown in FIG. 4).
  • the first medical device may correspond to any of the example medical devices listed herein and may be an IMD.
  • the first medical device may determine if the programmable control parameter for which the pending value has been received is a dependent parameter.
  • the pending parameter value may be indicated as a dependent parameter in the programming command received from the external programming device 50 at block 404.
  • the first medical device may determine if the control parameter is flagged as a dependent parameter in IMD memory 82 (shown in FIG. 4).
  • the first device may update the control parameter to the pending value at block 418. If the control parameter being programmed is a dependent parameter, the first medical device may initiate communication with a second medical device operating in or on the patient. The communication with the second medical device may be via TCC, RF communication or any other implemented communication mode, but may be a different mode of communication than the established communication link with external programming device 50.
  • the first medical device transmits a request to the second medical device in response to determining that the pending value is a dependent parameter value.
  • the control circuit 80 of IMD 214 operating as the first medical device that receives the pending value of the dependent parameter, is described as being configured to determine if the pending value is compatible with control parameter status information received from the second medical device.
  • the first medical device may be configured to initiate communication with the second medical device but may not be configured to solely determine compatibility between the pending dependent parameter value and the status of one or more control parameters of the second medical device.
  • Processing circuitry included in the medical device system may determine compatibility of the pending value with the second medical device control parameter status information.
  • the external programming device 50, the first medical device and/or the second medical device operating in/on the patient may be configured to cooperatively determine if the pending value of the dependent parameter is compatible with the status of one or more control parameters of the second medical device.
  • the first medical device transmits a request to the second medical device at block 410 that includes the pending parameter value and a request to determine compatibility of the pending parameter value with control parameters and functions of the second medical device.
  • the processing and control circuitry of the second medical device may determine at block 412 if the pending value received from the first medical device is compatible with programmed control parameters that are in effect in the second medical device.
  • the second medical device may transmit a compatibility result back to the first medical device at block 414.
  • the first medical device may implement the pending value, e.g., by updating the dependent parameter value stored in memory of the first medical device to the pending value, at block 418.
  • the first medical device may begin operating in accordance with the updated value of the dependent parameter, e.g., for controlling physiological signal sensing, physiological event detection, therapy delivery control or other device functions.
  • the first medical device may cancel the pending value at block 416 if the compatibility result is negative (undesirable device interactions or conflicts could result if the pending value is implemented).
  • the first medical device may transmit a request to the second medical device at block 410 for status information relating to one or more control parameters of the second medical device.
  • the first medical device may receive the status information from the second medical device and transmit the status information to the external programming device 50 with a request for determining compatibility at block 412.
  • the external programming device 50 may determine if the pending value transmitted to the first medical device is compatible with the status of control parameters received from the second medical device via the first medical device.
  • the external programming device 50 may transmit the compatibility result back to the first medical device at block 414.
  • the first medical device may cancel the pending value at block 416 if the compatibility result is negative (undesirable device interactions or conflicts could result if the pending value is implemented).
  • the first medical device may implement the pending value at block 418 if the compatibility result is positive (acceptable device interactions and operations if the pending value is implemented).
  • the second medical device status information may be displayed by the external programming device 50 for review by a clinician or other user.
  • the clinician may determine compatibility or confirm a compatibility result determined by the external programming device processor 52.
  • the clinician may approve and transmit the compatibility result, which may be automatically determined by the external programming device processor 52 or overridden by the clinician.
  • the first medical device may receive the compatibility result at block 414 and either cancel the pending value at block 416 or implement the pending value at block 418 in accordance with the compatibility result.
  • the medical device system may be configured to determine an acceptable or alternative setting of the dependent parameter that would be compatible with the status of the second medical device when IMD 214 cancels or rejects the pending value at block 416.
  • Control circuitry of the medical device system e.g., control circuit 80 of IMD 214, control circuitry of the second medical device, or external programming device processor 52 may be configured to identify an alternative setting of the dependent parameter that is compatible with the second device parameter status when IMD 214 cancels a pending value at block 416.
  • IMD 214 may transmit the identified alternative setting of the dependent parameter to the external programming device 50 to receive a confirmation of the alternative setting as a new pending value and may implement the alternative setting (as generally described above in conjunction with FIG. 5). In some examples, IMD 214 may implement the alternative setting automatically and transmit a notification of the implemented alternative setting to the external programming device 50.
  • the external programming device processor 52 may determine a limited set of programmable settings for the dependent parameter.
  • the limited or reduced set of dependent parameter settings may be determined by the external programming device processor 52 in response to receiving a notification from IMD 214 indicating that the pending value of the dependent parameter is cancelled based on information that IMD 214 received from the second medical device regarding its control parameter status.
  • the limited or reduced set of dependent parameter settings may be determined by the external programming device processor 52 based on information on the second medical device control parameter status that is received by IMD 214 and may be transmitted by IMD 214 to the external programming device 50.
  • a user may select a new pending value of the dependent parameter from the limited or reduced set of programmable settings for the dependent parameter.
  • Example 1 A medical device comprising circuitry configured to operate according to a first control parameter for performing a medical device function and communication circuitry configured to receive a pending value of the first control parameter transmitted from an external programming device and receive information on a second medical device control parameter status.
  • the medical device may further include a control circuit configured to, based on at least the received information on the second medical device control parameter status, perform one of: a) cancel the pending value of the first control parameter or b) implement the pending value of the first control parameter for performing the medical device function.
  • Example 2 The medical device of example 1 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter that, when used to control the medical device function, can result in an interaction with a function of the second medical device.
  • the control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, control the communication circuitry to transmit a first communication signal requesting a second device control parameter status.
  • the communication circuitry may be further configured to receive the information on the second medical device control parameter status as a second communication signal that is a response to the first communication signal requesting the second device control parameter status.
  • Example 3 The medical device of any one of examples 1 — 2 wherein the control circuit is further configured to perform one of cancel the pending value or implement the pending value by, based on at least the received information on the second medical device control parameter status, determining if the pending value of the first control parameter is compatible with the second device control parameter status and either cancelling the pending value of the first control parameter when the pending value of the of the first control parameter is determined to be not compatible with the second device control parameter status or implementing the pending value of the first control parameter when the pending value of the first control parameter is determined to be compatible with the second device control parameter status.
  • Example 4 The medical device of example 3 wherein the control circuit is further configured to determine if the pending value of the first control parameter is compatible with the second medical device control parameter status by controlling the communication circuitry to transmit the pending value and receiving the information on the second medical device control parameter status including an indication of compatibility of the pending value and the second device control parameter status.
  • Example 5 The medical device of any one of examples 1 — 4 wherein the control circuit is further configured to, based on at least the received information on the second medical device control parameter status, perform one of cancel the pending value or implement the pending value by controlling the communication circuitry to transmit a notification to the external programming device; receive, via the communication circuitry, one of a cancellation command or a confirmation command from the external programming device; and cancelling the pending value of the first control parameter in response to receiving the cancellation command or implementing the pending value of the first control parameter in response to receiving the confirmation command.
  • Example 6 The medical device of any one of examples 1 — 5 wherein the circuitry comprises therapy delivery circuitry configured to operate according to the first control parameter for delivering a therapy.
  • Example 7 The medical device of example 6 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter when the first control parameter is one of: a cardiac pacing mode; a cardiac pacing rate; a cardiac pacing pulse amplitude; or an enable or disable cardiac pacing therapy command.
  • the control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 8 The medical device of any one of examples 1 — 5 wherein the circuitry comprises sensing circuitry configured to operate according to the first control parameter for sensing a physiological signal.
  • Example 9 The medical device of example 8 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter when the first control parameter is one of: a sensitivity; a blanking period; a refractory period; or a sensing electrode vector.
  • the control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 10 The medical device of any one of examples 1 — 5 wherein the circuitry comprises processing circuitry configured to operate according to the first control parameter for detecting a physiological condition.
  • Example 11 The medical device of example 10 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter when the first control parameter is one of: a detection threshold; an alert control parameter; a data storage control parameter; or an enable or disable command for turning on or off detecting the physiological condition.
  • the control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 12 The medical device of any one of examples 1 — 11 wherein the control circuit is further configured to receive via the communication circuitry the information on the second device control parameter status corresponding to a second control parameter that is a different control parameter than the first control parameter.
  • Example 13 The medical device of any one of examples 1 — 12 wherein the control circuit is further configured to determine that the first control parameter is a dependent control parameter when the first control parameter is one of: a date; a time of day; a temporary operating mode; or a test command.
  • the control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 14 The medical device of any one of examples 1 — 13 wherein the communication circuitry is further configured to receive the pending value of the first control parameter via a first communication protocol and receive the information on the second medical device control parameter status via a second communication protocol, the first communication protocol different than the second communication protocol.
  • Example 15 The medical device of any one of examples 1 — 14 wherein the communication circuitry further comprises a first communication circuit configured to receive the pending value of the first control parameter and a second communication circuit configured to receive the information on the second medical device control parameter status as a tissue conductance communication signal, the second communication circuit different than the first communication circuit.
  • Example 16 The medical device of any one of examples 1 — 15 wherein the control circuit is further configured to, in response to cancelling the pending value of the first control parameter, identify an alternative setting of the first control parameter based on the received information on the second medical device control parameter status.
  • the control circuit may be further configured to control the communication circuitry to transmit the alternative setting to the external programming device.
  • Example 17 A method comprising receiving, by a first medical device, a pending value of a first control parameter transmitted from an external programming device and receiving by the first medical device information on a second medical device control parameter status.
  • the first control parameter can be used by the first medical device to perform a medical device function.
  • the method may further include, based on at least the received information on the second medical device control parameter status, performing one of: a) cancelling the pending value of the first control parameter or b) implementing the pending value of the first control parameter for performing the medical device function according to the pending value of the first control parameter.
  • Example 18 The method of example 17 further comprising determining that the first control parameter is a dependent parameter that, when used to control the medical device function, can result in an interaction with a function of a second medical device.
  • the method may further include, in response to determining that the first control parameter is a dependent parameter, transmitting a first communication signal requesting the second medical device control parameter status.
  • the method may further include receiving the information on the second medical device control parameter status by receiving a second communication signal that is a response to the first communication signal requesting the second medical device control parameter status.
  • Example 19 The method of any one of examples 17 — 18 further comprising performing one of cancelling the pending value or implementing the pending value by, based on at least the received information on the second medical device control parameter status, determining if the pending value of the first control parameter is compatible with the second device control parameter status and either cancelling the pending value of the first control parameter when the pending value of the of the first control parameter is determined to be not compatible with the second device control parameter status or implementing the pending value of the first control parameter when the pending value of the first control parameter is determined to be compatible with the second device control parameter status.
  • Example 20 The method of example 19 wherein determining if the pending value of the first control parameter is compatible with the second medical device control parameter status comprises controlling the communication circuitry to transmit the pending value and receiving the information on the second medical device control parameter status including an indication of compatibility of the pending value and the second medical device control parameter status.
  • Example 21 The method of any one of examples 17 — 20 further comprising, based on at least the received information on the second medical device control parameter status, performing one of cancelling the pending value or implementing the pending value by transmitting a notification to the external programming device, receiving one of a cancellation command or a confirmation command from the external programming device and either cancelling the pending value of the first control parameter in response to receiving the cancellation command or implementing the pending value of the first control parameter in response to receiving the confirmation command.
  • Example 22 The method of any one of examples 17 — 21 further comprising delivering a therapy according to the first control parameter.
  • Example 23 The method of example 22 further comprising determining that the first control parameter is a dependent parameter when the first control parameter is one of: a cardiac pacing mode; a cardiac pacing rate; a cardiac pacing pulse amplitude; or an enable or disable cardiac pacing therapy command.
  • the method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 24 The method of any one of examples 17 — 21 further comprising sensing a physiological signal according to the first control parameter.
  • Example 25 The method of example 24 further comprising determining that the first control parameter is a dependent parameter when the first control parameter is one of a sensitivity; a blanking period; a refractory period; or a sensing electrode vector.
  • the method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 26 The method of any one of examples 17 — 21 further comprising detecting a physiological condition according to the first control parameter.
  • Example 27 The method of example 26 further comprising determining that the first control parameter is a dependent parameter when the first control parameter is one of: a detection threshold; an alert control parameter; a data storage control parameter; or an enable or disable command for turning on or off detecting the physiological condition.
  • the method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 28 The method of any one of examples 17 — 27 further comprising receiving the information on the second device control parameter status corresponding to a second control parameter that is a different control parameter than the first control parameter.
  • Example 29 The method of any one of examples 17 — 28 further comprising determining that the first control parameter is a dependent control parameter when the first control parameter is one of: a date; a time of day; a temporary operating mode; or a test command.
  • the method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
  • Example 30 The method of any one of examples 17 — 29 further comprising receiving the pending value of the first control parameter via a first communication protocol and receiving the information on the second medical device control parameter status via a second communication protocol, the first communication protocol different than the second communication protocol.
  • Example 31 The method of any one of examples 17 — 30 further comprising receiving the pending value of the first control parameter via a first communication circuit and receiving the information on the second medical device control parameter status as a tissue conductance communication signal via a second communication circuit different than the first communication circuit.
  • Example 32 The method of any one of examples 17 — 31 further comprising, in response to cancelling the pending value of the first control parameter, identifying an alternative setting of the first control parameter based on the received information on the second medical device control parameter status.
  • the method may further include transmitting the alternative setting to the external programming device.
  • Example 33 A non-transitory computer-readable medium comprising a set of instructions that, when executed by processing circuitry of a medical device system, cause the medical device system to perform a medical device function according to a control parameter, receive a transmitted pending value of the control parameter and receive information on a second medical device control parameter status.
  • the instructions may further cause the medical device system to, based on at least the received information on the second medical device control parameter status, perform one of: a) cancel the pending value of the control parameter or b) implement the pending value of the control parameter for performing the medical device function.
  • Example 34 A medical device system comprising an external programming device comprising external communication circuitry, a first medical device and a second medical device.
  • the first medical device may be configured to control a medical device function according to a programmable control parameter, receive a pending value of the programmable control parameter from the external programming device and, in response to receiving the pending value of the programmable control parameter, transmit a first communication signal requesting a second device control parameter status.
  • the second medical device may be configured to receive the first communication signal and transmit a second communication signal in response to receiving the first communication signal.
  • the first medical device can be further configured to, based on at least the received second communication signal, perform one of: a) cancel the pending value of the programmable control parameter or b) implement the pending value of the programmable control parameter for performing the medical device function.
  • the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware -based processing unit.
  • Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other non- transitory computer-readable medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
  • processors such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable logic arrays
  • processors such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable logic arrays

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Abstract

A medical device system includes a first medical device having circuitry configured to operate according to a first control parameter for performing a medical device function. The first medical device includes communication circuitry for receiving a pending value of the first control parameter and receiving information on a second medical device control parameter status. The first medical device may include a control circuit configured to, based on at least the received information on the second medical device control parameter status, either cancel the pending value of the control parameter or implement the pending value of the control parameter for performing the medical device function.

Description

MEDICAL DEVICE PROGRAMMING
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/586,394, filed September 28, 2023, the entire content of which is incorporated herein by reference.
TECHNICAL FIELD
[0002] The disclosure relates generally to medical devices, systems and methods for programming control parameter values in a medical device that is operating in a patient having at least one other medical device.
BACKGROUND
[0003] A wide variety of implantable medical devices (IMDs) for delivering a therapy to or monitoring a physiological condition of a patient have been used clinically or proposed for clinical use in patients. Examples include IMDs that deliver therapy to and/or monitor conditions associated with the heart, muscle, nerve, brain, stomach or other tissue. Some therapies include the delivery of electrical stimulation to such tissues. Some IMDs may employ electrodes for the delivery of therapeutic electrical signals to such organs or tissues, electrodes for sensing intrinsic physiological electrical signals within the patient, which may be propagated by such organs or tissue, and/or other sensors for sensing physiological signals of a patient. In some situations, two or more medical devices can be implanted within and/or worn by a single patient. Each of the two or more medical devices may operate individually to perform a monitoring function and/or deliver a therapy to the patient.
[0004] Implantable cardioverter defibrillators (ICDs), for example, may be used to deliver high energy cardioversion or defibrillation (CV/DF) shocks to a patient's heart when ventricular tachyarrhythmia, e.g., tachycardia or fibrillation, is detected. An ICD may detect a tachyarrhythmia based on an analysis of a cardiac electrogram (EGM) or electrocardiogram (ECG) sensed via electrodes, and may deliver anti-tachyarrhythmia shocks, e.g., defibrillation shocks and/or cardioversion shocks, via electrodes. An ICD or an implantable cardiac pacemaker, as another example, may provide cardiac pacing therapy to the heart when the natural pacemaker and/or conduction system of the heart fails to provide synchronized atrial and ventricular contractions at rates and intervals sufficient to sustain healthy patient function. ICDs and cardiac pacemakers may also provide overdrive cardiac pacing, referred to as anti-tachycardia pacing (ATP), to suppress or convert detected tachyarrhythmias in an effort to avoid cardioversion/defibrillation shocks.
SUMMARY
[0005] The techniques of this disclosure generally relate to techniques performed by a medical device system during a programming session for avoiding programming a control parameter of a medical device that results in conflicting operations or undesired interactions between two medical devices operating in or on a patient. A first medical device operating according to the techniques disclosed herein may receive a programming instruction from an external programming device to set a value of a programmable control parameter used by the first medical device to control a medical device function. In response to receiving the pending value, the first medical device may determine whether the control parameter is a dependent parameter that may be associated with conflicting or undesired interactions with functions performed by a second medical device operating in or on the patient. If the control parameter is a dependent parameter, the first medical device may request the status of one or more control parameters from the second medical device via inter-device, intrabody communication. The first medical device may perform one or more actions in response to receiving the requested status of the control parameter(s) from the second medical device.
[0006] In some examples, the first medical device may determine compatibility of the pending value of the programmable control parameter with the status of the control parameter(s) received from the second medical device. The first medical device may implement the pending value of the control parameter when compatibility with the status of the control parameter of the second medical device is determined. Additionally or alternatively, the first medical device may transmit a notification or warning to the external programming device based on the control parameter status information received from the second medical device.
[0007] In one example, the disclosure provides a medical device comprising circuitry configured to operate according to a control parameter for performing a medical device function and communication circuitry for receiving a pending value of a first control parameter transmitted from an external programming device. The communication circuitry may be further configured to receive information on a second medical device control parameter status. The control circuit may be configured to, based on at least the received information on the second medical device control parameter status, perform one of: cancel the pending value of the first control parameter or implement the pending value of the first control parameter for performing the medical device function.
[0008] In another example, the disclosure provides a method comprising receiving by a medical device a pending value of a first control parameter transmitted from an external programming device and receiving information on a second medical device control parameter status. The method may further include, based on at least the received information on the second medical device control parameter status, performing one of: cancelling the pending value of the first control parameter or implementing the pending value of the first control parameter for performing the medical device function according to the pending value of the first control parameter.
[0009] In another example, the disclosure provides a non-transitory computer-readable medium comprising a set of instructions that, when executed by processing circuitry of a medical device system cause the medical device system to perform a medical device function according to a control parameter, receive a transmitted pending value of the control parameter and receive information on a second medical device control parameter status. The instructions may further cause the medical device system to, based on at least the received information on the second medical device control parameter status, perform one of: cancel the pending value of the control parameter; or implement the pending value of the control parameter for performing the medical device function.
[0010] In another example the disclosure provides a medical device system comprising an external programming device comprising external communication circuitry, a first medical device configured to control a medical device function according to a programmable control parameter and a second medical device. The first medical device is configured to receive a pending value of the programmable control parameter from the external programming device and, in response to receiving the pending value of the programmable control parameter, transmit a first communication signal requesting a second device control parameter status. The second medical device is configured to receive the first communication signal and transmit a second communication signal in response to receiving the first communication signal. The first medical device is further configured to, based on at least the received second communication signal, perform one of: cancel the pending value of the programmable control parameter or implement the pending value of the programmable control parameter for performing the medical device function.
[0011] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
BRIEF DESCRIPTION OF DRAWINGS
[0012] FIG. 1 is a conceptual diagram of a method for controlling programming of a medical device according to some examples.
[0013] FIG. 2 is a conceptual diagram of an implantable medical device (IMD) system including multiple medical devices in operative contact with a patient and capable of intrabody communication for managing medical device programming according to one example.
[0014] FIG. 3 is a conceptual diagram of a pacemaker that may be included in the IMD system of FIG. 2 according to some examples.
[0015] FIG. 4 is a conceptual diagram of a programmable medical device capable of performing intrabody communication according to some examples.
[0016] FIG. 5 is a flow chart of a method that may be performed by a programmable medical device according to some examples.
[0017] FIG. 6 is a flow chart of a medical device programming method according to another example.
DETAILED DESCRIPTION
[0018] FIG. 1 is a conceptual diagram 1 of a method for controlling programming of a medical device that includes intrabody medical device communication according to some examples. In FIG. 1, an external programming device 50 is configured to communicate with two or more medical devices 4, 6. Medical devices 4, 6 can be operatively positioned for delivering a therapy to a patient and/or monitoring a physiological function of the patient. Medical devices 4, 6 may be IMDs that can be co-implanted in a patient. Illustrative examples presented herein generally relate to medical device systems in which two or more IMDs are co-implanted in a patient and an external programming device 50 can be used to program at least one of the IMDs, and at least two of the co-implanted IMDS are configured to communicate via an intrabody communication method.
[0019] In other examples, however, one or both of medical devices 4 and/or 6 may be external devices, which may or may not be wearable devices but can be operatively coupled to the patient, e.g., using one or more cutaneous or transcutaneous sensors, electrodes, catheters, patches or the like, for performing one or more patient monitoring and/or therapy delivery functions. Examples of medical devices 4, 6 that may be included in a medical device system configured to operate according to the techniques disclosed herein include, but are not limited to, cardiac monitoring devices, blood pressure monitors, electroencephalogram monitoring devices, glucose monitoring devices, fall detectors, pacemakers, ICDs, drug delivery devices, neurostimulators for delivering electrical stimulation to the brain, spinal cord, nerves or muscles, or other IMDs or external medical devices.
[0020] The medical devices 4 and 6 can be configured to communicate with each other to exchange data relating to control parameter programming of each individual device. Medical devices 4 and 6 may perform independent functions, e.g., physiological signal monitoring and/or therapy delivery functions, but may communicate via an intrabody communication method to manage programming of control parameters in at least one of the medical devices 4 or 6 that may lead to undesirable device interactions or functional redundances. As used herein, intrabody communication refers to the transmitting and receiving of signals through at least a portion of the patient’s body. The term “intrabody communication” may refer to the transmission and reception of communication signals wholly or entirely within a patient’s body, e.g., when both medical devices are IMDs, but is not necessarily limited to being wholly within the patient’s body. In some cases, the intrabody communication includes transmitting and receiving communication signals via electrodes, antennas, light emitting diodes (LED), microphones, or other transmitting/receiving members of the intrabody communication system that are implanted in the patient’s body and/or positioned cutaneously on the patient’s skin. As such, in some examples, intrabody communication could include transmission and/or reception of signals at the surface of the patient’s skin.
[0021] External programming device 50 may be configured to communicate with at least one of the medical devices 4, 6 for retrieving data from the medical device 4 and/or 6 and for transmitting values or settings of one or more programmable control parameters to the medical device 4 and/or 6, e.g., in the form of a programming command. External programming device 50 may communicate with medical device 4 or medical device 6, e.g., one at a time, during an individual programming session. The programmable control parameters that may be programmed by external programming device 50 may be used by the respective medical device 4 or 6 for controlling the medical device functions, such as sensing a physiological signal, detecting a physiological condition or event, responding to a physiological event detection (e.g., by recording data and/or generating a notification or alert) and/or delivering a therapy (e.g., an electrical stimulation therapy, a prescribed medication or biological therapy).
[0022] External programming device 50 may include a processor 52, memory 53, display unit 54, user interface 56 and communication unit 58. Processor 52 controls external programming device operations and processes data and signals received from medical devices 4 and 6. Display unit 54, which may include a graphical user interface (GUI), displays data and other information to a user for reviewing medical device operation and programmed parameters as well as physiological signals retrieved from medical device 4 or 6, for example. During an interrogation session with a respective medical device 4 or 6, processor 52 may receive data from medical device 4 or 6 relating to sensed physiological signals or detected physiological events. During an interrogation session with a respective medical device 4 or 6, processor 52 may receive programmed control parameter values from the medical device 4 or 6. Data received from the medical device 4 or 6 during the interrogation session may be displayed by display unit 54 for review by a clinician.
[0023] During a programming session, which may be performed in conjunction with an interrogation session, various windows or menus of programmable control parameters and selectable values of the control parameters may be displayed by display unit 54 for selection by a user, e.g., the patient, a clinician or other caregiver, or a medical device expert. The user may select a pending value of a programmable control parameter for producing a programming command that can be transmitted by communication unit 58 to the respective medical device 4 or 6 via a communication link.
[0024] Processor 52 may execute instructions stored in memory 53. Processor 52 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processor 52 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processor 52 herein may be embodied as software, firmware, hardware or any combination thereof.
[0025] Memory 53 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital or analog media. Memory 53 may be configured to store various medical device control parameters, e.g., physiological signal sensing control parameters, physiological event detection control parameters, and/or therapy delivery control parameters, and associated programmable settings for each of medical device 4 and medical device 6. In some examples, memory 53 may store tables of programmable control parameters of each medical device 4 and 6, which can include an identification of which control parameters are dependent control parameters in some examples, as further described below.
[0026] User interface 56 may include a mouse, touch screen, keypad or the like to enable a user to interact with external device 50 to initiate a communication session with medical device 4 or medical device 6 for retrieving data from and/or transmitting data to the respective medical device. A user interacting with user interface 56 may cause communication unit 58 to send and receive data to and from medical device 4 or medical device 6 during the communication session. User interface 56 may include one or more input devices and one or more output devices, which may include display unit 54. The input devices of user interface 56 may include a communication device such as a network interface, keyboard, pointing device, voice responsive system, video camera, biometric detection/response system, button, sensor, mobile device, control pad, microphone, presence- sensitive screen, touch-sensitive screen (which may be included in display unit 54), or any other type of device for detecting input from a human or machine.
[0027] The one or more output devices of user interface 56 may include a network interface, display, sound card, video graphics adapter card, speaker, presence-sensitive screen, one or more USB interfaces, video and/or audio output interfaces, or any other type of device capable of generating tactile, audio, video, or other output. Display unit 54 may function as an input and/or output device using technologies including liquid crystal displays (LCD), quantum dot display, dot matrix displays, light emitting diode (LED) displays, organic light-emitting diode (OLED) displays, cathode ray tube (CRT) displays, e-ink, or monochrome, color, or any other type of display capable of generating tactile, audio, and/or visual output. In other examples, user interface 56 may produce an output to a user in another fashion, such as via a sound card, video graphics adapter card, speaker, presence- sensitive screen, touch-sensitive screen, one or more USB interfaces, video and/or audio output interfaces, or any other type of device capable of generating tactile, audio, video, or other output. In some examples, display unit 54 is a presence- sensitive display that may serve as a user interface device that operates both as one or more input devices and one or more output devices.
[0028] Communication unit 58 may include a transceiver and antenna configured for bidirectional communication with a communication circuit included in medical device 4 and/or medical device 6. Communication unit 58 is configured to operate in conjunction with processor 52 for sending and receiving data to and from a medical devices 4 or 6 during a communication session. A bidirectional communication link, e.g., represented by arrows 2, 7 with medical device 4 and arrows 9,11 with medical device 6, may be established between external programming device 50 and the respective medical device 4 or medical device 6 using a radio frequency (RF) link such as BLUETOOTH®, Wi-Fi, Zigbee or other IEEE specification based communication protocol, Global System for Mobile Communication (GSM) or other mobile communication protocol, Medical Implant Communication Service (MICS) or other RF, cellular or infrared communication protocols as examples.
[0029] In some examples, external programming device 50 may be configured to communicate via a communication protocol performed by communication unit 58 under the control of external device processor 52 with at least one medical device, e.g., medical device 4, but not necessarily all medical devices operating in or on the patient. For example, external programming device 50 may communicate with medical device 4 but not necessarily with medical device 6. The two medical devices 4 and 6 may be configured to communicate directly with each other, however. The two medical devices 4 and 6 may communicate with each other according to a different communication protocol and/or using different communication circuitry than that used for executing communication between external programming device 50 and medical device 4. As such, even though bidirectional communication is represented in FIG. 1 between external programming device 50 and both of medical devices 4 and 6, it is to be understood that within the medical device system configured to perform the techniques disclosed herein, external programming device 50 may be configured for bidirectional communication with medical device 4 but not necessarily medical device 6. When external programming device 50 is configured to perform bidirectional communication with both medical devices 4 and 6, the communication sessions between external programming device 50 and medical device 4 may occur at discrete times different than the times of communication sessions between external programming device 50 and medical device 6. External programming device 50 may not be configured to perform simultaneous communication with medical device 4 and medical device 6, for example.
[0030] External programming device 50 may be configured for wireless communication to enable programming of medical devices 4 and/or 6 when implanted inside a patient’s body. In some examples, external device 50 may include a programming head that can be placed proximate a medical device 4 or 6 to establish and maintain a communication link with the respective medical device. In other examples, external programming device 50 may be configured to communicate with a respective medical device 4 or 6 using a distance telemetry algorithm and circuitry that does not require the use of a programming head and does not require user intervention to maintain a communication link, allowing for ambulatory and/or remote programming of medical device 4 and/or 6. In some examples, external programming device 50 may include connection ports 55 for connecting communication wires or cables extending between external programming device 50 and another medical device 4 or 6 for wired communication with the respective medical device if the medical device 4 or 6 is an external, e.g., wearable, device. Data stored or acquired by medical devices 4 and/or 6, including physiological signals or associated data derived therefrom, results of device diagnostics, and histories of detected physiological events or episodes and/or delivered therapies, may be retrieved from medical device 4 and/or medical device 6 by external programming device 50 following an interrogation command transmitted to the respective medical device 4 or 6.
[0031] External programming device 50 may be embodied as a programmer used in a hospital, clinic or physician’s office to retrieve data from medical devices 4 and 6 and to program operating parameters and algorithms in medical devices 4 and 6 for controlling medical device functions. External device 50 may alternatively be embodied as a home monitor or hand-held device, such as a smart phone, tablet or other hand-held device. Aspects of external programming device 50 may generally correspond to the external programming/monitoring unit disclosed in U.S. Pat. No. 5,507,782 (Kieval, et al.), hereby incorporated herein by reference in its entirety. An example programmer that may be configured to perform the techniques disclosed herein is the CARELINK® Programmer, commercially available from Medtronic, Inc., Dublin, Ireland.
[0032] As disclosed herein, a medical device system including two or more medical devices, e.g., medical devices 4 and 6, operatively coupled to a patient to monitor and/or deliver therapy to the patient, is configured to perform intrabody communication between the two or more medical devices 4 and 6 in at least some instances when a programming instruction is received by one of the medical devices. The programming instruction may include a programmable value of a control parameter used by the medical device for controlling a function of the medical device, e.g., related to patient monitoring or delivering a therapy. The medical device may determine when the control parameter is a dependent parameter. As used herein, the term “dependent parameter” refers to a programmable control parameter that is used by the medical device to control a device function that can result in an interaction with a function performed by another medical device that is implanted in or otherwise operatively coupled to the same patient. As used herein, performing a medical device function that results in an interaction with another medical device may include, but is not limited to, performing a function that is in conflict with a function performed by the other medical device, performing a function that results in an undesired outcome when performed in combination with a function of the other medical device, performing a function that is a redundant to a function performed by the other medical device when redundancy is not intended or desired, and/or performing a function that interferes with or prevents the other medical device from performing a programmed function. An appropriate value of a dependent parameter in a first medical device for avoiding an undesired interaction with a second medical device may be dependent on the value of a control parameter in the second medical device. The control parameter in the second medical device may or may not be the same control parameter as the dependent parameter in the first device. For example, a therapy delivery control parameter in the first medical device may be a dependent parameter that can be programmed to a value that could cause an undesired interaction with the second medical device depending on a sensing or monitoring control parameter in the second medical device. Additionally or alternatively, a therapy delivery control parameter in the first medical device may be in conflict with the same therapy delivery control parameter programmed in the second medical device.
[0033] As used herein, the term “independent parameter” refers to a control parameter that is used by a medical device to control a device function that generally will not interact or conflict with a function of another medical device that is implanted in or otherwise operatively coupled to the same patient. The independent parameter may be a control parameter used to control a medical device function that may or may not be redundant to a function of another medical device that is implanted in or otherwise operatively coupled to the same patient. In some instance, redundant functions of two or more medical devices is not desired in order to avoid unnecessary power drain of a medical device battery if another device is performing the same or equivalent function. For example, medical device 4 and medical device 6 shown in FIG. 1 may both perform a common monitoring function, such as detecting atrial tachyarrhythmia for tracking an atrial tachyarrhythmia burden, monitoring thoracic impedance for monitoring a patient fluid status, or detecting a patient fall as a few illustrative examples of many types of monitoring functions that a medical device may perform. A control parameter used by medical device 4 for performing a common monitoring function of medical device 6 may be defined as a dependent parameter if redundant monitoring is undesired in order to conserve the longevity of the power source of medical device 4, free up processing circuitry of medical device 4 to perform other device functions, and/or avoid accumulating duplicate or conflicting data for review by a clinician. However, in other examples, a control parameter used by medical device 4 for performing a monitoring function that is also performed by medical device 6 may be defined as an independent parameter if redundant monitoring is desired in order to provide redundant detection of physiological events for confirming or verifying detection of the physiological events by both medical devices 4 and 6.
[0034] Medical devices 4 and 6 may be configured to perform intrabody communication via radiofrequency (RF) signals, infrared (IR) signals, acoustical signals, tissue conductance communication (TCC) signals or other communication protocol signals. The methods disclosed herein for managing programming of a control parameter of a medical device are not limited to practice in conjunction with a particular form or type of intrabody communication. Rather, the intrabody communication performed for transmitting second medical device control parameter information to a first medical device, which may be in response to the first medical device receiving a programming instruction for setting a value of a dependent parameter or other triggering event, can conform to any communication method that the medical devices, e.g., medical devices 4 and 6, are configured to perform.
[0035] In accordance with the programming techniques disclosed herein, external programming device 50 may transmit a pending value of a programmable control parameter to medical device 4 (as shown by arrow 2). Medical device 4 may determine whether the programmable control parameter is a dependent control parameter. If the programmable control parameter is not dependent (e.g., independent), medical device 4 may implement the pending value of the control parameter and transmit a confirmation of the programmed value back to external programming device 50, e.g., as notification 7. However, when medical device 4 determines that the programmable control parameter for which a pending value has been received is a dependent control parameter, medical device 4 may transmit an intrabody communication to medical device 6 (as shown by arrow 3). The intrabody communication may include a request for the status of a control parameter of medical device 6. The control parameter of medical device 6 may be a fixed or programmable control parameter in medical device 6. However, the control parameter of medical device 6 may be used to control a function of medical device 6 that could interact with, conflict with or be redundant to the function of medical device 4 that is controlled at least in part by the dependent control parameter being programmed in medical device 4. [0036] Medical device 6 may transmit an intrabody communication signal back to medical device 4 (as indicated by arrow 5) in response to receiving the control parameter status request. The intrabody communication signal 5 may include the status of the control parameter of medical device 6. The status may be communicated as a value of the control parameter, which may be a quantitative (e.g., numerical) value or a qualitative value (e.g., on/off or enabled/disabled). In other examples, the first intrabody communication signal 3 requesting the second medical device control parameter status may not be required. Medical device 6 may transmit information on the status of one or more control parameters to medical device 4 (as indicated by arrow 5) in response to any of a number of triggering events. A triggering event may be detecting the presence of medical device 4, a command from external programming device 50, or detecting the presence of a magnet applied to the patient’s body to trigger a communication session, as non-limiting examples.
[0037] In some examples, medical device 4 may determine if the pending value of the programmable control parameter received from external programming device 50 is compatible with the control parameter status received from the second medical device 6. In other examples, medical device 4 may receive an indication of compatibility from medical device 6 as the parameter status response signal 5. If compatible, medical device 4 may implement the pending value of the dependent control parameter and transmit a programming confirmation notification (arrow 7) back to external programming device 50. If medical device 4 determines that the pending value of the programmable control parameter is not compatible with the control parameter status of medical device 6, e.g., may result in undesired device interactions, and/or undesired redundant function, medical device 4 may transmit a notification to external programmer 50 that a potential programming conflict is detected. The processor 52 of the external programming device 50 may generate data for display on display unit 54 for review by the user. The user may resend the pending value as a programming instruction or otherwise confirm programming of the pending value, select a different value of the programmable control parameter to transmit as a programming instruction to medical device 4, or cancel the programming of the programmable control parameter in medical device 4.
[0038] Additionally or alternatively, the user may use external programming device 50 to transmit a new parameter value (arrow 9) as a programming instruction to medical device 6 to alter the function of the second medical device 6 to avoid any potential conflict, undesired device interaction, or undesired redundancy when the pending value of the dependent parameter transmitted to the first medical device 4 (arrow 2) is implemented. The second medical device 6 may return a confirmation signal to external device 50 in response to receiving and implementing the programmed parameter value of medical device 6.
[0039] In other examples, medical device 4 may transmit the parameter status received from medical device 6 (arrow 5) to external programming device 50 as a notification (arrow 7) to enable the user to determine if the parameter status of the second medical device 6 and the pending value of the programmable control parameter of the first medical device 4 are compatible. In still other examples, medical device 4 may transmit the parameter status received from medical device 6 (arrow 5) to external programming device 50 as a notification (arrow 7), and processor 52 of external programming device 50 may determine if the parameter status of the second medical device 6 and the pending value of the programmable control parameter of the first medical device 4 are compatible. If the pending value is not compatible with the parameter status of the second medical device 6, the external programming device may be configured to determine and display one or more recommended settings to the user as alternative control parameter values that are compatible with the parameter status of the second medical device. A programming confirmation of the pending value of the programmable control parameter or a different value of the programmable control parameter may be transmitted as a programming instruction to medical device 4 from communication unit 58 based on the compatibility determination.
[0040] In this example, medical device 4 is shown as initiating the intrabody communication by transmitting the parameter status request (arrow 3) to medical device 6, in response to receiving a pending value for a control parameter that is identified as a dependent parameter, and subsequently receiving a parameter status signal (arrow 5) from medical device 6. It is to be understood that analogous intrabody communication signals may be transmitted between medical device 6 and medical device 4 when medical device 6 receives a pending value of a programmable control parameter from external programming device 50. The analogous intrabody communication signals are not shown in FIG. 1 for the sake of clarity. It is to be understood, however, from the general diagram of FIG. 1, that medical device 6 may initiate an intrabody communication by transmitting a parameter status request to medical device 4 in response to receiving a pending value of a programmable control parameter from external programming device 50 that is identified as a dependent parameter. In other examples, medical device 6 may be programmed independently of medical device 4 without performing intrabody communication whereas medical device 4 may be programmed in a manner that is dependent on the status of control parameters of medical device 6 such that intrabody communication methods for controlling and managing the implementation of pending values of dependent control parameters are utilized.
[0041] FIG. 2 is a conceptual diagram of an IMD system 10 including multiple medical devices in operative contact with a patient and capable of intrabody communication for managing medical device programming according to one example. IMD system 10 is provided as an illustrative example of two medical devices 14 and 114 that may be coimplanted in a patient and operate in a medical device system including external programming device 50 for managing programming of at least one of the two medical devices 14 and 114 in a manner that utilizes intrabody communication between medical devices 14 and 114.
[0042] In this example, IMD system 10 includes an ICD 14 and a pacemaker 114. ICD 14 and pacemaker 114 are configured to communicate wirelessly in this example although in some instances two or more devices may be coupled via communication cables or wires for conducting communication signals between medical devices. In some examples, ICD 14 and pacemaker 114 are configured to communicate via TCC to exchange the status of a programmable value of a control parameter. Examples of medical devices and methods for performing TCC that may be adapted for performing the techniques disclosed herein are generally disclosed in U.S. Patent No. 9,636,511 (Carney, et al., filed January 23, 2015) and U.S. Patent No. 9,808,632 (Reinke, et al., filed January 23, 2015), the entire content of both incorporated herein by reference. In other examples, ICD 14 and pacemaker 114 may be configured to communicate via an RF communication protocol, e.g., BLUETOOTH® Low Energy (BLE), Wi-Fi, an IEEE standard, Medical Implant Communication Service (MICS) or other communication protocol. IMD system 10 including ICD 14 and pacemaker 114 may be capable of sensing cardiac electrical signals produced by the patient’s heart 8 and delivering CV/DF shocks and/or cardiac pacing pulses to the patient’s heart 8. The cardiac signal sensing functions and the delivery of cardiac electrical stimulation pulses by ICD 14 and pacemaker 114 can be controlled by the control circuitry included in the respective individual device 14 or 114 according to various operating control parameters. At least some of the operating control parameters utilized by ICD 14 and pacemaker 14 can be programmable by external programming device 50.
[0043] ICD 14 includes a housing 15 that forms a hermetic seal that protects internal components of ICD 14. The housing 15 of ICD 14 may be formed of a conductive material, such as titanium or titanium alloy. The housing 15 may function as an electrode (sometimes referred to as a “can” electrode). In other instances, the housing 15 of ICD 14 may include a plurality of electrodes on an outer portion of the housing. The outer portion(s) of the housing 15 functioning as an electrode(s) may be coated with a material, such as titanium nitride for reducing post-stimulation polarization artifact. Housing 15 may be used as an active can electrode for use in delivering CV/DF shocks or other high voltage pulses delivered using a high voltage therapy circuit. In other examples, housing 15 may be available for use in delivering relatively lower voltage cardiac pacing pulses and/or for sensing cardiac electrical signals in combination with electrodes carried by lead 16. In any of these examples, housing 15 may sometimes be used in a transmitting and/or receiving electrode vector for transmitting and/or receiving TCC signals according to the intrabody communication techniques performed for programming of ICD 14 or pacemaker 114 as disclosed herein.
[0044] ICD 14 is shown coupled to a medical electrical lead 16 (referred to hereafter as “lead” 16) carrying one or more electrodes positioned in operative proximity to the patient’s heart 8. ICD 14 includes a connector assembly 17 (also referred to as a connector block or header) that includes electrical feedthroughs crossing housing 15 to provide electrical connections between conductors extending within the lead body 18 of lead 16 and electronic components included within the housing 15 of ICD 14. As will be described in further detail herein, housing 15 may house one or more processors, memories, transceivers, cardiac electrical signal sensing circuitry, therapy delivery circuitry, communication circuitry, power sources, other optional sensors and/or other components for sensing cardiac electrical signals, detecting a heart rhythm, and controlling and delivering electrical stimulation pulses to treat an abnormal heart rhythm.
[0045] In this example lead 16 includes an elongated lead body 18 having a proximal end 27 that includes a lead connector (not shown) configured to be connected to ICD connector assembly 17 and a distal portion 25 that includes one or more electrodes. The distal portion 25 of lead body 18 may include defibrillation electrodes 24 and 26 and pace/sense electrodes 28 and 30. In some cases, defibrillation electrodes 24 and 26 may together form a defibrillation electrode in that they may be configured to be activated concurrently. Alternatively, defibrillation electrodes 24 and 26 may form separate defibrillation electrodes in which case each of the electrodes 24 and 26 may be selectively activated independently.
[0046] Electrodes 24 and 26 (and in some examples housing 15) are referred to herein as defibrillation electrodes because they can be utilized, individually or collectively, for delivering high voltage stimulation therapy (e.g., cardioversion or defibrillation shocks). Electrodes 24 and 26 may be elongated coil electrodes and generally have a relatively high surface area for delivering high voltage electrical stimulation pulses compared to pacing and sensing electrodes 28 and 30. However, electrodes 24 and 26 and housing 15 may also be utilized to provide pacing functionality, sensing functionality, and/or TCC signal transmitting and receiving in addition to or instead of high voltage stimulation therapy. In this sense, the use of the term “defibrillation electrode” herein should not be considered as limiting the electrodes 24 and 26 for use in only high voltage cardioversion/defibrillation shock therapy applications. For example, electrodes 24 and 26 may be used in a sensing vector used to sense cardiac electrical signals and detect and discriminate tachyarrhythmias. Electrodes 24 and 26 may be used in a TCC signal transmitting electrode vector in combination with each other, collectively with housing 15, or individually with housing 15. When ICD 14 operates in a receiving mode for receiving TCC signals from pacemaker 114, electrodes 24, 26 and/or housing 15 may be used in a TCC receiving electrode vector. The TCC transmitting and receiving electrode vectors may be the same or different vectors.
[0047] Electrodes 28 and 30 are relatively smaller surface area electrodes which can be available for use in sensing electrode vectors for sensing cardiac electrical signals and may be used for delivering relatively low voltage pacing pulses in some configurations. Electrodes 28 and 30 are referred to as pace/sense electrodes because they are generally configured for use in low voltage applications, e.g., delivery of relatively low voltage pacing pulses and/or sensing of cardiac electrical signals, as opposed to delivering high voltage CV/DF shocks. In some instances, electrodes 28 and 30 may provide only pacing functionality, only sensing functionality or both. Furthermore, one or both of electrodes 28 and 30 may be used for TCC signal transmission and/or receiving in some examples, together or in combination with any of electrodes 24, 26 and/or housing 15. In the example illustrated in FIG. 1, electrode 28 is located proximal to defibrillation electrode 24, and electrode 30 is located between defibrillation electrodes 24 and 26. Electrodes 28 and 30 may be ring electrodes, short coil electrodes, hemispherical electrodes, or the like. Electrodes 28 and 30 may be positioned at other locations along lead body 18 and are not limited to the positions shown. In other examples, lead 16 may include none, one or more pace/sense electrodes and/or one or more defibrillation electrodes.
[0048] ICD 14 may obtain cardiac electrical signals corresponding to electrical activity of heart 8 via a combination of sensing electrode vectors that include combinations of electrodes 24, 26, 28, 30 and/or housing 15. Various sensing electrode vectors utilizing combinations of electrodes 24, 26, 28, and 30 may be selected by sensing circuitry included in ICD 14 for receiving a cardiac electrical signal via one or more sensing electrode vectors.
[0049] A TCC transmitting/receiving electrode vector may be selected from the available electrodes, e.g., defibrillation electrodes 24, 26, 28, 30 and housing 15 of ICD 14. The TCC transmitting/receiving electrode vector may be used for transmitting TCC signals produced by a TCC transmitter included in ICD 14 and for receiving TCC signals from another device, e.g., pacemaker 114.
[0050] ICD 14 may include an RF antenna in connector assembly 17 for receiving and transmitting RF communication signals with an RF transceiver enclosed within housing 15. In some examples, RF communication signals may be received from and transmitted to pacemaker 114 in response to receiving a programming command from external programming device 50. For example, when a pending value of a programmable control parameter is received from external programming device 50 and ICD 14 determines that the programmable control parameter is a dependent parameter, ICD 14 may transmit a communication signal to pacemaker 114 for requesting the status of a corresponding dependent parameter that is used by pacemaker 114 for controlling pacemaker functions. It is recognized, however, that communication circuitry included in ICD 14 may include an RF antenna and transceiver for bidirectional communication with external programming device 50 and TCC circuitry for transmitting and receiving intrabody TCC signals, e.g., via transmitting and receiving pairs of electrodes carried by lead 16. TCC may be used for intrabody communication with pacemaker 114 and RF communication may be used for communication with external programming device 50. More generally, ICD 14 may include communication circuitry for communicating according to two different methods such that during a programming session with external programming device 50, ICD 14 may conduct intrabody communication as needed with pacemaker 114.
[0051] In the example shown, lead 16 extends subcutaneously or submuscularly over the ribcage 32 medially from the connector assembly 27 of ICD 14 toward a center of the torso of patient 12, e.g., toward xiphoid process 20 of patient 12. At a location near xiphoid process 20, lead 16 bends or turns and extends superiorly, e.g., subcutaneously or submuscularly over the ribcage and/or sternum or substernally under the ribcage and/or sternum 22. Although illustrated in FIG. 2 as being offset laterally from and extending substantially parallel to sternum 22, the distal portion 25 of lead 16 may be implanted at other locations, such as over sternum 22, offset to the right or left of sternum 22, angled laterally from sternum 22 toward the left or the right, or the like. Alternatively, lead 16 may be placed along other subcutaneous, submuscular or substernal paths. The path of extra-cardiovascular lead 16 may depend on the location of ICD 14, the arrangement and position of electrodes carried by the lead body 18, and/or other factors.
[0052] ICD 14 is shown implanted subcutaneously on the left side of patient 12 along the ribcage 32. ICD 14 may, in some instances, be implanted between the left posterior axillary line and the left anterior axillary line of patient 12. ICD 14 may, however, be implanted at other subcutaneous or submuscular locations in patient 12. For example, ICD 14 may be implanted in a subcutaneous pocket in the pectoral region. In this case, lead 16 may extend subcutaneously or submuscularly from ICD 14 toward the manubrium of sternum 22 and bend or turn and extend inferiorly from the manubrium to the desired location subcutaneously or submuscularly. In yet another example, ICD 14 may be placed abdominally.
[0053] The lead body 18 of lead 16 may be formed from a non-conductive material and shaped to form one or more lumens within which the one or more conductors extend. Lead body 18 may be a flexible lead body that conforms to an implant pathway. In other examples, lead body 18 may include one or more preformed curves. Electrical conductors (not illustrated) extend through one or more lumens of the elongated lead body 18 of lead 16 from the lead connector at the proximal lead end 27 to electrodes 24, 26, 28, and 30 located along the distal portion 25 of the lead body 18. The elongated electrical conductors contained within the lead body 18 are each electrically coupled with respective defibrillation electrodes 24 and 26 and pace/sense electrodes 28 and 30, which may be separate respective insulated conductors within the lead body 18. The respective conductors electrically couple the electrodes 24, 26, 28, and 30 to circuitry of ICD 14, such as a signal generator for therapy delivery and TCC signal transmission, when intrabody communication is performed via TCC, and/or a sensing circuit for sensing cardiac electrical signals and/or receiving TCC signals in some examples, via connections in the connector assembly 17, including associated electrical feedthroughs crossing housing 15.
[0054] The electrical conductors may transmit therapy from a therapy delivery circuit within ICD 14 to one or more of defibrillation electrodes 24 and 26 and/or pace/sense electrodes 28 and 30 and transmit sensed electrical signals from one or more of defibrillation electrodes 24 and 26 and/or pace/sense electrodes 28 and 30 to the sensing circuit within ICD 14. When ICD 14 and pacemaker 114 communicate via TCC, the electrical conductors also transmit TCC signals from a TCC transmitter to electrodes selected for transmitting the TCC signals. ICD 14 may receive TCC signals from pacemaker 114 conducted from a receiving pair of electrodes of ICD 14 to a TCC signal receiver enclosed by housing 15.
[0055] ICD 14 analyzes the cardiac electrical signals received from one or more sensing electrode vectors to monitor for abnormal rhythms, such as bradycardia, tachycardia or fibrillation. ICD 14 may analyze the heart rate and morphology of the cardiac electrical signals to monitor for tachyarrhythmia in accordance with any of a number of tachyarrhythmia detection techniques. ICD 14 generates and delivers electrical stimulation therapy in response to detecting a tachyarrhythmia, e.g., ventricular tachycardia (VT) or ventricular fibrillation (VF), using a therapy delivery electrode vector which may be selected from any of the available electrodes 24, 26, 28 30 and/or housing 15. ICD 14 may deliver ATP in response to VT detection, and in some cases may deliver ATP prior to a CV/DF shock or during high voltage capacitor charging in an attempt to avert the need for delivering a CV/DF shock. If ATP does not successfully terminate VT or when VF is detected, ICD 14 may deliver one or more CV/DF shocks via one or both of defibrillation electrodes 24 and 26 and/or housing 15. ICD 14 may generate and deliver other types of electrical stimulation pulses such as post-shock pacing pulses or bradycardia pacing pulses using a pacing electrode vector that includes any of electrodes 24, 26, 28, and 30 and/or the housing 15 of ICD 14. Bradycardia or post-shock pacing pulses may be delivered by ICD 14 to pace the ventricles of the patient’s heart when an R-wave is not sensed by ICD 14 before a pacing escape interval expires. The pacing escape interval may be a lower pacing rate interval corresponding to a programmed lower rate. The programmed lower rate may be used by ICD 14 for controlling the rate of delivered cardiac pacing pulses for maintaining a minimum heart rate of the patient.
[0056] Pacemaker 114 is shown as a leadless intracardiac pacemaker configured to communicate with ICD 14. Pacemaker 114 may include one or more housing-based electrodes as described below in conjunction with FIG. 3 for sensing cardiac electrical signals and delivering cardiac pacing pulses. Pacemaker 114 may be delivered transvenously and anchored by a fixation member at an intracardiac pacing and sensing site. For example, pacemaker 114 may be implanted in an atrial or ventricular chamber of the patient’s heart. In other examples, pacemaker 114 may be attached to an external surface of heart 8 (e.g., in contact with the pericardium and/or epicardium) such that pacemaker 114 is disposed outside of heart 8.
[0057] Pacemaker 114 is configured to deliver cardiac pacing pulses via a pair of housingbased electrodes and may be configured to sense cardiac signals for determining the need and delivery time of a pacing pulse. For example, pacemaker 114 may deliver bradycardia pacing pulses, rate responsive pacing pulses, ATP, post-shock pacing pulses and/or other pacing therapies based on sensed cardiac signals. In some examples, pacemaker 114 may include an accelerometer or other motion sensor for sensing acceleration signals associated with mechanical activity of heart 8. For instance, pacemaker 114 may be configured to sense atrial event signals corresponding to atrial mechanical systole for triggering atrial synchronous ventricular pacing pulses delivered by pacemaker 114.
[0058] Pacemaker 114 may be implanted in the right atrium or the right ventricle of heart 8 to sense cardiac signals and deliver pacing therapy. Pacemaker 114 may be implanted in the ventricle for sensing a ventricular electrogram (EGM) signal and deliver ventricular pacing pulses. Pacemaker 114 may be implanted at or near the ventricular apex in the right ventricle to pace the ventricular myocardium. In other examples, pacemaker 114 may be implanted along the interventricular septum to provide pacing of the cardiac conduction system (e.g., via the left and/or right bundle branches) and/or septal myocardium. In some examples, pacemaker 114 is implanted in the right atrium and configured for sensing a ventricular EGM signal and delivering ventricular pacing pulses from a right atrial position. For example, a distal tip electrode (shown in FIG. 3) may be advanced toward the His bundle from a location beneath the AV node and near the tricuspid valve annulus, generally in the Triangle of Koch, to position an electrode near the His bundle from a right atrial approach. Pacing pulses may be delivered to this location for capturing the ventricles via the native conduction system of the heart and/or ventricular myocardium. When implanted in the right atrium, pacemaker 114 may additionally or alternatively sense an atrial EGM signal and/or deliver atrial pacing pulses. Pacemaker 114 may operate in an atrial synchronous ventricular pacing mode, e.g., denoted as a VDD or DDD pacing mode. Ventricular pacing pulses may be delivered by pacemaker 114 at an atrioventricular pacing interval from a sensed P-wave or delivered atrial pacing pulse. At other times, pacemaker 114 may operate in a single chamber atrial pacing mode or a single chamber, asynchronous ventricular pacing mode, e.g., a VVI or VOO pacing mode.
[0059] External programming device 50 is configured for wireless telemetric communication with ICD 14, e.g., via a wireless communication link 42, and for wireless telemetric communication with pacemaker 114, e.g., via a wireless communication link 44. Communication link 42 or 44 may be established between ICD 14 or pacemaker 114, respectively, and external device 50 using any of the example communication techniques described above in conjunction with FIG. 1. In some examples, ICD 14 and/or pacemaker 114 may communicate with external device 50 using TCC, e.g., using TCC transmitting/receiving electrodes coupled to external device 50 and placed externally on patient 12.
[0060] As generally described in conjunction with FIG. 1, external programming device 50 may be used to program operating parameters and algorithms in ICD 14 for controlling ICD functions and/or to program operating parameters and algorithms in pacemaker 114 for controlling pacemaker functions. External device 50 may be used to program cardiac signal sensing control parameters, cardiac rhythm detection control parameters and therapy delivery control parameters used by ICD 14 and by pacemaker 114 in respective programming sessions with the individual devices 14 and 114. Data stored or acquired by ICD 14 and/or pacemaker 114, including physiological signals or associated data derived therefrom, results of device diagnostics, and histories of detected rhythm episodes and delivered therapies, may be retrieved from ICD 14 and/or pacemaker 114 by external device 50 following an interrogation command.
[0061] FIG. 3 is a conceptual diagram of pacemaker 114 that may be included in the medical device system of FIG. 2 according to some examples. Pacemaker 114 may be a leadless pacemaker configured to communicate with another medical device in operative contact with a patient, e.g., ICD 14 as shown in FIG. 2. Pacemaker 114 may be implanted in a ventricular heart chamber for sensing cardiac signals and delivering ventricular pacing pulses. However, in some examples pacemaker 114 may be configured for implantation in the right atrium for providing atrial pacing and/or ventricular pacing from a right atrial location.
[0062] Pacemaker 114 may include a housing 150 carrying housing-based electrodes 162, 164 and 165. The type, number and location of housing based electrodes provided on pacemaker 114 may be adapted for a particular implant location and sensing/pacing application. Other features of a leadless pacemaker such as fixation members, size, etc. may be adapted as necessary for a particular pacing and sensing application. As such, pacemaker 114 shown in FIG. 3 is illustrative in nature of a leadless pacemaker that can be one type of device that may be included in a medical device system that performs intrabody communication for coordinating programming of medical device control parameters according to the techniques disclosed herein. The illustrative example of pacemaker 114 is not intended to be a limiting example of a pacemaker or more generally an IMD that may be included in a medical device system configured to operate according to the disclosed techniques, particularly with regard to a specific implant location or features adapted for that implant location. In other examples, pacemaker 114 may be configured to receive one or more leads, each carrying one or more electrodes, which may be advanced transvenously into the patient’s heart for sensing and/or cardiac electrical stimulation therapy delivery in one or more heart chambers.
[0063] In this example, pacemaker 114 includes a housing 150 having a distal end face 102 and a proximal end face 104. The lateral sidewall 170 of housing 150 extending from distal end face 102 to proximal end face 104 may be generally cylindrical to facilitate transvenous delivery, e.g., via a catheter, of pacemaker 114 to an implant site. Distal end face 102 is referred to as “distal” in that it is expected to be the leading end as pacemaker 114 is advanced through a delivery tool, such as a catheter, and placed against a targeted implant site. In other examples, housing 150 may have a generally prismatic shape. The housing 150 encloses the electronics and a power supply for sensing cardiac signals, producing pacing pulses and controlling therapy delivery and other functions of pacemaker 114 as described herein.
[0064] Pacemaker 114 is shown including electrodes 162, 164 and 165 spaced apart along the housing 150 of pacemaker 114 for sensing cardiac electrical signals and delivering pacing pulses. Pacemaker 114 may have more than or fewer than three electrodes, however. In another example, pacemaker 114 may only include electrodes 162 and 165 or only electrodes 162 and 164 for instance. Electrodes 162, 164 and 165 may be, without limitation, titanium, platinum, iridium or alloys thereof and may include a low polarizing coating, such as titanium nitride, iridium oxide, ruthenium oxide, platinum black, among others. Electrode 164, also referred to herein as “tip electrode” 164, is shown extending from distal end face 102 of housing 150. Tip electrode 164 is shown as a screw-in helical electrode which may provide fixation of pacemaker 114 at an implant site as well as serving as a pacing and sensing electrode. In some examples, pacemaker 114 may be implanted in the right atrium so that electrode 164 can be advanced from within the right atrial chamber to a ventricular pacing site, e.g., toward or into the interventricular septum, for delivering pacing to the His-Purkinje conduction system and/or for pacing of ventricular septal myocardial tissue. A proximal portion of tip electrode 164, nearest housing distal end face 102, may be provided with an electrically insulative coating. The more distal portion of tip electrode 164, positioned at a target pacing site, may be uninsulated to function as the electrically conductive portion of tip electrode 164 for pacing pulse delivery and for sensing cardiac electrical signals, e.g., a ventricular EGM signal. Examples of insulating coatings that may be provided on the proximal portion of tip electrode 164 include parylene, urethane, poly ether ether ketone (PEEK), or polyimide, among others.
[0065] In other examples, tip electrode 164 is not necessarily a tissue piercing electrode as shown in this example. Electrode 164 may be a dot, button, ring, hemispherical, segmented, fishhook, helical, or other type of electrode positioned on the distal end face 102 for positioning in operative proximity to or within tissue at a targeted pacing site. When implemented as a non-tissue piercing electrode, tip electrode 164 may be implanted in intimate proximity to myocardial tissue and held in a stable position via other fixation means, e.g., anchored in the atrium or the ventricle via fixation tines, for pacing atrial myocardium or ventricular myocardium respectively. An example of a leadless pacemaker, which may be implemented in a medical device system performing the techniques disclosed herein, having a button-type distal tip electrode and fixation tines is generally disclosed in U.S. Patent No. 9,775,982 (Grubac, et al., filed October 3, 2017), incorporated herein by reference in its entirety.
[0066] Electrode 165 is shown as a ring electrode along the lateral side wall 170 of housing 150. In other examples, electrode 165 may be a dot, button, ring, hemispherical, segmented or other type of electrode positioned on the distal end face 102 of housing 150 and/or along the lateral sidewall 170. Electrode 162 is shown as a ring electrode along the lateral sidewall 170 of housing 150 spaced proximally from electrode 165, toward proximal end face 104 of housing 150. In other examples, electrode 162 may be a dot, button, ring, hemispherical, segmented or other type of electrode positioned on the proximal end face 104 of housing 150 and/or along the lateral sidewall 170, spaced proximally and/or laterally from electrode 165. Electrodes 162 and 165 may both be ring electrodes circumscribing the lateral sidewall 170 in some examples, e.g., adjacent proximal end face 104 and adjacent distal end face 102, respectively. Other portions of housing 150 may be electrically insulated by an insulating coating.
[0067] Tip electrode 164 may serve as a cathode electrode with ring electrode 162 serving as a return anode for delivering ventricular pacing pulses, which may be delivered to capture of at least a portion of the His-Purkinje system and/or ventricular myocardium. Tip electrode 164 and ring electrode 162 may be used as a bipolar pair for ventricular pacing and for receiving a ventricular electrical signal from which R-waves can be sensed by sensing circuitry enclosed by housing 150. When pacemaker 114 is implanted in the right atrium, electrodes 165 and 162 may form a second cathode and return anode pair for bipolar atrial pacing and sensing an atrial electrical signal from which P-waves can be sensed by the sensing circuitry enclosed by housing 150. In some examples, any combination of electrodes 162, 164 and 165 may be used in an electrode sensing vector for sensing one or more cardiac electrical signals from which P-waves and/or R-waves may be sensed. [0068] Electrodes 162, 164 and 165 may be positioned at locations along pacemaker 114 other than the locations shown. Furthermore, in some examples, pacemaker 114 includes a distal tip electrode 164 and one proximal electrode 162 or 165. A TCC transmitting electrode pair and a TCC receiving electrode pair (which may or may not be the same electrode pair) may be selected from the available electrodes 162, 164 and 165 when pacemaker 114 is configured to perform intrabody communication via TCC signals. A sensing/pacing electrode pair and the TCC electrode pair carried by housing 150 may include no shared electrodes, one shared electrode or two shared electrodes in various examples. In some examples, at least one electrode pair may be carried by housing 150 for sensing cardiac signals and delivering cardiac pacing and another electrode pair may be carried by housing 150 as a TCC electrode pair. The sensing/pacing electrode pair and the TCC electrode pair may be dedicated electrode pairs or selectable from available electrodes carried by housing 150.
[0069] Pacemaker 114 may be configured to communicate with another medical device implanted in or operatively coupled to the patient. For example, as shown in FIG. 2, pacemaker 114 may communicate with an ICD 14. Pacemaker 114 and ICD 14 may communicate via TCC when one of pacemaker 114 or ICD 14 receives a pending value for a programmable control parameter that is identified as a dependent parameter as generally described above in conjunction with FIG. 1. In other examples, pacemaker 114 may be coimplanted with another leadless pacemaker (e.g., implanted in a different heart chamber), another pacemaker coupled to transvenous lead(s) carrying electrodes positioned for pacing and sensing at a different location than pacemaker 114, an ICD coupled to transvenous leads, a cardiac monitor such as the REVEAE LINQ™ Insertable Cardiac Monitor (available from Medtronic, Inc., Dublin, Ireland), a blood pressure monitor, a fluid status monitor, an oxygen saturation monitor, or other monitor including one or more sensors, a drug pump, a neurostimulator, or other medical device configured to perform intrabody communication with pacemaker 114 during a device programming session. [0070] Housing 150 is formed from a biocompatible material, such as a stainless steel or titanium alloy. In some examples, the housing 150 may include an insulating coating. Examples of insulating coatings include parylene, urethane, PEEK, or polyimide, among others. The entirety of the housing 150 may be insulated, but only electrodes 162, 164 and 165 uninsulated. Electrodes 162, 164 and 165 are electrically coupled to internal circuitry, e.g., a pacing pulse generator and cardiac electrical signal sensing circuitry, enclosed by housing 150. Electrodes 162 and 165 may be formed as a conductive portion of housing 150 defining respective electrodes that are electrically isolated from each other and from the other portions of the housing 150 as generally shown in FIG. 3.
[0071] Pacemaker 114 may include features for facilitating deployment to and fixation at an implant site. For example, pacemaker 114 may optionally include a delivery tool interface 158. Delivery tool interface 158 may be located at the proximal end 104 of pacemaker 114 and is configured to connect to a delivery device, such as a catheter, guidewire or other tool used to position pacemaker 114 at an implant location during an implantation procedure. The delivery tool interface 158 may enable a clinician to advance, retract and steer pacemaker 114 to an implant site and rotate pacemaker 114 to advance the helical tip electrode 164 into the cardiac tissue. Helical tip electrode 164 in this example provides fixation of pacemaker 114 at the implant site. In other examples, however, pacemaker 114 may include a set of fixation tines, hooks or other fixation members at or near distal end face 102 to secure pacemaker 114 to cardiac tissue. Numerous types of fixation members may be employed for anchoring or stabilizing pacemaker 114 in an implant position.
[0072] As generally described in conjunction with FIG. 4 below, a medical device, such as pacemaker 114, that is included in a multi-device system operating according to the programming techniques disclosed herein may include processing and control circuitry, memory, pulse generating circuitry for generating therapeutic electrical stimulation pulses, sensing circuitry for sensing physiological signals, TCC circuitry for transmitting and receiving TCC signals and a power source. In some examples, a pulse generator of pacemaker 114 used to generate cardiac pacing pulses may be controlled for generating TCC signals transmitted via electrodes 162, 164 and/or 165.
[0073] Pacemaker 114 may be configured for sensing cardiac electrical signals, e.g., R- waves or P-waves, attendant to intrinsic depolarizations of the myocardial tissue. Pacemaker 114 may include a TCC receiver for receiving and detecting a TCC signal transmitted by another medical device, e.g., ICD 14 or any of the other examples described herein. A voltage potential develops across an electrode pair, e.g., tip electrode 164 and ring electrode 162 or between ring electrodes 162 and 165, in response to current conducted via a tissue pathway during TCC signal transmission from another medical device.
[0074] FIG. 4 is a conceptual diagram of a programmable medical device 214 capable of performing intrabody communication according to some examples. For the sake of convenience, the medical device 214 is referred to herein as an “implantable medical device” or IMD 214. In various examples, two medical devices configured to perform intrabody communication may be IMDs. As mentioned previously herein, however, a medical device performing intrabody communication may be an external device configured to perform intrabody communication with another medical device by receiving and passing communication signals through a patient’s body via electrodes, an antenna or other transmitting/receiving device that is positioned on the patient’s skin or positioned transcutaneously. For the sake of convenience, the device 214 of FIG. 4 is generally described as being a cardiac pacing device or ICD, e.g., ICD 14 or pacemaker 114 shown in FIG. 2, coupled to two or more electrodes 224, 226, 228, and 230. In some examples, the device housing 215 may serve as one of the at least two electrodes and is represented conceptually as an electrode in FIG. 4, available for sensing, electrical stimulation pulse delivery and, in some examples, as a receiving and/or transmitting electrode during TCC. [0075] It is to be understood, however, that the circuitry and components shown in FIG. 4 may generally correspond to physiological sensing circuitry and/or therapy delivery circuitry included in any of the example medical devices referred to herein and can be adapted for performing physiological signal sensing and/or therapy delivery functions according to a particular clinical application for signal monitoring and/or therapy delivery. For instance, a device configured to perform intrabody communication in association with programming of a control parameter value as disclosed herein may have more or fewer electrodes than the four electrodes 224, 226, 228 and 230 shown in FIG. 4 and may not include any electrodes at all when configured to perform functions that do not require an electrode for sensing electrophysiological signals, delivering electrical stimulation pulses, or performing intrabody communication. In some instances, at least two electrodes may be provided for performing TCC transmission and receiving functions when IMD 214 is configured to perform intrabody communication via TCC. The TCC electrodes may be leadless, housing-based electrodes and/or carried by a lead extending away from the device housing. [0076] IMD 214 may include a control circuit 80, memory 82, therapy delivery circuit 84, sensing circuit 86, sensors 87, communication circuit 88, TCC circuit 90 and power source 89. Power source 89 provides power to the circuitry of IMD 214, including each of the circuits 80, 82, 84, 86, 87, 88 and 90 as needed. Power source 89 may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. The connections between power source 89 and each of the other circuits 80, 82, 84, 86, 87, 88 and 90 are to be understood from the general block diagram of FIG. 4 but are not shown for the sake of clarity. For example, power source 89 may be coupled to charging circuits included in therapy delivery circuit 84 for charging capacitors or other charge storage devices and activating output switching circuitry included in therapy delivery circuit 84 for producing electrical stimulation pulses such as cardiac electrical stimulation pulses (e.g., CV/DF shock pulses or pacing pulses) or neurostimulation pulses. Power source 89 may be coupled to an optional TCC circuit 90 for providing power for generating TCC signals by transmitter 91 and powering TCC receiver 92. Power source 89 provides power to processors and other components of control circuit 80, memory 82, amplifiers, analog-to-digital converters and other components of sensing circuit 86, any additional sensors 87 optionally included in IMD 214 and a transceiver of communication circuit 88, when included, as examples.
[0077] Memory 82 may store computer-readable instructions that, when executed by a processor included in control circuit 80, cause IMD 214 to perform various functions attributed to IMD 214 (e.g., sensing physiological signals, communication with another device, and/or delivery of an electrical stimulation therapy). Memory 82 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other digital or analog media.
[0078] Control circuit 80 may communicate with therapy delivery circuit 84 and sensing circuit 86 for sensing physiological electrical activity (e.g., cardiac electrical signals), detecting physiological events (e.g., cardiac arrhythmias), and controlling delivery of electrical stimulation therapies in response to sensed physiological signals. The functional blocks shown in FIG. 4 represent functionality included in IMD 214 and may include any discrete and/or integrated electronic circuit components that implement analog and/or digital circuits capable of producing the functions attributed to IMD 214 herein. Providing software, hardware, and/or firmware to accomplish the described functionality in the context of any modem medical device system, given the disclosure herein, is within the abilities of one of skill in the art.
[0079] Sensing circuit 86 may be selectively coupled to electrodes 224, 226, 228, 230 and/or housing 215 in order to monitor electrical activity of the patient’s heart. Sensing circuit 86 may include switching circuitry for selecting which electrodes 224, 226, 228, 230 and housing 215 are coupled to sense amplifiers or other cardiac event detection circuitry included in event detector 85. Switching circuitry may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple sense amplifiers to selected electrodes. The event detector 85 within sensing circuit 86 may include one or more sense amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), or other analog or digital components configured to detect a feature from a sensed physiological signal to enable processing circuitry of control circuit 80 to monitor cardiac electrical signals for detecting a heart rhythm. In the example of IMD 214 sensing one or more cardiac electrical signals (e.g., an ECG or EGM), cardiac electrical event signals attendant to myocardial depolarizations, e.g., P-waves attendant to atrial depolarizations and/or R- waves attendant to ventricular depolarizations, may be sensed by event detector 85 from a cardiac electrical signal received via a sensing electrode vector.
[0080] In some examples, sensing circuit 86 includes multiple sensing channels for acquiring cardiac electrical signals from multiple sensing electrode vectors selected from electrodes 224, 226, 228, 230 and housing 215. Each sensing channel may be configured to amplify, filter, digitize and rectify the cardiac electrical signal received from selected electrodes coupled to the respective sensing channel to improve the signal quality for sensing cardiac event signals, e.g., P-waves and/or R-waves. For example, each sensing channel in sensing circuit 86 may include an input or pre-filter and amplifier for receiving a cardiac electrical signal developed across a selected sensing electrode vector, an analog- to-digital converter, a post- amplifier and filter, and a rectifier to produce a filtered, digitized, rectified and amplified cardiac electrical signal. The event detector 85 may include a sense amplifier, comparator or other circuitry for comparing the rectified, filtered and amplified cardiac electrical signal to a cardiac event sensing threshold, such as a P- wave sensing threshold amplitude or an R-wave sensing threshold amplitude, which may be an auto-adjusting threshold. Event detector 85 may produce a sensed cardiac event signal in response to a sensing threshold crossing that is passed to control circuit 80. The sensed cardiac event signals corresponding to detected R-waves and/or P-waves can be used by control circuit 80 for determining a heart rate, detecting cardiac rhythms and determining a need for a pacing and/or CV/DF therapy.
[0081] Control circuit 80 may include interval timers or counters, which may be reset upon receipt of a cardiac sensed event signal from sensing circuit 86. The value of the interval timer or counter when reset by a cardiac sensed event signal, for example, may be used by control circuit 80 to measure the cardiac cycle length or other cardiac event intervals, e.g., durations of R-R intervals, or P-P intervals, which are measurements that may be stored in memory 82. Control circuit 80 may use the cardiac event intervals to detect an arrhythmia, e.g., bradycardia or tachyarrhythmias such as fibrillation or tachycardia.
[0082] The therapy delivery circuit 84 may include a pulse generator configured to generate cardiac electrical stimulation pulses, e.g., CV/DF shock pulses and cardiac pacing pulses for delivery to the patient’s heart via selected electrodes 224, 226, 228, 230 and/or 215. Therapy delivery circuit 84 may include one or more energy storage elements, such as one or more capacitors, configured to store the energy required for a therapeutic CV/DF shock or pacing pulse. In response to detecting a shockable tachyarrhythmia, control circuit 80 controls therapy delivery circuit 84 to charge the energy storage element(s) to prepare for delivering a CV/DF shock. Therapy delivery circuit 84 may include other pulse generating circuitry, such as a transformer, charge pump, charge storage capacitors and switches to couple the charge storage capacitors to electrode terminals via an output capacitor or other output circuitry such as an H-bridge to discharge and deliver the electrical stimulation pulses. Therapy delivery circuit 84 may include voltage levelshifting circuitry, switches, transistors, diodes, or other circuitry as needed for generating and delivering electrical stimulation pulses. In some examples, therapy delivery circuit 84 may include both a low voltage therapy circuit for generating and delivering relatively low voltage therapy pulses, such as cardiac pacing or neurostimulation pulses, and a high voltage therapy circuit for generating and delivering CV/DF shocks or other relatively higher voltage stimulation pulses which may include cardiac pacing pulses delivered via extra-cardiac electrodes as described in conjunction with FIG. 2.
[0083] In some examples, IMD 214 can be configured to monitor the impedance of an electrode vector. For example, therapy delivery circuit 84 may apply a current (or voltage) drive signal to a pair of electrodes coupled to IMD 214. Sensing circuit 86 may detect the resulting voltage (or current) developed across a pair of recording electrodes. Impedance monitoring may be performed to monitor bioimpedance in a tissue volume, e.g., thoracic impedance or cardiac impedance, for monitoring a patient condition. For example, impedance monitoring may be performed for tracking a fluid status of the patient, e.g., correlated to lung wetness in patients with symptoms of congestive heart failure. A fluid status metric may be determined from impedance measurements by control circuit 80 and stored in memory 82 over time for detecting when the fluid status metric meets a threshold for detecting a pulmonary edema condition for example.
[0084] TCC circuit 90 may include a TCC transmitter 91 configured to generate TCC signals for transmission from a transmitting electrode vector selected from the electrodes 224, 226, 228, 230 and housing 215 via a conductive tissue pathway. TCC transmitter 91 is configured to generate and transmit a TCC signal to communicate with another IMD (or in some cases an external device coupled to the patient via skin electrodes or transcutaneous electrodes). In some examples, TCC circuit 90 may include a pulse generator for generating TCC signals and switching circuitry for selectively coupling TCC transmitter 91 to a selected transmitting electrode vector, e.g., using any two or more of electrodes 224, 226, 228, 230 and housing 215.
[0085] The TCC signal may be transmitted by TCC circuit 90 having a carrier signal, which may be an oscillating signal having a peak-to-peak amplitude and carrier frequency selected to avoid stimulation of excitable tissue, e.g., nerve, smooth muscle, skeletal muscle or cardiac tissue, of the patient. In some examples, the carrier frequency of the TCC signal may be 100 kilohertz (kHz) or higher. A TCC signal emitted or received, for example by a TCC electrode pair, at a frequency of at least approximately 100 kHz may be less likely to stimulate nearby tissue, e.g., muscles or nerves, or cause pain or other sensation than lower frequency waveforms. Consequently, a TCC signal having a frequency of at least approximately 100 kHz can have a higher amplitude than a lower frequency signal without causing extraneous nerve or muscle stimulation. A relatively higher amplitude signal may increase the likelihood that another medical device successfully receives the TCC signal from IMD 214. The peak-to-peak amplitude of the TCC signal may be within a range from approximately 100 microamps to 10 milliamps (mA) or more, such as within a range from approximately 1 mA to approximately 10 mA. In some examples, the amplitude of the TCC signal may be approximately 3 mA. A TCC signal having a frequency of at least approximately 100 kHz and an amplitude no greater than approximately 10 mA may be unlikely to stimulate nearby tissue, e.g., muscles or nerves, or cause pain or other sensation. For a transmitting electrode vector having an impedance of 200 ohms injecting a current signal having an amplitude of 10 mA peak-to- peak, the voltage signal at the transmitting electrode vector may be 2 Volts peak-to-peak. The voltage developed at the receiving electrode vector may be in the range of 0.1 to 100 millivolts peak-to-peak, as illustrative examples. However, it is contemplated that other frequencies and amplitudes of TCC signals may be used in conjunction with the techniques disclosed herein.
[0086] The TCC circuit 90 may transmit a TCC signal as a modulated signal in some examples. Amplitude modulation (AM), frequency modulation (FM), or digital modulation (DM), such as frequency- shift keying (FSK) or phase-shift keying (PSK) may be performed by TCC circuit 90. In some examples, the modulation can be FM toggling between two frequencies, e.g., toggling between approximately 100-150 kHz and approximately 200-250 kHz. In some examples, the TCC signal has a frequency of 150- 200 kHz and is modulated using FSK modulation at 12.5 kbps. In other examples, a TCC signal having a carrier frequency of 100 kHz is modulated to encode data using binary phase shift keying (BPSK). Balanced pulses of opposite polarity may be used to shift the phase of the TCC signal, e.g., by 180 degrees positively or negatively, and balance the charge injected into the body tissue during the phase shift to minimize the likelihood of interfering with cardiac event sensing operations of sensing circuit 86. Techniques for BPSK modulation of the TCC carrier signal using charge balanced phase shifts are disclosed in U.S. Patent No. 11,110,279 (Roberts, et al.), incorporated herein by reference in its entirety. The data carried by modulated or unmodulated TCC signals, e.g., being sent to or received from a second medical device, may include wake up signals, a request to receive the status of one or more control parameters of the second medical device, a confirmation signal following receipt of a control parameter status signal from the second medical device, acknowledgment of a wake up signal transmitted from the second medical device, and the status of a programmed control parameter of ICD 214 transmitted in response to a request from the second medical device, as examples.
[0087] TCC circuit 90 includes TCC receiver 92 to facilitate “two-way” TCC between IMD 214 and a second medical device. A voltage signal that develops on a TCC receiving electrode pair when a TCC signal is transmitted by a second medical device may be received and demodulated by the TCC receiver 92 and decoded by processing circuitry included in control circuit 80. The TCC receiver 92 may include amplifiers, filters, analog- to-digital converters, rectifiers, comparators, counters, a phase locked loop and/or other circuitry configured to detect a signal from a transmitting device and detect and demodulate a modulated carrier signal, which may be transmitted in data packets including encoded data. For example, TCC receiver 92 may include a pre-amplifier and a high-Q filter tuned to the carrier frequency of a carrier signal that is used to transmit wake up signals and/or data signals during a TCC session between two medical devices implanted in or otherwise operatively coupled to the patient. The filter may be followed by another amplifier and a demodulator that converts the received signals to a binary signal representing coded data.
[0088] The circuitry of TCC receiver 92 may include circuitry shared with electrical signal sensing circuitry of sensing circuit 86 in some examples. The filters included in a TCC receiver and cardiac electrical signal sensing circuitry, however, are expected to operate at different passbands, for example, for detecting different signal frequencies. The TCC signals may be transmitted with a carrier frequency in the range of 33 to 250 kHz, in the range of 60 to 200 kHz, or at 100 kHz as examples. Cardiac electrical signals generated by heart 8 are generally less than 100 Hz.
[0089] IMD 214 may transmit a parameter status request from TCC transmitter 91 to another medical device when IMD 214 receives a programming command from external programming device 40 for programming a dependent parameter. IMD 214 may receive the requested status signal from the other medical device via TCC receiver 92. A modulated or non-modulated carrier signal may be received by TCC receiver 92 via TCC receiving electrodes (e.g., any of electrodes 224, 226, 228, 230 and/or housing 215) selectively coupled to TCC circuit 90. TCC receiver 92 may include an amplifier, filter and demodulator to pass the demodulated signal, e.g., as a stream of digital values, to control circuit 80 for decoding of the received signal and further processing as needed. [0090] In other examples, TCC receiver 92 may be included in or share sensing circuitry with sensing circuit 86. TCC transmitter 91 may be included in or share signal generating circuitry with therapy delivery circuit 84. In some examples, TCC circuit 90 or the functionality for performing TCC implemented in therapy delivery circuit 84 and sensing circuit 86 may be omitted if IMD 214 is configured to communicate with other medical devices by other means, e.g., using RF communication which may be conducted by communication circuit 88.
[0091] Memory 82 may be configured to store a variety of operational control parameters, therapy control parameters, sensing control parameters, sensed and detected data, and any other information related to the monitoring of and therapy delivered to the patient.
Memory 82 may store, for example, thresholds and control parameters used in determining a need for therapy from a sensed physiological signal and control parameters used in controlling therapy delivery. Memory 82 may store communications transmitted to and/or received from another medical device. Memory 82 may store a list of dependent parameters that require IMD 214 to determine a parameter status from another medical device coupled to or implanted in the patient before implementing a pending value of a dependent parameter received from external programming device 50.
[0092] IMD 214 may be equipped with one or more other physiological sensors 87 for sensing physiological signals, such as an accelerometer, pressure sensor, temperature sensor, oxygen saturation sensor, gyroscope, heart sound sensor or the like. In some examples, IMD 214 includes a single axis or multi-axis, e.g., three dimensional, accelerometer that may be used for sensing patient posture, sensing patient physical activity level, and/or sensing cardiac mechanical events, e.g., associated ventricular systole, ventricular diastole and/or atrial systole. Control circuit 80 may monitor one or more physiological signals received from sensors 87 for detecting a patient condition or physiological event. Control circuit 80 may generate a notification or alert, record data in memory 82 and/or control therapy delivery circuit 84 based on events or conditions detected from one or more physiological signals.
[0093] IMD 214 may be provided with a communication circuit 88 including an antenna and transceiver for RF telemetry communication with another implanted or external device, e.g., with external programming device 50 shown in FIGs. 1 and 2. IMD 214 may perform intrabody communication with another medical device, which may be coimplanted with IMD 214, for exchanging data relating to the status of a dependent parameter during or before a programming session between IMD 214 and external programming device 50. Communication circuit 88 may include an oscillator and/or other circuitry configured to generate a carrier signal at the desired frequency. Communication circuit 88 further includes circuitry configured to modulate data, e.g., stored physiological data, therapy delivery data, and programmable control parameter values or status on the carrier signal. The modulation of RF communication signals may be, as examples, AM, FM, or DM, such as FSK or PSK.
[0094] In some examples, communication circuit 88 is configured to modulate the TCC signal for transmission by TCC transmitter 91. Although communication circuit 88 may be configured to modulate and/or demodulate both RF telemetry signals and TCC signals within the same frequency band, e.g., within a range from approximately 150 kHz to approximately 200 kHz, the modulation techniques for the two signals may be different. In other examples, TCC transmitter 91 may include a modulator for modulating TCC signals. [0095] In some examples, communication circuit 88 may include communication circuitry for communicating with external programming device 50 according to a first communication protocol, e.g., BLUETOOTH® Low Energy, and communication circuitry for communicating with a second medical device according to a second communication protocol, e.g., via MICS or another RF communication protocol operating at a different frequency than the first communication protocol. In still other examples, IMD 214 may communicate with external programming device 50 via first communication circuitry included in communication circuit 88 configured to operate according to an RF communication protocol. IMD 214 may communicate with a second IMD via second communication circuitry included in communication circuit 88 and configured to operate according to a different mode of communication than RF communication, e.g., using TCC, LEDs, acoustical communication, IR, modulated electrical stimulation pulses (e.g., modulated rate of pacing pulses), or other communication means. It is to be understood that transmission of data between IMD 214 and a second IMD may occur only non- concurrently with the transmission of data between IMD 214 and external programming device 50 in some examples. Depending on the communication protocol(s) and communication circuitry used by IMD 214, in some examples, data transmission to and/or data reception from external programming device 50 may occur concurrently with data transmission to and/or data reception from the second medical device.
[0096] Communication circuit 88 may be configured to receive, e.g., from external programmed device 50, a pending value of a control parameter used by IMD 214 for controlling a medical device function. Communication circuit 88 is further configured to receive information on a second medical device control parameter status. In some examples, communication circuit 88 may receive the second medical device control parameter status during a communication session with the second medical device that is initiated upon implantation of IMD 214, upon implantation of the second medical device, at the time of reprogramming of the second medical device, or when IMD 214 receives a pending value of a dependent parameter and transmits a request to the second medical device.
[0097] In the illustrative examples described below in conjunction with flow charts presented herein, IMD 214 initiates communication with the second medical device by transmitting a first communication signal as a request for second medical device control parameter status. IMD 214 may receive the information on the second medical device control parameter status in a second communication signal that is a response to the first communication signal. It is to be understood however, that receiving information on the second medical device control parameter status may not necessarily require transmission of a first communication signal by IMD 214 for requesting the status. Transmission of information on the status of one or more second medical device control parameters may be initiated by the second medical device, e.g., upon detecting the presence of IMD 214, in response to a command from external programming device 50, upon a programming change received from external programming device 50, upon automatic adjustment of a second medical device control parameter by the second medical device, upon application of a magnet to the patient to initiate an exchange of control parameter status, or other triggering event.
[0098] FIG. 5 is a flow chart 300 of a method that may be performed by a programmable medical device included in a medical device system according to some examples. For the sake of convenience, the process of flow chart 300 is described with reference to the IMD 214 of FIG. 4, which may correspond to ICD 14 or pacemaker 114 in some examples but may correspond to other types of medical devices as listed herein.
[0099] At block 302, control circuit 80 may receive a programming request via communication circuit 88 from external device 50. The programming request may be transmitted from external device 50 after establishing a communication link between external device 50 and IMD 214. The programming request may include a pending value of a programmable control parameter value as indicated at block 304. The pending parameter value is a value of a control parameter that can be used by control circuit 80 to control a device function which may be any of delivery of a therapy by therapy delivery circuit 84, sensing of a physiological signal by sensing circuit 86 or sensors 87, or detecting tachyarrhythmias or other physiological conditions, e.g., cooperatively by circuitry included in sensing circuit 86 and control circuit 80.
[0100] At block 306, control circuit 80 may determine if the programmable control parameter for which the pending value is received is a dependent parameter. In some examples, external programming device 50 may store classifications or labels of programmable control parameters as being dependent parameters according to a particular combination of IMDs implanted in the patient (or otherwise operatively coupled to the patient). External programming device memory 53 may store multiple look up tables of control parameters for different possible device combinations. For example, when ICD 14 is implanted with pacemaker 114, a table of programmable control parameters for each device 14 and 114 may be stored in external programmer memory 53 indicating which programmable control parameters are dependent parameters for each device. The pending parameter value transmitted to IMD 214 may be flagged as a dependent parameter.
Control circuit 80 may determine that the associated control parameter is a dependent parameter based on whether the pending parameter value received at block 304 is flagged as being a dependent parameter. In some cases, each programmable control parameter may be labeled as either dependent or independent for a given medical device based on a second device that is co-implanted with the first device. Patient related data may be stored in external programming device 50 indicating all co-implanted IMDs so that dependent parameters can be flagged or identified in a look up table in external programming device memory 53, for example. [0101] In other examples, IMD 214 may store flags or labels in IMD memory 82 indicating which programmable control parameters are dependent based on the identification of a co-implanted second medical device. When IMD 214 is implanted in a patient, IMD 214 may be enabled to communicate with another, previously implanted IMD to detect the presence of the second IMD. When IMD 214 is already present in a patient when a second IMD is implanted, a communication session may be established between the two IMDs so that each IMD can recognize each other and store, in a respective memory, labels or flags of dependent parameters identified based on the other IMD type. In other examples, IMD 214 may transmit a communication signal to ping other devices that may be implanted or otherwise operatively coupled to the patient. A second medical device may respond to the ping so that IMD 214 can identify the second medical device. Based on the identity of the second medical device, IMD 214 may determine if the pending value of the control parameter received at block 304 is a dependent parameter or not. In some examples, IMD 214 may transmit the identity of the second medical device to external programming device 50 with a query requesting whether the control parameter for which a pending value has been received is a dependent parameter or not.
[0102] Dependent parameters can be therapy delivery control parameters used to schedule and deliver therapy which may result in competitive delivery of therapies by the two devices or other device interactions as further described below. Dependent parameters can be sensing control parameters used in sensing physiological signals. For example, undesired oversensing of pacing pulses delivered by a second device could occur when sensing control parameters are programmed to relatively more sensitive settings (e.g., higher sensitivity for sensing cardiac event signals, shorter blanking or refractory periods, etc.). Therefore, in some cases sensing control parameters could be dependent parameters. Dependent parameters may include detection control parameters used in detecting a physiological event or condition from one or more sensed physiological signals and/or control parameters used to control a response to a detected physiological event, such as data storage, alert generation, etc. Dependent parameters may, in some cases, include device-related control parameters that may generally relate to the overall operation of the medical device, such as date/time settings, temporary operating modes during clinical procedures, etc. Additional examples of dependent parameters are described below. [0103] When IMD 214 determines that the control parameter for which a pending value has been received is not a dependent parameter, IMD 214 may update the control parameter to the pending value at block 314 and control the associated medical device function according to the updated control parameter. When IMD 214 receives the pending parameter value at block 304 identified as a dependent parameter at block 306, control circuit 80 may initiate intrabody communication with a second, co-implanted device at block 308.
[0104] As indicated at block 310, control circuit 80 may request the status of one or more related control parameters from the second device. For example, if a dependent parameter that is a cardiac pacing control parameter is received at block 306, control circuit 80 may request the pacing mode, pacing rate, and/or other pacing control parameters from the second device. At block 312, control circuit 80 may determine if the pending value received at block 304 is compatible with the control parameter status received from the second device. A pending value can be compatible with the status of a control parameter of the second device when the pending value is to program a device function off when the device function is redundant to a second device function having a status of being on or enabled. For instance, if a therapy is being turned off, e.g., a cardiac pacing therapy, and that therapy is turned on in the second device, the dependent parameter may be determined to be compatible at block 312. In another example, if fluid status monitoring, fall detection, or other monitoring for a physiological event or condition is being programmed off when the status of monitoring for the same physiological event or condition is turned on in the second device, the dependent parameter may be determined to be compatible. Other examples of determining that a pending value of a dependent parameter is compatible with the status of the second device are described below. When determined to be compatible, control circuit 80 of IMD 214 may implement the pending value of the control parameter at block 314, e.g., by updating the parameter value stored in memory 82 to the pending value received at block 304. IMD 214 may operate, e.g., perform the associated medical device function, in accordance with the updated programmed control parameter.
[0105] If the pending value is not determined to be compatible, or if compatibility is indeterminable by control circuit 80, control circuit 80 may transmit a notification to external programming device 50 at block 315. The notification transmitted at block 315 may indicate that programming of the pending value is not allowed based on the status of a control parameter of the second device. A user may reprogram the second device to different control parameter values that would not conflict and then resend the programming command with the same pending value to IMD 214. In other examples, the user may select a different control parameter value for the dependent parameter that will not conflict with the current control parameter status of the second device. In still other examples, the notification transmitted at block 315 may be a warning indicating that device interactions or conflicts could occur. The user may select a different control parameter value for programming in IMD 214, reprogram the second medical device to avoid any undesired device interactions, or override the warning and continue with programming the pending value.
[0106] Referring again to block 306, therapy delivery control parameters that may be identified as dependent parameters may include bradycardia pacing control parameters, ATP control parameters, and CV/DF shock control parameters, e.g., when IMD 214 is a pacemaker or ICD and is co-implanted with another pacemaker or ICD capable of delivering cardiac pacing therapies and/or CV/DF shocks. Depending on the type of medical device, programmable therapy delivery control parameters that can be dependent parameters may be used to control neurostimulation, drug delivery, or other types of therapy delivery. In an illustrative example, when IMD 214 and a co-implanted device are both capable of delivering cardiac pacing, e.g., as shown in the example of FIG. 2, examples of dependent parameters may include the cardiac pacing mode, pacing rate, enabling or disabling ATP therapies, pacing pulse amplitude and/or other cardiac pacing control parameters.
[0107] For instance, if ICD 14 shown in FIG. 2 is programmed to deliver ventricular pacing according to one pacing mode and pacing rate and pacemaker 114 is programmed to deliver ventricular pacing according to a different pacing mode and/or different pacing rate, competitive cardiac pacing or other pacing interactions could occur between ICD 14 and pacemaker 114. Generally, if two co-implanted devices are programmed to pace at different rates, the device programmed to pace at a higher rate may dominate, depending on the programmed pacing mode, which may or may not be desired. If both devices are programmed to pace at the same rate, and one device is not sensing pacing pulses or pacing evoked responses caused by the other device, the combined pacing pulses delivered by both devices may be delivered at a rate that is faster than the programmed rate of either device, at variable rates, or at improper pace delivery times, e.g., relative to atrial activity or during the vulnerable period associated with the repolarization phase of the ventricular cycle.
[0108] In an illustrative example, two co-implanted devices may be programmed in a VOO pacing mode. In a VOO pacing mode, ventricular pacing pulses are delivered at a fixed rate without sensing for ventricular event signals, e.g., R-waves, that would normally inhibit ventricular pacing pulse delivery in other pacing modes, e.g., in a VVI pacing mode that includes ventricular pacing and ventricular sensing. The two devices could each be pacing at the same or different rates resulting in a higher than expected pacing rate. For example, two devices pacing in a VOO pacing mode at 60 beats per minute could result in an effective pacing rate of 120 beats per minute if the pacing pulses are delivered out of phase from each other.
[0109] In other examples, if two co-implanted devices are programmed to deliver pacing according to two different pacing modes, e.g., one in an atrial synchronous ventricular pacing mode (such as a VDD or DDD pacing mode) and the other in an asynchronous ventricular pacing mode (such as a VVI or VOO pacing mode), competitive pacing may occur. If the programmed pacing rate in the device operating in the asynchronous ventricular pacing mode is faster than the intrinsic atrial rate, asynchronous ventricular pacing may dominate when atrial synchronous pacing may be desired.
[0110] As such, when IMD 214 receives a pending value for programming the pacing rate and/or pacing mode at block 304, IMD 214 may identify the pending value as being associated with a dependent parameter at block 306 and transmit an intrabody communication signal to a second device at block 310 requesting the status of the pacing mode and pacing rate programmed in the second device. IMD 214 may receive the pacing mode and pacing rate status from the second medical device at block 312 and compare the pacing mode and pacing rate to its own pacing mode and pacing rate if the pending parameter value received at block 304 is implemented. If two different pacing rates and/or pacing modes that could result in competitive pacing or other pacing interactions, the pending parameter value may be determined to be incompatible at block 312. If the pending parameter value is to turn pacing off or program the rate to a value less than the programmed pacing rate of the second device, the pending parameter value may be determined to be compatible at block 312 in that the other device may be programmed to be the primary pacing device. In other instances, if pacing is turned off or the second device pacing rate is set to a value less than the pacing rate of IMD 214 after implementing the pending parameter value, IMD 214 may be the primary pacing device. The pending parameter value may be determined to be compatible at block 312 by control circuit 80 of IMD 214. IMD 214 may update the programmed parameter value at block 314 and transmit a programming confirmation to external programming device 50. IMD 214 may operate to control delivery of cardiac pacing in accordance with the programmed parameter value.
[0111] It is contemplated that even when a pending parameter value is determined to be compatible with the second device status at block 312, IMD 214 may still transmit a notification to the external programming device 50 at block 315 to alert the user to the combination of programmed dependent parameters that will result if the pending parameter value is implemented. The user may have the opportunity to transmit a confirmation or acceptance signal using external programming device 50 back to IMD 214 (received at block 316) to proceed with updating dependent parameter to the pending value. In this way, the user may confirm that the desired pacing therapy delivery configuration is implemented between the two co-implanted devices according to the programmed control parameter values.
[0112] In other instances, the pending value received at block 304 may be a control parameter for controlling ATP therapy delivery. If ATP therapy is enabled in one device it may be desirable to program ATP therapy off or disabled in a second device to avoid delivering ATP from two devices in response to detecting ventricular tachyarrhythmia. Accordingly, when a pending parameter value for controlling ATP therapy is received at block 304, IMD 214 may request the status of ATP therapy control parameter values from the second medical device at block 310 to determine if the programmed status of ATP therapies in the second medical device is compatible with the pending value received at block 304. For instance, control circuit 80 of IMD 214 may verify at block 312 that ATP therapies are turned off in the second medical device if ATP therapies are being turned on or enabled in response to the pending parameter value. Control circuit 80 of IMD 214 may verify that ATP therapies are turned off in the second medical device if a sequence or programmed menu of ATP therapies, ATP pulse amplitude, ATP pulse intervals or other control parameter used by IMD 214 is being programmed to a new value based on the pending value received at block 304. If ATP therapies are programmed off in the second medical device, IMD 214 may determine a compatible pending parameter value at block 312 and implement the programmed pending parameter value at block 314 for controlling ATP therapies.
[0113] In other instances, if ATP therapies are being programmed off in IMD 214 and the second medical device parameter status indicates that ATP therapies are also programmed off, IMD 214 may transmit a notification at block 315 to notify the user that ATP therapies will be off in all devices if the pending value is implemented. The user may confirm the pending value to program ATP therapy off in IMD 214 or choose not to confirm programming ATP therapy off. Control circuit 80 of IMD 214 may either confirm and implement the pending programmed value or return to block 302 to wait for another programming request based on an instruction from external programming device 50 received at block 316.
[0114] In still other instances, if ATP therapies are being programmed off in IMD 214 and the second device parameter status indicates that ATP therapies are programmed on, control circuit 80 may determine that the pending parameter value is compatible at block 312. The second medical device may be the primary device for delivering ATP. Control circuit 80 may update the pending value for disabling ATP therapy in IMD 214 at block 314.
[0115] In still other examples, a cardiac pacing control parameter may be a pending pacing pulse amplitude that could cause other types of device interactions, even when the second device is not programmed to or capable of delivering cardiac pacing. For instance, other device interactions could include interference with cardiac signal sensing or other electrical signal sensing by the second device when the pacing pulse amplitude is increased and/or a pacing rate is increased. A cardiac pacing rate programmed to a high rate or to a rate response pacing mode in IMD 214 could prevent certain features in a second medical device from operating correctly. For example, a detected heart rate greater than a threshold rate, e.g., greater than 85 beats per minute may prevent the second medical device from performing a capture management test. This interaction of the function of two different medical devices could cause undesired consequences when, for example, the first device, e.g., IMD 214, is programmed to be the primary bradycardia pacing device and the second medical device is programmed to deliver other pacing therapies, such as ATP or post-shock pacing. If the second medical device cancels a pending capture threshold test due to the detected heart rate being greater than a threshold rate, the second medical device may deliver ATP or post-shock pacing using a pacing pulse amplitude that has not been confirmed to successfully capture the heart based on capture threshold testing.
[0116] As such, when an increased pacing rate, increased pacing pulse amplitude, and/or rate response pacing is enabled, IMD 214 may obtain, at block 310, the status of pacing therapies that are enabled in the second medical device, the status of sensing control parameters (e.g., the programmed sensitivity) and/or the status of capture management testing (e.g., if enabled or disable and scheduled time of day for testing) in the second medical device. If a potential conflict or interaction is identified based on the status of the second medical device control parameters, feedback to the user can be provided at block 315 by transmitting a notification indicating “programming not allowed” based on the second medical device settings, or transmitting an informational or warning message to consider the implications of the programming attempt given how the second medical device is programmed. The user may transmit an override or confirmation instruction to IMD 214 via external programming device 50 at block 316 to cause IMD 214 to update the dependent parameter to the pending value received at block 304. In other instances, IMD 214 may receive a cancellation instruction to cancel the pending value (or may not receive a confirmation message within a time out limit) and return to block 302 to wait for another programming request without implementing the pending value of the dependent parameter. Accordingly, in some instances, requesting a second device parameter status at block 310 may be a request for currently programmed value of the same dependent parameter (e.g., pacing mode or pacing rate) and/or a request for programmed value(s) of other control parameters of the second medical device that may control functions that can be affected by a change in the dependent parameter value.
[0117] Examples of programmable control parameters that can be identified as dependent control parameters at block 306 can include sensing control parameters, e.g., used by sensing circuit 86 for sensing event signals. When IMD 214 is configured to sense cardiac event signals, one or more sensing control parameters such as a sensing electrode vector, a blanking period, refractory period, and parameters used to control the cardiac event sensing threshold amplitude, such as a starting cardiac event sensing threshold amplitude and the sensitivity, which is sometimes referred to as the “sensing floor” because it is the minimum signal amplitude that may be sensed as a cardiac event signal. Changes to a sensing control parameter may result in interactions with the second medical device, e.g., due to oversensing of electrical stimulation pulses delivered by the second medical device. Accordingly, before implementing a pending value of a sensing control parameter, IMD 214 may determine if the pending value is compatible with the control parameter status of the second medical device.
[0118] As an illustrative example, a high pacing pulse amplitude in the second medical device may be incompatible with increasing the sensitivity (lowering the sensitivity setting to a lower voltage) in IMD 214. A different sensing electrode vector used for sensing a cardiac electrical signal by IMD 214 may be incompatible with a pacing pulse amplitude or pacing electrode vector of the second medical device, e.g., if the pending sensing electrode vector is more proximate to the pacing electrode vector than the currently implemented sensing electrode vector. When the pending value is an increased sensitivity, change in sensing electrode vector, shortened refractory period or shortened blanking period or other sensing control parameter that may lead to oversensing by IMD 214, IMD 214 may determine that the pending value may not be compatible at block 312 or that compatibility is indeterminate at block 312. IMD 214 may transmit a notification to external programming device 50 to alert the user to possible sensing issues before implementing the pending value.
[0119] In other examples, when both IMDs are capable of detecting a physiological condition or event, examples of dependent parameters may include enabling or disabling detection of the physiological condition or event, enabling or disabling storage of a physiological signal episode or other related data in memory 82, and/or enabling or disabling transmission of an alert or notification to external programming device 50. For instance, transmitting redundant alerts to external programming device 50 from multiple medical devices configured to detect the same condition or event in the patient may be undesirable. As such, a control parameter that enables transmission of an alert or notification may be a dependent parameter. However, control parameters related to storage of a physiological signal or other related data may or may not be dependent. When an alert or notification is transmitted by one medical device in response to detecting a physiological condition or event, a clinician may want to interrogate a second medical device configured to monitor for the same physiological condition or event to retrieve stored physiological signal episodes and/or related data to confirm or further review the detected condition or event. Tachyarrhythmia episodes, fluid status (e.g., related to edema or lung wetness), or a patient fall are a few examples among a wide variety of physiological conditions or events that may be detected by two medical devices implanted in or otherwise operatively coupled to a patient.
[0120] Furthermore, control parameters that may be dependent parameters may include one or more thresholds or other criteria applied to a monitored signal or data derived therefrom for detecting a physiological condition or event. When two devices are both programmed to detect the same physiological condition or event, e.g., a tachyarrhythmia episode, a detection control parameter, e.g., a tachycardia detection interval, fibrillation detection interval, and/or number of intervals to detect (NID), may be a dependent parameter to avoid conflicting detection status of the two medical devices (e.g., one device detecting and the other device not detecting). Detection control parameters may be identified as dependent parameters to avoid conflicting detection information (e.g., time of detection, time of termination, duration of detected episode(s), etc.). Detection control parameters may be identified as dependent parameters to provide a single source of truth, e.g., one medical device enabled to detect and the other medical device disabled for detecting the same physiological condition or event, or for promoting detection according to a common set of detection criteria as defined by one or more programmed values of detection control parameter(s) to reduce the likelihood of conflicting detection data acquired by the two medical devices.
[0121] IMD 214 may include processing circuitry, e.g., included in sensing circuit 86 and/or control circuit 80, for detecting a physiological condition from one or more sensed physiological signals according to one or more control parameters. The detection control parameters may be dependent control parameters, such as a detection threshold (e.g., threshold number of tachyarrhythmia intervals, threshold acceleration for detecting a patient fall, or threshold cumulative impedance change for detecting edema. Other control parameters that may be dependent parameters relating to physiological condition detection may include an alert control parameter, a data storage control parameter and/or an enable or disable command for turning on or off detection of the physiological condition. [0122] A device-related dependent parameter may be the date and time of day stored in the medical device. It may be desirable to confirm that co-implanted devices are programmed to the same date and time to avoid receiving confounding time stamped data from two or more medical devices. When a pending date and/or time value is received by IMD 214, IMD 214 may request the date and/or time status from a second medical device to ensure that the date and time match before accepting the pending value. Another devicerelated dependent parameter may be enabling or disabling a temporary operating mode of the medical device that may enable other clinical testing or monitoring to be performed. One example is a temporary magnetic resonance imaging (MRI) operating mode. The dependent control parameter may be enabling or disabling the temporary MRI mode. If the MRI mode is being enabled or disabled in IMD 214, IMD 214 may verify that an MRI mode of a co-implanted, second medical device is also enabled or disabled. If the MRI mode status of the second medical device conflicts, IMD 214 may transmit a notification to external programming device 50 to notify the user that the MRI mode status of the second medical device may need to be programmed to the same status.
[0123] In some instances, a clinician may perform an in-office underlying cardiac rhythm test or other clinical evaluations that require a temporary operating mode, e.g., suspending cardiac pacing of IMD 214. The external programming device 50 may be used to place IMD 214 in a temporary operating mode that suspends pacing pulse delivery. The temporary operating mode may be a dependent parameter. IMD 214 may request the status of one or more control parameters of the second medical device to verify that the second medical device is not operating in a conflicting pacing mode (e.g., delivering cardiac pacing) when IMD 214 receives a suspend pacing mode command from external programming device 50. Additionally or alternatively, IMD 214 may request the status of a control parameter of the second medical device relating to detecting and storing a cardiac signal episode, e.g., when a long pause or asystole is detected. Storage of an episode by the second medical device when cardiac pacing is temporarily suspended during an in-office clinician visit may create a data record that is confusing to a clinician at a later follow-up. If the second medical device is programmed to deliver cardiac pacing and/or to store cardiac signal episodes when an arrhythmia is detected, according to a control parameter status received from the second medical device received at block 312, IMD 214 may transmit a notification to the external programming device 50 to indicate that the second medical device may require programming to a temporary operating mode before or in conjunction with implementing a temporary operating mode programming command received by IMD 214 at block 304.
[0124] Yet another device-related dependent parameter may be a command to perform an automatic test by the IMD 214. IMD 214 may be configured to perform automatic test algorithms upon receiving a command from external programming device 50, such as a pacing capture threshold test or a defibrillation threshold test. Depending on control parameter status of the second medical device, the automatic test may interfere with functions of the second medical device or the functions of the second medical device may interfere with the automatic test performed by IMD 214. For example, when IMD 214 is embodied as an ICD capable of performing an automatic defibrillation threshold (DFT) test, IMD 214 may request an operating status of a second medical device and/or transmit a notification to the external programming device 50 that prior to initiating the defibrillation threshold test, reprogramming of the second medical device may be required to reduce the likelihood of any interference in the DFT test by the second medical device or potential damage to the second medical device. For example, cardiac pacing by the second medical device may need to be disabled to avoid pacing interference with fibrillation induction. Cardiac pacing by the second medical device may interfere with detection of the induced fibrillation and synchronizing or scheduling a CV/DF shock delivery by IMD 214 with intrinsic R-waves. Some sensing operations of the second medical device may need to be disabled or adjusted to avoid high voltage signals from interfering with sensing operations and/or damaging the second medical device. As such, IMD 214 may request the status of pacing control parameters and/or sensing control parameters from the second medical device. If pacing is turned off, IMD 214 may determine that the DFT test request is compatible with the status of the second medical device at block 312 and perform the DFT test according to the programmed request at block 314.
[0001] Several examples of programmable control parameters that can be identified as dependent parameters by IMD 214 at block 306 are described herein. Several examples of pending values of dependent parameters that may be identified as compatible or not compatible based on a control parameter status of a second medical device are described herein. It is recognized, however, that these examples may represent only a few of the numerous types of device functions that may be controlled by dependent parameters that can be programmed according to the techniques disclosed herein. Methods described herein for performing intrabody communication for determining whether to implement a pending value of a programmable control parameter based on the status of a second, e.g., co-implanted, medical device provide improvements in medical device systems for managing medical device programming for avoiding conflicts or undesired interactions between two medical devices functioning in/on the same patient. The techniques disclosed herein therefore provide improvements in the computer-related field of medical device programming. By providing a medical device system capable of performing intrabody communication and dependent parameter value analysis according to the techniques herein, for example, the complexity and likelihood of human error in programming medical devices that are co-implanted or otherwise operatively coupled to the same patient is reduced. The clinical benefit of two or more medical devices operating in/on the patient can be improved by the disclosed techniques by simplifying the process of programming the medical devices and avoiding undesired consequences or device interactions. The techniques disclosed herein may enable selection and programming of medical devices with a high degree of confidence in a manner that is simplified, flexible, and patientspecific while avoiding human error.
[0125] Each time a dependent parameter is identified, or each time a dependent parameter is identified for which the pending value is determined to be potentially incompatible with a control parameter or function of the second medical device, IMD 214 may transmit a notification at block 315. The notification may indicate that the programming is not allowed, include a warning that the programming could result in an undesired interaction or that the programmed parameters of the second medical device should be reviewed or reprogrammed prior to programming the pending value in IMD 214. The notification may include an acceptable or alternative setting of the dependent parameter that would be compatible with the status of the second medical device. IMD 214 may be configured to reject or cancel the pending parameter value that is determined not to be compatible with the second device control parameter status. Control circuit 80 of IMD 214 may be configured to identify an alternative setting of the dependent parameter that is compatible with the second device control parameter status. IMD 214 may transmit the compatible alternative setting of the dependent parameter to the external programming device at block 315 to receive a confirmation of the alternative setting as a new pending value at block 316. In some examples, IMD 214 may implement the alternative setting automatically and transmit a notification of the implemented alternative setting at block 315. The alternative setting may be a pacing rate, pacing mode, or other therapy delivery control parameter that is compatible with the second device parameter status. The alternative setting may be a sensing control parameter that is compatible with the second device control parameter status. The alternative setting may be a detection control parameter that is compatible with the second device control parameter status. The alternative setting may be disabling or enabling a device function to be compatible with the second device control parameter status.
[0126] In some examples, the data transmitted at block 315 can include the status information received from the second medical device by IMD 214. In this way, external programming device 50 may display control parameter values or the status of a device function of a second medical device without establishing a communication link directly with the second medical device during the existing communication session with the first medical device, e.g., with IMD 214. The clinician or other user may confirm or cancel the pending value of the dependent parameter based on the displayed status information retrieved by IMD 214 from the second device. The clinician or other user may terminate the communication session with the first medical device, IMD 214, and start a communication session with the second medical device to alter the status of a control parameter or device function based on the information received via IMD 214.
Alternatively, the user may select a different pending value or confirm the programming of the existing pending value based on the review of the second medical device control parameter status.
[0127] FIG. 6 is a flow chart 400 of a medical device programming method according to another example. At block 402, a first medical device, e.g., IMD 214, receives a programming request from external programming device 50, e.g., via IMD communication circuit 88 (shown in FIG. 4). The first medical device may correspond to any of the example medical devices listed herein and may be an IMD. At block 404, the first medical device receives a pending value of a programmable control parameter from the external programming device 50, e.g., via communication circuit 88. [0128] At block 406, the first medical device may determine if the programmable control parameter for which the pending value has been received is a dependent parameter. Any of the methods described above may be performed for determining if the control parameter is a dependent parameter. For example, the pending parameter value may be indicated as a dependent parameter in the programming command received from the external programming device 50 at block 404. In other examples, the first medical device may determine if the control parameter is flagged as a dependent parameter in IMD memory 82 (shown in FIG. 4).
[0129] If the control parameter being programmed is not a dependent parameter, the first device may update the control parameter to the pending value at block 418. If the control parameter being programmed is a dependent parameter, the first medical device may initiate communication with a second medical device operating in or on the patient. The communication with the second medical device may be via TCC, RF communication or any other implemented communication mode, but may be a different mode of communication than the established communication link with external programming device 50.
[0130] At block 410, the first medical device transmits a request to the second medical device in response to determining that the pending value is a dependent parameter value. In the example of FIG. 5 described above, the control circuit 80 of IMD 214, operating as the first medical device that receives the pending value of the dependent parameter, is described as being configured to determine if the pending value is compatible with control parameter status information received from the second medical device. In various examples, however, the first medical device may be configured to initiate communication with the second medical device but may not be configured to solely determine compatibility between the pending dependent parameter value and the status of one or more control parameters of the second medical device. Processing circuitry included in the medical device system, e.g., processing circuitry in external programming device 50, the first medical device, and/or the second medical device, may determine compatibility of the pending value with the second medical device control parameter status information. The external programming device 50, the first medical device and/or the second medical device operating in/on the patient may be configured to cooperatively determine if the pending value of the dependent parameter is compatible with the status of one or more control parameters of the second medical device.
[0131] In one example, the first medical device transmits a request to the second medical device at block 410 that includes the pending parameter value and a request to determine compatibility of the pending parameter value with control parameters and functions of the second medical device. The processing and control circuitry of the second medical device may determine at block 412 if the pending value received from the first medical device is compatible with programmed control parameters that are in effect in the second medical device. The second medical device may transmit a compatibility result back to the first medical device at block 414. When the compatibility result is positive, the first medical device may implement the pending value, e.g., by updating the dependent parameter value stored in memory of the first medical device to the pending value, at block 418. The first medical device may begin operating in accordance with the updated value of the dependent parameter, e.g., for controlling physiological signal sensing, physiological event detection, therapy delivery control or other device functions. The first medical device may cancel the pending value at block 416 if the compatibility result is negative (undesirable device interactions or conflicts could result if the pending value is implemented).
[0132] In another example, the first medical device may transmit a request to the second medical device at block 410 for status information relating to one or more control parameters of the second medical device. The first medical device may receive the status information from the second medical device and transmit the status information to the external programming device 50 with a request for determining compatibility at block 412. The external programming device 50 may determine if the pending value transmitted to the first medical device is compatible with the status of control parameters received from the second medical device via the first medical device. The external programming device 50 may transmit the compatibility result back to the first medical device at block 414. The first medical device may cancel the pending value at block 416 if the compatibility result is negative (undesirable device interactions or conflicts could result if the pending value is implemented). The first medical device may implement the pending value at block 418 if the compatibility result is positive (acceptable device interactions and operations if the pending value is implemented). [0133] In still another example, when the external programming device 50 receives the second medical device status information via the first medical device for determining compatibility at block 412, the second medical device status information may be displayed by the external programming device 50 for review by a clinician or other user. The clinician may determine compatibility or confirm a compatibility result determined by the external programming device processor 52. The clinician may approve and transmit the compatibility result, which may be automatically determined by the external programming device processor 52 or overridden by the clinician. The first medical device may receive the compatibility result at block 414 and either cancel the pending value at block 416 or implement the pending value at block 418 in accordance with the compatibility result. [0134] As described above, in some examples, the medical device system may be configured to determine an acceptable or alternative setting of the dependent parameter that would be compatible with the status of the second medical device when IMD 214 cancels or rejects the pending value at block 416. Control circuitry of the medical device system, e.g., control circuit 80 of IMD 214, control circuitry of the second medical device, or external programming device processor 52 may be configured to identify an alternative setting of the dependent parameter that is compatible with the second device parameter status when IMD 214 cancels a pending value at block 416. IMD 214 may transmit the identified alternative setting of the dependent parameter to the external programming device 50 to receive a confirmation of the alternative setting as a new pending value and may implement the alternative setting (as generally described above in conjunction with FIG. 5). In some examples, IMD 214 may implement the alternative setting automatically and transmit a notification of the implemented alternative setting to the external programming device 50.
[0135] In still other examples, the external programming device processor 52 may determine a limited set of programmable settings for the dependent parameter. The limited or reduced set of dependent parameter settings may be determined by the external programming device processor 52 in response to receiving a notification from IMD 214 indicating that the pending value of the dependent parameter is cancelled based on information that IMD 214 received from the second medical device regarding its control parameter status. The limited or reduced set of dependent parameter settings may be determined by the external programming device processor 52 based on information on the second medical device control parameter status that is received by IMD 214 and may be transmitted by IMD 214 to the external programming device 50. A user may select a new pending value of the dependent parameter from the limited or reduced set of programmable settings for the dependent parameter.
[0136] Further disclosed herein is the subject matter of the following examples:
[0137] Example 1. A medical device comprising circuitry configured to operate according to a first control parameter for performing a medical device function and communication circuitry configured to receive a pending value of the first control parameter transmitted from an external programming device and receive information on a second medical device control parameter status. The medical device may further include a control circuit configured to, based on at least the received information on the second medical device control parameter status, perform one of: a) cancel the pending value of the first control parameter or b) implement the pending value of the first control parameter for performing the medical device function.
[0138] Example 2. The medical device of example 1 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter that, when used to control the medical device function, can result in an interaction with a function of the second medical device. The control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, control the communication circuitry to transmit a first communication signal requesting a second device control parameter status. The communication circuitry may be further configured to receive the information on the second medical device control parameter status as a second communication signal that is a response to the first communication signal requesting the second device control parameter status.
[0139] Example 3. The medical device of any one of examples 1 — 2 wherein the control circuit is further configured to perform one of cancel the pending value or implement the pending value by, based on at least the received information on the second medical device control parameter status, determining if the pending value of the first control parameter is compatible with the second device control parameter status and either cancelling the pending value of the first control parameter when the pending value of the of the first control parameter is determined to be not compatible with the second device control parameter status or implementing the pending value of the first control parameter when the pending value of the first control parameter is determined to be compatible with the second device control parameter status.
[0140] Example 4. The medical device of example 3 wherein the control circuit is further configured to determine if the pending value of the first control parameter is compatible with the second medical device control parameter status by controlling the communication circuitry to transmit the pending value and receiving the information on the second medical device control parameter status including an indication of compatibility of the pending value and the second device control parameter status.
[0141] Example 5. The medical device of any one of examples 1 — 4 wherein the control circuit is further configured to, based on at least the received information on the second medical device control parameter status, perform one of cancel the pending value or implement the pending value by controlling the communication circuitry to transmit a notification to the external programming device; receive, via the communication circuitry, one of a cancellation command or a confirmation command from the external programming device; and cancelling the pending value of the first control parameter in response to receiving the cancellation command or implementing the pending value of the first control parameter in response to receiving the confirmation command.
[0142] Example 6. The medical device of any one of examples 1 — 5 wherein the circuitry comprises therapy delivery circuitry configured to operate according to the first control parameter for delivering a therapy.
[0143] Example 7. The medical device of example 6 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter when the first control parameter is one of: a cardiac pacing mode; a cardiac pacing rate; a cardiac pacing pulse amplitude; or an enable or disable cardiac pacing therapy command. The control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0144] Example 8. The medical device of any one of examples 1 — 5 wherein the circuitry comprises sensing circuitry configured to operate according to the first control parameter for sensing a physiological signal. [0145] Example 9. The medical device of example 8 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter when the first control parameter is one of: a sensitivity; a blanking period; a refractory period; or a sensing electrode vector. The control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0146] Example 10. The medical device of any one of examples 1 — 5 wherein the circuitry comprises processing circuitry configured to operate according to the first control parameter for detecting a physiological condition.
[0147] Example 11. The medical device of example 10 wherein the control circuit is further configured to determine that the first control parameter is a dependent parameter when the first control parameter is one of: a detection threshold; an alert control parameter; a data storage control parameter; or an enable or disable command for turning on or off detecting the physiological condition. The control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0148] Example 12. The medical device of any one of examples 1 — 11 wherein the control circuit is further configured to receive via the communication circuitry the information on the second device control parameter status corresponding to a second control parameter that is a different control parameter than the first control parameter. [0149] Example 13. The medical device of any one of examples 1 — 12 wherein the control circuit is further configured to determine that the first control parameter is a dependent control parameter when the first control parameter is one of: a date; a time of day; a temporary operating mode; or a test command. The control circuit may be further configured to, in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status. [0150] Example 14. The medical device of any one of examples 1 — 13 wherein the communication circuitry is further configured to receive the pending value of the first control parameter via a first communication protocol and receive the information on the second medical device control parameter status via a second communication protocol, the first communication protocol different than the second communication protocol.
[0151] Example 15. The medical device of any one of examples 1 — 14 wherein the communication circuitry further comprises a first communication circuit configured to receive the pending value of the first control parameter and a second communication circuit configured to receive the information on the second medical device control parameter status as a tissue conductance communication signal, the second communication circuit different than the first communication circuit.
[0152] Example 16. The medical device of any one of examples 1 — 15 wherein the control circuit is further configured to, in response to cancelling the pending value of the first control parameter, identify an alternative setting of the first control parameter based on the received information on the second medical device control parameter status. The control circuit may be further configured to control the communication circuitry to transmit the alternative setting to the external programming device.
[0153] Example 17. A method comprising receiving, by a first medical device, a pending value of a first control parameter transmitted from an external programming device and receiving by the first medical device information on a second medical device control parameter status. The first control parameter can be used by the first medical device to perform a medical device function. The method may further include, based on at least the received information on the second medical device control parameter status, performing one of: a) cancelling the pending value of the first control parameter or b) implementing the pending value of the first control parameter for performing the medical device function according to the pending value of the first control parameter.
[0154] Example 18. The method of example 17 further comprising determining that the first control parameter is a dependent parameter that, when used to control the medical device function, can result in an interaction with a function of a second medical device. The method may further include, in response to determining that the first control parameter is a dependent parameter, transmitting a first communication signal requesting the second medical device control parameter status. The method may further include receiving the information on the second medical device control parameter status by receiving a second communication signal that is a response to the first communication signal requesting the second medical device control parameter status.
[0155] Example 19. The method of any one of examples 17 — 18 further comprising performing one of cancelling the pending value or implementing the pending value by, based on at least the received information on the second medical device control parameter status, determining if the pending value of the first control parameter is compatible with the second device control parameter status and either cancelling the pending value of the first control parameter when the pending value of the of the first control parameter is determined to be not compatible with the second device control parameter status or implementing the pending value of the first control parameter when the pending value of the first control parameter is determined to be compatible with the second device control parameter status.
[0156] Example 20. The method of example 19 wherein determining if the pending value of the first control parameter is compatible with the second medical device control parameter status comprises controlling the communication circuitry to transmit the pending value and receiving the information on the second medical device control parameter status including an indication of compatibility of the pending value and the second medical device control parameter status.
[0157] Example 21. The method of any one of examples 17 — 20 further comprising, based on at least the received information on the second medical device control parameter status, performing one of cancelling the pending value or implementing the pending value by transmitting a notification to the external programming device, receiving one of a cancellation command or a confirmation command from the external programming device and either cancelling the pending value of the first control parameter in response to receiving the cancellation command or implementing the pending value of the first control parameter in response to receiving the confirmation command.
[0158] Example 22. The method of any one of examples 17 — 21 further comprising delivering a therapy according to the first control parameter.
[0159] Example 23. The method of example 22 further comprising determining that the first control parameter is a dependent parameter when the first control parameter is one of: a cardiac pacing mode; a cardiac pacing rate; a cardiac pacing pulse amplitude; or an enable or disable cardiac pacing therapy command. The method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0160] Example 24. The method of any one of examples 17 — 21 further comprising sensing a physiological signal according to the first control parameter.
[0161] Example 25. The method of example 24 further comprising determining that the first control parameter is a dependent parameter when the first control parameter is one of a sensitivity; a blanking period; a refractory period; or a sensing electrode vector. The method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0162] Example 26. The method of any one of examples 17 — 21 further comprising detecting a physiological condition according to the first control parameter.
[0163] Example 27. The method of example 26 further comprising determining that the first control parameter is a dependent parameter when the first control parameter is one of: a detection threshold; an alert control parameter; a data storage control parameter; or an enable or disable command for turning on or off detecting the physiological condition. The method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0164] Example 28. The method of any one of examples 17 — 27 further comprising receiving the information on the second device control parameter status corresponding to a second control parameter that is a different control parameter than the first control parameter.
[0165] Example 29. The method of any one of examples 17 — 28 further comprising determining that the first control parameter is a dependent control parameter when the first control parameter is one of: a date; a time of day; a temporary operating mode; or a test command. The method may further include, in response to determining that the first control parameter is a dependent parameter, performing one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
[0166] Example 30. The method of any one of examples 17 — 29 further comprising receiving the pending value of the first control parameter via a first communication protocol and receiving the information on the second medical device control parameter status via a second communication protocol, the first communication protocol different than the second communication protocol.
[0167] Example 31. The method of any one of examples 17 — 30 further comprising receiving the pending value of the first control parameter via a first communication circuit and receiving the information on the second medical device control parameter status as a tissue conductance communication signal via a second communication circuit different than the first communication circuit.
[0168] Example 32. The method of any one of examples 17 — 31 further comprising, in response to cancelling the pending value of the first control parameter, identifying an alternative setting of the first control parameter based on the received information on the second medical device control parameter status. The method may further include transmitting the alternative setting to the external programming device.
[0169] Example 33. A non-transitory computer-readable medium comprising a set of instructions that, when executed by processing circuitry of a medical device system, cause the medical device system to perform a medical device function according to a control parameter, receive a transmitted pending value of the control parameter and receive information on a second medical device control parameter status. The instructions may further cause the medical device system to, based on at least the received information on the second medical device control parameter status, perform one of: a) cancel the pending value of the control parameter or b) implement the pending value of the control parameter for performing the medical device function.
[0170] Example 34. A medical device system comprising an external programming device comprising external communication circuitry, a first medical device and a second medical device. The first medical device may be configured to control a medical device function according to a programmable control parameter, receive a pending value of the programmable control parameter from the external programming device and, in response to receiving the pending value of the programmable control parameter, transmit a first communication signal requesting a second device control parameter status. The second medical device may be configured to receive the first communication signal and transmit a second communication signal in response to receiving the first communication signal. The first medical device can be further configured to, based on at least the received second communication signal, perform one of: a) cancel the pending value of the programmable control parameter or b) implement the pending value of the programmable control parameter for performing the medical device function.
[0171] Thus, various examples of a medical device system have been presented in the foregoing description with reference to illustrative diagrams and flow charts shown in the drawings. It should be understood that, depending on the example, certain acts or events of any of the methods described herein can be performed in a different sequence, may be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the method). Moreover, in certain examples, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors, rather than sequentially. In addition, while certain aspects of this disclosure are described as being performed by a single device, circuit or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices, circuits or components associated with, for example, a medical device system and/or a single circuit or component may perform multiple functions that are represented as separate circuits or components in the accompanying drawings.
[0172] In one or more examples, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware -based processing unit. Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other non- transitory computer-readable medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
[0173] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the terms “processor” and “processing circuitry” as used herein may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. Also, the techniques could be fully implemented in one or more circuits or logic elements.
[0174] Thus, a medical device system has been presented in the foregoing description with reference to specific examples. It is to be understood that various aspects disclosed herein may be combined in different combinations than the specific combinations presented in the accompanying drawings. It is appreciated that various modifications to the referenced examples may be made without departing from the scope of the disclosure and the following claims.

Claims

WHAT IS CLAIMED IS:
1. A medical device comprising: circuitry configured to operate according to a first control parameter for performing a medical device function; communication circuitry to: receive a pending value of the first control parameter transmitted from an external programming device; and receive information on a second medical device control parameter status; and a control circuit configured to, based on at least the received information on the second medical device control parameter status, perform one of: a) cancel the pending value of the first control parameter; or b) implement the pending value of the first control parameter for performing the medical device function.
2. The medical device of claim 1 wherein: the control circuit is further configured to: determine that the first control parameter is a dependent parameter that, when used to control the medical device function, can result in an interaction with a function of a second medical device; and in response to determining that the first control parameter is a dependent parameter, control the communication circuitry to transmit a first communication signal requesting the second medical device control parameter status; and the communication circuitry being further configured to receive the information on the second medical device control parameter status by receiving a second communication signal that is a response to the first communication signal requesting the second medical device control parameter status.
3. The medical device of any one of claims 1 — 2 wherein the control circuit is further configured to perform one of cancel the pending value or implement the pending value by: based on at least the received information on the second medical device control parameter status, determining if the pending value of the first control parameter is compatible with the second device control parameter status; cancelling the pending value of the first control parameter when the pending value of the of the first control parameter is determined to be not compatible with the second device control parameter status; and implementing the pending value of the first control parameter when the pending value of the first control parameter is determined to be compatible with the second device control parameter status.
4. The medical device of claim 3 wherein the control circuit is further configured to determine if the pending value of the first control parameter is compatible with the second medical device control parameter status by: controlling the communication circuitry to transmit the pending value; and receiving the information on the second medical device control parameter status including an indication of compatibility of the pending value and the second device control parameter status.
5. The medical device of any one of claims 1 — 4 wherein the control circuit is further configured to, based on at least the received information on the second medical device control parameter status, perform one of cancel the pending value or implement the pending value by: controlling the communication circuitry to transmit a notification to the external programming device; receiving via the communication circuitry one of a cancellation command or a confirmation command from the external programming device; and cancelling the pending value of the first control parameter in response to receiving the cancellation command; and implementing the pending value of the first control parameter in response to receiving the confirmation command.
6. The medical device of any one of claims 1 — 5 wherein the circuitry comprises therapy delivery circuitry configured to operate according to the first control parameter for delivering a therapy.
7. The medical device of claim 6 wherein the control circuit is further configured to: determine that the first control parameter is a dependent parameter when the first control parameter is one of: a cardiac pacing mode; a cardiac pacing rate; a cardiac pacing pulse amplitude; or an enable or disable cardiac pacing therapy command; and in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
8. The medical device of any one of claims 1 — 5 wherein the circuitry comprises sensing circuitry configured to operate according to the first control parameter for sensing a physiological signal.
9. The medical device of claim 8 wherein the control circuit is further configured to: determine that the first control parameter is a dependent parameter when the first control parameter is one of: a sensitivity; a blanking period; a refractory period; or a sensing electrode vector; and in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
10. The medical device of any one of claims 1 — 5 wherein the circuitry comprises processing circuitry configured to operate according to the first control parameter for detecting a physiological condition.
11. The medical device of claim 10 wherein the control circuit is further configured to: determine that the first control parameter is a dependent parameter when the first control parameter is one of: a detection threshold; an alert control parameter; a data storage control parameter; or an enable or disable command for turning on or off detecting the physiological condition; and in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
12. The medical device of any one of claims 1 — 11 wherein the control circuit is further configured to receive via the communication circuitry the information on the second device control parameter status corresponding to a second control parameter that is a different control parameter than the first control parameter.
13. The medical device of any one of claims 1 — 12 wherein the control circuit is further configured to: determine that the first control parameter is a dependent control parameter when the first control parameter is one of: a date; a time of day; a temporary operating mode; or a test command; and in response to determining that the first control parameter is a dependent parameter, perform one of cancelling the pending value or implementing the pending value based on the received information on the second medical device control parameter status.
14. The medical device of any one of claims 1 — 13 wherein the communication circuitry is further configured to: receive the pending value of the first control parameter via a first communication protocol; and receive the information on the second medical device control parameter status via a second communication protocol, the first communication protocol different than the second communication protocol.
15. The medical device of any one of claims 1 — 14 wherein the communication circuitry further comprises: a first communication circuit configured to receive the pending value of the first control parameter; and a second communication circuit configured to receive the information on the second medical device control parameter status as a tissue conductance communication signal, the second communication circuit different than the first communication circuit.
16. The medical device of any one of claims 1 — 15 wherein the control circuit is further configured to, in response to cancelling the pending value of the first control parameter: identify an alternative setting of the first control parameter based on the received information on the second medical device control parameter status; and control the communication circuitry to transmit the alternative setting to the external programming device.
17. A medical device system comprising: an external programming device comprising external communication circuitry; a first medical device configured to: control a medical device function according to a programmable control parameter; receive a pending value of the programmable control parameter from the external programming device; and in response to receiving the pending value of the programmable control parameter, transmit a first communication signal requesting a second device control parameter status; and a second medical device configured to: receive the first communication signal; and transmit a second communication signal in response to receiving the first communication signal; wherein the first medical device is further configured to, based on at least the received communication signal, perform one of: a) cancel the pending value of the programmable control parameter; or b) implement the pending value of the programmable control parameter for performing the medical device function.
PCT/IB2024/057102 2023-09-28 2024-07-22 Medical device programming WO2025068782A1 (en)

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