Medical device communications for controlling medical device system functionality

Abstract

A medical device system includes a first medical device having circuitry configured to perform a medical device system function, communication circuitry, and control circuitry configured to detect a condition for disabling execution of the medical device system function by the first circuitry. The control circuit may send, via the communication circuit, a communication signal to a second medical device capable of performing the medical device system function in response to detecting the condition. The control circuitry may disable execution of medical device system functions by the circuitry.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 590,369, filed October 13, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to medical devices, systems, and methods for performing inter-device communication to control the functions of a medical device system. Background Technology

[0003] Various medical devices for delivering treatment and / or monitoring a patient's physiological condition are already in clinical use or proposed for clinical use in patients. Examples include implantable medical devices (IMDs) that deliver therapy to the heart, muscles, nerves, brain, stomach, or other tissues and / or monitor conditions related to the heart, muscles, nerves, brain, stomach, or other tissues. Some treatments involve delivering electrical stimulation to such tissues. Some IMDs may employ electrodes to deliver therapeutic electrical signals to these organs or tissues, use electrodes to sense physiological electrical signals inherent in the patient's body (which can be propagated by such organs or tissues), and / or use other sensors to sense the patient's physiological signals.

[0004] For example, when ventricular tachyarrhythmias (e.g., tachycardia or fibrillation) are detected, an implantable cardioverter-defibrillator (ICD) can be used to deliver a high-energy cardioverter-defibrillator (CV / DF) shock to the patient's heart. An ICD can detect tachyarrhythmias based on analysis of an electrocardiogram (EGM) or electrocardiogram (ECG) sensed via electrodes, and can deliver anti-tachyarrhythmic shocks, such as defibrillation and / or cardioverter-defibrillation shocks, via electrodes. As another example, when the heart's natural pacemaker and / or conduction system fails to provide synchronized atrial and ventricular contractions at a frequency and interval sufficient to maintain function in a healthy patient, an ICD or implantable pacemaker can provide cardiac pacing therapy to the heart. ICDs and pacemakers can also provide over-pacing (known as anti-tachycardia pacing (ATP)) to suppress or convert detected tachyarrhythmias, thereby attempting to avoid cardioverter-defibrillation shocks.

[0005] In some cases, two or more medical devices may be implanted in a single patient and / or worn by a single patient. Each of the two or more medical devices may operate independently to perform monitoring functions and / or deliver treatment to the patient. Summary of the Invention

[0006] This disclosure generally relates to techniques for controlling the functions of a medical device system, performed by the system itself. A first medical device of the medical device system can be configured to perform a medical device system function and has a priority for performing that function. The first medical device can determine a condition for disabling a function within the first medical device. In response to determining the condition for disabling a function in the first medical device, the first medical device can send a signal to a second medical device of the system. The second medical device can send a response signal to the first medical device. In some examples, the second medical device can assume control over the functions of the first medical device by enabling the second medical device to perform the medical device function.

[0007] In one example, this disclosure provides a medical device system including a first medical device comprising circuitry configured to perform medical device system functions, communication circuitry, and control circuitry configured to detect a condition for disabling the execution of medical device system functions by the circuitry. In response to detecting the condition, a communication signal is sent via the communication circuitry to a second medical device capable of performing medical device system functions, and the execution of medical device system functions by the circuitry is disabled. The first medical device may include a power source configured to provide power to the circuitry, communication circuitry, and control circuitry.

[0008] In another example, this disclosure provides a method comprising: performing medical device system functions by a first medical device; detecting a condition for disabling the performance of medical device system functions by the first medical device; and, in response to detecting the condition, sending a communication signal to a second medical device capable of performing medical device system functions. The method may include disabling the performance of medical device system functions by the first medical device.

[0009] In another example, this 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 medical device system functions by a first medical device of the medical device system; detect a condition for disabling the performance of medical device system functions by the first medical device; and, in response to detecting the condition, send a communication signal to a second medical device capable of performing medical device system functions. The instructions may also cause the medical device system to disable the performance of medical device system functions by the first circuitry.

[0010] In another example, this disclosure provides a medical device system including a first medical device comprising a first circuit, a first communication circuit, and a first control circuit configured to perform medical device system functions. The first control circuit is configured to detect a condition for disabling the performance of medical device system functions by the first circuit, and in response to detecting the condition, transmit a communication signal via the first communication circuit. The first control circuit may be further configured to disable the performance of medical device system functions by the first circuit. The medical device system also includes a second medical device. The second medical device includes: a second circuit configured to perform medical device system functions; a second communication circuit configured to receive communication signals; and a second control circuit configured to enable the second circuit to perform medical device system functions in response to receiving a communication signal via the second communication circuit.

[0011] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description, drawings, and claims. Attached Figure Description

[0012] Figure 1 This is a conceptual diagram of a medical device system 1 that includes at least two medical devices 4 and 6.

[0013] Figure 2 This is based on a conceptual diagram of an example medical device system that includes multiple IMDs that operatively contact a patient and are capable of in-vivo communication.

[0014] Figure 3 It can be included based on some examples. Figure 2 A conceptual diagram of a pacemaker in a medical device system.

[0015] Figure 4 This is a conceptual diagram of a medical device that can be included in a medical device system and is capable of performing in vivo communication with another member medical device in the medical device system.

[0016] Figure 5 This is a flowchart illustrating, based on some examples, a method for controlling the automatic adjustment of control parameters by member medical devices of a medical device system.

[0017] Figure 6 This is a flowchart illustrating, based on some examples, a method for controlling the adjustment of control parameters by incorporating a test algorithm executed by a medical device.

[0018] Figure 7This is a flowchart of a method for controlling the adjustment of control parameters by combining a test algorithm executed by a medical device, according to another example.

[0019] Figure 8 This is a flowchart of a method for controlling the adjustment of control parameters of a medical device using in vivo communication, based on another example. Detailed Implementation

[0020] Figure 1 This is a conceptual diagram of a medical device system 1 comprising at least two medical devices 4 and 6, which may also be referred to herein as “members” of the medical device system 1. Each member of the medical device system is implanted in or otherwise operatively coupled to a patient to perform physiological signal monitoring and / or therapeutic delivery, according to various control parameters and protocols or algorithms programmed into the respective medical devices 4 and 6. At least one of the medical devices 4 and / or 6 is configured to automatically adjust control parameters used by the respective medical device to control the function of the medical device. As used herein, the term “control parameter” refers to a parameter used by the medical device to control the function of the medical device performed by the respective medical device. Multiple control parameters may be used by the circuitry of the medical device to control a given function. An “adjustable control parameter” is a control parameter that can be adjusted between two or more values ​​to change the manner in which the function of the medical device is performed or to turn a given medical device function on (enabled) or off (disable).

[0021] Automatic adjustment of control parameters can be performed during the execution of a test protocol, and the medical device can be configured to execute the test protocol based on commands, scheduling, or triggers. Automatic adjustment of control parameters may additionally or alternatively be performed based on the results of a measurement or test protocol executed by the medical device. Methods for adjusting control parameters by members of the medical device system may include inter-device communication between a medical device (e.g., medical device 4) and a second medical device (e.g., medical device 6) operating within or on the same patient. Inter-device communication may be performed to send a request signal 5 to alert the second medical device to perform automatic adjustment and / or request approval to perform automatic adjustment. The second medical device may respond to the request by sending a response signal 7, which may be an approval signal or a disapproval signal. In some cases, the disapproval signal may be a delay signal requesting the first medical device 4 to postpone the adjustment of the control parameters. In other cases, the disapproval signal may be a cancellation signal requesting the first medical device 4 to cancel any pending adjustments to the control parameters. In some examples, the second medical device 6 may temporarily change one or more of its own functions to allow the first medical device to execute the test protocol without interference from the functions performed by the second medical device.

[0022] exist Figure 1Two medical devices 4 and 6 are shown in the illustration; however, the techniques disclosed herein are adaptable to operation in medical device systems comprising more than two devices that operate within or on a patient. While the illustrative examples described herein generally refer to medical device systems comprising two or more IMDs co-implanted within the same patient, in some examples one or both of medical devices 4 and / or 6 may be external or percutaneous devices, which in some cases may be wearable, and which are operatively coupled to the patient to perform one or more patient monitoring and / or treatment delivery functions. Examples of medical devices that may be included in a multi-device system that operates within or on a patient include, but are not limited to, cardiac monitors, pacemakers, implantable cardioverter defibrillators (ICDs), drug pumps, neurostimulators (e.g., spinal cord stimulators, deep brain stimulators, or other electrical stimulation devices configured to deliver electrical impulses to excitable tissues (e.g., nerve or muscle tissue), glucose monitors, blood pressure monitors, blood pumps (such as ventricular assist devices), fall detectors, and the like.

[0023] Medical devices 4 and 6 (or medical electrical leads carrying electrodes and / or other sensors extending from medical device 4 or medical device 6) can be operatively positioned for delivering treatment to a patient and / or monitoring one or more physiological signals from the patient to detect physiological conditions or events. Although in Figure 1 Not explicitly shown, electrodes and / or other sensors may be mounted on the housing of medical device 4 and / or medical device 6 to perform various functions belonging to the respective medical device 4 or 6. In other examples, electrodes or other sensors may be carried by medical electrical leads extending from medical device 4 or 6.

[0024] Medical devices 4 and 6 may be IMDs configured to communicate via in vivo communication methods. However, in other examples, one or both of medical devices 4 and / or 6 may be external devices, which may or may not be wearable devices, but may be operatively coupled to a patient, for example using one or more skin or percutaneous sensors, electrodes, catheters, patches, etc., to perform one or more patient monitoring and / or treatment delivery functions. When both medical devices 4 and 6 are implanted in a patient or otherwise operatively coupled to a patient, the two medical devices 4 and 6 may send and receive communication signals to and from each other for controlling the automatic adjustment of control parameters via one of the two medical devices according to the techniques disclosed herein.

[0025] Medical devices 4 and 6 can perform independent functions, such as physiological signal monitoring and / or treatment delivery. For example, each medical device 4 and 6 can be fully functional without requiring a second device present in the patient to perform its intended physiological monitoring and / or treatment delivery functions. However, at least one medical device 4 or 6 can be configured to adjust at least one control parameter that may lead to undesirable device interactions or conflicts when both devices 4 and 6 are present in and operating within the patient. Therefore, the two medical devices 4 and 6 can be configured to send and receive communication signals to and from each other to control the automatic adjustment of at least one of the medical devices 4 or 6 to at least one control parameter. When one medical device 4 or 6 adjusts its control parameter without verifying compatibility with adjustments made by the second medical device 6 or 4 prior to the adjustment, it may result in undesirable outputs of the medical device system 1 as a whole. For example, treatment delivered by the first medical device 4 according to the adjusted control parameter may interfere with the treatment being delivered, the sensed physiological signals, or the measurement or testing protocols or algorithms being performed by the second medical device 6.

[0026] Therefore, before adjusting the control parameters, medical device 4 can be configured to send in vivo signals to medical device 6 to confirm that the adjustment is not expected to result in undesirable interactions with the second medical device 6. As used herein, "in vivo communication" refers to the transmission and reception of signals through at least a part of the patient's body. The term "in vivo communication" can refer to the transmission and reception of communication signals entirely or entirely within the patient's body (e.g., between two IMDs). In some cases, in vivo communication includes the transmission and reception of communication signals via electrodes, antennas, light-emitting diodes (LEDs), microphones, or other transmitting / receiving devices of an in vivo communication system implanted within the patient's body and / or percutaneously positioned on the patient's skin. Thus, in some examples, in vivo communication may include the transmission and / or reception of signals at the surface of the patient's skin.

[0027] Medical devices 4 and 6 can be configured to perform in vivo communication via radio frequency (RF) signals, infrared (IR) signals, acoustic signals, tissue conduction communication (TCC) signals, or other communication protocol signals. The methods disclosed herein for controlling the automatic adjustment of control parameters by medical devices are not limited to practice in conjunction with a specific form or type of in vivo or inter-device communication. Rather, the performed in vivo inter-device communication can conform to any communication method configured to be performed by the medical devices (e.g., medical devices 4 and 6).

[0028] According to the technology disclosed herein, the first medical device 4 can determine that control parameter adjustments are needed, for example, by determining whether a test protocol needs to be executed or a measurement from a physiological signal needs to be performed, or by determining that criteria for adjusting the control parameters have been met. In some cases, a single control parameter needs to be adjusted from its current setting or value to a new pending setting or value. In other cases, multiple control parameter adjustments may be pending in order to execute a test protocol or a measurement from a physiological signal. For example, executing a test protocol may involve one or more adjustments to one or more control parameters. An example of a test protocol that may involve multiple control parameter adjustments is a cardiac pacing capture test. A pacing capture test may be a capture verification test in which a pacing pulse is applied and an evoked response signal is sensed after the pacing pulse at the current pacing output settings (e.g., pacing pulse amplitude and pacing pulse width). However, to ensure that the pacing pulse is delivered before the inherent depolarization, the pacing interval may be shortened to deliver the pacing pulse earlier in the cardiac cycle than the expected inherent depolarization, sometimes referred to as overdrive cardiac pacing. A shortened pacing interval can be a lower frequency interval or an atrioventricular (AV) pacing interval.

[0029] In other cases, pacing capture testing can be performed to determine the minimum pacing pulse output required to detect pacing capture. During capture threshold testing, the pacing interval (e.g., AV pacing interval or lower frequency pacing interval) can be shortened to facilitate delivery of the test pacing pulse before inherent depolarization. Additionally, the pacing pulse output (e.g., pacing pulse amplitude) can be adjusted to one or more settings to test which pacing pulse amplitudes result in cardiac capture. In some cases, the pacing pulse output can be adjusted by additionally or alternatively adjusting the pacing pulse width to one or more settings during pacing capture threshold testing. Other examples of test protocols that can be performed by a medical device are described below, which require adjustments to control parameters to be made prior to in vivo communication between the medical device performing the adjustments and a second medical device.

[0030] Before adjusting the control parameters that can be adjusted in conjunction with the execution of a test protocol, the first medical device 4 may send a request signal 5 to the second medical device 6. The request signal 5 may include an indication of the control parameter to be adjusted, the current value of the control parameter, a new or pending value of the control parameter, and / or a test to be performed by the first medical device 4. The request signal 5 may be sent by the first medical device 4 to receive a response signal 7 from the second medical device 6 indicating whether the first medical device 4 may continue with the automatic adjustment of the control parameter. The request signal 5 may include only data related to the control parameter adjustment, such as the identity of the control parameter, the current or pending value of the control parameter, and / or the test protocol to be performed. The request signal 5 may not include any other data derived from the functions performed by the medical device 4, such as data derived from physiological signals sensed by the medical device 4 or data related to treatments delivered or already delivered by the medical device 4. However, the control parameter and its current or pending value may be used by the medical device 4 to control such functions. Furthermore, the request signal 5 may not be a request for the second medical device 6 to modify its functions based on pending control parameter adjustments.

[0031] The second medical device 6 is configured to receive a request signal 5, determine a response to the request signal 5, and send a response signal 7 back to the first medical device 4. The response signal 7 may be an approval signal indicating that automatic adjustments can continue. The second medical device 6 may determine to send the approval signal by determining that the automatic adjustment of control parameters (or the execution of a test protocol involving one or more automatic adjustments of one or more control parameters) is not expected to interfere with the function of the second medical device. For example, the second medical device 6 may determine that a test, measurement, or other operation that may interfere with the function of either the first or second medical device is currently being performed.

[0032] In some cases, the second medical device 6 can determine to send an approval signal by determining that it is permissible to temporarily suspend its functions or temporarily adjust the control parameters used by the second medical device 6 to control its functions, allowing the first medical device 4 to continue executing the test protocol without interference from the second medical device's functions. The second medical device 6 can reverse the temporary suspension or adjustment after a specified period or until it receives a test completion signal from the first medical device 4. In other cases, the second medical device 6 can automatically adjust one or more of its own control parameters, allowing the first medical device 4 to continue implementing the new control parameter settings for controlling its functions without interference from the functions performed by the second medical device 6. (See below for further details.) Figure 8In some examples, the first medical device 4 may determine that control parameters are being adjusted from an on or enabled setting to a off or disabled setting, such that the function currently being performed by the medical device 4 will be disabled. To retain this function within the overall medical device system 1, the request signal 5 may be a notification to disable the function in the medical device 4. The second medical device 6 may respond with an approval signal and enable the function to be performed by the medical device 6 (if not already enabled), allowing the overall medical device system 1 to continue performing that function. In yet other examples, the second medical device 6 does not modify its own control parameters or functions in any way and sends an approval or disapproval signal based on an assessment of whether changing the control parameters in the first medical device 4 would cause a medical device system conflict between the functions of the two medical devices 4 and 6. A medical device system conflict may be an unexpected or undesirable medical device system output or a failure to perform the expected function as intended.

[0033] When the second medical device determines that a conflict has occurred in the medical device system due to pending control parameter adjustments (e.g., interference between the functions of the first medical device 4 and the second medical device 6), the second medical device 6 may send a response signal 7 as a disapproval signal. In some cases, the disapproval signal is a delay request. The second medical device 6 may be executing a test protocol or performing a measurement, which requires sensing physiological signals, impedance signals, or other signals, and may require generating electrical signals (e.g., cardiac pacing pulses, impedance drive signals, etc.) to execute the test protocol or measurement. In this case, if the first medical device 4 performs automatic adjustments to the control parameters of the first medical device while the second medical device is executing a test protocol or measurement, the function of the second medical device may be interfered with. Therefore, the second medical device 6 may send a disapproval signal with a delay request as a response signal 7. The first medical device 4 may suppress the automatic adjustment of the control parameters by delaying the adjustment by a specified period of time, or by repeating the request signal 5 at a later time (e.g., after the specified period of time or at the next scheduled time for executing the protocol involving the automatic adjustment of the control parameters).

[0034] In other examples, the second medical device 6 may send a response signal 7 as a disapproval signal (which is a rejection signal). The second medical device 6 can determine that the response signal 7 will be a rejection signal by determining that a requested adjustment of the control parameters (or associated test protocol) to be performed by the first medical device 4 will interfere with the function of the second medical device 6. The first medical device 4 can suppress the adjustment of the control parameters (or test protocol) by canceling the automatic adjustment of the control parameters (or test protocol) for an indeterminate period of time. In some cases, if the first medical device 4 determines again that the control parameters need adjustment, the first medical device 4 may repeat the request signal 5 at a subsequent time point.

[0035] Figure 2 This is a conceptual diagram of an example medical device system 10, which includes multiple IMDs that are operatively contacted by a patient and capable of in vivo communication. The medical device system 10 is provided as an exemplary example of two IMDs 14 and 114 that can be co-implanted in a patient. In this example, the medical device system 10 includes an ICD 14 and a pacemaker 114. The ICD 14 and pacemaker 114 are configured to communicate wirelessly in this example; however, in some cases, two or more devices may be coupled via a communication cable or wire to conduct in vivo communication signals between the medical devices. In some examples, the ICD 14 and pacemaker 114 are configured to communicate via a TCC to exchange request and response signals, as described above. Figure 1 Generally described. Examples of medical devices and methods for performing TCC that can be adapted to perform 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 contents of which are incorporated herein by reference. In other examples, the ICD 14 and pacemaker 114 may be configured to communicate via an RF communication protocol (e.g., Bluetooth). ® It can communicate using Low Energy (BLE), Wi-Fi, IEEE standards, Medical Implantable Communication Service (MICS), or other communication protocols.

[0036] The medical device system 10, including ICD 14 and pacemaker 114, is capable of sensing cardiac electrical signals generated by the patient's heart 8 and delivering CV / DF shocks and / or cardiac pacing pulses to the patient's heart 8. The sensing of cardiac signals and the delivery of cardiac electrical stimulation pulses performed by ICD 14 or pacemaker 114 can be controlled by corresponding control circuitry included in the respective individual ICD 14 and pacemaker 114 according to operational control parameters. At least some of the operational control parameters utilized by ICD 14 and / or pacemaker 14 can be programmable by an external programming device 50.

[0037] The ICD 14 includes a housing 15 that forms a hermetically sealed enclosure protecting the internal components of the ICD 14. The housing 15 of the ICD 14 may be formed of a conductive material such as titanium or a titanium alloy. The housing 15 may function as electrodes (sometimes referred to as "can" electrodes). In other instances, the housing 15 of the ICD 14 may include multiple electrodes on an outer portion of the housing. The outer portion of the housing 15 that functions as electrodes may be coated with a material such as titanium nitride to reduce post-stimulation polarization artifacts. The housing 15 may be used as an active can electrode for delivering CV / DF shocks or other high-voltage pulses delivered using high-voltage therapeutic circuitry. In other examples, the housing 15 may be used to deliver relatively low-voltage cardiac pacing pulses and / or for sensing cardiac electrical signals in conjunction with electrodes carried by leads 16. In any of these examples, housing 15 may sometimes be used to send and / or receive electrode vectors for sending and / or receiving TCC signals in accordance with in vivo communication techniques performed for the automatic adjustment of one or more control parameters for controlling at least one of ICD 14 or pacemaker 114 as disclosed herein.

[0038] ICD 14 is shown coupled to a medical electrical lead 16 (hereinafter referred to as "lead" 16) carrying one or more electrodes positioned operatively close to a patient's heart 8. ICD 14 includes a connector assembly 17 (also referred to as a connector block or connector) comprising an electrical feedthrough through a housing 15 to provide electrical connection between a conductor 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 accommodate one or more processors, memories, transceivers, cardiac electrical signal sensing circuitry, therapeutic delivery circuitry, communication circuitry, power supplies, other optional sensors, and / or other components for sensing cardiac electrical signals, detecting heart rhythm, and controlling and delivering electrical stimulation pulses to treat abnormal heart rhythms.

[0039] In this example, lead 16 includes an elongated lead body 18 having: a proximal end 27 including a lead connector (not shown) configured to connect to an ICD connector assembly 17; and a distal portion 25 including one or more electrodes. The distal portion 25 of lead body 18 may include defibrillation electrodes 24 and 26, and pacing / sensing electrodes 28 and pacing / sensing electrodes 30. In some cases, defibrillation electrodes 24 and 26 may form a defibrillation electrode together, as they can be configured to be activated simultaneously. Alternatively, defibrillation electrodes 24 and 26 may form a separate defibrillation electrode, in which case each of electrodes 24 and 26 may be selectively and independently activated.

[0040] Electrodes 24 and 26 (and in some examples, housing 15) are referred to herein as defibrillation electrodes because they are used individually or collectively for delivering high-voltage stimulation therapy (e.g., cardioversion or defibrillation shock). 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 pacing and sensing electrodes 30. However, in addition to or instead of high-voltage stimulation therapy, electrodes 24 and 26, along with housing 15, may also be used to provide pacing functionality, sensing functionality, and / or TCC signal transmission and reception. In this sense, the use of the term "defibrillation electrode" herein should not be construed as limiting electrodes 24 and 26 to high-voltage cardioversion / defibrillation shock therapy applications only. For example, electrodes 24 and 26 may be used in sensing vectors for sensing cardiac electrical signals and detecting and distinguishing rapid arrhythmias. Electrodes 24 and 26 may be combined with each other, collectively with housing 15, or individually with housing 15 in TCC signal transmission electrode vectors. When the ICD 14 is operating in receive mode for receiving TCC signals from the pacemaker 114, electrodes 24, 26 and / or housing 15 may be used in the TCC receive electrode vector. The TCC transmit and receive electrode vectors may be the same or different vectors.

[0041] Electrodes 28 and 30 are relatively small surface area electrodes that can be used in a sensing electrode vector for sensing cardiac electrical signals, and in some configurations can be used to deliver relatively low-voltage pacing pulses. Electrodes 28 and 30 are referred to as pacing / sensing electrodes because they are typically configured for low-voltage applications, such as delivering relatively low-voltage pacing pulses and / or sensing cardiac electrical signals, in contrast to delivering high-voltage CV / DF shocks. In some instances, electrodes 28 and 30 may provide pacing functionality only, sensing functionality only, or both. Furthermore, in some examples, one or both of electrodes 28 and 30 may be used together with or in combination with any of electrodes 24, 26, and / or housing 15 for TCC signal transmission and / or reception. Figure 1 In the illustrated example, electrode 28 is located proximal to defibrillator electrode 24, and electrode 30 is located between defibrillator electrode 24 and defibrillator electrode 26. Electrodes 28 and 30 may be ring electrodes, short coil electrodes, hemispherical electrodes, etc. 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 not include pacing / sensing electrodes, may include one or more pacing / sensing electrodes, and / or may include one or more defibrillator electrodes.

[0042] The ICD 14 can acquire cardiac electrical signals corresponding to the electrical activity of the heart 8 via a combination of sensing electrode vectors including combinations of electrodes 24, 26, 28, 30 and / or housing 15. Various sensing electrode vectors utilizing combinations of electrodes 24, 26, 28 and 30 can be selected by sensing circuitry included in the ICD 14 for receiving cardiac electrical signals via one or more sensing electrode vectors.

[0043] The TCC transmit / receive electrode vector can be selected from available electrodes (e.g., defibrillator electrodes 24, 26, 28, 30 and housing 15 of ICD 14). The TCC transmit / receive electrode vector can be used to transmit TCC signals generated by the TCC transmitter included in ICD 14 and to receive TCC signals from another device (e.g., pacemaker 114).

[0044] The ICD 14 may include an RF antenna in the connector assembly 17 for receiving and transmitting RF communication signals using an RF transceiver enclosed within a housing 15. In some examples, RF communication signals may be sent to and received from the pacemaker 114 while control parameter adjustments by the control circuitry of the ICD 14 are pending. For example, the ICD 14 may send a communication signal requesting a response to the pacemaker 114 while control parameter adjustments are pending. As an example, the response may be an approval or disapproval signal. In some examples, the communication circuitry included in the ICD 14 may include an RF antenna and transceiver for bidirectional communication with an external programming device 50, and TCC circuitry for transmitting and receiving in vivo TCC signals, for example, via transmit and receive electrode pairs carried by leads 16, and / or a housing 15 for communication with the pacemaker 114. TCC can be used for in vivo communication with the pacemaker 114, and RF communication can be used for communication with the external programming device 50. More generally, ICD 14 may include communication circuitry for communicating according to two different methods (e.g., two different protocols and / or two different communication circuits), for communicating with external programming device 50, and in some examples for communicating with pacemaker 14. In other examples, ICD 14 and pacemaker 114 may be configured to communicate via the same circuitry and communication protocol used for communicating with external programming device 50.

[0045] In the example shown, lead 16 extends from connector assembly 27 of ICD 14 toward the center of the patient 12's torso (e.g., toward the xiphoid process 20 of patient 12) subcutaneously or submuscularly over the thorax 32. Near the xiphoid process 20, lead 16 bends or turns and extends upward, for example, subcutaneously or submuscularly above the thorax and / or sternum, or substernally below the thorax and / or sternum 22. Although in Figure 2The lead 16 is illustrated as extending laterally offset from and substantially parallel to the sternum 22, but the distal portion 25 of the lead 16 can be implanted in other locations, such as above the sternum 22, offset to the right or left of the sternum 22, or angled laterally to the left or right of the sternum 22. Alternatively, the lead 16 can be placed along other subcutaneous, submuscular, or substernal pathways. The path of the cardiovascular lead 16 may depend on the location of the ICD 14, the arrangement and positioning of the electrodes carried by the lead body 18, and / or other factors.

[0046] ICD 14 is shown subcutaneously implanted on the left side of patient 12 along the thoracic rim 32. In some instances, ICD 14 may be implanted between the left posterior axillary line and the left anterior axillary line of patient 12. However, ICD 14 may be implanted at other subcutaneous or submuscular locations in patient 12. For example, ICD 14 may be implanted in a subcutaneous pouch in the pectoral muscle region. In this case, lead 16 may extend subcutaneously or submuscularly from ICD 14 toward the manubrium of sternum 22, and bend or turn downward from the manubrium and extend to the desired subcutaneous or submuscular location. In yet another example, ICD 14 may be placed in the abdomen.

[0047] In other arrangements, the cardiovascular external lead 16 of system 10 is at least partially implanted below the sternum 22 of patient 12. Lead 16 may extend subcutaneously or submuscularly from ICD 14 toward xiphoid process 20, and bends or turns within the anterior mediastinum and extends upwards in a substernal position near xiphoid process 20. The anterior mediastinum may be laterally defined by the pleura, posteriorly by the pericardium, and anteriorly by the sternum 22. The distal portion of lead 16 may extend substantially within the loose connective tissue and / or substernal muscle tissue of the anterior mediastinum along the posterior aspect of the sternum 22. Leads implanted such that the distal portion 25 is substantially within the anterior mediastinum may be referred to as "substernal leads".

[0048] As a substernal guide, guide 16 can be substantially centered below the sternum 22. However, in other cases, guide 16 may be implanted such that it is laterally offset from the center of the sternum 22. In some cases, guide 16 may extend laterally such that, in addition to or in place of the sternum 22, the distal portion 25 of guide 16 is below / below the pleural cavity 32. In other examples, the distal portion 25 of guide 16 may be implanted in other intrathoracic locations outside the heart, including within the pleural cavity or around the pericardium of the heart 8 and adjacent to the pericardium of the heart.

[0049] The lead body 18 of lead 16 may be formed of a non-conductive material and shaped to form one or more lumens within which one or more conductors extend. Lead body 18 may be a flexible lead body conforming to an implantation pathway. In other examples, lead body 18 may include one or more pre-shaped curves. Electrical conductors (not illustrated) extend from a lead connector at the proximal lead end 27 through one or more lumens of the elongated lead body 18 of lead 16 to electrodes 24, 26, 28, and 30 positioned along the distal portion 25 of lead body 18. Elongated electrical conductors contained within lead body 18 are electrically coupled to respective defibrillation electrodes 24 and 26, and pacing / sensing electrodes 28 and pacing / sensing electrodes 30, respectively; these elongated electrical conductors may be separate, respective insulated conductors within lead body 18. The corresponding conductors electrically couple electrodes 24, 26, 28, and 30 to the circuitry of ICD 14, such as a signal generator for therapeutic delivery and TCC signal transmission when performing in vivo communication via TCC, and / or, in some examples, sensing circuitry for sensing cardiac electrical signals and / or receiving TCC signals via connections in connector assembly 17 (including associated electrical feedthroughs through housing 15).

[0050] The electrical conductors can transmit treatment from the treatment delivery circuitry within the ICD 14 to one or more of the defibrillator electrodes 24 and 26 and / or the pacing / sensing electrodes 28 and 30, and transmit sensed electrical signals from one or more of the defibrillator electrodes 24 and 26 and / or the pacing / sensing electrodes 28 and 30 to the sensing circuitry within the ICD 14. When the ICD 14 and the pacemaker 114 communicate via TCC, the electrical conductors also transmit TCC signals from the TCC transmitter to the selected electrode for transmitting the TCC signal. The ICD 14 can receive TCC signals from the receiving electrode pair of the ICD 14 to the TCC signal receiver enclosed by the housing 15.

[0051] ICD 14 analyzes cardiac electrical signals received from one or more sensing electrode vectors to monitor abnormal rhythms, such as bradycardia, tachycardia, or fibrillation. ICD 14 can analyze the heart rate and morphology of the cardiac electrical signals to monitor tachyarrhythmias according to any of a variety of tachyarrhythmia detection techniques. In response to the detection of a tachyarrhythmia (e.g., ventricular tachycardia (VT) or ventricular fibrillation (VF)), ICD 14 generates and delivers electrical stimulation therapy using a therapeutic delivery electrode vector, selectable 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 before a CV / DF shock or during high-voltage capacitor charging to attempt to avoid the need for a CV / DF shock. If ATP fails to terminate VT or when VF is detected, ICD 14 may deliver one or more CV / DF shocks via defibrillation electrodes 24 and 26 and / or housing 15. The ICD 14 can use any of electrodes 24, 26, 28, and 30 and / or the pacing electrode vector of the ICD 14 housing 15 to generate and deliver other types of electrical stimulation pulses, such as post-shock pacing pulses or bradycardia pacing pulses. When an R wave is not sensed by the ICD 14 before the pacing escape interval expires, a bradycardia or post-shock pacing pulse can be delivered by the ICD 14 to pace the ventricles of the patient's heart. The pacing escape interval can be a lower pacing frequency interval corresponding to a programmed lower frequency. The frequency of the delivered cardiac pacing pulses can be controlled by the ICD 14 using a programmed lower frequency to maintain a minimum heart rate in the patient.

[0052] In this exemplary example, ICD 14 is implanted together with pacemaker 114. However, it should be understood that the techniques disclosed herein can be implemented in conjunction with medical device systems including ICDs coupled to one or more transvenous and / or non-transvenous leads, one or more leadless pacemakers, pacemakers coupled to one or more transvenous leads and / or other sensors, ICDs coupled to transvenous leads, cardiac monitors, blood pressure monitors, fluid status monitors, oxygen saturation monitors, or other monitors including one or more sensors, drug pumps, neurostimulators, or other medical devices or any combination thereof configured to perform in vivo communication with each other.

[0053] Pacemaker 114 is shown as a leadless intracardiac pacemaker configured to communicate with ICD 14. Pacemaker 114 may include, in conjunction with the following: Figure 3One or more housing-based electrodes are described for sensing cardiac electrical signals and delivering cardiac pacing pulses. The pacemaker 114 may be delivered intravenously and anchored by a fixation member at the intracardiac pacing and sensing site. For example, the pacemaker 114 may be implanted in the atrium or ventricular cavity of a patient's heart. In other examples, the pacemaker 114 may be attached to the outer surface of the heart 8 (e.g., in contact with the pericardium and / or epicardium), such that the pacemaker 114 is positioned externally to the heart 8.

[0054] Pacemaker 114 is configured to deliver cardiac pacing pulses via a pair of housing-based electrodes and can be configured to sense cardiac signals to determine the need for and timing of pacing pulses. 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 the mechanical activity of the heart 8. For example, pacemaker 114 may be configured to sense atrial event signals corresponding to atrial mechanical contractions to trigger atrial-synchronized ventricular pacing pulses delivered by pacemaker 114. In other examples, pacemaker 114 may sense atrial electrical signals for triggering atrial-synchronized ventricular pacing pulses.

[0055] Pacemaker 114 may be implanted in the right atrium or right ventricle of heart 8 to sense cardiac signals and deliver pacing therapy. Pacemaker 114 may be implanted in the right ventricle to sense electrocardiogram (EGM) signals 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 ventricular septum to provide pacing of the conduction system (e.g., via the left bundle branch and / or right bundle branch) and / or the septal myocardium.

[0056] In some examples, the pacemaker 114 is implanted in the right atrium and configured to sense ventricular EGM signals and deliver ventricular pacing pulses from the right atrium. For example, a distal tip electrode (such as...) Figure 3The pacemaker 114 (shown) can be advanced from below the AV node and near the tricuspid annulus (typically in the Koch's triangle) toward the His bundle to position the electrode near the His bundle via a right atrial approach. A pacing pulse can be delivered to this location to capture the ventricle via the heart's intrinsic conduction system and / or ventricular myocardium. When implanted in the right atrium, the pacemaker 114 can additionally or alternatively sense the atrial EGM signal and / or deliver an atrial pacing pulse. The pacemaker 114 can operate in atrial-synchronous ventricular pacing modes (e.g., denoted as VDD or DDD pacing modes). The ventricular pacing pulse can be delivered by the pacemaker 114 from the sensed P wave or the delivered atrial pacing pulse at the atrioventricular pacing interval. At other times, the pacemaker 114 can operate in single-chamber atrial pacing modes or single-chamber asynchronous ventricular pacing modes (e.g., VVI or VOO pacing modes).

[0057] External programming device 50 is shown configured for, for example, wireless telemetry communication with ICD 14 via wireless communication link 42, and for, for example, wireless telemetry communication with pacemaker 114 via wireless communication link 44. The above can be used in conjunction with... Figure 1 Any of the example communication techniques described herein is used to establish a communication link 42 or 44 between the ICD 14 or pacemaker 114 and the external programming device 50, respectively. Although Figure 2 Both communication links 42 and 44 are illustrated, but it should be understood that the external programmer 50 can be configured to communicate with the ICD 14 or pacemaker 114 in separate, non-simultaneous communication sessions. In some examples, the ICD 14 and / or pacemaker 114 may communicate with the external programmer 50 using a TCC (e.g., using TCC transmit / receive electrodes coupled to the external programmer 50 and placed outside the patient 12).

[0058] The external programming device 50 can be used to program the operating parameters and algorithms in the ICD 14 for controlling ICD functions and / or the operating parameters and algorithms in the pacemaker 114 for controlling pacemaker functions. The external programming device 50 can be used to program cardiac signal sensing control parameters, rhythm detection control parameters, and treatment delivery control parameters used by the ICD 14 and pacemaker 114 in corresponding programming sessions with the individual devices 14 and 114. Data stored or acquired by the ICD 14 and / or pacemaker 114 (including physiological signals or associated data derived therefrom, device diagnostic results, and a history of detected rhythm episodes and delivered treatments) can be retrieved by the external programming device 50 from the ICD 14 and / or pacemaker 114 upon request.

[0059] The external programming device 50 may include a processor 52, a memory 53, a display unit 54, a user interface 56, and a communication unit 58. The processor 52 controls the operation of the external programming device and processes data and signals received from the ICD 14 and / or the pacemaker 114. The display unit 54, which may include a graphical user interface (GUI), displays data and other information to the user for reviewing the operation of the medical device and programmed parameters, as well as physiological signals retrieved from the ICD 14 and / or the pacemaker 114. During an inquiry session with the corresponding medical device 14 or 114, the processor 52 may receive data related to sensed physiological signals or detected physiological events or conditions. During an inquiry session with the corresponding medical device 14 or 114, the processor 52 may receive values ​​of currently valid control parameters. Data received from the ICD 14 and / or the pacemaker 114 during the inquiry session may be displayed by the display unit 54 for review by a clinician.

[0060] Processor 52 can execute instructions stored in memory 53. Processor 52 may include any one or more of the following: 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) and other discrete or integrated logic circuitry. The functionality of processor 52 as defined herein may be embodied in software, firmware, hardware, or any combination thereof.

[0061] The memory 53 may include any volatile, non-volatile, magnetic, optical, or electrical medium, such as 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 medium. The memory 53 may be configured to store various medical device control parameters, such as physiological signal sensing control parameters, physiological event detection control parameters, and / or treatment delivery control parameters, as well as associated programmable settings for each of the ICD 14 and the pacemaker 114.

[0062] User interface 56 may include a mouse, touchscreen, keypad, etc., to enable a user to interact with external programming device 50 to initiate a communication session with ICD 14 or pacemaker 114 for retrieving data from and / or sending data to the respective medical device. The user interacting with user interface 56 can cause communication unit 58 to transmit and receive commands during the communication session. User interface 56 may include one or more input devices and one or more output devices, the one or more output devices including display unit 54. Input devices of user interface 56 may include communication devices such as network interfaces, keyboards, pointing devices, voice response systems, cameras, biometric detection / response systems, buttons, sensors, mobile devices, control panels, microphones, presence-sensitive screens, touch-sensitive screens (which may be included in display unit 54), or any other type of device for detecting input from a person or machine.

[0063] One or more output devices of the user interface 56 may include a network interface, a display, a sound card, a video graphics adapter card, a speaker, a presence-sensitive screen, one or more USB interfaces, a video and / or audio output interface, or any other type of device capable of generating tactile, audio, video, or other outputs. The display unit 54 may be used as an input and / or output device employing technology, including a liquid crystal display (LCD), a quantum dot display, a dot matrix display, a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, a cathode ray tube (CRT) display, electronic ink, or a monochrome, color, or any other type of display capable of generating tactile, audio, and / or visual outputs. In other examples, the user interface 56 may generate outputs to the user in another manner, such as via a sound card, a video graphics adapter card, a speaker, a presence-sensitive screen, a touch-sensitive screen, one or more USB interfaces, a video and / or audio output interface, or any other type of device capable of generating tactile, audio, video, or other outputs. In some examples, the display unit 54 is a presence-sensitive display that can be used as a user interface device, operating as one or more input devices and one or more output devices.

[0064] The communication unit 58 may include a transceiver and an antenna configured for bidirectional communication with communication circuitry included in each of the ICD 14 and / or the pacemaker 114. The communication unit 58 is configured to operate in conjunction with the processor 52 for transmitting and receiving data to and from one of the ICD 14 or the pacemaker 114 during a communication session. For example, a radio frequency (RF) link (such as Bluetooth, for example) may be used. ®A bidirectional communication link is established between the external programming device 50 and the corresponding ICD 14 or pacemaker 44, for example, by arrows 42 and 44, using Wi-Fi, Zigbee or other IEEE-based communication protocols, Global System for Mobile Communications (GSM) or other mobile communication protocols, Medical Implantable Communication Service (MICS) or other RF, cellular or infrared communication protocols.

[0065] The external programming device 50 can be configured for wireless communication to program the ICD 14 and / or pacemaker 114 when the respective medical device is implanted in a patient. In some examples, the external programming device 50 may include a programming head that can be placed near the ICD 14 or pacemaker 14 to establish and maintain a communication link with the respective medical device. In other examples, the external programming device 50 may be configured to communicate using distance telemetry algorithms and circuitry that do not require the use of a programming head and do not require user intervention to maintain the communication link, thereby allowing for the mobility and / or remote programming of the ICD 14 and / or pacemaker 114.

[0066] External programming device 50 may be embodied as a programmer used in a hospital, clinic, or physician's office to retrieve data from a medical device and program operating parameters and algorithms within the medical device to control its functions. External programming device 50 may alternatively be embodied as a home monitor or handheld device, such as a smartphone, tablet, or other handheld device. Aspects of external programming device 50 generally correspond to the external programming / monitoring unit disclosed in U.S. Patent No. 5,507,782 (Kieval et al.), the entire contents of which are incorporated herein by reference. An example programmer that can be configured to program an IMD in a medical device system configured to perform the techniques disclosed herein is CARELINK, available from Medtronic, Inc., Dublin, Ireland. ® Programmer.

[0067] Figure 3 It can be included based on some examples. Figure 2 A conceptual diagram of a pacemaker 114 in a medical device system. The pacemaker 114 may be a leadless pacemaker configured to operatively contact another medical device (e.g., such as...) in conjunction with the patient. Figure 2 The pacemaker 114 communicates with the ICD 14 shown. The pacemaker 114 can be implanted in the ventricular chamber of the heart to sense cardiac signals and deliver ventricular pacing pulses. However, in some examples, the pacemaker 114 can be configured to be implanted in the right atrium to provide atrial pacing and / or ventricular pacing from the right atrial location.

[0068] Combined with the following text Figure 4As generally described, a medical device (such as pacemaker 114) included in a multi-device system operating according to the techniques disclosed herein may include processing and control circuitry, a memory, a pulse generation circuitry for generating therapeutic electrical stimulation pulses, a sensing circuitry for sensing physiological signals, a TCC circuitry for transmitting and receiving communication signals and / or other communication circuitry, and a power supply. In some examples, a pulse generator for generating cardiac pacing pulses in pacemaker 114 may be controlled to generate TCC signals transmitted via electrodes 162, 164, and / or 165 for communication with another medical device (e.g., ICD 14).

[0069] Pacemaker 114 may include a housing 150 carrying housing-based electrodes 162, 164, and 165. The type, number, and location of the housing-based electrodes provided on pacemaker 114 can be adapted to specific implantation sites and sensing / pacing applications. Other features of the leadless pacemaker, such as fixation components, dimensions, etc., can be tailored as needed for specific pacing and sensing applications. Therefore, Figure 3 The pacemaker 114 shown is essentially an example of a leadless pacemaker, which can be a type of device that can be included in a medical device system that performs in vivo communication for coordinating the automatic adjustment of control parameters according to the techniques disclosed herein. This illustrative example of pacemaker 114 is not intended to be a limiting example of a pacemaker or (more generally) IMD that can be included in a medical device system configured to operate according to the disclosed techniques, particularly regarding a particular implantation site or features suitable for that site. In other examples, pacemaker 114 may be configured to receive one or more leads, each lead carrying one or more electrodes, which can be advanced via a vein into a patient's heart for sensing and / or delivery of cardiac electrical stimulation therapy in one or more cardiac chambers.

[0070] In this example, pacemaker 114 includes a housing 150 having a distal end face 102 and a proximal end face 104. The transverse sidewalls 170 of the housing 150 extending from the distal end face 102 to the proximal end face 104 may be generally cylindrical to facilitate transvenous delivery of the pacemaker 114 to the implantation site, for example, via a catheter. The distal end face 102 is referred to as “distal” because it is expected to be the tip when the pacemaker 114 is advanced through a delivery tool (such as a catheter) and placed against the target implantation site. In other examples, housing 150 may have a generally prismatic shape. Housing 150 encloses the electronics and power supply for sensing cardiac signals, generating pacing pulses, controlling therapeutic delivery, and other functions of the pacemaker 114 as described herein.

[0071] Pacemaker 114 can be configured to sense cardiac electrical signals, such as R waves and / or P waves, associated with inherent depolarization of myocardial tissue, and to deliver pacing pulses. Pacemaker 114 is shown as including electrodes 162, 164, and 165 spaced apart along a housing 150 of pacemaker 114 for sensing cardiac electrical signals and delivering pacing pulses. However, pacemaker 114 may have more or fewer than three electrodes. In another example, pacemaker 114 may include, for example, only electrodes 162 and 165 or only electrodes 162 and 164. Electrodes 162, 164, and 165 may be, but are not limited to, titanium, platinum, iridium, or alloys thereof, and may include a low-polarization coating, such as titanium nitride, iridium oxide, ruthenium oxide, platinum black, etc.

[0072] Electrode 164 (also referred to herein as “tip electrode” 164) is shown extending from the distal end face 102 of housing 150. The tip electrode 164 is shown as a screw-in helical electrode that can provide fixation of pacemaker 114 at the implantation site and also serve as a pacing and sensing electrode. In some examples, pacemaker 114 may be implanted in the right atrium, allowing electrode 164 to be advanced from within the right atrial cavity to a ventricular pacing site, e.g., toward or into the interventricular septum, for pacing delivery to the His-Purkinje conduction system and / or for pacing of the interventricular septal myocardial tissue. The proximal portion of tip electrode 164 closest to the distal end face 102 of housing may be provided with an electrically insulating coating. Further distal portions of tip electrode 164 positioned at the target pacing site may be non-insulated to serve as conductive portions of tip electrode 164 for pacing pulse delivery and for sensing cardiac electrical signals, such as ventricular EGM signals. Examples of insulating coatings that can be disposed on the proximal portion of the tip electrode 164 include parylene, polyurethane, polyetheretherketone (PEEK), or polyimide.

[0073] In other examples, the tip electrode 164 is not necessarily a tissue puncture electrode as shown in this example. Electrode 164 can be a point, button, ring, hemispherical, segmented, hook-shaped, spiral, or other type of electrode positioned on the distal end face 102 for operatively approaching or positioning within tissue at a target pacing site. When implemented as a non-tissue puncture electrode, the tip electrode 164 can be implanted close to myocardial tissue and held in a stable position via other fixation components, such as being anchored in the atrium or ventricle via fixation teeth, for pacing atrial or ventricular myocardium and the heart's conduction system (e.g., His bundle, left bundle branch, and / or right bundle branch), respectively. For example, Figure 2 The image shows a pacemaker 114, which has a tip electrode 164' in the form of a button electrode instead of... Figure 3 The spiral tip electrode 164 is shown. (See example.) Figure 2As shown, pacemaker 114 may include a retaining tooth 168 for anchoring the tip electrode 164' at the implantation site, rather than the helical retaining mechanism of the tip electrode 164 shown herein. An example of a leadless pacemaker with a button-shaped distal tip electrode and retaining tooth, which can be implemented in a medical device system performing the technology disclosed herein, is generally disclosed in U.S. Patent No. 9,775,982 (filed October 3, 2017 by Grubac et al.), the entire contents of which are incorporated herein by reference.

[0074] Electrode 165 is shown as an annular electrode along the transverse sidewall 170 of housing 150. In other examples, electrode 165 may be a point, button, ring, hemispherical, segmented, or other type of electrode positioned on the distal end face 102 of housing 150 and / or along the transverse sidewall 170. Electrode 162 is shown as an annular electrode along the transverse sidewall 170 of housing 150, which is proximally spaced from electrode 165 towards the proximal end face 104 of housing 150. In other examples, electrode 162 may be a point, button, ring, hemispherical, segmented, or other type of electrode positioned on the proximal end face 104 of housing 150 and / or along the transverse sidewall 170, which is proximally and / or transversely spaced from electrode 165. In some examples, both electrode 162 and electrode 165 may be annular electrodes surrounding the transverse sidewall 170, for example, adjacent to the proximal end face 104 and adjacent to the distal end face 102, respectively. Other parts of the housing 150 may be electrically insulated by an insulating coating.

[0075] Tip electrode 164 can function as a cathode electrode, while loop electrode 162 functions as a return positive electrode for delivering ventricular pacing pulses that can be delivered to capture at least a portion of the His-Purkinje system and / or ventricular myocardium. Tip electrode 164 and loop electrode 162 can serve as a bipolar pair for ventricular pacing and for receiving ventricular electrical signals 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 can form a second cathode and return anode pair for bipolar atrial pacing and sensing atrial electrical signals from which P waves can be sensed by sensing circuitry enclosed by housing 150. In some examples, any combination of electrodes 162, 164, and 165 can be used in a sensing electrode vector to sense one or more cardiac electrical signals from which P waves and / or R waves can be sensed.

[0076] Electrodes 162, 164, and 165 may be positioned along the pacemaker 114 instead of where shown. Furthermore, in some examples, pacemaker 114 includes a distal tip electrode 164 and a proximal electrode 162 or 165. Pacemaker 114 may include a TCC receiver for receiving and detecting TCC signals transmitted by another medical device (e.g., ICD 14 or any of the other examples described herein). A voltage potential is generated across the electrode pair (e.g., tip electrode 164 and loop electrode 162) or between loop electrode 162 and loop electrode 165 in response to a current conducted via a tissue pathway during TCC signal transmission from another medical device (e.g., ICD 14).

[0077] When pacemaker 114 is configured to perform in vivo communication via TCC signals, a TCC transmitting electrode pair and a TCC receiving electrode pair (which may or may not be the same electrode pair) can be selected from available electrodes 162, 164, and 165. In various examples, the sensing / pacing electrode pair and the TCC electrode pair carried by housing 150 may not include a shared electrode, may include one shared electrode, or may include two shared electrodes. 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 may be selected from available electrodes carried by housing 150.

[0078] The pacemaker 114 can be configured to communicate with another medical device implanted in or operatively coupled to the patient. For example, as Figure 2 As shown, pacemaker 114 can communicate with ICD 14. When either pacemaker 114 or ICD 14 is scheduled or triggered to adjust control parameters, pacemaker 114 and ICD 14 can communicate via TCC or another communication protocol. In other examples, pacemaker 114 may be co-implanted (e.g., implanted in different heart chambers) with: another leadless pacemaker; another pacemaker coupled to a transvenous lead carrying electrodes positioned for pacing and sensing at a different location than pacemaker 114; an ICD coupled to the transvenous lead; and a cardiac monitor, such as REVEAL LINQ. ™ An insertable cardiac monitor (available from Medtronic, Inc., Dublin, Ireland); a blood pressure monitor; a body fluid status monitor; an oxygen saturation monitor; or other monitors including one or more sensors, a drug pump, a neurostimulator, or other medical devices configured to perform in vivo communication with the pacemaker 114.

[0079] The housing 150 is formed of a biocompatible material, such as stainless steel or titanium alloy. In some examples, the housing 150 may include an insulating coating. Examples of insulating coatings include parylene, polyurethane, PEEK, or polyimide. The housing 150 as a whole may be insulating, except for electrodes 162, 164, and 165, which are not insulating. Electrodes 162, 164, and 165 are electrically coupled to internal circuitry enclosed by the housing 150, such as a pacemaker pulse generator and cardiac electrical signal sensing circuitry. Electrodes 162 and 165 may be formed as conductive portions of the housing 150 defining corresponding electrodes, which are electrically isolated from each other and from other portions of the housing 150, such as... Figure 3 The overall picture is shown in the middle.

[0080] The pacemaker 114 may include features for facilitating deployment and fixation at the implantation site. For example, the pacemaker 114 may optionally include a delivery tool interface 158. The delivery tool interface 158 may be located at the proximal end 104 of the pacemaker 114 and is configured to connect to a delivery device (such as a catheter, guidewire, or other tool) for positioning the pacemaker 114 at the implantation site during implantation procedures. The delivery tool interface 158 allows a clinician to advance, retract, and guide the pacemaker 114 to the implantation site and rotate the pacemaker 114 to advance the helical tip electrode 164 into the cardiac tissue. The helical tip electrode 164 provides fixation of the pacemaker 114 at the implantation site in this example. However, in other examples, the pacemaker 114 may include a set of fixing teeth, hooks, or other fixation members at or near the distal end face 102 to fix the pacemaker 114 to the cardiac tissue. Various types of fixation components can be used to anchor or stabilize the pacemaker 114 in the implantation location.

[0081] Figure 4 This is a conceptual diagram of a medical device 214, which may be included in a medical device system and is capable of performing in vivo communication with another member medical device in the system, according to some examples. For convenience, the medical device 214 is referred to herein as an "implantable medical device" or IMD 214. In various examples, the two medical devices configured to perform in vivo communication may be IMDs. However, as previously mentioned herein, the medical device performing in vivo communication may be an external device configured to perform in vivo communication with another medical device by receiving communication signals via electrodes, antennas, or other transmitting / receiving devices positioned on or percutaneously on the patient's skin and allowing these communication signals to pass through the patient's body. For convenience, Figure 4 The IMD 214 is typically described as a cardiac pacemaker or ICD coupled to two or more electrodes 224, 226, 228, and 230, for example, Figure 2The ICD 14 or pacemaker 114 is shown. In some examples, the device housing 215 can be used as one of at least two electrodes, and is conceptually represented as... Figure 4 The electrode in the middle is used because it can be used to sense electrophysiological signals, deliver electrical stimulation pulses, and in some examples can be used as a receiving and / or transmitting electrode during TCC.

[0082] However, it should be understood that Figure 4 The circuitry and components shown are generally compatible with the physiological sensing and / or treatment delivery circuitry in any of the example medical devices included in the examples mentioned herein, and are adapted to perform physiological signal sensing and / or treatment delivery functions according to a specific clinical application for signal monitoring and / or treatment delivery. The circuitry of the IMD214 is configured to perform functions based on adjustable control parameters.

[0083] The IMD214, configured to perform in-body communication in association with the automatic adjustment of control parameter values ​​as disclosed herein, may have a higher... Figure 4 The four electrodes 224, 226, 228, and 230 shown may have more or fewer electrodes, and may not include any electrodes at all when configured to perform functions that do not require electrodes for sensing electrophysiological signals, delivering electrical stimulation pulses, or performing in vivo communication. In some cases, when the IMD 214 is configured to perform in vivo communication with another member of the medical device system via TCC, at least two electrodes may be provided for performing TCC transmitting and receiving functions. The TCC electrodes may be leadless, housing-based electrodes and / or carried by leads extending away from the device housing.

[0084] IMD 214 may include control circuitry 80, memory 82, treatment delivery circuitry 84, sensing circuitry 86, sensor 87, communication circuitry 88, TCC circuitry 90, and power supply 89. Power supply 89 supplies power to the circuitry of IMD 214 (including each of circuits 80, 82, 84, 86, 87, 88, and 90) as needed. Power supply 89 may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. Figure 4The overall block diagram provides an understanding of the connections between power supply 89 and each of the other circuits 80, 82, 84, 86, 87, 88, and 90, but these connections are not shown for clarity. For example, power supply 89 may be coupled to a charging circuit included in therapeutic delivery circuitry 84 for charging capacitors or other charge storage devices, and to activate an output switching circuit included in therapeutic delivery circuitry 84 for generating electrical stimulation pulses, such as cardiac electrical stimulation pulses (e.g., CV / DF shock pulses or pacing pulses) or nerve stimulation pulses. Power supply 89 may be coupled to an optional TCC circuitry 90 for powering the TCC signal generated by transmitter 91 and powering TCC receiver 92. As an example, power supply 89 provides power to the processor and other components of control circuitry 80, memory 82, amplifiers, analog-to-digital converters, and other components of sensing circuitry 86, any additional sensors 87 optionally included in IMD 214, and the transceiver of communication circuitry 88 (when included). Because each IMD in a medical device system can be configured to operate independently of any other IMD when not co-implanted with another IMD, each IMD can be provided with power for powering the various circuits and components of the individual IMD.

[0085] Memory 82 may store computer-readable instructions that, when executed by a processor included in control circuitry 80, cause IMD 214 to perform various functions attributable to IMD 214 (e.g., sensing physiological signals, communicating with another device, and / or delivering electrical stimulation therapy). Memory 82 may include any volatile, non-volatile, magnetic, optical, or electrical medium, such as 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 medium.

[0086] The control circuit 80 can communicate with the treatment delivery circuit 84 and the sensing circuit 86 to sense physiological electrical activity (e.g., cardiac electrical signals), detect physiological events (e.g., arrhythmias), and control the delivery of electrical stimulation therapy in response to the sensed physiological signals. Figure 4 The illustrated functional blocks represent the functionality included in IMD 214 and may include any discrete and / or integrated electronic circuit components that implement analog and / or digital circuitry capable of producing the functionality attributed to IMD 214. Given the disclosure herein, providing software, hardware, and / or firmware to implement the described functionality in the context of any modern medical device system is within the capabilities of those skilled in the art.

[0087] Sensing circuitry 86 may be selectively coupled to electrodes 224, 226, 228, 230 and / or housing 215 to monitor the electrical activity of a patient's heart. Sensing circuitry 86 may include switching circuitry for selecting which electrodes 224, 226, 228, 230 and housing 215 are coupled to a sensing amplifier 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 for selectively coupling the sensing amplifier to selected electrodes. Event detector 85 within sensing circuitry 86 may include one or more sensing amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), or other analog or digital components configured to detect features from sensed physiological signals so that processing circuitry of control circuitry 80 can monitor cardiac electrical signals for heart rhythm detection. In an example where the IMD 214 senses one or more cardiac electrical signals (e.g., ECG or EGM), the event detector 85 can sense cardiac electrical event signals associated with myocardial depolarization from the cardiac electrical signals received via the sensing electrode vector, such as P waves associated with atrial depolarization and / or R waves associated with ventricular depolarization.

[0088] In some examples, sensing circuitry 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 a selected electrode coupled to the respective sensing channel to improve signal quality for sensing cardiac event signals (e.g., P waves and / or R waves). For example, each sensing channel in sensing circuitry 86 may include an input or pre-filter and amplifier, analog-to-digital converter, post-amplifier and filter, and rectifier for receiving cardiac electrical signals generated across a selected sensing electrode vector to generate filtered, digitized, rectified, and amplified cardiac electrical signals. Event detector 85 may include a sensing amplifier, comparator, or other circuitry for comparing the rectified, filtered, and amplified cardiac electrical signals with cardiac event sensing thresholds, such as the P wave sensing threshold amplitude or the R wave sensing threshold amplitude, which may be automatically adjusted thresholds. Event detector 85 may generate a sensed cardiac event signal in response to a sensing threshold crossing delivered to control circuitry 80. The sensed cardiac event signals corresponding to the detected R wave and / or P wave can be used by the control circuit 80 to determine the heart rate, detect the heart rhythm, and determine the need for pacing and / or CV / DF therapy.

[0089] Sensing circuit 86 is operable to sense cardiac event signals based on a plurality of sensing control parameters for applying a blanking period, refractory period, and cardiac event sensing threshold to the sensed cardiac electrical signal. The cardiac event sensing threshold can be controlled according to a programmed sensitivity that defines a “sensing limit” or the lowest amplitude signal that can be sensed as a cardiac event signal. The cardiac event sensing threshold can be controlled according to a programmed initial sensing threshold amplitude, which can be set as a percentage of the maximum peak amplitude of the immediately preceding sensed event (e.g., the peak amplitude of a sensed P wave or the peak amplitude of a sensed R wave). The cardiac event sensing threshold (e.g., a P wave sensing threshold or an R wave sensing threshold) can be controlled to decrease from the initial sensing threshold amplitude to the programmed sensitivity until the cardiac event sensing threshold is exceeded. The decrease from the initial sensing threshold amplitude to the programmed sensitivity can be controlled by sensing circuit 86 under the control of control circuit 80 according to one or more fall times, step decrement, decay time, and / or decay rate. In some examples, IMD 214 can be configured to automatically adjust one or more sensing control parameters among the sensing control parameters, such as one or more blanking period, refractory period, and / or cardiac event sensing threshold control parameters.

[0090] Control circuitry 80 may include interval timers or counters that can be reset upon receiving a cardiac sensing event signal from sensing circuitry 86. For example, when reset by a cardiac sensing event signal, the value of the interval timer or counter may be used by control circuitry 80 to measure the duration of cardiac cycle length or other cardiac event intervals, such as the duration of the RR interval, PR interval, or PP interval, which are measurements that can be stored in memory 82. Control circuitry 80 may use cardiac event intervals to detect arrhythmias, such as bradycardia or tachyarrhythmias, such as fibrillation or tachycardia. The measured PR interval may be used to determine the AV conduction time, which may then be used to adjust one or more control parameters for controlling the delivery of cardiac pacing pulses, such as the AV pacing interval, pacing mode, and / or the pacing electrode vector for delivering pacing therapy, such as cardiac resynchronization therapy, conduction system pacing therapy, or atrial-ventricular pacing therapy.

[0091] The therapeutic delivery circuit 84 may include a pulse generator configured to generate cardiac electrical stimulation pulses, such as 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. The therapeutic delivery circuit 84 may include one or more energy storage elements, such as one or more capacitors, configured to store energy required for a therapeutic CV / DF shock or pacing pulse. In response to detection of a shockable tachyarrhythmia, control circuitry 80 controls the therapeutic delivery circuit 84 to charge the energy storage elements in preparation for CV / DF shock delivery. The therapeutic delivery circuit 84 may include other pulse generation circuitry, such as transformers, charge pumps, charge storage capacitors, and switches, to couple the charge storage capacitors to electrode terminals via output capacitors or other output circuitry, such as H-bridges, thereby discharging and delivering the electrical stimulation pulses. The therapeutic delivery circuit 84 may include voltage level shifting circuitry, switches, transistors, diodes, or other circuitry required for generating and delivering the electrical stimulation pulses. In some examples, the treatment delivery circuit 84 may include low-voltage treatment circuitry for generating and delivering relatively low-voltage treatment pulses (such as cardiac pacing or nerve stimulation pulses), and high-voltage treatment circuitry for generating and delivering CV / DF shocks or other relatively high-voltage stimulation pulses, which may be delivered via, for example, a combination of Figure 2 The cardiac pacing pulses delivered by the described extracardiac electrode.

[0092] In some examples, IMD 214 can be configured to monitor the impedance of an electrode vector. For example, treatment delivery circuitry 84 can apply a current (or voltage) drive signal to a pair of electrodes coupled to IMD 214. Sensing circuitry 86 can detect the resulting voltage (or current) generated across the pair of recording electrodes. Impedance monitoring can be performed to monitor bioimpedance in tissue volumes, such as pleural or cardiac impedance, for monitoring patient condition. For example, resistance monitoring can be performed to track a patient's fluid status (e.g., lung humidity associated with symptoms of congestive heart failure). Fluid status metrics can be determined by control circuitry 80 based on impedance measurements and stored in memory 82 over time for detecting when the fluid status metric meets a threshold for detecting, for example, pulmonary edema.

[0093] The TCC circuit 90 may include a TCC transmitter 91 configured to generate a TCC signal for transmission via a conductive tissue pathway from a transmitting electrode vector selected from electrodes 224, 226, 228, 230, and housing 215. The TCC transmitter 91 is configured to generate and transmit the TCC signal for communication with another IMD (or, in some cases, an external device coupled to the patient via a skin electrode or percutaneous electrode). In some examples, the TCC circuit 90 may include a pulse generator for generating the TCC signal and switching circuitry for selectively coupling the TCC transmitter 91 to a selected transmitting electrode vector, for example, using any two or more of electrodes 224, 226, 228, 230, and housing 215.

[0094] The TCC signal can be transmitted by a TCC circuit 90 with a carrier signal, which can be an oscillating signal with peak-to-peak amplitude and carrier frequency selected to avoid stimulating excitable tissues of the patient, such as nerves, smooth muscle, skeletal muscle, or cardiac tissue. In some examples, the carrier frequency of the TCC signal can be 100 kHz or higher. For example, a TCC signal transmitted or received by a TCC electrode pair at a frequency of at least approximately 100 kHz is less likely to stimulate nearby tissues (e.g., muscles or nerves) or cause pain or other sensations compared to a lower frequency waveform. Therefore, a TCC signal with a frequency of at least approximately 100 kHz can have a higher amplitude than a lower frequency signal without causing exogenous nerve or muscle stimulation. A relatively high amplitude signal can increase the likelihood that another medical device can successfully receive the TCC signal from the IMD 214. The peak-to-peak amplitude of the TCC signal can range from approximately 100 microamps to 10 milliamps (mA) or greater, such as in the range from approximately 1 mA to approximately 10 mA. In some examples, the amplitude of the TCC signal can be approximately 3 mA. A TCC signal with a frequency of at least approximately 100 kHz and an amplitude of no more than approximately 10 mA is unlikely to stimulate nearby tissues (e.g., muscles or nerves) or cause pain or other sensations. For a transmitting electrode vector with a 200-ohm impedance and an injected current signal having a peak-to-peak amplitude of 10 mA, the voltage signal at the transmitting electrode vector could be a 2-volt peak-to-peak signal. As an illustrative example, the voltage generated at the receiving electrode vector could range from 0.1 mV to 100 mV peak-to-peak. However, other frequencies and amplitudes of the TCC signal are contemplated for use in conjunction with the techniques disclosed herein.

[0095] In some examples, the TCC circuit 90 can transmit the TCC signal as a modulated signal. Amplitude modulation (AM), frequency modulation (FM), or digital modulation (DM) (such as frequency shift keying (FSK) or phase shift keying (PSK)) can be performed by the TCC circuit 90. In some examples, modulation can be an FM switch between two frequencies, for example, switching between approximately 100kHz-150kHz and approximately 200kHz-250kHz. In some examples, the TCC signal has a frequency of 150kHz-200kHz and is modulated at 12.5kbps using FSK modulation. In other examples, the TCC signal is modulated with a carrier frequency of 100kHz to encode data using binary phase shift keying (BPSK). A balancing pulse of opposite polarity can be used to shift the phase of the TCC signal, for example, shifting it positively or negatively by 180 degrees, and balance the charge injected into the body tissue during the phase shift to minimize the possibility of interference with the cardiac event sensing operation of the sensing circuit 86. Techniques for BPSK modulation of TCC carrier signals using charge-balanced phase shift are disclosed in U.S. Patent No. 11,110,279 (Roberts et al.), the entire contents of which are incorporated herein by reference.

[0096] As an example, data carried by a modulated or unmodulated TCC signal (e.g., data transmitted to or received from the second medical device) may include a wake-up signal, a request to approve the automatic adjustment of control parameters by the IMD 214, an acknowledgment signal after receiving a response signal from the second medical device, an acknowledgment of the wake-up signal sent from the second medical device, and an acknowledgment signal sent in response to the request from the second medical device to approve the adjustment of control parameters by the second medical device.

[0097] TCC circuit 90 includes TCC receiver 92 to facilitate “bidirectional” TCC between IMD 214 and the second medical device. Voltage signals generated on the TCC receiving electrode pair when a TCC signal is transmitted by the second medical device can be received and demodulated by TCC receiver 92 and decoded by processing circuitry included in control circuitry 80. TCC receiver 92 may include amplifiers, filters, analog-to-digital converters, rectifiers, comparators, counters, phase-locked loops, and / or other circuitry configured to detect signals from the transmitting device and detect and demodulate modulated carrier signals that may be transmitted in data packets including coded data. For example, TCC receiver 92 may include a preamplifier tuned to a carrier frequency of a carrier signal 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 a patient. Following the filter may be another amplifier and a demodulator that converts the received signal into a binary signal representing the decoded data.

[0098] In some examples, the circuitry of the TCC receiver 92 may include circuitry shared with the electrical signal sensing circuitry of the sensing circuitry 86. However, the filters included in the TCC receiver and the cardiac electrical signal sensing circuitry are intended to operate at different passbands, for example, to detect different signal frequencies. As an example, the TCC signal may be transmitted in the range of 33 kHz to 250 kHz, in the range of 60 kHz to 200 kHz, or at a carrier frequency of 100 kHz. The cardiac electrical signal generated by the heart 8 is typically less than 100 Hz.

[0099] When IMD 214 determines that a control parameter adjustment is needed or imminent, IMD 214 may send a request from TCC transmitter 91 to another medical device. IMD 214 may receive a response signal from the other medical device via TCC receiver 92. Modulated or unmodulated carrier signals 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 circuitry 90. TCC receiver 92 may include amplifiers, filters, and demodulators to deliver demodulated signals (e.g., as a stream of digital values) to control circuitry 80 for decoding the received signals and further processing as needed.

[0100] In other examples, the TCC receiver 92 may be included in or share sensing circuitry with sensing circuitry 86. The TCC transmitter 91 may be included in or share signal generation circuitry with treatment delivery circuitry 84. In some examples, if the IMD 214 is configured to communicate with other medical devices by other means (e.g., using RF communication that can be performed by a transceiver included in communication circuitry 88), the TCC circuitry 90 or the functionality for performing the TCC implemented in treatment delivery circuitry 84 and sensing circuitry 86 may be omitted.

[0101] Memory 82 can be configured to store various control parameters, such as treatment control parameters and sensing and detection control parameters. Memory 82 may store sensed signals and / or data derived therefrom, as well as any other information related to the IMD 214's monitoring of the patient and the delivery of treatment to the patient. Memory 82 may store, for example, thresholds and other control parameters used to determine the need for treatment based on sensed physiological signals, as well as control parameters used to control treatment delivery. Memory 82 may store communications sent to and / or received from another medical device. Memory 82 may store a list of automated control parameter adjustments (or associated automated testing protocols) that require the IMD 214 to send a request to another medical device coupled to or implanted in the patient before performing the control parameter adjustments (or associated testing protocols).

[0102] The IMD 214 may be equipped with one or more other physiological sensors 87 for sensing physiological signals, such as accelerometers, pressure sensors, temperature sensors, oxygen saturation sensors, gyroscopes, heart sound sensors, etc. In some examples, the IMD 214 includes a single-axis or multi-axis (e.g., three-dimensional) accelerometer that can be used to sense patient posture, sense patient activity levels, and / or sense cardiac mechanical events, such as associated ventricular contraction, ventricular diastole, and / or atrial contraction. Control circuitry 80 may monitor one or more physiological signals received from the sensors 87 for detecting patient conditions or physiological events. Control circuitry 80 may generate notifications or alarms, record data in memory 82, and / or control treatment delivery circuitry 84 based on events or conditions detected from one or more physiological signals, which are sensed by sensing circuitry 86, sensors 87, and / or impedance measurements performed by the IMD 214.

[0103] The IMD 214 may be provided with communication circuitry 88, which includes communication circuitry for communicating with another implanted or external device (e.g., with...). Figure 1 and Figure 2The external programming device 50 shown includes an antenna and transceiver for RF telemetry communication. IMD 214 can perform in-vivo communication with another medical device, which can be co-implanted with IMD 214, to exchange requests and responses related to impending or pending adjustments of control parameters by IMD 214 (or a second medical device). Communication circuitry 88 may include an oscillator and / or other circuitry configured to generate a carrier signal at a desired frequency. Communication circuitry 88 further includes circuitry configured to modulate data on the carrier signal for transmitting request and response signals to the other IMD prior to automatic control parameter adjustments and / or for transmitting stored physiological data, treatment delivery data, and control parameter values ​​to external programming device 50. As an example, the modulation of the RF communication signal may be AM, FM, or DM, such as FSK or PSK.

[0104] In some examples, communication circuitry 88 is configured to modulate a TCC signal for transmission by TCC transmitter 91. Although communication circuitry 88 may be configured to modulate and / or demodulate both RF telemetry and TCC signals within the same frequency band (e.g., in the range from approximately 150 kHz to approximately 200 kHz), the modulation techniques used for the two types of communication signals may differ. In other examples, TCC transmitter 91 may include a modulator for modulating the TCC signal.

[0105] In some examples, the communication circuit 88 may include a method for communicating according to a first communication protocol (e.g., Bluetooth). ®The IMD 214 includes communication circuitry for communicating with the external programming device 50, and communication circuitry for communicating with the second medical device according to a second communication protocol (e.g., via MICS or another RF communication protocol operating at a frequency different from the first communication protocol). In yet another example, the IMD 214 may communicate with the external programming device 50 via a first communication circuitry included in a communication circuitry 88 configured to operate according to an RF communication protocol. The IMD 214 may also communicate with the second IMD (or other device coupled to the patient) via a second communication circuitry included in the IMD 214 and configured to operate according to a communication mode different from RF communication (e.g., using TCC, LED, acoustic communication, IR, modulated electrical stimulation pulses (e.g., modulated pacing pulse frequency) or other communication means). It should be understood that in some examples, data transmission between the IMD 214 and the second IMD may occur non-concurrently with data transmission between the IMD 214 and the external programming device 50. Depending on the communication protocol and communication circuitry used by the IMD214, in some examples, data transmission to and / or data reception from the external programming device 50 may occur concurrently with data transmission to and / or data reception from the second medical device. Other examples of medical device communication methods that can be implemented in conjunction with the techniques disclosed herein are generally disclosed in U.S. Patent Nos. 5,113,859 (Funke), 7,406,105 (DelMain et al.), and 10,357,159 (Schmidt et al.).

[0106] Figure 5 This is a flowchart 300 illustrating, based on some examples, a method for controlling the automatic adjustment of control parameters by members of a medical device system. For clarity, refer to... Figure 4 IMD 214 is used to describe the process to the right of the vertical dashed line in flowchart 300, representing a first medical device adjusting control parameters. The process to the left of the vertical dashed line in flowchart 300 can be performed by a second medical device configured to receive a request signal from the first medical device. (Reference) Figure 2 In a medical device system, the first medical device performing the function to the right of the vertical dashed line may correspond to ICD 14 in some cases and pacemaker 114 in others. Thus, the second medical device may correspond to pacemaker 114 in some cases and ICD 14 in others. In other examples, the first medical device that adjusts control parameters and the second medical device that receives request signals from the first medical device may correspond to other types of medical devices, such as any of the example medical devices listed herein, without limitation.

[0107] For example, the first medical device may be a leadless pacemaker implanted in the right atrium, and the second medical device may be a leadless pacemaker implanted in the right ventricle, or vice versa. In other examples, one (first or second) of the medical devices may be a cardiac monitor configured to sense ECG, EGM, blood pressure, heart sounds, cardiac motion, impedance, and / or other cardiac signals, and the other (second or first) medical device may be a pacemaker (leadless or with one or more leads coupled to a carrier electrode) or an ICD (e.g., coupled to a transvenous or extravascular lead), or vice versa. In other examples, one or both of the medical devices may be non-cardiac devices, such as a neurostimulator, a patient monitor, etc.

[0108] Referring to IMD 214 for illustrative purposes, at block 302, control circuitry 80 of IMD 214 determines that control parameter adjustments are required. Control parameters are parameters used by control circuitry 80 and / or other circuitry of IMD 214 to perform device functions such as delivering therapy, sensing physiological signals, detecting physiological event signals (e.g., cardiac event signals), and detecting physiological conditions (e.g., tachyarrhythmias, pulmonary edema, cardiac arrest, bradycardia, AV block, or other physiological conditions) from sensed signals. In some cases, control parameters are parameters used and adjusted to perform test protocols, such as performing capture tests to confirm pacing capture or performing pacing capture threshold tests, measuring lead impedance, testing atrioventricular (AV) conduction, or determining impedance measurements, etc. The functions performed by IMD 214 can be performed by circuitry of IMD 214, which may include combinations of... Figure 4 Any of the described circuits or components, which cooperate to perform a function according to control parameters. The function performed by the circuitry of IMD 214 according to adjustable control parameters can be performed independently of any other medical device implanted in or operated on the patient (e.g., not required to be present).

[0109] IMD 214 can be configured to automatically adjust any of a plurality of control parameters to optimize its performance in detecting patient conditions and / or delivering one or more types of treatment to achieve desired clinical benefits. Various examples of automatically adjustable control parameters are described below. As used herein, an "adjustable control parameter" is a control parameter that can be adjusted by the medical device without having to receive programming commands or instructions from another medical device to initiate an adjustment of the control parameter from its currently valid value to a new, different value. However, it should be recognized that in some cases, IMD 214 may receive commands from an external programming device 50 to initiate a test protocol, which may involve automatically adjusting one or more control parameters to multiple test settings to execute the test protocol.

[0110] At block 304, control circuitry 80 can determine whether a request signal needs to be sent to a second medical device operating inside or on the patient before performing adjustments to the control parameters. One or more adjustable control parameters can be identified as restricted control parameters, and adjusting these restricted control parameters without approval from at least one other medical device operating inside or on the patient could lead to a medical device system conflict. A medical device system conflict can be an unintended functional output of a combination of medical devices operating inside or on the patient in the medical device system, such as the simultaneous delivery of multiple treatments. For example, the delivery of treatment by IMD 214 could interfere with the sensing, testing, or measuring functions of the second medical device operating inside or on the patient, or vice versa, thereby introducing unintended cumbersome functions of the medical device system or the loss of intended functions.

[0111] In an illustrative example, at box 302, ICD 14 can determine that a scheduled pacing capture threshold test is pending or imminent. A pacing capture threshold test may require adjustment of one or more pacing control parameters, such as pacing pulse amplitude, pacing pulse width, pacing interval (e.g., a lower frequency interval or AV pacing interval to facilitate overdrive pacing of the heart), and / or pacing mode. Any of these pacing control parameters can be marked as a restricted control parameter in memory 82, which requires approval from another medical device present in or on the patient (e.g., pacemaker 114 when IMD 214 corresponds to ICD 14, and vice versa) via a request signal sent at box 304 to avoid undesirable medical device system interactions or conflicts. If pacemaker 114 delivers ventricular pacing, for example, in an atrial synchronous pacing mode, and no pacing pulse is sensed by ICD 14, the high-rate ventricular pacing resulting from both ICD 14 and pacemaker 114 delivering pacing pulses may be a medical device system conflict. In another example, if pacemaker 114 is scheduled to perform a pacing threshold test and ICD 14 is performing tachyarrhythmia detection, the pacing threshold test may interfere with ICD 14's tachyarrhythmia detection, resulting in premature detection of tachyarrhythmias and / or failure to detect tachyarrhythmias as a medical device system conflict or an undesirable outcome.

[0112] Pacing rate interval, pacing mode, pacing pulse output (e.g., pulse amplitude and / or pulse width), AV pacing interval, and pacing electrode vector are examples of treatment delivery control parameters. These treatment delivery control parameters may be restricted control parameters, requiring in vivo communication between the IMD 214 and one or more other medical devices in the medical device system before the restricted control parameters are adjusted by the IMD 214. In some cases, adjustments to the restricted control parameters are performed to perform a test protocol or diagnostic function. In other cases, adjustments to the restricted control parameters may be performed based on the results of a recently or recently performed test protocol, physiological signal analysis, or measurements from acquired signals. In still other cases, adjustments may be performed as part of continuous optimization of treatment delivery, such as to provide rate-smooth pacing rate intervals, rate-responsive pacing, pacing mode switching for patients experiencing intermittent AV block or long AV conduction times, pacing mode and pacing rate adjustments to control ventricular pacing during atrial tachyarrhythmias, etc.

[0113] For example, when the IMD 214 is configured to deliver biventricular pacing for cardiac resynchronization therapy (CRT), the IMD 214 can perform AV conduction tests to determine when AV conduction is intact. When AV block is present, univentricular or biventricular pacing of one or both of the right and left ventricles can be delivered. When AV conduction is present, ventricular pacing can be suppressed, or only left ventricular pacing can be delivered to achieve fusion with right ventricular depolarization with inherent conduction. Therefore, the IMD 214 can be configured to adjust the AV pacing interval according to the pacing therapy as needed by the patient. Based on the AV conduction test results, the IMD 214 can, for example, switch between biventricular and univentricular chamber pacing modes. A second medical device can perform tests (such as cardiac pacing capture threshold testing, morphological matching analysis, or heart rhythm analysis) or collect physiological signal data while the IMD 214 is performing control parameter adjustments according to CRT or another pacing therapy. For example, the second medical device can collect cardiac signal episodes to perform signal morphology analysis, thereby detecting heart rhythm, establishing morphological templates, or for other purposes. For instance, when the second medical device is anticipating a stable or unchanging heart rhythm for acquiring and storing cardiac signal episodes, changes to control parameters in IMD 214 can alter the heart rhythm. Therefore, prior to any of these therapeutic control parameter adjustments, IMD 214 can determine at box 304 that a signal request is needed.

[0114] In yet another example, IMD 214 can be configured to detect atrial tachyarrhythmias and switch the ventricular pacing mode from atrial synchronous ventricular pacing mode to non-atrial tracking (asynchronous) pacing mode. During asynchronous ventricular pacing mode, control circuitry 80 can adjust the ventricular pacing interval (increasing or decreasing) to achieve ventricular capture to facilitate effective ventricular pacing pulse delivery at a regular ventricular rate during atrial tachyarrhythmias. IMD 214 can be configured to determine if a request signal is needed before switching pacing modes and / or before adjusting the ventricular pacing interval to achieve a relatively high percentage of effective pacing ventricular cycles during atrial tachyarrhythmias. When atrial tachyarrhythmias are no longer detected, control circuitry 80 can switch back to atrial synchronous ventricular pacing mode. If the second medical device is currently running a cardiac capture threshold test or capture management test, or other test pacing algorithm involving changes in pacing rate or pacing output, the function of the second medical device may interfere with the function of the IMD 214, for example, by delivering competing pacing pulses that can pace the heart before the IMD 214. Competing pacing rates may confuse the results of algorithms performed by one or both of the IMD 214 and the second medical device. Therefore, the control circuit 80 may determine at block 304 that a request signal is required before switching pacing modes, adjusting the pacing interval, or adjusting another restricted treatment control parameter.

[0115] The IMD 214 can generate additional electrical pulses for measuring lead or electrode impedance, measuring impedance for monitoring a patient's fluid status, delivering rapid arrhythmia treatments (such as ATP or CV / DF shocks), or delivering rapid arrhythmia sensing pulses. At any time the IMD 214 is adjusting the control parameters used to deliver electrical pulses, these control parameters can be identified as restricted parameters because the delivery of unintended electrical pulses, or pulses delivered at different rates or outputs, may interfere with sensing, detection, treatment delivery, or testing protocols or diagnostics that may be in progress or about to be scheduled for execution by a second medical device within the medical device system.

[0116] When a second medical device performs a critical life-saving function (e.g., ventricular pacing or CV / DF shock delivery) while another medical device does not perform a life-saving function (e.g., atrial pacing or monitoring for atrial arrhythmias), the first medical device (e.g., an atrial pacemaker) can be configured to send a request signal to the second medical device (e.g., a ventricular pacemaker or ICD) before any control parameter adjustments that might interfere with the life-saving function of the second medical device. While control parameters are being adjusted, the second life-saving medical device may or may not be required to send a request signal to the first medical device, as any function of the second medical device can be prioritized. If control parameters are being adjusted, the second life-saving medical device can send a notification to the first (non-life-saving) medical device, giving the second medical device an opportunity to cancel or delay operations, signal acquisition, testing, or other functions that might be disrupted by control parameter adjustments performed by the first medical device.

[0117] In other examples, when IMD 214 determines that an alarm signal needs to be generated to alert another caregiver to a detected condition, IMD 214 may determine at box 302 that a restricted control parameter adjustment is required. IMD 214 may be configured to generate an alarm signal in response to the detection of a physiological condition (e.g., pulmonary edema, atrial fibrillation, or other rapid arrhythmias) or a device-related condition (e.g., the need for battery replacement, lead / electrode condition, circuit problem, or other device-related condition), which may require a prescribed action by the patient or a clinician follow-up. The alarm signal may be generated by IMD 214 as an audible alarm, vibration, or another signal perceptible to the patient. When the second medical device includes sensors for sensing heart sounds, cardiac motion, or other physiological signals, the sensor signals of the second medical device may be disrupted by the alarm signal generated by IMD 214.

[0118] Therefore, IMD 214 can determine that generating an alarm signal is a restricted control parameter that requires a request signal to be sent to the second medical device before generating the alarm signal (e.g., when the alarm signal is not due to the detection of an urgent, life-threatening condition). The request signal can indicate whether to send an alarm signal. The second medical device can temporarily disable the sensor or suspend sensor signal analysis to avoid system conflicts and approve IMD 214 to generate the alarm signal. Alternatively, the second medical device can send a delay or rejection signal (at box 356, as further described below) to enable the second medical device to complete functions involving sensing and storing and / or analyzing sensor signals before generating an alarm signal, functions that might be disrupted by the alarm signal generated by IMD 214. In other examples, the second medical device can be configured to detect or identify alarm signal corruption present in the sensor signals, such that when the corruption disappears, the second medical device can resume normal sensing and analysis using the sensor signals and ignore the alarm signal corruption.

[0119] In some cases, when the functionality of IMD 214 is limited or impaired, such as due to the remaining capacity of power supply 89, the remaining storage capacity allocated in memory 82, the detection of lead / electrode problems, or the detection of short circuits or other circuit problems, IMD 214 may determine at block 302 that the limited control parameters need adjustment. To avoid overburdening the medical device system with functionality, when multiple medical devices are operating inside or on a patient, one medical device (e.g., IMD 214) can be enabled to perform functions disabled in a second medical device. This conserves power and / or storage capacity in the second medical device, avoids excessive alarm transmission, and / or avoids generating and transmitting excessive or conflicting data from two different medical devices in the medical device system, which could confuse or overburden clinicians interpreting the data. However, if IMD 214 is enabled to perform a function disabled in the second medical device, and IMD 214 reaches the end of the lifespan of power supply 89, the limited capacity of memory 82, detects a lead or electrode problem (e.g., lead breakage or electrode displacement), detects a short circuit or other internal circuitry problem, or detects another limiting or impaired function based on its own device diagnostics, then IMD 214 can be configured to disable that function. Adjusting a function from enabled to disabled can be a restricted control parameter adjustment to avoid losing the intended medical device system function. Therefore, IMD 214 can determine at block 304 that a request signal needs to be sent before disabling the function. In some cases, the second medical device can be configured to enable medical device functions in response to the sending of a request signal. The following is in conjunction with... Figure 8 Examples of medical device functions that can be disabled by a first medical device and enabled by a second medical device are further described.

[0120] At block 304, control circuitry 80 can determine whether a request needs to be sent based on whether another medical device is being operated on or inside the patient, and if so, determine whether the control parameter to be adjusted is a restricted control parameter based on the type or identity of the other medical device. Control parameters designated as restricted control parameters can be tagged in IMD memory 82. In some examples, external programming device 50 can store classifications or labels of control parameters that can be automatically adjusted by IMD 214 (e.g., without programming commands from external programming device 50) as restricted parameters depending on a specific combination of medical devices implanted in the patient (or otherwise operatively coupled to the patient). External programming device memory 53 can store multiple lookup tables for restricted control parameters for different possible combinations of medical devices. For example, when ICD 14 is implanted together with pacemaker 114, a table of adjustable control parameters for one or both of ICD 14 and / or pacemaker 114 can be stored in external programming device memory 53, indicating which adjustable control parameters are restricted control parameters for the respective devices. When the second device is implanted in the same patient as the IMD 214, or when the second medical device is already in the patient's body when the IMD 214 is implanted, the external programming device 50 can send data to the IMD 214 to notify the IMD 214 of the presence of the second medical device and mark the restricted control parameters to be stored in the IMD memory 82.

[0121] In other examples, IMD 214 may store a tag or label in IMD memory 82 to indicate which adjustable control parameters are restricted based on the identification of the co-implanted second device. When IMD 214 is implanted in a patient, it 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 the patient at the time of implantation of the second IMD, a communication session may be established between the two IMDs, allowing each IMD to recognize each other and store a tag or label in its respective memory indicating the restricted control parameters based on the type of the other IMD. In other examples, IMD 214 may send a communication signal to verify other devices that are implantable or otherwise operatively coupled to the patient. The second medical device may respond to the verification by allowing IMD 214 to identify the second medical device. Based on the identity of the second medical device, IMD 214 may determine whether the adjustable control parameters are restricted control parameters. In some examples, IMD 214 can send a query for the identity of the second medical device along with a request for identification that can be adjusted by the IMD 214 for restricted control parameters to the external programming device 50.

[0122] When control circuit 80 determines that control parameter adjustment is required and the control parameter is not a restricted control parameter (or the second medical device is not currently operating in or on a patient), control circuit 80 may perform control parameter value adjustment at block 312. In some cases, IMD 214 may have recently or previously received information from the second medical device regarding programmed control parameter settings and / or information related to scheduled tests performed by the second medical device. The second medical device may send information to IMD 214 so that IMD 214 can determine whether control parameter adjustment can be performed without sending a request signal prior to adjustment. For example, if IMD 214 has already received a programmed schedule for performing tests from the second medical device, such as a capture threshold test schedule as an example, IMD 214 may determine that a request signal is not required. IMD 214 may delay the adjustment of restricted control parameters so as not to conflict with the scheduling time of the second medical device's functions.

[0123] However, when control circuit 80 determines at block 302 that control parameter adjustment is needed and at block 304 that the control parameter is a restricted control parameter, control circuit 80 may initiate communication with the second medical device at block 306. Control circuit 80 may control TCC circuit 90 or communication circuit 88 to send a request signal to the second medical device. The request signal may include the control parameter to be adjusted, the current control parameter value, and / or a pending new control parameter value, or may indicate a test protocol or measurement to be performed (e.g., pacemaker capture test, impedance measurement, AV conduction test, etc.), which is an indication of what control parameter adjustment may be involved in the second medical device.

[0124] The second medical device can receive a request sent from IMD 214 at box 350. It should be understood that IMD 214 and the second medical device can be configured to communicate according to a protocol that includes sending a wake-up signal or a ping with a return acknowledgment signal to establish a communication session between the two medical devices, followed by sending request signal data. The second medical device can send an acknowledgment signal to IMD 214 to confirm receipt of the sent request signal. In other examples, the request signal data can be sent by IMD 214 once or more until a response signal is received from the second medical device.

[0125] At box 352, the second medical device can determine whether the adjustment of the restricted control parameters is expected to result in undesirable medical device system outputs or other medical device system conflicts. If the second medical device is not performing, or is not about to perform, a test or diagnostic that may be interfered with by the adjustment of the control parameters by IMD 214, the second medical device can determine at box 352 that there is no system conflict. If the second medical device is not performing a sensing, detection, or treatment delivery function that may be interfered with by the adjustment of the control parameters by IMD 214, the second medical device can determine at box 352 that there is no system conflict.

[0126] In some cases, if the second medical device is performing a function that could cause a conflict within the medical device system, the second medical device can suspend that function or adjust its own control parameters to avoid such a conflict. For example, if the second medical device is performing or is about to perform a test, measurement, or device diagnostic protocol that might be interfered with when the first medical device adjusts its control parameters, the second medical device can reschedule or cancel the test, measurement, or device diagnostic protocol to avoid test failures or inaccurate measurements. When rescheduling or canceling its own test, measurement, or device diagnostic protocol based on request signal data received from IMD 214, the second medical device can then determine at block 352 that there is no system conflict.

[0127] If the second medical device determines that a loss of medical device functionality may occur, for example, if the sent request signal is to disable the function of IMD 214, the second medical device can enable the function and subsequently determine at box 352 that there is no system conflict. If the second medical device determines that adjusting control parameters may cause a medical device system conflict, the second medical device can adjust its own control parameters to eliminate the medical device system conflict. The second medical device can then determine at box 352 that there is no system conflict.

[0128] For example, if pacemaker 114 is a second medical device and is operating in atrial-synchronous ventricular pacing mode and receives a request from ICD 14 for adjustment of control parameters associated with a pacing capture threshold test, pacemaker 114 may switch to a temporary asynchronous ventricular pacing mode (which would result in ventricular pacing suppression if ICD 14 is pacing at a rate faster than its intrinsic ventricular rate) or temporarily suspend ventricular pacing. Such control parameter adjustments by pacemaker 114 would allow ICD 14 to perform the pacing capture threshold test without interference from pacing pulse delivery by pacemaker 114. Therefore, in determining whether a medical device system conflict would occur if control parameter adjustments were made in IMD 214, the second medical device may make its own control parameter adjustments to exclude or avoid undesirable medical device system outputs or other conflicts, thereby determining at box 350 that no system conflict exists.

[0129] When the second medical device determines at block 352 that there is no system conflict (“No” branch), the second medical device may send an approval signal at block 354. When the IMD 214 receives the approval signal at block 308 in response to the sent request, the control circuit 80 may perform control parameter adjustments at block 312. The circuitry of the IMD 214 operates cooperatively according to the adjusted control parameters to perform the functions of the IMD 214. The circuitry of the IMD 214 involved in performing the IMD functions according to the adjusted control parameters may include sensing circuitry (e.g., sensing circuitry 86 and / or sensor 87), treatment delivery circuitry 84, communication circuitry (e.g., TCC circuitry 90 and / or communication circuitry 88), and IMD memory 82, which operate under the control of the control circuitry 80.

[0130] In combination Figure 5 In the illustrative example described, the second medical device is described as being configured to determine whether a medical device system conflict is expected in response to a received request signal and the current operating and control parameters of the second medical device. The control circuitry 80 of the IMD 214 may determine the expected medical device system conflict based on communication signals made by the second medical device confirming and approving or disapproving adjustments to restricted control parameters. However, in response to the request signal, the second medical device may send information related to its operation and / or current control parameter settings. The control circuitry 80 of the IMD 214 may receive this information related to the current operating and / or control parameter settings of the second medical device and determine whether a medical device system conflict is expected to occur if the control parameters are adjusted in the IMD 214.

[0131] Control parameters can be adjusted by IMD 214 to control the function of the medical device within an indeterminate time period. The second medical device may or may not change its own control parameters to approve the control parameter adjustments made by IMD 214. As described in the examples above, in other cases, control parameter adjustments by IMD 214 can be made to control temporary operations, such as executing testing or diagnostic algorithms, and the second medical device can temporarily adjust its own operation to allow IMD 214 to perform tests without system conflicts. In this case, although in Figure 5 Although not explicitly shown, it should be understood that IMD 214 can perform a temporary operation at box 314 and, upon completion, send a completion signal back to the second medical device. In this way, the second medical device can restore any control parameter values ​​adjusted in the second medical device to avoid system conflicts while IMD 214 is performing a temporary operation.

[0132] Referring again to box 352, in some cases, if the requested control parameter adjustment is performed by IMD 214, the second medical device can determine an anticipated medical device system conflict. If the second medical device is performing an ongoing test or device diagnostic protocol or is prior to IMD 214 in performing control parameter adjustments, the second medical device can determine that a medical device system conflict will occur. For example, if pacemaker 114 is performing a pacing capture threshold test and receives a request for pacing control parameter adjustment from ICD 14, pacemaker 114 can determine a system conflict at box 352. At box 356, pacemaker 114 can send a disapproval signal, such as a delay or rejection signal. IMD 214 (in this example, it could be ICD 14 or a second leadless pacemaker implanted in the right atrium) can suppress the control parameter adjustment by canceling or delaying the requested adjustment at box 310 in response to not receiving an approval signal (the "No" branch of box 308).

[0133] In some cases, if the second medical device is performing a test, measurement, or device diagnostic protocol or other temporary operation, the system conflict may be temporary. In this case, the second medical device may identify the system conflict at box 352 and send a disapproval signal as a delay signal at box 356. The delay signal may indicate a delay time after which the IMD 214 may perform the requested control parameter adjustment. The delay time may allow the second medical device to complete the test, measurement, or device diagnostic protocol or other temporary operation before the control parameter adjustment is performed by the IMD 214. The delay time may be 10 seconds, 30 seconds, one minute, several minutes, one hour, or other selected time; in some examples, it may be a default specified delay time. The IMD 214 may receive the delay signal at box 308 and perform the control parameter adjustment after the specified delay time at box 310.

[0134] It is conceivable that IMD 214 can store timestamps associated with approval, rejection, and / or delay signals in memory 82, and can "learn" the times of day when a second medical device might be performing scheduled ad hoc operations, which could be system conflicts associated with control parameter adjustments made by IMD 214. In this way, at least for ad hoc operations performed by IMD 214 involving control parameter adjustments, control circuitry 80 can identify different times of day for performing ad hoc operations or adjust the scheduling time for performing ad hoc operations such as threshold capture tests, impedance measurements, or other testing, measurement, or diagnostic protocols. In this way, control circuitry 80 can be configured to learn the times of day to avoid making control parameter adjustments to reduce the likelihood of receiving rejection or delay signals in response to future request signals (and increase the likelihood of receiving approval signals).

[0135] In some cases, system conflicts can be identified by the second medical device as unintended interference with critical medical device system functions being performed by the second medical device, such as sensing cardiac event signals or detecting or delivering medically necessary, urgent, or life-saving treatments. For example, if the second medical device is in the process of detecting a rapid arrhythmia, it may send a rejection signal at box 356. If the second medical device is in the process of delivering treatment for a rapid arrhythmia, it may send a rejection signal at box 356. If the second medical device is in the process of delivering ventricular pacing in a pacing-dependent patient and control parameter adjustments may disrupt or interfere with ventricular pacing, it may send a disapproval signal as a rejection signal at box 356. In response to the rejection signal, IMD 214 may cancel the control parameter adjustment. When a rejection signal is received at box 308 (“No” branch), IMD 214 may cancel the control parameter adjustment or reschedule the control parameter adjustment for a later time and send a new request signal at the later time.

[0136] At box 310, IMD 214 may store cancelled or delayed adjustments with timestamps received from the second medical device and associated rejection or delay signals. This information may be sent to an external device, such as external programming device 50, to notify patients, clinicians, or other users of the timeline of approval, rejection, and / or delay of control parameter adjustments. In this way, users can be aware of control parameter adjustments that have not yet been performed due to potential system conflicts, including any test algorithms or temporary operations that have not yet been executed by IMD 214 due to rejection or delay signals received from the second medical device. In some cases, users may reprogram control parameters or test protocols to be unrestricted, enabling IMD 214 to automatically perform associated control parameter adjustments without being restricted by prior approval from the second medical device. In other examples, the user can program the IMD 214 to perform automatic control parameter adjustments within a finite set of possible settings for control parameters (e.g., a finite pacing rate interval, pacing pulse amplitude, a scheduling time for control parameter adjustments throughout the day, or another finite set of control parameter settings). This avoids system conflicts and removes the limitation of needing a request signal (at box 304) for approval from a second medical device before automatic control parameter adjustments can be performed.

[0137] Figure 6This is a flowchart 400 illustrating, according to some examples, a method for controlling the adjustment of control parameters in conjunction with a test algorithm executed by a medical device. As an example, the IMD 214 may be configured to execute various test protocols or procedures for monitoring patient condition or for determining updated values ​​of control parameters used by the IMD 214 when performing device functions. At block 402, the control circuitry 80 may determine when it is time to execute the test algorithm.

[0138] The testing algorithm can be scheduled to execute at a specified time of day or at scheduled time intervals. For example, control circuit 80 can be configured to perform impedance measurements (e.g., for monitoring fluid status, respiration, and / or lead / electrode impedance) at a specified time of day or at specified time intervals daily. Control circuit 80 can be configured to perform pacing capture tests (e.g., to verify capture and / or determine pacing capture thresholds) at a specified time of day or at specified time intervals daily. Control circuit 80 can be configured to perform tests or measurements of AV conduction time, ventricular synchrony (e.g., interventricular activation time difference, or QRS width) or other heart rhythm tests or measurements at specified time intervals or times of day, enabling control circuit 80 to adjust the pacing mode, pacing electrode vector, pacing rate, and / or AV pacing interval according to patient needs. In some cases, control circuit 80 can acquire cardiac electrical signals for establishing cardiac signal waveform morphology templates and / or comparing the morphology of unknown sensed signal waveforms with established morphology templates.

[0139] The testing algorithm can be triggered in response to the detection of a change in the sensing signal or in response to the delivery of treatment. For example, a pacing capture threshold test can be triggered in response to the control circuit 80 detecting a loss of capture. The control circuit 80 can perform an AV conduction time measurement test in response to the treatment delivery circuit 84 delivering a threshold number of ventricular pacing pulses. Therefore, some tests or measurements can be performed by the IMD 214 at times that may be unscheduled or unpredictable.

[0140] In some cases, a test algorithm can be triggered in response to a command received from an external device (e.g., external programming device 50). For example, IMD 214 can be configured to perform pacing capture threshold testing, AV conduction testing or ventricular synchronization testing, lead impedance testing, basic (non-pacing) rhythm testing, electrophysiological testing that may involve inducing tachyarrhythmias to verify anti-tachyarrhythmia detection, and successful treatment delivery or determination of defibrillation thresholds by IMD 214, or other tests, in response to a command received from external programming device 50. In this case, control circuitry 80 can determine at block 402 when it is time to execute the test in response to a command received from external programming device 50.

[0141] At box 404, in response to determining whether a scheduled or triggered test should be performed, control circuit 80 can control communication circuit 88 or TCC circuit 90 to send a request signal. (As described above...) Figure 5 Generally described, a second medical device implanted in or otherwise operatively coupled to a patient can receive a sent request signal, acknowledge the request signal, determine whether a medical device system conflict might occur if a test is performed during the current operation of the second medical device, and send a response signal based on that determination. In various cases, the second medical device can send an approval signal, a delay signal, or a rejection signal. In some examples, the second medical device can be configured to send an approval signal or a disapproval signal.

[0142] At block 406, the control circuit 80 of IMD 214 receives a response signal from the second medical device via communication circuit 88 or TCC circuit 90. When the response signal is an approval signal, the control circuit 80 performs a pending test at block 408. If the response signal received at block 406 is not an approval signal, the control circuit 80 may cancel or delay the test at block 410. In some cases, the test is canceled and can be performed on the next scheduling or triggering, as determined at block 402. In other cases, the test may be delayed, for example, by a specified time interval. When the control circuit 80 delays the test, for example, by one minute, five minutes, one hour, or other specified time interval, the control circuit 80 may return to block 402 after the specified time interval and repeat the request signal transmission to verify that the execution of the delayed test has been approved by the second medical device signal.

[0143] It is conceivable that when a test is triggered in response to a command received from the external programming device 50, the communication circuit 88 can send a notification signal to the external programming device 50 to inform the external device 50 of the test status (e.g., approval, delay, or cancellation), and to notify of a potential system conflict if the second medical device does not approve. In some cases, the user can use the external programming device 50 to send an overwrite signal that causes the IMD 214 to perform the test without receiving approval from the second medical device, or the user can modify the programming of the second medical device so that the test can be performed using an approval signal from the second medical device.

[0144] Figure 7 This is a flowchart 450 of another example of a method for controlling the adjustment of control parameters by combining a test algorithm executed by a medical device. Figure 7 The boxes with the same number correspond to those described above. Figure 6The same numbered boxes in flowchart 400. Depending on the test performed by IMD 214 at box 408, control circuitry 80 can use the test results to automatically adjust the control parameters used to control the function of IMD 214. For example, IMD 214 can adjust the control parameters used to control the function of IMD 214 based on the test results until the test is performed again. For example, if the test is a pacing capture threshold test, control circuitry 80 can determine that the pacing capture threshold has changed since a previous pacing capture threshold test. Based on the newly determined pacing capture threshold, control circuitry 80 can determine a new pacing pulse amplitude, such as a new pacing pulse amplitude or a new pacing pulse width. In another example, if the test is an AV conduction test, control circuitry 80 can determine that the inherent AV conduction time has changed since a previous AV conduction test. Control circuitry 80 can determine that pacing mode switching criteria are met (e.g., to switch between AV synchronous (e.g., DDD or VDD) pacing mode and asynchronous (e.g., DDI or VDI) pacing mode). Control circuit 80 may determine that the AV pacing interval should be adjusted based on a new AV conduction time measurement and / or a sensed or paced heart rate. In other examples, based on AV conduction testing, ventricular synchronization testing, lead / electrode impedance testing, or pacing capture threshold testing, control circuit 80 may determine that the pacing therapy and / or pacing electrode vector configuration should be adjusted to a different pacing therapy and / or pacing electrode vector configuration.

[0145] After performing the test at block 408, control circuitry 80 may determine at block 412, based on the test results, that control parameter adjustments are needed. In some examples, control circuitry 80 may adjust the control parameters at block 418 based on the test results (e.g., based on measurements performed during the test) and return to block 402 to await the next scheduled or triggered test time. Control parameter adjustments may be performed at block 418 without sending another request signal after receiving approval from the second medical device to perform the test. However, in some examples, the control parameter being adjusted may be a restricted control parameter. Therefore, control circuitry 80 may determine at block 413, after determining that control parameter adjustments are needed based on the performed test, whether a request signal needs to be sent.

[0146] For example, treatment delivery control parameters (e.g., electrical stimulation pulse amplitude, pulse width, pacing interval, pacing electrode vector, or pacing mode) may need to be adjusted based on the results of the performed test. Treatment delivery control parameters determined to need adjustment may be restricted control parameters that require the transmission of a request signal. In other examples, the test interval used to schedule the next test may be adjusted based on the test results. For example, when an AV conduction test is performed and AV block is detected, the interval used to schedule the next AV conduction test may be increased, for example, doubled, so that the AV conduction test is not repeated at relatively short intervals during AV conduction block. The time interval adjusted for scheduling the next test may not be a restricted control parameter.

[0147] When the control parameter being adjusted is not a restricted control parameter, control circuit 80 can determine at block 413 that a request signal does not need to be sent. Control circuit 80 can adjust the control parameter at block 418. Control circuit 80 can return to block 402 to wait for the next scheduled or triggered test, and can operate simultaneously according to the adjusted control parameter.

[0148] When the control parameter being adjusted is a restricted control parameter, control circuit 80 may determine at block 413 that a request signal needs to be sent. Communication circuitry of IMD 214 (e.g., communication circuitry 88 or TCC circuitry 90) may send the request signal at block 414. If an approval signal is received from a second medical device operating inside / on the patient (the "Yes" branch of block 416), control circuit 80 may adjust the control parameter at block 418. If the response signal received from the second medical device is not an approval signal, such as a rejection or delay signal, control circuit 80 may cancel or delay the control parameter adjustment at block 420.

[0149] In the example shown, the process of flowchart 450 returns to box 402 to wait for the next scheduled or triggered test to be executed after delaying or canceling the control parameter adjustment at box 420. However, it should be understood that when control circuitry 80 delays the control parameter adjustment at box 420, control circuitry 80 may not wait for the subsequent scheduled or triggered test to be executed. Control circuitry 80 may wait for a specified delay time interval, such as one minute, one hour, or one day, and return to box 414 to resend the request signal to determine whether the control parameter adjustment has been approved by the second medical device. When an approval signal is received after one or more delays in adjusting the control parameters, control circuitry 80 may adjust the control parameters at box 418. It is also conceivable that when a test is canceled or delayed, control circuitry 80 may store a timestamp in memory 82 and / or send a notification to external programming device 50 to alert clinicians or other users to any delayed or canceled test.

[0150] Figure 8This is a flowchart 500 of another example of a method for controlling the adjustment of control parameters of a medical device using in vivo communication. In some cases, two or more medical devices operating inside or on a patient in a medical device system can each be independently able to perform a common function, which may be related to monitoring patient condition, storing data, delivering treatment, generating alarms or notifications, etc. When two or more co-implanted devices in a medical device system are each able to perform a common function, one medical device in the medical device system can be programmed to have priority control over the common function. A second medical device in the medical device system can be used for backup control of the common function. The common function can be enabled in the first device and disabled in the second device to save power, reduce processing requirements, reduce memory requirements, and avoid excessive or conflicting data or excessive alarm generation in the second medical device.

[0151] Figure 2 The medical device system is an example of a medical device system comprising at least two IMDs, each capable of performing a common function, such as cardiac pacing capability. Pacemaker 114 can be programmed to have priority control over all or some cardiac pacing therapies used to deliver, for example, bradycardia pacing, ATP, and / or, in some cases, post-shock pacing. ICD 14 can be programmed to disable all pacing functions and is operable to detect tachyarrhythmias and deliver a high-voltage CV / DF shock, but will give priority to providing pacing functionality within the medical device system to pacemaker 114. However, if pacemaker 114 is nearing or reaches the end of its power supply life or is no longer able to capture the heart due to electrode displacement or a problem with another electrode or circuitry, ICD 14 can be used to provide backup control for cardiac pacing. Pacemaker 114 can determine that its own pacing capability may be limited or impaired, and according to… Figure 8 The method shown prioritizes pacing control over ICD 14, as further described below.

[0152] In another example, ICD 14 may have priority control over the detection of arrhythmias and the storage of cardiac signal events in its own memory for later transmission to external programming device 50. Detected arrhythmias may include atrial and / or ventricular arrhythmias, and may include bradycardia, long pauses or ventricular arrest, and tachyarrhythmias such as atrial flutter, atrial fibrillation, ventricular tachycardia, or ventricular fibrillation. For example, any of a variety of arrhythmia detection methods may be implemented in ICD 14 and / or pacemaker 114 (or another medical device in the medical device system) based on sensing cardiac event intervals and / or signal morphology analysis. A physically smaller pacemaker 114 may have more limited processing power, memory capacity, power capacity, and, due to its deeper implantation in the patient, more limited communication with external devices used to transmit large amounts of data.

[0153] Therefore, when co-implanted with pacemaker 114, ICD 14 can have priority control over the storage of cardiac signal data and the transmission of data associated with detected arrhythmia episodes. While pacemaker 114 can sense ventricular event signals (e.g., R waves) to determine the need for pacing, pacemaker 114 may not be programmed to detect ventricular arrhythmias and / or store episodes of sensed cardiac electrical signals in response to the detection of a ventricular arrhythmia episode. In other examples, pacemaker 114 may be configured to detect ventricular tachyarrhythmia episodes to control when ATP is delivered, but the storage of cardiac electrical signal episodes during tachyarrhythmia detection may be programmed off (disabled) in pacemaker 114. If ICD 14 detects problems limiting its ability to detect and / or store arrhythmia episodes and / or transmit data to external devices (e.g., reaching a threshold capacity of its power supply or a threshold storage capacity of its allocated memory), ICD 14 may prioritize cardiac electrical signal episode storage functionality over pacemaker 114. When the ICD 14 detects a problem that may impair or limit its ability to detect, store, and / or transmit arrhythmia episodes, the ICD 14 may, as further described below, [take appropriate action]. Figure 8 The method yields priority control of storing arrhythmia episodes for later transmission to an external device to the pacemaker 114. While cardiac signal episodes are given here as an example, it should be understood that signal episodes from any sensor included in the medical device system can be stored in the medical device memory for transmission to an external programming device 50. Other examples of sensors and physiological signals include, but are not limited to, any of those listed herein.

[0154] In other examples, a medical device can be implanted relatively deeper into the patient's body, and a medical device can be implanted more superficially, making communication with the external programming device 50 more reliable and efficient. Figure 2In an exemplary example, ICD 14 may have a larger power supply, a larger physical volume for containing communication circuitry, and / or be implanted more superficially than pacemaker 114, allowing ICD 14 to prioritize control over communication functions with external devices (e.g., external programming device 50). For example, ICD 14 may have priority control over generating alarms or notifications sent to external programming device 50. ICD 14 may have priority control over sending physiological data, treatment delivery data, and / or device diagnostic data to external programming device 50. ICD 14 may serve as a relay communication device between pacemaker 114 and external programming device 50. Thus, data sent from ICD 14 to external programming device 50 may include data received by ICD 14 from pacemaker 114. Data received by ICD 14 from external programming device 50 may be sent to pacemaker 114. In this way, the power required for pacemaker 114 to transmit and receive data from external programming device 50 can be reduced.

[0155] In some cases, it can be done by Figure 4 The IMD 214 executes a test algorithm in response to a command received from an external device (e.g., external programming device 50). Upon receiving a test command, the IMD 214 may determine that a function may need to be disabled to perform the test. In other cases, the IMD 214 may receive a command from the external programming device 50 to temporarily suspend a function or operate in a temporary operating mode where a function needs to be disabled. For example, a clinician may perform an office-based baseline rhythm test or other clinical assessment, which may require temporarily suspending cardiac pacing, switching the pacing mode to a temporary pacing mode different from its permanent pacing mode, or setting the pacing rate to the minimum pacing rate. If the IMD 214 has priority control over detecting arrhythmias and storing cardiac signal episodes, the IMD 214 may suspend episode storage during testing or temporary operating modes, as, for example, a cardiac arrest interval or a long ventricular pause may be a result of the temporary operating mode. The IMD 214 may send a request signal to a second medical device to notify the second medical device, thereby ensuring that the second medical device does not deliver a backup pacing pulse in the absence of the expected pacing delivered by the IMD 214. If the second medical device has priority control over the storage of cardiac signal episodes, the IMD 214 can send a notification to the second medical device to temporarily suspend the storage of cardiac signal episodes.

[0156] Figure 8Flowchart 500 is described as being performed by an IMD 214 (to the right of the vertical dashed line) communicating with a second medical device implanted in or otherwise operatively coupled to the patient. To the left of the vertical dashed line is shown a function that can be performed by the second medical device in the medical device system. In some cases, the IMD 214 and the function performed to the right of the vertical dashed line may correspond to ICD 14, where the second medical device is a pacemaker 114 or another medical device implanted in or otherwise operatively coupled to the patient. In other cases, the IMD 214 and the function performed to the right of the vertical dashed line may correspond to pacemaker 114, where the second medical device is ICD 14 or another medical device implanted in or otherwise operatively coupled to the patient. In other examples, the IMD 214 and the second medical device may correspond to any of the example medical devices listed herein, without limitation.

[0157] It should be understood that priority is given to controlling and executing the functions of medical device systems. Figure 8 The roles of the operations to the right of the vertical dashed line and the roles of the operations to the left of the vertical dashed line in flowchart 500, which provide reserved or backup control for the functions of the medical device system and execute the process, can be reversed and can be changed back and forth between the two medical devices in the medical device system at different times during the operational life of each device. The device with the role of priority control over the functions of the medical device system can be programmed by the clinician and can depend on the specific combination of medical device members in the medical device system.

[0158] At box 502, IMD 214 may determine which medical device system functions require prior control by IMD 214 and need to be disabled. These functions may be, for example, treatment delivery functions, signal analysis functions, data storage functions, or alarm sending functions, and may be any of the example functions described herein or a combination thereof. IMD 214 may perform device diagnostic protocols or other measurements to determine which medical device system functions need to be disabled.

[0159] For example, IMD 214 can perform diagnostic tests to determine the estimated capacity of power supply 89 and determine that the remaining estimated capacity of power supply 89 has reached a threshold capacity. The threshold capacity may correspond to a specified voltage threshold, an optional replacement capacity, or an estimated time before the end of the life of power supply 89 (e.g., days, weeks, or months). Battery consumption required to continue performing medical device system functions can prevent IMD 214 from performing other critical functions, such as treatment delivery functions, before reaching the end of its power supply life. Examples of methods for determining the remaining life or capacity of power supply 89 are substantially disclosed in U.S. Patent No. 6,671,552 (Merritt et al., filed October 2, 2001) and U.S. Patent Application Publication No. 2021 / 0187305 (Pender, filed December 4, 2020), the entire contents of which are incorporated herein by reference.

[0160] In other examples, the IMD 214 may execute a testing algorithm that includes processing and analyzing sensed physiological signals to detect sensing problems, which may be undersensitization, oversensitization, or noise-induced distortion of the sensed physiological signals. Sensing problems can be detected by analyzing physiological signals (e.g., cardiac electrical signals) to detect sensing event intervals, signal amplitude, signal morphology, or other characteristics of the signal indicating oversensitization, undersensitization, noise-induced distortion, or poor signal quality. Sensing problems may prevent the IMD 214 from effectively performing medical device functions. Examples of methods for detecting sensing problems due to oversensitization of cardiac event signals are generally disclosed in U.S. Patent No. 9,597,525 (Cao et al., filed May 6, 2015) and U.S. Patent No. 11,135,441 (Zhang et al., filed June 24, 2019), the entire contents of which are incorporated herein by reference. U.S. Patent No. 8,386,024 (filed June 2, 2009 by Gunderson et al.) and U.S. Patent No. 10,750,970 (filed December 17, 2018 by Stadler et al.) substantially disclose example methods for detecting noise disruption in sensed physiological signals, which can be performed at box 502 to determine whether a medical device system function needs to be disabled, the entire contents of which are incorporated herein by reference. U.S. Patent No. 7,496,409 (filed February 24, 2009 by Greenhut et al.) and U.S. Patent No. 7,904,153 (filed March 8, 2011 by Greenhut et al.) substantially disclose examples of signal quality metrics for detecting sensing problems that can be determined during diagnostic testing, performed at box 502, for determining whether a medical device system function needs to be disabled, the entire contents of which are incorporated herein by reference.

[0161] In other examples, the IMD 214 can perform electrical diagnostic tests to detect internal circuitry problems occurring in the circuitry enclosed by the housing 215 or connector blocks or joints coupled to the housing 215. Internal circuitry problems can be detected by measuring impedance, voltage, or current to detect leakage current paths due to short circuits or insulation failures. Internal circuitry problems can be detected by performing impedance, voltage, or current measurements to detect open circuits that may be due to faulty electrical connections. Detected circuitry problems may prevent the IMD 214 from effectively performing medical device functions. An example of a method for detecting circuitry problems is substantially disclosed in U.S. Patent No. 10,220,204 (Stanslaski et al., filed March 5, 2019), which can be performed at block 502 to determine the need to disable medical device system functions; the entire contents of that patent are incorporated herein by reference.

[0162] IMD 214 can determine that a function needs to be disabled within IMD 214 due to remaining capacity of power supply 89, measured lead or electrode impedance, detected circuit problems, remaining storage capacity of memory 82, detected noise in sensed physiological signals, suspected undersensitivity or oversensitivity of cardiac event signals, communication transmission failure, or other detected limitations or impairments to the functionality of IMD 214. Various diagnostic tests, not limited to the examples given above, can be performed by IMD 214 to determine when a medical device system function needs to be disabled. In some cases, control circuitry 80 can determine the need to disable a function in response to a signal received from external programming device 50.

[0163] In response to determining that a function of IMD 214 needs to be disabled, control circuitry 80 may determine at block 504 whether a request signal is required. In some cases, the function may be available only in IMD 214 when other co-implanted devices cannot perform the same function. In other cases, the function may not be a critical function requiring a reserved or backup device to assume control. If no request is required, control circuitry 80 may disable the function at block 512. Control circuitry 80 may generate an alarm or notification to be sent by IMD 214's communication circuitry to an external device (e.g., external programming device 50) to notify clinicians or other caregivers or technicians that the function has been disabled.

[0164] When a second medical device capable of performing the functions of the medical device is available, control circuitry 80 may determine at block 504 that a request signal is required. At block 506, communication circuitry of IMD 214 (e.g., TCC circuitry 90 or communication circuitry 88) may send a request signal to the second medical device. It should be understood that in some examples, when more than two medical devices are members of the medical device system, the request may be sent to multiple medical devices operating inside / on the patient. The second medical device may receive the request at block 550 and may send an acknowledgment signal. At block 552, the second medical device may determine whether a function to be disabled by IMD 214 is available for performance by the second medical device. If so, the second medical device may enable the function at block 556 to assume priority control over the functions of the medical device system. The second medical device may send an approval / notification signal at block 558 to notify IMD 214 that the function has been enabled by the second medical device and can be disabled by IMD 214.

[0165] IMD 214 can receive an approval / notification signal at block 508, and control circuitry 80 can disable functions in IMD 214 at block 512. In this way, when the ability of IMD 214 to perform functions may be impaired, a medical device system including IMD 214 and a second medical device can continue to seamlessly perform its functions by switching the function from IMD 214 to the second medical device. In this way, by conserving power and memory capacity in the second medical device before the first medical device relinquishes priority control over its functions, the lifespan of medical device system functions can be extended in a medical device system comprising multiple member devices, each capable of performing functions independently.

[0166] In some cases, the second medical device may determine that a function disabled by IMD 214 is currently unavailable for execution by the second medical device, or that the second medical device is unable to perform the function. The second medical device may perform the test during the detection of rapid arrhythmias or other physiological conditions, thereby delivering treatment that prevents the second medical device from immediately activating the function. In other cases, the second medical device may be able to perform the function, but may have reached the end of its own power supply lifespan, have limited remaining memory storage capacity, or another detected limitation that prevents the second medical device from assuming priority control over the medical device system functions. Therefore, in some cases, the second medical device may send a rejection signal at block 554 indicating that the function is currently unavailable in the second medical device.

[0167] IMD 214 may receive a rejection signal at block 508. The response to the rejection signal, performed by IMD 214, may depend on remaining power capacity, memory capacity, or other conditions detected by IMD 214 as reasons why the function must be disabled. The response to the rejection signal may depend on what function is being disabled. In some cases, if the function is critical (e.g., a treatment delivery function) and a second medical device cannot assume priority control, IMD 214 may delay or cancel disabling the function at block 510. At block 514, control circuitry 80 may generate an alarm to be sent to an external device (e.g., external programming device 50) to notify the patient, clinician, or another caregiver that the medical device system function is continuing, but may be terminated or become unavailable if device replacement or other intervention is not performed. In some cases, the function may remain enabled in IMD 214, and IMD 214 may repeatedly request signal transmission to determine if a second medical device can be used to assume priority control of the function at a later time.

[0168] In other examples, IMD 214 may respond to a rejection signal received at box 508 by disabling the function and generating an alarm to be sent at box 514 to external programming device 50 (or another external device) to notify the patient, clinician, or other caregiver or technician that the medical device function is no longer being performed. Even when the second medical device cannot assume control of the medical device system function, IMD 214 may not have the ability to continue performing the function. Although IMD 214 is shown as sending an alarm at box 514 indicating the status of the medical device system function, it should be understood that the communication circuitry of IMD 214 and / or the communication circuitry of the second medical device can be configured to send notifications related to the medical device system function being disabled in the first medical device and / or enabled in the second medical device.

[0169] In the foregoing example, the control circuitry 80 of IMD 214 is described at block 502 as determining that a medical device system function currently being performed by IMD 214 needs to be disabled. However, in other examples, control circuitry 80 may determine that a medical device system function that needs to be disabled is currently being performed by a second medical device within the medical device system. For example, when IMD 214 receives a command from external programming device 50 to operate in a temporary mode (e.g., disable pacing or other functions) to enable the performance of an in-office basic rhythm test or other electrophysiological test, IMD 214 may determine that a medical device system function, such as storing cardiac signal episodes, should be disabled as part of its own temporary operation or in addition to its own temporary operation. If IMD 214 does not currently have priority control over the storage of cardiac signal episodes, control circuitry 80 may determine at block 504 that a request signal is needed to disable the medical device system function.

[0170] Control circuit 80 may send a request signal at block 506, in which case, a request to disable the medical device system function that the second medical device has priority control over. The second medical device may receive the sent request at block 550 as a notification that the medical device system function needs to be disabled. At block 552, the second medical device may determine that the function is currently enabled, and in this case, not as... Figure 8 Box 556 shows enabling the function, but instead disables the medical device system function in response to a request signal received from IMD 214. At box 558, the second medical device can send an approval indicating that the function has been disabled.

[0171] At block 508, control circuitry 80 can receive an approval signal, and in this case, no further action may be required. In some examples, IMD 214 can send a notification to external programming device 50 that the medical device system is ready for testing, confirms a temporary operating mode, and / or that medical device system functions have been disabled. The second medical device can disable the medical device system functions for a specified time interval and then automatically re-enable them. In other examples, when the test is complete, IMD 214 can receive a command from external programming device 50 to restore its normal or permanent operating mode. Control circuitry 80 can determine that the medical device system functions can be restored and send a notification to the second medical device to re-enable the medical device system functions and continue priority control over the system functions.

[0172] This document also discloses the subject matter of the following embodiments: Example 1. A medical device system, the medical device system including a first medical device, the first medical device including a first circuit, a first communication circuit, and a first control circuit configured to perform functions of the medical device system. The first control circuit is configured to detect a condition for disabling the performance of the medical device system functions by the first circuit, and in response to detecting the condition, to send a communication signal via the first communication circuit to a second medical device capable of performing the medical device system functions, and to disable the performance of the medical device system functions by the first circuit. The first medical device may include a power source configured to provide power to the first circuit, the first communication circuit, and the first control circuit.

[0173] Example 2. The medical device system according to Example 1, wherein the first control circuit is further configured to detect the condition for disabling the function of the medical device system by: determining the estimated capacity of the power supply, and determining that the estimated capacity of the power supply has reached a threshold capacity.

[0174] Example 3. A medical device system according to Examples 1 and 2, wherein the first medical device further includes a memory for storing data related to the function of the medical device system. The first control circuit is further configured to detect the condition for disabling the function of the medical device system by: determining the available capacity of the memory for storing data related to the function of the medical device, and determining that the available capacity of the memory has reached a threshold capacity.

[0175] Example 4. A medical device system according to any one of Examples 1 to 3, wherein the first control circuit is further configured to detect the condition for disabling the function of the medical device system by performing an electrical diagnostic test and detecting the condition for disabling the function of the medical device system by detecting a circuit problem based on the electrical diagnostic test.

[0176] Example 5. A medical device system according to any one of Examples 1 to 4, wherein the first control circuit is further configured to detect the condition for disabling the function of the medical device system by performing an impedance measurement and detecting the condition for disabling the function of the medical device system based on the impedance measurement.

[0177] Example 6. A medical device system according to any one of Examples 1 to 5, wherein the first circuit includes a sensing circuit configured to sense at least one physiological signal and a memory. The first circuit is configured to perform the functions of the medical device system by: sensing the at least one physiological signal and storing the occurrence of the at least one physiological signal in the memory.

[0178] Example 7. A medical device system according to any one of Examples 1 to 6, wherein the first circuit further includes a sensing circuit configured to sense at least one physiological signal, a memory, and a processing circuit configured to detect at least one physiological condition based on the sensed at least one physiological signal. The first circuit is further configured to perform the medical device function by detecting the at least one physiological condition and storing data associated with the detection of the at least one physiological signal in the memory.

[0179] Example 8. A medical device system according to any one of Examples 1 to 7, wherein the first circuit further includes a treatment delivery circuit configured to perform the functions of the medical device system by delivering treatment.

[0180] Example 9. The medical device system according to Example 8, wherein the treatment delivery circuit is configured to deliver the treatment by delivering one or more cardiac electrical stimulation pulses.

[0181] Example 10. A medical device system according to any one of Examples 1 to 9, wherein the first circuit configured to perform the functions of the medical device system further includes a second communication circuit configured to send data to an external medical device.

[0182] Example 11. A medical device system according to any one of Examples 1 to 10, the medical device system further comprising a second medical device. The second medical device comprises: a second circuit configured to perform the functions of the medical device system; a second communication circuit configured to receive the communication signal; and a second control circuit configured to enable the second circuit to perform the functions of the medical device system in response to receiving the communication signal via the second communication circuit.

[0183] Example 12. The medical device system according to Example 11, wherein at least one of the first communication circuit or the second communication circuit is further configured to send a notification relating to disabling the function of the medical device system in at least the first medical device.

[0184] Example 13. A medical device system according to any one of Examples 1 to 12, wherein the second control circuit is further configured to determine, in response to receiving the communication signal via the second communication circuit, that a criterion for causing the second circuit to perform the functions of the medical device system is met. The second control circuit is configured to enable the second circuit to perform the functions of the medical device system in response to meeting the criterion for causing the second circuit to perform the functions of the medical device system.

[0185] Example 14. A medical device system according to any one of Examples 1 to 10, the medical device system further comprising a second medical device. The second medical device includes a second circuit configured to perform the functions of the medical device system, a second communication circuit configured to receive the communication signal, and a second control circuit. The second control circuit is configured to determine, in response to receiving the communication signal via the second communication circuit, that a criterion for causing the second circuit to perform the functions of the medical device system is not met. The second communication circuit is further configured to send a rejection signal in response to the second control circuit determining that the criterion for causing the second circuit to perform the functions of the medical device system is not met.

[0186] Example 15. The medical device system according to Example 14, wherein the first communication circuit is further configured to receive the rejection signal. The first control circuit is further configured to delay disabling the medical device system functions performed by the first circuit in response to receiving the rejection signal.

[0187] Example 16. A medical device system according to any one of Examples 1 to 15, wherein the first communication circuit includes at least one of a tissue conduction communication circuit or a radio frequency communication circuit.

[0188] Example 17. A method comprising: performing medical device system functions by a first medical device; detecting a condition for disabling the performance of the medical device system functions by the first medical device; and, in response to detecting the condition, sending a communication signal to a second medical device capable of performing the medical device system functions. The method may further include disabling the performance of the medical device system functions by the first medical device.

[0189] Example 18. According to the method of Example 17, detecting the condition for disabling the function of the medical device system includes: determining the estimated capacity of the power supply of the first medical device, and determining that the estimated capacity of the power supply has reached a threshold capacity.

[0190] Example 19. A method according to any one of Examples 17 to 18, wherein performing the medical device function includes: storing data related to the medical device system function in the memory of the first medical device. The method further includes detecting the condition for disabling the medical device system function by: determining the available capacity of the memory used to store the data related to the medical device function, and determining that the available capacity of the memory has reached a threshold capacity.

[0191] Example 20. The method according to any one of Examples 17 to 19, wherein detecting the condition for disabling the function of the medical device system comprises: performing an electrical diagnostic test, and detecting the condition for disabling the function of the medical device system by detecting a circuit problem based on the electrical diagnostic test.

[0192] Example 21. The method according to any one of Examples 17 to 20, wherein detecting the condition for disabling the function of the medical device system comprises: performing an impedance measurement, and detecting the condition for disabling the function of the medical device system based on the impedance measurement.

[0193] Example 22. The method according to any one of Examples 17 to 21, wherein performing the functions of the medical device system includes: sensing at least one physiological signal, and storing the occurrence of the at least one physiological signal in the memory of the first medical device.

[0194] Example 23. The method according to any one of Examples 17 to 22, wherein performing the functions of the medical device system includes: sensing at least one physiological signal, detecting at least one physiological condition based on the sensed at least one physiological signal, and storing data associated with the at least one detected physiological signal in the memory of the first medical device.

[0195] Example 24. The method according to any one of Examples 17 to 23, wherein performing the functions of the medical device system includes delivering treatment.

[0196] Example 25. The method according to Example 24, wherein delivering the treatment includes delivering one or more cardiac electrical stimulation pulses.

[0197] Example 26. The method according to any one of Examples 17 to 25, wherein performing the medical device system function includes sending data to an external medical device.

[0198] Example 27. The method according to any one of Examples 17 to 26, the method further comprising: receiving the communication signal by the second medical device, and in response to receiving the communication signal, enabling the second medical device to perform the medical device system function.

[0199] Example 28. The method according to any one of Examples 17 to 27, the method further comprising: sending a notification to disable the medical device system function in at least the first medical device.

[0200] Example 29. The method according to any one of Examples 17 to 28, the method further comprising: determining a criterion that enables the second medical device to perform the medical device system function, and in response to the criterion being met, enabling the second medical device to perform the medical device system function.

[0201] Example 30. The method according to any one of Examples 17 to 26, further comprising: receiving the communication signal by the second medical device, and determining, in response to receiving the communication signal, that a criterion for the second medical device to perform the medical device system function is not met. The method further comprises sending a rejection signal in response to determining that the criterion for the second medical device to perform the medical device system function is not met.

[0202] Example 31. The method according to Example 30, the method further comprising: receiving the rejection signal by the first medical device; and in response to receiving the rejection signal, delaying the disabling of the medical device system functions performed by the first medical device.

[0203] Example 32. The method according to any one of Examples 17 to 31, the method further comprising: transmitting the communication signal as either an organization-conducted communication signal or a radio frequency communication signal.

[0204] Example 33. A non-transitory computer-readable medium storing a set of instructions, which, when executed by processing circuitry of a medical device system, cause the medical device system to: perform medical device system functions by a first medical device of the medical device system; detect a condition for disabling the performance of the medical device system functions by the first medical device; and, in response to detecting the condition, send a communication signal to a second medical device capable of performing the medical device system functions. The instructions may also cause the medical device system to disable the performance of the medical device system functions by the first medical device.

[0205] Example 34. A medical device system, the medical device system including a first medical device and a second medical device. The first medical device includes a first circuit configured to perform medical device system functions, a first communication circuit, and a first control circuit. The first control circuit is configured to detect a condition for disabling the performance of the medical device system functions by the first circuit, and in response to detecting the condition, transmit a communication signal via the first communication circuit. The first control circuit may be further configured to disable the performance of the medical device system functions by the first circuit. The second medical device may include a second circuit configured to perform the medical device system functions, a second communication circuit configured to receive the communication signal, and a second control circuit. The second control circuit is configured to enable the second circuit to perform the medical device system functions in response to receiving the communication signal via the second communication circuit.

[0206] Therefore, various examples of medical device systems have been presented in the foregoing description with reference to the illustrative diagrams and flowcharts shown in the accompanying drawings. It should be understood that, depending on the example, certain actions or events in any of the methods described herein may be performed in a different order, and may be added, combined, or omitted entirely (e.g., not all described actions or events are necessary for practicing the method). Furthermore, in some examples, actions or events may be performed simultaneously, for example, through multithreading, interrupt handling, or multiple processors, rather than sequentially. Additionally, although for clarity some aspects of this disclosure are described as being performed by a single device, circuit, or component, 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 represented as separate circuits or components in the drawings.

[0207] In one or more examples, the described functionality may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a computer-readable storage medium, as opposed to a tangible medium such as a data storage medium (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 is accessible by a computer).

[0208] Instructions can 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 arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the terms "processor" and "processing circuit" as used herein can refer to any of the foregoing structures or any other structures suitable for implementing the techniques described herein. Furthermore, these techniques can be fully implemented in one or more circuit or logic elements.

[0209] Therefore, a medical device system has been presented in the foregoing description with reference to specific examples. It should be understood that the various aspects disclosed herein can be combined in combinations different from the specific combinations presented in the accompanying drawings. It should be understood that various modifications may be made to the referenced examples without departing from the scope of this disclosure and the following claims.

Claims

1. A medical device system, the medical device system comprising a first medical device, wherein the first medical device comprises: A first circuit, configured to perform medical device system functions; First communication circuit; A first control circuit, configured to: Detects a condition used to disable the medical device system functions performed by the first circuit; In response to the detection of the condition, a communication signal is sent via the first communication circuit to a second medical device capable of performing the functions of the medical device system. as well as Disable the execution of the medical device system functions by the first circuit; and A power source configured to provide power to the first circuit, the first communication circuit, and the first control circuit.

2. The medical device system of claim 1, wherein the first control circuit is further configured to detect the condition for disabling the execution of the function of the medical device system by the first circuit by: Determine the estimated capacity of the power supply; and It is determined that the estimated capacity of the power supply has reached the threshold capacity.

3. The medical device system according to claims 1 to 2, wherein the first medical device further includes a memory for storing data related to the function of the medical device system; and The first control circuit is further configured to detect the condition for disabling the execution of the medical device system function by the first circuit by: Determine the available capacity of the memory used to store the data related to the functionality of the medical device system; and It is determined that the available capacity of the memory has reached the threshold capacity.

4. The medical device system according to any one of claims 1 to 3, wherein the first control circuit is further configured to detect the condition for disabling the execution of the function of the medical device system by the first circuit by: Perform electrical diagnostic tests; and Circuit problems are detected based on the aforementioned electrical diagnostic tests.

5. The medical device system according to any one of claims 1 to 4, wherein the first control circuit is further configured to detect the condition for disabling the execution of the function of the medical device system by the first circuit by: Perform impedance measurement; and The state of execution for disabling the function of the medical device system is detected based on the impedance measurement.

6. The medical device system according to any one of claims 1 to 5, wherein the first circuit comprises: A sensing circuit configured to sense at least one physiological signal; and Memory; The first circuit is configured to perform the functions of the medical device system by: Sensing at least one of the physiological signals; as well as The onset of at least one physiological signal is stored in the memory.

7. The medical device system according to any one of claims 1 to 6, wherein the first circuit further comprises: A sensing circuit configured to sense at least one physiological signal; Memory; and A processing circuit configured to detect at least one physiological condition based on at least one sensed physiological signal. The first circuit is further configured to perform the functions of the medical device by: Detecting at least one of the physiological conditions; and The data associated with the detection of the at least one physiological signal is stored in the memory.

8. The medical device system according to any one of claims 1 to 7, wherein the first circuit further comprises a treatment delivery circuit configured to perform the functions of the medical device system by delivering treatment.

9. The medical device system of claim 8, wherein the treatment delivery circuit is configured to deliver the treatment by delivering one or more cardiac electrical stimulation pulses.

10. The medical device system according to any one of claims 1 to 9, wherein the first circuit configured to perform the functions of the medical device system further includes a second communication circuit, the first circuit being further configured to perform the functions of the medical device system by sending data to an external medical device.

11. The medical device system according to any one of claims 1 to 10, further comprising the second medical device, the second medical device comprising: A second circuit, configured to perform the functions of the medical device system; A second communication circuit, configured to receive the communication signal; and A second control circuit is configured to activate the second circuit to perform the functions of the medical device system in response to receiving the communication signal via the second communication circuit.

12. The medical device system of claim 11, wherein at least one of the first communication circuit or the second communication circuit is further configured to send a notification relating to disabling the functionality of the medical device system in at least the first medical device.

13. The medical device system according to any one of claims 1 to 12, wherein the second control circuit is further configured to: In response to receiving the communication signal via the second communication circuit, it is determined that the criteria for enabling the second circuit to perform the functions of the medical device system are met; and In response to meeting the criteria for enabling the second circuit to perform the functions of the medical device system, the second circuit is enabled to perform the functions of the medical device system.

14. The medical device system according to any one of claims 1 to 10, wherein the medical device system further comprises a second medical device, the second medical device comprising: A second circuit, configured to perform the functions of the medical device system; A second communication circuit, configured to receive the communication signal; and A second control circuit is configured to, in response to receiving the communication signal via the second communication circuit, determine that the criteria for enabling the second circuit to perform the functions of the medical device system are not met; and The second communication circuit is further configured to send a rejection signal in response to the second control circuit determining that the criteria for enabling the second circuit to perform the functions of the medical device system are not met.

15. The medical device system according to claim 14, wherein: The first communication circuit is further configured to receive the rejection signal; and The first control circuit is further configured to delay disabling the medical device system functions performed by the first circuit in response to receiving the rejection signal.

16. The medical device system according to any one of claims 1 to 15, wherein the first communication circuit comprises at least one of a tissue conduction communication circuit or a radio frequency communication circuit.

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