Delivery of anti-tachycardia pacing therapy

Abstract

A system includes an implantable medical device (IMD) configured to deliver an anti-tachycardia pacing (ATP) therapy to a patient, and an external device; the external device includes: a communication circuit configured to communicate with the IMD; and processing circuitry configured to receive a connection request from the IMD via the communication circuitry, determine whether the IMD is connected to an external device, and transmit an instruction to the IMD via the communication circuitry to deliver ATP therapy to a patient based on a determination that the IMD is connected to the external device.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 377,903, filed on September 30, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates to medical devices, and more particularly to implantable medical devices configured to detect cardiac arrhythmias and treat the arrhythmias using anti-tachycardia pacing (ATP) therapy. Background Art

[0003] Implantable medical devices (eg, implantable cardiac devices) can provide electrical overdrive stimulation, such as ATP therapy, to inhibit or convert tachyarrhythmias, thereby providing symptomatic relief and preventing or terminating arrhythmias that could lead to sudden cardiac death. Summary of the invention

[0004] An implantable medical device (IMD) can deliver anti-tachycardia pacing (ATP) therapy to a patient's heart to inhibit or convert a tachyarrhythmia (e.g., ventricular tachycardia (VT)). ATP therapy can provide the patient with symptom relief and / or terminate the arrhythmia experienced by the patient. Some IMDs may include pacing functionality and may be configured to deliver anti-tachyarrhythmia shocks to the patient in lieu of, or in addition to, ATP therapy. Other IMDs may be configured only to deliver ATP therapy to the patient.

[0005] In some examples, delivering ATP therapy may produce unintended consequences in the patient. Unintended consequences may include, but are not limited to, acceleration of a hemodynamically stable VT to a hemodynamically unstable VT, acceleration to ventricular fibrillation (VF), and the like. Anti-tachyarrhythmia shocks and / or other electrical stimulation may need to be delivered to the patient to mitigate, terminate, and / or reverse the unintended consequences. Therefore, patients with an IMD configured only to deliver ATP therapy may want to have the opportunity to find a caregiver and / or obtain medical care (e.g., emergency medical services (EMS)) to reduce the likelihood and / or severity of unintended consequences.

[0006] In some examples, the technology of the present disclosure includes connecting the IMD to an external device and / or a user before delivering ATP therapy to the patient. The connection between the IMD and the external device can facilitate the detection of any unexpected results of the ATP therapy and the ability to provide emergency assistance to the patient in the event of an unexpected result.

[0007] In some examples, the present disclosure describes selecting and / or adjusting ATP therapy based on the availability of emergency assistance. A medical device system can select ATP therapy and / or adjust parameters of ATP therapy based on the availability of emergency assistance to reduce the risk of unintended outcomes, for example, if emergency assistance is relatively unavailable.

[0008] In one example, the present disclosure relates to an implantable medical device (IMD) configured to deliver anti-tachycardia pacing (ATP) therapy to a patient, the IMD comprising: a therapy delivery circuit connected to one or more electrodes; a communication circuit; and a processing circuit configured to: transmit a connection request to an external device via the communication circuit, determine whether the IMD is communicating with the external device based on a signal received from the external device; and transmit an instruction to the therapy delivery circuit to deliver ATP therapy to the patient based on a determination that the IMD is communicating with the external device.

[0009] In another example, the present disclosure relates to a system comprising: an implantable medical device (IMD) and an external device, the implantable medical device being configured to deliver anti-tachycardia pacing (ATP) therapy to a patient; the external device comprising: a communication circuit configured to communicate with the IMD; and a processing circuit configured to: receive a connection request from the IMD via the communication circuit; determine whether the IMD is communicating with the external device; and based on determining that the IMD is communicating with the external device, transmit instructions to deliver the ATP therapy to the patient to the IMD via the communication circuit.

[0010] In another example, the present disclosure relates to a system comprising: an external device and an implantable medical device (IMD), the external device being configured to communicate with a network; the implantable medical device comprising: a memory configured to store a plurality of medical therapies, wherein each of the plurality of medical therapies is configured to be delivered to a patient by the IMD; a communication circuit configured to communicate with the external device; a signal generating circuit; and a processing circuit configured to: select a first medical therapy from the plurality of medical therapies; receive data about one or more background factors of the patient from the external device via the communication circuit; determine whether the received data satisfies one or more threshold risk conditions of the patient based on the received data; select a second medical therapy from the plurality of medical therapies based on determining that the received data satisfies at least one of the one or more threshold risk conditions of the first medical therapy, wherein the second medical therapy is less aggressive than the first medical therapy; and deliver the second medical therapy to the patient via the signal generating circuit.

[0011] In another example, the present disclosure relates to a method, comprising: transmitting a connection request to an external device through a communication circuit of an implantable medical device (IMD); receiving a signal from the external device through the communication circuit; determining through a processing circuit of the IMD whether the IMD is communicating with the external device based on the received signal; and based on determining that the IMD is communicating with the external device, delivering anti-tachycardia pacing (ATP) therapy to a patient through a therapy delivery circuit of the IMD.

[0012] In another example, the present disclosure relates to a method, comprising: receiving, by a processing circuit of an external device, a connection request from an implantable medical device (IMD); determining, by the processing circuit, whether the IMD is communicating with the external device; and transmitting, by the processing circuit, an instruction to the IMD to deliver anti-tachycardia pacing (ATP) therapy to a patient based on determining that the IMD is communicating with the external device.

[0013] In another example, the present disclosure relates to a method comprising: selecting a first medical therapy from a plurality of medical therapies by a processing circuit of an IMD, wherein each of the plurality of medical therapies is configured to be delivered to a patient by the IMD; receiving data about one or more background factors of the patient from a network via an external device; determining, by the processing circuit based on the received data, whether the received data satisfies one or more threshold risk conditions of the patient; selecting, by the processing circuit based on determining that the received data satisfies at least one of the one or more threshold risk conditions of the first medical therapy, a second medical therapy from the plurality of medical therapies, wherein the second medical therapy is less aggressive than the first medical therapy; and delivering the second medical therapy to the patient by a signal generating circuit of the IMD.

[0014] In another example, the present disclosure relates to a computer-readable storage medium comprising instructions that, when executed, cause a processing circuit within a system to perform a method comprising the following steps: causing a communication circuit of an implantable medical device (IMD) to transmit a connection request to an external device; receiving a signal from the external device via the communication circuit; determining whether the IMD is communicating with the external device based on the received signal; and causing a therapy delivery circuit of the IMD to deliver anti-tachycardia pacing (ATP) therapy to a patient based on determining that the IMD is communicating with the external device.

[0015] In another example, the present disclosure relates to a computer-readable storage medium comprising instructions that, when executed, cause a processing circuit within a system to perform a method comprising the following steps: receiving a connection request from an implantable medical device (IMD), determining whether the IMD is communicating with an external device; and based on determining that the IMD is communicating with the external device, transmitting an instruction to the IMD to deliver anti-tachycardia pacing (ATP) therapy to a patient.

[0016] In another example, the present disclosure relates to a computer-readable storage medium comprising instructions that, when executed, cause processing circuitry within a system to perform a method comprising the steps of: selecting a first medical therapy from a plurality of medical therapies, wherein each of the plurality of medical therapies is configured to be delivered to a patient by an IMD; receiving data regarding one or more background factors of the patient from a network via an external device; determining, by the processing circuitry based on the received data, whether the received data satisfies one or more threshold risk conditions for the patient; selecting a second medical therapy from the plurality of medical therapies based on determining that the received data satisfies at least one of the one or more threshold risk conditions for the first medical therapy, wherein the second medical therapy is less aggressive than the first medical therapy; and causing a signal generating circuitry to deliver the second medical therapy to the patient.

[0017] In another example, the present disclosure relates to a system including an IMD and an external device. The IMD is configured to deliver anti-tachycardia pacing (ATP) therapy to a patient, and includes: a therapy delivery circuit connected to one or more electrodes; a communication circuit; and a processing circuit configured to: transmit a connection request to the external device via the communication circuit; determine whether the IMD is communicating with the external device based on a signal received from the external device; and based on determining that the IMD is communicating with the external device, transmit an instruction to the therapy delivery circuit to deliver ATP therapy to the patient. The external device includes: a communication circuit configured to communicate with the IMD; and a processing circuit configured to: receive a connection request from the IMD via the communication circuit; determine whether the IMD is communicating with the external device; and based on determining that the IMD is communicating with the external device, transmit an instruction to deliver ATP therapy to the patient to the IMD via the communication circuit.

[0018] The present disclosure is intended to provide an overview of the subject matter described in the present disclosure. It is not intended to provide an exclusive or exhaustive explanation of the devices and methods described in detail in the following figures and descriptions. Details of one or more aspects of the present disclosure are set forth in the following figures and descriptions. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a conceptual diagram illustrating an example medical device system according to one or more aspects of the present disclosure.

[0020] Figure 2 It is shown Figure 1 A functional block diagram of an exemplary configuration of an IMD.

[0021] Figure 3 It is a display Figure 1 Functional block diagram of an example configuration of an external device.

[0022] Figure 4is a flow chart illustrating an example process for delivering a medical therapy to a patient.

[0023] Figure 5 is a flow chart illustrating another example process for delivering a medical therapy to a patient. DETAILED DESCRIPTION

[0024] An implantable medical device (IMD) can deliver anti-tachycardia pacing (ATP) therapy to a patient's heart to inhibit or convert a tachyarrhythmia (e.g., ventricular tachycardia (VT)). The IMD can sense signals from the patient's heart, determine that the patient is experiencing a tachyarrhythmia, and then deliver ATP therapy to the patient. In some examples, delivering ATP therapy may produce unexpected results in the patient's body. Unexpected results may include, but are not limited to, acceleration of a hemodynamically stable VT to a hemodynamically unstable VT, acceleration to ventricular fibrillation (VF), and the like. It may be necessary to deliver anti-tachyarrhythmia shocks and / or other electrical stimulation to the patient to mitigate, terminate and / or reverse the unexpected results. In some examples, the IMD may be unable to deliver anti-tachyarrhythmia shocks or other electrical stimulation to resolve the unexpected results.

[0025] The devices, systems, and methods described in the present disclosure can increase the likelihood of resolving unexpected results and / or reduce the likelihood of unexpected results occurring. The IMD described in the present disclosure can request connection with an external device and / or system (e.g., a patient monitoring system, an EMS system, etc.) and / or a user (e.g., an EMS, a healthcare provider, a family member, etc.), and can confirm connection with the external device before delivering ATP therapy to the patient. If a patient experiences an unexpected result, the connection between the IMD and the external device can facilitate notification of the occurrence of an unexpected result to a user capable of delivering an anti-tachyarrhythmia shock, and can shorten the time elapsed between the occurrence of the unexpected result and the delivery of an anti-tachyarrhythmia shock.

[0026] In some examples, certain contextual factors of the scene surrounding the patient can increase and / or reduce the risk of an unexpected outcome, and / or increase and / or reduce the severity of any unexpected outcome. These factors may include, but are not limited to: the distance of any healthcare provider from the patient, the response time of any nearby healthcare provider, the patient's health status, or the patient's behavioral patterns. In such examples, the devices, systems, and methods described in the present disclosure can select a relatively less aggressive ATP therapy (e.g., a less arrhythmic ATP therapy) or a relatively more aggressive ATP therapy (e.g., a more arrhythmic ATP therapy) based on data corresponding to these factors. Using contextual factors and other data (e.g., behavioral data, clinical data, etc.) can provide more effective medical therapy delivery to patients, for example, by reducing the risk of unexpected outcomes while delivering optimal ATP therapy to patients.

[0027] Although the devices, systems, and methods of the present disclosure are primarily described with reference to delivering ATP therapy to treat tachyarrhythmias, these devices, systems, and methods may also be used to deliver other medical therapies to patients to treat other medical conditions.

[0028] Figure 1 1 is a conceptual diagram illustrating an example medical device system 100 according to one or more aspects of the present disclosure. The medical device system 100 includes an implantable medical device (IMD) 106 implanted within a heart 104 of a patient 102. The IMD 106 communicates with one or more external devices 108. Each of the external devices 108 can communicate with a network 112 and / or a user 110.

[0029] IMD 106 can sense signals from heart 104, determine that a tachyarrhythmia has occurred within heart 104, and then deliver ATP therapy to heart 104. In some examples, such as Figure 1 As shown, IMD 106 can be completely implanted within heart 104 (e.g., within one or more chambers of heart 104) and can deliver sensing signals from heart 104 and / or deliver ATP therapy and / or other electrical stimulation signals to heart 104 via one or more electrodes (not shown). In some examples, at least a portion of IMD 106 (e.g., a housing of IMD 106, as shown in FIG. 1 ) is implanted within heart 104. Figure 2 104 (e.g., tissue of a wall of heart 104), and may be connected to a portion of IMD 106 located outside of heart 104, for example, via one or more electrical leads.

[0030] The IMD 106 may detect and record heart rate data from the heart 104. The heart rate data may include, but is not limited to, a rate / interval determined based on detecting depolarization of one or more chambers of the heart 104 (e.g., left ventricle (LV), right ventricle (RV), left atrium (LA), right atrium (RA)). The IMD 106 may determine the heart rate (e.g., ventricular rate) of the heart 104 and determine whether the heart 104 of the patient 102 is operating in a manner that may correspond to a tachyarrhythmia. For example, the IMD 106 determines that the patient 102 may be experiencing a tachyarrhythmia based on one or more electrical signals (e.g., heart rate, rhythm irregularity of the heart 104, electrical morphology of the signals of the heart 104) and / or non-electrical signals (e.g., pressure, acceleration, etc.) detected by the IMD 106.

[0031] IMD 106 can wirelessly communicate with one or more external devices 108. External device 108 may include a computing device configured to monitor the status of IMD 106 or patient 102. External device 108 may include a computing device including, but not limited to, a tablet computer, a smart phone, a smart watch, a laptop computer, or a desktop computer. In some examples, external device 108 may be part of a medical care system (e.g., an EMS system, a hospital's computing system, etc.). External device 108 may also include, but is not limited to, a wearable defibrillator, or an automatic external defibrillator (AED). In some examples, external device 108 may include a display and / or user interface (UI) that can be interacted with by user 110. User 110 may include a family member, a medical care provider, an EMS provider, and / or any other person capable of delivering an anti-tachyarrhythmia shock to patient 102. External device 108 may communicate in accordance with one or more wireless communication protocols (e.g., in accordance with or Low Energy (BLE) protocol) to wirelessly communicate with IMD 106 and / or network 112.

[0032] In some examples, when external device 108 is an AED or a wearable defibrillator, external device 18 may, in response to a notification from IMD 106 (e.g., indicating the presence of a tachyarrhythmia, the need to deliver ATP pacing, the presence of one or more adverse events, etc.), notify user 110 to bring external device 108 to patient 102, e.g., to deliver an electrotherapy signal to user 110. External device 108 may output an audible, visual, tactile, or other output to remind user 110 to bring external device 108 to patient 102 and / or to remind user 110 of the location of external device 108.

[0033] The network 112 can communicate with the external device 108 and transfer data between the network 112 and the external device 108. In some examples, behavioral data, clinical data, and / or data regarding one or more contextual factors (e.g., the distance between the patient 102 and the medical care provider, the response time of the medical care provider, etc.). The data can be stored in one or more computing devices, computing systems, and / or cloud computing environments that are in communication with the network 112.

[0034] The network 112 may include one or more computing devices, such as one or more non-edge switches, routers, hubs, gateways, security devices (such as firewalls), intrusion detection and / or intrusion prevention devices, servers, cellular base stations and nodes, wireless access points, bridges, cable modems, application accelerators, or other network devices. The network 112 may include one or more networks managed by a service provider and may therefore form part of a large-scale public network infrastructure (e.g., the Internet).

[0035] In some examples, before delivering ATP therapy to the heart 104, the IMD 106 can transmit a connection request to the external device 108. For example, the IMD 106 can transmit one or more advertisements for the wireless connection. The external device 108 can transmit a signal to the IMD 106 indicating that the external device 108 is connected to the IMD 106. For example, the external device 108 can transmit a response to these advertisements, and the IMD 106 and the external device can exchange one or more messages to establish a communication session. The signal can be a response or another message during the establishment of the communication session, or a dedicated message transmitted by the external device 108 after the session is established. The IMD 106 can receive the signal from the external device 108 and deliver the ATP therapy to the heart 104 when confirming that the IMD 106 is connected to the external device 108.

[0036] In some examples, external device 108 may retrieve data (e.g., data regarding contextual factors, behavioral data, clinical data, etc.) from network 112 and / or IMD 106. Based on the retrieved data, external device 108 may select an appropriate ATP therapy and / or one or more parameters of the ATP therapy and then transmit instructions to IMD 106 to deliver the selected ATP therapy to heart 104. The selected ATP therapy may reduce the likelihood of unintended outcomes while suppressing tachyarrhythmias experienced by patient 102.

[0037] Figure 2 It is a display Figure 11 is a functional block diagram of an example configuration of an IMD 106. The IMD 106 may be an implanted cardiac device, including, but not limited to, an implantable pacemaker device, an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a cardiac resynchronization therapy (CRT) device, and the like. The IMD 106 may include a plurality of components, including, but not limited to, electrodes 202A-B (hereinafter referred to as "electrodes 202"), switching circuitry 204, a sensor 206, a communication circuitry 208, a signal generating circuitry 208, a sensing circuitry 210, a processing circuitry 212, a memory 214, and a power supply 216 that provides operating power to the other components. The various circuits may be, or include, programmable or fixed function circuits that are configured to perform the functions attributed to the respective circuits.

[0038] Memory 214 may store computer-readable instructions that, when executed by processing circuit 212, cause IMD 106 to perform various functions. Memory 214 may be a storage device or other non-transitory medium. Memory 214 may include any volatile medium, non-volatile medium, magnetic medium, optical medium, or electronic 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 medium.

[0039] The electrodes 202 are electrically connected to wall tissue of one or more chambers of the heart 104, for example, via at least one electrode 202 in physical contact with the wall tissue. The electrodes 202 may be electrically connected to the switching circuit 204 of the IMD 106 via an electrical connector 203. In some examples, where a portion of the IMD 106 including the switching circuit 204 is implanted outside the heart 104, the electrical connector 203 may include electrical leads extending into the heart 104 and connecting the electrodes 202 to the wall tissue of the heart 104. In other examples, the electrodes 202 may be disposed directly on the IMD 106, for example, on a housing of the IMD 106. Multiple electrodes 202 may be connected to the same chamber of the heart 104, or to different chambers of the heart 104. Although Figure 2 The IMD 106 illustrated in FIG. 1 includes two electrodes 202 , but other example IMDs may include three or more electrodes 202 .

[0040] The switching circuit 204 can selectively couple the sensing circuit 210 and / or the signal generating circuit 209 to selected combinations of electrodes 202, for example, to sense electrical activity of the atria and / or ventricles of the heart 104, respectively, or to deliver electrical stimulation signals (e.g., for ATP therapy) to wall tissue of the heart 104. The switching circuit 302 can include one or more switch arrays, one or more multiplexers, one or more switches (e.g., a switch matrix or other set of switches), one or more transistors, or other circuits.

[0041] Sensing circuit 210 may include filters, amplifiers, analog-to-digital converters, or other circuits configured to sense cardiac electrical signals via electrodes 202 or deliver electrical signals to cardiac tissue via electrodes 202. In some examples, sensing circuit 210 is configured to detect an event (e.g., a depolarization) within the cardiac electrical signals and provide an indication of the event to processing circuit 212. In this manner, processing circuit 212 may determine the heart rate and / or ventricular rate of heart 104 based on the sensed cardiac electrical signals, and may determine whether patient 102 may be experiencing a tachyarrhythmia based on the determined heart rate and / or ventricular rate.

[0042] Sensing circuit 210 can be electrically connected to one or more sensors (not shown) disposed within IMD 106. One or more sensors can be configured to sense other signals (e.g., mechanical signals, chemical signals, non-cardiac electrical signals, etc.), and processing circuit 212 can determine heart rate, ventricular rate, and / or the presence of a tachyarrhythmia based at least in part on the sensed signals. The one or more sensors can include, but are not limited to, accelerometers, oxygenation sensors, chemical sensors, etc. Processing circuit 212 can store the sensed cardiac electrical signals, the determined heart rate, the sensed mechanical signals, and / or the determined ventricular rate in memory 214.

[0043] The processing circuit 212 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), discrete logic circuits, or any other processing circuit configured to provide the functionality attributed to the processing circuit 212 herein, and may be embodied as firmware, hardware, software, or any combination thereof.

[0044] Processing circuit 212 may determine a heart rate, such as a ventricular rate, of heart 104 based on sensed data (e.g., sensed electrical signals from electrodes 202, sensor data from sensor 204). Processing circuit 212 may determine whether patient 102 may be experiencing a tachyarrhythmia based on the determined heart rate. In some examples, processing circuit 212 may determine whether patient 102 is experiencing one or more other cardiac conditions, such as one or more other types of tachycardia.

[0045] After determining that the patient 102 may be experiencing a tachyarrhythmia, the processing circuit 212 can instruct the communication circuit 208 to send a connection request to the external device 108. After the communication circuit 208 receives confirmation that the IMD 106 is connected to the external device 108 (i.e., the IMD 106 communicates with the external device 108), the processing circuit 212 can then instruct the signal generation circuit 209 to generate an electrical stimulation signal (e.g., ATP therapy) and deliver the electrical stimulation signal to the cardiac tissue of the heart 104 via the electrode 202 and the switching circuit 204. If the communication circuit 208 does not receive confirmation that the external device 108 is connected, the processing circuit 212 can instruct the communication circuit 208 to resend the connection request after a period of time. The clinician can adjust the time period, for example, based on the medical needs of the patient 102. In some examples, the processing circuit 212 does not deliver any electrical stimulation signals to the heart 104 unless the processing circuit 212 receives confirmation of the connection with the external device 108.

[0046] Processing circuitry 212 may determine, based at least in part on the sensed data, that patient 102 is experiencing one or more adverse events. Adverse events may include one or more conditions experienced by patient 102 that may indicate to IMD 106 that patient 102 is experiencing hemodynamic collapse. Adverse events may include, but are not limited to, patient 102 falling, patient 102 respiratory arrest, a more severe (e.g., fatal) tachycardia event experienced by patient 102, movement of heart 104 of patient 102 (e.g., increased movement, cessation of movement, decreased movement), decreased tissue oxygenation of patient 102, and the like. If processing circuitry 212 determines that at least one adverse event has occurred, processing circuitry 212 may instruct signal generation circuitry 209 to deliver electrical stimulation signals to heart 104 without requiring IMD 106 to be connected to external device 108.

[0047] In some examples, for example, after processing circuit 212 receives confirmation that IMD 106 is connected to external device 108, processing circuit 212 may receive, for example, from external device 108, ATP therapy to be delivered to heart 104 and / or parameters of the ATP therapy. These parameters may include ATP parameters, and / or the number of safety checks performed by IMD 106 before delivering electrical stimulation signals. IMD 106 performs these safety checks to determine whether IMD 106 is detecting an arrhythmia that requires delivery of electrical stimulation signals to heart 104. Safety checks may include, but are not limited to, determining whether patient 102 is exercising or engaging in strenuous activity, or determining whether patient 102 is in an appropriate position (e.g., near an AED, near a caregiver, etc.). Processing circuit 212 may adjust the therapy configured to be delivered by signal generation circuit 209 (e.g., to comply with the received ATP therapy and / or received parameters), and instruct signal generation circuit 209 to deliver electrical stimulation signals corresponding to the adjusted ATP therapy and / or adjusted parameters to heart 104.

[0048] ATP therapy parameters may include pulse interval, pulse width, current and / or voltage amplitude, and duration of each pacing mode. For example, the pulse interval may be between about 150 milliseconds (ms) and 500 ms (e.g., between about 2.0 hertz (Hz) and 7.0 Hz) based on a fraction of the detected ventricular tachycardia (VT) cycle length, and the pulse width may be between about 0.5 ms and 2.0 ms. The amplitude of each pacing pulse may be between about 2.0 volts (V) and 10.0 V. In some examples, the pulse amplitude may be about 6.0 V and the pulse width may be about 1.5 ms; another example may include a pulse amplitude of about 5.0 V and a pulse width of about 1.0 ms. Each pulse train during ATP therapy may last for a duration between about 0.5 seconds (s) and about 15 s, or may be defined as a specific number of pulses. Each pulse or group of pulses may include a ramp-up of the amplitude or pulse rate. Furthermore, trains of pulses in successive ATP cycles can be delivered at increasingly higher pulse rates to capture the heart 104 and terminate tachyarrhythmias.

[0049] The signal generating circuit 209 may be configured to generate an electrical stimulation signal (e.g., of ATP therapy) and deliver the generated electrical stimulation signal to the heart 104 through the electrode 202, the conductor 203, and the switching circuit 204. The signal generating circuit 209 may include, for example, a current source or a voltage source, a capacitor, a charge pump, or other signal generating circuits.

[0050] The sensor 206 may include one or more sensing elements that convert patient physiological activity into electrical signals to sense the value of a corresponding patient parameter. The sensor 206 may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other type of sensor. The sensor 206 may output patient parameter values, which the processing circuit 212 may use to determine the heart rate, ventricular rate, and / or the occurrence of one or more adverse events.

[0051] The communication circuitry 208 (alternatively referred to as “telemetry circuitry 312”) supports wireless communication between the IMD 106 and the external device 108. The processing circuitry 212 of the IMD 106 may transmit a connection request to the external device 108 via the communication circuitry 312. The processing circuitry 212 may receive a confirmation of the connection between the IMD 106 and the external device 108 via the communication circuitry 312. The processing circuitry 312 may transmit sensed data to the external device 108 via the communication circuitry 312, and receive adjusted ATP therapy and / or adjusted ATP therapy parameters from the external device 108 via the communication circuitry 312, e.g., based at least in part on the sensed data.

[0052] The communication circuit 208 may communicate with the external device 108 via wireless communication techniques. The wireless communication techniques may include, for example, radio frequency (RF) communication techniques via an antenna (not shown). In some examples, the system 100 may include a second IMD that communicates with the IMD 106. The IMD 106 may communicate with the second IMD via the communication circuit 208, and the second IMD may relay the communication from the IMD 106 to the external device 108, for example, via the wireless communication techniques. In some examples, the second IMD may determine whether the decision made by the IMD 106 is accurate after receiving the communication from the IMD 106. If the second IMD determines that the decision made by the IMD 106 (e.g., determining that a tachyarrhythmia is present, deciding to deliver an electrical stimulation signal to the heart 104, etc.) is accurate, the second IMD may continue to relay these decisions to the external device 108. If the second IMD determines that the decision made by the IMD 106 is inaccurate, the second IMD may adjust and / or overrule the decision made by the IMD 106. In some examples, IMD 106 may similarly communicate with a wearable medical device (such as a patch, watch, other wrist-worn device, or garment) in lieu of or in addition to a second IMD.

[0053] Figure 3 It is a display Figure 1 Functional block diagram of an example configuration of the external device 108. Figure 3As shown, the external device 108 may include processing circuitry 302, memory 304, communication circuitry 306, and a user interface (UI) 308. The memory 304 may include one or more modules, including an application module 310 and a data module 318. The application module 310 may include a therapy selection module 312, which includes a therapy parameter module 314 and a safety feature module 316. The data 318 stored in the memory 304 may include location data 320, clinical data 322, and behavioral data 324.

[0054] The processing circuit 302 may include fixed function circuits and / or programmable processing circuits. The processing circuit 302 may include any one or more of a microprocessor, a controller, a GPU, a TPU, a digital signal processor (DSP), an ASIC, an FPGA, or an equivalent discrete or analog logic circuit. In some examples, the processing circuit 302 may include multiple components (such as any combination of one or more microprocessors, one or more controllers, one or more GPUs, one or more TPUs, one or more DSPs, one or more ASICs, or one or more FPGAs), as well as other discrete or integrated logic circuits. The functions attributed to the processing circuit 302 herein may be embodied as software, firmware, hardware, or any combination thereof. In some examples, the memory 304 includes computer-readable instructions that, when executed by the processing circuit 302, cause the external device 108 and the processing circuit 302 to perform various functions and / or processes attributed to the external device 108, the network 112, and / or the processing circuit 302 herein. Memory 304 may include any volatile, non-volatile, magnetic, optical, or electronic media, such as RAM, ROM, NVRAM, EEPROM, flash memory, or any other digital media.

[0055] Processing circuitry 302 may receive a connection request from IMD 106 via communication circuitry 306. Processing circuitry 302 may transmit a confirmation of the connection to IMD 106 via communication circuitry 306 after receiving the connection request. In some examples, processing circuitry 302 may determine that user 110 is connected to external device 108, and confirm the connection between IMD 106 and external device 108 based on determining that user 110 is connected to external device 108.

[0056] In some examples, where the user 110 is one or more other persons (e.g., a medical care provider, a family member, etc.), the processing circuit 302 may query the user 110 via the UI 308 and determine whether the external device 108 is accessible to the user 110 (e.g., whether the user 110 is using or has access to the external device 108) based on the user feedback or lack of user feedback. The UI 308 may receive the user feedback and transmit the user feedback to the processing circuit 302, for example, in the form of an electronic communication. In some examples, where the external device 108 is a wearable device (e.g., a smart watch, etc.) worn by the user 110, the UI 308 may determine whether the user 110 is physically connected to (e.g., wearing) the external device 108 and / or is in physical contact with the external device by detecting the pulse of the user 110, thereby determining whether the external device 108 is accessible to the user 110. In some examples, where user 110 is a computing system, a computing device, a cloud computing environment, etc. (e.g., an EMS server), processing circuit 302 can transmit a connection request to user 110 via communication circuit 306, and determine that the connection exists when confirmation of the connection is received from user 110.

[0057] Processing circuit 302 may retrieve and execute instructions stored in therapy selection module 312 of application module 310 of memory 304 to select an ATP therapy stored in therapy selection module 312. The ATP therapy may include ATP therapy parameters stored in therapy parameter module 314, and a plurality of safety checks stored in safety feature module 316. In other examples, the information stored in therapy selection module 312 may be stored in network 112, and processing circuit 302 may retrieve the information from network 112 via communication circuit 306.

[0058] Processing circuit 302 may retrieve data 318 about one or more contextual factors of patient 102 from memory 304 and / or network 112. One or more contextual factors may include, but are not limited to, availability (e.g., proximity, responsiveness) of a medical service provider, a medical care provider, and / or an EMS provider, health indicators (also referred to as "health status") of patient 102 (e.g., age, weight, presence of comorbidities, other medical conditions, etc.), or behavioral patterns of patient 102 (e.g., exercise patterns of patient 102, exercise levels of patient 102, etc.). In some examples, data corresponding to the location of patient 102, medical service provider, medical care provider, EMS provider, etc. may be stored in location data 320. The location of patient 102 may be programmed or determined based on the location of IMD 106 and / or external device 108. Data corresponding to health indicators of patient 102 may be stored in clinical data 322. Data corresponding to behavioral patterns of patient 102 may be stored in behavioral data 324. In some examples, data 318 includes data obtained from network 112 , user 110 (eg, via UI 308 ), and / or IMD 106 (eg, from sensed data from IMD 106 ).

[0059] Each of the plurality of ATP therapies stored in the therapy selection module 312 may have a corresponding threshold risk condition for each of the one or more contextual factors. For example, an ATP therapy may have a maximum allowable distance between the patient 102 and a medical service provider, a medical care provider, and / or an EMS provider, and may have a maximum allowable response time between the patient 102 and the medical service provider, a medical care provider, and / or an EMS provider.

[0060] Some of the multiple ATP therapies may be more aggressive (e.g., more arrhythmic) or less aggressive (e.g., less arrhythmic) than another therapy in the multiple ATP therapies. A more aggressive ATP therapy may require fewer safety checks and / or may have a higher maximum therapy amplitude and / or therapy delivery frequency than a less aggressive ATP therapy. A more aggressive ATP therapy may also have a lower threshold risk condition than a less aggressive ATP therapy. For example, compared with a less aggressive ATP therapy, a more aggressive ATP therapy requires a shorter maximum allowed distance, a shorter maximum allowed response time, a better health index for the patient 102, and / or a higher behavioral consistency for the patient 102, for example, due to an increased risk of an unexpected event and / or an increased severity of any unexpected event. In another example, a less aggressive ATP therapy may require a longer maximum allowed distance, a longer maximum allowed response time, a poorer health index for the patient 102, and / or a lower behavioral consistency for the patient 102, for example, due to a reduced risk of an unexpected event and / or a reduced severity of any unexpected event. In some examples, the behavior of patient 102 (e.g., exercise) may result in a potential false positive report of a tachyarrhythmia. In such cases, the safety check allows system 100 to detect the occurrence of a false positive and prevent the delivery of ATP therapy to heart 104 during such an occurrence. Less aggressive ATP therapies may perform an increased number of safety checks and thus may be more likely to detect a false positive occurrence, for example, due to the increased number of safety checks.

[0061] In some examples, processing circuitry 302 may select a first ATP therapy and then replace the first ATP therapy with another ATP therapy based on data 318 regarding one or more contextual factors. If data 318 satisfies at least one threshold risk condition for the first ATP therapy, processing circuitry 302 may select a second, less aggressive ATP therapy if data 318 does not satisfy any threshold risk condition for the second ATP therapy. In some examples, if data 318 does not satisfy any threshold risk condition for the first ATP therapy, processing circuitry 302 may alternatively select a third, more aggressive ATP therapy, where data 318 does not satisfy any threshold risk condition for the third ATP therapy but will satisfy at least one threshold risk condition for an ATP therapy that is more aggressive than the third ATP therapy.

[0062] Once processing circuitry 302 selects an ATP therapy, processing circuitry 302 may transmit to IMD 106 via communication circuitry 306 to deliver the selected ATP therapy to patient 102. In some examples, when IMD 106 is already configured to deliver an existing ATP therapy, processing circuitry 302 may instruct IMD 106 to replace the existing ATP therapy with the selected ATP therapy, or to modify parameters of the existing ATP therapy to correspond to the selected ATP therapy.

[0063] The memory 304 can store information in the external device 108, for example, for processing during the operation of the external device 108. The memory 304 can be described as a computer-readable storage medium. In some examples, the memory 304 includes temporary memory or volatile memory, including but not limited to random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), or other forms of volatile memory known in the art. In some examples, the memory 304 also includes one or more memories configured for long-term storage of information, for example, including non-volatile storage elements. Examples of such non-volatile storage elements include magnetic hard disks, optical disks, floppy disks, flash memory, or various forms of electrically programmable memory (EPROM) or electrically erasable and programmable memory (EEPROM). In some examples, the memory 304 includes a storage device associated with the cloud.

[0064] The communication circuitry 306 may facilitate communication between the processing circuitry 302 of the external device 108 and the IMD 106 and / or the network 112. The communication circuitry 306 may communicate with other devices and / or systems via wired and / or wireless communication techniques. The wireless communication techniques may include, for example, RF communication techniques implemented via an antenna (not shown). The communication circuitry 306 may include a radio transceiver configured for communication in accordance with a wireless communication protocol such as 3G, 4G, 5G, WiFi (e.g., 802.11 or 802.15 ZigBee), or Bluetooth Low Energy (BLE) and other protocols for communication.

[0065] The UI 308 may be configured to receive input, for example, from the patient 110 or another user. Examples of input are tactile input, audio input, dynamic input, or optical input. The UI 308 may include a mouse, keyboard, voice response system, camera, button, control pad, microphone, presence sensitive or touch sensitive component (e.g., screen), or any other means for detecting input from the user 110. The UI 308 may also be configured to generate output, for example, to the patient 102 or another user. Examples of output include tactile output, haptic output, audio output, or visual output.

[0066] UI 308 of external device 108 may include a presence-sensitive screen, sound card, video graphics adapter card, speakers, cathode ray tube (CRT) monitor, liquid crystal display (LCD), light emitting diode (LED), or any other type of device for generating output to user 110.

[0067] In some examples, such as Figure 3 As shown in FIG. 3 , application 310 may be executed in user space in external device 108. As part of executing application 310, processing circuit 302 may select an ATP therapy, for example, as described in more detail above.

[0068] Figure 4 is a flow chart illustrating an example process of delivering medical therapy to patient 102. An example IMD (e.g., IMD 106) of medical device system 100 can monitor one or more sensor signals from patient 102 (402). The one or more sensed signals can include sensed data (e.g., from electrodes 202, sensors 206) or cardiac electrical signals. IMD 106 can determine whether IMD 106 detects an event (e.g., a tachyarrhythmia) that can be treated by medical therapy (e.g., ATP therapy) (404). Based on determining that IMD 106 did not detect the event (the "no" branch of 404), IMD 106 can continue to monitor one or more sensed signals from patient 102 (402).

[0069] If the IMD 106 detects the event (the "yes" branch of 404), the IMD 106 may send a connection request (also referred to as a "request for connection") to one or more external devices 108 (406). The medical device system 100 may then determine whether the IMD 106 is communicating with the external device 108 (408). Once the processing circuitry 302 of the external device 108 receives the connection request and sends an acknowledgement to the IMD 106 that is received by the processing circuitry 212 of the IMD 106, the external device 108 communicates with the IMD 106. The connection enables communication between the IMD 106 and the external device 108, for example, to transmit information (e.g., sensed data, health indicators of the patient 102, etc.), initiate delivery of ATP therapy to the patient 102, modify delivery of ATP therapy, and / or terminate delivery of ATP therapy. If IMD 106 is not communicating with external device 108 ("NO" branch of 408), IMD 106 may return to monitoring one or more sensed signals from patient 102 (402). IMD 106 may resend a connection request to external device 108, for example, after a predetermined period of time.

[0070] If the IMD 106 is communicating with the external device 108 ("yes" branch of 408), the medical device system 100 may query the external device 108 for a connection with the user 110 (410). The external device 108 may establish a connection with the user 110 via the UI 208. The medical device system 100 may then determine whether the external device 110 is available to or accessible by the user 110 (412). The external device 108 may be available to the user 110 if the user 110 is actively interacting with the external device 108, is wearing the external device 108, and / or may be alerted to an unexpected event within a short period of time.

[0071] If the external device 108 is available or accessible to the user 110 (the "yes" branch of 412), the medical device system 100 may deliver a medical therapy (e.g., ATP therapy) to the patient 102 (416). In some examples, the external device 108 may instruct the IMD 106 to deliver the medical therapy to the patient 102. If the external device 108 is not available or accessible to the user 110 (the "no" branch of 412), the IMD 106 may determine whether the patient 102 is experiencing an adverse event (414). An adverse event may be an event that indicates that the patient 102 is experiencing hemodynamic collapse. If the IMD 106 determines that the patient 102 is experiencing an adverse event (the "yes" branch of 414), the medical device system 100 may deliver the medical therapy to the patient 102 (416). If the IMD 106 determines that the patient 102 is not experiencing an adverse event, the medical device system 100 may return to monitoring one or more sensed signals from the patient 102 (402).

[0072] In some examples, such as Figure 4 As shown, user 110 may be one or more persons, and a connection between user 110 and external device 108 may be required to deliver medical therapy to patient 102. In other examples, such as where user 110 is a computing device, computing system, or cloud computing environment (e.g., an EMS server), after IMD 106 communicates with external device 108 ("yes" branch of 408), medical device system 100 may deliver medical therapy to patient 102 (416) without requiring external device 108 to be available to user 110. If IMD 106 is not communicating with external device 108 ("no" branch of 408), IMD 106 may then determine whether the patient is experiencing an adverse event (414), e.g., according to the example process described above.

[0073] Figure 5is a flow chart illustrating another example process of delivering a medical therapy to a patient 102. The medical device system 100 may select a medical therapy (e.g., an ATP therapy) from a plurality of available therapies (e.g., a plurality of ATP therapies) (502). The plurality of available therapies may be stored on an external device 108 and / or network 112 of the medical device system 100. The medical device system 100 may retrieve data 318 regarding one or more contextual factors (504). The contextual factors may include the availability of a medical service provider, a medical care provider, and / or an EMS provider to the patient 102, the health status of the patient 102, and / or the behavioral patterns of the patient 102. The medical device system 100 may retrieve data 318 from the IMD 106 and / or one or more other computing devices, computing systems, and / or one or more cloud computing environments connected to the network 112.

[0074] The medical device system 100 may determine whether the data 318 satisfies a threshold risk condition for the selected medical therapy (506). The selected medical therapy may have a corresponding threshold risk condition for each of the one or more contextual factors. Each corresponding threshold risk condition may correspond to a risk of an unexpected event exceeding a predetermined threshold of acceptable risk. Based on determining that the data 318 does not satisfy any threshold risk condition (the "no" branch of 506), the medical device system 100 may continue to perform the selected medical therapy, and the medical device system 100 may instruct the IMD 106 to deliver the selected medical therapy to the patient 102 (510).

[0075] If the medical device system 100 determines that the data 318 satisfies at least one threshold risk condition (the "yes" branch of 506), the medical device system 100 may select a less aggressive medical therapy (e.g., a less arrhythmogenic ATP therapy) from the plurality of medical therapies (508). The medical device system 100 may then determine whether the data 318 satisfies the threshold risk condition for the selected less aggressive medical therapy (506). The medical device system 100 may iteratively perform steps 506 and 508 until the data 318 no longer satisfies the threshold risk condition for the selected medical therapy.

[0076] The devices, systems and techniques of the present disclosure provide improvements over other medical therapy delivery systems. Establishing a connection between an external device and an implanted device prior to delivering a medical therapy ensures that external assistance is available in the event of an unexpected event, thereby reducing the severity of the effects of any such unexpected event. In some examples, using contextual factors to select medical therapies based on the aggressiveness of each medical therapy can increase the accuracy of predicting tachyarrhythmias, reduce the severity of the effects of an unexpected event, and / or increase the efficacy of a medical therapy while reducing the risk of an unexpected event.

[0077] The technology of the present disclosure can be implemented in a wide range of computing devices, medical devices, or any combination thereof. Any of the described units, modules, or components can be implemented together or individually as discrete but interoperable logic devices. Describing different features as modules or units is intended to highlight different functional aspects, and does not necessarily imply that such modules or units must be implemented by separate hardware components or software components. On the contrary, the functions associated with one or more modules or units can be performed by separate hardware or software components, or integrated in common or separate hardware or software components.

[0078] The present disclosure contemplates a computer-readable storage medium that includes instructions that cause a processor to perform any of the functions and techniques described herein. The computer-readable storage medium may take the example form of any volatile, non-volatile, magnetic, optical, or electrical medium such as RAM, ROM, NVRAM, EEPROM, or tangible flash memory. The computer-readable storage medium may be referred to as non-transient. The server, client computing device, or any other computing device may also include a more portable type of removable memory to enable easy data transfer or offline data analysis.

[0079] The techniques described in this disclosure, including those attributable to various modules and various component parts, may be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, various aspects of these techniques may be implemented in one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated discrete logic circuits or other processing circuits, as well as any combination of such components, remote servers, remote client devices, or other devices. The term "processor" or "processing circuit" may generally refer to any of the foregoing logic circuits, alone or in combination with other logic circuits, or any other equivalent circuits.

[0080] Such hardware, software, firmware may be implemented in the same device or in separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules or components may be implemented together or individually as discrete but interoperable logic devices. Describing different features as modules or units is intended to highlight different functional aspects, and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. On the contrary, the functions associated with one or more modules or units may be performed by separate hardware or software components, or integrated in common or separate hardware or software components. For example, any module described herein may include a circuit configured to perform the features attributed to the particular module, such as a fixed-function processing circuit, a programmable processing circuit, or a combination thereof.

[0081] The techniques described in this disclosure may also be embedded or encoded in an article comprising a computer-readable medium encoded with instructions. The instructions embedded or encoded in the article comprising the encoded computer-readable storage medium may cause one or more programmable processors or other processors to implement one or more of the techniques described herein, such as when the instructions included or encoded in the computer-readable storage medium are executed by one or more processors. Example computer-readable storage media may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, hard disk, compact disk ROM (CD-ROM), floppy disk, cassette, magnetic media, optical media, or any other computer-readable storage device or tangible computer-readable medium. Computer-readable storage media may also be referred to as storage devices.

[0082] In some examples, computer-readable storage media include non-transitory media. The term "non-transitory" may indicate that the storage media is not embodied in a carrier wave or propagating signal. In some examples, non-transitory storage media may store data that may change over time (e.g., in RAM or cache).

[0083] It should be noted that the medical device system 100 and the techniques described herein may not be limited to use in human patients. In alternative examples, the medical device system 100 may be implemented in non-human patients, such as primates, canines, equines, pigs, and felines. These other animals may undergo clinical or research therapies that may benefit from the disclosed subject matter. Various embodiments are described herein, such as the following embodiments.

[0084] Embodiment 1: An implantable medical device (IMD) configured to deliver anti-tachycardia pacing (ATP) therapy to a patient, the IMD comprising: a therapy delivery circuit connected to one or more electrodes; a communication circuit; and a processing circuit, the processing circuit being configured to: transmit a connection request to an external device via the communication circuit; determine whether the IMD is communicating with the external device based on a signal received from the external device; and transmit an instruction to the therapy delivery circuit to deliver the ATP therapy to the patient based on a determination that the IMD is communicating with the external device.

[0085] Embodiment 2: The IMD of Embodiment 1, wherein the IMD is implanted within the patient's heart, and wherein the therapy delivery circuit is configured to deliver the ATP therapy to tissue or wall tissue of one or more chambers of the patient's heart.

[0086] Embodiment 3: An IMD according to any one of Embodiments 1 and 2, wherein, in order to determine whether the IMD communicates with the external device, the processing circuit is configured to: determine whether the external device is accessible to the user based on the received signal; and determine that the IMD communicates with the external device based on determining that the external device is accessible to the user.

[0087] Embodiment 4: The IMD of any one of Embodiments 1 to 3, wherein the processing circuit is further configured to: transmit a second connection request to the external device after a predetermined time period based on determining that the IMD is not communicating with the external device.

[0088] Embodiment 5: The IMD according to any one of Embodiments 1 to 4 further includes a sensing circuit, and wherein the processing circuit is further configured to: determine, based on the received data, that the IMD is not communicating with the external device; determine, based on the sensing data from the sensing circuit, whether the patient is experiencing an adverse event indicative of hemodynamic collapse; and based on determining that the patient is experiencing the adverse event, transmit an instruction to deliver the ATP therapy to the patient via the one or more electrodes to the therapy delivery circuit.

[0089] Embodiment 6: The IMD of Embodiment 5, wherein the adverse event comprises one or more of the following: the patient falling, the patient stopping breathing, the patient's cardiac movement, the patient's decreased tissue oxygenation, or the patient experiencing a tachycardia event.

[0090] Example 7: A system comprising: an implantable medical device (IMD) configured to deliver anti-tachycardia pacing (ATP) therapy to a patient; and an external device comprising: a communication circuit configured to communicate with the IMD; and a processing circuit configured to: receive a connection request from the IMD via the communication circuit; determine whether the IMD communicates with the external device; and based on determining that the IMD communicates with the external device, transmit an instruction to the IMD via the communication circuit to deliver the ATP therapy to the patient.

[0091] Example 8: A system according to Example 7, wherein the IMD comprises an implantable cardiac device, and wherein the IMD is configured to deliver the ATP therapy to tissue or wall tissue of one or more chambers of the patient's heart after receiving the instruction to deliver the ATP therapy to the patient.

[0092] Embodiment 9: A system according to any one of embodiments 7 and 8, wherein, in order to transmit the instruction to the IMD, the processing circuit is configured to: determine whether the external device is accessible to the user; and based on determining that the external device is accessible to the user, transmit the instruction to the IMD.

[0093] Embodiment 10: A system according to Embodiment 9, wherein the external device also includes a user interface (UI), and wherein in order to determine whether the external device is accessible to the user, the processing circuit is configured to determine whether the UI receives user input from the user.

[0094] Embodiment 11: The system of Embodiment 10, wherein the user input comprises one or more of tactile input, visual input, or auditory input.

[0095] Embodiment 12: The system of any one of Embodiments 9 to 11, wherein the user comprises one or more of a medical service provider or emergency medical services.

[0096] Embodiment 13: The system of any one of Embodiments 7 to 12, wherein the IMD is configured to transmit the connection request to the external device after a predetermined period of time if the instruction is not received.

[0097] Example 14: A system according to any one of Examples 7 to 13, wherein the IMD is configured to: determine that the IMD is not communicating with the external device; determine whether the patient is experiencing an adverse event indicative of hemodynamic collapse based on data sensed by the IMD; and deliver the ATP therapy to the patient based on determining that the patient is experiencing the adverse event.

[0098] Embodiment 15: The system of embodiment 14, wherein the adverse event comprises one or more of the following: the patient falling, the patient stopping breathing, the patient's cardiac movement, the patient's decreased tissue oxygenation, or the patient experiencing a tachycardia event.

[0099] Embodiment 16: A system comprising: an external device and an implantable medical device (IMD), the external device being configured to communicate with a network; the implantable medical device comprising: a memory configured to store a plurality of medical therapies, wherein each of the plurality of medical therapies is configured to be delivered to a patient by the IMD; a communication circuit configured to communicate with the external device; a signal generating circuit; and a processing circuit configured to: select a first medical therapy from the plurality of medical therapies; receive data about one or more background factors of the patient from the external device via the communication circuit; determine whether the received data satisfies one or more threshold risk conditions of the patient based on the received data; select a second medical therapy from the plurality of medical therapies based on determining that the received data satisfies at least one of the one or more threshold risk conditions of the first medical therapy, wherein the second medical therapy is less aggressive than the first medical therapy; and deliver the second medical therapy to the patient via the signal generating circuit.

[0100] Example 17: The system of Example 16, wherein the IMD comprises an implantable cardiac device, and wherein delivering the second medical therapy to the patient comprises delivering the second medical therapy to tissue or wall tissue of one or more chambers of the patient's heart.

[0101] Embodiment 18: The system of Embodiment 17, wherein the second medical therapy is less arrhythmic than the first medical therapy.

[0102] Example 19: A system according to any one of Examples 16 to 18, wherein the first medical therapy includes a first anti-tachycardia pacing (ATP) therapy, wherein the second medical therapy includes a second ATP therapy, and each of the first ATP therapy and the second ATP therapy includes a set of corresponding therapy parameters.

[0103] Embodiment 20: The system of Embodiment 19, wherein each corresponding set of therapy parameters comprises a maximum therapy amplitude, a therapy delivery frequency, and a number of safety checks.

[0104] Embodiment 21: A system according to Embodiment 20, wherein the corresponding set of therapy parameters for the first ATP therapy comprises one or more of the following items relative to the corresponding set of therapy parameters for the second ATP therapy: a higher maximum therapy amplitude, a higher frequency of therapy delivery, or a fewer number of safety checks.

[0105] Embodiment 22: A system according to any one of Embodiments 16 to 21, wherein the external device is configured to: receive a connection request from the IMD; determine whether the IMD is communicating with the external device; and based on determining that the IMD is communicating with the external device, transmit an instruction to the IMD to deliver the second medical therapy to the patient.

[0106] Embodiment 23: A system according to any one of embodiments 16 to 22, wherein the one or more contextual factors include one or more of the following: proximity of a healthcare provider to the patient, responsiveness of the healthcare provider to the patient, proximity of emergency medical services, health status of the patient, or behavioral patterns of the patient.

[0107] Embodiment 24: A system according to Embodiment 23, wherein the one or more threshold conditions include one or more of the following: a threshold distance between the healthcare provider and the patient, or a threshold response time of the healthcare provider to a medical event experienced by the patient.

[0108] Embodiment 25: A system according to Embodiment 24, wherein the medical event comprises a cardiac arrhythmia.

[0109] Embodiment 26: The system of any one of Embodiments 23 to 25, wherein the one or more threshold conditions include a threshold distance between the emergency medical service and the patient.

[0110] Embodiment 27: A system according to any one of Embodiments 16 to 26, wherein the processing circuit is configured to select a third medical therapy from the multiple medical therapies based on determining that the received data does not satisfy any of the one or more threshold conditions, wherein the third medical therapy is more aggressive than the first medical therapy.

[0111] Embodiment 28: The system of any one of Embodiments 16-27, wherein the third medical therapy is more arrhythmic than the first medical therapy.

[0112] Embodiment 29: The system of any of Embodiments 27 and 28, wherein the IMD is configured to perform fewer safety checks prior to administering the third medical therapy relative to the first medical therapy.

[0113] Embodiment 30: The system of any one of Embodiments 27 to 29, wherein the third medical therapy comprises instructions to deliver electrical stimulation signals to the patient at a higher frequency relative to the first medical therapy.

[0114] Embodiment 31: A method, comprising: transmitting a connection request to an external device through a communication circuit of an implantable medical device (IMD); and receiving a signal from the external device through the communication circuit.

[0115] Example 32: The method of Example 31, wherein the IMD is implanted within the patient's heart, and wherein transmitting and delivering ATP therapy to the patient comprises: delivering the ATP therapy to tissue or wall tissue of one or more chambers of the heart via the therapy delivery circuit.

[0116] Embodiment 33: A method according to any one of Embodiments 31 and 32, wherein determining whether the IMD communicates with the external device comprises: determining, by the processing circuit, whether the external device is accessible to a user based on the received signal; and determining, by the processing circuit, that the IMD communicates with the external device based on determining that the external device is accessible to the user.

[0117] Embodiment 34: The method according to any one of Embodiments 31 to 33 further includes: based on determining that the IMD is not communicating with the external device, transmitting a second connection request to the external device through the communication circuit after a predetermined time period.

[0118] Example 35: The method according to any one of Examples 31 to 34, further comprising: determining, by the processing circuit based on the received data, that the IMD is not communicating with the external device; sensing data from the patient by the sensing circuit of the IMD; determining, by the processing circuit based on the sensed data, whether the patient is experiencing an adverse event indicating hemodynamic collapse; and based on determining that the patient is experiencing the adverse event, delivering the ATP therapy to the patient by the therapy delivery circuit.

[0119] Example 36: The method of Example 35, wherein the adverse event comprises one or more of the following: the patient falling, the patient arresting respiratory function, the patient's cardiac movement, the patient's decreased tissue oxygenation, or the patient experiencing a tachycardia event.

[0120] Example 37: A method comprising: receiving a connection request from an implantable medical device (IMD) by a processing circuit of an external device; determining by the processing circuit whether the IMD is communicating with the external device; and transmitting, by the processing circuit, an instruction to deliver anti-tachycardia pacing (ATP) therapy to a patient to the IMD based on determining that the IMD is communicating with the external device.

[0121] Example 38: A method according to Example 37, wherein the IMD comprises an implantable cardiac device, and wherein the method further comprises: delivering the ATP therapy to tissue or wall tissue of one or more chambers of the patient's heart by the IMD in response to receiving the instruction to deliver the ATP therapy to the patient.

[0122] Embodiment 39: A method according to any one of Embodiments 37 to 38, wherein transmitting the instruction to the IMD comprises: determining, by the processing circuit, whether the external device is accessible to the user; and based on determining that the external device is accessible to the user, transmitting the instruction to the IMD by the processing circuit.

[0123] Embodiment 40: A method according to Embodiment 39, wherein the external device includes a user interface (UI), and wherein determining whether the external device communicates with the user includes: determining, by the processing circuit, whether the UI receives user input from the user.

[0124] Embodiment 41: The method of Embodiment 40, wherein the user input comprises one or more of tactile input, visual input, or auditory input.

[0125] Embodiment 42: The method of any one of Embodiments 39 to 41, wherein the user comprises one or more of a medical service provider or emergency medical services.

[0126] Embodiment 43: The method according to any one of Embodiments 37 to 42 further includes transmitting, by the IMD, the connection request to the external device after a predetermined period of time without receiving the instruction.

[0127] Example 44: The method according to any one of Examples 37 to 43, further comprising: determining, by the processing circuit, that the IMD is not communicating with the external device; determining, based on data sensed by the IMD, whether the patient is experiencing an adverse event indicative of hemodynamic collapse; and based on determining that the patient is experiencing the adverse event, transmitting, by the processing circuit, to the IMD an instruction to deliver the ATP therapy to the patient.

[0128] Example 45: The method of Example 44, wherein the adverse event comprises one or more of the following: the patient falling, the patient's respiratory arrest, the patient's cardiac movement, the patient's decreased tissue oxygenation, or the patient experiencing a tachycardia event.

[0129] Example 46: A method, comprising: selecting a first medical therapy from a plurality of medical therapies by a processing circuit of an IMD, wherein each of the plurality of medical therapies is configured to be delivered to a patient by the IMD; receiving data about one or more background factors of the patient from a network via an external device; determining by the processing circuit whether the received data satisfies one or more threshold risk conditions of the patient based on the received data; selecting a second medical therapy from the plurality of medical therapies by the processing circuit based on determining that the received data satisfies at least one of the one or more threshold risk conditions of the first medical therapy, wherein the second medical therapy is less aggressive than the first medical therapy; and delivering the second medical therapy to the patient by a signal generating circuit of the IMD.

[0130] Example 47: A method according to Example 46, wherein the IMD comprises an implantable cardiac device, and wherein delivering the second medical therapy to the patient comprises: delivering the second medical therapy to tissue or wall tissue of one or more chambers of the patient's heart via the signal generating circuit.

[0131] Embodiment 48: The method of Embodiment 47, wherein the second medical therapy is less arrhythmic than the first medical therapy.

[0132] Example 49: A method according to any one of Examples 47 and 48, wherein the first medical therapy comprises a first anti-tachycardia pacing (ATP) therapy, wherein the second medical therapy comprises a second ATP therapy, each of the first ATP therapy and the second ATP therapy comprising a set of corresponding therapy parameters.

[0133] Embodiment 50: The method of Embodiment 49, wherein each corresponding therapy parameter group comprises a maximum therapy amplitude, a therapy delivery frequency, and a number of safety checks.

[0134] Example 51: A method according to Example 50, wherein the corresponding therapy parameter set of the first ATP therapy includes one or more of the following items relative to the corresponding therapy parameter set of the second ATP therapy: a higher maximum therapy amplitude, a higher therapy delivery frequency, or a fewer number of safety checks.

[0135] Embodiment 52: The method according to any one of Embodiments 46 to 51 further includes: delivering, by the processing circuit, a connection request to the external device via the communication circuit; determining, by the processing circuit, whether the IMD is communicating with the external device; and transmitting, by the processing circuit, an instruction to deliver the second medical therapy to the signal generating circuit based on determining that the IMD is communicating with the external device.

[0136] Embodiment 53: A method according to any one of Embodiments 46 to 52, wherein the one or more contextual factors include one or more of the following: proximity of a healthcare provider to the patient, responsiveness of the healthcare provider to the patient, proximity of emergency medical services, health status of the patient, or behavioral patterns of the patient.

[0137] Embodiment 54: A method according to Embodiment 53, wherein the one or more threshold conditions include one or more of the following items: a threshold distance between the medical service provider and the patient, or a threshold response time of the medical service provider to a medical event experienced by the patient.

[0138] Example 55: A method according to Example 54, wherein the medical event includes a cardiac arrhythmia.

[0139] Embodiment 56: The method of any one of Embodiments 53 to 55, wherein the one or more threshold conditions include a threshold distance between the emergency medical service and the patient.

[0140] Embodiment 57: The method of any one of Embodiments 46-56, wherein the second medical therapy comprises instructions instructing the IMD to perform an increased number of safety checks relative to the first medical therapy prior to administering the second medical therapy.

[0141] Embodiment 58: The method of any one of Embodiments 46 to 57, wherein the second medical therapy comprises instructions instructing the IMD to deliver electrical stimulation signals to the patient at a lower frequency relative to the first medical therapy.

[0142] Example 59: The method according to any one of claims 46 to 58 further includes: selecting a third medical therapy from the multiple medical therapies based on determining by the processing circuit that the received data does not satisfy any of the one or more threshold conditions, wherein the third medical therapy is more aggressive than the first medical therapy.

[0143] Embodiment 60: The method of any one of Embodiments 46 to 59, wherein the third medical therapy is more arrhythmic than the first medical therapy.

[0144] Embodiment 61: The method of any of Embodiments 59 and 60, wherein the third medical therapy comprises instructions instructing the IMD to perform a reduced number of safety checks relative to the first medical therapy prior to administering the third medical therapy.

[0145] Embodiment 62: The method of any one of Embodiments 59 to 61, wherein the third medical therapy comprises instructions to deliver electrical stimulation signals to the patient at a higher frequency relative to the first medical therapy.

[0146] Embodiment 63: A computer-readable storage medium comprising instructions, which, when executed, cause a processing circuit within a system to perform a method as described in any one of Embodiments 31 to 36.

[0147] Embodiment 64: A computer-readable storage medium comprising instructions, which, when executed, cause a processing circuit within a system to perform a method as described in any one of Embodiments 37 to 45.

[0148] Embodiment 65: A computer-readable storage medium comprising instructions, which when executed cause a processing circuit within a system to perform a method as described in any one of Embodiments 46 to 62.

[0149] Embodiment 66: A system comprising the IMD of any one of Embodiments 1-6 and the external device of any one of Embodiments 7-15.

Claims

1. An implantable medical device (IMD) configured to deliver anti-tachycardia pacing (ATP) therapy to a patient, the IMD comprising: a therapy delivery circuit connected to the one or more electrodes; Communication circuits; and A processing circuit, the processing circuit being configured to: transmitting the connection request to the external device via the communication circuit; determining, based on a signal received from the external device, whether the IMD is in communication with the external device; as well as Based on determining that the IMD is in communication with the external device, instructions are transmitted to the therapy delivery circuitry to deliver the ATP therapy to the patient.

2. The IMD of claim 1, wherein the IMD is implanted within a heart of the patient, and wherein the therapy delivery circuit is configured to deliver the ATP therapy to tissue of one or more chambers of the heart of the patient.

3. The IMD of any one of claims 1 and 2, wherein to determine whether the IMD is in communication with the external device, the processing circuit is configured to: determining whether the external device is accessible to a user based on the received signal; and Based on determining that the external device is accessible to the user, determining that the IMD is in communication with the external device.

4. The IMD of any one of claims 1 to 3, wherein the processing circuit is further configured to: Based on determining that the IMD is not communicating with the external device, a second connection request is transmitted to the external device after a predetermined period of time.

5. The IMD of any one of claims 1 to 4, further comprising a sensing circuit, and wherein the processing circuit is further configured to: determining, based on the received data, that the IMD is not communicating with the external device; determining whether the patient is experiencing an adverse event indicative of hemodynamic collapse based on the sensed data from the sensing circuit; as well as Based on determining that the patient is experiencing the adverse event, instructions are transmitted to the therapy delivery circuitry via the one or more electrodes to deliver the ATP therapy to the patient.

6. The IMD of claim 5, wherein the adverse event comprises one or more of: the patient falling, the patient stopping breathing, the patient's cardiac motion, the patient's decreased tissue oxygenation, or the patient experiencing a tachycardia event.

7. A system comprising: an implantable medical device (IMD) configured to deliver anti-tachycardia pacing (ATP) therapy to a patient; and An external device, the external device comprising: a communications circuit configured to communicate with the IMD; and A processing circuit, the processing circuit being configured to: receiving a connection request from the IMD via the communication circuit; determining whether the IMD is in communication with the external device; and Based on determining that the IMD is in communication with the external device, instructions are transmitted to the IMD via the communication circuit to deliver the ATP therapy to the patient.

8. The system of claim 7, wherein the IMD comprises an implantable cardiac device, and wherein the IMD is configured to deliver the ATP therapy to tissue of one or more chambers of the patient's heart after receiving the instruction to deliver the ATP therapy to the patient.

9. The system according to any one of claims 7 and 8, wherein to transmit the instruction to the IMD, the processing circuit is further configured to: determining whether the external device is accessible to a user; and Based on determining that the external device is accessible to the user, the instruction is transmitted to the IMD.

10. The system of claim 9, wherein the external device further comprises a user interface (UI), and wherein to determine whether the external device is accessible to the user, the processing circuit is configured to determine whether the UI receives user input from the user.

11. The system of claim 10, wherein the user input comprises one or more of tactile input, visual input, or auditory input.

12. The system of claim 9, wherein the user comprises one or more of a medical service provider or emergency medical services.

13. The system of any one of claims 7 to 12, wherein the IMD is configured to transmit the connection request to the external device after a predetermined period of time if the instruction is not received.

14. The system of any one of claims 7 to 13, wherein the IMD is configured to: determining that the IMD is not communicating with the external device; determining whether the patient is experiencing an adverse event indicative of hemodynamic collapse based on data sensed by the IMD; and Based on determining that the patient is experiencing the adverse event, delivering the ATP therapy to the patient.

15. The system of claim 14, wherein the adverse event comprises one or more of: the patient falling, the patient stopping breathing, the patient's cardiac motion, the patient's decreased tissue oxygenation, or the patient experiencing a tachycardia event.

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