Integrated implantable pulse generator

Abstract

A method of treating the heart, the method including providing an implantable pulse generator (IPG) adapted to deliver a combination of at least two therapy modalities, the combination including a cardiac contractility modulation therapy and another therapy selected from the group consisting of cardiac pacing, cardioversion, defibrillation, cardioversion and defibrillation, and cardiac resynchronization therapy (CRT), sensing a patient's physical condition, selecting a combination of the cardiac contractility modulation therapy and at least one therapy modality from the group, and delivering the combination of the cardiac contractility modulation therapy and at least one therapy modality. Related devices and methods are also described.

Description

Technical Field

[0001] (Related Application) This application is a continuation-in-part (CIP) of and claims priority from U.S. Provisional Patent Application No. 63 / 124,824 entitled "COMBINED IMPLANTABLE PULSE GENERATOR DEVICE" filed on December 13, 2020, and is related to U.S. Provisional Patent Application No. 62 / 957,243 entitled "IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WITH HIGH LONGEVITY" filed on January 5, 2020. The entire contents of these applications are incorporated herein by reference as if fully set forth herein in their entirety.

[0002] In some of its embodiments, the present invention relates to an implantable pulse generator (IPG) device, and more specifically, but not exclusively, to a method of operating an IPG.

Background Art

[0003] As additional background art, there is U.S. Patent No. 8,311,629 to Ben Haim et al.

[0004] The disclosures of all documents mentioned above and throughout this specification, together with the disclosures of all documents referenced in those documents, are incorporated herein by reference.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problem to be Solved by the Invention

[0006] In some embodiments, the present invention relates to an implantable pulse generator (IPG) device, and more specifically, to a method for operating an IPG, although it is not limited thereto. [Means for solving the problem]

[0007] Some embodiments include devices that integrate one or more cardiac treatments, such as cardiac contractility regulation, cardioversion, defibrillation, cardiac pacing, and cardiac resynchronization therapy (CRT).

[0008] Some embodiments include treatment methods that combine one or more of the above-described treatments with at least one other of the above-described treatments.

[0009] According to one aspect of several embodiments of the present disclosure, an implantable pulse generator (IPG) is provided, comprising: a cardiac contractility control generator circuit adapted for the provision of a cardiac contractility control therapeutic modality; a pacing generator circuit adapted for the provision of a cardiac pacing therapeutic modality; a cardioversion generator circuit adapted for the provision of a cardioversion therapeutic modality; a defibrillation pulse generator circuit adapted for the provision of a defibrillation therapeutic modality such as an implantable cardioverter-defibrillator (ICD); a cardiac resynchronization therapy (CRT) generator circuit adapted for the provision of a cardiac resynchronization therapy (CRT) therapeutic modality; and a controller adapted to collect cardiac data during an evaluation period to evaluate the clinical utility of providing at least one therapeutic modality, wherein the IPG can determine clinical utility by comparing at least some cardiac data with reference data included in the IPG.

[0010] According to some embodiments of this disclosure, the IPG includes storage for storing values ​​of clinical utility.

[0011] According to some embodiments of this disclosure, the controller can automatically provide a specific therapeutic modality based on clinical utility.

[0012] According to some embodiments of the present disclosure, the controller is adapted to record decisions relating to one or more of the following: cardiac contractility control generator circuits, pacing generator circuits, cardioversion generator circuits, defibrillation pulse generator circuits, and CRT generator circuits, even if the circuit does not provide pulse drive.

[0013] According to some embodiments of this disclosure, the controller is adapted to detect a decline in the clinical utility of a therapeutic modality.

[0014] According to some embodiments of the present disclosure, the controller is adapted to provide a combination of ICD and CRT treatment modalities if providing a cardiac contractility-modulating therapeutic modality did not provide clinical utility during the evaluation period.

[0015] According to some embodiments of the present disclosure, the controller is adapted to provide a combination of an ICD and a cardiac contractility control therapy modality if the provision of a CRT therapy modality did not provide clinical utility during the evaluation period.

[0016] According to some embodiments of the present disclosure, the controller is adapted to provide a combination of ICD, cardiac contractility control, and CRT as therapeutic modalities if the provision of cardiac contractility control and CRT as therapeutic modalities provides clinical utility during the evaluation period.

[0017] According to some embodiments of the present disclosure, the controller is programmable to provide a series of therapeutic modalities and combinations of therapeutic modalities, measure cardiac parameters during an evaluation period associated with a therapeutic modality, compare the cardiac parameters with respect to the therapeutic modality, and select a therapeutic modality or combination of therapeutic modalities based on the patient's cardiac parameters obtained during the series.

[0018] According to some embodiments of the present disclosure, the IPG is configured to measure one or more cardiac parameters selected from the group consisting of a ventricular arrhythmia level, an atrial arrhythmia level, QRS complex duration, cardiac output (CO), stroke volume (SV), and end-diastolic volume (EDV), and store data related to the cardiac parameters during an evaluation period.

[0019] According to some embodiments of the present disclosure, the evaluation period is at least one month.

[0020] According to some embodiments of the present disclosure, the controller is adapted to provide an ICD treatment modality when the level of ventricular arrhythmia exceeds a ventricular arrhythmia threshold.

[0021] According to some embodiments of the present disclosure, the controller is adapted to provide a CRT treatment modality when the QRS complex duration exceeds a QRS duration threshold.

[0022] According to some embodiments of the present disclosure, the controller is adapted to provide a cardiac contractility modulation treatment modality when the SV / EDV ratio is less than an SV / EDV ratio threshold.

[0023] According to some embodiments of the present disclosure, the controller is adapted to control the IPG and a generator circuit to switch between providing one treatment modality and providing another treatment modality.

[0024] According to some embodiments of the present disclosure, the IPG includes a lead dimensioned to reach a location where a treatment modality is to be provided.

[0025] According to some embodiments of the present disclosure, the IPG is adapted to select which two treatment modalities are to be provided.

[0026] According to some embodiments of the present disclosure, the IPG is adapted to selectively provide a cardiac contractility modulation treatment modality and one other treatment modality.

[0027] According to some embodiments of the present disclosure, the IPG is adapted to provide all treatment modalities.

[0028] According to some embodiments of the present disclosure, the IPG comprises a first lead for providing cardiac contractility modulation therapy, a second lead for providing cardiac contractility modulation therapy, and a therapy controller adapted to control delivery of contractility modulation therapy via the first lead and the second lead within the same heartbeat, and the device is adapted to provide different cardiac contractility modulation pulses via the first lead and via the second lead.

[0029] According to some embodiments of the present disclosure, the IPG comprises a first lead shaped and configured to provide myocardial contractility modulation therapy to the right ventricle, a second lead shaped and configured to provide myocardial contractility modulation therapy to the right ventricle, and a third lead shaped for placement in the right atrial, a controller adapted to switch delivery between at least two treatment modalities selected from the group consisting of cardiac contractility modulation, cardiac pacing, cardioversion, defibrillation, cardioversion and defibrillation, and cardiac resynchronization therapy (CRT), wherein the controller is adapted to control delivery of contractility modulation therapy via the first lead and the second lead within the same heartbeat.

[0030] According to some embodiments of the present disclosure, at least one of the leads comprises a shock coil and a pacing electrode within the lead.

[0031] According to some embodiments of the present disclosure, the device is adapted to deliver pacing signals to the right ventricle through the first lead and to the right atrium through the third lead within the same heartbeat.

[0032] According to one aspect of several embodiments of the present disclosure, an implantable pulse generator (IPG) is provided for providing cardiac contractility-regulating therapy. The IPG includes a first lead for providing cardiac contractility-regulating therapy, a second lead for providing cardiac contractility-regulating therapy, and a therapy controller adapted to control the provision of contractility-regulating therapy via the first and second leads within the same heartbeat, wherein the device is adapted to provide different cardiac contractility-regulating pulses via the first lead and via the second lead.

[0033] According to one aspect of several embodiments of the present disclosure, a method for selecting a treatment or combination of treatments is provided. This method includes programming an IPG to provide a series of treatments and combinations of treatments, having the IPG measure cardiac parameters during an evaluation period associated with a treatment, comparing the treatment-related cardiac parameters, and selecting a treatment or combination of treatments based on the patient's cardiac parameters obtained during the series.

[0034] According to some embodiments of this disclosure, the comparison is performed by IPG.

[0035] According to some embodiments of this disclosure, the selection is made by the IPG.

[0036] According to one aspect of several embodiments of the present disclosure, a method for treating the heart is provided. The method includes providing an implantable pulse generator (IPG) adapted to provide a combination of at least two therapeutic modalities, comprising cardiac contractility regulation therapy and another therapy selected from the group consisting of cardiac pacing, cardioversion, defibrillation, cardioversion and defibrillation, and cardiac resynchronization therapy (CRT); detecting the patient's condition; selecting a combination of cardiac contractility regulation therapy and at least one therapeutic modality from the group described above; and providing the combination of cardiac contractility regulation therapy and at least one therapeutic modality.

[0037] According to some embodiments of the present disclosure, the provision of a combination includes refraining from providing cardiac contractility control therapy during the cardiac cycle when at least one therapeutic modality is provided.

[0038] According to some embodiments of the present disclosure, the provision of a combination includes refraining from providing cardiac contractility regulation therapy during the cardiac cycle when at least one therapeutic modality is provided by detection.

[0039] According to some embodiments of this disclosure, detecting a patient's physical condition includes a physician detecting a patient's physical condition.

[0040] According to some embodiments of this disclosure, the detection of a patient's physical condition is based on clinical parameters that involve the analysis of physiological measurements selected from the group consisting of blood pressure, electrocardiogram (ECG) signals, respiratory rate, ejection fraction, arrhythmia, bioelectrical impedance, blood tests, cardiac imaging, health checkups, and biopsies.

[0041] According to some embodiments of this disclosure, the detection of a patient's physical condition includes the use of clinical parameters provided by a physician.

[0042] According to some embodiments of this disclosure, detecting a patient's physical condition involves using data provided by sensors included in the IPG.

[0043] According to some embodiments of this disclosure, detecting a patient's physical condition involves using data provided by sensors located outside the patient's body.

[0044] According to some embodiments of the present disclosure, the provision of visceral contractility-modulating therapy includes providing an increased amount of cardiac contractility-modulating therapy after providing cardioversion therapy.

[0045] According to some embodiments of the present disclosure, the provision of visceral contractility control therapy includes providing an increased amount of cardiac contractility control therapy after defibrillation therapy.

[0046] According to some embodiments of the present disclosure, an IPG is used to provide defibrillation therapy and, after the provision of such defibrillation therapy, refrain from providing cardiac contractility control therapy until the arrhythmia frequency falls below a certain threshold.

[0047] According to some embodiments of this disclosure, a specific threshold for arrhythmia frequency is pre-programmed into the IPG.

[0048] According to some embodiments of this disclosure, a particular threshold for arrhythmia frequency is one arrhythmia per minute.

[0049] According to some embodiments of this disclosure, sensors within an IPG are used to determine the frequency of arrhythmias.

[0050] According to some embodiments of the present disclosure, an IPG is used to provide defibrillation therapy and, after the provision of such defibrillation therapy, refrain from providing cardiac contractility control therapy for a pre-programmed period.

[0051] According to some embodiments of this disclosure, the period is in the range of 1 to 90 days.

[0052] According to some embodiments of this disclosure, IPG is used to provide cardiac contractility adjustment therapy during the cardiac cycle when CRT pacing is not provided.

[0053] According to some embodiments of this disclosure, IPG is used to provide cardiac contractility adjustment therapy during the same cardiac cycle in which CRT pacing is provided.

[0054] According to some embodiments of the present disclosure, IPG is used to provide cardiac contractility control therapy only during cardiac cycles triggered by a pacemaker or CRT pulse.

[0055] According to some embodiments of the present disclosure, IPG is used to provide cardiac contractility control therapy only during cardiac cycles that are not triggered by a pacemaker or CRT pulse.

[0056] According to some embodiments of the present disclosure, an IPG is used to provide cardiac contractility control therapy only when it is determined that the heart rate is within a specific range.

[0057] According to one aspect of several embodiments of the present disclosure, an implantable pulse generator (IPG) is provided. This includes a cardiac contractility control generator circuit adapted for providing a cardiac contractility control therapy modality, a pacing generator circuit adapted for providing a cardiac pacing therapy modality, a cardioversion generator circuit adapted for providing a cardioversion therapy modality, a defibrillation pulse generator circuit adapted for providing a defibrillation therapy modality, a cardiac resynchronization therapy (CRT) generator circuit adapted for providing a cardiac resynchronization therapy (CRT) therapy modality, and a controller adapted for controlling the IPG and the generator circuit to switch between providing one therapy modality and providing another therapy modality.

[0058] According to some embodiments of this disclosure, at least some of the therapeutic modality generator circuits are separate circuits.

[0059] According to some embodiments of this disclosure, the IPG includes a lead of dimensions that can reach the location where the therapeutic modality is provided.

[0060] According to some embodiments of this disclosure, IPG is adapted to provide all therapeutic modalities.

[0061] According to one aspect of several embodiments of the present disclosure, an implantable pulse generator (IPG) is provided, which includes a cardiac contractility control generator circuit adapted to provide a cardiac contractility control therapy modality, a pacing generator circuit adapted to provide a cardiac pacing therapy modality, a cardioversion generator circuit adapted to provide a cardioversion therapy modality, a defibrillation pulse generator circuit adapted to provide a defibrillation therapy modality, a cardiac resynchronization therapy (CRT) generator circuit adapted to provide a cardiac resynchronization therapy (CRT) therapy modality, and a controller adapted to control the generator circuit and thereby select which of a plurality of therapy modalities should be provided.

[0062] According to some embodiments of this disclosure, at least some of the therapeutic modality generator circuits are separate circuits.

[0063] According to some embodiments of this disclosure, the IPG is adapted to select which two therapeutic modalities it should provide.

[0064] According to some embodiments of this disclosure, the IPG is adapted to select which two therapeutic modalities should be delivered within the same heartbeat.

[0065] According to some embodiments of this disclosure, the IPG is adapted to select to provide a cardiac contractility-modulating therapeutic modality and one other therapeutic modality.

[0066] According to one aspect of several embodiments of the present disclosure, a method is provided for implanting an implantable pulse generator (IPG) and selecting a preferred therapeutic modality. The method includes implanting an IPG having cardiac contractility modulation and at least one additional stimulation modality; selecting one or more preferred therapeutic modalities; periodically checking whether the selection of one or more modalities is appropriate; continuing the periodic checks if the selection of one or more modalities is appropriate; and returning to the selection of one or more preferred modalities if it is not.

[0067] According to one aspect of several embodiments of the present disclosure, an implantable pulse generator (IPG) is provided for providing cardiac contractility control therapy. The IPG comprises a first lead having a shape and configuration for providing myocardial contractility control therapy to the right ventricle, a second lead having a shape and configuration for providing myocardial contractility control therapy to the right ventricle, and a third lead having a shape for placement in the right atrium. The system includes a controller adapted to switch between providing at least two therapies selected from the group consisting of cardiac contractility control therapy, cardiac pacing, cardioversion, defibrillation, cardioversion and defibrillation, and cardiac resynchronization therapy (CRT), wherein the controller is adapted to control the provision of contractility control therapy via a first and second lead within the same heartbeat.

[0068] According to some embodiments of this disclosure, the device includes a fourth lead shaped to be positioned in the left ventricle.

[0069] According to some embodiments of the present disclosure, at least one of the leads includes a shock coil and a pacing electrode within the lead.

[0070] According to some embodiments of the present disclosure, the device is adapted to provide pacing signals to the right ventricle through a first lead and to the right atrium through a third lead within the same heartbeat.

[0071] According to one aspect of several embodiments of the present disclosure, a method is provided for adding a cardiac therapeutic modality to an implantable pulse generator (IPG). This method includes adding a program to provide an additional therapeutic modality to the controller of an IPG that already has a program to provide a cardiac therapeutic modality, and connecting an additional lead associated with the additional cardiac therapeutic modality to the IPG.

[0072] According to some embodiments of the present disclosure, the IPG is implanted in a patient, and connecting additional leads related to additional cardiac treatment modalities includes implanting those additional leads.

[0073] According to one aspect of several embodiments of the present disclosure, a method for providing cardiac contractility regulation therapy is provided. This method includes alternately providing one biphasic cardiac contractility regulation pulse at a time within the same heartbeat via a first lead and a second lead.

[0074] According to some embodiments of the present disclosure, providing cardiac contractility regulation therapy via a first lead and then providing cardiac contractility regulation therapy via a second lead involves a time delay between the provision via the first lead and the provision via the second lead.

[0075] According to some embodiments of the present disclosure, the amplitude of the cardiac contractility regulating pulse through the first lead is not equal to the amplitude of the cardiac contractility regulating pulse through the second lead.

[0076] According to some embodiments of the present disclosure, the interval between the positive and negative phases of a biphasic cardiac contractility regulated pulse via a first lead is not equal to the interval between the positive and negative phases of a biphasic cardiac contractility regulated pulse via a second lead.

[0077] According to one aspect of several embodiments of the present disclosure, an implantable pulse generator (IPG) is provided for providing cardiac contractility-regulating therapy. The IPG includes a first lead for providing cardiac contractility-regulating therapy, a second lead for providing cardiac contractility-regulating therapy, and a therapy controller adapted to control the provision of contractility-regulating therapy via the first and second leads within the same heartbeat, wherein the device is adapted to provide different cardiac contractility-regulating pulses via the first lead and via the second lead.

[0078] According to one aspect of several embodiments of the present disclosure, a method for providing cardiac therapy is provided. This method includes providing cardiac contractility regulation therapy, receiving a control signal for providing cardioversion therapy, and terminating the cardiac contractility regulation therapy and providing cardioversion therapy based on the reception of the signal.

[0079] According to one aspect of several embodiments of the present disclosure, a method for providing cardiac therapy is provided. This method includes providing cardiac contractility control therapy, receiving a control signal for providing defibrillation, and terminating the cardiac contractility control therapy and providing defibrillation therapy based on the reception of the signal.

[0080] According to one aspect of several embodiments of the present disclosure, a method for providing cardiac therapy is provided. This method includes providing cardiac synchronization therapy (CRT), receiving a control signal to provide cardiac contractility adjustment therapy, and providing cardiac contractility adjustment therapy.

[0081] According to some embodiments of this disclosure, the provision of cardiac contractility adjustment therapy is limited to the cardiac cycle during which CRT is not provided.

[0082] According to some embodiments of the present disclosure, providing cardiac contractility regulation therapy only during cardiac cycles in which CRT is not provided is controlled by a controller contained within an implantable pulse generator (IPG), which suppresses the provision of cardiac contractility regulation therapy during cardiac cycles in which the IPG provides CRT.

[0083] According to some embodiments of this disclosure, the provision of cardiac contractility control therapy is performed during the same cardiac cycle as the provision of CRT.

[0084] According to some embodiments of this disclosure, CRT is provided using cardiac contractility regulatory therapy signals.

[0085] According to some embodiments of the present disclosure, the provision of cardiac contractility control therapy during the same cardiac cycle as the provision of CRT is controlled based on an implantable pulse generator (IPG) that timings cardiac contractility control therapy for a specific period following the provision of CRT by the IPG.

[0086] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Similar or equivalent methods and materials to those described herein may be used in carrying out or trying out embodiments of the present invention, but exemplary methods and / or materials are described below. In case of any conflict, the specification of the present invention, including definitions, shall prevail. Furthermore, the materials, methods and examples are illustrative and not necessarily intended to be restrictive.

[0087] As those skilled in the art will understand, some embodiments of the present invention may be embodied as systems, methods, or computer program products. Accordingly, some embodiments of the present invention may take the form of entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware. All of these may be collectively referred to herein as “circuits,” “modules,” or “systems.” Furthermore, some embodiments of the present invention may take the form of computer program products embodied in one or more computer-readable media having embodied computer-readable program code therein. Implementation of some embodiments of the present invention methods and / or systems may involve performing and / or completing selected tasks manually, automatically, or in combination thereof. Furthermore, according to actual instrumentation and equipment of some embodiments of the present invention methods and / or systems, some selected tasks may be performed by hardware, or by software or firmware and / or a combination thereof, for example, using an operating system.

[0088] For example, hardware for performing selected tasks according to some embodiments of the present invention can be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention can be implemented as a set of software instructions executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, one or more tasks according to some exemplary embodiments of the method and / or system described herein are performed by a data processor, such as a computing platform that executes a set of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage devices for storing instructions and / or data, such as magnetic hard disks and / or removable media. Optionally, network connectivity is also provided. A display and / or user input devices such as a keyboard and mouse are also optionally provided.

[0089] Any combination of one or more computer-readable media is available for some embodiments of the present invention. The computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination thereof. More specific examples of computer-readable storage media (a non-exhaustive list) may include: electrical connections having one or more wires, portable computer diskettes, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fibers, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof. In the context of this specification, a computer-readable storage medium may be any tangible medium capable of holding or storing programs used by or connected to a system, apparatus, or device that executes instructions.

[0090] A computer-readable signaling medium may contain, for example, a baseband or as part of a carrier wave, a propagating data signal in which computer-readable program code is embodied. Such a propagating signal may be any form of which, but is not limited to, electromagnetic, optical, or any appropriate combination thereof. A computer-readable signaling medium may be any computer-readable medium other than a computer-readable storage medium that can communicate, propagate, or transport a program for use in or connected to a system, apparatus, or device that executes instructions.

[0091] Program code embodied on a computer-readable medium, and / or data used thereby, may be transmitted using any suitable medium, including, but not limited to, wireless, wired, fiber optic cables, RF, or any suitable combination thereof.

[0092] Computer program code for performing operations of some embodiments of the present invention can be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java®, Smalltalk, and C++, and conventional procedural programming languages ​​such as the C programming language or similar languages. The program code can be executed entirely on the user's computer, partially on the user's computer as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or it may be connected to an external computer (for example, via the Internet using an Internet service provider).

[0093] Some embodiments of the present invention are described below with reference to flowcharts and / or block diagrams of methods, apparatuses (systems) and computer program products according to embodiments of the present invention. It will be understood that each block of the flowchart and / or block diagram, and combinations of multiple blocks of the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions are provided to the processor of a general-purpose computer, a dedicated computer, or other programmable data processing device forming a machine, so that instructions executed via the processor of the computer or other programmable data processing device generate means for performing functions / operations identified in one or more blocks of the flowchart and / or block diagram.

[0094] Furthermore, these computer program instructions can be stored in a computer-readable medium capable of instructing a computer, other programmable data processing device, or other device to function in a particular manner, and the instructions stored in the computer-readable medium include instructions that perform functions / operations specified in one or more blocks of a flowchart and / or block diagram to manufacture a product.

[0095] Computer program instructions can also be loaded into a computer or other programmable data processing device or other device to cause the computer or other programmable data processing device or other device to execute a series of operational steps to generate a computer implementation process. In this way, the instructions executed by the computer or other programmable device provide processing that performs the functions / operations specified in one or more blocks of a flowchart and / or block diagram.

[0096] Some of the methods described herein are generally designed for computer use only and may not be feasible or practical to perform purely manually by a human expert. A human expert attempting to perform a similar task manually, such as one of the treatments described above, may be expected to use entirely different methods, such as leveraging expert knowledge and / or the human brain's pattern recognition capabilities. This may be different from, or far more efficient than, performing all the steps of the methods described herein manually.

[0097] Some embodiments of the present invention are described herein only as illustrative with reference to the accompanying drawings. Herein, with detailed and specific reference to the drawings, it is emphasized that the details shown are illustrative and intended to illustrate embodiments of the present invention. In this regard, the description made in conjunction with the drawings will make it clear to those skilled in the art how embodiments of the present invention may be carried out. [Brief explanation of the drawing]

[0098] [Figure 1A] This is a simplified diagram showing an IPG and leads placed in the heart. [Figure 1B] This is a simplified diagram showing an IPG and leads placed in the heart. [Figure 2] This is a simplified block diagram of an IPG and lead according to an exemplary embodiment. [Figure 3A] This is a simplified diagram of a graph showing cardiac contractility regulated stimulation according to an exemplary embodiment. [Figure 3B] This is a simplified diagram of a graph showing cardiac contractility regulated stimulation according to an exemplary embodiment. [Figure 3C] This is a simplified graph of cardiac contractility regulation stimulation by two leads, according to an exemplary embodiment. [Figure 3D] This is a simplified graph of cardiac contractility regulation stimulation by two leads, according to an exemplary embodiment. [Figure 4A] This is a simplified flowchart of a method for treating the heart according to an exemplary embodiment. [Figure 4B] This is a simplified flowchart illustrating a method for treating the heart using an implantable pulse generator, according to an exemplary embodiment. [Figure 4C] This is a simplified flowchart illustrating a method for treating the heart using an implantable pulse generator, according to an exemplary embodiment. [Figure 4D] This is a simplified flowchart illustrating a method for treating the heart using an implantable pulse generator, according to an exemplary embodiment. [Figure 5] This is a simplified flowchart illustrating a method for treating the heart using an implantable pulse generator (IPG) according to an exemplary embodiment. [Figure 6A] This is a simplified flowchart of a method for providing cardiac contractility regulation therapy according to an exemplary embodiment. [Figure 6B] This is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment. [Figure 6C] This is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment. [Figure 6D] This is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment. [Figure 6E] This is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment. [Figure 6F] This is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment. [Figure 6G] This is a simplified flowchart of a cardiac treatment method according to an exemplary embodiment. [Figure 6H] This is a simplified flowchart illustrating a method for adding a cardiac treatment modality to an implantable pulse generator (IPG) according to an exemplary embodiment. Description of a specific embodiment of the present invention. [Modes for carrying out the invention]

[0099] In some embodiments, the present invention relates to an implantable pulse generator (IPG) device, and more specifically, to a method for operating an IPG, although it is not limited thereto. Introduction

[0100] One aspect of several embodiments relates to packaging multiple therapeutic functions into a single implantable pulse generator (IPG) device.

[0101] Current cardiac contractility regulation therapy is performed using standalone devices that provide cardiac contractility-regulating stimulation to the ventricles, and may also have detection electrodes in the right atrium.

[0102] Patients requiring both cardiac contractility regulation and other cardiac stimulation therapies will be fitted with at least two separate implantable devices: one for cardiac contractility regulation and one or more for other therapies.

[0103] In some embodiments, an integrated implantable pulse generator (IPG) device is described that provides a cardiac contractility adjustment therapy modality and at least one additional modality, for example, in non-limiting examples, at least one additional modality such as a univentricular or biventricular pacemaker, cardiac resynchronization therapy (CRT) including biventricular pacing, cardioversion and / or defibrillation.

[0104] Some embodiments include treatment methods that combine one or more of the above-described treatments with at least one other of the above-described treatments.

[0105] In some embodiments, methods for using one or more therapeutic functions in series or in parallel are also provided.

[0106] In some embodiments, a device is provided that packages one or more cardiac treatments, including cardiac contractility regulation, cardioversion, defibrillation, cardiac pacing, and cardiac resynchronization therapy (CRT).

[0107] One embodiment of several embodiments relates to an integrated IPG device that has multiple modalities in the same device, allowing the selection of modalities based on clinical needs. Examples of treatment modality selection include at least one of the following: cardiac contractility control + implantable cardioversion / defibrillation, cardiac contractility control + CRT, cardiac contractility control + pacemaker, cardiac contractility control + implantable cardioversion / defibrillation + CRT, and cardiac contractility control + implantable cardioversion / defibrillation + pacing.

[0108] In some embodiments, the treatment modality can be optionally changed after the device is implanted, enabling optimal treatment for the patient.

[0109] In some embodiments, having an implantable cardioversion / defibrillation modality along with cardiac contractility control potentially enables the following activities: The detection of arrhythmias requiring defibrillation leads to the cessation of cardiac contractility control therapy. In some embodiments, arrhythmias are automatically detected by the IPG, which then, at its discretion, automatically stops providing cardiac contractility control. This automatic cessation may provide a faster response than a physician instructing the IPG to stop providing cardiac contractility control. For a certain period after defibrillation, the dose of cardiac contractility regulators is increased to potentially strengthen the myocardium and prevent further arrhythmias. In some embodiments, defibrillation is generated by an IPG, which automatically controls the provision of cardiac contractility regulators at will. Automatic control may provide cardiac contractility regulation for defibrillation even in the absence of a physician. In some embodiments, the IPG is optionally pre-programmed, and the dose of cardiac contractility regulation can be increased by increasing the number of hours per day for which cardiac contractility regulation is provided and / or by increasing the number of heart cycles per day for which cardiac contractility regulation is provided. Following defibrillation, in non-limiting cases, cardiac contractility regulation activity may be suppressed for a period of 1 to 90 days, or until arrhythmias cease for a specific period. In some embodiments, defibrillation is automatically detected by the IPG, which then optionally automatically controls the suppression of cardiac contractility regulation. Automatic suppression may provide a faster response than a physician instructing the IPG to stop providing cardiac contractility regulation. To optionally provide defibrillation shock using the same lead for cardiac contractility-modulating stimulation.

[0110] In some embodiments, for example, when cardiac contractility regulation is combined with CRT or pacemaker modality, the following activities can be optionally performed. Delivering cardiac contractility adjustment therapy during unpaced heartbeats. In some embodiments, the IPG senses when there is no pacing signal for the heartbeat and automatically provides cardiac contractility adjustment therapy at such times, at its discretion. The IPG delivers cardiac contractility adjustment after a set delay time following pacing of the right ventricle (RV) or left ventricle (LV). In some embodiments, the IPG senses when a pacing signal is provided and, optionally, automatically delivers cardiac contractility adjustment therapy without interfering with the pacing signal. The same electrode is used for both pacing and cardiac contractility regulation. In some embodiments, a pacing signal and subsequent cardiac contractility regulation are provided during a single cardiac cycle. Use cardiac contractility regulatory signals for both cardiac contractility regulatory therapy and pacing.

[0111] Some embodiments include providing an IPG that includes hardware suitable for providing the cardiac treatment described herein.

[0112] In some embodiments, the IPG includes one or more suitable power supplies.

[0113] In some embodiments, different power applications require different batteries.

[0114] In some non-limiting embodiments, implantable cardiac devices such as implantable cardioverter-defibrillators (ICDs) may have applications requiring low current (e.g., cardiac contractility regulation therapy, sensing, VT / VF (ventricular tachycardia / ventricular fibrillation) detection, housekeeping, communication, operation of non-electric shock components of the implantable device, etc.) and applications requiring significantly high current (e.g., cardioversion and / or defibrillation).

[0115] In some embodiments, the implantable device includes two batteries: one for low-current operation and one for high-current operation.

[0116] In some embodiments, three or more batteries are included.

[0117] A potential advantage of using two batteries in an implantable device—one for low-current operation and one for high-current operation—is that by using a rechargeable battery for low-current applications such as cardiac contractility regulation therapy, sensing, VT / VF detection, housekeeping, and communication, it becomes possible to potentially store more electrical energy in the non-rechargeable battery for high-current applications such as cardioversion and / or defibrillation.

[0118] As a non-limiting example, the aforementioned U.S. Provisional Patent Application No. 62 / 957,243, filed on January 5, 2020, entitled “An Implantable Cardioverter Defibrillator (ICD) device with high longevity,” describes a system having the capability to supply power for different treatments and a method for managing that system.

[0119] In some embodiments, the IPG includes appropriate electrodes and leads for sending electrical signals to the heart and / or sensing physiological parameters.

[0120] In some embodiments, the IPG includes appropriate electrodes and leads for providing the therapeutic combinations described herein.

[0121] The table below shows which electrode positions are used selectively for which cardiac treatments. The following abbreviations are used in the table: RV = right ventricle, RA = right atrium, LV = left ventricle, VC = superior vena cava. [Table 1]

[0122] In some embodiments, the IPG optionally includes two or more lead and electrode combinations to support cardiac treatment as listed in the table above. That is, the leads are configured to reach each of the one or more electrode locations listed above with respect to cardiac treatment.

[0123] In some embodiments, the IPG optionally includes two or more combinations of electrodes that support cardiac treatment as listed in the table above. That is, the electrodes are placed at one or more electrode positions as described above with respect to cardiac treatment.

[0124] One aspect of several embodiments relates to an activation method for IPG that combines at least one of the therapies of cardiac contractility regulation, ICD, and CRT.

[0125] In some embodiments, methods are described for increasing the cardiac contractility-modulating dose for a set period of time after defibrillation. Such stimulation may strengthen the myocardium and prevent the development of additional arrhythmias.

[0126] In some embodiments, methods are provided for optionally suppressing cardiac contractility regulation activity following defibrillation for a predetermined period (between 1 and 90 days) or until the arrhythmia level falls below a predetermined threshold (e.g., one arrhythmia per minute).

[0127] In some embodiments, following the provision of an anti-tachycardia pacing mode, a method is provided for providing pacing using a pulse pattern such as a "cardiac contractility modulation," for example, a biphasic pulse with a pulse width of, for example, about 10 ms, although this is not an exhaustive example. In some cases, such a method may provide a better anti-tachycardia effect by disrupting the re-entry cycle within the heart.

[0128] One aspect of several embodiments relates to a method for activating an integrated IPG for cardiac contractility regulation, ICD, and CRT.

[0129] In some embodiments, for example, the selection of modality for a patient whose heart failure condition has changed (e.g., worsened) is optionally evaluated by the physician based on the patient's needs and optionally entered into the IPG as a program to initiate a sequence of treatment modalities.

[0130] In some embodiments, the selection method is based on machine learning and / or personalization of startup parameters by arbitrary selection.

[0131] In some embodiments, the selection method is by choice and based on machine learning of activation parameters and / or treatment modality sequences based on patient groups. In some embodiments, patients are grouped into similar groups by a physician for input to a machine learning module. This is by choice and based on the patient's condition and / or on patients with similar IPG devices.

[0132] In some embodiments, the evaluation process is optionally based on information from sensors that are part of or connected to the IPG, or from an external unit that evaluates the patient's condition. In some embodiments, a treatment method or combination of treatment methods is optionally selected, at least in part, based on the evaluation. Non-limiting examples of sensors include implantable sensors for blood pressure, ECG, respiratory rate, and / or external sensors. In some embodiments, the evaluation is optionally based on analysis of the ECG signal (optionally at various frequencies) and detection of arrhythmias. In some embodiments, the evaluation is optionally based on analysis of bioelectrical impedance for potential hyperemia measurement.

[0133] In some embodiments, the evaluation process is optionally based on one or more studies, such as blood tests, cardiac imaging, and biopsies.

[0134] In some embodiments, the physician performs an evaluation and provides a treatment program to the IPG device, optionally including a therapy control and housekeeping module as shown in Figure 1B.

[0135] In some embodiments, a therapy control module within the IPG, such as the therapy control module 151 shown in Figure 1B, receives input from sensors and evaluates and / or determines a treatment program by arbitrary selection. Alternatively, the treatment program may be automatically determined by arbitrary selection.

[0136] Some non-limiting examples of possible cardiac therapeutic initiation sequences include: Defibrillation is performed using rapid pacing, followed by optional cardioversion shock. Defibrillation is performed, followed by optional adjustment of cardiac contractility. After defibrillation and improvement in heart rate, cardiac contractility control may be offered at the patient's discretion. Perform a cardioversion using rapid cardiac pacing. Cardiac resynchronization therapy is performed, followed by cardiac contractility regulation. This includes the following.

[0137] In some embodiments, improvement in cardiac condition is optionally determined based on one or more of the following: clinical procedures such as measuring ejection fraction, and / or classification of the patient's condition according to the New York Heart Association (NYHA) functional classification, and / or the results of a 6-minute walk test.

[0138] Some embodiments relate to a method for initiating an IPG having an integrated cardiac contractility regulator / CRT configuration.

[0139] In some embodiments, cardiac contractility control therapy is optionally administered during cardiac cycles that do not include CRT pacing. In some embodiments, cardiac contractility control therapy is optionally administered based on the patient's atrioventricular (AV) delay period and / or heart rate. In some embodiments, cardiac contractility control therapy is optionally provided only during cardiac cycles that do not include CRT pacing. In some embodiments, cardiac contractility control therapy is optionally provided during a specific percentage of such cardiac cycles. In some embodiments, cardiac contractility control therapy is optionally provided during such cardiac cycles, but not exclusively.

[0140] In some embodiments, cardiac contractility-modulating pulses are optionally provided in the opposite polarity following the delivery of CRT pacing.

[0141] Some embodiments relate to a pacing method for an IPG integrated with cardiac contractility regulation and / or pacemaker function.

[0142] In some embodiments, cardiac contractility regulation therapy is optionally provided following the delivery of defibrillation therapy.

[0143] In some embodiments, the pacing method is provided specifically for the treatment of sick sinus syndrome. In some embodiments, the physician determines when to apply the pacing method to sick sinus syndrome, based on the physician's judgment that the patient has sick sinus syndrome.

[0144] In some embodiments, cardiac contractility adjustment therapy is optionally provided only during the cardiac cycle triggered by the pacemaker.

[0145] In some embodiments, cardiac contractility control therapy is optionally delivered during an unpaced cardiac cycle.

[0146] In some embodiments, cardiac contractility-regulating therapy is optionally delivered during the cardiac cycle related to a specific range of heart rates (HR), in non-limiting examples being 60–80 beats per minute (BPM).

[0147] Here, we will describe the structure and operation of the IPG according to an exemplary embodiment of the present invention.

[0148] Figure 1A is a simplified diagram showing the IPG and the leads placed in the heart.

[0149] Figure 1A shows the IPG 104 and leads 108, 110, 112, and 114 positioned in the heart 102. The first lead 108 is positioned in the right atrium of the heart, the second lead 110 is positioned in the left ventricle of the heart, the third lead 112 is positioned in the first position of the right ventricle of the heart, and the fourth lead 114 is positioned in the second position of the right ventricle of the heart.

[0150] Figure 1A also shows the location of the impact coil 116 included in the third lead 112, and the outer casing 106 referred to as the can 106 of the IPG 104.

[0151] As a non-limiting example, Figure 1A shows that the lower left lead 112 optionally has both a coil and optionally two electrodes (referred to as a bipolar configuration), and the electrodes can optionally be used for both sensing and pacing.

[0152] In some embodiments, as a non-limiting example, electrodes on leads such as leads 108, 110, 112, and 114 within the heart are optionally used for electrical sensing and stimulation / pacing.

[0153] In some embodiments, as a non-limiting example, electrodes on leads such as leads 108, 110, 112, and 114 within the heart are optionally used for stimulation and / or pacing.

[0154] In some embodiments, as a non-limiting example, electrodes on leads such as leads 108, 110, 112, and 114 within the heart may be used, at will, for two of the following: electrical sensing, stimulation, or pacing.

[0155] In some embodiments, electrodes or sensors are optionally attached to the PG and optionally positioned at least inside or outside the heart to sense bioimpedance and / or blood pressure.

[0156] In some embodiments, for example, an impact coil located on the third lead 112, or for example, the impact coil 116, may be optionally used for defibrillation treatment.

[0157] In some embodiments, as a non-limiting example, leads such as the lead 110 in the left ventricle of the heart are optionally used in cardiac resynchronization therapy.

[0158] In some embodiments, as a non-limiting example, the above-mentioned lead 108 in the right atrium of the heart and one or more leads 112, 114, etc. in the left ventricle are used to provide pacing therapy by choice.

[0159] In some embodiments, as a non-limiting example, one or more leads, such as the leads 112, 114 described above in the left ventricle of the heart, are optionally used for cardiac contractility adjustment therapy.

[0160] Here, refer to Figure 1B, which shows a simplified representation of the IPG and the leads placed in the heart.

[0161] Figure 1B is intended to show the components of the IPG in more detail.

[0162] Figure 1B shows an IPG134 with leads 136, 138, 140, and 142 positioned in the heart 132. The first lead 138 is positioned in the right atrium of the heart, the second lead 138 is positioned in the left ventricle of the heart, the third lead 142, a V1 / ICD lead, is positioned in the first position in the right ventricle of the heart, and the fourth lead 140 is positioned in the second position in the right ventricle of the heart.

[0163] Figure 1B also shows the therapy control module 151, the HV defibrillator pulse generator 146, the pacing pulse generator 148, the ICD sensor 149, the cardiac contractility regulator generator 150, the communication module 152, an optional magnetic sensor 154, and an optional temperature sensor 156.

[0164] In some embodiments, cardioversion and / or defibrillation therapy is optionally provided to one or more electrodes in the right ventricle and / or one or more leads in the left ventricle.

[0165] In some embodiments, cardiac contractility regulation therapy is optionally provided to one or more electrodes in the right ventricle.

[0166] In some embodiments, cardiac contractility regulation is optionally provided to one or more electrodes in the left ventricle in addition to electrodes in the right ventricle.

[0167] In some embodiments, cardiac contractility regulation is provided using electrodes in the right atrium, which are optionally used for sensing.

[0168] Next, refer to Figure 2. This is a simplified block diagram of the IPG and lead according to an exemplary embodiment.

[0169] Figure 2 shows the IPG200 and several leads 210a, 210b, ..., 210z. In various exemplary embodiments, the number of leads may vary. In some non-limiting examples, there may be 2, 3, 4, 5, 6, 7, 8 leads, and the maximum may be more than 8 leads, for example.

[0170] In some embodiments, the lead is used in multiple therapeutic modalities by choice. In some embodiments, the same lead is used for both defibrillation and pacing and / or cardiac contractility regulation.

[0171] In some embodiments, one or more leads 210, 210b, ..., 210z can be optionally used for both sensing and providing therapeutic modalities.

[0172] In some embodiments, the lead 210 provides one or more sensing signals 212 to the therapy controller 208, which determines which therapy, if any, should be delivered to the heart via the lead 210.

[0173] In some embodiments, the therapy controller 208 optionally determines which therapy to administer, if any, and controls one or more pulse generators 202, 204, 205, 206, 208 (214) to deliver pulses to the patient via the lead 210 (216).

[0174] In the exemplary embodiment shown in Figure 2, the IPG200 includes modules for providing cardiac contractility control therapy 202, cardioversion 204 and / or defibrillation 205, and cardiac resynchronization 206.

[0175] In some embodiments, the IPG200 includes fewer modules than the number of therapy types. For example, it may include one or two modules (not shown in Figure 2) for providing one or more of the following: cardiac contractility regulation therapy, cardioversion / defibrillation, and cardiac resynchronization.

[0176] In some embodiments, the IPG200 includes a module that integrates two or more types of therapy, such as a module that integrates the generation of cardioversion and defibrillation signals.

[0177] Next, refer to Figure 3A. This is a simplified diagram of a graph of cardiac contractility-modulating stimulation according to an exemplary embodiment.

[0178] Figure 3A is a graph with time on the X-axis 302 and the voltage applied to the cardiac contractility control lead on the Y-axis 304. Figure 3A shows a non-limiting example of a cardiac contractility control pulse pattern. Figure 3A shows a series of biphasic pulses 306, each pulse having an exemplary typical pulse width of 5.14 milliseconds. This pulse is followed by an equilibrium phase 310 or equilibrium period 310.

[0179] Next, refer to Figure 3B. This is a simplified diagram of a graph of cardiac contractility-modulating stimulation according to an exemplary embodiment.

[0180] Figure 3B shows a graph of cardiac contractility-modulating stimulation via a single lead from either channel 1 or channel 2, or cardiac contractility-modulating stimulation with both leads from channel 1 and channel 2 synchronized in parallel to simultaneously provide cardiac contractility-modulating stimulation to both channels. In some embodiments, when cardiac contractility-modulating stimulation is provided via two channels, there is a delay in the onset of stimulation between one channel and the other.

[0181] Figure 3B shows a non-limiting example of a cardiac contractility control pulse pattern. Figure 3B is a graph with time on the X axis (322) and the voltage applied to the cardiac contractility control lead on the Y axis (324). Figure 3B shows a series of three biphasic pulses 326, each having an exemplary typical width of 5.14 milliseconds. This pulse is followed by an equilibrium phase 328 or equilibrium period 328.

[0182] Figure 3B shows a biphasic pulse 326 in which, by choice, there is an interphase delay 330 between the positive and negative phases, and in some embodiments, there are interphase delays of the same or different magnitudes between pairs of positive and negative pulses, i.e., between biphasic pulses 326.

[0183] Next, refer to Figure 3C. This is a simplified graph of cardiac contractility-modulating stimulation by two leads, according to an exemplary embodiment.

[0184] Figure 3C shows a graph of cardiac contractility-modulating stimulation using two leads, also called channel 1 and channel 2. Figure 3C also shows a graph of cardiac contractility-modulating stimulation pulses, where pulses alternate one at a time.

[0185] Figure 3C shows a non-restrictive example of a cardiac contractility control pulse pattern. Figure 3C is a graph with time represented by two X axes 342a and 342b, and the voltage applied to the cardiac contractility control lead represented by the Y axis 344. The two X axes 342a and 342b represent the time for channel 1 and channel 2, respectively. The two X axes 342a and 342b are aligned with each other. The voltage on the Y axis 344 is represented such that the height of the intersection of the X axis 342a and Y axis 344 for channel 1 is the 0 voltage for channel 1, and the height of the intersection of the X axis 342b and Y axis 344 for channel 2 is the 0 voltage for channel 2.

[0186] Figure 3C shows a set of three biphasic pulses 346a applied to channel 1 and a set of three biphasic pulses 346b applied to channel 2. In the example in Figure 3C, each biphasic pulse has a positive portion with width Φ1 and a negative portion with width Φ2.

[0187] In some embodiments, the absolute value of the amplitude of the positive portion is, by choice, equal to the absolute value of the amplitude of the negative portion. In some embodiments, the absolute value of the amplitude of the positive portion is, by choice, not equal to the absolute value of the amplitude of the negative portion.

[0188] In some embodiments, the duration of the positive portion is optionally equal to the duration of the negative portion. In some embodiments, the duration of the positive portion is optionally not equal to the duration of the negative portion.

[0189] In some embodiments, the total charge given by one pulse of the positive portion is, optionally, equal to the total charge given by one pulse of the negative portion.

[0190] In some embodiments, the total charge of the positive portion of multiple pulses delivered during one pulse train is, optionally, equal to the total charge of the negative portion of multiple pulses delivered during one pulse train.

[0191] In some embodiments, each channel has optionally balanced stimuli, and the magnitude of the stimuli is equal across the two channels.

[0192] In some embodiments, each channel has optionally balanced stimuli, and the magnitudes of the stimuli are not equal between the two channels.

[0193] In some embodiments, the magnitude of the stimulation is optionally determined based on the electrode position in the heart, the electrode impedance, and the cardiac bioelectrical impedance.

[0194] Figure 3C shows two-phase pulses 346a and 346b, which, by choice, have interphase delays 350a and 350b between the positive and negative phases, and in some embodiments, have interphase delays of the same or different magnitudes between pairs of positive and negative pulses, i.e., between two-phase pulses 346a and 346b.

[0195] Now, refer to Figure 3D. This is a simplified graph of cardiac contractility-modulating stimulation by two leads, according to an exemplary embodiment.

[0196] Figure 3D shows a graph of cardiac contractility-modulating stimulation from two leads, also called channel 1 and channel 2. Figure 3D shows a graph of cardiac contractility-modulating stimulation pulses, where a sequence of n1 pulses in one channel, e.g., channel 1, is followed by a sequence of n2 pulses in the other channel, e.g., channel 2. Figure 3D shows the case where n1=n2=3, but the number of pulses does not necessarily have to be 3, and the number of pulses is not necessarily equal between different channels.

[0197] Figure 3D shows a non-restrictive example of a cardiac contractility control pulse pattern. Figure 3D is a graph with two X axes 362a and 364b representing time and a Y axis 364 representing the voltage applied to the cardiac contractility control lead. The two X axes 362a and 362b represent the time for channel 1 and channel 2, respectively. The two X axes 362a and 362b are aligned with each other. The Y axis 364 for voltage represents the voltage such that the height of the intersection of X axis 362a and Y axis 364 for channel 1 is the 0 voltage for channel 1, and the height of the intersection of X axis 362b and Y axis 364 for channel 2 is the 0 voltage for channel 2.

[0198] Figure 3D shows a set of three biphasic pulses 366a applied to channel 1 and a set of three biphasic pulses 366b applied to channel 2. In the example in Figure 3D, each biphasic pulse has a positive portion with width Φ1 and a negative portion with width Φ2.

[0199] Note that typically, the positive and negative amplitudes of a biphasic pulse are, by arbitrary choice, equal.

[0200] In some embodiments, the positive and negative amplitudes of the biphasic pulses may be unequal by choice.

[0201] Figure 3D shows that after the pulse, equilibrium phases 368a and 368b, or equilibrium periods 368a and 368b, follow for channel 1 and channel 2, respectively.

[0202] Figure 3D shows two-phase pulses 366a, 366b, in which the pulses have an interphase delay 370a, 370b between the positive and negative phases, which can be optionally selected. In some embodiments, there are interphase delays of the same or different magnitudes between pairs of positive and negative pulses, i.e., between the two-phase pulses 366a, 366b.

[0203] Next, refer to Figure 4A, which is a simplified flowchart of a method for treating the heart according to an exemplary embodiment.

[0204] The method shown in Figure 4A includes providing an implantable pulse generator (IPG) adapted to provide a combination of at least two therapeutic modalities (452), including cardiac contractility regulation therapy and another therapy selected from the group (454) consisting of cardiac pacing, cardioversion and / or defibrillation and cardiac resynchronization therapy (CRT).

[0205] In some embodiments, the therapeutic modalities are delivered together within the duration of one heartbeat.

[0206] In some embodiments, therapeutic modalities are served sequentially within the duration of one heartbeat, and when one therapeutic modality is completed, another therapeutic modality is served.

[0207] Next, refer to Figure 4B. This is a simplified flowchart of a method for treating the heart using an implantable pulse generator, according to an exemplary embodiment.

[0208] Figure 4B shows how to implant an implantable pulse generator (IPG) and select a suitable treatment modality.

[0209] The method shown in Figure 4B includes implanting an IPG having cardiac contractility modulation and at least one additional stimulation modality (432), selecting one or more preferred therapeutic modalities (434), periodically checking whether the selection of one or more modalities is correct for the patient (436), continuing the periodic checks if the modality selection is correct (436), and otherwise returning to the selection of one or more preferred therapeutic modalities (434).

[0210] In some embodiments, the selection of a preferred therapeutic modality is optionally performed by a control module, such as the therapy control module 151 shown in Figure 1B as a non-limiting example. In some embodiments, the control module optionally automatically selects a preferred treatment based on at least one of receiving data from a sensor or an external signal.

[0211] Next, refer to Figure 4C. This is a simplified flowchart of a method for treating the heart using an implantable pulse generator, according to an exemplary embodiment.

[0212] Figure 4C shows a method for providing cardiac contractility control therapy after providing defibrillation therapy.

[0213] The method in Figure 4C includes providing defibrillation therapy (402) and, after providing defibrillation therapy, providing cardiac contractility regulation therapy (404).

[0214] In some embodiments, the provision of cardiac contractility regulating therapy is optionally carried out by a control module, such as the therapy control module 151 shown in Figure 1B as a non-limiting example. In some embodiments, the control module optionally automatically selects a preferred therapy based on at least one of receiving data from a sensor or an external signal.

[0215] It should be noted that providing cardiac contractility control therapy after defibrillation may strengthen the myocardium and / or prevent or reduce the onset of arrhythmias.

[0216] In some embodiments, cardiac contractility adjustment therapy is provided a set time after defibrillation therapy.

[0217] In some embodiments, cardiac contractility adjustment therapy is provided after defibrillation therapy, at a set time interval after fibrillation is no longer detected.

[0218] In some embodiments, cardiac contractility adjustment therapy is provided after defibrillation therapy when the arrhythmia level falls below a certain threshold.

[0219] As a non-limiting example, this threshold is when the patient's ventricular premature contractions fall below 5%, 10%, 15%, and 20%.

[0220] In some embodiments, cardiac contractility adjustment therapy is provided to a patient unless the patient has not experienced an increase in PVC percentage beyond 0%, 10%, 20%, 50%, or 100% of their historical PVC percentage.

[0221] Next, refer to Figure 4D. This is a simplified flowchart of a method for treating the heart using an implantable pulse generator, according to an exemplary embodiment.

[0222] Figure 4D shows how to provide cardiac contractility control therapy after providing defibrillation therapy.

[0223] The method in Figure 4D includes providing defibrillation therapy (412), suppressing the provision of cardiac contractility control therapy after providing defibrillation therapy (414), checking whether the suppression termination condition has been met (416), initiating cardiac contractility control therapy if the termination condition has been met (418), and continuing to suppress the provision of cardiac contractility control therapy otherwise (414).

[0224] In some embodiments, checking whether the inhibition termination condition has been met is performed by a control module, such as the therapy control module 151 shown in Figure 1B as a non-limiting example.

[0225] In some embodiments, when providing anti-tachycardia pacing therapy, pacing is provided using a pulse pattern similar to "cardiac contractility regulation," as shown in Figures 3A, 3B, 3C, and 3D. For example, this involves providing a biphasic pulse with a width of 10 mS. In some embodiments, the width of the biphasic pulse is, at will, in non-limiting examples, between 1–20 ms, 5–20 ms, 8–12 ms, or 9–11 ms. In some embodiments, such therapy may potentially produce a superior anti-tachycardia effect compared to conventional methods by disrupting re-entry cycles within the heart.

[0226] Next, refer to Figure 5. This is a simplified flowchart of a method for treating the heart using an implantable pulse generator (IPG) according to an exemplary embodiment.

[0227] Figure 5 illustrates how to select a treatment modality based on an assessment of the patient's condition.

[0228] The method in Figure 5 includes assessing the patient's condition (502), selecting a treatment modality (504), and providing treatment according to the selected treatment modality (506).

[0229] In some embodiments, the assessment of the patient's condition includes determining the patient's condition based on the analysis of electrical signals acquired by a part of the IPG or sensors connected to the IPG.

[0230] In some embodiments, the assessment of the patient's condition includes determining the patient's condition based on the analysis of electrical signals acquired by sensors from an external unit that assesses the patient's condition.

[0231] In some embodiments, the analysis includes analyzing one or more of the following: ECG signals, blood pressure, bioelectrical impedance, and arrhythmias, which may be from either an implanted sensor or an external sensor.

[0232] In some embodiments, the assessment of the patient's condition includes detecting an exacerbation of the patient's condition.

[0233] In some non-limiting examples, detecting an exacerbation of a patient's condition includes, at the discretion of a physician, detecting one or more of sick sinus syndrome and / or heart failure, which, according to medical guidelines, suggests the need for cardioversion and / or defibrillation and / or cardiac resynchronization therapy and / or cardiac contractility regulation.

[0234] In some embodiments, the assessment of a patient's condition includes evaluating electrical signals using machine learning.

[0235] In some embodiments, the assessment of the patient's condition includes using input from the caregiver.

[0236] In some embodiments, the assessment of the patient's condition optionally includes the use of personal data about the patient.

[0237] In some embodiments, the assessment of the patient's condition includes using personal data about the patient, which is optionally provided as input from the caregiver.

[0238] Some embodiments include providing an IPG that offers a treatment comprising a combination of cardiac contractility regulation therapy and cardiac resynchronization therapy (CRT).

[0239] In some operational configurations, IPS optionally provides cardiac contractility regulation therapy during cardiac cycles in which IPG is programmed not to provide CRT pacing therapy.

[0240] In some operational configurations, IPG optionally provides cardiac contractility control therapy in all cardiac cycles where IPG does not provide CRT pacing.

[0241] In some operational configurations, IPG optionally provides cardiac contractility regulation therapy during certain cardiac cycles in which IPG does not offer CRT pacing therapy.

[0242] In some practice, IPG (intracardiac regulating pulse) therapy is provided for a limited period of time per day, for example, less than 5 hours per day, at the discretion of the patient.

[0243] In some practice, IPG (intravascular pulmonary pressure) therapy is selectively provided only when the heart rate is below a specific percentage, for example, below 50%, 40%, or 20% of the heart rate.

[0244] In some embodiments, the IPG provides cardiac contractility regulation therapy that optionally begins with a pulse polarity opposite to that of the CRT pacing. For example, if the CRT pacing uses positive pulses, the cardiac contractility regulation therapy may optionally be biphasic, optionally beginning with a negative pulse followed by a positive pulse.

[0245] It should be noted that applying a negative cardiac contractility regulation pulse after a positive CRT pacing signal may help balance the electrical state of the heart.

[0246] In some embodiments, the IPG optionally waits for a certain period of time, then detects spontaneous ventricular contraction, and then provides cardiac contractility-regulating therapy.

[0247] In some embodiments, the duration is in the range of 20 to 50 ms. In some embodiments, the duration is in the range of 0 to 100 ms, 0 to 50 ms, 10 to 50 ms, or 30 to 40 ms.

[0248] Some embodiments include providing an IPG that offers a treatment comprising a combination of cardiac contractility regulation therapy and pacemaker therapy.

[0249] In some embodiments, a combination of cardiac contractility regulation therapy and pacemaker therapy is used, at the discretion of choice, for the treatment of sick sinus syndrome.

[0250] In some embodiments, cardiac contractility regulation therapy is provided only during cardiac cycles triggered by a pacemaker.

[0251] In some embodiments, cardiac contractility adjustment therapy is provided during cardiac cycles that are not triggered by a pacemaker, for example, during cardiac cycles triggered by spontaneous pacing.

[0252] In some embodiments, cardiac contractility adjustment therapy is provided during a cardiac cycle that is not triggered by a pacemaker when the patient's heart rate is within a specific range. In non-limiting examples, the heart rate range is a range of 60–100, or a higher range of 100–140, or a comprehensive range of 100–140, or 45–140.

[0253] IPG can potentially analyze electrical signals from the heart to determine the heart rate in less than one beat, measure and calculate the heart rate, and determine whether cardiac contractility control therapy should be provided within that same heartbeat.

[0254] Next, refer to Figure 6A. This is a simplified flowchart of a method for providing cardiac contractility regulation therapy according to an exemplary embodiment.

[0255] The method shown in Figure 6A includes providing an implantable pulse generator (IPG) device comprising a first lead for providing cardiac contractility control therapy and a second lead for providing cardiac contractility control therapy (602), and providing cardiac contractility control therapy within the same heartbeat via the first and second leads (604).

[0256] Next, refer to Figure 6B, which is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment.

[0257] The method shown in Figure 6B includes providing cardioversion therapy (612), receiving a control signal to provide cardiac contractility regulating therapy (614), and providing cardiac contractility regulating therapy (616).

[0258] In some embodiments, cardioversion therapy provides a synchronized or timed signal, and cardiac contractility regulation therapy is optionally provided after the cardioversion signal, in some embodiments within the same heartbeat, and in some embodiments on a subsequent heartbeat.

[0259] In some embodiments, the control signals are automatically provided from a control module, such as the control module 151 shown in Figure 1B. In some embodiments, the control module measures the time between the provision of cardioversion therapy and cardiac contractility adjustment therapy.

[0260] Next, refer to Figure 6C, which is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment.

[0261] The method shown in Figure 6C includes providing cardiac contractility control therapy (618), receiving a control signal to provide cardioversion therapy (619), and stopping cardiac contractility control therapy and providing cardioversion therapy based on the reception of the signal (620).

[0262] Next, refer to Figure 6D, which is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment.

[0263] The method in Figure 6D includes providing defibrillation therapy (622), receiving a control signal for providing cardiac contractility control therapy (624), and providing cardiac contractility control therapy (626).

[0264] In some embodiments, defibrillation therapy optionally provides an asynchronous signal, and cardiac contractility modulation therapy is optionally provided, after the defibrillation signal, to the one or more heartbeats subsequent to the heartbeat for which the defibrillation signal was provided.

[0265] In some embodiments, the control signal is automatically provided from a control module, such as the control module 151 shown in FIG. 1B. In some embodiments, the control module senses when the IPG provides defibrillation during a heartbeat and automatically determines whether a control signal for providing cardiac contractility modulation therapy should be provided.

[0266] Reference is now made to FIG. 6E, which is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment.

[0267] The method of FIG. 6E includes providing cardiac contractility modulation therapy (628), receiving a control signal for providing defibrillation (629), and stopping cardiac contractility modulation therapy based on the reception of the signal and providing defibrillation therapy (630).

[0268] Reference is now made to FIG. 6F, which is a simplified flowchart of a method for providing cardiac therapy according to an exemplary embodiment.

[0269] The method of FIG. 6F includes providing cardiac resynchronization therapy (CRT) (632), receiving a control signal for providing cardiac contractility modulation therapy (634), and providing cardiac contractility modulation therapy (636).

[0270] In some embodiments, the control signal is automatically provided from a control module, such as the control module 151 shown in FIG. 1B. In some embodiments, the control module senses when the IPG provides cardiac resynchronization therapy and automatically determines whether and / or when a control signal for providing cardiac contractility modulation therapy should be provided.

[0271] Reference is now made to FIG. 6G, which is a simplified flowchart of a method for treating a heart according to an exemplary embodiment.

[0272] The method of FIG. 6G, providing (642) an implantable pulse generator (IPG) adapted to provide a combination of at least two treatment modalities comprising cardiac contractility modulation therapy and another therapy selected from the group consisting of cardiac pacing, cardioversion, defibrillation, cardioversion and defibrillation, and cardiac resynchronization therapy (CRT); detecting (644) a patient's physical condition; selecting (646) a combination of cardiac contractility modulation therapy and at least one treatment modality from the above group; providing (648) the combination of cardiac contractility modulation therapy and said at least one treatment modality; comprising.

[0273] Reference is now made to FIG. 6H, which is a simplified flowchart of a method for adding a cardiac treatment modality to an implantable pulse generator (IPG) according to an exemplary embodiment.

[0274] The method of FIG. 6H comprises adding (652) a program providing an additional treatment modality to a controller of an IPG that already has a program providing a cardiac treatment modality, and connecting (654) an additional lead associated with the additional cardiac treatment modality to the IPG. (IPG measurement of therapeutic effect during an evaluation period)

[0275] In some embodiments, the IPG optionally measures and records cardiac parameters during a specific period of time, also referred to herein as an evaluation period. The one or more cardiac parameters may reflect the efficacy of one or more treatment modalities provided by the IPG over part or all of the evaluation period.

[0276] In some embodiments, the IPG uses sensing logic or algorithms incorporated in various treatment modality circuits, for example as shown in FIG. 1B or FIG. 2.

[0277] In some embodiments, the IPG uses circuits related to various therapeutic modalities to sense, optionally analyze, optionally arrive at decisions regarding treatment delivery, and record those decisions over part or all of the evaluation period.

[0278] In some embodiments, blocks 202, 204, 205, 206, and 208 shown in Figure 2 can be used individually or in parallel to sense, analyze, and determine whether or not to provide the therapeutic modality associated with that block. Optionally, the IPG can also record this decision or statistical parameters related to the decision even if the therapeutic modality does not provide pulses associated with it.

[0279] In some embodiments, some or all of the blocks 202, 204, 205, 206, and 208 shown in Figure 2 may include a first subblock (not shown) for sensing, analyzing, and determining whether or not to provide a therapeutic modality associated with that block, and a second subblock (not shown) for providing an appropriate pulse for that therapeutic modality.

[0280] In some embodiments, a single treatment modality module, i.e., blocks 202, 204, 205, 206, and 208 in Figure 2, may optionally include multiple algorithms for determining whether or not to provide the relevant treatment, and the IPG can record each of the decisions and the identifiers of the associated algorithms.

[0281] In some embodiments, additional hardware such as timers and / or sensors and / or computer cores for parallel processing of multiple analyses may be added to the IPG.

[0282] As a non-limiting example, the defibrillation generator 205 shown in Figure 2 can be used to count the number of defibrillation decisions, both when an actual defibrillation pulse is provided and when it is not.

[0283] As another non-limiting example, the defibrillator generator 204 in Figure 2 can be used to count the number of cardioversion determinations with and without providing an actual cardioversion pulse.

[0284] The evaluation period typically spans multiple heartbeats and lasts for minutes, hours, days, weeks, months, years, or longer. Cardiac parameter values ​​reflect statistical summaries of cardiac parameters over the evaluation period. In some embodiments, the summary may include the number, frequency, mean (e.g., mean QRS duration), minimum, and maximum values ​​of cardiac events. Storing parameter summaries allows the IPG to optionally record the patient's clinical state within its limited memory. Transmitting the parameter summaries to an external device or physician may provide the benefit of at least partially analyzed clinically relevant data.

[0285] In some embodiments, the device outside the patient's body may include one or more of the following: a charger associated with the IPG, a programming device associated with the IPG, and a computer that communicates with the IPG.

[0286] In some embodiments, the selection and / or provision of a therapeutic modality and / or combination of therapeutic modalities is based on information that may optionally reflect the clinical efficacy of a therapeutic modality or multiple therapeutic modalities.

[0287] In some embodiments, the IPG includes a memory for one or more thresholds related to one or more cardiac parameters. This potentially enables the IPG to automatically select the treatment modality to be offered and / or assist the physician in making decisions.

[0288] In some embodiments, as a non-limiting example, a physician may input a first arrhythmia value when instructing the IPG to perform defibrillation or ICD treatment. The IPG can collect arrhythmia data over time and compare the collected arrhythmia data with the first arrhythmia value to demonstrate the clinical effectiveness of the treatment.

[0289] In some embodiments, the IPG can optionally automatically determine delivery of one or more specific treatment modalities using the recorded cardiac parameters. This may include continuing a treatment modality, changing to a different treatment modality, or adding a treatment modality to be delivered in addition to an ongoing treatment modality.

[0290] In some embodiments, the recorded cardiac parameters are reported to a physician, and the physician may determine delivery of a specific treatment modality by receiving the cardiac parameters collected during an evaluation period from the IPG. This may include continuing a treatment modality, changing to a different treatment modality, or adding a treatment modality to be delivered in addition to an ongoing treatment modality. The physician may instruct the IPG to deliver a specific treatment modality.

[0291] The collected cardiac information includes the following, as some non-limiting examples: Ventricular arrhythmia burden (e.g., measured as the number of arrhythmia occurrences per unit time) Atrial arrhythmia burden (e.g., measured as the number of arrhythmia occurrences per unit time) QRS complex duration (e.g., measured as one or more of average duration, minimum duration, maximum duration, and standard deviation of duration per unit time) Cardiac output (e.g., measured as one or more of average cardiac output, minimum cardiac output, maximum cardiac output, and standard deviation of cardiac output per unit time) Stroke volume (SV) (e.g., measured as one or more of average SV, minimum SV, maximum SV, and standard deviation of SV per unit time) End-diastolic volume (EDV) (e.g., measured as one or more of average EDV, minimum EDV, maximum EDV, and standard deviation of EDV per unit time) SV / EDV ratio (e.g., measured as one or more of average SV / EDV ratio, minimum SV / EDV ratio, maximum SV / EDV ratio, and standard deviation of SV / EDV ratio per unit time)

[0292] In some embodiments, the specific period can range from one day to one year, or it may be, for example, one month.

[0293] In some embodiments, the time units used for storing measurements and / or calculating measurement statistics per unit of time may be minutes, hours, days, weeks, months, or years, and may be, for example, hours or days.

[0294] In some embodiments, the selection of two or more modalities is based on cardiac information accumulated over a specific period.

[0295] In some cases, the selection is made by an external operator, which in some embodiments selects two or more modalities by receiving cardiac information accumulated from the IPG over a specific period and evaluating that cardiac information.

[0296] In some embodiments, the selection of the ICD treatment modality is made, at the discretion of the patient, based on an assessment of the patient's arrhythmia level and / or the patient's medical history.

[0297] In some embodiments, the selection of the CRT modality is based on an assessment of the duration of the QRS complex and / or the patient's medical history. As a non-limiting example, if the duration of the QRS complex exceeds 120 milliseconds, the IPG initiates the operation of the CRT modality or instructs the physician that operation of the CRT modality is desirable.

[0298] In some embodiments, the selection of a cardiac contractility modality is optional, based on the patient's level of cardiac contractility, for example, information on SV and / or EDV and / or the patient's medical history.

[0299] In some cases, patient medical history information (including, in some non-exclusive examples, hypertension, history of myocardial infarction, history of ventricular arrhythmias, history of atrial arrhythmias, BMI, blood glucose levels, NYHA class, ejection fraction, SV / EDV, age, and sex) is transmitted by the operator and stored in the device.

[0300] In some embodiments, patient medical history information is used to select two or more treatment modalities at the discretion of the patient.

[0301] In some embodiments, medical data such as those described herein may be collected in the IPG over a specific period of time.

[0302] In some embodiments, the IPG can evaluate the clinical efficacy of CRT and / or cardiac contractility modalities and select one or two treatment modalities based on the clinical efficacy of those modalities over a specific period of time.

[0303] In some embodiments, the IPG may, at its discretion, select the following combination of modalities based on the following conditions, or provide a positive adaptation. - Both ICD and CRT are selected - typically used when the use of cardiac contractility modality does not provide clinical benefit during the evaluation period. - Both ICD and cardiac contractility control are selected - This is typically used when the CRT modality does not provide clinical benefit during the evaluation period. -Select all of ICD, cardiac contractility control, and CRT- This is typically used when both the cardiac contractility control modality and the CRT modality, either alone or in combination, provide usefulness during the evaluation period.

[0304] In some embodiments, parameters measured to assess clinical utility may optionally include one or more of the following: cardiac output, NYHA class, quality of life score, mean HR, and SV / EDV ratio.

[0305] In some embodiments, clinical utility is determined by optional determination based on one or more parameter values. In some embodiments, clinical utility is determined by optional determination based on comparing one or more parameter values ​​with reference values ​​associated with the treatment modality stored in the IPG.

[0306] In some embodiments, clinical utility is determined based on an improvement in the value of one or more parameters, at the discretion of the judge.

[0307] In some embodiments, improvement in one or more parameters is considered clinically useful when it occurs without deterioration of other parameters.

[0308] In some embodiments, cardiac contractility regulation is optionally selected as one of two or more modalities.

[0309] In some embodiments, if the arrhythmia level exceeds the arrhythmia threshold, ICD therapy is optionally selected as one of two or more modalities.

[0310] In some embodiments, if the level of ventricular arrhythmia exceeds the ventricular arrhythmia threshold, ICD therapy is optionally selected as one of two or more modalities.

[0311] In some embodiments, if the atrial arrhythmia level exceeds the atrial arrhythmia threshold, ICD therapy is selected as one of two or more modalities at the discretion of the physician.

[0312] In some embodiments, if the duration of the QRS complex exceeds a threshold for QRS duration, CRT treatment is optionally selected as one of two or more modalities.

[0313] In some embodiments, if the SV / EDV ratio is lower than the SV / EDV ratio threshold, a cardiac contractility adjustment therapy modality is optionally selected as one of two or more modalities.

[0314] Additional examples of IPG indications or automated IPG treatment selection include the following: Example 1

[0315] The IPG provides defibrillation therapy (ICD), and the IPG measures at least cardiac parameters related to the effectiveness of the defibrillation therapy over the first evaluation period. IPG adds cardiac resynchronization therapy (CRT) to ICD treatment, and IPG measures at least cardiac parameters relevant to treatment efficacy over the second evaluation period. Cardiac parameters from the first and second evaluation periods are compared (by the IPG itself, by the person or programmer interacting with the IPG, by a cloud program receiving data from the IPG, or by a physician), and one of the two treatments described above is continued depending on which treatment is more effective. Example 2

[0316] Similar to Example 1 above, the first treatment is an ICD, and the second treatment is cardiac contractility regulation. Example 3

[0317] The IPG provides defibrillation therapy (ICD), and the IPG measures at least cardiac parameters related to the effectiveness of the defibrillation therapy over the first evaluation period. IPG adds two more treatments to ICD therapy: CRT and cardiac contractility regulation. IPG measures at least one cardiac parameter related to treatment efficacy over the second evaluation period. Cardiac parameters from the first and second evaluation periods are compared (by the IPG itself, by the person or programmer interacting with the IPG, by a cloud program receiving data from the IPG, or by a physician), and one of the two treatments described above is continued depending on which treatment is more effective. Example 4

[0318] IPG provides cardiac contractility-regulating therapy, and IPG measures at least cardiac parameters related to the effectiveness of cardiac contractility-regulating therapy over the first evaluation period. IPG adds ICD to cardiac contractility control therapy, and IPG measures at least cardiac parameters relevant to treatment efficacy over the second evaluation period. Cardiac parameters from the first and second evaluation periods are compared (by the IPG itself, by the person or programmer interacting with the IPG, by a cloud program receiving data from the IPG, or by a physician), and one of the two treatments described above is continued depending on which treatment is more effective. Example 5

[0319] Similar to Example 4 above, the first treatment is cardiac contractility regulation, and the second treatment is CRT. Example 6

[0320] IPG provides cardiac contractility regulation, and IPG measures at least cardiac parameters relevant to treatment efficacy over the first evaluation period. IPG adds both ICD and CRT to cardiac contractility control therapy, and IPG measures at least cardiac parameters relevant to treatment efficacy over the second evaluation period. Cardiac parameters from the first and second evaluation periods are compared (by the IPG itself, by the person or programmer interacting with the IPG, by a cloud program receiving data from the IPG, or by a physician), and one of the two treatments described above is continued depending on which treatment is more effective. Example 7

[0321] IPG provides cardiac contractility-regulating therapy, and IPG measures at least cardiac parameters related to the effectiveness of cardiac contractility-regulating therapy over the first evaluation period. If cardiac parameters related to arrhythmia are found to be above a threshold, the IPG itself, the person or programmer who interacts with the IPG, the cloud program that receives data from the IPG, or the physician will instruct and / or order the addition of ICD treatment in addition to CCM treatment. Example 8

[0322] PG provides cardiac contractility-regulating therapy, and IPG measures at least cardiac parameters related to the effectiveness of cardiac contractility-regulating therapy over the first evaluation period. If parameters related to the duration of the QRS complex wave are found to be longer than the threshold, the IPG itself, the person or programmer who interacts with the IPG, the cloud program that receives data from the IPG, or the physician will instruct and / or order the addition of CRD treatment in addition to CCM treatment.

[0323] It should be noted that in some embodiments, the IPG allows for the optional programming of a series of treatments and combinations of treatments, measurement of cardiac parameters during the evaluation period related to the treatments, and comparison of cardiac parameters related to the treatments, as described above.

[0324] In some embodiments, after the above, the IPG may suggest the potentially most beneficial treatment or combination of treatments based on the patient's cardiac parameters obtained during the series of treatments.

[0325] In some embodiments, after the above, it is possible to select the potentially most beneficial treatment or combination of treatments (by IPG or the physician) based on the patient's cardiac parameters obtained during the series of treatments.

[0326] In some embodiments, the physician optionally communicates with the IPG via a programmer or operator or control device, or via other forms of communication, to provide data such as which treatment sequence to provide, the duration of its provision, and thresholds that can even instruct changes to the treatment and actual changes to the treatment.

[0327] While it is expected that many relevant IPGs will be developed during the term of this patent application and as it matures, the scope of the term IPG is intended to a priori include such new technologies.

[0328] In this specification, the term "approximately" as used in relation to quantity or value means "within ±25%."

[0329] The terms "equipped," "includes," "contains," and "possess," as well as their conjugations, all mean "include but not limited to."

[0330] The term "consisting of" is intended to mean "including and limiting."

[0331] The term "essentially consisting of" means that the composition, method, or structure may include additional components, steps, and / or parts, but only if such additional components, steps, and / or parts do not substantially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0332] As used herein, the singular forms “a, an” and “the” can also refer to multiple units unless explicitly indicated otherwise in the context. For example, the terms “one unit” or “at least one unit” can include multiple units, including combinations thereof.

[0333] The terms “example” and “exemplary” are used herein to mean “example, example, or illustrative.” Any embodiment described as “example” or “exemplary” should not necessarily be construed as being preferable or advantageous to other embodiments, or as excluding the incorporation of features of other embodiments, or both.

[0334] The term “optionally” is used herein to mean “provided in one embodiment and not provided in another embodiment.” Any particular embodiment of the present invention may include several “optionally” features, provided that such features do not conflict with each other.

[0335] Through this application, various embodiments of the present invention may be presented in range form. It should be understood that range form descriptions are merely for convenience and simplification and should not be interpreted as a fixed and immutable limitation of the scope of the present invention. Therefore, range descriptions should be considered to specifically disclose all possible subranges, along with the individual numerical values ​​within that range. For example, a range description such as 1-6 should be considered to have specifically disclosed subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, and individual numerical values ​​within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0336] Whenever a numerical range is given herein (for example, “10 to 15”, “10 to 15”, or any pair of numbers joined by another such range), it is meant that any number (fraction or integer) within the limits of the given range is included, including the limits of that range, unless the context explicitly indicates otherwise. The phrases “to” the first and second designations and “the range of” and the phrases “to” the first designation and the second designation and “up to” the second designation, “until” the first designation and “through” the second designation (or any other word indicating such a range) are used interchangeably herein to mean that the first and second designations, as well as all fractions and integers between them, are included.

[0337] Unless otherwise indicated, the numbers used herein and any range of numbers derived therefrom are approximations within reasonable measurement and rounding error tolerances as understood by those skilled in the art.

[0338] As used herein, the term “method” means, but does not include, methods, means, techniques and procedures for accomplishing a given task, including methods, means, techniques and procedures that are known to experts in chemistry, pharmacology, biology, biochemistry and medicine, or that can be readily developed by such experts from known methods, means, techniques and procedures.

[0339] As used herein, the term “treat” includes invalidating, substantially inhibiting, delaying or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of the clinical or aesthetic symptoms of a condition.

[0340] It is understood that certain features of the present invention, even if described in the context of separate embodiments for clarity, may be combined and provided in a single embodiment. Conversely, various features of the present invention described in the context of a single embodiment for brevity may be provided separately, in any suitable partial combination, or in a manner appropriate to any other described embodiment of the present invention. Certain features described in the context of various embodiments are not considered essential features of those embodiments unless the embodiment would be inoperable without those elements.

[0341] While the present invention has been described in relation to its specific embodiments, it will be obvious to those skilled in the art that many alternatives, modifications, and variations are apparent. Therefore, the spirit of the appended claims and all such alternatives, modifications, and variations within their broad scope are intended to be encompassed.

[0342] All publications, patents, and patent applications referenced herein are intended to be incorporated herein by reference in whole, as if each individual publication, patent, and patent application were specifically and individually noted to be incorporated herein by reference. Furthermore, no citation or specification of any reference within this application should be construed as an admission that such reference is available as prior art to the present invention. Insofar as they are used in section titles, they should not necessarily be construed as restrictive. Furthermore, all priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. An implantable pulse generator (IPG), A cardiac contractility control generator circuit adapted for the provision of cardiac contractility control therapy modalities, A pacing generator circuit adapted for the provision of cardiac pacing therapy modalities, A cardioversion generator circuit adapted for the provision of the cardioversion therapeutic modality, A defibrillation pulse generator circuit suitable for providing defibrillation therapy modalities such as implantable cardioverter-defibrillators (ICDs), A cardiac resynchronization therapy (CRT) generator circuit adapted for providing the cardiac resynchronization therapy (CRT) treatment modality, To evaluate the clinical utility of providing at least one therapeutic modality among the cardiac contractility adjustment therapeutic modality, the cardiac pacing therapeutic modality, the cardioversion therapeutic modality, the defibrillation therapeutic modality, and the cardiac resynchronization therapy (CRT) therapeutic modality, a controller adapted to collect cardiac data during an evaluation period lasting several hours is provided. Equipped with, The IPG is configured to determine the clinical usefulness by comparing at least some of the cardiac data with reference data included in the IPG. The controller is adapted to give value to the clinical utility, The controller is configured to automatically provide a specific therapeutic modality selected from the cardiac contractility adjustment therapeutic modality, the cardiac pacing therapeutic modality, the cardioversion therapeutic modality, the defibrillation therapeutic modality, and the cardiac resynchronization therapy (CRT) therapeutic modality, based on the clinical utility value and the stored values ​​of cardiac parameters included in the cardiac data. Implantable pulse generator (IPG).

2. The IPG according to claim 1, wherein the IPG includes storage for storing the value of the clinical utility.

3. The IPG according to claim 1, wherein the controller is adapted to sense, analyze and determine whether the particular therapeutic modality should be provided and whether one or more of the cardiac contractility control generator circuit, the pacing generator circuit, the cardioversion generator circuit, the defibrillation pulse generator circuit, and the CRT generator circuit are used to provide the particular therapeutic modality, and is adapted to record the determination even if the circuit does not provide pulse drive.

4. The IPG according to claim 1, wherein the controller is adapted to detect a decline in the clinical usefulness of the therapeutic modality.

5. The IPG according to claim 1, wherein the controller is adapted to provide a combination of ICD and CRT treatment modalities if providing the cardiac contractility adjustment treatment modality does not provide clinical utility during the evaluation period.

6. The IPG according to claim 1, wherein the controller is adapted to provide a combination of ICD and cardiac contractility control therapy modality if the provision of the CRT therapy modality does not provide clinical utility during the evaluation period.

7. The IPG according to claim 1, wherein the controller is adapted to provide a combination of ICD, cardiac contractility adjustment, and CRT as therapeutic modalities if the provision of cardiac contractility adjustment and CRT as therapeutic modalities provides clinical utility during the evaluation period.

8. The aforementioned controller, We offer a series of treatment modalities and combinations of multiple treatment modalities. The cardiac parameters included in the cardiac data collected during the evaluation period related to the aforementioned treatment modality are measured. The cardiac parameters for the aforementioned treatment modalities were compared, Based on the patient's cardiac parameters obtained during the series, a treatment modality, or a combination of multiple treatment modalities, is selected. The IPG according to claim 1, which is programmable in this manner.

9. The IPG according to claim 8, configured to measure one or more cardiac parameters selected from the group consisting of ventricular arrhythmia level, atrial arrhythmia level, QRS complex duration, cardiac output (CO), stroke volume (SV), and end-systolic volume (EDV), and to store data relating to the cardiac parameters during the evaluation period.

10. The IPG according to claim 1, wherein the evaluation period is at least one day.

11. The IPG according to claim 1, wherein the controller is adapted to provide an ICD treatment modality when the level of ventricular arrhythmia exceeds the ventricular arrhythmia threshold.

12. The IPG according to claim 1, wherein the controller is adapted to provide a CRT treatment modality when the QRS complex wave duration exceeds a QRS duration threshold.

13. The IPG according to claim 1, wherein the controller is adapted to provide a cardiac contractility control therapy modality when the SV / EDV ratio is less than the SV / EDV ratio threshold.

14. The IPG according to claim 1, wherein the controller is adapted to control the IPG and generator circuit to switch between providing one therapeutic modality and providing another therapeutic modality.

15. The IPG according to claim 1, wherein the IPG comprises leads of dimensions that can reach the location where the therapeutic modality is provided.

16. The aforementioned IPG is a. Choosing which two treatment modalities should be offered. b. Choosing to provide a cardiac contractility adjustment therapy modality and one other therapy modality. c. To provide all treatment modalities. d. Record the patient's clinical status and transmit the status to an external device outside the patient's body. to do, The IPG according to claim 1, which is adapted to perform any one of the following.

17. The aforementioned IPG is First lead for providing cardiac contractility control therapy, A second lead to provide cardiac contractility control therapy, A therapy controller adapted to control the delivery of contractile control therapy via the first and second leads within the same heartbeat, Equipped with, The IPG according to claim 1, wherein the therapy controller is adapted to provide different cardiac contractility regulating pulses via the first lead and via the second lead.

18. The aforementioned IPG is A first lead having a shape and configuration for providing myocardial contraction control therapy to the right ventricle, A second lead having a shape and configuration for providing myocardial contraction control therapy to the right ventricle, A third lead shaped to be placed in the right atrium, It is a controller, Cardiac contractility regulation and, Cardiac pacing and, Cardio version and Defibrillation and, Cardioversion and defibrillation, Cardiac resynchronization therapy (CRT) and, A controller adapted to switch between offerings between at least two treatment modalities selected from the group consisting of, Equipped with, The IPG according to claim 1, wherein the controller is adapted to control the provision of contractility control therapy via the first lead and the second lead within the same heartbeat.

19. The IPG according to claim 17, wherein at least one of the leads comprises a shock coil and a pacing electrode within the lead.

20. The IPG according to claim 18, wherein the controller is adapted to provide pacing signals to the right ventricle through the first lead and to the right atrium through the third lead within the same heartbeat.

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