His bundle pacing and cardiac contractility modulation treatment

Abstract

The present invention discloses means and methods of providing pacing treatment and Cardiac Contractility Modulation treatment and, more particularly, but not exclusively, to means and method of providing His Bundle Pacing (HBP) treatment and Cardiac Contractility Modulation treatment.

Description

[0001] HIS BUNDLE PACING AND CARDIAC CONTRACTILITY MODULATION TREATMENT

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 609,920 filed on December 14, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to means and method of providing pacing treatment and Cardiac Contractility Modulation treatment and, more particularly, but not exclusively, to means and method of providing His Bundle Pacing (HBP) treatment and Cardiac Contractility Modulation treatment.

[0006] The bundle of His (or His bundle) is an elongated connecting segment between the AV Node and the branching point of the left and right bundle branches. The length of the His bundle is approximately 1.8 cm long in the matured heart. His bundle pacing (HBP) is an alternative approach to RV and biventricular pacing and is used to activate the native His-Purkinje system, thus maintain the physiological pattern of ventricular activation. Placing leads at the His bundle location is more challenging due to the need to accurately place the electrodes in proximity of the His bundle. The placement requires electroanatomic mapping to identify the location and measurement of the electrogram morphology at multiple sites to determine the best location.

[0007] Additional background art includes U.S. Patent No. US 10926095B2 disclosing systems and methods for pacing cardiac conductive tissue consisting of a medical system including an electrostimulation circuit to generate His-bundle pacing (HBP) pulses for delivery at or near a His bundle of the heart. A control circuit may time the delivery of the HBP pulses within a tissue refractory period subsequent to an intrinsic His-bundle activation of a first His-bundle portion. Based on an evoked His-bundle activation of a second His-bundle portion, the system may determine whether correction of intra-Hisian block has occurred. The system additionally includes a threshold test circuit to determine an individualized pacing threshold representing minimal energy to excite the His bundle and to correct the cardiac conduction abnormality.

[0008] U.S. Patent No. US11547859B2 disclosing an implantable medical device system that receives a cardiac electrical signal produced by a patient's heart and comprising atrial P-waves and delivers a His bundle pacing pulse to the patient's heart via a His pacing electrode vector. The system determines a timing of a sensed atrial P-wave relative to the His bundle pacing pulse and determines a type of capture of the His bundle pacing pulse in response to the determined timing of the atrial P-wave. SUMMARY OF THE INVENTION

[0009] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0010] Example 1. A method of providing cardiac treatment, comprising: a. implanting a first lead at a location close to the His bundle or close to the Purkinje fibers; b. providing pacing treatment via said first lead; and c. providing Cardiac Contractility Modulation treatment.

[0011] Example 2. The method according to example 1, wherein said providing said Cardiac Contractility Modulation treatment comprises providing said Cardiac Contractility Modulation treatment via said first lead.

[0012] Example 3. The method according to example 1 or example 2, wherein said implanting said first lead comprises implanting said first lead near a location close to the His bundle.

[0013] Example 4. The method according to any one of examples 1-3, wherein said implanting said first lead comprises implanting said first lead near a left Purkinje fibers branch.

[0014] Example 5. The method according to any one of examples 1-4, wherein said implanting said first lead comprises implanting said first lead near a right Purkinje fibers branch.

[0015] Example 6. The method according to any one of examples 1-5, wherein Cardiac Contractility Modulation treatment comprises providing an effective amount of non-excitatory electrical heart failure therapy; said providing said effective amount comprises providing a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, at a time that the ventricle is in its absolute refractory period.

[0016] Example 7. The method according to any one of examples 1-6, further comprising implanting at least one additional lead at a location within a right ventricle (RV).

[0017] Example 8. The method according to any one of examples 1-7, further comprising providing at least one more treatment via said at least one additional lead.

[0018] Example 9. The method according to any one of examples 1-8, wherein said at least one more treatment comprises providing Cardiac Contractility Modulation treatment.

[0019] Example 10. The method according to any one of examples 1-9, wherein said at least one more treatment comprises providing pacing treatment.

[0020] Example 11. The method according to any one of examples 1-10, wherein said at least one more treatment comprises providing defibrillation treatment. Example 12. The method according to any one of examples 1-11, wherein when said at least one additional lead provides said pacing treatment, the method further comprises providing said pacing treatment by said at least one additional lead with a delay from said pacing treatment provided by said first lead.

[0021] Example 13. The method according to any one of examples 1-12, wherein said location within said right ventricle is one or more of an RV septum or RV Apex.

[0022] Example 14. The method according to any one of examples 1-13, further comprising providing said at least one additional lead with one or more defibrillation coils to provide said defibrillation treatment.

[0023] Example 15. The method according to any one of examples 1-14, wherein when said at least one additional lead provides said Cardiac Contractility Modulation treatment, the method further comprises providing said Cardiac Contractility Modulation treatment by said at least one additional lead with a delay from said Cardiac Contractility Modulation treatment provided by said first lead. Example 16. The method according to any one of examples 1-15, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment following a pacing pulse within a said cardiac cycle.

[0024] Example 17. The method according to any one of examples 1-16, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment after a time delay of between 5ms to 75ms following a pacing pulse within a said cardiac cycle.

[0025] Example 18. The method according to any one of examples 1-17, wherein said Cardiac Contractility Modulation treatment is used for said pacing treatment.

[0026] Example 19. The method according to any one of examples 1-18, further comprising measuring intra cardiac electrogram signals using said first lead.

[0027] Example 20. The method according to any one of examples 1-19, further comprising measuring intra cardiac electrogram signals using said at least one additional lead.

[0028] Example 21. The method according to any one of examples 1-20, further comprising: a. comparing intra cardiac electrogram signals from said first lead and said at least one additional lead; b. identifying if there is a bundle branch block.

[0029] Example 22. The method according to any one of examples 1-23, wherein when more than one lead is implanted, said method further comprises providing said Cardiac Contractility Modulation treatment in one or more of the following treatment modes: a. only one lead provides Cardiac Contractility Modulation treatment at a certain time; b. two or more leads provide Cardiac Contractility Modulation treatment contemporarily; c. two or more leads provide Cardiac Contractility Modulation treatment sequentially.

[0030] Example 23. A system for providing cardiac therapy to a patient, comprising: a. a first lead configured to be implanted at a location close to His bundle or close to the Purkinje fibers; and b. an implantable controller, said controller configured to carry out a method of providing pacing treatment via said first lead and providing Cardiac Contractility Modulation treatment.

[0031] Example 24. The system according to example 23, wherein said providing Cardiac Contractility Modulation treatment comprises providing Cardiac Contractility Modulation treatment via said first lead.

[0032] Example 25. The system according to example 23 or example 24, wherein said implanting said first lead comprises implanting said first lead near a location close to the His bundle.

[0033] Example 26. The system according to any one of examples 23-25, wherein said implanting said first lead comprises implanting said first lead near a left Purkinje fibers branch.

[0034] Example 27. The system according to any one of examples 23-26, wherein said implanting said first lead comprises implanting said first lead near a right Purkinje fibers branch.

[0035] Example 28. The system according to any one of examples 23-27, wherein Cardiac Contractility Modulation treatment comprises providing an effective amount of non-excitatory electrical heart failure therapy; said providing said effective amount comprises providing a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, at a time that the ventricle is in its absolute refractory period.

[0036] Example 29. The system according to any one of examples 23-28, further comprising at least one additional lead configured to be implanted at a location within a right ventricle (RV).

[0037] Example 30. The system according to any one of examples 23-29, wherein said controller is further configured to carry out said method which further comprises providing at least one more treatment via said at least one additional lead.

[0038] Example 31. The system according to any one of examples 23-30, wherein said at least one more treatment comprises providing Cardiac Contractility Modulation treatment.

[0039] Example 32. The system according to any one of examples 23-31, wherein said at least one more treatment comprises providing pacing treatment.

[0040] Example 33. The system according to any one of examples 23-32, wherein said at least one more treatment comprises providing defibrillation treatment. Example 34. The system according to any one of examples 23-33, wherein when said at least one additional lead provides said pacing treatment, the method further comprises providing said pacing treatment by said at least one additional lead with a delay from said pacing treatment provided by said first lead.

[0041] Example 35. The system according to any one of examples 23-34, wherein said location within said right ventricle is one or more of an RV septum or RV Apex.

[0042] Example 36. The system according to any one of examples 23-35, wherein said at least one additional lead comprises one or more defibrillation coils to provide said defibrillation treatment. Example 37. The system according to any one of examples 23-36, wherein when said second lead provides said Cardiac Contractility Modulation treatment, the method further comprises providing said Cardiac Contractility Modulation treatment by said at least one additional lead with a delay from said Cardiac Contractility Modulation treatment provided by said first lead.

[0043] Example 38. The system according to any one of examples 23-37, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment following a pacing pulse within a cardiac cycle.

[0044] Example 39. The system according to any one of examples 23-38, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment after a time delay of between 5ms to 75ms following a pacing pulse within a cardiac cycle.

[0045] Example 40. The system according to any one of examples 23-39, wherein said Cardiac Contractility Modulation treatment is used for said pacing treatment.

[0046] Example 41. The system according to any one of examples 23-40, wherein said method further comprises measuring intra cardiac electrogram signals using said first lead and said at least one additional lead.

[0047] Example 42. The system according to any one of examples 23-41, further comprising: a. comparing intra cardiac electrogram signals from said first lead and said at least one additional lead; b. identifying if there is a bundle branch block.

[0048] Example 43. The system according to any one of examples 23-42, wherein when more than one lead is implanted, said method further comprises providing said Cardiac Contractility Modulation treatment in one or more of the following treatment modes: a. only one lead provides Cardiac Contractility Modulation treatment at a certain time; b. two or more leads provide Cardiac Contractility Modulation treatment contemporarily; c. two or more leads provide Cardiac Contractility Modulation treatment sequentially. Example 44. A method of providing cardiac treatment, comprising: a. implanting a first lead at a location close to the His bundle or close to the Purkinje fibers; b. implanting a second lead at a location within a right ventricle (RV); c. providing pacing treatment via said first lead; and d. providing Cardiac Contractility Modulation treatment via said second lead.

[0049] Example 45. A system for providing cardiac therapy to a patient, comprising: a. a first lead configured to be implanted at a location close to His bundle or close to the Purkinje fibers; b. a second lead configured to be implanted at a location within a right ventricle (RV); and c. an implantable controller, said controller configured to carry out a method of providing pacing treatment via said first lead and providing Cardiac Contractility Modulation treatment via said second lead.

[0050] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0051] As will be appreciated by one skilled in the art, some embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and / or system of some embodiments of the invention can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and / or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and / or by a combination thereof, e.g., using an operating system.

[0052] For example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and / or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is provided as well. A display and / or a user input device such as a keyboard or mouse are optionally provided as well.

[0053] Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0054] A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0055] Program code embodied on a computer readable medium and / or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0056] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0057] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0058] These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function / act specified in the flowchart and / or block diagram block or blocks.

[0059] The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0060] Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, might be expected to use completely different methods, e.g., making use of expert knowledge and / or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

[0061] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0062] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0063] In the drawings:

[0064] Figure la is a schematic block diagram of an exemplary cardiac therapy device 100, in accordance with some embodiments of the invention;

[0065] Figure lb is a schematic diagram of an exemplary implantable cardiac device 120, according to some embodiments of the invention;

[0066] Figure 1c is a schematic diagram of an exemplary implantable cardiac device 120 configured to function also as cardioverter defibrillator (ICD), according to some embodiments of the invention;

[0067] Figure 2a is a schematic representation of exemplary locations for positioning two leads, according to some embodiments of the invention;

[0068] Figure 2b is a schematic representation of exemplary locations for positioning three leads, according to some embodiments of the invention;

[0069] Figure 2c is a schematic representation of exemplary locations for positioning two leads, according to some embodiments of the invention;

[0070] Figure 2d is a schematic representation of an exemplary location for positioning one lead, according to some embodiments of the invention;

[0071] Figure 3 a is a schematic representation of a monophasic pulse and a biphasic pacing pulse, according to some embodiments of the invention; and

[0072] Figure 3b is a schematic representation of a Cardiac Contractility Modulation pulse, according to some embodiments of the invention;

[0073] Figure 4 is a flowchart of an exemplary method of providing heart treatment to a patient.

[0074] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0075] The present invention, in some embodiments thereof, relates to means and method of providing pacing treatment and / or Cardiac Contractility Modulation treatment and, more particularly, but not exclusively, to means and method of providing His Bundle Pacing (HBP) treatment and / or Cardiac Contractility Modulation treatment.

[0076] Overview

[0077] An aspect of some embodiments of the invention relates to providing pacing treatment and / or Cardiac Contractility Modulation treatment, while the pacing is provided in proximity of the bundle of His (also referred to His Bundle Pacing) and the Cardiac Contractility Modulation treatment is provided in proximity of the bundle of His and / or at a different location. In some embodiments, an implantable pulse generator (IPG) provides the His Bundle Pacing (HBP) treatment and the Cardiac Contractility Modulation treatment. In some embodiments, the IPG comprises at least one lead placed in proximity of the His bundle (also referred as His bundle lead) or in proximity of the left Purkinje fiber branch (Left Bundle Branch or “LBB”) and is configured for providing one or more of: “physiological” cardiac pacing, which includes prompt activation of the left ventricle, and Cardiac Contractility Modulation stimulation. In some embodiments, a second lead (also referred as RV lead) is placed in the Right ventricle (RV), for example, located in the RV septum or Apex. In some embodiments, the second RV lead (RVL) may also have a defibrillation coil. In some embodiments, cardiac pacing is done by providing one or more pacing pulses to the His bundle lead (HBL). In some embodiments the HBL or the RVL may be located in proximity of the Left Bundle Branch in order to stimulate the Left Bundle Branch (LBB). In some embodiments, cardiac pacing can be done by providing pacing pulses to both HBL and RVL. In some embodiments, when providing pacing pulses to both HBL and RVL, the providing comprises a delay between the timing of the pacing pulse in the HBL and in the RVL. In some embodiments, Cardiac Contractility Modulation stimulation is delivered through the HBL, the RVL or both. In some embodiments, when providing Cardiac Contractility Modulation stimulation via both HBL and RVL, the providing comprises a delay between the timing of the Cardiac Contractility Modulation pulse in the HBL and in the RVL. In some embodiments, Cardiac Contractility Modulation stimulation can be delivered following delivery of a pacing pulse within the same cardiac cycle. Typically the Cardiac Contractility Modulation stimulation is delivered after a time delay (typically 5-75 ms) from the provision of the pacing pulse. In some embodiments, such pacing pulse can be done using the HBL, the RVL or in both leads. In some embodiments, optionally, a detection of the R-wave is performed before providing the Cardiac Contractility Modulation stimulation. In some embodiments, the Cardiac Contractility Modulation stimulation parameters are a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, optionally at a time that the ventricle is in its absolute refractory period (e.g., 20 to 50ms after the start of electrical depolarization). In some embodiments, the HBL and the RVL provide pacing and / or Cardiac Contractility Modulation stimulation. In some embodiments, a controller comprises instructions to assess which lead provides pacing and which lead provides Cardiac Contractility Modulation, or both. In some embodiments, one or more of the HBL and RVL are used to measure intra cardiac electrogram signals. In some embodiments, by comparing the intra cardiac electrogram signals, the system identifies if there is a bundle branch block in one of the branches, including Right Bundle Branch Block (RBBB) or Left Bundle Branch Block (LBBB). In some embodiments, if a patient is found to suffer from RBBB, then the system provides dual pacing of HBL and RVL. In some embodiments, if a patient is found to suffer from LBBB, a lead is placed in the RV septum, in proximity of the Left Bundle Branch.

[0078] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0079] Referring now to Figure la showing a schematic block diagram of an exemplary cardiac therapy device 100, in accordance with some embodiments of the invention.

[0080] In some embodiments, an exemplary cardiac device 100, as shown, includes one or more leads 102 (optionally two leads), which are optionally couplable to device 100 at one or more can connectors (not shown). In some embodiments, one lead is connected to the location where the Bundle of His is located in the right atrium, while another lead (or more than one lead) is connected at a location in the right ventricle. In the following explanations, the lead connected to the location where the Bundle of His is located in the right atrium will be referred to His bundle lead or HBL, while the lead connected at a location in the right ventricle will be referred to RV lead or RVL.

[0081] A pulse generator 104 is optionally used to generate the signal, for example, including a power circuitry, for example, including one or more storage capacitors.

[0082] In some embodiments of the invention, a ventricular detector 106 is provided and used to detect atypical ventricular activation, which can be a contra-indication to signal application.

[0083] In some embodiments of the invention, optionally, an atrial detector 108 is provided and used to detect atypical atrial activation, which may be used as an input to decision making by device 100.

[0084] A sensor input 110 may receive data from one or more sensors, for example electrical sensors or other sensors, such as flow, pressure and / or acceleration sensors. Data from the sensors are optionally further processed (e.g., by a controller 112 and / or detectors 106, 108) and are optionally be used as an input to decision making processes in device 100.

[0085] A controller 112 is optionally provided and executes one or more logics to decide, for example, a timing and / or other parameters of a signal and / or if a signal is to be applied.

[0086] In some embodiments, the controller controls the applying of stimulation pulses according to the treatment plan. Optionally, the controller effects a change in the plan, for example so as to compensate for real time deviations from the treatment plan (e.g., a skipped stimulation).

[0087] A memory 114 is optionally provided, for example, to store logic, past effects, therapeutic plan, adverse events, and / or pulse parameters.

[0088] In some embodiments, the controller and / or memory are programmed with one or more treatment plans (optionally set for the specific patient) and / or with one or more fallback treatment plans.

[0089] In some embodiments, instructions for “compensating” for a change from the planned treatment are stored and are addressed by the device controller when relevant, including for example modifications in treatment duration, number of stimulations, stimulation signal parameters (e.g., current intensity), and / or other modifications which may be applied to compensate for a real time change in the original plan. In some embodiments, the instructions include numerical factors according to which one or more parameters of treatment are modified. In some examples, the instructions may include: a factor by which the stimulation current intensity should be multiplied in case the actual applied stimulations did not reach the target amount of energy; a factor by which output voltage should be modulated to result in the desired current intensity; a factor by which the stimulation rate should be multiplied in case the actual applied stimulation did not reach the target total number of stimulations (optionally within a set time period); time related modifications such as factors by which the treatment session duration should be lengthened in case a target was not reached; and the like.

[0090] In some embodiments, the controller refers to a look-up table or the like which ties between specific situations (e.g., a skipped stimulation, number of actual stimulations delivered being lower than planned, etc.) and the instructions for compensating for that situation (e.g., by updating one or more parameters, such as updating the length of a treatment session).

[0091] A logger 116 is optionally provided to store activities of device 100 and / or of the patient. Such a log and / or programming may use a communication module 118 (e.g., of a type known in the art) to send data from device 100, for example, to a programmer (not shown) and / or to receive data, for example, programming, for example, pulse parameters. Referring now to Figure lb, showing a schematic diagram of an exemplary implantable cardiac device 120, according to some embodiments of the invention.

[0092] In some embodiments, the device is configured for performing a plurality of actions, for example, one or more of:

[0093] 1. Configured for delivery of cardiac electrical stimulation, such as Cardiac Contractility Modulation stimulation.

[0094] 2. Configured to function as a pacing device, preferably as a His Bundle Pacing (HBP) device that performs His Bundle Pacing (HBP).

[0095] In some embodiments, the device comprises an HBP lead 122 (also referred as His bundle lead or HBL), and a Cardiac Contractility Modulation lead 124.

[0096] In some embodiments, the device comprises a power source (e.g., a battery 132) and power source management circuitry 134. In some embodiments, the device optionally comprises a battery recharge and power regulation unit 160 configured for configured for recharging the rechargeable battery (when one is used) and for regulating the power between batteries. In some embodiments, the device comprises a pacing pulse generator 156 that is controlled by a pacing control unit 158. In some embodiments, activation of the one or more cardiac contractility modulation lead(s) 124, which are optionally positioned in the right ventricle (RVL), is by a cardiac contractility modulation module which includes or is connected to: Cardiac Contractility Modulation control 142, a Cardiac Contractility Modulation generator 144.

[0097] In some embodiments, the leads are connected to isolation 146, which are also passed through one or more (two are shown) RV sense 138, 140.

[0098] In some embodiments, the device comprises a housekeeping module 148, which includes or is connected to one or more sensor such as a temperature sensor 150, a magnetic sensor 152, and communication means 154 such as an antenna, a receiver and the like. Other sensors may include flow sensors, pressure sensors, acceleration sensors, and / or other transducers.

[0099] In some embodiments, data received from the one or more sensors are received as input. Optionally, the input is processed by the device control (e.g., by the cardiac contractility modulation control, and / or a general controller, not shown) and is optionally used as input to decision making processes in device 120.

[0100] In some embodiments, the device control (e.g., the Cardiac Contractility Modulation control, and / or a general controller, not shown) executes one or more logics to decide, for example, a timing and / or other parameters of a signal and / or if a signal is to be applied.

[0101] A memory (not shown) is optionally provided, for example, to store logic, past effects, therapeutic plan, adverse events and / or pulse parameters. A logger (not shown) is optionally provided to store activities of device 120 and / or of the patient. Such a log and / or programming may use a communication module 154 to send data from device 120, for example, to a programmer (not shown) and / or to receive data, for example, programming, for example, pulse parameters.

[0102] Referring now to Figure 1c, showing a schematic diagram of an exemplary implantable cardiac device 120 configured to function also as cardioverter defibrillator (ICD), according to some embodiments of the invention.

[0103] In some embodiments, the device is configured for performing a plurality of actions, for example, one or more of:

[0104] 1. Configured for delivery of cardiac electrical stimulation, such as Cardiac Contractility Modulation stimulation.

[0105] 2. Configured to function as cardioverter defibrillator (ICD).

[0106] 3. Configured to function as a pacing device, preferably as a His Bundle Pacing (HBP) device that performs His Bundle Pacing (HBP).

[0107] In some embodiments, the device comprises an HBP lead 122 (also referred as His bundle lead or HBL), and a Cardiac Contractility Modulation lead 124. In some embodiments, the Cardiac Contractility Modulation lead 124 is also used as an ICD lead.

[0108] In some embodiments, activation of the ICD lead is by an ICD module which includes or is connected to: ICD control 126, a defibrillation pulse generator 128 (via one or more capacitors 130), a power source (e.g., a battery 132) and power source management circuitry 134, and ICD sense 136 which senses an applied pulse to verify the pulse is within a selected (e.g., programmed) amplitude and / or duration. In some embodiments, the device optionally comprises a battery recharge and power regulation unit 160 configured for recharging the rechargeable battery (when one is used) and for regulating the power between batteries. In some embodiments, the device comprises a pacing pulse generator 156 that is controlled by a pacing control unit (not shown). In some embodiments, activation of the one or more cardiac contractility modulation lead(s) 124, which are optionally positioned in the right ventricle, is by a cardiac contractility modulation module which includes or is connected to: Cardiac Contractility Modulation control 142, a Cardiac Contractility Modulation generator 144.

[0109] It is noted that in some embodiments, the ICD coil and one more electrodes for pacing and / or cardiac contractility modulation are configured on the same lead.

[0110] In some embodiments, the leads are connected to isolation 146, which are also passed through one or more (two are shown) RV sense 138, 140. In some embodiments, the device comprises a housekeeping module 148, which includes or is connected to one or more sensor such as a temperature sensor 150, a magnetic sensor 152, and communication means 154 such as an antenna, a receiver and the like. Other sensors may include flow sensors, pressure sensors, acceleration sensors, and / or other transducers.

[0111] In some embodiments, data received from the one or more sensors are received as input. Optionally, the input is processed by the device control (e.g., by the ICD control, cardiac contractility modulation control, and / or a general controller, not shown) and is optionally used as input to decision making processes in device 120.

[0112] In some embodiments, the device control (e.g., the ICD control, Cardiac Contractility Modulation control, and / or a general controller, not shown) executes one or more logics to decide, for example, a timing and / or other parameters of a signal and / or if a signal is to be applied.

[0113] A memory (not shown) is optionally provided, for example, to store logic, past effects, therapeutic plan, adverse events and / or pulse parameters.

[0114] A logger (not shown) is optionally provided to store activities of device 120 and / or of the patient. Such a log and / or programming may use a communication module 154 to send data from device 120, for example, to a programmer (not shown) and / or to receive data, for example, programming, for example, pulse parameters.

[0115] Exemplary positioning of leads

[0116] Referring now to Figures 2a-2d, showing schematic representation of exemplary locations for positioning leads, according to some embodiments of the invention. Same part are provided with same reference numbers.

[0117] In some embodiments, one or more leads are positioned within the heart of the patient.

[0118] In some embodiments, an exemplary cardiac therapy device 100 (or implantable pulse generator - IPG) comprises 2 leads, as shown for example in Figure 2a:

[0119] 1. An HBP lead 122 (also referred as His bundle lead or HBE) connected to a location within the heart in proximity of the His bundle 202 or in proximity of the left Purkinje fiber branch (Eeft Bundle Branch or EBB); and

[0120] 2. A Cardiac Contractility Modulation lead 124, optionally connected to a location 204 within the right ventricle (also referred as RV lead or RVE).

[0121] In some embodiments, the HBL is positioned either from the right atrium (RA) or from the right ventricle (RV).

[0122] In some embodiments, the RVE is used for providing Cardiac Contractility Modulation and / or pacing. In some embodiments, the HBL is used for pacing and optionally also for Cardiac Contractility Modulation.

[0123] In some embodiments, Cardiac Contractility Modulation treatment is provided by any of the leads. In some embodiments, Cardiac Contractility Modulation treatment can be provided by one or more of the leads in more than one fashion, for example in one or more of the following fashions:

[0124] 1. Only one lead provides Cardiac Contractility Modulation treatment at a certain time;

[0125] 2. Cardiac Contractility Modulation treatment is provided simultaneously via the two leads;

[0126] 3. Cardiac Contractility Modulation treatment is provided sequentially via the two leads.

[0127] In some embodiments, an exemplary cardiac therapy device 100 (or implantable pulse generator - IPG) comprises 3 leads, as shown for example in Figure 2b:

[0128] 1. An HBL 122 connected to a location within the heart close to the His bundle 202 or in proximity of the left Purkinje fiber branch (Left Bundle Branch or LBB); and

[0129] 2. Two RVLs 124 and 206, connected to two locations 204 and 208 within the right ventricle, for example located in the RV septum and Apex.

[0130] In some embodiments, the HBL is positioned either from the right atrium (RA) or from the right ventricle (RV).

[0131] In some embodiments, either RVL is used for providing Cardiac Contractility Modulation and / or pacing.

[0132] In some embodiments, the HBL is used for pacing and optionally also for Cardiac Contractility Modulation.

[0133] In some embodiments, Cardiac Contractility Modulation treatment is provided by any of the leads. In some embodiments, Cardiac Contractility Modulation treatment can be provided by one or more of the leads in more than one fashion, for example in one or more of the following fashions:

[0134] 1. Only one lead provides Cardiac Contractility Modulation treatment at a certain time;

[0135] 2. Cardiac Contractility Modulation treatment is provided simultaneously via two leads or three leads;

[0136] 3. Cardiac Contractility Modulation treatment is provided sequentially via two leads or three leads.

[0137] In some embodiments, an exemplary cardiac therapy device 100 (or implantable pulse generator - IPG) comprises 2 leads, as shown for example in Figure 2c:

[0138] 1. An HBL connected to a location within the heart close to the His bundle 202 or in proximity of the left Purkinje fiber branch (Left Bundle Branch or LBB); and 2. An RVL 124, connected to a location 204 within the right ventricle.

[0139] In some embodiments, the HBL is positioned wither from the right atrium (RA) or from the right ventricle (RV). In some embodiments, the HBL is used for pacing and optionally also for Cardiac Contractility Modulation.

[0140] In some embodiments, the RVL is used for providing Cardiac Contractility Modulation and / or pacing and / or defibrillation. In some embodiments, the RVL further comprises a single RV coil 210, or dual RV coils having one RV coil 210 within the RV and an additional RV coil 212 in the Superior Vena Cava (SVC).

[0141] In some embodiments, Cardiac Contractility Modulation treatment is provided by any of the leads. In some embodiments, Cardiac Contractility Modulation treatment can be provided by one or more of the leads in more than one fashion, for example in one or more of the following fashions:

[0142] 1. Only one lead provides Cardiac Contractility Modulation treatment at a certain time;

[0143] 2. Cardiac Contractility Modulation treatment is provided simultaneously via the two leads;

[0144] 3. Cardiac Contractility Modulation treatment is provided sequentially via the two leads.

[0145] In some embodiments, an exemplary cardiac therapy device 100 (or implantable pulse generator - IPG) comprises 1 lead, as shown for example in Figure 2d:

[0146] 1. An HBL 122 connected to a location within the heart close to the His bundle 202 or in proximity of the left Purkinje fiber branch (Left Bundle Branch or LBB).

[0147] In some embodiments, the HBL is positioned either from the right atrium (RA) or from the right ventricle (RV). In some embodiments, the HBL is used for pacing and also for Cardiac Contractility Modulation.

[0148] Exemplary activation of the exemplary cardiac therapy device 100

[0149] In some embodiments, as mentioned above, an exemplary cardiac therapy device is configured for providing pacing treatment and / or Cardiac Contractility Modulation treatment and / or optionally defibrillation treatment, while the pacing is provided through a bundle of His (His Bundle Pacing) and the Cardiac Contractility Modulation treatment is provided at the bundle of His and / or at a different location, for example at the right ventricle (RV).

[0150] Exemplary pacing

[0151] In some embodiments, the exemplary cardiac therapy device is configured for providing “physiological” cardiac pacing, which includes prompt activation of the left ventricle. In some embodiments, cardiac pacing is done by providing one or more pacing pulses to the His bundle lead (HBL), which may be alternatively located to stimulate the Left Bundle Branch (LBB). In some embodiments, cardiac pacing can be done by providing pacing pulses to both HBL and RVL. In some embodiments, when providing pacing pulses to both HBL and RVL, the providing comprises a delay between the timing of the pacing pulse in the HBL and in the RVL.

[0152] Exemplary Cardiac Contractility Modulation stimulation

[0153] In some embodiments, Cardiac Contractility Modulation stimulation is delivered through the HBL, the RVL or both. In some embodiments, when providing Cardiac Contractility Modulation stimulation via both HBL and RVL, the providing comprises a delay between the timing of the Cardiac Contractility Modulation pulse in the HBL and in the RVL. In some embodiments, Cardiac Contractility Modulation stimulation is delivered following delivery of a pacing pulse within the same cardiac cycle. In some embodiments, the Cardiac Contractility Modulation stimulation is delivered after a time delay (typically 5-75 ms) from the provision of the pacing pulse. In some embodiments, optionally, a detection of the R-wave is performed before the delay. In some embodiments, the Cardiac Contractility Modulation stimulation pulse is used for the HBP. In some embodiments, Cardiac Contractility Modulation stimulation comprises monophasic pulses or biphasic pulses, as shown for example in Figure 3a. In some embodiments, the Cardiac Contractility Modulation consists of a pulse train of 2 to 4 biphasic pulses, where each biphasic pulse has a duration of 10 to 14 ms, and a pulse amplitude of +7.5V, as shown for example in Figure 3b. In some embodiments, the Cardiac Contractility Modulation stimulation parameters are a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, optionally at a time that the ventricle is in its absolute refractory period (e.g., 20 to 50ms after the start of electrical depolarization).

[0154] Exemplary general features

[0155] In some embodiments, the HBL provides pacing while the RVL provides Cardiac Contractility Modulation. In some embodiments, the RVL provides pacing and the HBL provides Cardiac Contractility Modulation. In some embodiments, a controller comprises instructions to assess which lead provides pacing and which lead provides Cardiac Contractility Modulation, or both. In some embodiments, one or more of the HBL and RVL are used to measure intra cardiac electrogram signals. In some embodiments, by comparing the intra cardiac electrogram signals, the system identifies if there is a bundle branch block in one of the branches, including Right Bundle Branch Block (RBBB) or Left Bundle Branch Block (LBBB). In some embodiments, if a patient is found to suffer from RBBB, then the system provides dual pacing of HBL and RVL. In some embodiments, if a patient is found to suffer from LBBB, a lead is placed in the RV septum, in proximity of the Left Bundle Branch.

[0156] Exemplary methods

[0157] Referring now to Figure 4, showing a flowchart of an exemplary method of providing heart treatment to a patient, according to some embodiments of the invention. In some embodiments, exemplary methods include one or more of the following actions:

[0158] 1. Implanting a first lead at a location close to His bundle (402);

[0159] 2. Providing pacing treatment via said first lead (404); and

[0160] 3. Providing Cardiac Contractility Modulation treatment (406).

[0161] In some embodiments, providing Cardiac Contractility Modulation treatment comprises providing said Cardiac Contractility Modulation treatment via said first lead. In some embodiments, implanting the first lead comprises implanting the first lead near a left Purkinje fiber branch. In some embodiments, Cardiac Contractility Modulation treatment comprises providing an effective amount of non-excitatory electrical heart failure therapy; said providing said effective amount comprises providing a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, at a time that the ventricle is in its absolute refractory period. In some embodiments, the method further comprises implanting at least one additional lead at a location within a right ventricle (RV). In some embodiments, the method further comprises providing at least one more treatment via the at least one additional lead. In some embodiments, the at least one more treatment comprises providing Cardiac Contractility Modulation treatment. In some embodiments, the at least one more treatment comprises providing pacing treatment. In some embodiments, the at least one more treatment comprises providing defibrillation treatment. In some embodiments, when the at least one additional lead provides pacing treatment, the method further comprises providing pacing treatment by the at least one additional lead with a delay from the pacing treatment provided by the first lead. In some embodiments, the location within said right ventricle is one or more of an RV septum or RV Apex. In some embodiments, the method further comprises providing the at least one additional lead with one or more defibrillation coils to provide the defibrillation treatment. In some embodiments, when the at least one additional lead provides the Cardiac Contractility Modulation treatment, the method further comprises providing the Cardiac Contractility Modulation treatment by the at least one additional lead with a delay from the Cardiac Contractility Modulation treatment provided by the first lead. In some embodiments, providing the Cardiac Contractility Modulation treatment further comprises providing the Cardiac Contractility Modulation treatment following a pacing pulse within a the cardiac cycle. In some embodiments, providing the Cardiac Contractility Modulation treatment further comprises providing the Cardiac Contractility Modulation treatment after a time delay of between 5ms to 75ms following a pacing pulse within a said cardiac cycle. In some embodiments, the Cardiac Contractility Modulation treatment is used for said pacing treatment. In some embodiments, the method further comprises measuring using said first lead and said second lead intra cardiac electrogram signals. In some embodiments, the method further comprises one or more of comparing intra cardiac electrogram signals from said first lead and said second lead, and identifying if there is a bundle branch block. In some embodiments, when more than one lead is implanted, the method further comprises providing the Cardiac Contractility Modulation treatment in one or more of the following treatment modes: a. only one lead provides Cardiac Contractility Modulation treatment at a certain time; b. two or more leads provide Cardiac Contractility Modulation treatment contemporarily; c. two or more leads provide Cardiac Contractility Modulation treatment sequentially.

[0162] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0163] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0164] The term “consisting of’ means “including and limited to”.

[0165] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0166] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0167] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0168] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0169] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0170] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0171] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0172] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0173] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

1. A method of providing cardiac treatment, comprising:a. implanting a first lead at a location close to the His bundle or close to the Purkinje fibers;b. providing pacing treatment via said first lead; andc. providing Cardiac Contractility Modulation treatment.

2. The method according to claim 1, wherein said providing said Cardiac Contractility Modulation treatment comprises providing said Cardiac Contractility Modulation treatment via said first lead.

3. The method according to claim 1 or claim 2, wherein said implanting said first lead comprises implanting said first lead near a location close to the His bundle.

4. The method according to any one of claims 1-3, wherein said implanting said first lead comprises implanting said first lead near a left Purkinje fibers branch.

5. The method according to any one of claims 1-4, wherein said implanting said first lead comprises implanting said first lead near a right Purkinje fibers branch.

6. The method according to any one of claims 1-5, wherein Cardiac Contractility Modulation treatment comprises providing an effective amount of non-excitatory electrical heart failure therapy; said providing said effective amount comprises providing a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, at a time that the ventricle is in its absolute refractory period.

7. The method according to claim 1, further comprising implanting at least one additional lead at a location within a right ventricle (RV).

8. The method according to claim 7, further comprising providing at least one more treatment via said at least one additional lead.

249. The method according to claim 8, wherein said at least one more treatment comprises providing Cardiac Contractility Modulation treatment.

10. The method according to claim 8, wherein said at least one more treatment comprises providing pacing treatment.

11. The method according to claim 8, wherein said at least one more treatment comprises providing defibrillation treatment.

12. The method according to claim 10, wherein when said at least one additional lead provides said pacing treatment, the method further comprises providing said pacing treatment by said at least one additional lead with a delay from said pacing treatment provided by said first lead.

13. The method according to claim 8, wherein said location within said right ventricle is one or more of an RV septum or RV Apex.

14. The method according to claim 11, further comprising providing said at least one additional lead with one or more defibrillation coils to provide said defibrillation treatment.

15. The method according to claim 9, wherein when said at least one additional lead provides said Cardiac Contractility Modulation treatment, the method further comprises providing said Cardiac Contractility Modulation treatment by said at least one additional lead with a delay from said Cardiac Contractility Modulation treatment provided by said first lead.

16. The method according to any one of claims 1-15, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment following a pacing pulse within a said cardiac cycle.

17. The method according to any one of claims 1-16, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment after a time delay of between 5ms to 75ms following a pacing pulse within a said cardiac cycle.2518. The method according to any one of claims 1-17, wherein said Cardiac Contractility Modulation treatment is used for said pacing treatment.

19. The method according to claim 7, further comprising measuring intra cardiac electrogram signals using said first lead.

20. The method according to claim 7, further comprising measuring intra cardiac electrogram signals using said at least one additional lead.

21. The method according to claim 19 or claim 20, further comprising:a. comparing intra cardiac electrogram signals from said first lead and said at least one additional lead;b. identifying if there is a bundle branch block.

22. The method according to claim 7, wherein when more than one lead is implanted, said method further comprises providing said Cardiac Contractility Modulation treatment in one or more of the following treatment modes:a. only one lead provides Cardiac Contractility Modulation treatment at a certain time;b. two or more leads provide Cardiac Contractility Modulation treatment contemporarily;c. two or more leads provide Cardiac Contractility Modulation treatment sequentially.

23. A system for providing cardiac therapy to a patient, comprising:a. a first lead configured to be implanted at a location close to His bundle or close to the Purkinje fibers; andb. an implantable controller, said controller configured to carry out a method of providing pacing treatment via said first lead and providing Cardiac Contractility Modulation treatment.

24. The system according to claim 23, wherein said providing Cardiac Contractility Modulation treatment comprises providing Cardiac Contractility Modulation treatment via said first lead.

25. The system according to claim 23 or claim 24, wherein said implanting said first lead comprises implanting said first lead near a location close to the His bundle.2626. The system according to any one of claims 23-25, wherein said implanting said first lead comprises implanting said first lead near a left Purkinje fibers branch.

27. The system according to any one of claims 23-26, wherein said implanting said first lead comprises implanting said first lead near a right Purkinje fibers branch.

28. The system according to any one of claims 23-27, wherein Cardiac Contractility Modulation treatment comprises providing an effective amount of non-excitatory electrical heart failure therapy; said providing said effective amount comprises providing a biphasic pulse amplitude of from about +1V to about +9V, a biphasic pulse width of from about 4ms to about 10ms duration per phase, and from 1 to 4 biphasic pulses per cardiac cycle, at a time that the ventricle is in its absolute refractory period.

29. The system according to any one of claims 23-28, further comprising at least one additional lead configured to be implanted at a location within a right ventricle (RV).

30. The system according to claim 29, wherein said controller is further configured to carry out said method which further comprises providing at least one more treatment via said at least one additional lead.

31. The system according to claim 30, wherein said at least one more treatment comprises providing Cardiac Contractility Modulation treatment.

32. The system according to claim 30, wherein said at least one more treatment comprises providing pacing treatment.

33. The system according to claim 30, wherein said at least one more treatment comprises providing defibrillation treatment.

34. The system according to claim 29, wherein when said at least one additional lead provides said pacing treatment, the method further comprises providing said pacing treatment by said at least one additional lead with a delay from said pacing treatment provided by said first lead.2735. The system according to claim 29, wherein said location within said right ventricle is one or more of an RV septum or RV Apex.

36. The system according to claim 29, wherein said at least one additional lead comprises one or more defibrillation coils to provide said defibrillation treatment.

37. The system according to claim 29, wherein when said second lead provides said Cardiac Contractility Modulation treatment, the method further comprises providing said Cardiac Contractility Modulation treatment by said at least one additional lead with a delay from said Cardiac Contractility Modulation treatment provided by said first lead.

38. The system according to any one of claims 23-37, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment following a pacing pulse within a cardiac cycle.

39. The system according to any one of claims 23-38, wherein said providing said Cardiac Contractility Modulation treatment further comprises providing said Cardiac Contractility Modulation treatment after a time delay of between 5ms to 75ms following a pacing pulse within a cardiac cycle.

40. The system according to any one of claims 23-39, wherein said Cardiac Contractility Modulation treatment is used for said pacing treatment.

41. The system according to claim 29, wherein said method further comprises measuring intra cardiac electrogram signals using said first lead and said at least one additional lead.

42. The system according to claim 41, further comprising:a. comparing intra cardiac electrogram signals from said first lead and said at least one additional lead;b. identifying if there is a bundle branch block.2843. The system according to claim 29, wherein when more than one lead is implanted, said method further comprises providing said Cardiac Contractility Modulation treatment in one or more of the following treatment modes:a. only one lead provides Cardiac Contractility Modulation treatment at a certain time;b. two or more leads provide Cardiac Contractility Modulation treatment contemporarily;c. two or more leads provide Cardiac Contractility Modulation treatment sequentially.

44. A method of providing cardiac treatment, comprising:a. implanting a first lead at a location close to the His bundle or close to the Purkinje fibers;b. implanting a second lead at a location within a right ventricle (RV);c. providing pacing treatment via said first lead; andd. providing Cardiac Contractility Modulation treatment via said second lead.

45. A system for providing cardiac therapy to a patient, comprising:a. a first lead configured to be implanted at a location close to His bundle or close to the Purkinje fibers;b. a second lead configured to be implanted at a location within a right ventricle (RV); andc. an implantable controller, said controller configured to carry out a method of providing pacing treatment via said first lead and providing Cardiac Contractility Modulation treatment via said second lead.

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