Patent Description:
An implantable cardioverter-defibrillator (ICD) is a device implantable inside the body, able to perform cardioversion and defibrillation. The ICD is a first-line treatment and prophylactic therapy for patients at risk for sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. Current devices can be programmed to detect abnormal heart rhythms and deliver therapy via programmable anti-tachycardia pacing in addition to low-energy and high-energy shocks.

Cardiac contractility modulation treatment is delivered by a pacemaker-like device that applies Non-excitatory Electrical Signals (NES), adjusted to and synchronized with electrical action in a cardiac cycle. Other than a pacemaker, which delivers an electrical signal with an intention to result in cardiac contraction, the CARDIAC CONTRACTILITY MODULATION treatment applies the NES, adjusted to and synchronized with electrical action in the cardiac cycle.

The present invention is defined in claim <NUM> and in some embodiments thereof, relates to an implantable cardiac device with two or more batteries, with at least two batteries having different attributes, suitable for different uses. In some embodiments, further relating to controlling power supply from the batteries for the various medical uses.

According to the present invention there is provided an implantable device containing a plurality of batteries, the plurality of batteries including at least one first non-rechargeable battery, and at least one second rechargeable battery.

According to the invention, the implantable device is comprised within a single housing.

According to some embodiments of the invention, the implantable device is configured so that either the first non-rechargeable battery or the second rechargeable battery may power a same output lead.

According to some embodiments of the invention, the implantable device is an Implantable Cardioversion Device (ICD).

According to some embodiments of the invention, the first non-rechargeable battery and the second rechargeable battery are attached to a same circuit board.

According to some embodiments of the invention, the first non-rechargeable battery is configured to deliver cardiac defibrillation shock powered by the first non-rechargeable battery.

According to some embodiments of the invention, the second rechargeable battery is configured to deliver Cardiac Contractility Modulation therapy powered by the second rechargeable battery. According to some embodiments of the invention, the second rechargeable battery is configured to deliver cardiac pacing powered by the second rechargeable battery.

According to some embodiments of the invention, further including a processor for measuring electric signals and controlling supplying power for an electric circuit between the first non-rechargeable battery and the second rechargeable battery.

According to some embodiments of the invention, the processor is configured to measure a patient's vital signs. According to some embodiments of the invention, the processor is configured to measure a patient's physiological parameter.

According to some embodiments of the invention, the processor is configured to use electric power from the second rechargeable battery.

According to some embodiments of the invention, the first non-rechargeable battery is an ICD battery.

According to some embodiments of the invention, if the electric power level of the rechargeable battery is less than the first threshold then setting an alert to recharge the rechargeable battery.

According to some embodiments of the invention, the first threshold is at a higher level than the second threshold.

According to some embodiments of the invention, the first threshold is equal to the second threshold.

According to some embodiments of the invention, if the electric power level of the rechargeable battery is less than a third threshold then setting an alert to recharge the rechargeable battery.

According to some embodiments of the invention, the third threshold is at a higher level than the first threshold.

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, such as switching power supply between batteries of different types in an implantable device, 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.

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings and images. With specific reference now to the drawings and images 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 and images makes apparent to those skilled in the art how embodiments of the invention may be practiced.

The present invention, in some embodiments thereof, relates to an implantable cardiac device with a long power supply life, high longevity and, more particularly, but not exclusively to a Cardiac Contractility Modulation device with high longevity, and, yet more particularly, but not exclusively, to an implantable Cardioverter Defibrillator plus Cardiac Contractility Modulation device with high longevity.

The term "cell" in all its grammatical forms is used in the present application and claims to describe an electric power source of all types, the source including a chemical cell, a rechargeable cell, a non-rechargeable cell, a primary cell, a secondary cell, and even a capacitor and/or a super capacitor and/or an ultra-capacitor.

The terms "cell" and "battery" in all their grammatical forms are used interchangeably in the present application and claims to describe an electric power source which includes one or more cells.

In some embodiments, two batteries are included in an implantable device, one battery for low current operations and one battery for high current operations.

In some embodiments, more than two batteries are included.

Some potential advantages of using two batteries are included in an implantable device, one battery for low current operations and one battery for high current operations include:
Using a rechargeable battery for low current uses such as Cardiac Contractility Modulation therapy, sensing, VT/VF detection, housekeeping, communications, can potentially keep more electric energy stored in a non-rechargeable battery for uses which draw higher current, such cardioversion and/or defibrillation.

Having a non-rechargeable battery in an implantable device potentially provides backup electric power for low current uses such as Cardiac Contractility Modulation therapy, sensing, VT/VF detection, housekeeping, communications, if a rechargeable battery charge level is below a specific threshold. In some embodiments when a controller detects that the rechargeable battery is below the specific threshold the controller switches providing electric power to some or all the low current uses from the non-rechargeable battery. In some embodiments when a controller detects that the rechargeable battery is back above the specific threshold, for example by the rechargeable battery having been recharged, the controller switches providing electric power to some or all the low current back to the rechargeable battery.

When describing two or more batteries, it is noted that in some embodiments the batteries may have the same attributes, and in some embodiments the batteries may have different attributes.

An aspect of the invention relates to managing the use of multiple batteries.

Some non-limiting examples of managing multiple batteries are described below, using language referring to a non-limiting example of one non-rechargeable battery and one rechargeable battery.

In some embodiments, power for low current functions is provided only by a rechargeable battery, and when the rechargeable battery charge reaches a threshold, changes are made to management of the low current functions. Some non-limiting examples of such management changes include:.

It is noted that when the rechargeable battery is recharged, functions which were sacrificed are optionally restarted. The methods described herein for gradual sacrificing of functions based on gradual reduction of battery power are optionally used in the opposite direction, by restarting functions based on gradual increase of battery power.

In some embodiments, the method for managing which function is powered by which battery is optionally a static method, that is, specific functions are powered by a specific battery, and when that battery does not have enough power, the functions of that battery are not performed.

In some embodiments, the method for managing which function is powered by which battery is optionally a dynamic method, that is, specific functions are initially powered by a specific battery, and when that battery does not have enough power, some or all of the functions of that battery may optionally be transferred to another battery. by way of a non-limiting example some sensing functions, typically powered by a rechargeable battery, may be provided power from a non-rechargeable battery, for example sensing and/monitoring a patient's need for shock therapy may be provided power from a non-rechargeable battery so that such shock therapy can be initiated when needed.

In some embodiments, a non-rechargeable battery is kept disconnected from the implantable device until its power is determined to be needed. Such disconnection potentially extends the non-rechargeable battery charge.

By way of a non-limiting example, the following table describes gradual progression of reducing electric power use from a rechargeable battery for various implantable device functions:.

Some non-limiting example embodiments of life-saving functions which are relevant to the above table include: cardioversion, defibrillation in case of VF and/or VT, pacing in patients that have AV block and/or AV ablation, pacing in patients that have sick sinus syndrome. In some embodiments VF and/or VT are detected by the device. In some embodiments AV block and/or AV ablation are conditions which are known in advance of implanting the device, and optionally set as a known parameter for managing battery use in the implantable device.

Some non-limiting example embodiments of non-life-saving functions which are relevant to the above table include: housekeeping (as described elsewhere herein), Cardiac Contractility Modulation, CRT, bio impedance sensing and blood pressure sensing.

In some embodiments, and not necessarily all embodiments, a rechargeable battery is typically used for electrical sensing, for example sensing for implantable devices like ICD, pacemaker, CRT and Cardiac Contractility Modulation, and/or for delivering pacing or stimulation energy needed for cardiac pacing and Cardiac Contractility Modulation stimulation, and/or computing in an implantable device, and/or decision making in an implantable device.

According to the inventory, a non-rechargeable battery is used for performing Cardioversion or defibrillation.

In some embodiments, two different types of battery are optionally used simultaneously for a same operation.

In some embodiments, two different types of battery are optionally used simultaneously for different operations.

In some embodiments, two different types of battery are optionally used simultaneously when a first rechargeable battery does not have enough energy for a needed operation and a second non-rechargeable battery is used to provide the additional energy needed.

In some embodiments, if a capacitor is charged for defibrillation and/or cardioversion, and sensing determines that the defibrillation and/or cardioversion are not needed any more, at least some of the electric charge in the capacitor is optionally used for recharging a rechargeable battery.

In some embodiments, Cardiac Contractility Modulation operation is optionally stopped in order to keep enough energy in a rechargeable battery for <NUM>-<NUM> days of pacing.

In some embodiments, energy deflation of a first permanent battery is optionally reduced by keeping an electrical potential difference between the first battery poles at a specific value by using power from second rechargeable battery.

In some embodiments, three batteries are optionally used, for example a rechargeable battery, optionally a low current battery; a non-rechargeable battery, optionally a high current non-rechargeable battery; and a capacitor or super capacitor.

A non-limiting example embodiment of the invention includes a combined Cardiac Contractility Modulation and ICD implantable device that incorporates a first rechargeable battery and a second non-rechargeable battery. In the device, as long as a patient is compliant with recharging instructions, power for one or more of Cardiac Contractility Modulation therapy, sensing, VT/VF detection, pacing and housekeeping operations is provided by the first rechargeable battery, and the second battery is optionally disconnected, potentially maximizing the second battery's availability when needed.

In practice, first type implantable-grade rechargeable batteries (e.g. Lithium-ion) are typically capable of delivering relatively small currents (e.g. <NUM> mA maximum), while there are second type small, implantable-grade batteries capable of high current operation (e.g. Li-SVO or hybrid Li-CFx/SVO). As such, as long as there is enough charge in the first type rechargeable battery, operations with low current demand (e.g. Cardiac Contractility Modulation therapy, sensing, VT/VF detection, pacing, housekeeping, communications, etc.) are powered from the first type rechargeable battery.

When cardioversion or defibrillation is required, energy is taken from the second type high current non-rechargeable battery.

When insufficient charge is left in the first type rechargeable battery due to non-compliance or battery depletion, power for the life-support operations (including those which have low current demand such as sensing, pacing, VT/VF detection, etc.) is optionally taken from the second type non-rechargeable battery.

A setup as described above potentially maximizes longevity of the implantable device by making use of the second type non-rechargeable battery to a minimum without placing the patient in danger when the first type rechargeable battery becomes discharged.

In some embodiments, an ICD module is designed to be powered from two implantable-grade batteries:.

During normal operation of the device, when the Li-ion battery has sufficient charge to power sensing, VT/VF detection and housekeeping operations, the ICD Module optionally derives power from the rechargeable battery to allow minimum use of the high current battery's charge.

Energy for ATP, defibrillation, induction, cardioversion, and post-shock Brady pacing is derived from a high current non-rechargeable battery.

In some embodiments when the Li-ion battery does not have sufficient charge to power sensing, then the ICD Module optionally derives power for sensing, VT/VF detection and ICD-specific housekeeping operations from the high current Lithium non-rechargeable battery.

Reference is now made to <FIG>, which is a simplified illustration of an example embodiment of the invention.

<FIG> shows an implantable device housing <NUM> containing two batteries <NUM><NUM>. <FIG> is intended to illustrate that more than one battery <NUM><NUM> may be included in an implantable device housing <NUM>.

In some embodiments, the batteries <NUM><NUM> are optionally attached to a same circuit board.

<FIG> shows an implantable device housing 100A containing three batteries <NUM><NUM><NUM>. <FIG> is intended to illustrate that more than two batteries may be included in an implantable device housing 100A, for example three batteries <NUM><NUM><NUM>, and even more.

In some embodiments, the batteries <NUM><NUM><NUM>, and optionally even more, are optionally attached to a same circuit board.

Further example embodiments will be described with reference to two batteries, with an intention that persons skilled in the art will understand how to implement similar embodiments with more than two batteries.

<FIG> shows an implantable device housing 100B containing two batteries <NUM><NUM>, each one of the batteries optionally powering a different output lead <NUM><NUM>.

The term lead is used in the present application and claims to describe an electric conductor and/or electrode.

In some embodiments, a first battery <NUM> optionally provides power to a first output lead <NUM>, for operations requiring electric power for which the first battery <NUM> is designed.

In some embodiments, a second battery <NUM> optionally provides power to a second output lead <NUM>, for operations requiring electric power for which the second battery <NUM> is designed.

<FIG> is intended to illustrate that the two batteries <NUM><NUM> may be powering two different leads <NUM><NUM> in parallel.

<FIG> shows an implantable device housing 100C containing two batteries <NUM><NUM>, each one of the batteries optionally supplying power 104A 105A to a controller <NUM>, which optionally controls power output to an output lead <NUM>.

<FIG> is intended to illustrate that the two batteries <NUM><NUM> may be powering a single output lead <NUM>.

In some embodiments the controller <NUM> optionally provides power from a selected one of the two batteries <NUM><NUM> to the output lead <NUM> according to an operation which the controller optionally selects to perform.

In some embodiments the controller <NUM> optionally provides power from both of the two batteries <NUM><NUM> to the output lead <NUM> according to an operation which the controller optionally selects to perform.

In some embodiments the controller <NUM> optionally provides power from a not-depleted battery to the output lead <NUM> when one of the batteries <NUM><NUM> is sensed to be depleted.

In some embodiments, the controller <NUM> optionally provides power from a higher current battery, for example battery <NUM>, to the output lead <NUM> when a lower current battery, for example battery <NUM>, is sensed to be depleted.

In some embodiments operation of the controller <NUM> itself is optionally powered by a lower-current battery, for example battery <NUM>.

Reference is now made to <FIG>, which is a simplified block diagram schematic illustration of an example embodiment of the invention.

<FIG> shows a block diagram schematic illustration <NUM> of an example embodiment of the invention.

The example embodiment of <FIG> shows a simplified circuit illustration <NUM> of a Cardiac Contractility Modulation Implantable Cardioverter Defibrillator (ICD) device including:.

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for providing power for a Cardiac Contractility Modulation Implantable Cardioverter Defibrillator (ICD) device according to an example embodiment of the invention.

In some embodiments, a micro-controller is used for sensing when the second battery cannot provide power for an operation powered by the second battery, and providing power from the first battery for the operation.

The first battery is a non-rechargeable battery.

The second battery is a rechargeable battery.

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for controlling power for an Implantable Cardioverter Defibrillator (ICD) device not in accordance with the invention.

The method of <FIG> is suitable for use in controlling power in an ICD and for controlling power in an ICD which includes additional module configurations such as pacing, Cardiac Contractility Modulation stimulation, sensing, VT/VF detection, housekeeping, communications, operation of non-electric shock components in the implantable device, etc..

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for controlling power for an Implantable Cardioverter Defibrillator (ICD) device.

The method of <FIG> includes:
comparing a rechargeable battery level to a first threshold (<NUM>);.

In some variants, the first threshold mentioned above with reference to <FIG> is greater than the second threshold mentioned above with reference to <FIG>.

In some variants, the first threshold and the second threshold mentioned above with reference to <FIG> are equal.

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for controlling power for an ICD (Cardiac Contractility Modulation plus Implantable Cardioverter Defibrillator) device according to an example embodiment of the invention.

In some embodiments, the first threshold mentioned above with reference to <FIG> is greater than the second threshold mentioned above with reference to <FIG>.

In some embodiments, the second threshold mentioned above with reference to <FIG> is greater than the third threshold mentioned above with reference to <FIG>.

In some embodiments, two or more of the first threshold, the second threshold, and the third threshold mentioned above with reference to <FIG> are equal.

In some embodiments if the electric power level of the rechargeable battery is not greater than the second threshold (<NUM>) then optionally producing a second alert,. The second alert optionally indicates that operation of Cardiac Contractility Modulation treatment has been stopped, potentially indicating urgency to recharging the rechargeable battery.

In some embodiments, if the electric power level of the rechargeable battery is not greater than the third threshold (<NUM>) then optionally producing a third alert. The third alert optionally indicates that operation of ICD has been switched to the non-rechargeable battery, potentially indicating urgency to recharging the rechargeable battery.

The method of <FIG> is suitable for use in controlling power in an ICD, for controlling power in an ICD plus Cardiac Contractility Modulation configuration, and for controlling power in an ICD which includes additional module configurations such as a pacemaker, sensing, VT/VF detection, housekeeping, communications, operation of non-electric shock components in the implantable device, etc..

Reference is now made to <FIG>, which is a simplified flow chart illustration of a method for controlling power for an ICD plus a sensing and/or monitoring configuration according to an example embodiment of the invention.

For example, the term "a unit" or "at least one unit" may include a plurality of units, including combinations thereof.

The words "example" and "exemplary" are used herein to mean "serving as an example, instance or illustration". Any embodiment described as an "example or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.

Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from <NUM> to <NUM> should be considered to have specifically disclosed sub-ranges such as from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM> etc., as well as individual numbers within that range, for example, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

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.

Claim 1:
An implantable device containing a plurality of batteries, the plurality of batteries comprising:
at least one first non-rechargeable battery (<NUM>); and
at least one second rechargeable battery (<NUM>),
wherein the implantable device is comprised within a single housing (<NUM>); and
wherein said second rechargeable battery (<NUM>) has a first state where its charge level is above a first threshold and a second state where its charge level is at or below said first threshold,
characterized in that:
said implantable device is configured to deliver cardiac electrical shock for a first therapy and powered by said first non-rechargeable battery (<NUM>) when said second rechargeable battery (<NUM>) is in said first state and when said second rechargeable battery (<NUM>) is in said second state, said first therapy being one of cardioversion therapy and defibrillation therapy; and
said implantable device is configured to deliver a second therapy powered by said second rechargeable battery (<NUM>) when said second rechargeable battery (<NUM>) is in said first state, said second therapy being one of Cardiac Contractility Modulation therapy and cardiac pacing therapy;
said implantable device is configured to use said rechargeable battery (<NUM>), when in said first state, for powering sensing for said first therapy and for powering sensing for said second therapy.