Use of multiple wearable electrical apparatuses

Abstract

The invention relates to optionally wearable electrical apparatus that may be battery powered and which may contain heat dissipating components that can require cooling, that may be worn or used for an extended period of time. The electrical apparatus can require that parts of the electrical apparatus are replaced as embedded resources are depleted. Kits of parts can be used to configure systems with electrical apparatuses in suitable configurations.

Description

USE OF MULTIPLE WEARABLE ELECTRICAL APPARATUSESTechnical Field

[0001] The invention relates to wearable electric systems for generating a high-power signal where parts of a system can be replaced while the system is in use.Background

[0002] There are many situations in which a person may need to wear a powered electrical device for an extended period of time. For example, various medical therapies are administered in the form of electrical stimulation.

[0003] As any powered electrical device without a constant external power supply will eventually deplete its stored energy or other relevant resources, there will be a need to replace parts of the system at some intervals to replenish the available resources. An example would be to replace a depleted battery pack with a fresh one.

[0004] Powered electrical devices will, due to the imperfect efficiency of any electrical system, generate waste heat. This excess heat must, if non-trivial, be managed such that the wearer is not exposed to elevated temperatures. Examples of such management techniques include actively venting the heat to the ambient air with a fan, and passively venting heat to the ambient air by having exposed surfaces, fins, or other heat sink(s) where ambient air can absorb and convect heat away.

[0005] Temperatures for enclosure surfaces (exterior surfaces and parts thereof) for some devices, such as medical devices, must typically not exceed certain limits according to relevant regulatory requirements, and this applies to wearable such devices. In the case of medical devices, according to IEC 60601-1, 3rdedition, the surface temperature must not surpass 41 °C for prolonged use, or 43 °C in some circumstances if information is provided, on safety grounds.

[0006] Whether a part is accessible to a user is determined, e.g., by probing with the 'Test finger' specified in IEC 60601-1, 3rded, where the tip has a radius as short as 2 mm (with 4 mm tip radius in the direction normal to that short radius).

[0007] For skin contact of 'applied parts' (that in normal use necessarily come into physical contact with the patient), the shortest intervals do not apply, and the shortest are e.g., 51 °C for metal < 1 min, and 60 °C for plastic < 1 min.

[0008] Thermal limits are also specified for other types of hand-held or wearable devices, e.g., in IEC 62368-1 which is applicable to battery powered AV / ICT products such as mobile phones and might not be the same as the ones referred to above.

[0009] One example of a high-powered wearable device worn for an extended period of time is equipment for delivering Tumor Treating Fields (TTFields). TTFields treatment systems are used todeliver electrical fields, typically oscillating in the 100 kHz - 300 kHz range (AC, typically sine wave, e.g., 150 kHz for mesothelioma and non-small cell lung cancer, or e.g., 200 kHz for glioblastoma), or 50 kHz- 500 kHz, through electrically insulated electrodes (capacitively coupling with a subject's body) attached to the body, with a preferred field strength between the electrodes of at least 1 V / cm (measured as peak voltage, or RMS), or 1-5 V / cm, where the purpose of the fields is to treat any tumors within the tissue. Electrodes are typically replaced about every three or four days. Typically, the delivery happens alternatingly through two pairs of transducer arrays (electrodes), with switching between directions represented by the two pairs happening every 250 ms or 1 sec. They typically have a battery to power the field generator while not connected to an external power source such as mains power. TTFields are used predominantly for solid tumor treatment and are preferably used at least 75% of the time, for best clinical results.Summary of the Invention

[0010] According to one embodiment of the present invention, a kit is provided that can be used to configure a system 100, where the kit contains a first electrical apparatus that can generate a first output signal, with a generator, and the kit also contains a second electrical apparatus that can be used to generate a second output signal, with its generator, where there is a means of communication 308 from the first electrical apparatus to the second. The first electrical apparatus can generate an output signal, and also collect information 312 that is useful for configuring the generation of a signal output. This information 312 can be transmitted through the means of communication 308 to the second electrical apparatus, such that it can be used to configure the output generation of the second apparatus.

[0011] According to some embodiments, the output signals can be TTFields signals 153.

[0012] According to some embodiments, the output signals can contain a frequency between 100 kHz and 500 kHz.

[0013] According to some embodiments, the system 100 is wearable.

[0014] According to some embodiments, the first and / or the second output signal can be configured to have a peak voltage of at least 50 V.

[0015] According to some embodiments, the first and / or the second output signal can be configured to have a peak output power of 20 W when a signal is on.

[0016] According to some embodiments, the first and second electrical apparatuses can be unitary electrical apparatuses 144, each containing a battery pack 103.

[0017] According to some embodiments, the first and second electrical apparatuses can be unitary electrical apparatuses 144, each containing a heat sink 104.

[0018] According to some embodiments, the first and second electrical apparatuses can be electrical apparatuses 135, each containing a generator 102.

[0019] According to some embodiments, the information 312 contains information related to temperatures associated with the first electrical apparatus.

[0020] According to some embodiments, the information 312 contains information related to tissue impedance.

[0021] According to some embodiments of a kit, the second electrical apparatus can be configured to output a signal as part of a system 100 only when the first electrical apparatus is configured not to output a signal.

[0022] According to some embodiments of a kit, the first and second electrical apparatuses are configured to take turns outputting a respective signal.

[0023] According to some embodiments of a kit, the kit also contains a central repository 314 that has means of communication 308 with each of the first and second electrical apparatuses, where information 312 that can be useful for directing and configuring the output of a signal, useful for creating an electrode location map, useful documenting a record of compliance with the treatment protocol, and / or useful for raising an alert or error message.

[0024] According to some embidments of a kit 133 for putting together a system 100 to generate a signal, the kit can contain first and second electrical apparatuses, each with a generator that can be configured to output a signal, as well as a first means of communication 308 from the first electrical apparatus to a central repository 314, where the first electrical apparatus can generate a signal and collect information 312, and then transmit the information 312 through the means of communication, and a second means of communication 314 can similarly transmit information from the second electrical apparatus, and the first and second electrical apparatus are used to generate output signals for an extended period of time to the same patient.

[0025] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features and advantages of the invention will be apparent from the descriptions and drawings, and from the modes and claims.Brief Description of the Drawings

[0026] Fig. 1 is an illustration, in accordance with one embodiment, of a system 100 having an electrical apparatus 135, in turn having a generator 102, and a replaceable module 101, several electrodes 130 and an optional external power source 126. The replaceable module 101 in turn has a heat sink 104 with two reservoirs 105, and five battery cells 114 in a battery pack 103. A heat path 110 carries heat energy from a heat interface 107 (not shown) of an interface 106 on the replaceable module 102 to thereservoirs 105. The generator 102 also has an interface 106, with a thermal interface 107 (also not shown).

[0027] Fig. 2 shows an embodiment of a kit 133 with several different types of replaceable modules 101 (a) having five battery cells, b) having two battery cells, c) having no battery cell but additional PCM material, d) having a fan), as well as a generator 102 and a detachable heat sink apparatus 125, the latter having a fan (powered by a replaceable module) and heat sink fins.

[0028] Fig. 3 is an illustration, in accordance with one embodiment, of a system 100 having a unitary electrical apparatus 144 connected to four electrodes 130.

[0029] Fig. 4 is an illustration, in accordance with one embodiment, of a unitary electrical apparatus 144 having a user-replaceable battery pack 103. An enclosure lid 318 is kept in place with two screws 316, removal of which can permit the insertion or removal of a battery pack 103. (In some embodiments, additional internal components can slide in or out during replacement).

[0030] Fig. 5 is an illustration, in accordance with one embodiment, of an electrical apparatus 135, containing a generator 102, and containing a memory 197 for storing information 312 and a controller 196 that can process the information. The electrical apparatus is connected by a means of communication 308a (e.g„ a cable, which in some embodiments can carry other channels as well, for example for a TTFields signal 153) to a node 150 and indirectly through the node to an electrode 130. (The node 150 and the electrode 130 each containing a memory 197). The electrical apparatus 135 is connected by a (wireless) means of communication 308b to a server 302 and is connected by a (wireless) means of communication 308c to a mobile app 301.

[0031] Fig. 6 is an illustration, in accordance with one embodiment, of a unitary electrical apparatus 144, containing a generator, and containing a memory 197 for storing information 312 and a controller 196 that can process the information. The unitary electrical apparatus is connected by a means of communication 308a (e.g„ a cable, which in some embodiments can carry other channels as well, for example for a TTFields signal 153) to an electrode 130. The unitary electrical apparatus 144 is connected by a (wireless) means of communication 308b to a server 302 and is connected by a (wireless) means of communication 308c to a mobile app 301.

[0032] Fig. 7 is an illustration, in accordance with one embodiment, of a kit 133 comprising two unitary electrical apparatuses 144 (a) and b)), each with high capacity (four battery cells 114), as well as a unitary electrical apparatus 144 (c)) with lower capacity (two battery cells 114).

[0033] Fig. 8 is an illustration, in accordance with one embodiment, of a ramping voltage envelope 175 over time that is delivered to a generator 102, showing two bursts 181 where the ramping of the voltage envelope 175 has a lower limit (3.3V). The TTFields signal 153 is generated within the voltage envelope 175 (shown only for the first two bursts 181). The frequency of the TTFields signal 153 in the illustration is significantly lower than typical TTFields signal 153 frequencies, and is show for illustration clarity only.

[0034] Fig. 9 is an illustration, accordance with one embodiment, of a kit 133 used to configure a system 100, where two unitary electrical apparatuses 144a and 144b, connected to each other by a means of connection 308a, as well as to central repository 314 by a respective means of connection 308b and 308c.Detailed description of the invention

[0035] The technical problem relates to wearable electric equipment that can be used for an extended period of time. In some embodiments, the wearable electric equipment can provide a signal or energy to the human body. Sustained use might require or make desirable that some or all parts of the wearable electric equipment to be removed or replaced during use. Sustained use might also benefit from using multiple parts of the same, similar or different types at the same time, as the multiple parts could each contribute some of the resources and capacities contained or embedded in them, where in some embodiments not all of the multiple parts are strictly necessary to include in order for the other parts to be configurable to deliver a basic signal and deliver it to a human body. The usage might require uninterrupted operation of the wearable electric equipment or permit shorter (e.g., seconds, minutes, hours) or longer (e.g., hours, days, weeks) intervals during which use is limited or not operating in its entirety, during such times replacement can conveniently be performed. The parts to be removed or replaced might include, e.g., battery packs (replaced with e.g., fully charged battery packs), cooling mechanisms (e.g., replaced with similar parts with non-depleted cooling capacity), generators and similar. In some embodiments, sometimes a single part is replaced, sometimes several parts can be replaced at essentially the same time. The embodiments disclosed herein include beneficial solutions that permit such changes and can benefit the operation of the wearable electric equipment and its various replacement parts.

[0036] In some embodiments, two or more parts of the wearable electric equipment can work cooperatively to provide the signal or energy to the human body by sharing some element of the workload, e.g., by pooling their available battery capacities, by sharing aspects of the work of forming the signal, or by taking turns generating a signal (with each providing the signal for a longer or shorter time, and with the respective signals of the two or more parts in some embodiments delivered to the same location, and in some embodiments delivered to different locations in a subject), or, e.g., some combination thereof.

[0037] As disclosed herein, embodiments where a generator shares an enclosure with a battery pack, in some embodiments with a heat sink as well, e.g., in a unitary electrical apparatus 144, can have advantages as for wearable high power electrical apparatuses, e.g., since interfaces need not be as robust and withstand as many connection - disconnection cycles for the various resources to be sharedbetween them, overall weight can be reduced and in some embodiments a user or subject can find the unitary electrical apparatus convenient. In embodiments where a generator would be replaced along with the expendable resources (battery energy, cooling power), of which the unitary electrical apparatus 144 is but one example, there can be a need to communicate information 312 useful for the configuration of a generator between parts of the system, such that e.g., a new generator can be configured to output a suitable output signal (e.g., a TTFields signal 153) when it replaced a previous generator. Information 312 useful for the configuration of a generator can include, e.g., the signal voltage amplitude, power, timing (e.g., a signal to start generation of an output, or an instruction to start at a given future point in time), burst length and / or ramping rate, burst intervals, output frequency, pattern of applied directions, and other information 312 disclosed herein. Similar needs can arise in other embodiments as well, e.g., if over time a part needs replacing or removal that contains information 312 important to the proper direction of the generation of an output signal.

[0038] In some embodiments, a means of communication 308 is established between parts working together in a wearable electric equipment or between parts replacing each other in a wearable electric equipment, such that information 312 can be exchanged and / or synchronized. The means of communication 308 can in some embodiments be a direct connection, e.g., through a wireless connection such as e.g., Bluetooth or Wi-Fi, or through a wired connection (e.g., USB C, or e.g., a custom cable, in some embodiments other signals such as TTFields signal 153 can be transmitted through the same cable). The means of communication can in some embodiments be an indirect connection, where the transmission is relayed through another part of the system 100 or kit 133, itself connected by similar means (in some embodiments, such relaying of information 312 could be performed through e.g., a node 150 or an electrode 130 is suitable storage is provided in such parts (e.g., memory 197), or a central repository 314. A node 150 would in some embodiments not contain any depletable resources, and would therefore not have to be replaced on a regular schedule, making it a suitable storage location. An electrode 130 is typically replaced every 3-4 days, which is less frequent than e.g., the replacement cycle for typical battery packs).

[0039] In some embodiments, especially but not limited where sensitive information 312 might be transmitted between parts, it is important to provide means of securing proper handling of the information 312. This can require means of identifying parts that belong to and / or should be operated exclusively by one or more specific users and / or subjects, such that information 312 is not transferred to non-trusted parts.

[0040] In some embodiments, two parts would be paired, such that they can identify each other as trusted to exchange information 312 with. In some embodiments, such pairing would be exclusive, and linked to usage with a particular user and / or patient (a.k.a. subject, or subject's body). In some embodiments, the pairing would be persistent, such that once paired the parts could exchange trustedinformation 312 as long as the pairing was valid. In some embodiments, multiple parts, representing some or all parts of an electrical apparatus, unitary 144 or non-unitary 135, additional parts of a system (e.g., a node 150, an electrode 130, a mobile app 301, a personal computer 304, or a server 302) or a kit 133, are connected into a network where all parts are trusted to exchange information 312 as long as their status as trusted remains. In some embodiments, one part, e.g., a mobile app 301, a personal computer 304 or a server 302 can serve as a central repository 314 that stores most or all of the information 312, while other parts of the system do not store or retain the entire body of information 312.

[0041] In some embodiments, the key means of communication 308 of the network runs through a mobile app 301, such that all parts each exchange information 312 through the mobile app, where the connection with the mobile app 301 is e.g., through a Bluetooth connection, or a cable (e.g., USB C or Lightning). In some embodiments, the key means of communication 308 of the network runs through a server 302, such that all parts each exchange information 312 through the server 302, where the connection with the server 302 is e.g., through a Wi-Fi or cellular connection. A server 302 can in some such embodiments serve as a central repository 314.

[0042] In some embodiments, the keys used to establish paired status and / or trusted network connection can be removed, reset or updated either in the part itself, e.g., through a user interface, or through another part of the system, e.g., a part that has a user interface, e.g., an app on a mobile phone or an interface on a generator. In some embodiments, the keys are hard-wired or stored into the parts of the equipment provided to a user or subject, such that it is not possible to change them.

[0043] In some embodiments, means of communication 308 can be used to transfer information 312 in real time or close to real time, such that multiple parts are essentially up to date with the latest information 312 during a period of operation. In some embodiments, a means of communication 308 is used to transfer an accumulated body of information 312 to bring a part up to date with the latest information 312, following some trigger. In some embodiments, information 312 is communicated between parts of a network through information sharing from one part to another in an information sharing chain. Protocols for the transfer of information 312 in some embodiments are synchronous, in some embodiments asynchronous, or some combination thereof, as the person skilled in the arts would know, are used in typical embodiments. Techniques for encryption of information in storage and under transmission are similarly well known.

[0044] Examples of possible triggers, some or all of which could be implemented, include manual input from a user of subject (e.g., through a user interface), the expiry of a period of time, a memory buffer full condition (a memory buffer 197 can be sized differently in different embodiments, and the length of time before a memory buffer is full can depend on such things as the choice of variables recorded and their sampling rate. In some embodiments, a full buffer condition can be mitigated by down-samplingone or more of the recorded variables to free up memory 197), establishment or reestablishment of a means of communication 308, random communications (e.g., during routine communications checks that are performed at some rate), or other events, such as e.g., connection or disconnection of any cables or connectors (e.g., to a node 150 or electrode 150) to any electrical apparatus, unitary or non- unitary, or connection or disconnection of e.g., a replaceable module 101 and generator 102, or a power-up or power-down sequence initiated in a part.

[0045] The information 312 communicated might include historic information (including one or more of, e.g., any treatment logs recording the progress of the operation of the electrical apparatus, e.g., technical performance metrics (e.g., output voltage, power, current per unit of time, battery charge status, temperature measurements (measured e.g., close to heat generating components, internal heat sinks, enclosure surfaces that could be touched by a user or subject, and / or skin electrodes), ambient temperature, and similar), metrics of biological response and condition (e.g., tissue or skin resistance or impedance, body and skin temperatures, body posture, body movement, respiratory rate, respiratory phase or respiratory volume, blood pressure, pulse, and similar vital signs or physiological characteristics), and similar, diagnostic information, in some embodiments based on measurements, in some embodiments based on patient or user provided feedback or other input, and similar), present state information (such as, e.g., the current time and / or date, measurements related to the current technical status of the electrical apparatus, as a whole or any particular subsystems (e.g., generator temperatures or other performance metrics, battery charge status, battery sink temperatures), any alerts (e.g., low battery, low cooling capacity, problem with electrode attachment to a subject, internal self-check failure), error conditions or particular equipment states (e.g., paused or delayed, indefinitely or for some expended time), measurements related to the status of the patient and / or the usage environment, e.g., ambient temperatures, atmospheric pressure, ambient light level, geolocation tagging), as well as forward looking information (e.g., treatment schedules, thresholds for various events). In some embodiments, measurements are used to estimate metrics such as e.g., the rate of heat dissipation into the environment from e.g., electrodes or e.g., an electrical apparatus, unitary or non-unitary. These metrics can in some embodiments be communicated, stored and / or processed similarly to the measurements. The information 312 might also include settings, personalizing information (e.g., chosen names, avatars, pictures, sounds and sound recordings, video and video recordings, user interface preferences), and similar. Personalizing information can be used to e.g., designate names to various parts of an electrical apparatus (unitary or non-unitary), either individually or two or more as a group (e.g., an entire system 100), or to e.g., designate names to one or more tumors or other malignancies. These names can then be used in some embodiments across various user interfaces. Successful results from TTFields treatment depends on compliance with the treatment regime, and personalization can be one way to nudge a patient or user to adhere to regime.

[0046] Information 312 in some embodiments can be timestamped, such that the precise moment a datapoint was recorded is available. Datapoints may be recorded in time series, in some embodiments recorded at regularly spaced intervals, in some embodiments recorded as an event happened to make such recording desirable or suitable. (Sufficiently accurate internal clocks in all parts making recordings might be necessary to permit timestamping).

[0047] Measurement of various variables according to the present invention can be performed by using e.g, various sensors such as e.g., thermistors, accelerometers, light sensors, and similar, as would be well known to the skilled person.

[0048] In some embodiments, a means of communication is used to synchronize or coordinate operations, by, e.g., performing hand-over of operating duties between different parts (this could be, e.g., signal generating duties, providing the active user interface for a user or subject), organizing the cooperative work of e.g., creating a signal with multiple parts each doing some aspect of the signal shaping, and similar.

[0049] Information 312, including the types of information disclosed above, can be used to present a historic record of variables relevant to the treatment progress, such as e.g., a record of the actual compliance with e.g., the targeted time-on-treatment (e.g., adherence with a planned regime). A user interface in some embodiments can also present current measurements or metrics (variables) of relevance to the treatment. A user interface in some embodiments will permit a user or subject to change a parameter considered during the operation of an electrical apparatus (unitary or non-unitary), such as e.g., one or more of temperature, power, voltage or current throttling and / or cutoff thresholds, or e.g., a schedule over time for such parameters (e.g., for controlling and changing parameters during sleep). Presentation and parameter manipulation might occur through a user interface, e.g., on a personal computer (e.g., through an app or browser) or mobile phone screen, or an interface on another part of the system.

[0050] In some embodiments, information 312 gathered as disclosed herein can be used to update, adjust and adapt an electrode location map, which can the be used to place electrodes in more suitable locations (e.g., to avoid locations that are associated with overheating, perhaps contingent on other variables such as local ambient temperatures).

[0051] In some embodiments, information 312 can be collected for one or more subjects or users (e.g., from a respective central repository 314), e.g., from a server or cloud storage provider (a cloud storage provider would typically provide a server at a remote location), with the information 312 in some cases anonymized, where the collected information 312 can be used to analyze the domains of information 312 to find patterns that can suggest improvements across different users and subjects.

[0052] Information 312 communicated between different parts, as disclosed above and otherwise, in some embodiments can be used to take actions, e.g., to direct the generation an output signal foradministration to a subject, trigger alarms or alerts (e.g., but not limited to, changes in body posture of pattern of movement indicative of a neurological or other medical condition), requests to a user or subject (e.g., through a user interface), change operating parameters (e.g., from which power source the active generator is powered, which can also be considered a type of direction of the generation). Parameters that in some embodiments can act to direct the generation of a signal include, but are not limited to, e.g., the signal amplitude, power, timing, burst length and / or ramping rate, burst intervals, pattern of applied spatial directions, and similar. In some embodiments, information 312 can be used to direct the generation of output and perform other actions by using automated processing techniques and / or pattern recognizing techniques to identify desirable generation and other parameters. In some embodiments, processing takes place in a generator 102, or a unitary electrical apparatus 144 or an electrical apparatus 135. In some embodiments, a controller 196 performs the processing. In some embodiments, processing takes place in a mobile phone app 301, or in a server 302. These techniques could be used to e.g., generate output signals and other parameters that are the most desirable given the constraints of e.g., available power resources, available cooling resources, current apparatus temperatures (e.g., at electrodes 130, nodes 150, unitary electrical apparatus 144, electrical apparatus 135, or parts thereof, e.g., power dissipating components and / or touchable surfaces) or skin / tissue temperatures, estimated heat dissipation rates (which can provide a best estimate of the dissipation rates into the environment that will be possible with a replacement part, even if e.g., battery and cooling capacity is different with the new part), estimated heat sink heat absorption rates (the rate at which phase change materials can absorb heat can be affected by factors such as the low thermal conductivity of many phase change materials), the physical movement activity level of the user, ambient temperature measurements, and / or ambient light level measurements (which can be indicative of e.g., sunlight levels), and so on using some combination of measured and / or estimated variables. In various embodiments, measurements and / or metrics in information 312 can be from a single point in time, or from a time series, or some combination thereof for the various measurements and / or metrics can be used with a chosen technique. In some embodiments, integrals or differentials over time, or between different measurements / metrics, can be used when a technique is applied to the information 312, which can be particularly useful considering that there may be time delays in the effects of e.g., a change in the output signal, e.g., delays in the propagation of heat and so on.

[0053] In some embodiments, information 312 can be stored in a memory separate from a controller directing the generation of any therapeutic signals. In such embodiments, this will permit the system to preserve information 312 while a part of the system 100 where a controller is located is replaced. In some embodiments, memory can be located in one or more of a generator, a replaceable module, an electrical apparatus, an electrode, a node or a hub. In some embodiments, information 312 is synchronized in the background between different parts of a system 100 and / or kit 133, as appropriate,through wired or wireless connections, without explicit user intervention. In some embodiments, such synchronization can be performed based on or initiated by user activity. In some embodiments, especially but not limited to, where wireless connections are used where third parties could potentially eavesdrop on transmissions, synchronization can be performed using encrypted communications, and limited to parts that have been actively identified and authorized as being used for a particular user. In some embodiments, information 312 stored in memory 197 is stored in an encrypted state. In some embodiments, a mobile phone application is used with or as part of a system, e.g., using the Android or iOS operating systems, and information 312 can be synchronized with memory in the phone using a wired or wireless link. In some embodiments, a server connected to a mobile phone application can have a memory where information 312 can be stored. In some embodiments, some or all parts of a system can connect through a wired or wireless connection to a server to transmit information 312 to the server or synchronize information 312 with it. Depending on the embodiment, the information 312 in a server can be accessible to the user, e.g., through a mobile app, or accessible to others such as a medical professional caring for the user.

[0054] In some embodiments, some of the information 312, especially containing logs, are not stored in its entirety in any local parts such as an electrical apparatus, a generator, a replaceable module, an electrode, a node or a hub, but removed from local memories after successful transfer to another physical location, a mobile phone or a server 302, perhaps hosted by a cloud storage provider (i.e., a server in a remote location). In some embodiments, during synchronization between two parts, where one first part has been informed that a certain part of information 312 has been successfully uploaded, and another second part still contains that same information 312, a message about a successful upload will be passed from the first part to the second part such that the second part can remove the same information 312 from its memory 197. In some embodiments, the second part would then be ready to inform yet other parts of the successful upload during any future synchronization events. The removal of some information 312 from memory 197 can serve to limit storage and transmission requirements in the local parts.

[0055] In some embodiments, different parts of the same nature, e.g., two battery packs, or two unitary electrical apparatuses 144, two generators 102, or two replaceable modules 101, might be of different configurations e.g., with respect to weight, dimensions and capacity. Replacing or removing such a part might change the characteristics of the wearable electric apparatus as a whole, by e.g., changing the weight, form factor, battery capacity, cooling capacity or some other aspect. These changed characteristics might in some cases be a better fit with the needs and desires of a user or patient, perhaps contingent on the usage environment, time of day, state of mind, social context or other external or internal factor. Such embodiments provide another example where information 312important to the proper direction of the generation of an output signal might need to be transmitted through a means of communication 308 as disclosed herein.

[0056] Wearable electric equipment, or similar equipment that can be carried close to the body (where 'close' can refer e.g., to both physical proximity or to thermal proximity, where in the latter case high thermal conductance or convection of any materials (or air) in between would lead to efficient thermal transport to the body, and in both cases there might be e.g., clothing, other fabric or other materials in between the body and the wearable equipment), that generates substantial amounts of waste heat that needs to be managed while the equipment is one or more of (but not limited to): located close to the body, otherwise prevented from venting excess heat into the ambient air, worn outside or underneath clothing, or when alternate methods such as fans are undesirable. (Note that the equipment need not be operated close to the body at all times. In some situations, the user might prefer to operate the equipment away from the body for some period of time, e.g., during sleep, riding a wheelchair, and so on).

[0057] Making a TTFields system easier to use and wear can serve to tilt the balance in favor of adopting the system for use and increasing compliance with the most advantageous usage regime. It can also make a system the preferred choice among competing product systems.

[0058] For some high-powered wearable systems, it is important to have a path with low thermal resistance from any heat source(s) to a heat sink or other point of controlled heat disposal, inside or external to the device, in order to prevent heat from spreading uncontrolled through the device and causing an enclosure surface 111, locally or across the entire surface, or other part (accessible or otherwise thermally sensitive) to reach a temperature level that is unacceptable or undesirable.

[0059] Some embodiments of the present invention disclose a system 100, used to deliver TTFields signals 153 or treatment, having an electrical apparatus 135 as well as several electrodes 130, and some embodiments can include a harness 129 or other accessories. The electrical apparatus 135 in turn has a generator 102 and a replaceable module 101, that can be detached from each other (accessible surfaces 131 are enclosure surfaces 111 or other accessible parts, e.g., parts accessible when a replaceable module 101 and a generator 102 are separated). A battery pack 103 is combined with a heat sink 104 that can absorb heat in any included heat reservoirs 105, into one replaceable module 101 (Fig. 1), typically housing the components (the battery pack 103, the heat sink 104, and any reservoirs 105) of the replaceable module 101 in a common enclosure. The replaceable module 101 connects to a generator 102 that generates a high-powered output, e.g., for TTFields electrodes. A thermal management system prevents dangerous or undesired heat from reaching the user. It should be understood that any battery cells might be primary (non-rechargeable) or secondary (rechargeable), and that while the battery pack 103 would typically contain battery cells 114, other sources of stored energy are conceivable such as e.g., supercapacitors. Where battery packs 103 are referenced with regard tovarious embodiments of the present invention in this document, this should therefore be interpreted to also encompass the wider genus of internal power sources.

[0060] The replaceable module 101 connects to the generator 102 through one or more interfaces 106, including at least one of an electrical interface 108, a thermal interface 107, a mechanical interface 109 and an information interface 121. For clarity, multiple instances of each of these types of interfaces might be included in an interface 106. During operation, while electrical power is delivered from the battery pack 103 to the generator 102, heat from the generator, as well as any internally generated heat from the battery pack 103 (or the replaceable module 101 more generally) as applicable, is typically at least in part (excepting perhaps e.g., cold ambient conditions) conducted to the one or more reservoirs 105 for storage until the heat can be dissipated from the replaceable module 101 without exceeding thermal limits. This heat dissipation can happen after the replaceable module 101 has been disconnected from the generator 102.

[0061] In embodiments where a generator 102 has a channel 138, it might be that a generator 102 may be able to continue to generate therapeutic output during the switching from one replaceable module 101 to another (though this is feature is not limited to this embodiment), if power is delivered from, e.g., some external power source 126 or a power source in the generator 102, and the generator is cooled by air circulating through the channel 138 in the generator 102 which is then vented into the ambient air in an open loop. It is noted that this might be a particularly efficient solution, but in no way limits other embodiments to achieving the same effect of cooling while not thermally connected to a replaceable module 101. In similar fashion, any channels 138 in a replaceable module 101 can be used to facilitate heat dissipation into the ambient while the replaceable module 101 is disconnected, especially if fluid flow is powered by a fan.

[0062] Since fans can create audible noise and may require access to ambient air, it may be desirable to design systems 100 such that their use can be limited through a reduced fan duty cycle, lower speed of fan rotation, limiting their use to temperatures above a certain threshold, or similar, or that they are eliminated entirely in favor of more passive means.

[0063] Facilitating passive heat dissipation can similarly be associated with drawbacks, primarily that the device system requires sufficiently free access to ambient air or other environmental heat sinks for convective flows to carry away enough heat. This can constrain options for how the system can be worn on or carried close to the human body, e.g., to what extent the system can be under clothing, to be hidden from view.

[0064] By optimizing the efficiency of the electronics, the amount of waste heat generated for a given power output level can also be reduced. A further technique can be to throttle or turn off the power output of the system in an effort to reduce waste heat production, which can be detrimental to the achievement of the purpose of the device.

[0065] Any surface not normally accessible but during disconnection and connection when a replaceable power source is replaced, is in some embodiments expected to be touched for no more than 1 second or optionally 10 seconds, depending on the product design, suggesting that 74 °C and 56 °C are the most likely applicable limits for parts with high thermal conductivity.

[0066] If a minimum 4 mm wide fingertip cannot reach any thermally conductive parts 134 in a thermal interface 107 (as measured by the standard test finger) that form the actual heat connection between two separable parts of an electrical device 135 (each thermally conductive part being located on the thermal interface 107 of its respective side), where the heat connection is predominantly through thermal conduction, predominantly through thermal convection or through some combination thereof, or by yet other means (e.g., radiation), then the temperatures in these thermally conductive parts 134 of the thermal interfaces can be permitted to have a significantly higher temperature without causing a safety problem.

[0067] By way of illustration, if a system is powered by 80 W from the battery pack and is 90% efficient it would generate up to 8 W of wasted power, mostly in the form of heat. In practice, a system is unlikely to be continuously powered at its maximum power, and efficiency can be higher or lower than 90%, for example in the 75-95% range, and in the 80-90% range. The amount of waste heat generated would thus vary in some range that can be higher or lower than 8 W, in some embodiments in the 4 W or 12 W range, but the waste heat might be lower than this e.g., for low output power / currents and higher for e.g., high output power and low efficiency. There are heat losses in each of the several steps in retrieving the energy stored in the battery cells 114 or from external power source 126 and delivering the desired therapeutic electrical output to a patient, and the efficiency depends on many factors such as the implemented electrical topology, the materials in the power components, the usage environment (ambient and body temperature, clothing or fabric coverage, etc.), the characteristics of the patient's body tissues, the charge status of the battery cells, and so on.

[0068] In typical embodiments, power is dissipated from internal resistance in the power cells, in the wiring and connectors between the different parts of the device system, and multiple power components (that implement e.g., a high-frequency DC-AC inverter for TTFields systems) that would tend to dissipate substantial heat during normal use (e.g., from one or more DC-DC regulators (regulators maintain a determined voltage) that bring the variable battery voltage to a stable level, from one or more power circuits that switch the current through a transformer such that a desired waveform is generated, likely at a higher voltage, in any output filters and from any subsequent switches that direct the generated signal through chosen sets of electrodes as needed). Efficiency in efficient DC-DC regulators is typically in the 92-98% range, and in a transformer perhaps 97-98%. The switching input into the transformer is typically of higher frequency than the output waveform's frequency, and losses from switching e.g., with MOSFETs, SiC or GaN transistors can be substantial.

[0069] In some embodiments, a DC-DC converter or regulator is located in a replaceable module 101, rather than in a generator 102 (where they can be located in some embodiments, e.g., to cut down on manufacturing costs as in typical use, more replaceable modules than generators are used). In such embodiments, any associated waste heat from the converter or regulator is produced closer to any heat sinks 104 in the replaceable module 101, potentially facilitating heat transport there. Such embodiments can reduce waste heat production in a generator 102, e.g., by permitting the use of switched-capacitor converters that have higher efficiency but lower flexibility than e.g., inductor-based regulators (e.g., fixed voltage conversion ratio) in the generator 102, or entirely eliminate heat-generating voltage conversion in a generator 102. Such embodiments can also reduce the capacity requirements on a thermal interface 107 for transmitting heat from a generator 102 to a replaceable module 101. In some embodiments, a DC-DC regulator in a replaceable module 101 is fed either from a battery pack 103 in the replaceable module or from an external power source 126. In some embodiments, a DC-DC regulator in a replaceable module 101 can be dynamically controlled so as to provide the voltage level required by a voltage converter or the switching circuitry in a generator 102 to provide a suitable output signal amplitude. In some embodiments, a DC-DC regulator in a replaceable module 101 can ramp its output voltage up and down, e.g., within 1-100 ms, so as to provide suitable voltages as a generator 102 provides output signals switched periodically in different directions (e.g., every 0.1-1.0 seconds). Far wider intervals can be considered, e.g., 5 seconds, 10 seconds, 30 seconds or one minute, in a range from 1 to 240 seconds.

[0070] Such dynamic control mentioned above, or control over voltage ramping, can be exercised by a controller and perhaps through communications through an information interface 121, e.g., between a replaceable module 101 and a generator 102. In some embodiments, such a controller would be located in a generator 102, and in some embodiments, a controller in a replaceable module 101 would manage the output voltage, perhaps in turn under the direction of a controller in a generator 102. Benefits with a separate controller in a replaceable module 101 can include reducing the communications needs across the information interface 121 (the replaceable module's controller can e.g., perform an automatic sequence of voltage changes over time) or control over the output voltage (from the replaceable module) while not connected to a generator 102.

[0071] In some embodiments, a replaceable module 101 can contain one or more of switching power circuits, a transformer, an output filter, such that it will contain most or all circuitry for generating a TTFields signal. In some such embodiments, a generator 102 can contain circuitry to direct a TTFields signal to different electrodes 130. In some such embodiments, a generator 102 can present a user interface 128 to a user. In some embodiments with a replaceable module 101 with most or all of the circuitry needed for producing and distributing one or more TTFields signals, a generator 102 can still comprise a controller for directing the generation of any therapeutic signals. In some embodiments withlimited power dissipating circuitry in a generator 102, a thermal interface 107 can be made small or excluded entirely between the generator and the replaceable module.

[0072] One exemplary method according to an embodiment is to, when replacing a replaceable module 101 in a system 100, also replacing its connected generator 102, such that the entire electrical apparatus 135 is replaced (not necessarily separating the replaceable module 101 and the generator 102), with any necessary information 312 transferred to a new electrical apparatus 135 by the means exhibited herein.

[0073] In some embodiments, a replaceable module contains features and interfaces associated with a generator, such that an electrical apparatus becomes one inseparable entity ('inseparable' in this context is to be understood as not separated in typical use. Regulations in force or under way, such as the European Union's "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning batteries and waste batteries, repealing Directive 2006 / 66 / EC and amending Regulation (EU) No 2019 / 1020, 10488 / 23", might mandate that battery packs or cells be removable and / or replaceable by an end-user, e.g., with the use of commercially available tools, perhaps based on a desire to reduce electronic waste. It is understood that embodiments permitting such removal or replacement can provide the thermal and electrical connections disclosed herein, and that they can operate as an inseparable entity during regular use, i.e., as a patient and user operates or wears the system, and that replacing the battery pack in some embodiments could require the use of a tool, e.g., a screwdriver), a unitary electrical apparatus 144 (Fig. 4) similar in function to an inseparable electrical apparatus 135. In such embodiments, a heat path can be implemented from generation-related heat sources 119 (e.g., a generator) to heat sinks without separable interfaces in between. In some embodiments, this can reduce ambient heat dissipation as the path to the heat sink can be more efficient (lower thermal resistance). In a unitary electrical apparatus 144, there is no need to separate parts into two enclosures with an interface in between, for mechanical, electrical, information, thermal or other connections, but the entirety of a unitary electrical apparatus can be housed in a single enclosure. The lack of interfaces within the unitary electrical apparatus 144 in some embodiments can enable reduced weight and volume, and in some embodiments lower unit cost. (A system based on unitary electrical apparatus 144 could in some embodiments have fewer parts overall that can be assembled. This can in some embodiments lead to fewer stock keeping units, lowering regulatory, manufacturing and / or logistical and / or inventory costs). In some embodiments, replacing the entire unitary electrical apparatus 144 can be more convenient to a user than replacing a replaceable module 101 of a separable electrical apparatus 135, especially but not limited to embodiments where a unitary electrical apparatus 144 has only one or two cable connections. Descriptions herein of any methods, and any embodiments of electrical apparatuses 135, generators 102, replaceable modules 101 or kits 133 related to electrical apparatuses 135 should be understood to apply to unitary electrical apparatuses 144 as well, and any methods for their use, wherever applicable and not explicitly excluded. Likewise,descriptions of any methods involving or embodiments comprising or relating to unitary electrical apparatuses should be understood to apply to electrical apparatuses 135 with removable replaceable modules 101 as well, wherever applicable and not explicitly excluded. For clarity, in some embodiments such a unitary electrical apparatus 144 can contain one or more heat sinks 104 each with one or more heat reservoirs 105 as disclosed herein, as well as a battery pack 103 containing one or more battery cells 114, in addition to power-dissipating components for generating an output signal. In some embodiments, a unitary electrical apparatus 144 contains a thermal management system 132 that monitors temperatures though one or more sensors 115 at accessible surfaces 131 on the enclosure surfaces 111. (In some embodiments, a system also contains temperature sensors that monitor the temperatures in electrodes that are used to deliver energy to a subject's body, making essentially the entire system monitored for thermal safety). In some embodiments, a unitary electrical apparatus contains a cooling fan, that can be used during at least one of delivering an output signal for therapy, and venting excess heat while not delivering therapy. While not connected to other parts of a system 100 to deliver therapy, a unitary electrical apparatus 144 can vent any stored heat and charge any battery cells. Some embodiments where a generator 102 and a replaceable module 101 are separable can have a cost advantage, e.g., as duplicating generating circuitry and other parts in multiple electrical apparatuses 135 that are replaced in their entirety can drive up overall manufacturing costs. In a unitary electrical apparatus 135 "power dissipating components" are enclosed in the same enclosure as the "power element" and "heat storage reservoir", as the energy is transformed inside the unitary electrical apparatus 135 to the form it will have when delivered to a user, in terms of voltage, frequency and similar parameters, with the exception of e.g., any dielectric insulation in e.g., insulated electrodes used to deliver the energy, or switching of the energy to direct it to any suitable target, without altering the fundamental characteristics of the energy signal delivered. Also, embodiments with a unitary electrical apparatus 144 enable a user to wear components including power dissipating components close to the body.

[0074] To make it possible to have the system near a body, the invention in some embodiments includes a thermal management system 132 (Fig 2) that measures temperatures at one or more locations within the system. The monitored locations can be close (physically or thermally, typically within a few mm distance or in direct contact) to one or more of the following accessible surfaces 131, as applicable: a) enclosure surfaces 111 of the generator 102 accessible with replaceable module 101 connected, b) enclosure surfaces 111 of the replaceable module 101 accessible when it is connected, c) surfaces of the generator 102, accessible only when replaceable module 101 is disconnected, d) surfaces of the replaceable module 101, accessible only when it is disconnected, e) thermally conductive parts 134 of thermal interfaces 107 on the generator 102, f) thermally conductive parts 134 of thermal interfaces 107 of the replaceable module 101.

[0075] Table 1 below describes thermal safety limits at different locations for a typical embodiment of the invention; the limits for thermally conductive parts only apply if these are accessible (lower limits might apply depending on the requirements for comfort, e.g., up to 30 °C, 34 °C, or 37 °C, etc.):

[0076] The thermal interfaces 107 are optionally not accessible when the replaceable module 101 is connected to the generator 102, but when the two are disconnected their respective thermal interfaces can become exposed and will be accessible to touch before any cooling off has had the time to occur, which means that its temperature must be controlled within acceptable limits already while the replaceable module 101 and the generator 102 are connected. Monitoring the temperature on enclosure surface 111 and / or on the interfaces 106 or thermally conductive parts 134 on the part of the system with the predominant heat source, typically the generator 102, is in some embodiments more important than monitoring accessible surfaces 131 on e.g., the replaceable module 101, as some heat will likely have been dissipated as the heat load is channeled over to the replaceable module 101 (but this might depend on e.g., the distribution insulation or other thermal resistance). In some embodiments, measuring the temperature at just a few locations or even at a single point within or on the system might provide enough information to have sufficient certainty that no specified thermal threshold is crossed for the system as a whole. In such cases, it might be advantageous to monitor the temperature at e.g., the thermal interface 107 of the generator 102 or other location, if it can be expected to have a temperature higher than other accessible surfaces 131 (e.g., the temperature at location e) can conservatively be limited to 41 °C, or if thermally conductive parts 134 are not accessible, location c) can be limited to e.g., 41 °C, permitting higher temperatures at the thermally conductive parts). Measuring and monitoring temperatures in multiple locations, each with a respective thresholdtemperature, might enable a system to increase overall system power output by not having to make conservative assumptions or estimates about the temperature in non-measured locations, and is the preferred solution in other embodiments. The temperature thresholds in Table 1 can be used, selecting rows based on the assessed maximum touch time for the application in question.

[0077] In some embodiments, the thermal management system 132 can also measure the temperatures at the connectors where the cables to the electrodes 130 are connected, to ensure that no impermissible or otherwise undesirable temperatures are found on the cables, as the cables are accessible to the user. Elevated temperatures can typically be found in the parts of the cables closest to the connectors. In one embodiment, a thermally insulating sheath extends around the cable for some length, e.g., between 2 and 15 cm, and preferably 10 cm. This prevents elevated temperatures from being accessible without having to throttle the power output or take other actions, as any heat will dissipated along a longer part of the wire.

[0078] The thermal management system 132 can in some embodiments vary the power output of the system (throttling it or turning it off for some period of time) if the measured temperature exceeds relevant thresholds. Thermal thresholds might in the typical embodiment be pre-specified, either hardwired or through a user-selectable setting, though other regimes are envisioned where thresholds are set dynamically in response to parameters such as remaining power levels, the nature of the employed power source, ambient temperatures, and the like.

[0079] The thermal management system 132 can contain logic and / or analog electrical circuitry 127 that acts as a controller, in some embodiments including one or more microcontrollers, on either of or both sides of the interface (e.g., in the generator 102 and / or replaceable module 101), depending on the application, to perform the monitoring of the information gathered from the thermistors or other thermal sensors 115. In some embodiments, the thermistors / temperature sensors 115 and / or any electrical circuitry 127 that interfaces with them can communicate across the information interface 121 (when so connected), to permit processing of thermal information as well as acting based on thermal information, such as varying / throttling generator power output or disconnecting battery power delivery. Thermistors are typically connected to logic circuitry through components, including Analog-to-Digital Converters (ADCs), comparators or similar, that can be used to measure their analog temperaturedependent electrical resistance. These analog connections can in some embodiments be implemented also across the information interfaces 121, though in some embodiments, the information interface 121 is implemented using digital technology. Communication between logic circuitry such as microcontrollers or temperature sensor 115 modules can thus in some embodiments be implemented using common digital, serial communications protocols such as I2C or SPI, or similar, and can include across the information interface.

[0080] In applications where the system is wearable, or possible to carry close to the body, in some embodiments a typical upper temperature threshold for accessible parts of the enclosure or other parts can be no more than 41 °C to permit continuous exposure to touch or body. In cases where the thermal interface 107 is not accessible to touch when the replaceable module 101 and the generator 102 are connected, the temperature in the thermal interface can be permitted to be higher, and can e.g., be limited to 74 °C (based on the standard) since the thermal interface is likely touched no longer than momentarily when the replaceable module is disconnected.

[0081] The thermal interface 107 in some embodiments is expected to have high thermal conductivity in some exposed parts (thermally conductive parts 134), and a lower thermal threshold associated with high-thermal conductivity materials such as metals is applicable for these parts.

[0082] In some embodiments, there is a margin between the threshold temperatures used and the maximum temperatures specified as permissible in applicable standards (a conservative approach might be to apply the most restrictive of several different standards, where applicable) or more stringent limits identified during evaluation of desirable product characteristics (e.g., for comfort). For example, the implemented temperature thresholds can be 5%, 10% or 20% lower than those specified in the standards or found to be the limit of comfort, or e.g., 1, 2, 3, 4, 5, 6, 8 or 10 °C below these limits. These margins can serve to reduce the risk that temperatures inadvertently exceeded a regulatory or design temperature threshold. Preventing impermissible temperatures might necessitate completely turning off power if the margin to that threshold is small (e.g., 1 °C, 2 °C or 3 °C). A larger margin might increase the scope for first attempting to manage the thermal load by throttling the output. The desirable margin might also depend on the inertia of the thermal system, where heat that has already been generated has not yet reached the monitored surfaces and can raise temperatures even after complete or partial power-off. The exact characteristics will depend on the specific implementation. In some embodiments, such as for TTFields systems, the output power can be throttled e.g., by varying voltage and / or current (lower voltage amplitudes typically leading to lower currents too, with currents typically displacement currents when using insulated electrodes), or varying the duty cycle. Given the desirability of field strengths of a certain magnitude for effective treatment, varying the duty cycle might be most advantageous.

[0083] In some embodiments of the present invention, a replaceable module 101 has a larger enclosure surface area than a generator 102 does, potentially permitting it to vent more waste heat to the environment than the generator can. This can be advantageous when a heat path is very effective in transferring heat energy to a replaceable module 101. In some embodiments a harness 129 can be designed to minimize the risk that a user, when a generator 102 and a replaceable module 101 are disconnected, has skin or touch exposed to high-temperature parts for more than 1 second, or in otherembodiments, more than 10 seconds, or in yet further embodiments longer periods (1 minute or 10 minutes), e.g., by limiting physical access or otherwise..

[0084] The harness 129 can in some embodiments include one or more heat spreaders, or body heat sinks 141, that can transfer heat from the system 100 or electric apparatus 135 (or unitary electrical apparatus 144) enclosure surface 111 to the user's body and spread it over a larger area, such that the local heat load on an area of skin is reduced. This body heat sink 141 is preferably flexible, permitting adaptation to the curvature of the body, in some embodiments this is achieved by using graphite or the like, which both conducts heat and is flexible. In some embodiments, the body heat sink covers an area between 10-500 cm2of the human skin (optionally with some clothing in between), though in some embodiments even larger areas can be beneficial (e.g., 1000 cm2or more). In some embodiments, the area is between 150 and 300 cm2. In some embodiments, a body heat sink can transfer at least 0.5 W to the user's body. The harness 129 in some embodiments is designed to include some or all electrodes 130 that receive energy from the generator 102 and deliver it to the human body. The harness can in some embodiments contain a mechanism by which the harness can signal the electrical apparatus 135 what its orientation is with respect to the user. Such a mechanism can consist of a magnet embedded in the harness 129 which can be detected by a generator 102 and / or replaceable module 101, or unitary electrical apparatus 144, with e.g., a reed switch. If this magnet is located away from the middle of the harness, its detection can indicate the orientation of the electrical apparatus 135, or unitary electrical apparatus 144, in the harness.

[0085] Any dedicated heat reservoir(s) 105 in the replaceable module 101 can in some embodiments include Phase-Change Materials (PCM) that can absorb heat energy when transitioning from a solid to a liquid state. (In some embodiments, the replaceable module 101 can have sufficient heat storage capacity for the application at hand in other parts included in its design, such as the battery cells 114 and various structural components (these would offer some capacity in all designs), without any such dedicated reservoir, and the reservoir 105 can then be constituted by these other parts and components. Active venting with e.g., fans, can also be considered in such embodiments. Critically, these embodiments may require a thermal management system 132 to ensure that undesired temperatures are not reached in accessible surfaces 131). The PCM materials can be one or more of but not limited to paraffin waxes, hydrated salts, metal hydrates, low melting temperature metal alloys, certain fatty acids, and polyglycols. Such PCM can in some embodiments be stored in flexible pouches or similar that can accommodate the changing volumes associated with the transitions, and optionally contain metal fibers, ceramic parts, or other highly thermally conductive structures embedded in or placed around the PCM to facilitate heat transfer to the various parts of a reservoir (PCM materials often have poor thermal conductivity).

[0086] PCM can be designed to have different properties, including different transition temperatures. In some embodiments, a suitable PCM can be RT 35 HC from Rubitherm Technologies GmbH, with a melting area around 34-36 °C and a heat storage capacity of 240 kJ / kg or 67 Wh / kg. In yet other embodiments, a suitable material can be RT 28 HC, where the melting area is around 27-29 °C and the storage capacity 250 kJ / kg or 70 Wh / kg. It is understood that other melting temperatures and storage capacities can be obtained and used depending on the requirements of the specific case. For example, at the time of writing, Rubitherm offers a number of RT-line materials with melting temperatures between -9 °C to 111 °C, including temperatures particularly relevant for some embodiments of the present invention e.g., 24 °C, 25 °C, 26 °C, 28 °C, 31 °C, and 35 °C, with custom transition temperatures offered in addition to these.

[0087] One advantage of a higher melting point is that if the reservoir is initially maintained at ambient temperature, and that ambient temperature is somewhat elevated as it tends to be in summer and perhaps is close to 30°C, then the higher melting point ensures that the reservoir has not expended its heat absorbing capacity to an undesirable extent even prior to usage, and it can also ensure that the PCM does not absorb heat from the user's body. An advantage of a lower melting point is that the reservoir more effectively maintains a lower temperature in the overall system during operation, as prior to having fully melted the effective mass of PCM in the reservoir it will tend to maintain the temperature close to the melting point.

[0088] Further, a higher melting point in the reservoir can lead to a relatively larger temperature differential between the heat path inside the system and the ambient environment 112 which can lead to a larger share of the waste heat getting dissipated through the enclosure. This will tend to increase the time until any reservoirs 105 exhaust their capacity but can reduce comfort by venting more heat close to the body (albeit at safe temperatures). The reverse is true for a lower melting point, of course. These effects can be managed by increasing or decreasing the thermal insulation 120 that slows such heat dissipation 137, but increasing such insulation adds undesirable volume to what is intended to be a wearable or easily carried device where space is at a premium.

[0089] In one embodiment of the invention, multiple reservoirs 105, e.g., two, three, four or even more, can be included that connect thermally to the one or more thermal interfaces 107 (Fig 6), and optionally also thermally connected directly or indirectly to the battery cells 114 and other parts that can generate heat internal to the replaceable module 101, where the reservoirs 105 may contain PCM materials with different melting points. With this arrangement, the system will, as temperatures rise as the reservoirs fill up with heat energy over time, first be maintained at a lower temperature through a first PCM reservoir with a lower melting point, and then, as that reservoir exhausts its heat absorbing capacity, the temperature will rise further to reach the higher melting point of another, second reservoir 124. While cooling is provided from this second reservoir as its PCM material undergoes a state transition toa melted state, the temperature difference between the internal heat path 110 and the ambient environment 112 surrounding the enclosure will, as noted above, be larger, which will lead a higher fraction of the heat load to be dissipated into the environment 112 as opposed to being absorbed in the reservoirs 105. As more heat is dissipated into the environment 112, this will extend the time it will take to exhaust the heat absorbing capacity of the second reservoir 124. The result will be that as the replaceable module 101 exhausts its overall heat absorption capacity over time, it will tend to increase its enclosure surface temperature, potentially making the device less comfortable that that with a cooler surface, while a thermal management system 132 can still keep it within acceptable levels from a regulatory, safety or other design perspective. This can extend the time before the generator output has to be throttled or turned off to avoid exceeding thermal thresholds.

[0090] In some embodiments, the melting point of a first PCM reservoir is in the 26-43 °C range. In some embodiments, the melting point of a second PCM reservoir is in the 35-43 °C range. There can be benefits to using PCM materials with melting temperatures below 40 °C, e.g., 38 °C or 39°C, in order to have some margin to the regulatory thresholds.

[0091] In some embodiments, the second reservoir 124 is smaller than the first reservoir, in some embodiments less than 20% the size, and intended to maintain a temperature that is safe, though in some embodiments not desirable with regard to comfort, with the user expected to replace the replaceable module 101 as soon as is convenient. In other embodiments, the reservoirs are of equal size.

[0092] In some embodiments, heat reservoirs 105 contain between 20 and 100 grams of a PCM material. In some embodiments, heat reservoirs 105 contain about 120 grams of PCM material, e.g., in an electrical apparatus 135 suitable for delivering TTFields to the head of a human subject ('subjects', 'patients' are generally used herein to refer to users of TTFields systems). In other embodiments, heat reservoirs 105 contain about 220 grams of PCM material, enabling more heat to be absorbed in higher- powered applications (such as for treating a torso, or other parts of the body, such as the abdomen, with TTFields). In some embodiments, heat reservoirs 105 contain between 75 and 400 grams of a PCM material. In some embodiments, heat reservoirs 105 contained in a replaceable module 101, an electrical apparatus 135 or in a unitary electrical apparatus 144 can contain between 1 and 20 grams of phase change material.

[0093] The amount of PCM material depends among other things on the efficiency of the electrical solutions implemented, and their distribution within the system 100 and any associated additional parts, e.g., external power supplies. With less heat dissipating components within an electrical apparatus 135, less PCM material can be required, depending on the details of the application.

[0094] The power output of known TTFields battery packs can be up to 80 W for torso treatment. Other TTFields systems in the Optune / NovoTTF series have about 35 W typical output power, or 20-40 W (thepower needs depend in part on the part of the body to be treated, power needs can be lower e.g., for glioblastoma treatment applied to the head).

[0095] Since higher power delivered to the tumorous cells has been associated with better clinical outcomes with better tumor control, and depending on the patient's condition, more parts of the body or larger areas might need treatment, it is likely that higher peak power output levels, such as 90 W, 100 W, 125 W or 150 W, can be desirable.

[0096] The power output of TTFields systems is continuous more often than intermittent (on the timescale of use; there can be direction switching, duty cycles etc. on the order of seconds and shorter), and thus any waste heat generation is too.

[0097] In some applications, it is desirable that battery packs that are used for power are permitted on airplanes. FAA safety regulations limit lithium ion (rechargeable) batteries to 100 Wh capacity.According to the TSA, passengers may also carry up to two spare larger lithium-ion batteries (101-160 Wh) with airline approval. Systems that deliver TTFields are typically designed to permit continuous therapy delivery, and this would include during flights and after arriving at a destination. Without special approval from the airline, the travelling patient could as passenger be limited to 100 Wh-capacity battery packs. At a peak battery power output of 80 W, this will drain a 100 Wh-capacity battery in 1 hour 15 minutes. A 160 Wh battery pack will be drained in two hours. Actual power output might be less, but battery packs can typically be expected to be drained of their stored energy in a matter of a few hours, perhaps before a flight arrives at its destination.

[0098] Since the capacity of a battery pack is a trade-off with weight and space constraints, in some cases battery packs with smaller capacities than the above-mentioned limits can be desirable. Such smaller packs would weigh less and / or occupy a smaller volume, but would also likely power the system for a shorter period of time. An example of a situation where such a solution can be desirable is if the user is cooking, cleaning, or performing other tasks at home, where replacing a replaceable module 101 or a unitary electrical apparatus 144 can be convenient and the lower weight and / or form factor volume desirable even if. e.g., it is associated with a shorter operating time.

[0099] Battery cells 114 that can be used in the construction of a suitable battery pack 103 can be of many different chemistries and form factors. A chemistry based on lithium-ion technology is one possible chemistry. Cylindrical battery cell form factors typically have relatively higher energy density than pouches, prismatic cells, and other forms, and can have higher mechanical integrity, and are sometimes suitable, though the form factor may be less flexible making them unsuitable in some other embodiments. Often, the specific chemistry and other design aspects of a cell are optimized for either permitting large power output, or for permitting storing large amounts of energy. Typical cylindrical form factors include 18650 (18 mm diameter and 65 mm length) and 2170 (21 mm diameter, 70 mm length). These form factors would occupy 16.5 cm3and 24.2 cm3of volume, respectively, with the larger2170 cell occupying about 47% larger volume than the 18650 cell. For example, an eight-cell 18650 battery pack would occupy 132 cm3just for the battery cells, while a five-cell 2170 battery pack would occupy 121 cm3for the cells alone. Actual volume for a battery pack would have to consider additional parts and components for e.g., enclosing, attaching, keeping, connecting, etc the battery cells, especially considering any particulars of the chosen form factor (e.g., cylindrical cells might lead to some inaccessible areas between cells). Examples of battery cells that can be suitable include Samsung SDI 50G, li ion with 2170 form factor, approx. 18.15 Wh capacity (5 Ah, 3.63 V), weighing ca 69 g, with capacities 267 Wh / kg and 749 Wh / L. Five such cells have a combined capacity of just over 90 Wh, close to the 100 Wh threshold. Similar capacity configurations can be achieved using the lower capacity 18650 cells, using larger numbers of cells. In some embodiments, lithium polymer-based battery cells can be used. These are often available in a prismatic or flexible pouch-type configuration, which can be advantageous in some embodiments on form factor and cost grounds. In some embodiments, lithium metal cells can be used that commonly are of a pouch type and that often have high energy capacity in relation to weight. For example, Sion Power Corp, Tucson, Arizona USA, disclosed a 20 Ah, lithium metal anode / nickel-rich cathode cell, weighing 158 g and with dimensions 80 x 91 x 10 mm (equivalent to a volume of 73 cm3). With a maximum continuous discharge of 40 A (2C) and a nominal voltage of 3.82 V, a single such cell could provide 152 W nominal output power and have a nominal capacity of 76 Wh. In some embodiments, a single lithium metal cell can thus be used.

[0100] Depending on the specific embodiment, the dimensions of the cells can favor one cell size over another, with five 2170 cells advantageous in some solutions.

[0101] By way of illustration, a pack with five 2170 cells like the Samsung 50G has a total cell weight of around 350 grams and a capacity of 90 Wh. A heat reservoir made from, say, 100 g of RT 28 HC would ideally have a heat capacity of 7 Wh (total capacity from 27 °C to 42 °C according to datasheet). A reservoir of this size is thus able to absorb, in the form of heat, up to 7.7% of the maximum energy stored in these five cells (the cooling capacity in some embodiments can be dimensioned as a fraction of the energy capacity of the batteries or other power sources envisioned). This reservoir adds about 30% to the weight considering just the battery cell 114 and reservoir 105 PCM weights themselves. In practice, the low thermal conductivity of PCM can create pockets of PCM somewhat more thermally isolated from the heat path than the rest of the mass, potentially making the system run out of heat capacity before all PCM has been used, and this suggests that the capacity be derated by 20-30% or so.

[0102] With eight 2170 Samsung 50G cells, a battery pack's capacity is 144 Wh, fitting within the 160 Wh maximum for flying. It is typically advantageous to have the cells in a battery pack be as similar as possible: the same model and preferably from the same manufacturing batch. This is to avoid undesirable interactions between the cells when they are connected in series or in parallel for charging and discharging.

[0103] Since some waste heat most probably can be dissipated through the generator 102 and replaceable module 101 enclosure surfaces 111 even in scenarios where the system has no access to ambient air and / or is stored under clothing, bedding or similar. A system as envisioned above can likely permit higher electrical heat losses from inefficiency than the 7.7% absorbed in the reservoir(s) 105 and 124 as applicable.

[0104] Using fewer cells more optimized for high power delivery (having less internal resistance), such as Samsung INR21700-40T, which can discharge continuously at 35-45A with 4 Ah nominal capacity, a solution can be made with lower weight for the replaceable module 101 which can sustain the system at full power for a shorter period of time. A single such cell can provide the power needed for a TTFields device, as say 40 A of current from a 3.6V nominal capacity cell would deliver 120 W even as voltage fell to 3.0 V during discharge, though a single 2170 cell would typically not be able to power the system for very long. With e.g., two cells the weight is cut by 60%, capacity is around 29 Wh, with time of operation cut by somewhat more than the 5-cell solution mentioned above (around 68%) given the lower capacity of high-power cells. More configurations could easily be envisioned. By having a compatible interface 106, replaceable modules 101 with different configurations could be used interchangeably with the same generator 102 to suit the specific needs of the user at that point in time.

[0105] If using 18650 form factor battery cells such as the Panasonic NCR-18650BF, with a nominal capacity of typically 3.35 A and a nominal voltage of 3.6 V, each cell has 12 Wh capacity. (Li ion batteries are often charged to between 4.1 V (common for medical devices), 4.2 V or 4.3 V, have a nominal voltage of 3.6 V or 3.7 V, and are discharged until the voltage is 3.0V, 2.8V or 2.5 V. Lower voltages can damage the battery cell. For e.g., five typical Li ion cells in series, the nominal voltage is 5 x 3.6 V = 18 V, and the cut-off voltage is no less than 5 x 2.5 V=12.5 V. The typical DC output of such a pack is thus in the 12.5-18V range). Eight such cells can be used to get a 96 Wh battery pack, just below the 100 Wh threshold. Similarly, 13 cells can be used to get a 156 Wh capacity battery pack, just below the 160 Wh threshold. With lower capacity cells with up to 10 Wh capacity, as is commonly the case among 18650 cells, 16 cells can form such a battery pack that can be permitted on aircraft.

[0106] A person skilled in the art would readily recognize that other cell counts can be appropriate for a battery pack to power a system. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 cells can be considered using the cell form factors considered in the examples above, and even more cells can be contemplated if other form factors are used (with lower capacity per cell). Suitable arrangements of battery packs can in some embodiments be configured with various battery cell form factors and capacities, in some using common standardized form factors and in some using custom form factors (especially but not limited to for prismatic or pouch types). Arrangements often include one or more series of cells, each containing the same number of identical cells, where the series are then arranged in parallel. To illustrate this typical arrangement common in battery packs, five cells can typically only beJ / 50 arranged as 5S1P or 1S5P, while eight cells can preferably be arranged as 1S8P, 2S4P, 4S2P, 8S1P. This can serve to constrain the most suitable arrangement in many applications, as the delivered voltage from a battery pack depends on the number of cells in series, and the delivered current depends on the number of cells in parallel, not considering any subsequent voltage regulation. The most desirable voltage from a battery pack can depend on several design considerations, such as the generator input DC range that would permit the most efficient electronic design, and the dimensional constraints from creepage and clearance distances required by applicable standards. (E.g., according to IEC 60601-1, 3rdEd, Table 12, creepage and clearance distances for two Means of Patient Protection increase from 3.4 mm and 1.6 mm, respectively, to 4 mm and 2 mm, respectively when the working DC voltage exceeds 17 V. These differences might be important when designing e.g., connectors. In some embodiments, this suggests having no more than three or four cells in series). If the electrical apparatus 135 is to be used with different replaceable modules 101 with different battery pack 103 configurations with different numbers of battery cells 114, this can further constrain battery pack output voltages, e.g., a pack with two cells in series would have a nominal voltage of 2 x 3.6 V = 7.2 V, and if other packs have more than two cells in series, they would have higher nominal voltages. The power electronics and components that are to be powered by the packs would then have to be designed to accommodate a wider range of input voltages, which might in turn constrain design choices and achieved efficiency. Another solution can be to have the larger pack of the system solution have more cells in parallel, rather than in series, e.g., the smaller replaceable module 101 having two cells in a 2S1P configuration, and the larger replaceable module 101 having a four cell 2S2P configuration, which will keep the output of both sizes of battery pack 103 within a narrower voltage range, which in turn can provide for a more efficient solution for generating the desired output to the electrodes, from the battery pack 103 output. (Though the battery pack 103 will then likely have a smaller capacity than what can be possible with some fivecell solutions as discussed with regard to aviation requirements). Similarly, the designed current determines the dimensions of required electrical cabling and other conductors (more current necessitates larger conductors).

[0107] For a system 100 to generate output to the electrodes of e.g., up to about 50 V to 100 V for TTFields, having higher voltage from the battery pack 103 might in some embodiments be conducive to a more efficient solution, as e.g., DC-DC converters (at least doubling the input voltage, but not having a much greater voltage difference, permits some efficient solutions), transformers (limited turns ratio often beneficial) and other parts can then be potentially more efficient.

[0108] The various configurations and characteristics of the battery pack 103 disclosed and discussed herein illustrate some of the trade-offs involved in design of a system 100.

[0109] A heat sink 104 in some embodiments can be designed, including, e.g., by considering the type, heat absorbing capacity, melting temperature and volume of PCM material, with a view to theconfiguration of a battery pack 103 with which it is to be used, the configuration parameters including e.g., the number, size, form factor, voltage, capacity and other characteristics of any battery cells used, the enclosure form factor, as well as external factors such as the expected ambient temperatures (taking e.g., weather and climate in the expected usage area into account. The capacity of a heat sink 104 can be sized, e.g., by the amount of PCM included, such that more cooling capacity is included for expected use in hot climes. Outdoor or indoor use is a similar consideration that can be considered as well). In general, the mass of PCM used is correlated with the electrical battery capacity such that some relatively constant fraction of the battery capacity can be absorbed by the heat sink. In some embodiments, the mass of PCM is determined while also considering that for a battery pack configured to power a system for a longer period of time, more energy can in some embodiments be vented into the ambient for a specific rate of heat dispersal (power). In some embodiments of a kit 133, a kit would include replaceable modules with different masses, geared toward different use cases (e.g., indoor or outdoor use, hot or cold temperatures, etc). In some embodiments, such considerations lead to 20 to 80% lower PCM weight included in some replaceable modules in a kit. In some embodiments, such as for use outdoors in cold climates, a mass of PCM might be entirely or almost entirely eliminated (less than 20% left), as waste heat might even be considered desirable.

[0110] The efficiency of the electrical implementation is important as higher efficiency would reduce the heat dissipation 137 for the same output, and so facilitate the successful operation of some embodiments of the present invention. This might include permitting the invention to fully manage the heat load without active cooling means (fans), in some embodiments with lower volumes or weights of PCM, and permitting the monitoring and maintenance of temperatures within specified limits with more precision. The disclosures in this document in general serve to identify specific designs and rationales behind them that might serve as advantageous implementations of the present invention. The rationales could readily be used by the person skilled in the art to identify further possible implementations in line with the invention.

[0111] In a typical configuration, the generator 102 can be used more or less continuously, optionally up to 24 / 7 and preferably more than 75% of the time, while the replaceable modules 101 with their internal battery packs 103 and heat sinks 104 with reservoirs 105 are replaced every few hours, perhaps every 1 to 6 hours, or 4 to 5 hours. Replaceable modules 101 are recharged, as needed, when not connected to be ready to swap in again. With a replaceable module 101 embodiment per this invention, any heat stored in any reservoir(s) 105 can be vented, actively or passively, in part or in full also in preparation for the next cycle of use with the generator 102, optionally while simultaneously also charging the battery pack 103 in the replaceable module 101, as needed. One generator 102 is thus typically used with multiple replaceable modules 101.

[0112] Battery packs are replaced every few hours to provide continuous treatment delivery while not tethering the system to an external power source 126 such as mains power. Optionally, the replaceable module 101 is connected to an external power source 126 while the system is operating, such that the generator 102 is powered by a combination of external power and the internal battery pack 103, or if external power is sufficient, the battery pack 103 is charged as the generator 102 is powered. (Alternative embodiments where an external power source 126 is connected to the generator 102 directly are also conceivable. In these embodiments, the generator 102 might also be able to charge a battery pack 103 in the replaceable module 101).

[0113] Additional solutions for thermal management can be incorporated into embodiments of the invention disclosed herein. For example, fans and other active cooling devices can be incorporated (they may otherwise not be required in many embodiments) into the system, in the generator 102 or in the replaceable module 101 or both, or in a unitary electrical apparatus 144. Some embodiments can reduce or eliminate the need for using a fan during normal operation, but can use such fans to make sure that the system can operate across the full range of desirable environmental and usage parameters (e.g., when ambient temperatures are high during summer and heat reservoir capacities might be exhausted, or in some cases permit the fan to operate at a lower speed or duty cycle for reduced noise), or when a replaceable module 101 has not vented its stored heat energy but its internal battery pack 103 is charged. If usage of an incorporated fan is reduced by the invention, in some embodiments a smaller or lighter fan that in some embodiments can be more audible could be acceptable, reducing weight and / or space requirements.

[0114] The same user (patient a.k.a. subject) of the system 100 can in some cases be provided with several different types of replaceable modules 101 as described herein, as a kit 133 together with the generator 102 and other parts as needed, to suit the user's particular usage situation and desired activity, while in other cases such a kit 133 will include the same type of replaceable module 101 only. A kit 133 thus contains different parts some or all of which can be used together to assemble (or configure) a system 100, or part of a system 100 (there might be other parts of a system 100 that at times are not explicitly included in a kit, e.g., carrying bags, harnesses 129, nodes 150, electrodes 130 and / or various accessories). Similar kits 133 based on unitary electrical apparatuses 144 can also be configured to meet a user's needs. In some embodiments, a kit 133 could include multiple generators 102 configured differently, e.g., with interfaces for replaceable modules of different dimensions and / or transfer capacities, such that a user or subject could chose to use e.g., a larger or smaller electrical apparatus 135 and change between them over time as desired or appropriate. A kit 133 could in some embodiments include two or more generators, in some embodiments having at least one generator with different configuration from at least one other generator. A kit 133 with such different generators wouldin some embodiments also include replaceable modules suitable for connection to the different interfaces used.

[0115] Any incorporated fans can also be advantageous and, for example when incorporated into the replaceable module 101, be used to speed the cooling off when a replaceable module 101 is disconnected from the generator 102 by actively venting excess heat from any reservoirs 105 and other parts of the replaceable module 101. In situations where a replaceable module 101, not connected to a generator 102, containing significant amounts of stored heat is connected to an external power source 126 for charging, the charging operation itself will generate some heat that will add to the overall load. Keeping such a replaceable module 101 in free air, not obstructed by insulating fabrics, would help the system dissipate the heat load more effectively, and having a cooling fan incorporated in the replaceable module 101, in accordance with some embodiments, can also support this thermal venting.

[0116] In some embodiments that use air as a fluid to transport heat between the generator 102 and the replaceable module 101, a fan, if present, that circulates the air can be used to vent the replaceable module's 101 stored heat while disconnected.

[0117] In some embodiments, a detachable heat sink 125, separate from the generator 102 and replaceable module 101, can be attached to a replaceable module 101, optionally while disconnected from a generator 102, to facilitate the venting of heat from the replaceable module 101. A detachable heat sink 125 can similarly be used with a unitary electrical apparatus 144. This detachable heat sink 125 can in some embodiments be connected to a replaceable module 101 through the thermal interface 107, and optionally also the electrical 108 and any mechanical (not shown) or information interfaces (not shown). The detachable heat sink 125 can in some embodiments be entirely passive, e.g., encompassing fins to facilitate heat transfer to ambient air, or at least in part be active, optionally powered by any available power in the battery cells in the attached replaceable module 101, such that a fan can actively vent heat into the ambient air. The detachable heat sink 125 can in some embodiments be in the form of a cradle in which the electrical apparatus 135, or parts thereof, can rest, and can cool the electrical apparatus 135, or part thereof, by conduction, thermally connecting to in some embodiments a large part of the surface area for improved heat transfer. As the convective heat transfer coefficient for unforced airflow is often just 2.5-25 W / (m2K), relying on ambient air convection around a disconnected thermal interface 107 on a replaceable module 101 would typically be associated with long cooling off times. The detachable heat sink 125 in some embodiments is designed to under normal conditions be able to vent all stored heat above ambient as well as heat generated by battery charging in the same time it takes to charge the battery pack from empty to full. Depending on the design, this could be e.g., in 2, 3 or 5 hours. This can permit the number of replaceable modules 101 provided to a user to be limited, as they would not be tied up in charging / cooling off.

[0118] Wearing a system, or parts of it, close to the body can serve multiple purposes. One aspect is the functional advantage of constraining the movement of the mass of the device system in relation to the body, making movement easier for the user. Movement may be constrained by such that a device, e.g., an electrical apparatus, is held against a torso, an abdominal area, an upper arm, a back, a leg (e.g., a thigh or a lower leg), or pelvic area, In some embodiments on a left or right side of a body, and in some embodiments with multiple parts to a system symmetrically on both left and right sides of a body for improved weight balance. A harness 129 can serve to constrain such movement. Currently available products are carried in bags, backpacks and similar that potentially offer more degrees of freedom for the device's movement causing them to swing or otherwise get in the way. Another aspect is being able to hide parts of the system, e.g., an electrical apparatus, from view or making it otherwise less conspicuous by carrying it underneath clothing, fabric or similar, obscuring it in full or in part or constraining its access to ambient air, e.g., by wearing it under a sweater, a jacket, a dress, or a coat, or wearing it in a pocket, something which places additional demands on the thermal solution as air flow might be restricted. Another aspect is not having to be bothered by audible fan noise, or other noise, which in some embodiments may be enabled by a suitable thermal solution, and in some embodiments the wearing underneath clothing also serves to reduce noise, and in some embodiments by a combination thereof. A further aspect can be to permit shorter wiring between the different components of the system 100, reducing weight and in some embodiments improving ease of use. User needs, preferences and usage situations are understood to be very diverse, and some embodiments of the present invention are intended to improve the user's experience in these aspects but are not limited to them.

[0119] A user can be advised to adjust how the system is used depending on the thermal needs. For example, by not covering the system with excessive clothing in situations where the cooling capacity of the system is getting stressed. This applies in particular e.g., when the environmental temperatures are elevated or while receiving external power to the electrical apparatus 135. This in some embodiments is implemented with a user interface (Ul) 128, including one or more of a display, a light, a buzzer, a speaker, or a vibrator, embedded in the system 100, or a remote Ul e.g., in a Bluetooth connected smartphone or smartwatch, that alerts the user when monitored temperatures, e.g., in view of remaining electrical power in the battery pack 103, are outside the bounds that expected to let the full electrical capacity be used prior to exhausting the cooling capacity or otherwise exceeding the thermal limits. A Ul 128 can also alert the user to the status of power or cooling capacity, and especially advise the user to replace the replaceable module 101 when warranted. Suitable temperature thresholds for such alerts can be e.g. (but not limited to), between 28-41 °C, at 35 °C, at 39 °C, or, if PCMs with two different melting points are used, some temperature in between them.

[0120] The Ul 128 in some embodiments is located in full or in part at or in the generator 102, which can be a cost advantage as the generator will be used for a relatively long time. The Ul 128 can in some embodiments be located in full or in part at or in a replaceable module 101, which can be an advantage in configurations where a replaceable module 101, with any reservoir(s) 105 inside, is oriented above a generator 102 with respect to gravity (in a superior orientation in relation to the user's body such that the Ul can be seen; the user might be upright or horizontal) such that efficient heat transport can be achieved, e.g., with heat pipes or other means. In some situations, it can be convenient for a user to be looking down, straight or at an angle, onto a user interface, and with the replaceable module 101 facing up, this can thus be suitable for some or all Ul 128 components. The information interface 121 can be used to communicate between different parts of the Ul 128 as well as electrical circuitry 127 on / in either the generator 102 or the replaceable module 101. In some embodiments, a Ul 128 is present both on the replaceable module 101 as well as on the generator 102, such that regardless of orientation a Ul 128 will be facing up and permitting user interaction or information, for improved ease of use.

[0121] The above disclosure of a Ul 128 does not preclude, in any way, having other user interface elements in the system 100, e.g., buttons to control various functions.

[0122] If the system 100 is used while connected to an external power source 126, where the power source supplies all or part of the energy input needs of the system for a prolonged period of time, then the generated waste heat can exceed the heat absorption capacity of the heat reservoir(s) 105. Examples of situations where this can occur including during sleep where unless the battery pack 103 is very large, it would not be able to supply enough power to supply the system at high power output for a solid night's sleep (e.g., perhaps 6, 7 or 8 hours uninterrupted, though solutions requiring the user to replace a replaceable module 101 say halfway through the night (e.g., 3, 3.5, 4 hours) can be envisioned, reducing the capacity requirements), or while connected to the power output connector in a car (typically 12 V and sometimes limited to 18 W and likely not be enough to power the system on its own).

[0123] Solutions to this can by way of example include one or more of:

[0124] a) advising the user not to excessively cover the system in insulating materials such as clothing but to expose it to ambient air as much as possible. E.g., if getting supplemental power from a car at 18 W, and using a 90% efficient system, this would supply 1.8 W of additional heat that might be dissipated so as not to erode the remaining cooling capacity of the replaceable module 101.

[0125] b) having dedicated cooling packs that are replaceable modules 101 that have more PCM material, but optionally having fewer or no battery cells (replaceable module without cells 142) and instead, in some embodiments, are used with an external power source 126 connected directly to the generator 102 or through the replaceable module 101. For example, if the system operates at 80 W power input with 90% efficiency, it will generate 8 W of waste heat. If 1.75 W can be dissipated, e.g., through the enclosure surfaces, then 6.25 W needs to be absorbed, or 36.75 Wh during 7 hours of sleep.If the PCM material can absorb 70 Wh / kg, 625 grams of PCM material are required in the reservoirs to absorb the required heat under ideal conditions. A person skilled in the art would recognize that these are calculations that demonstrate the invention, and that the parameters of the design, component materials and actual performance used can vary depending on requirements, component availability and other factors.

[0126] c) Operating an active cooling device such as a fan to vent heat into the ambient air. (In some embodiments of this solution, a special replaceable module 101 can be used in this situation that need not contain any heat reservoirs 105 and need not contain any battery, but rather depends predominantly on an external power source 126 and vents all heat using the fan. This will enable a low- weight and small-size system during e.g., sleeping or driving, and the removal or reduction of the above- mentioned components can free up space and enable a silent and efficient fan solution, where larger fans operating at lower RPMs can be advantageous). A kit 133 for a patient can in some embodiments contain some combination of replaceable modules 101 according to each b) and c) above, according to the needs of the patient.

[0127] In some embodiments, a kit 133 contains one or more unitary electrical apparatus 144. In some embodiments, a kit 133 contains unitary electrical apparatuses with different configurations, e.g., one or more of each of a unitary electrical apparatus 144 with two battery cells in a battery pack 103, a unitary electrical apparatus 144 with five cells in a battery pack 103 (alternatively, in some embodiments unitary electrical apparatuses 144 of two sizes are included in a kit 133, with the unitary electrical apparatuses 144 having about 2:5 weight and / or volume ratios, though with other battery cell configurations. Other ratios, like 1:2, 1:3, 1:4, 2:3, and / or 4:5 and are used in some embodiments. The weight and / or volume of one of the unitary electrical apparatuses can in some embodiments be 20-80% lower, in some embodiments 10-90% lower, than the corresponding values for another.), or a unitary electrical apparatus 144 configured to be used while a patient is sleeping. In some embodiments of a kit 133, a replaceable module 101 or a unitary electrical apparatus 144 is included that contains no phase change material, but is but has a fan, and is provided as an option in the kit for e.g., when the lowest possible weight is desired, e.g., for some activity.

[0128] In some embodiments of a kit 133, the kit would comprise two or more of a unitary electrical apparatus 144 and / or a replaceable module 101, neither of which contained a phase change material (or heat sink even), but which might contain a fan (in some embodiments).

[0129] In some embodiments of a kit 133, the kit comprises at least one unitary electrical apparatus 144 and at least one replaceable module 101. In some such embodiments, the kit would comprise a generator separate from the unitary electrical apparatus.

[0130] In some embodiments, it may be beneficial to connect a first replaceable module 101 to a generator 102 in an electrical apparatus 135, and then connect a second replaceable module 101 as anexternal power source 126 to the electrical apparatus 135. Both the first and second replaceable modules 101 can then in some embodiments be worn in the same harness 129 (which can be adapted to carrying two electrical apparatuses, or two replaceable modules 101, with at least one of the replaceable modules 101 also connected to a generator 102, e.g., by having one worn on either side of the subject's body, e.g., on the torso beneath the armpits), or in some embodiments using two harnesses 129, one for each. A similar arrangement can be made in some embodiments with two unitary electrical apparatuses 144, carried in one or more harnesses 129, which can be connected, e.g., with a cable, for example using one or more USB Type-C connectors and using the USB Power Delivery (PD) protocol, such that one can power the other from its power source. In some embodiments, the cable can be embedded in the harness 129 (for clarity, not all embodiments need include a harness 129). Similar additional cooperative arrangements can be used in some embodiments for more than power transfer. In some embodiments, two unitary electrical apparatuses 144 can be used such that a first one delivers a voltage envelope 175 to the other, unitary or non-unitary, electrical apparatus, where the other unitary electrical apparatus shapes the final output signal by processing the voltage envelope 175. A similar arrangement can be made with electrical apparatus 135, a replaceable module 101 as the first one or a generator 102. The voltage envelope 175 may define the overall shape of the bursts of signal that is output, but can lack one or more, or all, of the high frequency components (e.g., in the 10 kHz to 10 MHz band, or e.g., in the 100 kHz to 300 kHz band) that in some embodiments can be superimposed by the other electrical apparatus. In some embodiments, a first unitary or non-unitary electrical apparatus, or generator, would take turns (e.g., in an alternating sequence) with a connected second unitary or non-unitary electrical apparatus to generate the complete output signal, in some embodiments alternating these duties between bursts, such that each delivers an integer number (one or more) of bursts over some period of time before a switch occurs. In some embodiments, the period of time can be in the range from 0.1 seconds to 12 hours, in some embodiments between 1 and 120 seconds. In some embodiments, two unitary or non-unitary electrical apparatuses, each connected to separate pairs electrodes 130 (each can be connected to e.g., a single pair of electrodes, or e.g., more than two electrodes such that multiple directions can be provided from each electrical apparatus), either directly or, e.g., through a node 150, take turns to output an output signal to their respective pair(s) of electrodes. (This would imply that the electrical apparatuses each deliver its signal through a different direction or orientation through a subject's body from that of the other.) Embodiments where the operations of multiple generators and other parts are cooperate in some cases need coordination, which might be performed by employing a protocol which establishes one as parent and the other as child, where the parent sends instructions to the child to coordinate actions, or in some embodiments one would monitor the actions of another to determine the suitable time to perform a certain action. Various schemes to implement this would be immediately obvious to the person skilled in the art. Theseembodiments can extend the available electrical power and / or thermal cooling capacity in the wearable system. A kit 133 can in some embodiments contain an electrical apparatus, unitary or non-unitary, and a further electrical apparatus, unitary or non-unitary, or a generator or replaceable module, suitable for use in any of the above disclosed cooperative embodiments. In some embodiments, a first replaceable module 101 can have a larger capacity heat sink reservoir, such that it will absorb part, or all of the heat generated by a second replaceable module 101. The second replaceable module 101 would in some embodiments not be able to absorb heat from the electrical apparatus 135 (if it were not thermally connected to the electrical apparatus 135, which might be considered), and would be limited to absorbing heat energy from any included battery pack 103 and any internal circuitry. The usefulness of such an embodiment might be increased by using it in a way that eases thermal constraints, i.e., under thin or no clothing, in lower ambient temperatures, etc., perhaps in combination with other means of cooling as disclosed herein. In similar way, yet more replaceable modules 101 can be combined in daisy chain fashion.

[0131] In some embodiments, a replaceable module 101 can be configured to deliver power to a system unrelated to the primary purpose of the electrical apparatus 135, either while connected to a generator 102 or not. E.g., a replaceable module 101 could power or charge a cell phone. This can provide a convenience to a user as the wearable system is continuously available and auxiliary power might be useful for such purposes, especially for a user who might not be in perfect health and might need to make emergency phone calls.

[0132] In some embodiments, a TTFields signal 153 contains essentially only one frequency component, where the frequency component is in the 100 kHz to 300 kHz range, or in some embodiments 50 kHz - 500 kHz range. In some embodiments, a TTFields signal contains essentially only two frequency components, where the frequency components are in the 50 kHz to 500 kHz range, e.g., 200 kHz and 300 kHz. In some embodiments, a TTFields signal contains three or more significant frequency components in the 50 kHz to 500 kHz range. In some embodiments, a TTFields signal contains one or more frequencies in the 10 kHz to 10 MHz range. Having multiple frequency components can be beneficial, as e.g., tumor cells of different sizes can be effectively targeted, tumor motility can be reduced, increased permeability of a blood-brain-barrier, or yet other benefits. In embodiments with multiple frequencies (e.g., two, three or more), these would superimpose to form a single waveform, or can be applied sequentially in time during overlapping or mutually exclusive time periods. In some embodiments, only one frequency component has a field strength of at least 1 V / cm. The characteristics of the generated signal can have an impact on the overall efficiency of the signal-generating process, such that the amount of waste heat depends on the configuration of a particular embodiment. In general, simpler waveforms with lower frequency content with less switching action required, will lead to less waste heat.

[0133] In some embodiments, a system 100 contains a first and a second electrical apparatus 135, each containing a generator 102 and a replaceable module 101, the latter in some embodiments containing battery packs 103, where each electrical apparatus 135 provides a temporally separated part of the overall TTFields signal. In some embodiments, the first and the second electrical apparatuses 135 can each deliver treatment in a different direction, through e.g., a respective connected pair of electrodes 130. In some embodiments, the electrical apparatuses 135 would alternate on relatively short timescales, e.g., such that each apparatus delivers, during a period of time, perhaps but not limited to 0.1 to 5 seconds, one or a few bursts of TTFields, each lasting perhaps 0.1-1 second, perhaps with bursts delivered in alternating directions from the active electrical apparatus 135 during the period of time. This arrangement would, e.g., serve to distribute the waste heat load, e.g., in a generator, and facilitate dissipation thereof, and extend treatment duration. The electrical apparatuses 135 could also alternate on longer timescales, e.g., such that a substantial part of a battery pack 103 or a reservoir 105 is drained, perhaps completely, before alternating to the other electrical apparatus 135. This arrangement could, e.g., serve to extend the total treatment duration when under battery power. In embodiments with a first and a second electrical apparatus 135 (and in some embodiments perhaps yet more), there needs to be a mechanism for the first and the second electrical apparatuses 135 to communicate in order to hand over active treatment duties. This mechanism can be through one or more cables connecting the two electrical apparatuses 135, perhaps indirectly through other parts of the system 100, and perhaps wirelessly through, e.g., a radio connection, e.g., Bluetooth, Wi-Fi, cellular, or other standardized, adapted or custom protocol. In some embodiments, the mechanism can be to transmit electrical signals through the body of the wearer itself through electrodes in contact with the body, e.g., by modulating TTFields or transmitting another signal. In embodiments with two electrical apparatuses 135, these can in some embodiments be arranged for carrying with bilateral symmetry, e.g., one close to each armpit, or other weight-balancing arrangement. In some embodiments, a harness 129 is configured to carry two electrical apparatuses 135.In some embodiments with a replaceable module 101 with most or all of the circuitry needed for producing and distributing one or more TTFields signals, a generator 102 can still comprise a controller for directing the generation of any therapeutic signals, in some embodiments with an associated memory for preserving state information, such that e.g., any treatment logs, diagnostic information, treatment schedules, settings, personalizing information (e.g., names, avatars, pictures, sounds and sound recordings), or similar, can be preserved as replaceable modules 101 are changed.In some embodiments, the controller with associated memory can be located in another part of the system 100, such that the generator 102 is essentially incorporated into that other part, perhaps connected through a cable or connected through a wireless connection, e.g., through Wi-Fi, Bluetooth,or cellular connection, or yet other radio connection or protocol. It is understood that unitary electrical apparatuses 144 can be used for the above disclosed system 100 as well."Modes" of the invention

[0134] The following is a numbered list of non-limiting illustrative embodiments of the invention in several different modes:1. A kit 133 for configuring a signal generating system 100, comprising a first electrical apparatus comprising a first generator configurable to generate a first output signal, a second electrical apparatus comprising a second generator configurable to generate a second output signal, and a means of communication 308 from the first electrical apparatus to the second electrical apparatus, wherein the first electrical apparatus is configured to generate the first signal with the first generator, to collect information 312 useful for the configuration of a generator, and to transmit the information 312 through the means of communication 308, and the second electrical apparatus is configured to receive information 312, and configure the second generator based on the received information 312.2. A kit 133 according to mode 1, wherein the first output signal and / or the second output signal is a TTField signals 153.3. A kit 133 according to mode 1, wherein the first output signal and / or the second output signal contains a frequency component in the 100 kHz to 500 kHz range.4. A kit 133 according to mode 1, wherein the system 100 is wearable.5. A kit 133 according to mode 1, wherein the first output signal and / or the second output signal is configurable to have a peak voltage of at least 50 V.A kit 133 according to mode 1, wherein the first output signal and / or the second output signal is configurable to have an output power of at least 20 W. A kit 133 according to mode 1, wherein the first electrical apparatus is a unitary electrical apparatus 144, comprising a battery pack (103), and the second electrical apparatus is a unitary electrical apparatus 144, comprising a battery pack (103). A kit 133 according to any of modes 1 or 2, wherein the first electrical apparatus is a unitary electrical apparatus 144, comprising a first heat sink (104), and the second electrical apparatus is a unitary electrical apparatus 144, comprising a second heat sink (104). A kit 133 according to mode 1, wherein the first electrical apparatus is an electrical apparatus 135, comprising a first generator (102), and the second electrical apparatus is an electrical apparatus 135, comprising a second generator (102). A kit 133 according to mode 1, wherein the information 312 comprises temperature information related to the first electrical apparatus. A kit 133 according to mode 1, wherein the information 312 comprises tissue impedance- related information. A kit 133 according to mode 1, wherein the second electrical apparatus is configurable, when used in a system 100, to generate a signal with the second generator when the first electrical apparatus is configured not to generate a signal with the first generator. A kit 133 according to mode 1, wherein the first electrical apparatus and the second electrical apparatus, when used in a system 100, are configured to generate a respective signal with a respective generator in an alternating sequence. A kit 133 according to mode 1, comprising a central repository 314, a second means of communication 308 from the first electrical apparatus to the central repository, and a third means of communication 308 from the second electrical apparatus to the central repository, wherein information 312 from the first electrical apparatus is transmitted through the second means of communication 308 to the central repository, andinformation 312 from the second electrical apparatus is transmitted through the third means of communication 308 to the central repository, and the information 312 is useful for one or more of: the configuration of a generator, the configuration an electrode location map, recording regime adherence, or raising an alert. A system 100 comprising a first electrical apparatus comprising a first generator configurable to generate a first output signal, a second electrical apparatus comprising a second generator configurable to generate a second output signal, and a means of communication 308 from the first electrical apparatus to the second electrical apparatus, wherein the first electrical apparatus is configured to generate a signal with the first generator, to collect information 312 useful for the configuration of a generator, and to transmit the information 312 through the means of communication 308, the second electrical apparatus is configured to receive information 312, and configure the second generator based on the received information 312, and the first electrical apparatus and the second electrical apparatus are configured to generate a respective first signal and second signal with a respective generator in an alternating sequence. A system 100 according to mode 15, wherein the information 312 comprises timing information. A system 100 according to mode 15, wherein the first signal and the second signal are delivered to the same pairs of electrodes. A system 100 according to mode 15, wherein the first signal and the second signal are delivered to the different pairs of electrodes.A system 100 comprising a first electrical apparatus comprising a first generator configurable to generate an output signal, a second electrical apparatus comprising a second generator configurable to generate an output signal, and a means of communication 308 from the first electrical apparatus to the second electrical apparatus, wherein the first electrical apparatus is configured to generate a first signal with the first generator, the second electrical apparatus is configured to receive first signal, and generate a second signal by superimposing a signal on the first signal. A kit 133 for configuring a signal generating system 100, comprising a first electrical apparatus comprising a first generator configurable to generate an output signal, a second electrical apparatus comprising a second generator configurable to generate an output signal, and a first means of communication 308 from the first electrical apparatus to a central repository 314, wherein the first electrical apparatus is configured to generate a signal with the first generator, to collect information 312, and to transmit the information 312 through the first means of communication 308, and a second means of communication 308 from the second electrical apparatus to a central repository 314,wherein the second electrical apparatus is configured to generate a signal with the second generator, to collect information 312, and to transmit the information 312 through the second means of communication 308, and the first electrical apparatus and the second electrical apparatus are used to generate respective output signals for an extended period of time that are delivered to the same subject's body. A system 100 comprising a first unitary electrical apparatus and a second unitary electrical apparatus, the first unitary electrical apparatus is configured to generate a first output signal in a first period of time, wherein the first output signal is delivered to a first pair of electrodes 130, and the second unitary electrical apparatus is configured to generate a second output signal in a second period of time, wherein the second output signal is delivered to a second pair of electrodes 130, and wherein the first and second periods of time are repeated in an alternating pattern. A system 100 according to mode 21, wherein the first unitary electrical apparatus is configured to send instructions to the second unitary electrical apparatus to start and stop the second period of time. A system 100 comprising a first unitary electrical apparatus 144 and a second unitary electrical apparatus 144, wherein the first unitary electrical apparatus and the second unitary electrical apparatus each contains a generator, and wherein the first unitary electrical apparatus and the second unitary electrical apparatus are configured to cooperatively generate an output signal. A system 100 according to mode 23, wherein a first unitary electrical apparatus generates a voltage envelope, and a second unitary electrical apparatus generates an output signal.A system 100 according to mode 23, wherein a first unitary electrical apparatus generates an output signal during a first period of time, a second unitary electrical apparatus generates an output signal during a second period of time, and the first and the second unitary electrical apparatuses repeat their outputs in an alternating sequence. A system 100 according to mode 24, wherein the first and second periods of time do not overlap. A system 100 according to mode 24, wherein the first unitary electrical apparatus and the second unitary electrical apparatus deliver their outputs to the same electrodes 130. A kit 133 according to any of modes 1 or 2, wherein the first electrical apparatus is a unitary electrical apparatus 144, comprising a phase change material, and the second electrical apparatus is a unitary electrical apparatus 144, comprising a phase change material. A kit 133 according to mode 1, wherein the first electrical apparatus is a unitary electrical apparatus 144, comprising a battery pack (103), and the second electrical apparatus is an electrical apparatus 135, comprising a second generator (102). A kit 133 according to mode 1, wherein the information 312 comprises body posture information. A kit 133 according to mode 1, wherein the information 312 comprises one or more of historic information, present state information, information on the status of the patient, information on the usage information, forward looking information, and / or personalizing information. A unitary electrical apparatus 144 comprising 1-20 grams of phase change material. A kit 133 comprising a unitary electrical apparatus 144 comprising 1-20 grams of phase change material.A method of replacing a first generator comprised in system 100 with a second generator, the system 100 comprising is a means of communication 308 between the first generator and the second generator, wherein the first generator generates an output signal, and collects information 312 useful for the configuration of a second generator, the information 312 is transmitted through the means of communication 308 to the second generator, and the information 312 is used to configure the second generator, and the second generator generates an output signal. A method of replacing a first generator comprised in system 100 with a second generator, the system 100 comprising is a means of communication 308 between the first generator and the second generator, wherein the first generator generates an output signal, the first generator collects information 312 useful for the configuration of a second generator, the information 312 is transmitted from the first generator through the means of communication 308 to the second generator, and the information 312 is used to configure the second generator, the first generator stops generating an output signal, the second generator generates an output signal. A method according to mode 34, wherein the second generator is connected to the system 100 after the first generator starts generating an output signal.A method according to mode 34, wherein the second generator is connected to the system 100 after the first generator stops generating an output signal. A method according to mode 34, wherein the first generator is disconnected from the system 100 after it stops generating an output signal.Closing comments

[0135] While this specification contains many implementation details, these should not be construed as limitations on the scope of the invention or of what may be claimed, but as descriptions of features specific to implementations of the invention. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub combination or variation of a sub combination. Thus, unless explicitly stated otherwise, or unless the knowledge of one of ordinary skill in the art clearly indicates otherwise, any of the features of the embodiment described above can be combined with any of the other features of the embodiment described above. Thus, many variations to the above examples lie well within the scope of the attached claims and within the capabilities of a person having ordinary skill in the art.

Claims

1. Claims1. A kit 133 for configuring a signal generating system 100, comprising a first electrical apparatus comprising a first generator configurable to generate a first output signal, a second electrical apparatus comprising a second generator configurable to generate a second output signal, and a means of communication 308 from the first electrical apparatus to the second electrical apparatus, wherein the first electrical apparatus is configured to generate the first signal with the first generator, to collect information 312 useful for the configuration of the second generator, and to transmit the information 312 through the means of communication 308, and the second electrical apparatus is configured to receive information 312, and configure the second generator based on the received information 312.

2. A kit 133 according to claim 1, wherein the first output signal and / or the second output signal is a TTField signals 153.

3. A kit 133 according to claim 1, wherein the first output signal and / or the second output signal contains a frequency component in the 100 kHz to 500 kHz range.

4. A kit 133 according to claim 1, wherein the system 100 is wearable.

5. A kit 133 according to claim 1, wherein the first output signal and / or the second output signal is configurable to have a peak voltage of at least 50 V.

6. A kit 133 according to claim 1, wherein the first output signal and / or the second output signal is configurable to have an output power of at least 20 W.

7. A kit 133 according to claim 1, wherein the first electrical apparatus is a unitary electrical apparatus 144, comprising a battery pack (103), and the second electrical apparatus is a unitary electrical apparatus 144, comprising a battery pack (103).

8. A kit 133 according to any of claims 1 or 2, wherein the first electrical apparatus is a unitary electrical apparatus 144, comprising a first heat sink (104), and the second electrical apparatus is a unitary electrical apparatus 144, comprising a second heat sink (104).

9. A kit 133 according to claim 1, wherein the first electrical apparatus is an electrical apparatus 135, comprising a first generator (102), and the second electrical apparatus is an electrical apparatus 135, comprising a second generator (102).

10. A kit 133 according to claim 1, wherein the information 312 comprises temperature information related to the first electrical apparatus.

11. A kit 133 according to claim 1, wherein the information 312 comprises tissue impedance-related information.

12. A kit 133 according to claim 1, wherein the second electrical apparatus is configurable to generate a signal with the second generator when the first electrical apparatus is configured not to generate a signal with the first generator.

13. A kit 133 according to claim 1, wherein the first electrical apparatus and the second electrical apparatus are configured to generate a respective signal with a respective generator in an alternating sequence.

14. A kit 133 according to claim 1, comprising a central repository 314, a second means of communication 308 from the first electrical apparatus to the central repository, and a third means of communication 308 from the second electrical apparatus to the central repository, wherein information 312 from the first electrical apparatus is transmitted through the second means of communication 308 to the central repository, and information 312 from the second electrical apparatus is transmitted through the third means of communication 308 to the central repository, andthe information 312 is useful for one or more of: the configuration of a generator, the configuration an electrode location map, recording regime adherence, or raising an alert.

15. A kit 133 for configuring a signal generating system 100, comprising a first electrical apparatus comprising a first generator configurable to generate an output signal, a second electrical apparatus comprising a second generator configurable to generate an output signal, and a first means of communication 308 from the first electrical apparatus to a central repository 314, wherein the first electrical apparatus is configured to generate a signal with the first generator, to collect information 312, and to transmit the information 312 through the first means of communication 308, and a second means of communication 308 from the second electrical apparatus to a central repository 314, wherein the second electrical apparatus is configured to generate a signal with the second generator, to collect information 312, and to transmit the information 312 through the second means of communication 308, and the first electrical apparatus and the second electrical apparatus are used to generate respective output signals for an extended period of time that are delivered to the same subject's body.

Images