SE2350150A1 - Tumor treating fields (ttfields) equipment configurations for improved ease-of-use - Google Patents
Tumor treating fields (ttfields) equipment configurations for improved ease-of-useInfo
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- SE2350150A1 SE2350150A1 SE2350150A SE2350150A SE2350150A1 SE 2350150 A1 SE2350150 A1 SE 2350150A1 SE 2350150 A SE2350150 A SE 2350150A SE 2350150 A SE2350150 A SE 2350150A SE 2350150 A1 SE2350150 A1 SE 2350150A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/06—Electrodes for high-frequency therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0484—Garment electrodes worn by the patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0492—Patch electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/3603—Control systems
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01M—PROCESSES OR MEANS, e.g. BATTERIES, FOR THE DIRECT CONVERSION OF CHEMICAL ENERGY INTO ELECTRICAL ENERGY
- H01M10/00—Secondary cells; Manufacture thereof
- H01M10/60—Heating or cooling; Temperature control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36002—Cancer treatment, e.g. tumour
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
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- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Radiology & Medical Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Otolaryngology (AREA)
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- Physics & Mathematics (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Manufacturing & Machinery (AREA)
- Chemical & Material Sciences (AREA)
- Electromagnetism (AREA)
- Electrochemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Hospice & Palliative Care (AREA)
- Oncology (AREA)
- Electrotherapy Devices (AREA)
Abstract
Abstract A system 100 for the delivery of TTFields is disclosed that contains two nodes 150, each configured to co-operatively deliver 'lTFields signals to a respective one, two or three electrodes 130. With a view to the human body's bilateral symmetry, the nodes 150 are worn similarly on the left and right sides, respectively. Advantages in terms of weight and convenience are disclosed.
Description
1/27 TUMOR TREATING FIELDS (TFFIELDS) EQUIPMENT CONFIGURATIONS FOR IMPROVED EASE-OF-USE Technical Field id="p-1" id="p-1"
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[0001] The present invention relates to technology for delivering Tumor Treating Fields (TTFields) treatment to patients suffering from brain tumors.
Background id="p-2" id="p-2"
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[0002] id="p-3" id="p-3"
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[0003] id="p-4" id="p-4"
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[0004] 'lTFields systems are used to treat tumors in human patients. The main indication at the time of writing is brain tumors, or glioblastomas (also metastases of different cancer cell types), but other indications are being explored. The treatment technique requires attaching treatment arrays, typically four (arranged as two pairs), to the skin, each containing a number of electrode elements. The electrode elements are often electrically insulated, such that the coupling to the tissue is capacitive. A generator is used to subject the tissue, with the embedded tumor, to electrical fields that conventionally contain oscillations at 150 kHz (e.g., for mesothelioma) or 200 kHz (e.g., glioblastoma) and have a field strength of at least 1 V/cm (measured as peak voltage, or RMS). The treatment serves to extend overall survival and progression free survival. High compliance with the treatment regime is associated with successful treatment; the therapy should preferably be administered continuously (at least 18 hours a day) for months. Electrode arrays are typically changed two times per week, often with the assistance of a caretaker. Examples of 'lTFields equipment that incorporate a 'hub' between a generator and any electrodes can be found in, e.g., US-11097101-B2, US-11395916-B2, or US-20220096819-A1. A hub as disclosed in these prior art publications connects to a generator and to four electrodes, such that the four electrodes can provide TTFields treatment to a patient, and the hub is the only part connecting electrodes to the generator for the purpose of delivering some electric fields as part of TTFields therapy. A hub further contains no switching circuitry but rather passes the TTFields signals through as they are. ln spite of the name "Tumor Treating Fields," TTFields systems are known to have applications other than direct tumor therapy, such as but not limited to modulating the permeability of the blood-brain-barrier, or treating bacteria.
Summary of the |nvention id="p-5" id="p-5"
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[0005] ln some aspects, the techniques described herein relate to a system (100) including: an electrical apparatus (135), the electrical apparatus (135) further including a signal generator (102), two nodes (150), each node (150) being configured to deliver one or more tumor treating fields signals (153) from the signal generator (102) to at least one respective electrode (130), wherein each node (150) is configured to be carried either on a left side or a right side of a user. (The id="p-6" id="p-6"
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[0006] id="p-7" id="p-7"
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[0008] id="p-9" id="p-9"
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[0009] id="p-10" id="p-10"
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[0010] [0011] id="p-12" id="p-12"
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[0012] id="p-13" id="p-13"
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[0013] id="p-14" id="p-14"
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[0014] id="p-15" id="p-15"
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[0015] [0016] id="p-17" id="p-17"
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[0017] id="p-18" id="p-18"
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[0018] [0019] 2/27 user as typically referred to herein is the recipient of, or subject to, treatment, and would in most embodiments be the wearer of the system 100, and is also referred to as the patient). ln some embodiments, each node (150) is configured to deliver tumor treating fields signals (153) to two electrodes (130). ln some embodiments, each node (150) is configured to deliver tumor treating fields signals (153) to three electrodes (130). ln some embodiments, two nodes (150) co-operatively deliver different polarities of tumor treating fields signals (153) to a respective electrode 130. ln some embodiments, each node (150) is configured to be worn behind or in proximity of an ear. ln some embodiments, each node (150) is configured to be affixed to eyewear. ln some embodiments, a node (150) is configured to selectively switch a tumor treating fields signal (153) to an electrode (130), or to a set of electrode elements (184) in an electrode (130). ln some embodiments, a node (150) is configured to collect digitized information, including temperature information, from one or more electrodes (130) and transmit this information to a signal generator (102). ln some embodiments, a node (150) is configured to collect analog temperature information from one or more electrodes (130), digitize the temperature information, and transmit this information to a signal generator. ln some embodiments, the system further includes an electrode cable (151) having three conductors for connecting an electrode (130) to a node (150), wherein the electrode cable (151) has an electrode connector (156) for connecting an electrode (130) through the electrode cable (151) to a node (150). ln some embodiments, the electrode connector (156) is of a Tip-Ring-Sleeve type. ln some embodiments, the electrode connector (156) is of a Universal Serial Bus Type C type with fewer than 24 pins. ln some embodiments, the system further includes a generator cable (152) having three conductors for connecting a generator (102) to a node (150), wherein the generator cable (152) has a generator connector (158) for connecting a signal generator (102) through the generator cable (152) to a node (150). ln some embodiments, the generator connector (158) is of a Tip-Ring-Sleeve type. ln some embodiments, the generator connector (158) is of a Universal Serial Bus Type C type with fewer than 24 pins. id="p-20" id="p-20"
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[0020] 3/ 27 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 id="p-21" id="p-21"
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[0021] id="p-22" id="p-22"
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[0022] id="p-23" id="p-23"
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[0023] id="p-24" id="p-24"
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[0024] id="p-25" id="p-25"
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[0025] id="p-26" id="p-26"
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[0026] id="p-27" id="p-27"
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[0027] [0028] id="p-29" id="p-29"
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[0029] id="p-30" id="p-30"
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[0030] id="p-31" id="p-31"
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[0031] id="p-32" id="p-32"
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[0032] Fig. 1 is an illustration, in accordance with one embodiment, of a system 100 with an electrical apparatus 135.
Fig. 2 is an illustration, in accordance with one embodiment, of a node 150 affixed and supported behind an ear.
Fig. 3 is an illustration, in accordance with one embodiment, of a node 150, affixed to and supported by a pair of glasses.
Fig. 4 is an illustration, in accordance with one embodiment, of a node 150, connected to a generator 102 (not shown) through a generator cable 152, affixed to and resting on a temple of a pair of glasses.
Fig. 5 is an illustration, in accordance with one embodiment, of a node 150 affixed to the temple of a pair of glasses, where the glasses can be moved to rest on top of a person's head.
Fig. 6 is an illustration, in accordance with one embodiment, of a system 100 with two nodes 150 supported inside an eyeglass retainer 154, where for each node 150 two electrode cables 151 connect with a respective electrode 130 affixed to the side of the head (generator 102 not shown). ln some embodiments the two electrode cables 151 run in part through the eyeglass retainer 154.
Fig. 7 is an illustration, in accordance with one embodiment, of an electrode cable 151.
Fig. 8 is an illustration, in accordance with one embodiment, of a custom TRS connector 155 for connecting an electrode cable 151 to a custom TRS receptacle in a node 150 (not shown).
Fig. 9 is an illustration, in accordance with one embodiment, of a node 150, with one generator connector 158 with four conductors, three power switches 173, and four-conductor electrode connectors 156.
Fig. 10 is an illustration, in accordance with one embodiment, of a node 150, similar to that of Fig. 9 above, but with no switching circuitry for the 'lTFields signals 153.
Fig. 11 is an illustration, in accordance with one embodiment, of a node 150, which is configured to connect to two electrodes 130 through a respective electrode connector 156a and 156b.
Fig. 12 is an illustration, in accordance with one embodiment, of a node 150, where a three- conductor generator connector 158 has pins for TTFields signal 153, a 1-wire connector (for VDD and serial communications with a controller 165), and a common voltage reference. 4/27 id="p-33" id="p-33"
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[0033] Fig. 13 is an illustration, in accordance with one embodiment, of a system 100 with an electrical apparatus 135, where a generator cable assembly 159 connects the electrical apparatus 135 to two nodes 150.
Detailed Description of Preferred Embodiments id="p-34" id="p-34"
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[0034] id="p-35" id="p-35"
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[0035] id="p-36" id="p-36"
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[0036] As was described above, the technical problems that are solved by the various embodiments of the invention relate to 'lTFields equipment, which has suffered from limited adoption due to lacking ease of use and other drawbacks. For example, 'lTFields equipment typically requires a patient to shave his or her head entirely every few days, and also typically includes a lot of potentially cumbersome cabling and connectors. Some embodiments of the present invention permit a reduction in size, length, or weight in the cabling and/or connectors used in a TTFields system. Some embodiments permit keeping more of the patient's hair while treatment is applied. Some embodiments permit a combination of these benefits, and some embodiments have yet additional benefits. 'lTFields equipment typically includes a signal generator for therapeutic signals (typically delivered as an electric field using at least two therapeutic signals, each providing opposite polarities of the electric field), and several pairs of electrodes that are adhesively attached to the patient's head during treatment, with each pair activated in sequence to deliver therapeutic electric fields (e.g., in the form of 'bursts', as in some embodiments it is beneficial if the electric fields are shut down, ramped down, or similar, ahead of a switch in direction, and then turned on, or ramped up again to the deliver the next burst) in one direction after another. The change in direction may be configured to occur every second, every 250 ms, or at some rate where the switching occurs every 20 ms to 1 s (e.g., 500 ms). Faster or slower rates can be envisioned, e.g., every 10 ms or every 2 seconds. Delivering treatment in different directions, especially from perpendicular or orthogonal directions, or in some embodiments roughly so, e.g., within 20 degrees, or within 30 degrees, of being orthogonal, is associated with better clinical outcomes and is likely to be effective as treatment success for a cancer cell is dependent on its internal molecular orientation, among other things.
Electrodes in some embodiments include multiple electrode elements, nine in common products on the market today, that electrically connect with the patient's tissues. For head applications, one pair of electrodes is typically placed to the right and left (Left-right (LR) direction), and one pair typically on the forehead and the back of the head (anterior-posterior (AP) direction), with some adjustments to suit the specific tumor location and other requirements for a specific patient. These directions ideally permit about 90-degree changes in orientation of the applied fields. id="p-37" id="p-37"
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[0037] id="p-38" id="p-38"
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[0038] [0039] id="p-40" id="p-40"
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[0040] id="p-41" id="p-41"
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[0041] id="p-42" id="p-42"
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[0042] /27 Since the human head is typically longer in the anterior-posterior (AP) direction than in the LR- direction, a therapeutic signal has to pass through more tissue in the AP-direction. This increases conduction resistance to the applied field and reduces the field strength, for a given applied electrode voltage.
Stronger field strengths are associated with greater success in treating tumors with TTFields. ln some embodiments of the present invention, tumor treating fields (TTFields) signals (153) are used to deliver electric fields, with TTFields signals 153 containing a field oscillating in the 100 kHz to 300 kHz range with a field strength of at least 1 V/cm. ln some embodiments, a 'lTFields signal 153 contains oscillations in the 50 kHz to 500 kHz range. ln some embodiments, the field strength is no more than 5 V/cm. ln some embodiments, a 'lTFields 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 50-500 kHz range. ln some embodiments, a 'lTFields signal 153 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. ln some embodiments, a 'lTFields signal 153 contains three or more significant frequency components in the 50 kHz to 500 kHz 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. ln 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. ln some embodiments, only one frequency component has a field strength of at least 1 V/cm. ln some embodiments of the present invention, electrodes 130 in the system 100 are predominantly placed on the left and right sides of the head, with no electrodes placed predominantly on the forehead or the back of the head.
For some patients, such an arrangement can permit shaving only the left and the right sides of the head, while keeping hair in the middle of the head. This, to some patients, can offer an improvement in their quality of life. ln some embodiments, each of two nodes 150 are configured to be worn in similar fashion on either side of a patient's body. ln some embodiments, the nodes 150 are of identical design, which can be associated with cost and other benefits. ln some embodiments, the nodes 150 are designed to be symmetric (e.g., in the user's sagittal plane), such that they are mirror images of each other. The latter embodiment can be beneficial in terms of ease of use, appearance, or yet additional benefits. id="p-43" id="p-43"
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[0043] id="p-44" id="p-44"
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[0047] 6/27 ln some embodiments, a node 150 can be water resistant, waterproof or otherwise ingress protected. This can protect against condensation on the outside or inside of its enclosure. This can be particularly useful in embodiments of a system 100 where some parts can be beneficially cooled through e.g., refrigeration or being put in a cool environment, as it would be prudent to assume that a user would subject any part of a system 100 to such cooling. ln some embodiments, vents are included, e.g., membrane vents, that prevent the passing of liquid water, but may permit water vapor to pass. This can permit any water molecules that did pass into the enclosure to escape and prevent buildup of any pools of water on the inside (with any heat building up inside during operation, this process would be facilitated). ln some embodiments, a node 150 would be protected to |Px7 or |Px8, e.g., |P67, according to IEC 60529. Since cabling must run from the generator 102 to the electrodes 130 to deliver the therapeutic signals, it can in some embodiments be beneficial to have a connection node 150 in between, where one generator cable 152 extends from the generator 102 to the node 150, and one or more electrode cables 151 extend from the node 150 to each electrode 130. ln some embodiments, it can be beneficial to have the generator cable 152 from the generator to the node relatively longer than the electrode cables 151 from the node to the electrodes, in order that the total length of cabling in the system be kept shorter. ln some embodiments, it can be beneficial to not have a node 150 located roughly near the middle of the total cabling between a generator and an electrode, as this can be inconvenient. ln some embodiments, an electrical apparatus 135 can be connected to two or more nodes 150 through a generator cable assembly 159. ln some embodiments, a generator cable assembly 159 can connect directly between an electrical apparatus 135 and two or more electrodes 130. ln some embodiments of the present invention, a system 100 includes a generator 102 connected to two nodes 150, where each node 150 is used to deliver treatment to predominantly one side of the patient's head through one or more electrodes 130. ln such embodiments, any cables that extend from a node to any respective connected electrodes can be limited to delivering treatment to one side of the head.
Such embodiments make it possible to connect electrodes to both sides of the head without having electrode cables 151 that extends from one side (of the sagittal plane) to the other in the head area. Having two nodes 150 can also provide improved weight balance, as the similar weights of the nodes is symmetrically applied to the wearer's body. ln some embodiments, each node 150 is connected to just one electrode. This can be beneficial e.g., for some centrally located tumors where the benefit of having two or more pairs of electrodes can be limited. Another benefit is that, even in embodiments where such a node 150 essentially only passes the conductors/signals on to an electrode 130, the fixation to the ear id="p-48" id="p-48"
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[0048] id="p-49" id="p-49"
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[0049] id="p-50" id="p-50"
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[0050] id="p-51" id="p-51"
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[0053] 7/ 27 means that an electrode cable 151 moves with the frame of reference of the head, meaning that it can be shorter and will not mechanically pull on an electrode 130 to the same extent. ln some embodiments, each node 150 connects to two electrodes 130, e.g., on the same side of the head. ln such an embodiment, it is possible to change the orientation of the electric field delivered to the patient by selectively activating different electrodes on either side of the head, e.g., one electrode 130 for each node 150. ln some embodiments, each node connects to three electrodes, e.g., on the same side of the head. ln such an embodiment, the advantages of stimulation alternating in more than two directions can be exploited ln embodiments with two or more electrodes on the same side of the head, the electrodes can be placed side-by-side (Fig. 2) or one above the other (in the Superior-lnferior (SI) direction), see Fig. 3, or a combination thereof, to be able to deliver fields in different orientations as required. ln some embodiments, a node 150 is designed to be wearable behind the ear (or otherwise be worn in fixed proximity to the ear); in some embodiments supported by the ear. Such embodiments can contain a hook that rests over the ear. Other means of attaching a node 150 can in some embodiments be using adhesives, or a clip to attach to a patient's clothes, as otherwise disclosed in herein, or yet other means. ln some embodiments, a combination of means of affixing or supporting a node 150 are used, e.g., using a hook over the ear and adhesive together, where the combination serves to offer improved support for the weight of a node 150 and fixation of it to the head. ln some embodiments, a clip can be located on a generator cable, somewhere along its length, such that it can be clipped onto clothing to support some of the weight of the generator cable. ln some embodiments, such a clip would be located on the upper half of a generator cable (away from a generator), at least 2 cm from the top end (closest to a node).
This can in some embodiments have a physical appearance similar to that of some hearing aids or headsets. For some patients, having a 'lTFields system that at least in part mimics other, more generally known, technology (hearing aids, headsets, etc.) can be perceived as a benefit as it can reduce any perceived stigma associated with wearing the device and/or make it less conspicuous.
The US-11097101-B2 prior art discloses TTFields equipment embodiments with a 'hub' where "because only 4 conductors are needed in each of the cables 35 that interface with each transducer array 50" it is "possible to mount the hub 30 on the patient's head in the vicinity of the transducer arrays". However, the 'hub' as disclosed in '101-B2 is not suggested to connect to fewer than four electrode (transducer) arrays, making it not comparable to a node 150 according to embodiments of the present invention in important respects. For example, a 'hub' id="p-54" id="p-54"
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[0054] id="p-55" id="p-55"
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[0055] 8/27 can through its four electrodes deliver the entirety of TTFields signals that a patient is subjected to, whereas nodes 150 in typical embodiments are used pairwise and the two nodes 150 work together co-operatively to deliver one electric field through the body. Among other differences from the present invention, there is no suggestion of using more than one hub, mounting the 'hub' considering bilateral symmetry or weight balance, mounting the 'hub' on or near the ear, or behind the ear, or the various other affixing modes disclosed herein. The configuration of conductors between the different parts of the equipment is also different. Further, an 8-wire cable can be rather heavy, and in some embodiments, it can be unsuitable to support the weight of such a wire from a node 150, worn as disclosed herein, to a signal generator, suggesting that other means of mounting "on the patient's head" might be intended.
The US-20220096819-A1 prior art makes a stray mention of "The exemplary connectors may be positioned between one or more distal circuits and one or more hubs.", ln the context of this reference in '819-A1, the generator-hub cable has eight conductors, including "4 wiresfor TTFields signal (i.e., one for each of the four arrays)", suggesting that the conductors for 'lTFields signals pass their signals on directly to more 'distal circuits', and also suggests that four transducer arrays are meant to be connected to a 'hub'. Application '819-A1 does not suggest that two or more hubs should co-operate in delivering an electric field in a system, but rather that the hub be "electrical/y coupled to m of the plurality of transducer arrays" (emphasis added). This again suggests that a 'hub' is different from a node 150, inter alia because two nodes 150, that each delivers just one or more TTFields signals, are used cooperatively to generate a field as electrodes of opposite polarity are required to generate an electric field, whereas a 'hub' delivers all 'lTFields signals required for treatment of a part of a body (as the hub is connected to each of a plurality of transducer arrays, and each array has a plurality of electrode elements, "the electrode elements configured to provide TTFields"). Providing TTFields requires at least two TTFields signals of opposite polarity. Further, no clear suggestion is made that a 'hub' could contain circuitry to switch a 'lTFields signal on or off, e.g., for a distal circuit or electrode, but rather only that a 'lTFields signal is passed through between a generator and a transducer array. ln order to not obstruct the simultaneous use of any eyewear, a node 150 for use in some way close to an ear can in some embodiments extend no more than a few millimeters above the ear's attachment to the head, in some embodiments no more than 5 mm and in some embodiments 1 mm, such that a pair of eyeglasses can comfortably be worn at the same time. ln some embodiments, the eyeglass temples can rest to the side of a node 150, and in some such embodiments, the node 150 can have a geometry in the area closest to the eyeglass temple to make room to the side of the node 150 for the eyeglass temple, in some id="p-56" id="p-56"
id="p-56"
[0056] id="p-57" id="p-57"
id="p-57"
[0057] id="p-58" id="p-58"
id="p-58"
[0058] id="p-59" id="p-59"
id="p-59"
[0059] id="p-60" id="p-60"
id="p-60"
[0060] id="p-61" id="p-61"
id="p-61"
[0061] id="p-62" id="p-62"
id="p-62"
[0062] 9/ 27 embodiments a recess in the left or right directions of one or a few millimeters, e.g., 2 or 5 mm. ln some embodiments the eyeglass temples can rest on top of a node 150, and in some such embodiments, there can be a recess in the top of the node 150 where an eyeglass temple can rest. ln some embodiments, a node 150 is affixed to an eyeglass temple such that they can move together. The connection can be through one or more connections, e.g., through a clip, or mechanica| locking mechanism, made from p|astic or metal, or a piece of fabric with a locking mechanism, such as a hook-and-loop fastener (such as the Velcro hook-and-loop fastener).
One benefit of arrangements wearable behind the ear or supported by the ear is that a node 150 can be fixed in relation to any attached electrodes 130 within the frame of reference of the head. This can in turn permit shorter electrode cables 151 to be used, than would be the case if the node 150 was free to move in relation to the head. Shorter cables provide inter alia the advantages of less visibility, and less risk of entanglement. ln some embodiments, a node 150 can contain a pass-through connection for 'lTFields signals 153 that electrically connect a generator 102 with an electrode 130, without actively controlling the TTFields signal. ln some embodiments, a node can contain circuitry that enables it to selectively connect and disconnect (switch) a TTFields signal 153 from a generator 102 to an electrode 130. ln such embodiments, the generator cable 152 can have a common electrical connection for a TTFields signal 153 that can be routed to different electrodes 130, or it can have separate conductors for TTFields signals 153, one for each electrode 130, which can then be turned on or off. ln some embodiments, a node can contain circuitry that enables it to selectively connect and disconnect (switch) a TTFields signal 153 from one or more electrode elements 184 within an electrode 130 that contains additional electrode elements 184 that may be separately controllable.
Potential advantages associated with embodiments where a node 150 contains active switching functionality as disclosed above include that the generator cable 152 can be made thinner, as it does not need to contain as many conductors for the TTFields signal(s). ln some embodiments, a generator 102 produces two TTFields signals 153 with opposite polarity, suitable for application to each electrode 130 in a pair of electrodes such that the therapeutic signals are applied across tissue as an electric field, and delivers each of the two 'lTFields signals 153 to one of two respective nodes 150 for further furtherance to electrodes 130 connected to each node 150, such that the therapeutic signal is applied through both nodes and any active respective electrodes 130 or electrode elements 184. id="p-63" id="p-63"
id="p-63"
[0063] id="p-64" id="p-64"
id="p-64"
[0064] id="p-65" id="p-65"
id="p-65"
[0065] id="p-66" id="p-66"
id="p-66"
[0066] id="p-67" id="p-67"
id="p-67"
[0067] id="p-68" id="p-68"
id="p-68"
[0068] / 27 A further potential benefit of the above embodiments is associated with distributing heat dissipation in a system 100, as the switching circuitry will necessarily generate some waste heat, and performing it in a node 150 separate from the generator 102 will reduce the heat load in the generator (if corresponding switching or similar wave-forming would otherwise be performed there). Having two nodes 150 further divides the waste heat generation to further thermally separate parts in the system, potentially facilitating the heat dissipation of an overall system 100. ln embodiments where a node 150 is designed to be worn in fixed proximity of the ear, the node can be designed to preferentially vent heat in a direction away from the wearer. This can be performed e.g., by including thermal insulation on a side of the node 150 that touches the skin, and/or by including a suitable heat sink (in some embodiments with fins) that can vent heat into ambient air. By having a part of the node 150 surface facing away from the user in normal use, and so not continuously in physical contact, the surface temperature according to a relevant regulation (e.g., IEC 60601) can be permitted to be higher. ln some embodiments where a node 150 is worn close to an ear, a first node 150 can be designed to connect to one side of a pair of glasses, e.g., with a second node 150 designed to be attached to the other side of the pair of glasses, e.g., by getting strapped on the temple tips of the glasses in a fashion similar to how a typical eyewear retainer attaches to each side a pair of glasses to prevent the glasses from slipping from the user's head during use. ln some such embodiments, some of the weight of a first node and a second node, if present, can be borne directly and indirectly by some combination of the ears and the nose. Such an arrangement can enable a patient to wear eyeglasses of his or her choice together with a 'lTFields system. ln some embodiments, a pair of glasses with wide temples can be attached to a node 150, such that parts of electrodes 130 attached to the sides of the head can be obscured from view. To a patient, this can be beneficial as it can make the treatment apparatus less conspicuous. ln some embodiments, a node 150 can be designed to attach to and extend along a temple of on side of an eyeglass toward the front of the user's face. ln this arrangement, there can be several possible advantages: the weight of the node 150 can be more evenly balanced across support points at the ears and nose, a node 150 can in some embodiments be supported in free air (not touching skin, or not having significant thermal contact), permitting larger convective heat flows to dissipate waste heat. ln some embodiments, whether a node 150 is affixed to an eyeglass temple or not, connected eyeglasses can be lifted up to rest on top of the user's head, while any nodes 150 can still remain in contact with any electrodes 150 through electrode cables 151 (Fig. 5). ln id="p-69" id="p-69"
id="p-69"
[0069] id="p-70" id="p-70"
id="p-70"
[0070] id="p-71" id="p-71"
id="p-71"
[0071] id="p-72" id="p-72"
id="p-72"
[0072] id="p-73" id="p-73"
id="p-73"
[0073] id="p-74" id="p-74"
id="p-74"
[0074] 11/ 27 embodiments where the nodes 150 are not affixed to eyeglasses (e.g., by being affixed to temples), the eyeglasses can be removed without obstructing the use of the system 100. ln some embodiments there can be a strap or other part that connected the nodes 150 on either side of the head, similar to an eyeglass retainer. ln embodiments where any cabling is beneficially connecting the left and the right sides of the patient, it can be drawn in the strap or other part. ln some embodiments of a system 100, there is a first node 150 and a second node 150, and an eyeglass retainer 154. ln some embodiments, the first and the second node 150 can be attached to the eyeglass retainer 154. ln some embodiments, where the eyeglass retainer 154 is made from e.g., a fabric, the first and second nodes 150 can be partially or fully housed inside pockets in the eyeglass retainer 154. ln some such embodiments, the eyeglass retainer 154 can have perforations to facilitate heat dissipation into the ambient atmosphere. ln some embodiments the nodes 150 can be located very close to where the eyeglass retainer 154 attaches to a pair of glasses, such that their weight is predominantly worn by the ears. ln some embodiments, the nodes 150 can be located further toward the neck along the eyeglass retainer 154, in some embodiments resting more on the patient's neck and/or shoulders. ln some embodiments of a system 100 with two nodes 150, the nodes can be free hanging in their connecting cables, attached to clothing, or attached in some other way not explicitly disclosed herein, each on either side of the body. Such embodiments can also have some of the benefits here described, such as, but not limited to, better weight balance and thermal distribution. ln some embodiments, a user can detach a node 150 from any direct or indirect attachment to the user's body while continuing to operate the system to deliver 'lTFields therapy. This can e.g., apply when the user sleeps or rests, where a node 150 can be configured to rest e.g., on a pillow, in a bed, or in another suitable way, in some embodiments close to the user's head. Detaching a node 150 can be associated with several benefits, including but not limited to, e.g., making it more comfortable to rest a user's head on its side, improve any heat dissipation from a node 150, facilitating operating a system 100 with an electrical apparatus 135 or generator 102 not worn or located close to the body. ln some embodiments, a node 150, especially but not limited to one worn behind or on the ear, contains additional functionality not directly related to 'lTFields treatment, e.g., hearing aid functionality, or headset functionality, or acting as an eyewear retainer. ln some embodiments, an electrode cable 151 contains three conductors: one used for a 'lTFields signal, one for ground, and one for 1-wire communications (e.g., VDD and communications share a conductor). Communications through an electrode cable 151 is id="p-75" id="p-75"
id="p-75"
[0075] id="p-76" id="p-76"
id="p-76"
[0076] 12/ 27 required for such things as e.g., temperature monitoring and control, treatment delivery control, and other tasks. ln a 1-wire communications system, the same ground-referenced conductor is used to deliver power to a remote device by storing energy e.g., in a capacitor or inductor, in the remote device such that the voltage in the ground-referenced conductor can be dropped during short intervals in order to transfer a message. ln some embodiments, an electrode cable 151 is shielded, with the shield connected to ground at one end (typically the node's 150 end). Note that in some embodiments, such a shield in itself does not constitute a conductor as it does not make a connection between the ends connected by the electrode cable 151. An advantage of this three-conductor arrangement is that an electrode cable 150 can be made thinner than an embodiment that requires additional conductors, e.g., one that has one or two separate conductors for communications, without the additional circuitry required to e.g., harvest DC power from and superimpose communications on a TTFields signal 153. ln a 1-wire communications system, sending messaging signals on the shared VDD/comm conductor can be associated with increased power draw, as the voltage has to be lowered from its nominal level during signaling. ln some embodiments of a system 100, the communications requirements between circuits related to or embedded in an electrode 130 are limited, as only small volumes of data need to be communicated at intervals (e.g., every second or so, or in some embodiments every 0.1 - 4 seconds) that permit the communications to be idle for the most part (e.g., more than 90% of the time) such that the additional power draw from the 1- wire solution is limited. Similar limited signaling usage requirements applies to a generator cable 152, though in some embodiments, the generator cable might have to transmit information related to multiple electrodes 130, increasing communications requirements, and thus the power draw from 1-wire signaling. ln some embodiments, the power draw from signaling can be reduced by limiting the voltage drop that is specified according to the protocol as part of transmitting a signal. ln some embodiments, the higher the power requirements of any downstream circuits (e.g., in a node 150 or in an electrode 130), the less efficient a 1-wire solution would be as more current is available for a given voltage, and the voltage is lowered during signaling. For example, if a node 150 contains any power switches for switching a 'lTFields signal 153, this will require more power than a node 150 with a pass-through only for any 'lTFields signal 153. lf an electrode 130 contains additional functionality that requires electrical power, a similar situation applies if the additional power draw is not insignificant. For any high-power embodiments, separating VDD and communications can provide an efficiency benefit. ln some embodiments, an electrode cable 151 is connected to a node 150 with a connector 156, e.g., a TRS connector 155. A TRS connector enables connection of three conductors (the tip, the id="p-77" id="p-77"
id="p-77"
[0077] id="p-78" id="p-78"
id="p-78"
[0078] id="p-79" id="p-79"
id="p-79"
[0079] id="p-80" id="p-80"
id="p-80"
[0080] id="p-81" id="p-81"
id="p-81"
[0081] 13/27 ring, and the sleeve). An arrangement with three conductors provides advantages over e.g., Tip- Ring-Ring-Sleeve (TRRS), where four connectors are used through the addition of an additional ring conductor, since a TRS solution can be made smaller and lighter, e.g., by eliminating a conductor in a cable. ln some embodiments, it can be advantageous to electrically isolate a TTFields signal 153 from a user, such that it cannot reach a user's body other than as intended through any electrodes. The higher voltage in a 'lTFields signal can require additional clearance and creepage distances (as per, e.g., IEC 60601) than are required for other conductors, and in some embodiments, this is easier to accommodate with the TRS arrangement than a TRRS arrangement. (For example, common 3.5 mm diameter TRS and TRRS connectors typically have 14-17 mm length). ln an exemplary embodiment delivering up to 100 V peak voltage the IEC 60601 indicates that a 4.9 mm creepage distance is required. ln some embodiments, this can be achieved by e.g., having the TRS (or TRRS) receptacle in a recess in the enclosure, e.g., 5 mm, or more, deep, such that all conductors in the receptacle and plug, when mated, are separated by more than applicable creepage and clearance requirements from a user's touch. ln some such embodiments, the conductors in a receptacle and a plug are not separated by such distances from each other, requiring the same isolation requirements to be applied to all these conductors, and any indirectly connected conductors, throughout the system (including e.g., VDD/comm, GND, etc.). ln some embodiments, a potentially hazardous conductor (e.g., one for a TTFields signal 153) can be separated by a sufficient creepage distance from any other conductors as well as a user, such as with the custom TRS connector of Fig. 8.
A circular arrangement like with a TRS connector can facilitate ease of use as it need not be oriented to be inserted into a receptacle, but can rotate 360°. ln some embodiments, an electrode connector 156 is attached to an electrode cable 151 at the end that faces a node 150, or at the end that faces an electrode 130, or there can be electrode connectors 156 at both ends. The electrode connectors 156 mate with any corresponding receptacles in a node 150 and an electrode 130, as applicable. ln some embodiments, a generator connector 158 is attached to a generator cable 152 at the end that faces a node 150, or at the end that faces a generator 102, or there can be generator connectors 158 at both ends. The generator connectors 158 mate with any corresponding receptacles in a node 150 and a generator 102, as applicable. ln some embodiments, the receptacle for the TRS connector, e.g., located on a node 150, is recessed into the node 150 enclosure, such that creepage and clearance distances are as required. id="p-82" id="p-82"
id="p-82"
[0082] id="p-83" id="p-83"
id="p-83"
[0083] id="p-84" id="p-84"
id="p-84"
[0084] id="p-85" id="p-85"
id="p-85"
[0085] id="p-86" id="p-86"
id="p-86"
[0086] id="p-87" id="p-87"
id="p-87"
[0087] 14/ 27 ln some embodiments an electrode cable 151 is connected to a node 150 with a connector that is of the USB Type C type. A regular USB C connector has 24 pins, but there are also six and eight pin versions of USB C (intended for power-only solutions) where some of the connectors of the 24-pin variety have been removed. An important benefit of using USB C connectors with the reduced pin-count is that the spacing between the pins in the connector becomes significantly wider, reducing the risk of arcing in the connector. Reducing the pin count of the connector in some embodiments also matches the fewer conducts used e.g., in an electrode cable 151. Of note is that USB C connectors are rated for 48 V DC, but are required to tolerate one minute at 100 VAC, meaning that 'lTFields applications as commonly applied push the rating and specification boundaries of USB C, and perhaps in some embodiments cross them. The USB Type C connector standard can be used without following the protocols specified for USB C compatible devices. Since USB Type C connectors are reversible, they can be more convenient to connect and disconnect than a non-reversible connector. ln some embodiments, a similar USB Type C connector is used with a generator cable 152. ln some embodiments, 2.5 mm or 3.5 mm TRS connectors are used (either size may be used both for electrode connector 156 or generator connector 158). Using other connector embodiments than TRS or USB C can also be envisioned in some embodiments. ln other embodiments, more than one conductor is used for TTFields signals in an electrode cable 151, such that different sets of electrode elements 184 in an electrode 150 can deliver 'lTFields signals that differ e.g., in amplitude, phase, frequency content, or burst timing, or waveform, or that are turned on or off selectively. ln such embodiments, both the electrode cable 151 and any associated connector will have more conductors compared to some of the embodiments described above that have three. ln embodiments that do not include a node 150, a cable that directly connects a generator 102 with an electrode 130 can be implemented in the same way as an electrode cable 151. ln some embodiments, an electrode connector 156 can be optionally connected either to a node 150 or a generator 102 in the same system 100. ln some embodiments, where an electrode 150 is configured to use a TRS electrode connector 156, while a generator is configured to receive a generator connector 158 that is of the TRRS type (to connect to a node), the TRS electrode connector 156 can be directly mated with a TRRS generator connector. ln such embodiments, it can be advantageous if the unavailability of the fourth conductor is detected, such that a VDD conductor can be used for communications as well, e.g., through a 1-wire protocol. ln some embodiments, a system 100 is used to treat several different parts of the subject's body, with electrodes applied as needed to each part of the body. For example, a patient id="p-88" id="p-88"
id="p-88"
[0088] id="p-89" id="p-89"
id="p-89"
[0089] id="p-90" id="p-90"
id="p-90"
[0090] id="p-91" id="p-91"
id="p-91"
[0091] id="p-92" id="p-92"
id="p-92"
[0092] id="p-93" id="p-93"
id="p-93"
[0093] /27 treated for metastases in the brain can have a primary tumor located in the torso or abdomen. ln such embodiments, a patient can have a plurality of electrodes 150 attached on the head, connected through two nodes 150 to a generator 102, as well as electrodes 150 attached on the torso, connected directly to the generator 102. The generator 102 would then output electrical fields through the directly and indirectly connected electrodes 150, with suitable field strengths, directions and timings. ln some embodiments, a generator cable 152 contains three conductors: one used for a 'lTFields signal, one for ground, and one for 1-wire communications (e.g., VDD and communications share a conductor). ln some embodiments, such a generator cable 152 is shielded, with the shield connected to GND in one end. Such an embodiment can make it possible to have a thin cable between a generator 102 and a node 150, making it light-weight and convenient. ln some other embodiments, a generator cable 152 has four conductors, through the addition of an additional 'lTFields signal conductor. Such a cable can be used to deliver two different 'lTFields signals with e.g., different amplitude, phase, burst timing or waveform, to two different sets of electrode elements 184, that in turn can be located in one or more electrodes 130. Similarly, in some embodiments, a generator cable 152, otherwise similar to the above, has five conductors, through the implementation of three TTFields signals in the cable.
Referring again to Fig. 1, an exemplary embodiment of a system 100 with an electrical apparatus 135 is illustrated (not shown: in this embodiment the electrical apparatus 135 contains a generator 102 that creates one or more 'lTFields signals 153), connected with a respective generator cable 152 to two nodes 150 on either side of the head, worn supported by the ears (one node 150 not shown), with the visible node 150 connected to an electrode 130 with an electrode cable 151 (not shown). The exemplary embodiment has a user interface 128, on at least one of the nodes 150. (A user interface 128 can be used both by a user, and another person, e.g., a caretaker or medical professional).
Referring again to Fig. 2, an exemplary illustration of a node 150 affixed and supported behind an ear, with node 150 connected to two electrodes 130 on the side of the head, each through an electrode cable 151, where the patient is able to retain hair around the central sagittal plane. The electrode cables 151 and the generator cable 152 are each connected to the node 150 through a respective Tip-Ring-Sleeve (TRS) connector 155 (one not shown).
Referring again to Fig. 3, an exemplary illustration of a node 150, affixed to and supported by a pair of glasses, where the node 150 is attached to the eyewear's temple tip by covering it in an elastic fabric (this is like a typical eyewear retainer). ln the illustration, two electrodes 130 are shown one above the other in the superior-inferior (S|)-direction. Electrode cables 151 connect the electrodes 130, in some embodiments with connectors (not shown). id="p-94" id="p-94"
id="p-94"
[0094] id="p-95" id="p-95"
id="p-95"
[0095] id="p-96" id="p-96"
id="p-96"
[0096] id="p-97" id="p-97"
id="p-97"
[0097] id="p-98" id="p-98"
id="p-98"
[0098] 16/ 27 Referring again to Fig. 4, an exemplary illustration of a node 150, connected to two electrodes 130 through a respective electrode cable 151, with an electrode 130b that is connected to another node 150 on the other side of the head (not shown). The electrodes in the illustration are configured as one pair in the AP-direction and one in the left-right (LR)-direction, with one electrode of each pair connected to each respective node 150. More extensive hair removal is sometimes required compared to configurations that do not have electrodes in the central sagittal plane.
Referring again to Fig. 5, an exemplary illustration of a node 150 affixed to the temple of a pair of glasses where the node 150 is connected to two electrodes 130 through two electrode cables 151 (one not shown), where the glasses can be moved to rest on top of a person's head and the node 150 remains connected to the electrodes 130 through the electrode cables 151.
Referring again to Fig. 8, in an embodiment with up to 100 V peak voltage, the minimum creepage distance would need to be about 4.9 mm according to IEC 60601.
Referring again to Fig. 9, of an exemplary illustration of a node 150, with one generator connector 158 with four conductors: one for TTFields signal 153, one for DC power (VDD, short for Voltage at Drain), one for common reference voltage (ground, or VSS, Voltage at Source) and one for communications with a controller 165; three power switches 173a, 173b, and 173c, each of which controls, e.g., under the direction of the controller 165, whether the 'lTFields signal 153 is passed on to a respective four-conductor electrode connector 156a, 156b, and 156c. The electrode connectors 156a, 156b, and 156c can each be connected to an electrode 130, in some embodiments through an intermediary part and in some embodiments directly. The controller 165 can receive information in serial, digital from each electrode connector 156a, 156b, or 156c, e.g., with temperature measurements from any electrodes 130. ln some embodiments, the controller 165 can also transmit information or instructions through an electrode connector 156 to any suitable functionality in an electrode 130. The generator connector 158 can be connected to a 'lTFields signal generator. VDD and the common reference voltage are both passed from the generator connector 158 to each of the electrode connectors 156a, 156b, and 156c. ln some embodiments, an additional conductor for serial communications is added one or more of the electrode connectors 156, such that each communications line is available for a respective transmission direction and full duplex communications is possible. (With one conductor for communications, communication will be half duplex).
Referring again to Fig. 10, of an exemplary illustration of a node 150, with no switching circuitry for the 'lTFields signals 153a, 153b and 153c, each of which has its own conductor in the generator connector 158, and which is each passed through to their respective electrode connector 156a, 156b and 156c. |nstead of a dedicated communications conductor and a id="p-99" id="p-99"
id="p-99"
[0099] id="p-100" id="p-100"
id="p-100"
[0100] id="p-101" id="p-101"
id="p-101"
[0101] 17/27 dedicated VDD conductor, these share a common conductor through a 1-wire protocol (both in generator connector 158 and electrode connector 156). ln this exemplary embodiment, the generator connector 158 has five pins (conductors), and the electrode connectors 156a, 156b and 156c each has three pins.
Referring again to Fig. 11, the electrode connectors 156a and 156b each have a conductor for 'lTFields signal 153a and 153b, which in turn each have a conductor in generator connector 158. A controller 165 is connected to eight conductors in each connector 156a and 156b, each in turn connected to a temperature sensor, e.g., a thermistor, in a connected electrode 130 (not shown), such that signals with temperature information, and in some embodiments other information as needed, can be received. The controller 165 in some embodiments contain circuitry to digitize the temperature information, e.g., using one or more analog-to-digital converters (ADCs). ln some embodiments, the conductors for the temperature information are connected to any ADCs using multiplexers. ln some embodiments, no multiplexers are used but e.g., one ADC for each signal. The generator connector 158 in the exemplary embodiment has four pins, two for 'lTFields signals 153a and 153b, one for common voltage reference (ground), and one for 1-wire communications, that constitutes a communications channel between a controller 165 and a e.g., a signal generator (not shown) connected through generator connector 158. The VDD power rail is derived (not shown) from the 1-wire connection and is passed on to any connected electrodes 130 through electrode connectors 156a and 156b. ln some embodiments, a node 150 as in Fig. 11 can also have a conductor for digital communications through an electrode connector 156, in some embodiments implemented with a 1-wire protocol sharing the VDD conductor, in order to communicate in one or two directions with any other functionality located in an electrode 130. ln embodiments where 6- or 8-wire USB type C connectors are used, similar arrangements as in Fig. 11 can be used, but with fewer conductors connected to temperature sensors. E.g., with three connectors to temperature sensors, the total number of conductors would be six. With five connectors to temperature sensors, the total number of conductors would be eight. Referring again to Fig. 12, a controller 165 can control wither power switches 173 pass a 'lTFields signal 153 to their respective electrode connectors 156a and 156b. The tasks of controlling the switches 173 and the sampling of temperature information can in some embodiments be separate and conducted by different controllers 165. By having them in one controller 165, an advantage is that the node 150 can independently respond to any unsuitable temperatures sensed in the electrodes 130 by turning off the delivery of a TTFields signal 153, which can be e.g., a safety improvement (this in some embodiments can also be a backup safety feature, e.g., after first letting a connected signal generator reduce signal amplitude, duty cycle id="p-102" id="p-102"
id="p-102"
[0102] id="p-103" id="p-103"
id="p-103"
[0103] id="p-104" id="p-104"
id="p-104"
[0104] id="p-105" id="p-105"
id="p-105"
[0105] id="p-106" id="p-106"
id="p-106"
[0106] 18/ 27 or otherwise take measures to reduce a heat load). ln this exemplary embodiment, the voltage and current of each output 'lTFields signals 153 are measured in sensors 157.
Referring again to Fig. 13, a generator 135 is connected to two nodes 150 through a generator cable assembly 159. A generator cable assembly 159 connects to a node 150 the same way that a generator cable 152 would, and contains a similar configuration of conductors. The parts of respective generator cables 152 that connect to a respective node 150 then merge into a common cable, that in turn connects to an electrical apparatus 135 in a way similar to that of a generator cable 152. ln some embodiments, a connector with a larger number of pins must be chosen in order to accommodate a larger number of conductors. ln some embodiments, the common cable contains all the conductors for each connected node, all separated from each other. ln some embodiments, the conductors for VDD to each node 150 are connected in the common cable, such that a single conductor in the common cable can provide power to all connected nodes 150. ln some embodiments, the conductors for communications to each node 150 are connected in the common cable, such that a single conductor in the common cable can be used to communicate with each node 150, effectively on a common communications bus. ln the illustration of Fig. 13, the visible node 150 is connected to a single electrode 130, but other embodiments can connect a node 150 to e.g., two or three electrodes 130.
As is shown in Figures 9 through 13, different configurations of connectors 156 to nodes 150 are possible. Variations and combinations of the shown exemplary embodiments are understood to be disclosed in this document. For example, in some embodiments connecting a signal generator to a node 150 through a connector 156, that connector can have three pins (TTFields signal 153, common voltage reference, 1-wire communications protocol), but in other embodiments, the 1-wire connection can be replaced with separate VDD and serial communications (for four pins), or the 1-wire connection is separated into VDD, and two serial communications channels, one for each direction to enable full duplex communications (for five pins). lf in some embodiments, the node 150 receives three separate TTFields 153 signals for a signal generator, and e.g., full duplex, then the connector to the signal generator 156 will require seven connectors. ln currently available products, 10-wire cables are typically used to connect generators and 'hubs' that in turn connect to electrodes. ln some embodiments, a node 150 with switching circuitry for any 'lTFields signals 153 can also contain sensing circuitry (not shown) to measure, e.g., the output 'lTFields signal 153's current and/or voltage.
Electrical connections as disclosed herein should generally be understood to refer to electrical coupling more generally and not just direct galvanic connections, unless this is unsuitable from id="p-107" id="p-107"
id="p-107"
[0107] id="p-108" id="p-108"
id="p-108"
[0108] id="p-109" id="p-109"
id="p-109"
[0109] id="p-110" id="p-110"
id="p-110"
[0110] 19/ 27 the context. For example, for a 'lTFields signal 153, there can be a blocking capacitor in the circuit such that only higher-frequency content of a signal can pass. Such capacitive, but also inductive and optical coupling can be considered, e.g., optical connection for the information transmission between different parts of the system 100. ln several exemplary embodiments, cables are shown to connect to nodes 150 and other parts through connectors. lt should be understood that, unless otherwise clearly stated, that these connectors can be eliminated and that in such embodiments a cable can be firmly attached to a node 150 or other part. ln some embodiments, a node 150 has a user interface 128. The user interface 128 in some embodiments can produce audible output such as from a buzzer or a speaker. ln some embodiments, a user interface 128 can have one or more press buttons. ln some embodiments, one or more nodes 150 can contain a memory (not shown) such that state information for the system 100 can be preserved, even if other parts of the system are removed or replaced. The state information can in some embodiments contain, but is not limited to, e.g., settings, treatment schedules, treatment logs, technical telemetry, and similar. ln some embodiments, similar memory for state information can also be present in an electrical apparatus 130, or yet other parts of a system 100, to facilitate such state preservation. Communications channels between parts of a system 100 that needs to be able to exchange state information are understood to be implemented as would be well known to the person skilled in the art.
The following is a numbered list of non-limiting illustrative embodiments of the invention in several different modes: A system (100) comprising: an electrical apparatus (135), the electrical apparatus (135) further comprising a signal generator (102), two nodes (150), each node (150) being configured to deliver one or more tumor treating fields signals (153) from the signal generator (102) to at least one respective electrode (130), wherein each node (150) is configured to be carried either on a left side or a right side of a user.
A system (100) according to mode 1, wherein each node (150) is configured to deliver tumor treating fields signals (153) to two electrodes (130).
A system (100) according to mode 1, wherein each node (150) is configured to deliver tumor treating fields signals (153) to three electrodes (130).
A system (100) according to any one of modes 1-3, wherein two nodes (150) co-operatively deliver different polarities of tumor treating fields signal s(153) to a respective electrode (130). . 11. 12. 13. 14. . 16. 17. 18. / 27 A system (100) according to any one of the preceding modes, wherein each node (150) is configured to be worn behind or in proximity of an ear.
A system (100) according to any one of modes 1-4, wherein each node (150) is configured to be affixed to eyewear.
A system (100) according to any one of the preceding modes, wherein a node (150) is configured to selectively switch a tumor treating fields signal (153) to an e|ectrode (130), or to a set of e|ectrode elements (184) in an e|ectrode (130).
A system (100) according to any one of the preceding modes, wherein a node (150) is configured to co||ect digitized information, including temperature information, from one or more electrodes (130) and transmit this information to a signal generator (102).
A system (100) according to any of modes 1-7, wherein a node (150) is configured to co||ect analog temperature information from one or more electrodes (130), digitize the temperature information, and transmit this information to a signal generator.
A system (100) according to any one of modes 1-9, further comprising an e|ectrode cable (151) comprising three conductors for connecting an e|ectrode (130) to a node (150), wherein the e|ectrode cable (151) has an e|ectrode connector (156) for connecting an e|ectrode (130) through the e|ectrode cable (151) to a node (150).
A system (100) according to mode 10, wherein the e|ectrode connector (156) is of the Tip-Ring- Sleeve type.
A system (100) according to mode 10, wherein the e|ectrode connector (156) is of the Universal Serial Bus Type C type with fewer than 24 pins.
A system (100) according to any one of modes 1-12, further comprising a generator cable (152) comprising three conductors for connecting a generator (102) to a node (150), wherein the generator cable (152) has a generator connector (158) for connecting a signal generator (102) through the generator cable (152) to a node (150).
A system (100) according to mode 13, wherein the generator connector (158) is of the Tip-Ring- Sleeve type.
A system (100) according to mode 13, wherein the generator connector (158) is of the Universal Serial Bus Type C type with fewer than 24 pins.
A system (100) according to mode 10, wherein the e|ectrode connector (156) is of the Universal Serial Bus Type C type with 24 pins.
A system (100) according to mode 15, wherein the generator connector (158) is of the Universal Serial Bus Type C type with 24 pins.
A system (100) according to mode 10, wherein the e|ectrode connector (156) is located at the end of an e|ectrode cable (151) that is configurable to connect to a node (150). 19. . 21. 22. 23. 24. . 26. 27. 28. 29. . 31. 32. 33. 34. . 21/27 A system (100) according to mode 10, wherein the electrode connector (156) is located at the end of an electrode cable (151) that is configurable to connect to an electrode (130).
A system (100) according to mode 13, wherein the generator connector (158) is located at the end of an generator cable (152) that is configurable to connect to a node (150).
A system (100) according to mode 13, wherein the generator connector (158) is located at the end of an generator cable (152) that is configurable to connect to an generator (102).
A system (100) according to any one of modes 1-9, further comprising an electrode cable (151) comprising three conductors for connecting an electrode (130) to a node (150).
A system (100) according to any one of modes 1-12, further comprising a generator cable (152) comprising three conductors for connecting a generator (102) to a node (150).
A system (100) according to mode 23, wherein one of the three conductors in a generator cable (152) is for a tumor treating fields signal (153).
A system (100) according to mode 23, wherein a generator cable (152) comprises two or three conductors for tumor treating fields signals (153).
A system (100) according to any of the preceding modes, wherein the two nodes (150) are of identical design.
A system (100) according to any of the preceding modes, wherein the two nodes (150) are of symmetrical design.
A system (100) according to any of the preceding modes, wherein the two nodes (150) are configured to be worn symmetrically on a user's body.
A system (100) according to any of the preceding modes, wherein the electrodes (130) connected to a respective node (150) are predominantly placed on the left or the right side of the head.
A system (100) according to any of the preceding modes, wherein the electrodes (130) connected to a respective node (150) are electrically insulated.
A system (100) according to mode 5, wherein a node (150) is configured to be supported by a hook over the ear, adhesive on the skin, or a combination thereof.
A system (100) according to any of the preceding modes, wherein a node is water resistant or waterproof.
A system (100) according to mode 32, wherein a node has an ingress protection of |Px7 or |Px8. A system (100) according to any of the preceding modes, wherein a tumor treating fields signal (153) comprises an AC electric signal with a frequency of 100 kHz to 300 kHz, such that a field strength of 1 V/cm to 5 V/cm is generated in an electric field applied to a user's body.
A system (100) according to any one of modes 1-33, wherein a tumor treating fields signal (153) comprises an AC electric signal with a frequency of 50 kHz to 500 kHz. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 22/27 A system (100) according to any of modes 34 or 35, wherein the tumor treating fields signal (153) contains essentially only a single frequency component.
A system (100) according to mode 34 or 35, wherein the tumor treating fields signal (153) comprises three or more frequency components.
A system (100) according to any of modes 34 to 37, wherein the tumor treating fields signal (153) has a frequency at 200 kHz.
A system (100) according to any of modes 34 to 37, wherein the tumor treating fields signal (153) has a frequency at 150 kHz.
A system (100) according to any of modes 34 or 35, wherein the tumor treating fields signal (153) comprises a further AC electric signal with a frequency of between 50 kHz and 500 kHz. The method according to any of any of modes 34, 35 or 40, wherein the electric field contains essentially two frequency components.
A system (100) according to any of modes 34 or 36, wherein an electric field is applied from different directions in a sequence in time, wherein the direction is switched every 10 ms to 2 second.
A system (100) according to mode 42, wherein the direction is switched every 20 ms to 1 second.
A system (100) according to mode 42, wherein the direction is switched every 250 ms, 500 ms, or 1000 ms.
A system (100) according to any of modes 42 to 44, wherein the different directions are roughly orthogonal.
A system (100) according to any of modes 42 to 44, wherein the different directions are within 20 degrees of being orthogonal.
A system (100) according to any of modes 42 to 44, wherein the different directions are within 30 degrees of being orthogonal.
A system (100) according to any of the preceding modes, wherein tumor treating fields signals (153) are delivered to a user to treating a brain tumor.
A system (100) according to mode 48, wherein the tumor is a glioblastoma.
A system (100) according to any one of modes 10-12, or 16, wherein the electrode connector (156) can also be connected to a signal generator (102).
A system (100) according to any of the preceding modes, wherein a generator (102) is configured to connect to a further plurality of electrodes (130).
A node (150) comprising: a generator connector (158) comprising at least one conductor for a tumor treating fields signal (153), 53. 54. 55. 56. 57. 58. 23/ 27 one, two or three electrode connectors (156), each comprising at least one conductor for a tumor treating fields signal (153), at least one power switch (173) for every electrode connector (156), each power switch (173) connected to a respective electrode connector (156), a controller (165), wherein each power switch (173) controls, under the direction of a controller (165), whether a tumor treating fields signal (153) is delivered to the respective connected electrode connector (156).
A node (150) according to mode 52, wherein the node is water resistant or waterproof.
A node (150) according to mode 53, wherein the node is ingress protected according to |Px7, |Px8.
A node (150) according to any of modes 53 to 54, wherein the node comprises a membrane vent A generator cable assembly (159), configured to connect an electrical apparatus 135 with a plurality of nodes (150).
A generator cable assembly (159) according to mode 56, wherein a single conductor is configured to deliver a direct-current voltage to each node (150) from an electrical apparatus (135).
A generator cable assembly (159) according to mode 56, wherein a single conductor is configured to deliver for communications with each node (150) and an electrical apparatus (135).
Closing comments id="p-111" id="p-111"
id="p-111"
[0111] 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 24/ 27 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)
1.Claims A system (100) comprising: an electrical apparatus (135), the electrical apparatus (135) further comprising a signal generator (102), two nodes (150), each node (150) being configured to deliver one or more tumor treating fields signals (153) from the signal generator (102) to at least one respective electrode (130), wherein each node (150) is configured to be carried either on a left side or a right side of a user. A system (100) according to claim 1, wherein each node (150) is configured to deliver tumor treating fields signals (153) to two electrodes (130). A system (100) according to claim 1, wherein each node (150) is configured to deliver tumor treating fields signals (153) to three electrodes (130). A system (100) according to any one of claims 1-3, wherein two nodes (150) co-operatively deliver different polarities of tumor treating fields signals (153) to a respective electrode (130). A system (100) according to any one of the preceding claims, wherein each node (150) is configured to be worn behind or in proximity of an ear. A system (100) according to any one of claims 1-4, wherein each node (150) is configured to be affixed to eyewear. A system (100) according to any one of the preceding claims, wherein a node (150) is configured to selectively switch a tumor treating fields signal (153) to an electrode (130), or to a set of electrode elements (184) in an electrode (130). A system (100) according to any one of the preceding claims, wherein a node (150) is configured to collect digitized information, including temperature information, from one or more electrodes (130) and transmit this information to a signal generator (102). 26/ 27 A system (100) according to any one of claims 1-7, wherein a node (150) is configured to collect analog temperature information from one or more electrodes (130), digitize the temperature information, and transmit this information to a signal generator. A system (100) according any one of claims 1-9, further comprising an electrode cable (151) comprising three conductors for connecting an electrode (130) to a node (150), wherein the electrode cable (151) has an electrode connector (156) for connecting an electrode (130) through the electrode cable (151) to a node (150). A system (100) according to claim 10, wherein the electrode connector (156) is of a Tip-Ring- Sleeve type. A system (100) according to claim 10, wherein the electrode connector (156) is of a Universal Serial Bus Type C type with fewer than 24 pins. A system (100) according to any one of claims 1-12, further comprising a generator cable (152) comprising three conductors for connecting a generator (102) to a node (150), wherein the generator cable (152) has a generator connector (158) for connecting a signal generator (102) through the generator cable (152) to a node (150). A system (100) according to claim 13, wherein the generator connector (158) is of a Tip-Ring- Sleeve type. A system (100) according to claim 13, wherein the generator connector (158) is of a Universal Serial Bus Type C type with fewer than 24 pins.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE2350150A SE2350150A1 (en) | 2023-02-15 | 2023-02-15 | Tumor treating fields (ttfields) equipment configurations for improved ease-of-use |
| PCT/EP2024/053534 WO2024170521A1 (en) | 2023-02-15 | 2024-02-13 | Tumor treating fields (ttfields) equipment configurations for improved ease-of-use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE2350150A SE2350150A1 (en) | 2023-02-15 | 2023-02-15 | Tumor treating fields (ttfields) equipment configurations for improved ease-of-use |
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| SE2350150A1 true SE2350150A1 (en) | 2024-08-16 |
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| SE2350150A SE2350150A1 (en) | 2023-02-15 | 2023-02-15 | Tumor treating fields (ttfields) equipment configurations for improved ease-of-use |
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| SE (1) | SE2350150A1 (en) |
| WO (1) | WO2024170521A1 (en) |
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| WO2024170521A1 (en) | 2024-08-22 |
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