EP4622704A1 - Shiftable and flexible transducer arrays with layer of anisotropic material - Google Patents
Shiftable and flexible transducer arrays with layer of anisotropic materialInfo
- Publication number
- EP4622704A1 EP4622704A1 EP24713714.4A EP24713714A EP4622704A1 EP 4622704 A1 EP4622704 A1 EP 4622704A1 EP 24713714 A EP24713714 A EP 24713714A EP 4622704 A1 EP4622704 A1 EP 4622704A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- array
- electrodes
- layer
- subject
- transducer apparatus
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
-
- 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
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
-
- 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)
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/04—Arrangements of multiple sensors of the same type
- A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0004—Applications of ultrasound therapy
- A61N2007/0021—Neural system treatment
- A61N2007/0026—Stimulation of nerve tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0078—Ultrasound therapy with multiple treatment transducers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0086—Beam steering
- A61N2007/0095—Beam steering by modifying an excitation signal
Definitions
- FIG. 2 depicts an example of transducers located on a subject’s body.
- This application describes exemplary transducer apparatuses used to apply TTFields to a subject’s body for treating one or more cancers.
- Transducers used to apply TTFields to a subject’s body often include multiple electrode elements electrically coupled together on a substrate and attached to the subject’s body at a desired location, for example, via an adhesive backing of the substrate or a separately applied adhesive.
- Conventional transducers have large, rectangular surfaces so as to maximize a number of electrode elements that are located on the transducer for applying TTFields to the subject’s body.
- subjects can experience skin irritation on portions of their skin that are contacted by the electrode elements during TTField treatment. Such irritation may be more common at positions directly underneath the electrode elements, where heat and current may be at their highest concentrations, particularly for electrodes around the outer edge of the array.
- transducers that can reduce, minimize, prevent, soothe, heal, or treat skin irritation without significantly changing the field intensity of TTFields being induced in the subject’s body.
- transducers that are able to be shifted so that skin previously contacted by electrode elements can be uncovered (or covered by a topical medication) without substantially moving the transducer from an optimal location on the subject’s body are desired.
- the new position of the transducer after shifting is in substantially the same location if the footprint of the new position after shifting covers greater than or equal to 80% of the footprint of the original position before shifting; or if it covers greater than or equal to 90% of the footprint of the original position before shifting; or if it covers greater than or equal to 95% of the footprint of the original position before shifting.
- the footprint of the new position of the transducer after shifting covers 100% of the footprint of the original position of the transducer before shifting.
- the shifting of the transducer apparatuses can reduce, minimize, prevent, soothe, heal, and/or treat skin irritation while maintaining the transducer in an optimal location on the subject’s body. As a result, the transducers can continuously induce TTFields at an ideal location and power level for targeting a region of interest (e.g., tumor) in the subject’s body, thereby improving patient outcomes.
- the disclosed transducer apparatuses can be shifted via rotation about a centroid of the array of electrodes, or via translation of the array of electrodes, so that one or more portions of the subject’s skin that were previously contacted by electrode elements can be uncovered (or covered by a medication), while maintaining an optimal location of the transducer on the subject’s body.
- the array of electrodes does not include an electrode position that encompasses the centroid of the array.
- the disclosed transducer apparatuses may have a substantially rounded shape enabling the transducers to be positioned on a subject’s head. In other examples, the disclosed transducer apparatus may have other (e.g., non-rounded) shapes.
- a layer of anisotropic material as disclosed herein may spread heat and/or current over a greater area of the subject’s skin thereby reducing skin irritation compared to transducer arrays without a layer of anisotropic material.
- covering a greater area for example, on the torso, can make everyday movements of the body feel restrictive because the transducer apparatus with the layer of anisotropic material is largely inflexible and cannot stretch with movements of the body.
- the adhesive may prove to be aggressive and damage the skin, or the adhesive may prove to be unsuccessful in securing the array in place and may come loose. What is needed is a more flexible transducer array, wherein the flexibility can help absorb the stress forces between the adhesive and the area of the subject’s skin that is covered by the array when body movement causes such stress forces.
- the disclosed transducer apparatuses may be configured to stretch in one or more directions.
- the apparatuses may be capable of stretching such that a void space located between at least one pair of adjacent electrodes of the array is increased in size due to movement of one or more electrodes of at least one pair of adjacent electrodes of the array in a direction away from one another.
- the apparatuses may be stretched upon, or after, application to a subject to improve adherence to the subject.
- the disclosed transducer apparatuses may also include a flexible bandage layer.
- the flexible bandage layer for example a polymeric material layer (e.g., a polyurethane layer), secures the array of electrodes to a subject while also providing a degree of protection.
- the polyurethane layer may take the form of a polyurethane polymer film or bandage (or polyurethane dressing), and is stretchable in the plane of the film in multiple directions. Accordingly, the flexible bandage layer also improves the flexibility of the disclosed transducer apparatuses.
- FIG. 1 depicts transducers 100 positioned on the head of a subject’s body. Such arrangement of transducers 100 is capable of applying TTFields to a tumor in a region of the subject’s brain. Various other positions and/or orientations on the subject’s head may be selected for placement of transducers. Each transducer 100 may have an array of electrode elements disposed thereon. Each transducer 100 may be placed on a subject’s head with a face of the array of electrode elements facing and conforming to the subject’s head. As illustrated, the transducers 100 on the subject’s head do not overlap one another, e.g., due to their rounded shape.
- FIG. 2 depicts transducers 200 and 202 attached to other portions (e.g., a thorax/torso and a thigh) of the subject’s body.
- the transducers 200 and 202 may be affixed to the subject’s body via a medically appropriate gel or adhesive. In other embodiments, the transducers 200 and 202 may be attached to one or more garments and held against the subject’s body.
- Each of the transducers 200 and 202 may have an array of electrode elements 204 disposed thereon.
- Each transducer 200 and 202 may be placed over the subject’s body with a face of the array of electrode elements facing and conforming to the subject’s body.
- an outer perimeter 206 (defined by a dashed line in FIG. 2) traces the array of electrode elements 204.
- the outer perimeter 206 of the array on each transducer may have a substantially rounded edge.
- the outer perimeter 206 (or outer perimeter for any array herein) may be substantially circular, oval, ovaloid, ovoid, or elliptical in shape.
- the outer perimeter 206 may have a circular shape.
- the outer perimeter 206 (or outer perimeter for any array herein) may have other shapes such as, for example, a square or rectangular shape or substantially square or rectangular shape with rounded comers (e.g., as shown in FIG. 3E).
- the structure of the transducers may take many forms.
- the transducer 300A has a plurality of electrode elements 302A positioned on a substrate 304A.
- the substrate 304A is configured for attaching the transducer 300A to a subject’s body.
- Suitable materials for the substrate 304A include, for example, cloth, foam, flexible plastic, and/or a conductive medical gel.
- the transducer 300A may be affixed to the subject’s body via the substrate 304A (e.g., via an adhesive layer and/or a conductive medical gel).
- the adhesive layer that contacts the subject’s skin may be present around the outer perimeter of the array of electrodes, and/or may be present between one or more gaps between electrodes.
- FIG. 3B depicts another example of the structure of the transducer 300B.
- the transducer 300B includes a plurality of electrode elements 302B that are electrically and mechanically connected to one another without a substrate.
- electrode elements 302B are connected to each other through conductive wires 306B.
- the transducers 300C and 300D include one or more medication regions 308C and 308D, respectively.
- the medication regions 308C and 308D may be non-adhesive regions. For example, no exposed adhesive is present in the medication region(s) 308C and 308D.
- the medication region(s) 308C and 308D may each include a medication substrate.
- the medication substrate may be capable of at least one of receiving, absorbing, or holding a topical medication applied thereto.
- the medication substrate may include a cloth, a gauze, a non-woven material, a foam, or a sponge located between one or more pairs of electrode elements 302C or 302D.
- the medication region(s) 308C and 308D may also include a topical medication integrated in or on the medication substrate.
- the topical medication may include a base component of oil, water, petrolatum, wax, cellulose, or a combination thereof.
- the topical medication may be a cream, an ointment, a lotion, a gel, a wax, a paste, or a mineral oil jelly.
- the topical medication may include at least one of an antibiotic, a steroid, an antiseptic, an emollient, an anesthetic, a terpene, a plant extract, a silicon-based organic polymer, an antifungal agent, a burn relief agent, a skin repair agent, an astringent, or an antihistamine.
- the transducer 300C may include a transducer substrate 304C that is separate from the medication region(s) 308C.
- the array of electrode elements 302C may be disposed on a surface of the transducer substrate 304C, and the transducer substrate 304C may include an adhesive layer 310C for attaching the transducer apparatus to the subject’s body.
- the medication substrate may be a portion of the transducer substrate 304C, or may be disposed on the surface of the transducer substrate 304C.
- the medication region 308C may be disposed on the surface of the transducer substrate 304C (as shown in FIG. 3C). In other embodiments, for example as shown in FIG.
- the transducer 300D may not include a transducer substrate, but rather merely an adhesive layer 310D for attaching the transducer 300D to the subject’s body, and the medication region(s) 308D may be coupled between different portions of the adhesive layer 310D and span a distance between the electrode elements 302D.
- FIGS. 3E and 3F depict another example transducer 300E.
- FIG. 3F is a cross- sectional view of the transducer 300E shown in FIG. 3E, as viewed at 3F-3F’.
- the transducer 300E includes a plurality of electrode elements 302E positioned on a substrate 304E, similar to the substrate 304A described above with reference to FIG. 3A.
- the substrate 304E is configured for attaching the transducer 300E to a subject’s body.
- the electrode elements 302E may be connected to each other through conductive wires 306E.
- the dielectric material of the electrode elements 302A, 302B, 302C, 302D, and 302E can have a dielectric constant ranging from 10 to 50,000.
- the layer of dielectric material includes a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and/or poly(vinylidene fluoride-trifluoroethylene-l-chlorofluoroethylene). Those two polymers are abbreviated herein as “Poly(VDF-TrFE-CTFE)” and “Poly(VDF-TrFE-CFE),” respectively. The dielectric constant of these materials is on the order of 40.
- the polymer layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene- chlorofluoroethylene) or “Poly(VDF-TrFE-CTFE-CFE).”
- the layer of dielectric material of the electrode elements 302A, 302B, 302C, 302D, and 302E includes a terpolymer comprising polymerized units of monomers such as VDF, TrFE, CFE and/or CTFE in any suitable molar ratio.
- Suitable terpolymers include those, for example, having 30 to 80 mol% VDF, 5 to 60 mol% TrFE, with CFE and/or CTFE constituting the balance of the mol% of the terpolymer.
- the portions of the transducer arrays positioned directly beneath the electrode elements may become hotter than the portions of the transducer arrays positioned between the electrode elements. Furthermore, higher currents flow through the electrode elements that may be located along the edge of the array compared to the electrode elements located toward the middle of the array. Further still, an electrode element located at a comer or similar sharp bend in the edge of the array may have a higher current than other electrode elements along the edge and near the center of the array.
- embodiments described herein may incorporate into the transducer (e.g., 300E in FIGS. 3E and 3F) a layer of anisotropic material (e.g., 310E in FIGS. 3E and 3F).
- the layer of anisotropic material 310E has a front face 312E and a back face 314E, wherein the back face 314E faces the array of electrode elements 302E.
- the layer of anisotropic material 310E has anisotropic thermal properties and/or anisotropic electrical properties.
- the layer of anisotropic material 310E has anisotropic thermal properties (for example, greater thermal conductivity in the plane of the layer than through the plane of the layer), then the layer spreads the heat out more evenly over a larger surface area. If the layer of anisotropic material 310E has anisotropic electrical properties (for example, greater electrical conductivity in the plane of the layer than through the plane of the layer), then the layer spreads the current out more evenly over a larger surface area. In each case, this lowers the temperature of the hot spots and raises the temperature of the cooler regions when a given AC voltage is applied to the array of electrode elements. Accordingly, the current can be increased (thereby increasing the therapeutic effect) without exceeding the safety temperature threshold at any point on the subject’s skin.
- anisotropic thermal properties for example, greater thermal conductivity in the plane of the layer than through the plane of the layer
- anisotropic electrical properties for example, greater electrical conductivity in the plane of the layer than through the plane of the layer
- the layer of anisotropic material 310E is anisotropic with respect to electrical conductivity properties. In some embodiments, the layer of anisotropic material 310E is anisotropic with respect to thermal conductivity properties. In some preferred embodiments, the layer of anisotropic material 310E is anisotropic with respect to both electrical conductivity properties and thermal conductivity properties.
- the thermal conductivity of the sheet in directions that are parallel to the front face 312E may be more than: 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 100 times, 200 times, or even more than 1,000 times higher than the first thermal conductivity.
- the anisotropic electrical properties include directional electrical properties.
- the layer of anisotropic material 310E may have a first electrical conductivity (or, conversely, resistance) in a direction that is perpendicular to its front face 312E that is different from an electrical conductivity (or resistance) of the layer of anisotropic material 310E in directions that are parallel to the front face 312E.
- the resistance of the layer of anisotropic material 310E in directions parallel to the front face 312E may be less than the first resistance.
- the resistance in the parallel directions is less than half of the first resistance or less than 10% of the first resistance.
- the layer of anisotropic material 310E may include graphite (e.g., a sheet of graphite).
- graphite e.g., a sheet of graphite
- suitable forms of graphite include synthetic graphite, such as pyrolytic graphite (including, but not limited to, Pyrolytic Graphite Sheet (PGS), available from Panasonic Industry, Kadoma, Osaka, Japan), other forms of synthetic graphite, including but not limited to, graphite foil made from compressed high purity exfoliated mineral graphite (including, but not limited to, that supplied as MinGraph® 2010A Flexible Graphite, available from Mineral Seal Corp., Arlington, Arizona, USA), or graphitized polymer film, e.g., graphitized polyimide film, (including, but not limited to, that supplied by Kaneka Corp., Moka, Tochigi, Japan).
- conductive anisotropic materials other than graphite may be used instead of graphite.
- the layer of anisotropic material 310E is a sheet of pyrolytic graphite.
- Thermal conductivity of pyrolytic graphite sheets in directions that are parallel to the front face 312E of those sheets is typically more than 50 times higher than the thermal conductivity of those sheets in directions that are perpendicular to the front face 312E.
- electrical resistivity of pyrolytic graphite sheets in directions that are parallel to the front face 312E of those sheets is typically less than 2% of the electrical resistivity of those sheets in directions that are perpendicular to the front face 312E.
- the transducer 300E may further include at least one layer of conductive adhesive material 316E disposed on a front facing side of the layer of anisotropic material 310E.
- the at least one layer of conductive adhesive material 316E may be disposed on the front face 312E of the layer of anisotropic material 310E.
- the at least one layer of conductive adhesive material 316E may have a biocompatible front surface. Note that in the embodiment illustrated in FIG. 3F, there is only a single layer of conductive adhesive material 316E, and that single layer (the front layer) is biocompatible. But in alternative embodiments, there could be more than one layer, in which case only the front layer may be biocompatible, or the front layer and one or more other layers may be biocompatible.
- Non-hydrogel conductive adhesives may include a waterless polymer with adhesive properties and carbon particles, powder, fibers, flakes, granules and/or nanotubes.
- the adhesive polymer may be, for example, an acrylic polymer or a silicone polymer, or combination thereof, which may be available as acrylic- or silicone-based carbon-filled adhesive tapes.
- the adhesive may additionally include one or more conductive polymers (such as, for example, polyaniline (PANI), or poly(3,4-ethylenedioxythiophene) (PEDOT), or others known in the art).
- PANI polyaniline
- PEDOT poly(3,4-ethylenedioxythiophene)
- the conductive filler in the at least one layer of conductive adhesive material 316E or conductive material 318E may be non-metallic.
- the conductive adhesive may have a thickness between 10 and 2,000 pm, such as, from 20 to 1,000 pm, or 30 to 400 pm.
- the cuts or slits may be applied to transducers having any desired shape, number, and arrangement of electrodes, not just those configured to provide relief areas in response to stretching (e.g., FIGS. 4C-5C).
- an additional bandage overlay such as a CobanTM bandage (3M, St. Paul, MN, USA), or other self-adherent wrap, may be employed in addition to, or in place of, the polyurethane polymer film or bandage.
- the central 4-lobed trace may represent the areal footprint of the layer of anisotropic material, with areal traces of the electrode positions obscured but with a smaller areal footprint than that of the layer of anisotropic material, for example, as shown in FIGS. 4A and 4B.
- moving the transducer so that a void is positioned over an affected area of the subject’s skin may help to minimize, reduce, or prevent irritation of the subject’s skin throughout TTField treatment.
- positioning a medication region over the area of the subject’s skin that was previously covered by an electrode element allows an application of a topical medication to this area of the subject’s skin to soothe, heal, reduce inflammation or soreness, or otherwise improve the condition of the subject’s skin.
- spreading heat and/or current in a plane perpendicular to the direction from the electrode elements to the subject’s skin may allow for a reduction in the heat and/or current at any particular location above the subject’s skin, thereby reducing overall skin irritation. Since the transducer apparatus may be rotated about a centroid of the array of electrodes, this allows the transducer to continue outputting TTFields from the same optimal location on the subject’s body during treatment while providing relief and/or healing to areas of the subject’s skin.
- FIGS. 4C and 4D depict other example transducer apparatuses 400(3) for which similar features and labelling notations are present as those described with respect to embodiments of FIGS. 4A and 4B.
- the transducer apparatus 400(3) includes a bandage overlay 480.
- the bandage overlay 480 is composed of polyurethane.
- the bandage overlay 480 may be a polyurethane polymer film or bandage, as above (470) and elsewhere herein.
- the bandage overlay 480 (and 470 and elsewhere herein) has a thickness of less than or equal to 250 pm, or less than or equal to 200 pm, or less than or equal to 160 pm, such as, for example, in a range of from 50-250 pm, or from 50-200 pm, or from 50-160 pm. In further embodiments, the bandage overlay 480 has a thickness in a range of from 80-160 pm, or from 100-140 pm. In some embodiments, the bandage overlay 480 is disposed over the array of electrodes 402A(3)-402D(3) such that the bandage overlay 480 covers the array of electrodes 402A(3)- 402D(3) and void spaces 478A(3)-478D(3) between the electrodes 402A(3)-402D(3).
- the transducer apparatus 400(3) may be capable of stretching such that a void space 478 located between at least one pair of adjacent electrodes 402 of the array is increased in size due to movement of one or more electrodes 402 of at least one pair of adjacent electrodes 402 of the array in a direction away from one another, for example as shown in FIG. 4D.
- the transducer apparatus 400(3) may be configured to stretch upon or after application of the apparatus on a subject.
- the size and shape of the electrodes are not restricted to those shown in the Figures.
- a similar bandage overlay may be used in conjunction with other embodiments described herein.
- FIGS. 4E, 4F, and 4G depict other example transducer apparatuses 400(4), 400(5), and 400(6).
- the transducer apparatuses 400(4), 400(5), and 400(6) each include a bandage overlay 480 as described above with regards to apparatus 400(3).
- the illustrated areal trace is assumed to be representative of the shapes of the electrodes (that is, either the electrodes alone without any layer of anisotropic material; or representative of both the areas of the electrodes and of the area of the layer of anisotropic material, the areas being coincident).
- the illustrated areal trace represents the areal trace of the layer of anisotropic material
- the areal trace of the electrodes is a subset of the illustrated areal trace.
- the transducer apparatuses 400(4), 400(5), and 400(6) demonstrate different shapes of the array of electrodes 402A(4)-402D(4), 402A(5)-402D(5), and 402A(6)- 402D(6). In FIG.
- each electrode 402A(4)-402D(4) includes a lobe 451A(4)-451D(4) (e.g., square-shaped, rectangular- shaped, or polygonal- shaped lobe, or approximately squareshaped, approximately rectangular- shaped, or approximately polygonal- shaped lobe) connected via a connecting part 452A-452D to a central part 453.
- the central part 453 may be considered part of the electrodes 402A(4)-402D(4). Alternatively, in other embodiments, the central part 453 may be considered, or may include, a separate electrode from the electrodes 402A(4)-402D(4).
- the connecting parts 452A-452D may be considered part of the electrodes 402A(4)-402D(4) and/or the central part 453.
- the lobes 451A-451D, connecting parts 452A-452D, and the central part 453 may be made of the same material.
- the connecting parts 452A-452D may extend diagonally from the central part 453.
- each connecting part 452 may extend from a corner of the central part 453 when the apparatus 400(4) includes four electrodes 402. Similar descriptions and Figure labelling notations apply to transducers 400(5) and 400(6) in FIGS. 4F and 4G, respectively, with differences as noted below.
- each electrode 402A(5)-402D(5) includes a lobe 451A’-451D’ (e.g., square-shaped, rectangular- shaped, or polygonal- shaped lobe, or approximately squareshaped, approximately rectangular- shaped, or approximately polygonal- shaped lobe) connected via a connecting part 452A’-452D’ to a central part 453’.
- the central part 453’ may be considered part of the electrodes 402A(5)-402D(5). Alternatively, the central part 453’ may be considered, or may include, a separate electrode from the electrodes 402A(5)- 402D(5).
- the connecting parts 452A’-452D’ may be considered part of the electrodes 402A(5)-402D(5) and/or the central part 453’.
- the lobes 451A’-451D’, connecting parts 452A’-452D’, and the central part 453’ may be made of the same material.
- the connecting parts 452A’-452D’ may extend diagonally off-center from the central part 453’.
- each connecting part 452’ may extend from a point adjacent to a corner of the central part 453’ when the apparatus 400 includes four electrodes 402.
- FIGS. 4E and 4F both illustrate at least four electrodes and C4 rotational symmetry around the centroid 484.
- FIG. 4E also has mirror plane symmetry through the centroid 484 (in both x and y directions) - the two sides of the 452A-452D connecting parts connect equidistant from the vertex of the central part of 453.
- the embodiment of FIG. 4F is lacking such mirror plane symmetry through the centroid 484.
- FIG. 4G depicts an alternative embodiment of the four-lobed array of FIG. 4E, with different size and shape lobes, and wherein the connecting parts 453A”-453D” are minimized in length such that the four lobes effectively merge with the central part 453”.
- FIG. 4G depicts an alternative embodiment of the four-lobed array of FIG. 4E, with different size and shape lobes, and wherein the connecting parts 453A”-453D” are minimized in length such that the four lobes effectively merge with the central part 453”.
- each electrode 402A(6)-402D(6) includes a lobe 451A”-451D” (e.g., square-shaped, rectangular- shaped, or polygonal- shaped lobe, or approximately square- shaped, approximately rectangular- shaped, or approximately polygonal- shaped lobe) connected via a connecting part 452A”-452D” to a central part 453”.
- the central part 453” may be considered part of the electrodes 402A(6)-402D(6). Alternatively, the central part 453” may be considered, or may include, a separate electrode from the electrodes 402A(6)-402D(6).
- the connecting parts 452A”-452D may be considered part of the electrodes 402A(6)-402D(6) and/or the central part 453”.
- the lobes 451A”-451D”, connecting parts 452A”-452D”, and the central part 453” may be made of the same material.
- the lobes 451A”-451D” cover a larger surface area than the lobes 451A-451D and 451A’-451D’ depicted in FIGS. 4E and 4F, respectively.
- the bandage overlay 480 is disposed over the array of electrodes 402A-402D such that the bandage overlay 480 covers the array of electrodes 402A-402D and void spaces 478A-478D between the electrodes 402A-402D.
- the transducer apparatus 400 may be capable of stretching such that a void space 478 located between at least one pair of adjacent electrodes 402 of the array is increased in size due to movement of one or more electrodes 402 of at least one pair of adjacent electrodes 402 of the array in a direction away from one another, for example, as shown in FIG. 4D.
- the transducer apparatus 400 may be configured to stretch upon or after application of the apparatus on a subject.
- the bandage overlay 480 has at least one cut or slit 478 (FIG. 4B) extending from an outer edge of the bandage overlay 480 toward a center portion of the bandage overlay 480.
- the cuts or slits 478 formed in the bandage overlay 480 may be at least partially coincident with one or more of the void spaces 478A-478D between the electrodes 402A-402D.
- Transducer apparatus positioning and resulting flexibility with respect to the transducer apparatus and polyurethane film or bandage can be similar for the embodiments of FIGS. 4E, 4F and 4G.
- the array of electrodes 402 may include electrodes of various sizes and shapes. In some embodiments, each electrode of an array of electrodes is of similar size and shape. Similarly, the area of the array of electrodes situated over the centroid 484 of an apparatus 400 may be of varying size.
- a front face of the array of electrodes 502A-502D faces a subject’s body
- the layer of anisotropic material 572 covers the front face of the array of electrodes 502A- 502D and extends (radially) outwardly from each electrode 502 to at least partially cover each void space 578A-578D in the array.
- the layer of anisotropic material 572 may be composed of graphite (such as, for example, pyrolytic graphite).
- the apparatus 500 includes at least four electrodes 502.
- the array of electrodes 502A-502D has point symmetry.
- Transducer apparatus 500 may include an array of electrode elements 502A-502D arranged around a centroid 584.
- the array of electrodes may include four electrodes having point symmetry (C4 symmetry) about a centroid 584.
- Each electrode may be substantially similar in size and shape.
- the bandage 580 may cover all of the electrodes and all of the void spaces between the electrodes.
- the bandage 580 paired to the apparatus 500 includes one or more cutouts coincident with at least a portion of the void spaces 578A-578D between at least one of the pairs of electrodes 502.
- the cutouts may have an open shape so that the one or more cutouts define one or more concave portions along an outer edge of the bandage 580 when viewed from a direction perpendicular to the face of the array (FIGS. 5A and 5B).
- a 45° rotation of the existing electrode positions about the centroid 584 positions each void space over the former existing electrode position, thereby providing relief to the areas of skin that may have experienced skin irritation from the electrodes.
- the bandage e.g., polyurethane film or bandage
- the bandage provides flexibility to the transducer array apparatus and allows the array to accommodate movements of the skin due to movements of the torso of the subject.
- the bandage e.g., polyurethane film or bandage
- Similar constructs with other rotational symmetry are readily envisioned (e.g., with 5, 6, or more electrodes), as well as other electrode arrays spaced and arranged to allow for a translational shift of the electrode array.
- an additional substrate layer may be positioned between the electrodes 502 (optionally with the layer of anisotropic material) and the bandage overlay 580, and the closed cut-outs may go through the layer of anisotropic material in areas coincident with at least a portion of one or more (or each of the) void spaces between the electrodes leaving this additional substrate layer exposed in the void space areas.
- this area is free of adhesive.
- this additional substrate layer has some flexibility (for example, it may be a non-woven, cloth or gauze material).
- the cut out region may present just the substrate in the void space, or a region of medication may be introduced onto or into this exposed area of the substrate.
- FIG. 6 depicts an example method 600 of applying TTFields to a subject’s body in accordance with the present techniques.
- the method 600 begins at step S602 with positioning a first transducer in a first initial position at a first location of the subject’s body.
- the first transducer may include a plurality of electrodes, a substrate layer, and/or a bandage layer as described above.
- the first transducer may include a plurality of void spaces located between adjacent electrodes (e.g., as shown in the apparatuses of FIGS. 4C-5C).
- the transducer array may comprise a layer of anisotropic material as described herein.
- the method 600 may include positioning a second transducer in a second initial position at a second location of the subject’s body.
- the second transducer may include a plurality of electrodes in initial electrode positions, a substrate layer, and/or a bandage layer as described above.
- the second transducer may include a plurality of void spaces located between adjacent electrodes (e.g., as shown in the apparatuses of FIGS. 4C-5C).
- the transducer array may comprise a layer of anisotropic material as described herein.
- the method 600 includes stretching the first transducer and/or the second transducer to absorb one or more stress force due to movements of the subject’s body.
- stretching of the transducer may occur such that a void space located between at least one pair of adjacent electrodes of the array is increased in size due to movement of one or more electrodes of at least one pair of adjacent electrodes of the array in a direction away from one another, for example as shown in FIG. 4D.
- step S610 the method 600 includes determining whether a first period of time has passed. After inducing the electric field for more than the first period of time, the method 600 proceeds to step S612, which includes ceasing the electric field.
- the method 600 may also include, at step S620, moving the second transducer from a second initial position at a second location on the subject’s body into a second rotation position on the subject’s body (in analogous fashion to that described above for the first transducer in step 614).
- step S620 moving the second transducer to the second rotation position may include rotating (616) the second transducer about its centroid (as described above for movement of the first transducer).
- the method 600 includes inducing another electric field between the first transducer and the second transducer.
- the invention includes other illustrative embodiments (“Embodiments”) as follows.
- Embodiment 1 A transducer apparatus for delivering tumor treating fields to a subject’s body, the transducer apparatus comprising an array of electrodes, the array configured to be positioned over the subject’s body with a face of the array facing the subject’s body, the array comprising electrode elements positioned in substantially symmetrical positions arranged around a centroid of the array; a void space located between at least one pair of adjacent electrodes of the array; and a polymeric material layer overlaying the array of electrodes and located on a side of the array facing away from the subject’s body.
- Embodiment 1A The apparatus of Embodiment 1, wherein the polymeric material layer is flexible and stretchable.
- Embodiment 2 The apparatus of Embodiment 1, wherein the polymeric material layer comprises polyurethane.
- Embodiment 3 The apparatus of Embodiment 2, wherein the polymeric material layer comprises a polyurethane polymer film or bandage.
- Embodiment 4 The apparatus of Embodiment 1, wherein the polymeric material layer has a thickness of less than or equal to 250 pm.
- Embodiment 5 The apparatus of Embodiment 1, wherein the array of electrodes has point symmetry (rotational symmetry).
- Embodiment 5A The apparatus of Embodiment 1, wherein the array of electrodes includes four electrodes having point symmetry about the centroid.
- Embodiment 7 The apparatus of Embodiment 1, the polymeric material layer substantially covers the array of electrodes, and the polymeric material layer has one or more cutouts formed therein, at least one of the one or more cutouts being coincident with at least a portion of the void space located between at least one pair of adjacent electrodes in the array.
- Embodiment 8 A The apparatus of Embodiment 7, wherein the one or more cutouts have a closed shape so that the one or more cutouts are surrounded by the polymeric material layer when viewed from a direction perpendicular to the face of the array.
- Embodiment 9 The apparatus of Embodiment 1, wherein the apparatus is capable of stretching such that the void space located between at least one pair of adjacent electrodes of the array is increased in size due to movement of one or more electrodes of at least one pair of adjacent electrodes of the array in a direction away from one another.
- Embodiment 10 A transducer apparatus for delivering tumor treating fields to a subject’s body, the transducer apparatus comprising an array of electrodes, the array configured to be positioned over the subject’s body with a face of the array facing the subject’s body; a plurality of void spaces, each void space located between at least one pair of adjacent electrodes of the array; a layer of anisotropic material electrically coupled to the array of electrodes and located on a side of the array facing the subject’s body; and a polymeric material layer overlaying the array of electrodes and the layer of anisotropic material and located on a side of the array facing away from the subject’s body.
- Embodiment 11 The transducer apparatus of Embodiment 10, wherein the layer of anisotropic material comprises graphite.
- Embodiment 11 A The transducer apparatus of Embodiment 10, wherein the layer of anisotropic material comprises pyrolytic graphite, graphitized polymer, or graphite foil made from compressed high purity exfoliated mineral graphite.
- Embodiment 11B The transducer apparatus of Embodiment 10, wherein the layer of anisotropic material has a front face and a back face, wherein the back face of the layer of anisotropic material faces the array of electrodes, wherein the layer of anisotropic material has different thermal and/or electrical conductivities in a direction perpendicular to the front face than in directions that are parallel to the front face.
- Embodiment 11D The transducer apparatus of Embodiment 11B, wherein the layer of anisotropic material has a first electrical resistance in a direction that is perpendicular to the front face, and resistance of the sheet in directions that are parallel to the front face is less than 10%, or less than 1%, or less than 0.1% of the first resistance.
- Embodiment HE The transducer apparatus of Embodiment 11B, wherein the layer of anisotropic material has a first thermal conductivity in a direction that is perpendicular to the front face, and thermal conductivity of the sheet in directions that are parallel to the front face is more than two times higher than the first thermal conductivity.
- Embodiment 11F The transducer apparatus of Embodiment 11B, wherein the layer of anisotropic material has a first thermal conductivity in a direction that is perpendicular to the front face, and thermal conductivity of the sheet in directions that are parallel to the front face is more than 10 times, or more than 100 times, or more than 1,000 times higher than the first thermal conductivity.
- Embodiment 12 The transducer apparatus of Embodiment 10, wherein a front face of the array of electrodes faces the subject’s body, and wherein the layer of anisotropic material is positioned over the front face of the array of electrodes, including over each electrode of the array of electrodes, and extends outwardly from each electrode to at least partially cover each void space in the array.
- Embodiment 13 The transducer apparatus of Embodiment 10, wherein the polymeric material layer comprises polyurethane.
- Embodiment 14 The transducer apparatus of Embodiment 13, wherein the polymeric material layer comprises a polyurethane polymer film or bandage.
- Embodiment 14A The apparatus of Embodiment 13 or 14, wherein the polymeric material layer has a thickness of less than or equal to 250 pm.
- Embodiment 14C The apparatus of Embodiment 13 or 14, wherein the polymeric material layer has a thickness in a range of from 80-160 pm, or from 100-140 pm.
- Embodiment 15 The transducer apparatus of Embodiment 10, wherein the polymeric material layer covers the layer of anisotropic material and extends outwardly from the layer of anisotropic material to at least partially cover each void space in the array.
- Embodiment 16 The transducer apparatus of Embodiment 10, wherein a front face of the array of electrodes faces the subject’s body, and wherein the layer of anisotropic material is positioned over the front face of the array of electrodes, including over each electrode of the array of electrodes, and at least partially covers each void space in the array, wherein the polymeric material layer covers the layer of anisotropic material and at least partially covers each void space in the array, and wherein the polymeric material layer covers more of each void space in the array than the layer of anisotropic material.
- Embodiment 16B The transducer apparatus of Embodiment 16 A, wherein the one or more cutouts have an open shape so that the one or more cutouts define one or more concave portions along an outer edge of the polymeric material layer when viewed from a direction perpendicular to the face of the array.
- Embodiment 16D The transducer apparatus of claim Embodiment 16C, wherein at least a portion of each of the one or more cutouts in the polymeric material layer is coincident with at least a portion of a cutout in the layer of anisotropic material.
- Embodiment 17 The transducer apparatus of Embodiment 16, wherein the polymeric material layer covers each void space in the array.
- Embodiment 18 The transducer apparatus of Embodiment 10, further comprising at least one of: conductive adhesive material located on a front face of the layer of anisotropic material opposite the array of electrodes, or conductive adhesive material located between the array of electrodes and a back face of the layer of anisotropic material facing the array of electrodes.
- Embodiment 19 The transducer apparatus of Embodiment 10, wherein the array of electrodes includes four electrodes, or at least four electrodes, having point symmetry about the centroid.
- the voltage generation components supply the transducers with an electrical signal having an alternating current waveform at frequencies in a range from about 50 kHz to about 1 MHz and appropriate to deliver TTFields treatment to the subject’s body.
- the electrical signal has an alternating current waveform at frequencies in a range from about 100 kHz to about 500 kHz and appropriate to deliver TTFields treatment to the subject’s body.
- Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.
- embodiments described in dependent claim format for a given embodiment e.g., the given embodiment described in independent claim format
- other embodiments described in independent claim format or dependent claim format
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Abstract
Description
Claims
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| US202363443585P | 2023-02-06 | 2023-02-06 | |
| US202363523491P | 2023-06-27 | 2023-06-27 | |
| US18/432,933 US12268863B2 (en) | 2023-02-06 | 2024-02-05 | Shiftable transducer array with anisotropic material layer |
| PCT/IB2024/000053 WO2024165920A1 (en) | 2023-02-06 | 2024-02-06 | Shiftable and flexible transducer arrays with layer of anisotropic material |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4622704A1 true EP4622704A1 (en) | 2025-10-01 |
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| EP24713714.4A Pending EP4622704A1 (en) | 2023-02-06 | 2024-02-06 | Shiftable and flexible transducer arrays with layer of anisotropic material |
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| EP (1) | EP4622704A1 (en) |
| JP (1) | JP2026504309A (en) |
| CN (1) | CN120659642A (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US12599765B2 (en) | 2021-12-14 | 2026-04-14 | Novocure Gmbh | Shifting of transducer array to reduce skin irritation |
| US12268863B2 (en) | 2023-02-06 | 2025-04-08 | Novocure Gmbh | Shiftable transducer array with anisotropic material layer |
| US20250001192A1 (en) * | 2023-06-30 | 2025-01-02 | Novocure Gmbh | Transducers for delivery of tumor treating fields and capable of reducing creasing |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6088471A (en) * | 1997-05-16 | 2000-07-11 | Authentec, Inc. | Fingerprint sensor including an anisotropic dielectric coating and associated methods |
| US7599745B2 (en) | 2000-02-17 | 2009-10-06 | Standen Ltd | Treating a tumor or the like with an electric field |
| JP7777118B2 (en) * | 2020-09-25 | 2025-11-27 | ノボキュア ゲーエムベーハー | Varying the metallization coverage of individual electrode elements in the tumor treating field (TTField) to maximize current flow without overheating |
| CN116322890A (en) * | 2020-09-30 | 2023-06-23 | 诺沃库勒有限责任公司 | Implantable arrays for delivering tumor treatment fields |
| JP2024510812A (en) * | 2021-03-23 | 2024-03-11 | ノボキュア ゲーエムベーハー | Transducer device for delivering tumor treatment electric fields to the subject's body |
| US20220305276A1 (en) * | 2021-03-23 | 2022-09-29 | Novocure Gmbh | Transducer apparatuses for delivering tumor treating fields to a subject's body |
-
2024
- 2024-02-06 CN CN202480010781.4A patent/CN120659642A/en active Pending
- 2024-02-06 JP JP2025545257A patent/JP2026504309A/en active Pending
- 2024-02-06 WO PCT/IB2024/000053 patent/WO2024165920A1/en not_active Ceased
- 2024-02-06 EP EP24713714.4A patent/EP4622704A1/en active Pending
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| JP2026504309A (en) | 2026-02-04 |
| CN120659642A (en) | 2025-09-16 |
| WO2024165920A1 (en) | 2024-08-15 |
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