EP-4735098-A1 - ELECTRODE ASSEMBLY WITH FLUOROELASTOMER

EP4735098A1EP 4735098 A1EP4735098 A1EP 4735098A1EP-4735098-A1

Abstract

An apparatus for use in applying TTFields includes an electrode subassembly. The electrode subassembly includes at least one electrode element having a skin-facing side and a skin-facing surface and a dielectric layer on the skin-facing side of the at least one electrode element. The dielectric layer includes at least one fluoroelastomer. The electrode subassembly includes a skin-facing surface and the dielectric layer provides the skin-facing surface of the electrode subassembly. A skin contact subassembly is coupled to the electrode subassembly. The skin contact subassembly includes a skin contact conductive adhesive or gel configured to contact skin of a subject. The skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is disposed against the skin-facing surface of the electrode subassembly. The skin contact subassembly is releasably coupled to the electrode subassembly.

Inventors

BUNN, Andrew
OBUCHOVSKY, Stas
WASSERMAN, YORAM
SHAPIRO, DAVID

Assignees

Novocure GmbH

Dates

Publication Date: 20260506
Application Date: 20250328

Claims (1)

Attorney Docket No.37983.0107P1 WHAT IS CLAIMED IS: 1. An apparatus comprising: an electrode subassembly comprising: at least one electrode element having a skin-facing side and a skin-facing surface; and a dielectric layer on the skin-facing side of the at least one electrode element, wherein the dielectric layer comprises at least one fluoroelastomer, wherein the electrode subassembly comprises a skin-facing surface and wherein the dielectric layer provides the skin-facing surface of the electrode subassembly; and a skin contact subassembly coupled to the electrode subassembly, wherein the skin contact subassembly comprises a skin contact conductive adhesive or gel configured to contact skin of a subject, wherein the skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is disposed against the skin-facing surface of the electrode subassembly; and wherein the skin contact subassembly is releasably coupled to the electrode subassembly. 2. The apparatus of claim 1, wherein the at least one fluoroelastomer of the dielectric layer is or comprises one or more FKM polymers. 3. The apparatus of claim 1, wherein the at least one fluoroelastomer of the dielectric layer is or comprises poly(hexafluoropropylene-vinylidene fluoride) (p(HFP–VDF)). 4. The apparatus of claim 1, wherein the dielectric layer has a dielectric constant of at least 8 at at least one frequency between 50 kHz and 500 kHz and at at least one temperature between 15-45 ℃. 5. The apparatus of claim 1, wherein the electrode subassembly further comprises an adhesive layer or an adhesive structure positioned between the at least one electrode element and the dielectric layer. 6. The apparatus of claim 5, wherein the adhesive layer or adhesive structure comprises a conductive fluoroelastomer adhesive paste. Attorney Docket No.37983.0107P1 7. The apparatus of claim 1, wherein the electrode subassembly further comprises a conductive layer comprising fluoroelastomer. 8. The apparatus of claim 1, wherein the skin facing surface of the electrode subassembly is smooth and not tacky, and wherein the skin contact subassembly contacts the skin facing surface of the electrode subassembly. 9. The apparatus of claim 1, wherein the skin contact subassembly further comprises a layer of anisotropic conductive material. 10. The apparatus of claim 9, wherein the layer of anisotropic conductive material has a skin-facing side with a skin-facing surface and an opposing outwardly facing surface, wherein the layer of anisotropic conductive material is disposed in contact with the skin contact conductive adhesive or gel, and wherein the at least one electrode element is in electrical contact with the outwardly facing surface of the layer of anisotropic conductive material when the electrode subassembly is in contact with the skin contact subassembly. 11. The apparatus of claim 9, wherein the skin contact subassembly comprises a three layer unit comprising the skin contact conductive adhesive or gel, the layer of anisotropic conductive material, and a second conductive adhesive or gel layer; wherein the layer of anisotropic conductive material has a skin facing side with a skin facing surface and an opposing outwardly facing surface; and wherein the skin facing surface of the layer of anisotropic conductive material is in contact with the skin contact conductive adhesive or gel, and the outwardly facing surface of the layer of anisotropic conductive material is in contact with the second conductive adhesive or gel layer. 12. The apparatus of claim 9, wherein the layer of anisotropic conductive material is or comprises graphite. 13. The apparatus of claim 1, wherein the electrode subassembly further comprises a layer of anisotropic conductive material. 14. The apparatus of claim 1, wherein the dielectric layer comprises particles dispersed therethrough that are configured to provide an increased dielectric constant of the dielectric layer. 15. The apparatus of claim 14, wherein the particles dispersed through the dielectric layer comprise one or more of barium titanate (BaTiO3), strontium titanate (SrTiO3), barium Attorney Docket No.37983.0107P1 strontium titanate (BaSrTiO3), calcium copper titanate (CaCuTiO3 or CaCu3Ti4O12), titanium dioxide (TiO 2 ), zirconium dioxide (ZrO 2 ), and empirical formula modifications thereof.

Description

Attorney Docket No.37983.0107P1 ELECTRODE ASSEMBLY WITH FLUOROELASTOMER CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and the benefit of the filing date of U.S. Provisional Patent Application Nos.63/571,998, filed March 29, 2024 and 63/701,322, filed September 30, 2024, the entirety of each of which is hereby incorporated by reference herein. BACKGROUND [0002] Tumor Treating Fields (TTFields) therapy is a proven approach for treating tumors using alternating electric fields at frequencies between 50 KHz – 1 MHz, such as 100- 500 kHz. Conventionally, the alternating electric fields are induced by electrode assemblies (e.g., arrays of capacitively coupled electrodes, also called transducer arrays) placed on opposite sides of a target location in the subject’s body. When an AC voltage is applied between opposing electrode assemblies, an AC current is coupled through the electrode assemblies and into the subject’s body. And higher currents are strongly correlated with higher efficacy of treatment. [0003] The electrode assemblies used during application of TTFields typically include an electrically conductive hydrogel layer that serves as a skin contact layer that adheres to the skin of the subject. The electrically conductive hydrogel typically has a shorter lifespan than the rest of the electrode assembly. For example, with use, the skin contact layer can degrade, for example, by collecting oil and dirt, thereby reducing effectiveness of the electrically conductive hydrogel layer. The hydrogel is typically integral to the electrode assembly. Thus, upon expiration or contamination of the hydrogel, the entire electrode assembly must be disposed of and replaced. SUMMARY [0004] Disclosed herein, in various aspects, are apparatuses and kits for applying TTFields. [0005] In one aspect, an apparatus comprises an electrode subassembly. The electrode subassembly comprises at least one electrode element having a skin-facing side and a skin- facing surface and a dielectric layer on the skin-facing side of the at least one electrode element. The dielectric layer comprises at least one fluoroelastomer. The electrode subassembly comprises a skin-facing surface and the dielectric layer provides the skin-facing surface of the electrode subassembly. A skin contact subassembly is coupled to the electrode Attorney Docket No.37983.0107P1 subassembly. The skin contact subassembly comprises a skin contact conductive adhesive or gel configured to contact skin of a subject. The skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is disposed against the skin-facing surface of the electrode subassembly. The skin contact subassembly is releasably coupled to the electrode subassembly. [0006] In one aspect, an apparatus comprises an electrode subassembly. The electrode subassembly includes at least one electrode element having a skin-facing side and a skin- facing surface and a dielectric layer on the skin-facing side of the at least one electrode element. The dielectric layer comprises at least one fluoroelastomer. The electrode subassembly has a skin-facing surface. The apparatus further comprises a skin contact subassembly coupled to the electrode subassembly. The skin contact subassembly comprises a skin contact conductive adhesive or gel configured to contact skin of a subject. The skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is disposed against the skin-facing surface of the electrode subassembly. Optionally, the skin contact subassembly is releasably coupled to the electrode subassembly [0007] A method of using the apparatus includes removing the skin contact subassembly from the electrode subassembly. [0008] In one aspect, a method of making an electrode subassembly is disclosed. The electrode subassembly comprises a structure having at least one electrode element, the at least one electrode element has a skin-facing side and a skin-facing surface. The method comprises applying a dielectric layer to the structure on the skin-facing side of the at least one electrode element, wherein the dielectric layer is or comprises at least one polymer (optionally, fluoroelastomer). [0009] In one aspect, a kit comprises an electrode subassembly, the electrode subassembly comprising at least one electrode element having a skin-facing side and a skin- facing surface, and a dielectric layer on the skin-facing side of the at least one electrode element. The electrode assembly comprises a skin-facing surface. The kit further comprises a plurality of skin contact subassemblies, each skin contact subassembly configured to be removably coupled to the electrode subassembly. The skin contact subassembly comprises a skin contact conductive adhesive or gel configured to contact skin of a subject. When the Attorney Docket No.37983.0107P1 skin