Thermal heating element for use with endometrial ablation
Inventors
Allen, IV, James D. • Robinson, William E.
Assignees
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Publication Number
US-12458425-B2
Publication Date
2025-11-04
Expiration Date
Abstract
A device for endometrial ablation includes a selectively expandable bladder configured for insertion through a cervical canal of a patient and into a patient's cervix. The selectively expandable bladder defines an interior volume for receiving a thermally conductive medium which, when introduced into the interior volume, expands the selectively expandable bladder against the uterine tissue of the cervix. One or more insulative substrates is operably disposed within the interior volume and supports a thermal assembly on the one or more insulative substrates. The thermal assembly couples to an energy source and is configured to conduct thermal energy to a thermally conductive substrate upon activation of the thermal assembly, which, in turn, heats the thermally conductive medium in contact with the thermally conductive substrate to treat the uterine tissue of a patient.
Core Innovation
The invention relates to a thermal endometrial ablation device that uses a selectively expandable bladder inserted through a cervical canal into a cervix. The selectively expandable bladder defines an interior volume configured to receive a thermally conductive medium, so that introducing the medium expands the bladder against uterine tissue of the cervix.
A plurality of insulative substrates is disposed within the interior volume and supports a thermal assembly on at least one insulative substrate. The thermal assembly is adapted to couple to an energy source and conducts thermal energy to a thermally conductive substrate upon activation, heating the thermally conductive medium in contact with the thermally conductive substrate to treat uterine tissue.
The plurality of insulative substrates cooperates with a multiplexer or control algorithm to heat the thermally conductive medium, and at least one insulative substrate has a shape or size different from another insulative substrate to customize a treatment effect. The document further describes treating endometriosis using a similar bladder-and-insulative-substrate architecture, including modeling at least one of position, shape, size, or temperature of the insulative substrates based on a presurgical scan.
Claims Coverage
The independent claims cover a device for endometrial ablation and methods for treating endometriosis, with three independent claim sets: one device claim and two method claims. The inventive features center on a selectively expandable cervical bladder filled with a thermally conductive medium, a thermal assembly coupled to an energy source through insulative substrates and a thermally conductive substrate, and customization via substrate geometry and/or control or presurgical scan-based modeling.
Selectively expandable bladder with thermally conductive medium
A selectively expandable bladder configured for insertion through a cervical canal into a patient's cervix, defining an interior volume for receiving a thermally conductive medium which expands the bladder against the uterine tissue of the cervix.
Thermal assembly coupled via insulative substrates to a thermally conductive substrate
A plurality of insulative substrates disposed within the interior volume and supporting a thermal assembly on at least one of the plurality of insulative substrates, the thermal assembly adapted to couple to an energy source and configured to conduct thermal energy to a thermally conductive substrate upon activation to heat the thermally conductive medium in contact with the thermally conductive substrate to treat uterine tissue.
Multiplexer or control algorithm heating of thermally conductive medium with customized treatment effect
The plurality of insulative substrates cooperates with a multiplexer or control algorithm to heat the thermally conductive medium, and at least one insulative substrate has a shape or size different from another insulative substrate to customize a treatment effect.
Method of treating endometriosis using expandable bladder, conductive medium, and thermal assembly
Inserting an expandable bladder into a cervical canal in a collapsed condition and into a patient's cervix; introducing a thermally conductive medium into an interior volume of the expandable bladder to expand the bladder against interior walls of the uterine lining of the patient's cervix; activating an energy source to energize a thermal assembly to conduct thermal energy to a plurality of insulative substrates disposed within the interior volume including a thermally conductive substrate such that thermal energy is transferred to the conductive medium in contact with the thermally conductive substrate to treat uterine tissue; and modeling at least one of a position, shape, size, or temperature of at least one of the plurality of insulative substrates to customize a treatment effect prior to insertion.
Presurgical scan-based modeling of insulative substrate parameters for endometriosis treatment
Modeling at least one of a position, shape, size or temperature of at least one of the plurality of insulative substrates based on a presurgical scan in a method for treating endometriosis that includes inserting an expandable bladder into a cervical canal in a collapsed condition and into a patient's cervix, introducing a thermally conductive medium to expand the bladder, and activating an energy source to energize a thermal assembly to conduct thermal energy to the plurality of insulative substrates including a thermally conductive substrate to treat uterine tissue.
Across the independent claims, the inventive coverage centers on a cervical-insertable expandable bladder filled with a thermally conductive medium, heating of the medium via a thermal assembly that conducts thermal energy to a thermally conductive substrate supported by insulative substrates, and customization using either differing insulative substrate shapes or sizes with a multiplexer or control algorithm, or presurgical scan-based modeling of insulative substrate position, shape, size, or temperature.
Stated Advantages
Elimination of ground plates and improved heat delivery uniformity and efficiency, as contrasted with prior monopolar RF balloon devices.
Documented Applications
Thermal ablation of uterine tissue for endometrial ablation using the selectively expandable bladder and insulative-substrate-supported thermal assembly.
Treating endometriosis by inserting an expandable bladder into a cervical canal and cervix, expanding with a thermally conductive medium, and energizing a thermal assembly to transfer thermal energy to insulative substrates including a thermally conductive substrate, with customization based on modeling or a presurgical scan.
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