US-12622737-B2 - Methods and apparatus for controlled RF treatments and RF generator system

US12622737B2US 12622737 B2US12622737 B2US 12622737B2US-12622737-B2

Abstract

Electrosurgical systems and components thereof configured to deliver RF energy to a target site of a human or other animal patient with selectable RF energy delivery profiles, temperature sensors and controls, and/or electrodes configured to more uniformly or effectively delivery energy to target tissue.

Inventors

James Boll
Richard Shaun Welches
Daniel MASSE
Samuel Bruce
Jeffrey Simon
Ali Shajii
David Sonnenshein
Robert D. McCarthy
Rafael Armando Sierra

Assignees

CYNOSURE, LLC

Dates

Publication Date: 20260512
Application Date: 20230711

Claims (20)

1 . A method of treatment, comprising: causing an energizable electrode of the electrosurgical handpiece to emit a radio-frequency (RF) signal for a selected duration, the electrosurgical handpiece comprising a housing for a temperature sensor, wherein the housing defines a first patient-contact surface, an inner surface positioned opposite the first patient-contact surface, and an outer wall extending transversely relative to the first patient-contact surface; a temperature sensor thermally coupled with the inner surface of the housing; an energizable electrode defining a second patient-contact surface extending outward of the outer wall of the housing; an insulator positioned between the energizable electrode and the housing for the temperature sensor to inhibit thermal conduction between the energizable electrode and the housing for the temperature sensor; receiving from the temperature sensor of the electrosurgical handpiece while in a non-invasive use a temperature of a skin treatment surface in contact with the electrosurgical handpiece; comparing the received temperature to a threshold temperature; terminating the RF signal when the received temperature is equal to or higher than the threshold temperature; re-engaging or continuing the RF signal emission when the received temperature is lower than the threshold temperature; and further comprising: receiving a user selection of a value for one or more of a first frequency, a first amplitude, a first pulse-width, a second frequency, a second amplitude, and a second pulse-width; and causing the electrosurgical handpiece to emit a RF signal comprising a waveform blended from a first current waveform having the first frequency, the first amplitude, and the first pulse-width and a second current waveform having the second frequency, the second amplitude, and the second pulse-width; and wherein the waveform is non-ablative to tissue and applied by the energizable electrode on a dermal tissue layer of skin on an external side of a patient's body.
2 . The method of treatment according to claim 1 , further comprising: placing the electrosurgical handpiece in contact with the skin treatment surface.
3 . A method of treatment according to claim 2 , further comprising: moving the energizable electrode of the electrosurgical handpiece over the skin treatment surface to contact different regions of the skin treatment surface.
4 . A method of treatment according to claim 2 , further comprising moving the energizable electrode of the electrosurgical handpiece over the skin treatment surface continuously for the selected duration.
5 . A method of treatment according to claim 2 , further comprising: applying a topical solution to the skin treatment surface before placing the energizable electrode of the electrosurgical handpiece in contact with the skin treatment surface.
6 . A method of treatment according to claim 5 , wherein the topical solution is ultrasound gel.
7 . A method of treatment according to claim 1 , wherein the skin treatment surface is human skin, and wherein in addition to the dermal tissue layer the waveform is applied to least one of an epidermal layer or a deep tissue layer.
8 . A method of treatment according to claim 1 , wherein the skin treatment surface is heated to a range of about 39C-46C.
9 . A method of treatment according to claim 1 , wherein the treatment time period is between about 5 minutes to about 50 minutes.
10 . A method of treatment according to claim 1 , further comprising: causing the energizable electrode of the electrosurgical handpiece to emit a sinusoidal RF energy.
11 . The method of treatment of claim 1 wherein the first patient-contact surface and the second patient-contact surface are co-centrically aligned with each other.
12 . The method of treatment of claim 1 wherein the housing for the temperature sensor comprises a material having a thermal conductivity equal to or greater than about 200 W/mK.
13 . The method of treatment of claim 1 wherein the electrode comprises a dielectric coating defining the second patient contact surface.
14 . The method of treatment of claim 13 wherein the dielectric material has a dielectric constant of between about 4 to about 12 at an operating frequency of the energizable electrode.
15 . The method of treatment of claim 1 wherein the energizable electrode is capacitively coupled.
16 . The method of treatment of claim 15 wherein the energizable electrode is capacitively coupled via a dielectric material coating having a substantially even thickness of about 0.004 to about 0.020 inches.
17 . The method of treatment of claim 1 wherein the ratio of the thermal mass of the energizable electrode to the thermal mass of the temperature sensor is greater than 100:1.
18 . The method of treatment of claim 1 wherein the energizable electrode is configured to heat an area of a treatment surface having a diameter of greater than 30 mm when heating to a temperature of 39-46C with an energy flux not exceeding 4000 w/cm 2 .
19 . The method of treatment of claim 1 wherein the energizable electrode comprises a metal foil enclosing a volume and defining a patient contact surface; and the temperature sensor being disposed in the volume and thermally coupled to the patient contact surface.
20 . The method of treatment of claim 1 wherein the energizable electrode comprises a first layer and a second layer coating the first layer and defining the second patient contact surface, wherein a thermal mass of the energizable electrode is larger than a thermal mass of the temperature sensor, and the first layer comprises a material having a thermal mass lower than a thermal mass of a dermal layer of human skin.

Description

RELATED APPLICATIONS This application claims benefit of and priority to U.S. patent application Ser. No. 16/269,314, filed Feb. 6, 2019, which claims benefit of and priority to U.S. Patent Application No. 62/771,294, filed Nov. 26, 2018, and U.S. Patent Application No. 62/627,611, filed Feb. 7, 2018, which patent applications are hereby incorporated by reference in their entirety as fully as if reproduced in whole herein, for all purposes. BACKGROUND The subject matter disclosed herein (referred to as the “disclosure”) generally pertains to electrosurgical systems, such as, for example, electrosurgical devices and related electrical circuitry and methods. More particularly, but not exclusively, this disclosure relates, in part, to electrosurgical systems and components thereof configured to deliver radio-frequency (RF) energy to a target site of a human or other animal patient with selectable RF energy delivery profiles, temperature sensors and controls, and/or electrodes configured to more uniformly or effectively deliver energy to target tissue. In some respects, this disclosure pertains to electrosurgical methods and systems for providing electrosurgical treatments. U.S. Publication No. 2013/0006239, which is hereby incorporated by reference herein in its entirety, for all purposes, is commonly owned with this application and discloses a representative, known electrosurgical system, as seen in FIG. 34 of the instant application. The electrosurgical system includes a control unit 34 and an electrosurgical device 10. In this embodiment, the electrosurgical device 10 (sometimes referred to as a “handpiece”) includes a housing 12, e.g., for containing circuitry, and an energizable electrode 18 configured to treat a target site on or in a patient's body. The housing 12 can be configured as a graspable component of the handpiece, as shown for example in FIG. 34. In other instances, the graspable portion of the handpiece may be spaced from a circuit-containing housing. The control unit 34 is configured to provide power to the electrosurgical device 10 for energizing the electrode. The control unit 34 can be configured to provide energy having a selected combination of waveform and frequency. Some control units 34 are configured to provide RF energy to the electrosurgical device 10. As FIG. 34 shows, a cable 32 can extend between an electrical connector 33 on the control unit 34 and an electrical connector 31 on the electrosurgical device to electrically couple one or more conductive elements on or within the device 10 to one or more corresponding conductive elements of the controller 34. Some known control units provide three output terminals, with one of the terminals being an energizable terminal for conveying therapeutic energy, e.g., RF energy, to an energizable element of a handpiece. Such a control unit 34 is usually configured to energize the energizable terminal when a circuit between the two remaining output terminals is completed, as through the closing of a user actuatable switch 14. Some known electrosurgical control units, such as control units are described, for example, in U.S. Pat. No. 6,652,514, which is hereby incorporated by reference herein by reference in its entirety, provides a three-wire output connector for powering and controlling electrosurgical handpieces. Conventional control units can generate, for example, one or more radio-frequency (RF) modulated waveforms, including, for one non-limiting example, at a frequency of about 4 mega-Hertz (MHz), which can be delivered to a target site by way of an electrosurgical handpiece having an energizable electrode defining an active surface. The active surface of an electrosurgical system can be configured for ablative and/or non-ablative electrosurgery, depending on the physical configuration of the active surface and applied-power parameters. As used herein, an ablative procedure is one where the electrode and power settings result in cutting, coagulation, vaporization or other such traumatic disruption to the integrity of treated tissue, and a non-ablative procedure is one where such cutting, coagulation, vaporization or other such traumatic disruption to the integrity of treated tissue does not result. SUMMARY Principles disclosed herein overcome many problems in the prior art and address one or more of the aforementioned as well as other needs. This disclosure generally, but not exclusively, pertains to certain aspects of electrosurgical systems, devices, and methods. And they include, without limitation, the following innovative concepts: Blend Mode—Adjustability of Waveform Certain embodiments of the inventive subject matter are directed to two or more adjustable power sources each having independent switches to independently feed into an RF amplifier. Where solely cut mode is desired, only one of the power sources is employed. Where solely coagulation mode is desired, only the other of the power sources is employed. Where a blend of cu