Ceramic applicator for transcutaneous energy delivery

Abstract

An energy delivery device and a method of treating tissue with high-frequency energy. The energy delivery device may include an applicator, and the applicator includes an electrode and a substrate. The substrate may be made of a ceramic material and may have a surface with a variable thickness, such as a concave surface.

Description

Technical Field

[0001] The present invention relates to an energy delivery device and a method for treating tissue with high-frequency energy. Background Art

[0002] Some types of energy delivery devices can treat a patient's tissue with electromagnetic energy. These energy delivery devices emit electromagnetic energy in different frequency bands of the electromagnetic wave spectrum to treat tissue and can be used to treat various skin diseases. For example, an energy delivery device can treat skin diseases or other tissue diseases in a non-ablative and non-invasive manner.

[0003] There is an energy delivery device that emits high-frequency electromagnetic energy in the radio-frequency (RF) band of the electromagnetic wave spectrum. By passing high-frequency energy through the skin surface, it can be used to treat skin tissue while actively cooling the skin to avoid damaging the epidermal layer near the skin surface. The high-frequency energy can heat the tissue under the epidermis to a temperature sufficient to denature collagen, causing the collagen to contract and tighten the tissue. The treatment with high-frequency energy causes mild inflammation. The inflammatory response of the tissue will gradually generate new collagen during the three days to six months after the treatment, further contracting the tissue.

[0004] A typical energy delivery device includes a treatment end for contacting or being close to the patient's skin surface, and the electromagnetic energy emitted by the treatment end penetrates the skin surface and enters the tissue under the skin surface. The other side of the energy delivery device may include an element, such as an applicator containing an electrode, to supply high-frequency energy to the patient's tissue. Traditional applicators include a flexible polymer film with electrodes provided thereon. However, there is a problem of material obsolescence for polymer films because they are not widely used in other application fields.

[0005] Although traditional applicators for delivering high-frequency energy are already sufficiently applicable, there is still a need for improved high-frequency energy delivery devices and improved high-frequency energy delivery methods. Summary of the Invention

[0006] In one embodiment, an energy delivery device includes an applicator. The applicator includes an electrode and a substrate of ceramic material. The substrate has a first surface, a second surface opposite to the first surface, and an outer edge located between the first surface and the second surface. In addition, the thickness of the substrate between the first surface and the second surface can vary according to the position relative to the outer edge.

[0007] In another embodiment, an energy delivery device includes an applicator. The applicator includes an electrode and a substrate of ceramic material. The substrate has a first surface, a second surface opposite the first surface, and an outer edge located between the first surface and the second surface. In addition, the substrate has a thickness between the first surface and the second surface that varies symmetrically about an imaginary centerline. The aforementioned centerline is perpendicular to a major dimension of the first surface and the second surface.

[0008] Another embodiment provides a method of delivering high-frequency energy. The method includes delivering high-frequency energy from the electrode such that the high-frequency energy passes through the substrate to treat tissue adjacent to the electrode. The current density of the high-frequency energy near the outer edge of the electrode is less than the current density from the outer edge of the electrode inward. The substrate has a thickness that varies with respect to the position of the outer edge of the substrate, and the thickness of the substrate is greatest near the outer edge.

[0009] This summary of the invention only introduces a selection of concepts in a simplified form, which will be further described in detail below. This summary of the invention is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used alone to assist in determining the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The following drawings are incorporated into the specification of the present invention and form a part of the specification of the present invention, and the features are labeled with reference numerals to illustrate embodiments of the present invention, and the general description of the above summary of the invention is combined with the detailed description of the following embodiments to explain the principles of the present invention.

[0011] Figure 1 A block diagram of an energy treatment device according to an embodiment of the present invention.

[0012] Figure 2 A front view of an applicator according to an embodiment of the present invention.

[0013] Figure 3 is Figure 2 a cross-sectional view of the applicator. DETAILED DESCRIPTION

[0014] Please refer to Figures 1 to 3, according to an embodiment of the present invention, the energy treatment device 200 includes a system controller 210, a human-to-machine interface (HMI) 220, a high-frequency generator 230, a power supply 240, a handpiece 250, and a treatment tip 260. The system controller 210 generally controls the operation and functions of the device 200 by controlling other components of the device 200, such as the high-frequency generator 230 and the power supply 240. The system controller 210 is a high-level hardware controller that enables the application of high-frequency energy (e.g., radio-frequency energy (RF energy)) to a treatment area of a patient, such as for transcutaneous dermatological treatment. Low-level hardware controllers in other components of the device 200 can manage the operation of the component hierarchy under the guidance and coordination of the system controller 210.

[0015] To control and coordinate the operation of other components, the system controller 210 can also monitor status information and various operating parameters from the low-level hardware controllers during a procedure of applying high-frequency energy to the treatment area. The above operating parameters can include, for example, the maximum output power and average output power emitted by the treatment tip 260, the temperature of the treatment tip 260, the mechanical force applied by the patient, and the current value of the usage data of the treatment tip 260, and the like. If the status information or operating parameters from the low-level hardware controllers indicate an error condition, the system controller 210 can stop applying high-frequency energy to the treatment area. For example, if the current value of the usage data of the treatment tip 260 exceeds a threshold value, the system controller 210 will stop applying high-frequency energy to the treatment area.

[0016] The human-machine interface 220 provides an interface between an operator (such as a clinician) and the device 200 for communicating commands, requests, information, data, and the like, enabling the operator to interact with the functions provided by the device 200. In one embodiment, the human-machine interface 220 may include a touch screen that provides an input interface and an output interface between the operator and the device 200. In one embodiment, the human-machine interface 220 may include an audio interface, such as a microphone and / or a speaker. In one embodiment, the human-machine interface 220 may include physical input devices, such as buttons (such as push buttons, rocker buttons, or other known buttons), knobs, slide switches, rockers, click wheels, keyboards, or cursor devices (such as mice), and the like. The high-frequency generator 230 is configured to generate high-frequency energy (such as radio-frequency energy) for driving the electrode 12 in the treatment end 260 according to commands received from the operator and through the human-machine interface 220 when enabled by the system controller 210. In one embodiment, this high-frequency energy may be radio-frequency energy in the range of 1 MHz to 20 MHz.

[0017] The power supply 240 is configured to supply power from an external power source (such as an alternating current (AC) outlet) to various components of the device 200. In one embodiment, the power supply 240 is configured to convert the alternating current obtained from the external power source into direct current and supply it to various components of the device 200. In one embodiment, the power supply 240 is configured to provide electrical isolation between the external power source and other components of the device 200.

[0018] The handpiece 250 is configured to couple the treatment end 260 to other components of the device 200 along the transmission path of the high-frequency energy. The handpiece 250 is connected to the device 200 through a flexible cable containing wires, and the flexible cable containing wires electrically couples the handpiece 250 to other components. The handpiece 250 may have a smooth-profile grip for the clinician, the operator, to hold. The handpiece 250 may allow at least single-handed holding by the clinician to manipulate the positions of the handpiece 250 and the treatment end 260. During a treatment procedure, the operator brings the handpiece 250 (along with the treatment end 260 and its applicator 10) close to and contacts the treatment area of the patient. After a part of the treatment end 260 contacts the treatment area, as described below, the operator can indicate to control the device 200 to deliver high-frequency energy from the applicator 10 to the treatment area through control elements provided on the outer surface of the handpiece 250 and / or control elements on the control console. For example, the handpiece 250 may include control elements for the operator to start delivering high-frequency energy to the treatment area, terminate delivering high-frequency energy to the treatment area, and / or adjust the amount of high-frequency energy applied to the treatment area.

[0019] The treatment tip 260 is coupled to the handpiece 250 to deliver the high-frequency energy generated by the high-frequency generator 230 to the patient for treatment purposes. The treatment tip 260 includes an applicator 10. The applicator 10 is configured to deliver high-frequency energy to the patient at a specific density during a treatment procedure. The treatment tip 260 may include a housing for receiving the applicator 10. The treatment tip 260 may be configured to be removably fixed to the handpiece 250. Temperature indicator sensor data of the treatment tip 260 may be obtained within the treatment tip 260 using a temperature sensor (such as a thermistor).

[0020] In one embodiment, at least one subset of the components of the device 200 is included in a control console or mechanism attachment. For example, the control console may include a system controller 210, a high-frequency generator 230, and a power supply 240. In one embodiment, the handpiece 250 is physically coupled to the control console by a flexible cable containing wires, and the flexible cable containing wires electrically couples the handpiece 250 to the other components of the device 200. Part or all of the human-machine interface 220 may be disposed on an outward-facing surface of the control console.

[0021] A liquid dispenser 270 may be disposed within the handpiece 250 and / or the treatment tip 260. The control console of the device 200 may be provided with a coolant supply source (such as a coolant tank) that is piped-coupled to the liquid dispenser 270. The liquid dispenser 270 may be configured to controllably deliver the coolant to the applicator 10 in a spray or flowing manner in coordination with a treatment procedure. The coolant may be triggered under the control of the system controller 210 and may be delivered in a spray or flowing manner before, during, and / or after the applicator 10 delivers high-frequency energy to the patient's tissue.

[0022] A vibration device 280 may be disposed within the handpiece 250 and / or the treatment tip 260. The vibration device 280 is configured to vibrate or oscillate the treatment tip 260 and the applicator 10 at a frequency lower than that of the handpiece 250 and the treatment area. In particular, the vibration device 280 may cause the treatment tip 260 to oscillate or vibrate along an axis perpendicular or substantially perpendicular to the treatment area, with at least a portion of the treatment tip 260 in contact with the treatment area, so as to transmit the vibration to the treatment area. Without being limited by any particular theory, such vibration may provide a pain control mechanism for the patient during a treatment procedure.

[0023] Please refer to Figure 2 and Figure 3, the applicator 10 includes an electrode 12 and a substrate 14 that provides mechanical support for the electrode 12. The substrate 14 includes a surface 16, a surface 18 opposite the surface 16, and an outer edge 20. The outer edge 20 is disposed between the surface 16 and the surface 18 and extends to the entire periphery of the substrate 14. The electrode 12 also includes an outer edge 13 inside the outer edge 20 of the substrate 14 such that the electrode 12 only partially covers the surface 16 of the substrate 14.

[0024] The substrate 14 may include an outer frame 22 that surrounds the area on the substrate 14 where the electrode 12 is disposed. The electrode 12 and the outer frame 22 may be independent elements or may be machined or shaped from the same piece of material. Thus, the outer frame 22 and the electrode 12 may be composed of the same material or at least two different materials. The electrode 12 is embedded in the outer frame 22. The portion of the surface 16 located within the outer frame 22 is relatively recessed compared to the portion of the surface 16 covered by the electrode 12, and the plane of the portion of the surface 16 located within the outer frame 22 is parallel to the plane of the surface 18 such that the outer frame 22 has a uniform thickness that is different from the thickness of the area where the electrode 12 is disposed.

[0025] The substrate 14 has a thickness that is separated between the surface 16 and the surface 18. The thickness between the surface 16 and the surface 18 varies with the position relative to the outer edge 20 of the substrate 14. In particular, as Figure 3 shown, the thickness of the substrate 14 may increase with the distance relative to an imaginary centerline 26 that is perpendicular to the surfaces 16, 18. The above thickness does not need to increase uniformly from the centerline 26, but the increase in distance on both sides of the centerline 26 should be symmetric with respect to the centerline 26. For example, a non-linear profile includes the profile of a torus or a profile that initially increases in thickness with the radial distance from the centerline 26, passes through a given radius to define a turning point, and then begins to decrease in thickness with the radial distance from the centerline 26. In one embodiment, the surface 16 of the substrate 14 may be concave, with its radius of curvature presenting the above-described thickness variation according to position. In one embodiment, the thickness of the substrate 14 may be rotationally symmetric about the centerline 26 such that the above-described thickness variation according to position presents the same rotational symmetry with respect to the centerline 26. In one embodiment, the thickness of the substrate 14 may lack rotational symmetry about the centerline such that the above-described thickness variation according to position lacks rotational symmetry with respect to the centerline 26. The surface 18 of the substrate 14 may be generally planar and lack deliberately created depressions or protrusions. The surface 18 may serve as a reference plane for measuring the thickness variation of the substrate 14.

[0026] The applicator 10 can be disposed within the treatment tip 260 such that the substrate 14 is positioned between the electrode 12 and the tissue to be treated with high-frequency energy. In a representative embodiment, the electrode 12 can be disposed on the surface 16 of the substrate 14, and the surface 18 can face outward from the treatment tip 260 and directly contact the patient's tissue. In another embodiment, the electrode 12 can be disposed on the surface 18, and the surface 16 can face outward from the treatment tip 260 and directly contact the patient's tissue. The shape of the electrode 12 can be different from that Figure 2 shown.

[0027] The electrode 12 can be centered on the centerline 26 of the substrate 14. Alternatively, the center of the electrode 12 can be offset from the centerline 26 of the substrate 14. A plurality of connection points 24 can be disposed on the surface 16 including the electrode 12 as additional metal components. For example, the connection point 24 can be a metal pad for connecting a temperature sensor (such as an encapsulated thermistor or other types of sensors).

[0028] During the treatment procedure, high-frequency energy is delivered from the electrode 12 through the substrate 14 to treat the tissue near the treatment tip 260. The above-described thickness variation of the substrate 14 can effectively reduce the current density of the delivered high-frequency energy near the edge 13 of the electrode 12, which is generally greater than the current density from the edge 13 of the electrode 12 inward. The reduction of the current density near the edge 13 of the electrode 12 can improve the uniformity of the delivery of high-frequency energy to the patient's tissue, and accordingly, further improve the uniformity of tissue heating and treatment.

[0029] The substrate 14 can be made of a ceramic material and can be machined to provide the above-described thickness variation. The above-mentioned ceramic materials include, for example, but are not limited to, aluminum nitride, alumina, yttria stabilized zirconia (abbreviated as YTZP or YSZ), or a combination of the above materials. In one embodiment, the above ceramic material can be alumina.

[0030] In one embodiment, the substrate 14 can be made of a ceramic material having a thermal conductivity greater than that of a conventional polymer substrate (such as polyimide) to improve the heat conduction ability relative to the conventional polymer substrate. In certain embodiments, the substrate 14 can be made of a ceramic material having a thermal conductivity greater than 20 W / mK (watts per meter-Kelvin). For example, alumina has a thermal conductivity of 30 W / mK, aluminum nitride has a thermal conductivity of 60 W / mK, and polyimide has a thermal conductivity of 0.46 W / mK.

[0031] The ability of the substrate 14 to conduct heat effectively is directly related to its thermal conductivity, which is advantageous in a treatment procedure using the applicator 10, because the applicator 10 cools the tissue to protect the superficial tissue of the skin and heats the tissue to a therapeutically effective temperature. A higher thermal conductivity can provide a better cooling profile and / or a more uniform surface temperature, in contrast to the use of conventional polyimide substrates, which typically result in concentrated hot spots. For cooling, the applicator 10 can receive coolant from a liquid transporter 270 disposed within the handpiece 250 and / or the treatment tip 260 (see Figure 1 ). A coolant supply source, such as a coolant tank, can be provided at the control station of the device 200. The liquid transporter 270 can be configured to controllably deliver the coolant to the applicator 10 in a spray or flowing manner in accordance with the treatment procedure. The coolant can be triggered to be delivered in a spray or flowing manner under the control of the system controller 210 before, during, and / or after the electrode 12 delivers high-frequency energy to the patient's tissue. Due to the temperature difference between the cooled applicator 10 and the tissue heated by the high-frequency energy in contact therewith, heat conducts through the thickness of the substrate 14 from the contacting tissue, thereby extracting heat from the contacting tissue. Some portions of the handpiece 250 and / or the treatment tip 260 can provide a heat sink to dissipate the extracted heat to the surrounding environment. Such heat dissipation can cool the contacting tissue inward from the tissue surface to balance the heating near the tissue surface and can thus create a reverse thermal gradient from the tissue surface into the tissue. The above-described cooling and energy delivery can be balanced to avoid overly disturbing the heating of the tissue depth to be treated while also cooling the tissue between the tissue depth and the tissue surface that does not need to be heated to the treatment temperature.

[0032] In certain embodiments, the substrate 14 can be composed of a ceramic material having a dielectric constant (or permittivity) greater than 8 in the frequency range from 1 MHz to 20 MHz. For example, alumina has a dielectric constant of approximately 10 in the frequency range from 1 MHz to 20 MHz, aluminum nitride has a dielectric constant of approximately 9 in the frequency range from 1 MHz to 20 MHz, while polyimide has a lower dielectric constant of approximately 4.2 in the same frequency range. In certain embodiments, the substrate 14 can be composed of a ceramic material having a dielectric loss tangent less than 1×10 -4 in the frequency range from 1 MHz to 20 MHz, while the dielectric loss of polyimide in this frequency range is less than 5×10 -3 . In certain embodiments, the ceramic material of the substrate 14 can have at least one or all of the above-described properties of thermal conductivity, dielectric constant, and dielectric loss.

[0033] The electrode 12 can be composed of a conductor, such as copper or aluminum. The electrode 12 can be disposed on the substrate 14 by lamination, vapor deposition, sputter deposition, or other known methods, and can be patterned for subsequent applications by using photolithography or etching processes to define the outer edge 13 of the electrode 12 and the connection point 24 disposed near the outer edge 13 of the electrode 12. When the treatment end 260 is coupled to the handpiece 250, the electrode 12 can be contacted by, for example, a pogo pin within the handpiece 250 or the treatment end 260.

[0034] Reference terms used herein, such as "vertical", "horizontal", and similar terms in the examples, are not intended to be limiting to establish a reference framework. It should be understood that various different reference frameworks can be used to describe the present invention without departing from the spirit and scope of the present invention. It should also be understood that the features of the present invention are not necessarily in the proportions shown in the drawings. In addition, the terms "consisting of", "comprising", "having", "and" or their variants used in the embodiments or claims herein are in an open-ended manner similar to "including".

[0035] The language modifier "approximate" in this article, such as "about", "close to", and "substantially", does not limit a specific exact value. These "approximate" languages can apply to the accuracy of the instrument for measuring numerical values. Unless otherwise based on the instrument accuracy, the numerical values modified by these "approximate" words can also be replaced by a numerical range of the numerical value + / - 10%.

[0036] Two "connected" or "coupled" technical features can be directly connected or directly coupled, or, there can also be one or more existing intermediate technical features. If there are no intermediate technical features, the two technical features can be directly connected or directly coupled. If there is at least one intermediate technical feature, the two technical features can be indirectly connected or indirectly coupled. The feature of being "on" or "in contact with" another technical feature can be directly on or in direct contact with another technical feature, or, there can also be one or more intermediate technical features. If there are no intermediate technical features, one technical feature can be directly on or in direct contact with another technical feature. If there is at least one intermediate technical feature, one technical feature can be indirectly on or in indirect contact with another technical feature.

[0037] The terms used in this specification are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. As used herein, the singular forms "a" and "an" are also intended to include the plural unless the context clearly dictates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0038] The invention is illustrated by way of example and with reference to the embodiments of the various implementations, and details of these embodiments are described in considerable detail, which are not intended by the applicant to limit or in any way limit the scope of the claims. Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the broader embodiments of the invention are not limited to the specific details, representative devices or methods, and exemplary embodiments. Accordingly, such details may be modified without departing from the spirit or scope of the applicant's overall inventive concept.

Claims

1. An energy delivery device, comprising: An applicator including an electrode and a substrate composed of a ceramic material, the substrate having a first surface, a second surface opposite the first surface, and one or more outer edges between the first surface and the second surface, the substrate having a thickness between the first surface and the second surface, the thickness varying with respect to the position of the outer edges, wherein the electrode is disposed on the second surface of the substrate to deliver high-frequency energy through the thickness of the substrate to the first surface, and wherein the substrate has a centerline and the ceramic material of the substrate has a thickness that starts from the centerline and increases non-linearly as the distance from the centerline increases. Wherein the first surface of the substrate is a solid concave shape having a radius of curvature.

2. The energy delivery device according to claim 1, wherein The second surface of the substrate is a plane.

3. The energy delivery device according to claim 1, wherein, The electrode is centered on the centerline of the substrate.

4. The energy delivery device according to claim 1, further comprising: A treatment tip having a housing, wherein the applicator is disposed within the housing.

5. The energy delivery device according to claim 4, further comprising: A handpiece, wherein the treatment tip is configured to be removably fixed to the handpiece.

6. The energy delivery device according to claim 1, wherein, The ceramic material is alumina, and the alumina has a dielectric constant of approximately 10 in the frequency range of 1 MHz to 20 MHz.

7. The energy delivery device according to claim 1, wherein, The ceramic material is aluminum nitride, and the aluminum nitride has a dielectric constant of approximately 9 in the frequency range of 1 MHz to 20 MHz.

8. The energy delivery device according to claim 1, wherein, The ceramic material has a thermal conductivity greater than that of polyimide.

9. The energy delivery device according to claim 1, wherein, The ceramic material has a thermal conductivity greater than 20 W / mK.

10. The energy delivery device according to claim 1, wherein, The ceramic material has a dielectric constant greater than 8 in the frequency range of 1 MHz to 20 MHz.

11. The energy delivery device according to claim 1, wherein, The ceramic material has a dielectric loss less than 1x10-4 in the frequency range of 1 MHz to 20 MHz.

12. The energy delivery device according to claim 1, wherein, The thickness of the substrate lacks rotational symmetry with respect to the centerline.

13. The energy delivery device according to claim 1, wherein, The electrode is offset from the centerline of the substrate.

14. The energy delivery device according to claim 1, wherein, The thickness of the substrate exhibits rotational symmetry with respect to the centerline.

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