The present disclosure relates generally to electrosurgery and electrosurgical systems and apparatuses, and more particularly, to an apparatus and method for cold plasma skin resurfacing.
Skin resurfacing is a process that utilizes the application of energy to the skin of a patient to remove wrinkles, sun damage, age spots, scars, including acne scars, stretchmarks, actinic keratosis, and telangiectasia (e.g., “spider veins”). Skin resurfacing can be broadly divided into ablative and non-ablative skin resurfacing. Ablative skin resurfacing affects the skin to a greater depth, has a prolonged recovery period, but has long lasting effects. Non-ablative skin resurfacing is somewhat more superficial, has a shorter recovery period, but may require periodic retreatment.
Skin resurfacing has become a popular option for patients seeking to treat skin issues. However, using current techniques, patient may be required to endure long recovery times and/or inconsistent results in receiving skin resurfacing treatment. Therefore, a need exists for skin resurfacing techniques that reduce recovery times and provide for more consistent results.
The present disclosure is directed to a system, apparatus and method for cold plasma skin resurfacing. In one aspect of the present disclosure, a mask for use in fractionated skin resurfacing is provided. The mask includes a plurality of apertures distributed across a surface of the mask. The mask may be made of a flexible material including an adhesive surface, such that, the mask may be applied to a contoured surface of a patient's skin while remaining fixed in place. The material is resistant to the effects of a cold plasma beam. In this way, a cold plasma beam applicator may be used to scan a cold plasma beam over a surface of the mask, such that, only the portions of a patient's skin exposed by the apertures of the mask are treated by the cold plasma beam.
In another aspect of the present disclosure, a method for fractionated skin resurfacing is provided including: providing a mask for skin resurfacing, wherein the mask is made of a non-conductive material; applying the mask to an area of skin of a patient to be treated, the mask including a surface and a plurality of apertures disposed through the surface; and applying a cold plasma beam to the surface of the mask such that the cold plasma beam contacts portions of the area of skin exposed by the plurality of apertures.
In another aspect of the present disclosure, a system for fractionated skin resurfacing is provided including: a mask including a plurality of apertures disposed through a surface, wherein the mask is made of a non-conductive material and configured to be applied to an area of skin of a patient to be treated; and a cold plasma applicator configured to apply a cold plasma beam to the surface of the mask, wherein the cold plasma beam contacts portions of the area of skin exposed by the plurality of apertures.
In another aspect of the present disclosure, a mask for fractionated skin resurfacing is provided including: a surface including a plurality of apertures disposed through the surface, wherein the mask is made of a non-conductive material and configured to be applied to an area of skin of a patient to be treated, such that when a cold plasma beam is applied to the surface of the mask, the cold plasma beam contacts portions of the area of skin exposed by the plurality of apertures.
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
It should be understood that the drawings are for purposes of illustrating the concepts of the disclosure and are not necessarily the only possible configuration for illustrating the disclosure.
Preferred embodiments of the present disclosure will be described hereinbelow with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. In the drawings and in the description which follow, the term “proximal”, as is traditional, will refer to the end of the device, e.g., instrument, apparatus, applicator, handpiece, forceps, etc., which is closer to the user, while the term “distal” will refer to the end which is further from the user. Herein, the phrase “coupled” is defined to mean directly connected to or indirectly connected with through one or more intermediate components. Such intermediate components may include both hardware and software based components.
The present disclosure is directed to an apparatus and method for skin resurfacing. In one embodiment of the present disclosure, a mask for use in fractionated skin resurfacing is provided. The mask includes a plurality of apertures distributed across a surface of the mask. The mask may be made of a flexible material including an adhesive surface, such that, the mask may be applied to a contoured surface of a patient's skin while remaining fixed in place. In one embodiment, the material is resistant to the effects of a cold plasma beam. In this way, a cold plasma beam applicator may be used to scan a cold plasma beam over a surface of the mask, such that, only the portions of a patient's skin exposed by the apertures of the mask are treated by the cold plasma beam.
Fractionated skin resurfacing can be considered as a hybrid of ablative and non-ablative skin resurfacing. Fractionated skin resurfacing employs small localized regions of ablative skin resurfacing treatment with areas of untreated skin between these regions. This combination provides an overall effect similar to ablative skin resurfacing, but with much shorter recovery times, and comparable durability.
In ablative skin resurfacing, using a laser, for example, sufficient energy density is applied to the skin to cause a peeling of the surface layers. In laser fractional skin resurfacing, the laser is applied to an array of small regions of the skin in comparable energy density to the continuous ablative approach. The laser beam can be focused to a relatively small spot size and rapidly repositioned while being modulated on and off to produce the array pattern of treated areas. The laser beam, while being modulated, can scan in a raster pattern, a random “flying spot” approach, or other scan patterns to treat a given region. The laser applicator is then moved to a new region, and the process is repeated. An illuminated optical guide projection may be used in conjunction with the laser scanner to align treated and untreated regions.
In one embodiment of the present disclosure, a cold plasma applicator may be used for skin resurfacing. The cold plasma applicator may be used for ablative, non-ablative, and/or fractionated skin resurfacing procedures.
Cold plasma applicators can broadly be classified as a local discharge, or non-attached discharge type and direct discharge, or attached discharge type. In the local, or non-attached discharge cold plasma applicators, the plasma discharge is confined to the applicator, and may employ a ground ring or similar structure at the applicator exit nozzle. The cold plasma beam primarily consists of afterglow plasma effects, heated carrier gas, and long-lived radical species produced by the interaction of the plasma beam and the surrounding air. It should be noted that the term “cold” in cold plasma refers to the degree of ionization of the carrier gas, and the overall temperature of the carrier gas may well be in excess of 100 degrees centigrade. In contrast to thermal plasma, during the generation of cold plasma, only a small fraction of the atoms of the carrier gas are ionized. Examples of carrier gases include inert gases, such as, helium or argon, or nitrogen which, at typical application temperatures, are still chemically inert.
In a direct, or attached discharge cold plasma applicator, a continuous discharge path exists from the applicator to the target surface, e.g., a patient's skin. The target surface, which must necessarily be reasonably electrically conductive, acts as a second electrode comparable to the nozzle ring electrode of the local discharge applicator. The direct discharge cold plasma applicator deposits energy onto the target surface through both heated carrier gas and through direct (attached) contact electrical discharge of the plasma beam with the target surface. Both long-lived and short-lived radical species are present at the application surface.
Cold plasma applicators, particularly of the direct discharge type, can produce a fractionation effect by either modulating the plasma beam, both spatially and temporally, or by using a mask. Referring to
Although spatial and temporal modulation of plasma beam 104 may be used in skin resurfacing procedures as shown in
An alternate approach to achieve cold plasma fractionation is to use a fractionation mask. Referring to
As seen in
The mask 202 may be constructed of a non-conductive material that is resistant to the cold plasma beam 104 and also has sufficient dielectric strength such that the beam voltage will not cause the material to electrically break down in regions between the apertures 204. Generally, any plastic material may be used such as the typical plastics used in medical applications such as, but not limited to, polyethylene, polypropylene, polystyrene, polyester, polycarbonate, PVC, polysulfone, polyether ether ketone (PEEK), etc. In this way, when beam 104 is applied by applicator 102 over mask 202, beam 104 is only allowed to pass through apertures 204 to the skin of the patient.
It is to be appreciated that the diameter 206 and spacing 210 of the apertures 204 and mask thickness 208 may be optimized to achieve a desired effect for a given cold plasma power setting, carrier gas flow rate, and applicator scan speed. In some embodiments, the diameter 206, spacing 210 of apertures 204 and mask thickness 208 are selected based on the beam diameter of the plasma beam 104 that will be applied to the mask 202.
For example, in one embodiment, for a skin resurfacing procedure, the aperture diameter 206 is at least equal to, or greater than the beam diameter of beam 104 which, depending on the power setting, may be between 1 and 2 mm. The spacing 210 between apertures 204 is generally at least 1 beam diameter. The mask thickness 208 is limited by a cooling gas flow shadowing effect from the aperture walls. The plasma beam 104 itself consists of an inner core of plasma discharge, surrounded by sheath of un-ionized cooling gas flow. If the mask 202 is too thick, the associated cooling effect of the un-ionized beam sheath gas flow is reduced through interaction with the aperture walls of the mask 202. This results in excessive heating in this region and may produce undesirable tissue effects in proximity to the walls. To prevent this, in one embodiment, the mask thickness 208 is at least one half the beam diameter, and preferably, one tenth the beam diameter. The lower limit on mask thickness 208 is dictated by mask material considerations, such as mechanical strength and ability to withstand the effects of the plasma beam 104. The upper limit of aperture diameter 206 and spacing 210 is largely determined by a tradeoff of enhanced recovery time versus achieving the desired physiological effect. As a practical consideration, if the aperture 204 is substantially larger than ten beam diameters, the local tissue effect is the same as if no mask were used. Similarly, if the spacing 210 between apertures 204 is substantially greater than ten beam diameters, the overall physiological effect is reduced and may not achieve the desired resurfacing outcome.
Additionally, there are different considerations related to skin thickness which varies per region to be treated. Skin thickness differences may result in differences in optimizing the treated vs. non-treated tissue mentioned above.
In practice, the bottom surface 205 of mask 202 is applied to the region of skin to be treated, and the cold plasma applicator 102 is scanned across the top surface 203 of the mask 202. The cold plasma beam 104 enters a given aperture 204 as the applicator 102 passes over the given aperture 204 and the beam 104 contacts the skin at this location. The remainder of the mask 202 (e.g., the portions not including apertures 204) deflects the cold plasma beam 104, producing untreated areas between the apertures 204. The mask 202 is then removed, revealing a cold plasma fractionated skin resurfacing, i.e., small localized regions affected by the cold plasma beam with areas of untreated skin between and surrounding these regions. In this manner, healing may occur in the affected localized regions, not only by the underlying tissue, but assisted by the surrounding untreated areas resulting in shorter recovery times.
It is to be appreciated that depending on the material chosen, the mask 202 may be configured to be scanned as many times as necessary to get the desired effect without effecting the integrity of the mask 202. The rate of scanning the cold plasma beam 104 over the mask 202 is not controlled. This is one of the benefits of the mask (i.e. controlling scanning is not as critical). The skin is only treated through the apertures 204 and does not rely on the hand of an operator. In this way, the mask 202 provides a larger factor of safety.
In one embodiment, mask 202 may be configured as a plurality of strips of any desired shape (e.g., rectangular, circular, etc.) to be applied to one or more areas of a patient's skin.
It is to be appreciated that the mask 202 may be configured to be used on any skin surface of a patient. For example, the length 207 and width 209 of the mask may be chosen to accommodate larger or smaller surfaces areas of skin.
In another embodiment, the mask 202 is made of a material that retains cold temperatures (i.e., temperatures below the ambient temperature or temperature of the surrounding environment) for extended periods of time such as, but not limited to, hydroxyethyl cellulose, sodium polyacrylate, or vinyl-coated silica gel such as those used in gel packs for treating sports injuries, etc. Mask 202 may be refrigerated prior to application to the tissue of the patient to lower the temperature of mask 202 and keep the epidermal tissues of the patient cool during the treatment.
For example, the temperature of mask 202 may be lowered (e.g., via refrigeration or other means) so the surface 205 of the mask 202 contacting the patient's skin is below a predetermined temperature setpoint, e.g., 45 degrees Fahrenheit. Other temperature setpoints are contemplated to be within the scope of the present disclosure. In one embodiment, the mask 202 is chilled to a temperature at least lower than a surface temperature of the skin or tissue surface the mask 202 is to be applied to. The surface temperature of the skin the mask 202 is to be applied to may be determined by measuring the surface temperature of the skin with a temperature sensor before performing the skin resurfacing procedure. Alternatively, the surface temperature of the skin may be determined or estimated based on a normal average surface skin temperature (where the average is determined in normal ambient temperature settings) determined empirically. In one embodiment, the normal average surface skin temperature is between 90 and 97 degrees Fahrenheit and the mask 202 is chilled to at least below 90 degrees Fahrenheit.
In one embodiment, the mask 202 may consist of multiple layers, each having different heat transfer properties to keep the epidermal tissue of the patient cool during treatment. For example, referring to
Additionally, the mask 202 could be shaped and modified to accommodate different parts of a patient's body. For example, referring to
Although the mask is shown in
Referring again to
Referring to
It is to be appreciated that the scanning of the plasma beam over the mask may be repeated, e.g., at least two passes. In one embodiment, one pass of the plasma beam is applied, as in step 306, followed by removal of the desiccated tissue by applying saline to the treated skin, in step 308. In one embodiment, the applying the saline to the treated skin of step 308 further includes wiping the treated skin with a saline soaked gauze pad. Then, a second pass is applied, in step 310. In certain embodiments, a predetermined cooling period may be implemented between the initial application of step 306 and subsequent applications as in step 310. In other embodiments, there is enough of a delay between passes, because the second pass may be started at the same point on the mask 202 as the starting point of the first pass. Therefore, by the time the first pass has ended and the second pass is about to begin, the tissue treated at the beginning of the first pass has had time to cool.
It is further to be appreciated that the present disclosure contemplates procedures where one, two or more passes are implemented. After each pass of the cold plasma beam, the treated area is to be wiped with a saline soaked gauze pad to remove the desiccated tissue prior to the next pass. In one embodiment, the holes or apertures 204 of the mask 202 are sufficiently sized to enable the saline to reach the treated skin or tissue. In other embodiments, the mask 202 may be removed before wiping the treated skin. In this embodiment, the mask 202 needs to be realigned on the tissue before the second pass so the same specific points on the treated skin are accessed. In one embodiment, the mask 202 may include at least two additional apertures employed to align the mask. Before the first pass of cold plasma, a user may mark the skin to be treated, e.g., with a marker, through the at least two additional apertures. When applying the cold plasma beam on the first pass, the user may avoid these additional apertures. After removing the mask 202 to wipe the treated skin, the mask 202 may be aligned by aligning the additional apertures with the marked portion of the treated skin.
In one embodiment of the present disclosure, mask 202 may be configured as a hand-held card as an alternative method to including an adhesive backing. In this embodiment, an edge or corner of mask 202 may be configured to be held by a user during a procedure, such that mask 202 can be placed on (i.e., in contact with), or proximately to (i.e., just above), an area of skin to be treated as desired by the user. In this way, a user may move the hand-held card-type mask to any part of the patient's body as desired to perform skin resurfacing using cold plasma and mask 202 in the manner described above. In one embodiment, the hand-held card-type mask includes a handle extending from an edge or corner of mask 202 and configured to be gripped by a user, such that the user's hand may be further away from the mask 202 and the treatment area while mask 202 is in use. In some embodiments, the handle may extend at an acute angle relative to surface 203 of mask 202 to aid placement of mask 202 on a surface to be treated.
In some embodiments, the hand-held card-type mask 202 may be configured in predefined shapes to support various procedures relating to different portions of a patient's body. For example, the hand-held card-type mask 202 may be configured in the shape of a patient's eye to be placed over or on a patient' eye to perform skin resurfacing on a patient's eye lid. It is to be appreciated that the hand-held card-type mask 202 may be configured in other shapes as well, such as, but not limited to, shapes resembling a patient's chin, cheek, neck, etc. In some embodiments, predetermined portions of the hand-held card-type mask 202 may be configured without apertures to protect sensitive regions of a user's body (e.g., lips, eyes, nose, etc.) when skin area proximate to the sensitive regions are treated.
In another embodiment, the card-type mask may be configured to facilitate treatment around one or more body structures (e.g., the eyes or nose) of a patient. For example, referring to
Mask 402 includes a handle portion 408 configured to be gripped by a user, and a portion 406 shaped for performing the skin resurfacing procedure described above for the area surrounding a patient's nose 430. Portion 406 includes first and second extension members 410, 412, which each include a plurality of apertures 404. Extension members 410, 412 extend from hand portion 408 at an angle relative to each other. In this way, as shown in
Mask 450 includes a handle portion 458 configured to be gripped by a user, and a portion 456 shaped for performing the skin resurfacing procedure described above for the upper and lower eye lids 444, 442 surrounding a patient's eye 440. In one embodiment, portion 456 is curved to match the curved outline of a patient's eye. Portion 456 includes a plurality of apertures 454. In use, mask 450 is placed proximately to a patient's eye 440 such that portion 456 is disposed over the upper eye lid 444 or lower eye lid 442 of a patient. In this way, upper eye lid 444 or lower eye lid 442 may be treated by applying a cold plasma beam, using one or more passes, over portion 454. In one embodiment, handle portion 458 may include a bend 459, such that handle portion 458 extends away from portion 456 at an angle. Bend 459 is configured to enable mask 450 to be used without handle portion 458 being obstructed by irregular protrusions of the patient's face (e.g., the patient's nose 430).
It is to be appreciated that although masks 402, 450 are shaped for treating the areas around the nose 430 and eyes 440 of a patient, in accordance with the teaching of the present disclosure, other hand-held card-type masks may be used, which are shaped for treating the areas around other body structures of the patient (e.g., around the lips or ears of a patient).
In one embodiment, a hand-held card-type mask may be configured with multiple shapes to treat the areas around multiple body structures. For example, referring to
In another embodiment of the present disclosure, mask 202 may be configured without apertures 204. In this embodiment, after masks 202 is applied to a user's skin, a microneedling apparatus, such as a microneedle roller, may be used to puncture holes or apertures through the mask 202 and/or the user's skin.
For example, referring to
Referring to
It is to be appreciated that the number, density, spacing and diameter of the apertures 552 created by roller 500 being applied over mask 550 and tissue 560 may be configured using roller 500. For example, for an increased number and density of apertures 552, roller 500 may be applied over mask 550 and tissue 560 multiple times and rolled from different angles to create more apertures 552. In another embodiment, roller 500 may include multiple different roller units 510, each with pins of different diameter and spacing based on a desired density, spacing, and diameter to be included in apertures 552. The different roller units 510 may be replaceably mounted to handle 504 and applied to mask 550 and tissue 560 to achieve the desired density, spacing, and diameter for apertures 552 as desired.
In another embodiment of the present disclosure, a mask in accordance with the present disclosure may be created using a fluid that is applied to a patient skin or tissue 560. In one embodiment, the fluid may be applied to the patient's skin or tissue 560, using a pressurized spray can or other fluid applying apparatus (e.g., a spray gun). In another embodiment, the fluid may be configured as a cream and applied to the patient's skin or tissue 560. In either case, the fluid is configured to solidify or harden into a solid mask after being applied to the patient's skin or tissue 560. After the fluid solidifies into a mask, the mask and skin or tissue 560 may be punctured by a microneedling apparatus, such as, microneedle roller 500 to create apertures in mask and tissue. For example, referring to
It is to be appreciated that, as used herein, the word “mask” refers to any material that can be applied directly on, or in close proximity to, a skin or tissue surface to be treated during a skin resurfacing procedure performed in accordance with the principles of the present disclosure. The mask may be made from any of the materials disclosed herein or other suitable materials configured to support the skin resurfacing procedures (including the application of cold plasma to the mask) of the present disclosure.
It is to be appreciated that applicator 102 may be any type of cold plasma beam applicator. For example,
The plasma generator 14 comprises a handpiece or holder 26 having an electrode 28 at least partially disposed within a fluid flow housing 29 and coupled to the transformer 24 to receive the high frequency electrical energy therefrom to at least partially ionize noble gas fed to the fluid flow housing 29 of the handpiece or holder 26 to generate or create the plasma beam 16. The high frequency electrical energy is fed from the secondary of the transformer 24 through an active conductor 30 to the electrode 28 (collectively active electrode) in the handpiece 26 to create the plasma beam 16 for application to the surgical site 18 on the patient 20. Furthermore, in some embodiments, a current limiting capacitor 25 is provided in series with the electrode 28 to limit the amount of current being delivered to the patient 20.
The return path to the electrosurgical generator 12 is through the tissue and body fluid of the patient 20, the conductor plate or support member 22 and a return conductor 32 (collectively return electrode) to the secondary of the transformer 24 to complete the isolated, floating potential circuit.
In another embodiment, the electrosurgical generator 12 comprises an isolated non-floating potential not referenced to any potential. The plasma current flow back to the electrosurgical generator 12 is through the tissue and body fluid and the patient 20. From there, the return current circuit is completed through the combined external capacitance to the plasma generator handpiece 26, surgeon and through displacement current. The capacitance is determined, among other things, by the physical size of the patient 20. Such an electrosurgical apparatus and generator are described in commonly owned U.S. Pat. No. 7,316,682 to Konesky, the contents of which are hereby incorporated by reference in its entirety.
It is to be appreciated that, in some embodiments, the transformer 24 may be disposed in the plasma generator handpiece 26. In this configuration, other transformers may be provided in the generator 12 for providing a proper voltage and current to the transformer in the handpiece 26, e.g., a step-down transformer, a step-up transformer or any combination thereof.
It is to be appreciated that in some embodiments, applicator 102 may be a cold plasma applicator with a retractable blade. Such an electrosurgical apparatus is described in commonly owned U.S. Pat. No. 9,060,765, the contents of which are hereby incorporated by reference in its entirety.
It is to be appreciated that the various features shown and described are interchangeable, that is a feature shown in one embodiment may be incorporated into another embodiment.
While the disclosure has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims.
Furthermore, although the foregoing text sets forth a detailed description of numerous embodiments, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment, as describing every possible embodiment would be impractical, if not impossible. One could implement numerous alternate embodiments, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims.
It should also be understood that, unless a term is expressly defined in this patent using the sentence “As used herein, the term ‘______’ is hereby defined to mean . . . ” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.
This application claims priority to U.S. Provisional Patent Application No. 62/451,337, filed Jan. 27, 2017, entitled “APPARATUS AND METHOD FOR COLD PLASMA SKIN RESURFACING”, the contents of which are hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US18/15418 | 1/26/2018 | WO | 00 |
Number | Date | Country | |
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62451337 | Jan 2017 | US |