Patent Application
20230285071
This application relates to radio frequency (RF) microneedle systems for fractional injury, and more particularly to RF microneedle systems with enhanced cooling.
Various skin rejuvenation therapies have been developed such as to promote the growth of new collagen or to remove scarring and discoloration. For example, a chemical solution may be applied to the skin. In an alternative approach, a laser ablates the entirety of skin surface being treated. For example, a scan or uneven pigmentation may be ablated in this fashion. Since the chemical solution or laser is ablating the entire upper surface of the skin (the epidermis) being treated, these ablative treatments may be classified as a dermal peel. The injury to the upper skin layers triggers the underlying dermis to develop more collagen and thus cause beneficial tightening to address wrinkles and sagging such as caused by aging. But the cosmetic benefits of a dermal peel are also associated with risks of infection, increased healing time, and scarring.
To provide the benefits of a peel but with reduced risks, fractional dermal ablation was developed. As implied by the “fractional” designation, a fractional dermal ablation does not ablate the entire epidermis of a treatment area. For example, a laser is pulsed while scanning to form ablated columns of skin that are separated by healthy tissue. The presence of healthy, undamaged skin about each ablated column speeds healing and reduces the risk of infection. But the resulting damage to the dermis in each column of ablated tissue stimulates the growth and reorganization of collagen, which provides a beneficial rejuvenation of the skin.
Although fractional dermal treatment may rejuvenate the skin, the use of a laser may still cause unwanted side effects such as hyper or hypo pigmentation. To achieve fractional dermal ablation without these laser-induced risks, RF microneedle systems have been developed. In an RF microneedle system, a handpiece includes an array of microneedles that are may be actuated to pierce the skin and extend into the dermis at a desired and controlled depth. With the microneedles extended into the targeted tissue, an RF source in the system excites the microneedles with RF energy to cause an RF current to conduct from the microneedles. The targeted tissue has an Ohmic resistance to this current that causes electrothermal damage to achieve the desired fractional ablation or injury.
When initially developed, the microneedles were uninsulated and thus ablated from the skin surface all the way to the microneedle tips. To keep the skin surface (the epidermis) from excessive heat injury thus required aggressive cooling approaches such as a cooled metal template or housing through which the microneedles extended. To address this undesired heat injury to the epidermis, RF microneedle systems were developed in which the microneedles had insulated shafts such that the RF energy was delivered at a conductive tip of each microneedle. Since the fractional electrothermal damage is then concentrated around the microneedle tips as inserted into the dermis, the need for aggressive cooling of the skin surface was reduced.
Although insulated microneedle arrays no longer heat the epidermis, the RF excitation of the microneedles heats the microneedles. But existing cooling techniques such as a cooled metal housing do not address the microneedle heating. There is thus a need in the art for RF microneedle systems with improved cooling.
In accordance with a first aspect of the disclosure, an RF microneedle system is provided that includes: a handpiece including a microneedle housing at a distal end of the handpiece, the microneedle housing including an interior containing an array of microneedles; and a nozzle configured to at least partially surround a circumference of the microneedle housing, wherein a distal portion of the microneedle housing distally extends from the nozzle and includes at least one slot configured to open to the interior containing the array of microneedles and wherein the nozzle includes a lumen extending from a proximal end of the nozzle to an at least one opening at a distal end of the nozzle.
In accordance with a second aspect of the disclosure, a method of cooling an RF microneedle system is provided that includes: driving a cooled gas into a distal end of cooling duct; and driving the cooled gas from the distal cooling duct into a lumen of a nozzle to cause the cooled gas to exit a distal end of the nozzle that circumferentially surrounds a microneedle housing.
In accordance with a second aspect of the disclosure, an RF microneedle system is provided that includes: a microneedle housing including a distal portion and a proximal portion; and a nozzle configured to surround a circumference of the proximal portion of microneedle housing, wherein the distal portion of the microneedle housing extends from a distal end of the nozzle, and wherein the nozzle includes a circumferential opening at the distal end of the nozzle.
These and other advantageous features may be better appreciated through the following detailed description.
Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures.
An RF microneedle system is disclosed in which a cooling duct attaches to a microneedle handpiece. The handpiece includes a microneedle housing including an array of microneedles. A cooled gas supply (e.g., a cooled air supply) supplies cooled gas through the cooling duct to a nozzle that at least partially wraps a base portion of the microneedle housing. A distal portion of the microneedle housing extends from the base portion to a template that includes a perforation or hole for each microneedle in the array. In a default (non-actuated) state, the array of microneedles is contained within the housing. Conversely, each microneedle extends distally from its corresponding hole in the template in an actuated state.
The distal portion of the housing includes at least one slot or perforation that may extend from a proximal end of the distal portion to the template. The slot thus runs in a longitudinal direction with respect to the microneedle handpiece. The slot communicates with an interior of the housing that holds the array of microneedles in the non-actuated position. The cooled gas (e.g., cooled air) from the nozzle is thus at least partially directed through the at least one slot into the housing interior to chill the microneedles. This is quite advantageous as compared to traditional methods such as cooling the template. Although the microneedles pass through their respective holes in the template when actuated, there is no direct contact between the template and the microneedles. The traditional cooling of the template thus does not directly cool the microneedles. This is problematic in that the microneedles are heated from the RF excitation during treatment. In contrast, the cooling duct nozzle disclosed herein not only directs cooled gas longitudinally from the distal portion of the microneedle housing to cool the epidermis but also into the microneedle housing to cool the microneedles. In this fashion, the skin may be cooled to reduce discomfort during the RF microneedle treatment simultaneously with cooling the array of microneedles.
An example RF microneedle system 100 with this enhanced cooling is shown in longitudinal cross-sectional view in
Given this radial component of the cooled air as it exits nozzle 130, some cooled air will be directed through slots 145 into the interior 160 to cool microneedles 165. Handpiece 105 includes an actuator (not illustrated) that actuates the microneedles from a retracted or non-actuated position in which the microneedles are contained within the interior 160 of microneedle housing 110 to an extended or actuated position in which the microneedles 165 extend from a distally facing template 170 at a distal end of distal portion 135 so that microneedles 164 may penetrate the skin. Template 170 includes an array of perforations or holes 175 such that each microneedle 165 may extend through a corresponding hole 175 in template 170 when the microneedles 165 are actuated. Note that the term “microneedle” is used herein without limitation to the actual needle diameter. In general, a “microneedle” refers to a needle that is relatively thin so as to more easily pierce the skin in the actuated position. But the length and thickness of a microneedle may be varied depending upon the application.
In addition to the cooling of the microneedles 165, note that opening 180 surrounds a circumference of the distal portion 135 of microneedle housing 110. There is thus a 360 degree of cooling provided to the skin of a patient that faces template 170 from the longitudinal component of the cooled air exiting opening 180. The resulting 360 degrees of cooling advantageously enhances patient comfort. Cooling duct 115 may attach to handpiece 105 through a clip portion 150 that clips about handpiece 105. Nozzle 130 may magnetically couple to a distal end 155 of cooling duct 105 as discussed further herein.
Microneedles 165 may be insulated in some implementations. The energy of an RF source (not illustrated) for exciting the microneedles 165 determines the type of fractional injury. For example, if the tissue being fractionally injured by the RF excitation is heated to 100° C. or greater, the resulting fractional injury is typically denoted as being ablative. If the tissue being fractionally injured by the RF excitation is not heated to 100° C. or greater, the resulting fractional injury is commonly denoted as being non-ablative. There are various forms of non-ablative fractional injury. For example, if the tissue being fractionally injured is heated to greater than 70° C. but less than 100° C., the fractional injury is commonly denoted as a fractional coagulation or tissue necrosis. Should the RF excitation instead heat the tissue being fractionally injured to less than 70° C. but above 40° C., the fractional injury is often denoted as non-immediately destructive tissue heating.
Rather than surround the entire circumference of distal portion 135, an alternative nozzle 230 for a microneedle RF system 200 may instead surround a portion of the circumference of distal portion 135 as shown in
Referring again to nozzle 130, note that opening 180 is continuous with respect to surrounding the entire circumference of distal portion 135. In contrast, openings 205 in nozzle 230 are discrete and spaced apart across the approximately 270 degrees of the partial circumference of distal portion 135. It will be appreciated that nozzle 130 may instead have such discrete openings for the cooled gas to exit. Similarly, nozzle 230 may instead have a continuous opening for its cooled gas to exit.
Nozzle 230 is shown in isolation in
An example method of cooling of an RF microneedle system will now be discussed with respect to the flowchart of
Those of some skill in this art will by now appreciate and depending on the particular application at hand, many modifications, substitutions and variations can be made in and to the materials, apparatus, configurations and methods of use of the devices of the present disclosure without departing from the scope thereof. In light of this, the scope of the present disclosure should not be limited to that of the particular embodiments illustrated and described herein, as they are merely by way of some examples thereof, but rather, should be fully commensurate with that of the claims appended hereafter and their functional equivalents.
